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Objective: To investigate the effect of Puji Zhichuang suppository combined with Huazhuo Jiedu formula retention enema in the treatment of anal sinusitis and its influence on pain mediators, immune function and recurrence rate. Methods: 100 patients with anal sinusitis who were diagnosed in our hospital from January 2020 to July 2021 were selected. According to the random number table method, they were divided into control group (treated with Puji Zhichuang suppository, 50 cases) and experimental group (Puji Zhichuang suppository combined with Huazhuo Jiedu formula retention enema treatment, 50 cases). Changes in efficacy, traditional Chinese medical syndrome score, pain mediators, immune function and recurrence rate in the two groups were compared. Results: The total effective rate in the experimental group was higher than that in the control group (P<0.05). After 2 courses of treatment, the scores of fallen anus and dull pain, anal incomplete defecation, and anal dampness in the experimental group were lower than those of the control group (P<0.05). CD8+ in the experimental group after 2 courses of treatment was lower than that in the control group. CD3+, CD4+, CD4+ /CD8+ in the experimental group were higher than those of the control group (P<0.05). After 2 courses of treatment, prostaglandin E2 (PGE2), Substance P (SP), dopamine (DA) and 5-hydroxytryptamine (5-HT) in the experimental group were lower than those of the control group (P<0.05). The recurrence rate in the experimental group at 4 months and 6 months after treatment were lower than those in the control group (P<0.05). Conclusion: Puji Zhichuang suppository combined with Huazhuo Jiedu formula retention enema in the treatment of anal sinusitis can promote the improvement of clinical symptoms, and reduce the recurrence rate, which may be related to reducing the pain mediators level and regulating the immune function of the body. [ABSTRACT FROM AUTHOR]

Objective To systematic evaluation the effectiveness and safety of ProstantTM and placebo in the control treatment of chronic prostatitis（CP）. Methods Computer retrieved of PubMed，Wanfang，CNKI，and VIP and China′s dissertation full text database，retrieval time was January 2000 to May 2017. Based on manual retrieval，two researchers independently screened the literature，extracted the data and evaluated the quality of the literature according to the inclusion and exclusion criteria. The effect indexes were meta-analyzed with RevMan5.0 software. Results A total of 1 090 cases were studied in 7 literatures. Compared with the placebo（control group），the results showed that there was a statistically significant difference of the national institutes of health chronic prostate inflammation index after treatment in the ProstantTM（experimental group）（P= 0.02，MD=-1.34，95%CI -2.48--0.20）；the total efficiency after treatment between two groups was compared，the difference was statistically significant（P<0.001，ORmerge=3.11，95%CI 2.34-4.12）；main adverse reactions（anal discomfort and defecation， abdominal pain and diarrhea，anal bleeding，abdominal distension and anal discomfort and diarrhea）rate of two groups were compared，the differences were not statistically significant（P>0.05）. Conclusion ProstantTM is safe and effective in the treatment of CP，greatly improve the clinical symptoms，is worth wide use in the clinical. [ABSTRACT FROM AUTHOR]

Objective: Using clotrimazole vaginal tablet as a positive control, to evaluate the results of clotrimazole vaginal expansion suppository in the treatment of mild and moderate vulvovaginal candidiasis in terms of efficacy, patient satisfaction, side effects, and recurrence rate. Methods: This study was jointly conducted by 5 hospitals from August 2017 to October 2018, patients with mild and moderate vulvovaginal candidiasis confirmed by fungal culture and symptoms scores were selected. They were randomized to experimental group and control group as 1∶1 ratio. In the experimental group ( n =105), the subjects applied clotrimazole vaginal expansion suppository (150 mg) daily at night for 7 days. In the control group ( n =106), the subjects used a single dose of clotrimazole vaginal tablet (500 mg). Follow-ups were performed at (8±3) and (30±5) days after the discontinuation of the drugs, respectively. The difference in clinical symptoms and signs scores was used to evaluate the improvement of clinical symptoms, and the patient's satisfaction and side effects were recorded. Results: At the first follow-up, the experimental group and control group were followed up by fungal culture on the cure rate [66.7% (70/105) versus 63.2% (67/106), P >0.05] and total effective rate [98.1% (103/105) versus 99.1% (105/106), P >0.05], the differences were not statistically significant. At the second follow-up, the recurrence rates of the experimental group and the control group were 5.7% (4/70) and 14.9% (10/67), respectively, with no significant difference ( P >0.05). In the evaluation of patient satisfaction, the leakage of the drug in the experimental group was significantly better than that in the control group ( P <0.01). The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups ( χ 2 = 1.070, P =0.586). Conclusions: In the treatment of mild and moderate vulvovaginal candidiasis, clotrimazole vaginal expansion suppository is no less effective than clotrimazole vaginal tablet, and there is no significant difference in the recurrence rate between the two. In terms of patient satisfaction, clotrimazole vaginal expansion suppository is superior to clotrimazole vaginal tablet.

