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Objective: To investigate the prognosis impact of adjuvant trastuzumab treatment on human epidermal growth factor receptor 2 (HER-2) positive early breast cancer patients. Methods: A retrospective study was conducted, HER-2-positive T1N0M0 stage breast cancer patients who underwent surgery in the Affiliated Tumor Hospital of Xinjiang Medical University from January 2010 to December 2019 were divided into treatment group and control group according to whether they were treated with trastuzumab or not. Propensity score matching (PSM) was used to balance the confounding bias caused by differences in baseline characteristics between the two groups. Cox proportional hazards model was used to analyze the risk factors affecting disease-free survival (DFS). The Kaplan-Meier method was used to estimate the 3- and 5-year DFS and overall survival (OS) rates of the two groups before and after PSM. Results: There were 291 patients with HER-2 positive T1N0M0 stage breast cancer, including 21 cases in T1a (7.2%), 61 cases in T1b (21.0%), and 209 cases in T1c (71.8%). Before PSM, there were 132 cases in the treatment group and 159 cases in the control group, the 5-year DFS rate was 88.5%, and the 5-year OS rate was 91.5%. After PSM, there were 103 cases in the treatment group and 103 cases in the control group, the 5-year DFS rate was 86.0%, and the 5-year OS rate was 88.5%. Before PSM, there were significant differences in tumor size, histological grade, vascular invasion, Ki-67 index, postoperative chemotherapy or not and radiotherapy between the treatment group and the control group ( P <0.05). After PSM, there were no significant difference in clinicopathological features between the treatment group and the control group ( P >0.05). Multivariate analysis showed that histological grade ( HR =2.927, 95 CI: 1.476, 5.805; P =0.002), vascular invasion ( HR =3.410, 95 CI: 1.170, 9.940; P =0.025), menstrual status ( HR =3.692, 95 CI: 1.021, 13.344, P =0.046), and chemotherapy ( HR =0.238, 95 CI: 0.079, 0.720; P =0.011) were independent factors affecting DFS. After PSM, the 5-year DFS rate of the treatment group was 89.2%, while that of the control group was 83.5%( P =0.237). The 5-year OS rate of the treatment group was 96.1%, while that of the control group was 84.7%( P =0.036). Conclusion: Postoperative targeted therapy with trastuzumab can reduce the risk of recurrence and metastasis in patients with HER-2-positive T1N0M0 stage breast cancer.

Objective: To analyze the effect and safety of treatment in patients with airway stenosis caused by tracheotomy for mechanical ventilation. Method: We treated the patients with airway stenosis caused by granulation tissue. The patients with grade Ⅰ,Ⅱ airway stenosis were treated with adjustable flange tracheostomy tube, and the holmium laser under a fibro-laryngoscope were applied for the patients with grade Ⅲ airway stenosis.Two hundred and sixteen patients were enrolled in this study. Forty-four patients had been found tracheal stenosis caused by granulomatous hyperplasia, accounting for 20.4% of all patients, including 12 cases of gradeⅠ, 18 cases of grade Ⅱ, and 14 cases of grade Ⅲ. Result: Thirty patients with grade Ⅰ and Ⅱ were replaced with adjustable flange tracheostomy cannula. Fourteen cases of grade Ⅲ airway stenosis were treated with Ho:YAG laser under a fibro laryngoscope. All cases were completed operation successfully. None of cases bleeding, perforated and asphyxia during operation. The clinical symptoms disappeared after operation, and endoscopy showed that airways of patients were smooth. No recurrence were found after operation. Conclusion: Replacement of adjustable flange tracheostomy tube and Ho:YAG laser can safely and effectively treat airway obstruction caused by tracheal granulation tissue hyperplasia after tracheotomy., 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 Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.)

Objective: To ascertain the effects of a new method of photochemical reaction in vestibular function in guinea pigs. Method: Local photochemical reaction was initiated by systemic injection of rose bengal(20mg), photoillumination of the vestibule through medial wall of epitympanum for 30 minutes was started immediately after the injection of rose bengal, with a optic fiber connected to a xenon light (wavelength, 540nm; photointense, 500-600 mW/cm ²). There were 20 guinea pigs divided random equally into 2 groups. Group 1 was injected with rose bengal. Group 2 was control, injected with physiological saline solution. The ice caloric tests were performed on the second day. Result: The test group (7 ears) and the control group (6 ears) with test nystagmus showed mean frequencies were（2.0±0.33）times/s and（3.7±0.33）times/s,the mean amplitude were (3.1±0.39)mm and (3.5±0.54)mm,and the mean duration were (44.7±17.22)s and (62.0±7.22)s respectively.The nystagmus frequency difference was statistically significant, but the amplitude and the duration of the nystagmus were not significantly different. There was no obvious spontaneous nystagmus in the two groups, and there were negative results of ice water test (3 ears in the test group and 4 ears in the control group). Conclusion: Photochemical reaction can induce the ischemic state of the vestibule system in guinea pig, and produce an acute vestibular dysfunction, and ice water test shows that the frequency of nystagmus is reduced., 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 Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.)