To evaluate the efficacy and safety of Kangfu Xiaoyan Suppository in the treatment of pelvic inflammatory disease. Four Chinese databases,namely CNKI,VIP,WanFang and SinoMed,and three English databases Cochrane Library,namely Medline,and ClinicalTrail.gov were systematically and comprehensively retrieved from the establishment of each database to June 2018. The quality of the included studies was evaluated by using the risk assessment tools developed by the Cochrane Collaboration,and RevMan 5. 3 software was used for Meta-analysis. A total of 675 articles were retrieved,and finally 56 studies were included. The total sample size was 6 228,the test group included 3 267 cases,and the control group included 2 961 cases. The overall quality of the included studies was generally low. According to the intervention measures and outcome indicators,the included studies were divided into different subgroups for analysis. The main results of Meta-analysis showed that the recurrence rate of Kangfu Xiaoyan Suppository combined with antibiotics was lower than that of antibiotics alone. Kangfu Xiaoyan Suppository combined with antibiotics was superior to antibiotics alone in terms of abdominal pain,leucorrhea abnormality relief time,mass absorption time and pain relief time. In terms of safety,Kangfu Xiaoyan Suppository combined with antibiotics had a lower incidence of adverse reactions than antibiotics alone. Based on the results of this study,it is indicated that Kangfu Xiaoyan Suppository had a certain effect on the treatment of pelvic inflammatory disease,especially with a lower recurrence rate. The long-term effect is remarkable. No serious adverse reaction was observed. Restricted by the quality of the studies included,the above conclusion need to be further verified in high-quality,largesize,multi-center clinical researches.

Kangfu Xiaoyan Suppository is widely used in the treatment of gynecological inflammatory diseases. Long-term clinical application and a certain amount of research evidences show that Kangfu Xiaoyan Suppository can alleviate the clinical symptoms of pelvic inflammatory diseases,reduce the recurrence rate,and relieve sequelae,with a better safety and economic characteristics. As a type of nationally protected traditional Chinese medicine and type B medicine included in medical insurance,it has been selected as a Chinese patent medicine for rectal administration. It was included in the Guidelines for diagnosis and treatment of common gynecological diseases of traditional Chinese medicine published by the Chinese Academy of Traditional Chinese Medicine in 2012,the Pelvic inflammatory diseases diagnosis and treatment guidelines issued by the Infectious Diseases Collaborative Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association in 2014,and the group standard of Single use of traditional Chinese medicine/combined antibiot guidelines for clinical practice-pelvic inflammatory diseases of the Chinese Academy of Traditional Chinese Medicine in 2017. To further enhance clinicians' understanding of the drug and better guide its rational clinical use,experts from the field of gynecology of traditional Chinese and Western medicine were invited to develop and compile this expert consensus. This consensus takes full account of clinical evidences and expert clinical experience,and form recommendations for clinical problems based on evidences and consensus recommendations for clinical problems without evidence by nominal grouping method. The expert consensus is mainly formed in the consideration of six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on clinical research evidences and expert experience,this consensus provides a preliminary reference for the clinical use of the drug in a concise and clear format. However,evidence-based support is still required in a large number of high-quality studies,and this consensus will be revised in the future according to new clinical problems and the update of evidence-based evidence in practical application.

Objective: To study the disease process of vulvovaginal candidiasis (VVC) infection in rat model of VVC, and to study the immuno-repairing effect of different treatments on vaginal epithelium and the ultra-structural changes of vaginal epithelial cells. Methods: The VVC model of female rats were established. After successful modeling, the rats were treated with no treatment (model control group), nystatin and Kangfu Xiaoyan suppository. The vaginal epithelium was observed by transmission electron microscopy and immunohistochemical staining. The ultra-structural changes of epithelial cells and the expression of cytokines interferon γ (IFN-γ), interleukin (IL) 4, IL-17 and IgG in epithelial cells were observed and analyzed statistically. Results: The negative conversion rate of model control group was 0, and that of nystatin group was 6/6, and that of Kangfu Xiaoyan suppository group was 5/6; significant difference existed between nystatin, Kangfu Xiaoyan suppository group and model control group ( P< 0.05). The ultrastructures of vaginal epithelial cells were damaged obviously after VVC infection, and the ultrastructures were repaired by nystatin and Kangfu Xiaoyan suppository under transmission electron microscope. Immunohistochemical staining showed, the expressions of IFN-γ and IgG in the four cytokines which played a protective role increased after Kangfu Xiaoyan suppository treatment, significantly different from that of model control group ( P< 0.05), but there were no significant differences of the IFN-γ and IgG expression between Kangfu Xiaoyan suppository group and those of nystatin group ( P> 0.05); the expression of IL-17 was increased after nystatin treatment, but decreased after Kangfu Xiaoyan suppository treatment, and the difference between the two groups had statistical significance ( P< 0.05). Conclusions: The ultrastructure of vaginal epithelial cells after VVC infection could be damaged obviously, the local immune state is disordered, and the antifungal drug nystatin has a good therapeutic effect on VVC, it could significantly repair the damaged vaginal epithelium structure after VVC infection and strengthen the protective immune function of vaginal epithelium. Kangfu Xiaoyan suppository, one of Chinese medicine, has similar therapeutic effect with nystatin.

Objective: To evaluate the effectiveness of carboprost methylate suppository for cervical ripening before diagnostic hysteroscopy in premenopausal women. Methods: From July 2014 to July 2015, 1 614 women who were undergone diagnostic hysteroscopy in 12 hospitals were randomly assigned into study group ( n= 1 209) and control group ( n= 405) . The cases in study group were given 1 mg carboprost methylate suppository in vagina before hysteroscopy, the cases in control group were given 1 mg placebo. The extent of cervical ripening, the time of dilated cervix, pain scoring, incidence of drug side reactions after 24, 48, 72 hours, satisfaction degree of operators and patients, the time of hysteroscopy, incidence of complications between the two groups were observed and compared. Results: (1) Mean cervical widths in the study and control groups were 6.11±1.11 and 5.95±1.11, and showed a significant difference ( P= 0.034) ; the percentage of women requiring cervical dilatation in study group was lower than the percentage in control group significantly [28.3% (342/1 209) versus 34.6% (140/405) , P= 0.020]. (2) The time of dilated cervix in study group was shorter than the time in control group significantly [ (34±25) versus (52±49) s, P= 0.028] for the patients whose mean cervical widths≤4. (3) There was no significant difference in pain scores between the two groups ( P> 0.05) . (4) The incidence of side reactions 24, 48, 72 hours after operation were no significant difference between the two groups ( P> 0.05) . (5) The satisfaction degree of operators and patients, the time of hysteroscopy, incidence of complications between the two groups were no singnifcant difference between the two groups (all P> 0.05) . Conclusion: Application of carboprost methylate suppository by vagina before hysteroscopy is an effective and safe method of cervical ripening.

The main objective was to research the process of gallnut suppository preparation with its water extract as the main drug, and evaluate its irritation to rectal mucosa. gallnut extract was obtained by decocting method, and its suppository preparation was obtained by fusion method with semi-synthetic aliphatic esters and rose flower oil as the matrix. Weight difference and in vitro melting time limit of the suppository were assayed and UV-Vis was used to determine the contents of polyphenols, tannin and saccharide. The irritation to colon mucosa was evaluated after successive administration of 14 days to New Zealand white rabbits. Finally, the prescription compositions were determined: semi-synthetic aliphatic esters and rose flower oil with the ratio of 2:1 as the proper matrix, with the drug loading of 54%. The prepared suppository was brown, conical and smooth. The weight difference was (1.43±0.03) g, with an average melting time limit of (17±2) min. The Contents of Polyphenols, tannic and polysaccharide were 332.4, 245.0, 3.3 mg•g-1 respectively in each suppository. The results also showed that the continuous administration had no irritation to rectal mucosa. It can be concluded that the suppository was an acceptable administrate form, whose preparation process was easily controlled, and with no irritation to rectum mucosa., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

Objective: To observe the effect of Qingchang Suppository (QCS, a Chinese herbal preparation) on intestinal permeability in rat ulcerative colitis (UC) model induced by trinitrobenzene sulforic acid, and to explore the mechanism of QCS for healing the ulceration., Methods: Labelled by FITC-dextran 4 000 (FD-4), the permeability of colonic membrane in UC rat and effect of QCS on it were observed in vitro and in vivo., Results: In vivo study showed that the colonic FD-4 permeability of UC rat was increased significantly, being 6-fold of normal in 30 min. After treated with QCS of high/moderate dosage, it significantly attenuated to different degrees (P < 0.05). FD-4 permeability coefficient (Papp) determination in vitro showed that Papp in model rats increased to (5.001 +/- 1.316) x10(-8) cm/s in 120 min, being 2.5-fold of control; and which could be decreased by high/moderate dose QCS effectively (P < 0.05)., Conclusion: QCS could suppress the high colonic permeability in UC model rats, improve the barrier function of intestinal membrane and promote the healing of ulceration. Qingchang Suppository; ulcerative colitis; intestinal permeability in UC model rats, improve the barrier function of intestinal membrane and promote the healing of ulceration.

Objective: To investigate safety and efficacy of dinoprostone suppositories (0.8 mm) used in cervical ripening and labor induction in women with term premature rupture of the membranes., Methods: One hundred women of term monocyesis with premature rupture of the membranes, head presentation, bishop score less than 6 (test group) and 180 women with intact fetal membranes (control group) were enrolled into this multicenter, prospective clinical study. The vaginal delivery system was inserted into the posterior fornix, and the patients were recumbent for 2 hours after insertion. The interval time from using dinoprostone suppositories to uterine contraction, to labor and delivery were recorded. The following index were also recorded and compared, including the mean inserted time of dinoprostone suppositories, fetal heart beat, meconium stained amniotic fluid, hyperstimulation of uterus and the other complications, mode of delivery, stage of labor, postpartum hemorrhage, status of neonates., Results: Three cases in test group and 23 cases in control group weren't in labor within 24 hours. The rate of labor within 24 hours in test group was significant higher than that in control group (97.0% vs. 87.2%, P < 0.01). It was observed that 73 cases undergoing vaginal deliveries (75.3%, 73/97) and 24 cases undergoing cesarean section deliveries (24.7%, 24/97)in test group and 107 cases undergoing vaginal delivery (68.2%, 107/157) and 50 cases undergoing cesarean section delivery (31.8%, 50/157) in control group, when compared the rate of vaginal or cesarean section deliveries between two group, it didn't reach statistical difference (P > 0.05). It had no significant difference in the interval time from using dinoprostone suppositories to labor starting and the mean inserted time and the total labor time between two groups (P > 0.05). The incidence of uterine tachysystole was 11.3% (11/97) in test group and 19.1% (30/157) in control group (P > 0.05), which did not reach statistical difference (P > 0.05). There wasn't neonatal asphyxia in both groups., Conclusion: It was safe and efficient to use dinoprostone suppositories for cervical ripening and induction of term pregnancy with premature rupture of the membranes, however, monitoring should be intensified.

Objective: To investigate the suitable mode of induced termination of pregnancy at second and third trimester for women with scarred uterus., Methods: A retrospective study was performed in 90 cases of second and third trimester pregnant women with scarred uterus, who requested termination of pregnancy due to medical indications in Beijing Obstetrics and Gynecology Hospital from September 2002 to June 2009. The indications of termination of pregnancy were fetal anomaly, serious pregnant complication and intrauterine fetal deaths. 72 second trimester pregnant women and 18 third trimester pregnant women were included in this study. The interval time of previous operation to this pregnancy were recorded. And it was < 2 years in 20 cases and ≥ 2 years in 70 cases. The patients with normal Hepatic function began to take mifepristone and had an allergic test of Ethacridine Lactate. The method of mifepristone combined with Ethacridine Lactate were adopted when the allergic test was negative (group A, 54 cases). The method of mifepristone combined with carboprost methylate suppositories were used in the patients who had a positive reaction to the allergic test of Ethacridine Lactate, or who failed to amniotomy to inject Ethacridine Lactate because of oligohydramnios or small gestational age (group B, 36 cases). Record the detail information of every patient. (1) Age, gestational weeks, gravidity and parity. (2) The mode of previous operation (inducing the scar of uterus), previous operation time and indication. (3) The mode of induced labor in this pregnancy, the interval time from administration to uterine contraction, delivery or not and the interval time from induction to delivery. (4) Postpartum hemorrhage, the successful rate of induce labor, placental retention ratio and rupture of uterus or not., Results: (1) It had no significant difference between group A and group B in age, gravidity, parity and the interval time of previous operation to this pregnancy (P > 0.05). But there was significant difference between two groups in gestational weeks of induction (16 weeks vs. 25 weeks, P < 0.01). (2) It had no significant difference between two groups in successful rate of induction and postpartum hemorrhage (P > 0.05), but the time from induction to regular uterine contraction and delivery in group B was significant shorter than that of group A (P < 0.01). The rate of delivery with 24 hours in group B was 94%. It was significant higher than that of group A (13%, P < 0.01). (3) The rate of retained placenta in group B (31%, 11/35) was significant higher than group A (10%, 5/52), but the ratio of residual of placenta and membranes in group A was significant higher than that of group B (54% vs. 34%). It was no significant difference in total rate of postpartum complication between two groups. Further analysis was done in relationship of complication and the time of previous operation. It was no significant difference between the over 2 years group and the less 2 years group in the incidence rate of complications including placental retention, residual of placenta and membranes, rupture of uterus, placental abruption and postpartum hemorrhage. (4) There was 1 case of uterine rupture in group B and 1 case of placental abruption in group A., Conclusions: Both of methods of mifepristone combined with carboprost methylate suppositories and the mifepristone combined with Ethacridine Lactate are feasible to induced second trimester and late trimester termination of pregnancy for women with scarred uterus. But sufficient preoperation preparation and the course of induction and labor careful monitoring must be done to prevent the uterine rupture.

Objective: To investigate the clinical effect and safety of miconazole nitrate 1200 mg in treating vulvovaginal candidiasis (VVC)., Methods: An open, multicentre, non case control clinical trial was conducted in 568 patients suffering from VVC from Jul 1, 2006 to Nov 30, 2006. Routine examination, score of clinical symptoms and physical signs, mycetology test and safety evaluation were done in all patients before treatment, 7 - 14 days after treatment and 30 days after treatment., Results: Seven to fourteen days after treatment, 563 patients could be followed and 323 patients (57.3%) were cured. The overall effective rate was 90.2%. The mycologic cure rate was 91.3% (514). Thirty days after treatment, 480 patients could be followed and 411 patients (85.6%) were cured. The total effective rate was 96.0%. Mycologic cure rate was 92.3% (443/480). Adverse effect rate was 2.7% (15/563) and they were relieved without any treatment in one or two days., Conclusions: Miconazole nitrate 1200 mg is effective in the treatment of VVC, with good compliance and few adverse effects. Moreover, it can be accepted easily.

Objective: To observe the effect of hallux-trampling (HT) combined with Yaotongling suppository (YS) on the microcirculation at waist region and lower limbs in treating patients with lumbar intervertebral disc prolapse (LIDP), and to preliminarily explore its mechanism., Methods: Adopting randomized, double-blinded medicine and single-blinded manipulation controlled method, 108 patients with LIDP of cold-accumulation and blood-stasis syndrome were assigned equally to 3 groups in random. Group A was treated with HT plus YS, Group B treated with HT plus placebo suppository, and Group C treated with YS plus mock HT. After 2-week treatment, the changes in score of symptoms and signs as well as the microcirculation at various site-points of waist and lower limbs were observed before and after treatment., Results: The total scores of symptoms and signs after treatment in Group A, B and C was 7.340 +/- 4.627, 9.543 +/- 4.745 and 10.086 +/- 4.631 respectively, which was significantly lowered as compared with those before treatment respectively (P < 0.05). Significant difference of microcirculation between pre- and post-treatment was shown at all site-points in Group A and B (P < 0.05), but only shown at the site-points of lower limbs in Group C, so significant difference (P < 0.05) was shown when compared the microcirculation in Group A or B with that in Group C (P < 0.05)., Conclusion: HT combined YS in treating LIDP could markedly improve the microcirculation at waist and lower limbs to correct the nutritional disturbance of nerve root, and the improvement of microcirculation is correlated with the changes of clinical symptoms and signs.

Objective: To observe the clinical therapeutic effect of Airening Suppository (ARN) on carcinoma fever., Methods: Adopting randomized and double-blinded method, 54 patients with carcinoma fever were randomly assigned to the observation group and the control group, who were treated respectively with ARN and indomethacin suppository by anal administering, 7 days as one treatment course. The effect on body temperature on patients and side effect occurred were observed 7 days after discontinuation of the medication, and patients' serum tumor necrosis factor alpha (TNF-alpha), interleukin-1beta were determined by RIA, routine test of blood, urine and stool, liver and renal function were tested as well. Body temperature, changes of clinical symptoms, and adverse reaction were observed., Results: The effective rate of fever abating was 86.7% in the observation group and 66.7% in the control group, showing significant difference between them (chi2 = 8.06, P <0.05). After treatment, serum levels of TNF-alpha and IL-1beta in the observation group were much lower than those in the control group (t = 7.477, t = 3.492, P <0.01). Besides, patients' chief clinical symptoms and quality of life were markedly improved in the observation group (t =4.71, P <0.05, chi2 =7.38, P <0.05), all better than those in the control group (P < 0.05). No evident effect on peripheral blood figure, or harmful impact on heart, liver and kidney function was found., Conclusion: Airening Suppository has a standing and stable fever abating effect in treating cancerous fever with no obvious adverse reaction, so it is worthy of clinical use and spreading.

Objective: To explore the different effects of rectal application of Neiyi Kangfu Suppository (NYKFS) on the expressions of cytochrome C (Cyt C) and Survivin in ectopic and eutopic endometrium in endometriosis (EMT) model rats., Methods: EMT rats were randomly divided into 6 groups, the high- and low-dose NYKFS groups, the Danazol Capsule (DN) group, the Dan'e Fukang Soft Extract (DFE) group, the model group and the blank group. The expressions of Cyt C and Survivin were measured using immunohistochemical SP staining method., Results: (1) After treatment, the IOD value of Cyt C in ectopic endometrium significantly increased in the high-dose and low-dose NYKFS groups respectively to 6.08 +/- 0.35 and 6.23 +/- 0.35, which was significantly higher than that in the model group (5.07 +/- 0.70) and DFE group (5.98 +/- 1.02) respectively (P < 0.05, P < 0.01); while those of Survivin in ectopic endometrium was significantly decreased to 5.73 +/- 0.93 and 5.62 +/- 0.93 and was significantly lower than that in the model group (6.01 +/- 1.16, P < 0.05 or P < 0.01). (2) The lowered eutopic endometrial level of Cyt C in EMT rats after treatment was significantly higher in the two NYKFS groups than that in the model group (P < 0.05); while that of eutopic endometrial Survivin was insignificantly different between the NYKFS groups and the model group or the blank group (P > 0.05)., Conclusion: NYKFS plays its role in inducing apoptosis by increasing the expression of Cyt C and decreasing the expression of Survivin in ectopic endometrium, but it up-regulates expression of Cyt C, has no obvious effect on Survivin expression in eutopic endometrium.

A novel method was developed to determine the content of chlorhexidine acetate (CA) in chlorhexidine acetate suppositories by high performance liquid chromatography (HPLC) coupled with hollow fiber membrane solvent microextraction. The sample was extracted with 1.5 mol/L acetic acid solution five times, then a hollow fiber containing n-octanol was placed in the sample solution to perform microextraction for extracting 20 min. The extract was analyzed by HPLC with UV detection at 260 nm. The chromatographic conditions were as following: acetonitrile-redistilled water (29:71, v/v, containing 0.3% triethylamine, pH 3.0) as mobile phase with the flow rate of 1 mL/min. The calibration curve of CA was linear from 0.5 to 16 mg/L. The method recovery was over 98.0% with relative standard deviation less than 4.0%. By using hollow fiber membrane solvent microextraction, the enrichment of 24-fold was achieved. The method is specific, simple, fast, sensitive and suitable for the determination of chlorhexidine acetate.

Objective: To establish a method of determinating content of bilirubin in Niuhuang Compound Suppository by HPLC., Method: C18 column was used. The mobile phase was consisted of dimethylsulfoxide: acetonitrile: 0.5% acetic ammonium (1:1.4:1). Detector wavelength was 456 nm. The extraction solution for bilirubin was consisted of dlimethylsulfoxide: acetonitrile = 9:4., Results: The linearity was obtained over the range of 0.107 - 2.14 microg. The mean recovery was 101.0%, RSD = 0.518% (n = 5)., Conclusion: The method was sensitive, simple and accurate.

Objective: To evaluate the efficacy and safety of S (+) - ismer of ibuprofen supporsitory., Methods: One hundred and three cases of postopterative pain and 60 cases of fever, altogether 163 patients were randomly divided into 2 groups: S (+) -ismer of ibuprofen supporsitory treatment group (one supporsitory per day for 3 days) and ibuprofen supporsitory treatment group (one supporsitory per day for 3 days). The therapeutic effect was assessed and the side-effects were observed between the 2 groups., Results: After being given medicine in the first 4 hours, pain intensity difference, pain remission degree and the dropped level of fever in S (+) -ismer of ibuprofen were all bigger than those of the ibuprofen supporsitory treatment group. There was no difference in side-effects between the 2 groups., Conclusion: Therapeutic effect of S (+) -ismer of ibuprofen supporsitory is definite, whose action appears more quickly and stronger and it has fewer side-effects than those of ibuprofen supporsitory.

Objective: To compare the contraceptive efficacy of a new spermicide, bioadhesive nonoxynol (N-9) gel, with a traditional N-9 suppository., Methods: A total of 240 child-bearing aged woman volunteers were randomly divided into two groups: 120 cases using the gel for contraception, and another 120 using the suppository. Using lifetable method and log rank test, we compared the pregnancy rates and other discontinuation rates after follow-up for 6 months in two groups., Results: No abnormal findings of cervical smears were detected before and after this clinical trial in all 240 women. The follow-up rates at 6 months were 100.0% and 97.5% in the gel group and the suppository group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 6.39 and 2.95 per 100 women (P > 0.05), respectively. If we eliminated the 5 pregnancy women (3 in the gel group, and 2 in the suppository one), who did not consistently use the spermisides for every intercourse, the cumulative pregnancy rates at 6 month in perfect use would be 3.71 and 2.03 (P > 0.05). And the discontinuation rates due to allergy or other side effects at 6 months in typical use were 3.45 and 4.57 (P > 0.05), respectively. All of the results observed between two groups in this study were not statistically significant., Conclusion: The contraceptive efficacy of bioadhesive N-9 gel is as same as that of the N-9 suppository, and its clinical use is quite safe.

Objective: To explore the efficacy and safety of continuously released prostaglandin E(2) (PGE(2)) suppository-propess used for induction of term pregnancy., Methods: A multicenter, prospective, case control clinical study was carried out, propess was used in 100 cases as study group, the suppository without PGE(2) was used in 49 cases as control group. The cervical maturity (by Bishop scoring), the time to labor starting, membrane rupture and delivery, the application of oxytocin, ceserean section rate, fetal and neonatal condition were compared between 2 groups after inserting of the suppository. At the same time, side effects caused by propess were investigated., Results: Bishop score was increased >or= 2 points in 93% cases, >or= 3 points in 87% cases in study group, whereas only 4% cases whose Bishop score increased >or= 2 points in control group. The time to labor starting, membrane rupture, and delivery was shortened obviously in study group than that in control group after inserting suppository. The application of oxytocin was much less in study group, cesarean section rate was reduced in study group (32% vs 61%). There was no significant difference between 2 groups in fetal and neonatal conditions. The overstimulation of uterine contraction and mild gastrointestinal tract reaction occurred in 3 cases and 2 cases respectively in study groups., Conclusion: Propess can be used for induction of term pregnancy effectively and safely.

Objective: To make the soluble suppository of clindamycin which is an effective drug for treatment of Bacterial vaginosis and to treat patients in clinical trials., Methods: Outpatients who had vaginal infections from Sept. 1998 to Jan. 1999 were investigated. The diagnoses of bacterial vaginosis were made according to Amsel's criteria and 80 patients were included in this study. They were divided into two groups to be treated respectively by metronidanole suppository and clindamycin suppository which were made by our hospital pharmacy., Results: The cure rate of metronidanole was 87.5% and that of clindamycin 90.3%; No significant difference was noted between the two groups(P > 0.05). The new clindamycin suppository was not irritant and it was easy to dissolve in vagina. There was no discontinued treatment because of side-effect., Conclusion: The clindamycin suppository does not irritate the mucosa of vagina, it is an efficacious remedy for bacterial vaginosis.

The quality standards for Xianghe suppository were studied. The TLC methods for identification of Rhizoma Coptidis, Radix Sophorae Flavescentis and Flos Caryophylli were established. A simple high performance liquid chromatographic method was established for determination of berberine and palmatine. The mobile phase was acetonitrile-water(1:1, containing KH2PO4 3.4 g, CH3(CH2)11 SO4Na 1.7 g per 1000 ml). UV detecting wavelength was 345 nm. This method is suitable for the quality control of Xianghe suppository.

Objective: To approach the pharmacological mechanism of the suppository for anti-prostatis (SAP)., Method: Investigating the inflammation of prostate in rat models with bacterial and nonbacterial prostatis induced by colonbacillus and "Xiao Zhi Ling", as well as the change of rheology in the rat model with acute blood stasis. Several tests on anti-inflammation, analgesia and bacteriostasis were conducted., Result and Conclusion: SAP could restrain the inflammation of prostate and resume its secretion obviously. It is very effective for anti-inflammation, analgesia and bacteriostasis, and also helps improve the change of theology in rats with blood stasis.

A study on the anti-herpes simplex virus activity of the suppository or ointment form of Astragalus membranaceus(AM) combined with recombinant human interferon alpha 2b(IFN) was carried out in human diploid cell culture. AM is a Chinese herb medicine and have been used in China as a tonic for thousands of years and the IFN was produced from E. coli with 95% purity. Obtained results indicated that the placebo suppository and ointment(without AM and IFN) seemed not to decrease markedly the anti-viral activity of IFN in WISH/VSV assay system. The anti-herpes simplex virus activities of suppository and ointment forms of AM and IFN were shown to be significantly higher than that of IFN alone. It is well known that chronic cervicitis is closely related to papillomavirus, cytomegalovirus as well as herpes virus infections. The AM-IFN suppository is suggested to be used in the treatment of cervicitis and the ointment in the treatment of skin herpes.

Matrine and oxymatrine in Jieeryin and Fuyanshuan were separated and determined by Reversed Phase High Performance Liquid Chromatography, A chromatographic method for the separation and determination of matrine and oxymatrine in these preparations was established. Chromatographic coditions: ODS column with methanol-water-triethylamine(55:45:0.02) as the mobil phase, and UV detection at 215 nm. The method is simple, sensitive and accurate. This study provides the scientific basis for quality evaluation and quality control in making these preparations.

Objective: To investigate clinical reasonable dose of methyl carboprost suppository (15-methyl-PGF2 alpha) for induction of labor., Method: A total of 150 gravidas with singleton pregnancy and cephalic presentation, accepted for induction of labor, were randomly allocated into 3 groups: group 1, 15-methyl-PGF2 alpha 0.100 mg (n = 50); group 2, 0.125 mg (n = 50); and group 3, 0.200 mg (n = 50)., Results: The success rates of induction were 90.0%, 94.0% and 100.0% for group 1, 2 and 3, respectively. As cervical Bishop score < or = 5, the cases needed oxytocin intravenous infusion during the active phase were 48.5%, 40.7% and 5.0%, respectively; cervical Bishop score > or = 6, the cases were 11.8%, 13.0% and 0.0%, respectively. There were 3 cases of precipitate delivery in group 2 and 3. No uterine hyperstimulation occurred in group 1 and 2, while 3 cases of uterine hyperstimulation in group 3., Conclusion: (1) A single maximum dose of 15 methyl-PGF2 alpha for term labor induction should be < 0.200 mg. (2) The different dose was chosen according to cervical Bishop score, i.e. 0.200 mg or 0.125 mg for Bishop score < or = 5, and 0.100 mg for Bishop score > or = 6.

Objective: To observe the effects of methyl carprost suppository on postpartum bleeding in normal parturients., Methods: Three hundred and sixty normal parturients were randomized into study group (n = 260) and the control group (n = 100). Parturients in study group were administered methyl carprost suppository tents either vaginally (n = 130) or via the rectum (n = 130). The controls were given 10IU oxytocin immediately after the delivery of anterior shoulder of the fetus either intramuscularly (n = 50) or intravenously (n = 50). The amount of bleeding with in 2 hours postpartum was measured., Results: The mean amount of bleeding for parturients who received vaginal or rectal methyl carprost was 146.4 ml and 134.2 ml, respectively. In contrast, the mean amount of bleeding for parturients who received oxytocin intramuscularly or intravenously was 267.9 ml and 210.6 ml, respectively. The differences in the amount of bleeding between the two groups were statistically significant (P < 0.01), whereas differences between the routes of drug administration within each group were not significant (P > 0.05)., Conclusion: Methyl carprost suppository is more effective than oxytocin in controlling postpartum bleeding. Drug administration through the rectum is easy to perform and, therefore, suitable for use in rural areas.

The patients with cervical precancerous lesions were double-blindly randomized into two groups. The one was treated with retinamide II (RII) suppository intravaginally and the other with placebo, once daily for 50 days as a course. The results showed precancerous lesions in 68.57% of the patients disappeared, with an overall effective rate of 74.29% after two-course treatment with RII. Its long-term curative effect approximated to that with laser beam radiation and electrocautery (P > 0.05), and differed significantly (P < 0.01) from that with common antiphlogistic. So, RII can be used as a major measure in prevention and treatment for cervical cancer in high-incidence areas in our country.

Patients with cervical precancerous lesions were double blindly divided into 2 groups and treated with either Retinamide II (RII) or Riboflavin (VB2) suppository. The suppository containing RII 20mg or VB2 5mg was given intravaginally daily for 100 days, divided into 2 courses. Clinical examination, papanicolaou cytology and tissue biopsy under colposcope were carried out before and after treatment. The results showed that the disappearance rates of precancerous lesions (DRPL) after the second course of treatment with RII or VB2 were 68.5% and 52.00%, and the overall response rates were 74.29% and 56.0%, respectively. 1 or 2 yrs after treatment, DRPL of the RII, Riboflavin and laser groups did not show significant difference (P > 0.05). The statistically significant differences were among the RII, Riboflavin, laser groups and antiphlogistic treatment group (P < 0.01). The results indicate that local application of RII and Riboflavin may serve as chemopreventive agents for cervical cancer.

Qinghaosu (QHS), also known as artemisinin and arteannuin, is a novel type of sesquiterpene with a peroxide linkage isolated from the Chinese herb Artemisia annua L. Since its discovery as an antimalarial with low toxicity, hundreds of derivatives have been synthesized among them artesunate (ATS), artemether (ATM) and dihydroqinghaosu (DHQHS) were found to be more active than QHS itself. A suppository of QHS, a dual-pack dosage form of ATS (artesunic acid to be dissolved in sodium bicarbonate solution just before iv injection) and an oil solution of ATM for im injection had been approved by our Ministry of Health for clinical use. However, a preparation for oral administration is still not available. We have reported that when dogs were given QHS tablets orally at the dose of 70 mg/kg, no drug was detected in the serum using the RIA method, whereas appreciable serum concentration was found by the same method when dogs were given DHQHS tablets at a dose as low as 10 mg/kg. This paper reports the pharmacokinetics of DHQHS in man studied with the RIA method and compared with QHS. When DHQHS in tablet form was given to human volunteers at doses of 1.1-2.2 mg/kg, peak serum levels of 0.13-0.71 micrograms/ml were obtained in 1.33 h with MRT of 2.26-2.36 h. When QHS tablets were given at the dose as high as 15 mg/kg, however, the peak serum level found in 1.5 h was only 0.09 microgram/ml with MRT of 1.33 h. Therefore, the bioavailability of QHS tablets is only 1.62-10.08% that of DHQHS.(ABSTRACT TRUNCATED AT 250 WORDS)

From March 1981 to October 1985, 5-Fu was preoperatively given to 65 Dukes B and C rectal cancer patients (intrarectal suppository 40 and emulsion 20, intravenous 5). The results indicated that after intrarectal administration, marked changes and destruction of the cancer cells in morphology were observed in 40% of the resected rectal specimens for suppository and in 45% for emulsion; marked retrograde degeneration in ultrastructure was found in 47.5% for suppository and in 50% for emulsion; DNA synthesis was obviously reduced in 63% for suppository and in 75% for emulsion. It is suggested that the emulsion be a better preparation. No obvious changes or destruction in morphology and ultrastructure were observed in cancer cells treated by intravenous drip of high dose 5-Fu though leukopenia below 4000 was found in 2/5. However, it was 0/60 by rectal administration. This implies that the intrarectal route is more rational than the conventional intravenous route. This study presents an alternate supplementary treatment in addition to radiotherapy for the reduction of postoperative local recurrence of Dukes B and C rectal cancers.

Artemisinin, developed by Chinese scientists, is a new type of anti-malarial drug with quick effect and low toxicity. Since its solubility in water or oil is very low, it cannot be made into a clear injection to be given intramuscularly or intravenously for emergency use. The artemisinin suppositories used in the study was provided by the institute of Chinese Materia Medica in 1982. Phase I and Phase II clinical trials of the drug were made by Guangzhou College of TCM. The results showed that the therapeutic effect of Artemisinin suppositories was satisfactory with no apparent side effects. The total dosage recommended was 2800-3200 mg. In 1986, fifty-six adults with falciparum malaria were treated with a total dose of 2800 mg Artemisinin suppositories for 3 days and randomly compared with a control group of Piperaquine phosphate in the Dongfang Town Hospital, Dongfang ( ) County of Hainan Island. The parasite clearance time in Artemisinin suppositories group (71.8 +/- 16.0 hrs) was significantly faster than that of Piperaquine phosphate group (100.3 +/- 20.3hrs), but recrudescence rate by 28 days (48.2%) was much higher than that of Piperaquine phosphate (17.0%). Artemisinin suppositories is simple to administrate and therefore it could be applied in endemic area of remote countryside and to the patients of incapable of oral dosing.

Serum pancreatic polypeptide (pp) both at fasting state and after giving compound Datura stramonium suppositories were measured by RIA in 21 cases with bronchial asthma and 16 cases with chronic bronchitis during attacks. Comparing with matched control groups the levels of pp in asthma and chronic bronchitis were significantly higher (P less than 0.05 & 0.01) After using compound Datura stramonium, the levels decreased. The results showed serum pp is an useful biochemical index.

Experimental studies on more rational route and preparation of preoperative administration of 5-Fu were undertaken from March 1981 to June 1985. The experimental observation shows that intrarectal administration of radioisotope 14C tagged 5-Fu (suppository and emulsion) produces a much higher concentration in the rectal wall and mesenteric lymph nodes compared with its intravenous administration (40 rabbits) and produces a much higher concentration in cancer tissue than in surrounding tissues and in mesenteric lymph nodes than in the inferior mesenteric veins (4 patients). These findings favor the attenuation or destruction of cancer cells in the tumor and regional lymph nodes-the main route of spread. Also, after intrarectal administration of 14C tagged 5-Fu, its concentration in the lung, liver and bone marrow is much lower than that after intravenous administration (40 rabbits), and hence systemic toxicity is decreased. The above results indicate that the intrarectal route stands better than the conventional intravenous route for 5-Fu preoperative adjuvant chemotherapy in rectal cancer. Administration of 5-Fu emulsion produces a higher concentration in the rectal wall and mesenteric lymph nodes than that of 5-Fu suppository and peak concentration also appears earlier, i.e. 2 hours after the administration of 5-Fu emulsion. This will lessen the interference of 5-Fu absorption owing to its premature evacuation, indicating that emulsion is a better form for intrarectal 5-Fu.