Objective: The purpose of this study was to observe the clinical characteristics of two types of geotropic direction-changing positional nystagmus, the transient(nystagmus time <1 min) and the persistent(nystagmus time > 1 min), and to evaluate the efficacy of the barbecue roll maneuver. Methods: A total of 105 cases diagnosed by supine roll test were studied, which including 35 males and 70 females and the average age was (56.9±14.6)years. There were 70 transient geotropic DCPN and 35 persistent geotropic DCPN. The clinical characteristics and the immediate and one-week efficacy of the barbecue roll maneuver were discussed. Results: The nystagmus disappeared at the null-point position and the nystagmus in supine position were opposite to the bowing (90° nose-down) position in persistent geotropic DCPN cases. While to the transient geotropic DCPN cases, there were no NP and no nystagmus in prone position. The ratio of the first onset of the two groups was 28.6% (persistent) and 72.9% (transient) respectively, and the difference was statistically significant ( P <0.05). The immediate and one-week efficacy after barbecue roll maneuver were 91.4% and 80.0% in transient geotropic DCPN cases, and 0% and 42.9% in persistent geotropic DCPN cases, which were statistically significant different( P <0.05). Conclusions: The light cupula hypothesis can mainly explain the clinical features of persistent geotropic DCPN cases; the barbecue roll maneuver is invalid to persistent geotropic DCPN cases which can be self-healing.

The samples of Huangqi injection (HI) were analyzed by liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (LC-TOF-MS), and both positive and negative ion modes were employed to obtain the LC-TOF-MS analysis information of chemical compounds in HI. Then the mass defect filtering (MDF) approach, which was developed based on the previously published articles, was utilized to rapidly screen the astragalosides from the obtained LC-TOF-MS data. Each screened astragaloside was confirmed by the presence of no less than 2 quasi-molecular ions. All the screened astragalosides were then tentatively assigned according to the parent ion and daughter ion information. Finally, a total of 62 astragalosides were screened and characterized from the HI samples, including 15 new detected ones. The identification results indicated that acetylation, hydrogenation, dehydrogenation, methoxylation and hydration might be the major conversion reactions involved in the formation of the astragalosides. The LC-TOF-MS-based MDF approach was proved to be a feasible and efficient tool to screen the chemical constituents in complex matrices such as herbal medicines., 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.)

Spectrum-effect relationship of traditional Chinese medicine is a scientific method based on fingerprint of traditional Chinese medicine, which studied the correlations between fingerprint and activity. The method revealed the activity related peaks and clarified the active components. It provided directions and thoughts for the clarification of pharmacodynamic material basis and establishment of evaluation method to reflect the inherent quality of traditional Chinese medicine. In this text we would make a systematic review about the progress in the study of spectrum-effect relationship of traditional Chinese medicine after summarized the latest years of investigations from researchers at home and abroad, including the establishment of fingerprint, efficacy evaluation, and data processing. The key problems in each part were clarified and corresponding discussions were made, providing thoughts and advices for the following study of spectrum-effect relationship of traditional Chinese medicine. At last we made a expecting on the development trend of spectrum-effect relationship of traditional Chinese medicine.

The purpose of this study was to isolate and purify polysaccharide from Gynura divaricata and analyze its monosaccharide composition. A water-soluble crude polysaccharide was obtained by hot water extraction, ethanol precipitation and deproteinization after degreasing. The crude polysaccharide then purified with DEAE-Sepharose Fast Flow column chromatography and dialysis. The monosaccharide composition and structure were analyzed by HPLC, UV spectrophotometer and 1H-NMR. The results showed that the purity and molecular weight of GDPS-2 and GDPS-3 were 87.3%, 2.03 x 10(4) Da and 90.9%, 4.29 x 10(4) Da, respectively. The UV spectrophotometer and 1H-NMR data suggested that glycosidic bond of GDPS-2 and GDPS-3 were a type. Both GDPs-2 and GDPs-3 were homogeneous polysaccharides, and GDPs-2 was mainly composed of glucuronic acid and xylose at a molar ratio of 1.1:0.63. GDPs-3 was mainly composed of rhamnose, glucuronic acid, galactose, xylose and galacturonic acid at a molar ratio of 0.32:6.0:0.21:1.75:4.3.

Tripterygium glycosides preparation which extracted from the traditional Chinese herb Tripterygium wilfordii (TWHY), was widely used to treat the autoimmune diseases. Previous works demonstrated that TWHF had potent anti-inflammatory and immunosuppressive properties. But the different quality and high incident rate of side effects of different manufactures inhibited its clinical application. Since TWHF had been generally known to play a therapeutical effect by synergism of multiple constituents, it was necessary to build the relationship between the HPLC fingerprint and bioactivity so as to ensure the quality safety and efficacy. The HPLC fingerprint showed that description and content of peaks from different manufactures were diverse. Only 11 common peaks were found. In this study, mice spleen cells stimulated by Con A were used to test the proliferation inhibition bioactivity of TWHF preparations, which were incubated with 30, 15, 7.5, 3.75, 1.88 and 0.94 mg x L(-1) TWHF preparations for 48 h. The results showed that mice spleen cells proliferation was inhibited by all TWHF preparations significantly compared with the control group, which suggested the TWHF preparations showed immune suppress activity. The TWHF preparations from 7 manufacture showed different IC50 value, which might belong to different contents which showed in the HPLC fingerprint. Moreover, a relationship between the HPLC fingerprint and the bioactivity were established to identify important constituents by grey relational analysis (GRA). The result showed that all the contents were relative with the IC50, especially No. 5 and 10 peaks, but No. 1 peak, which was proved to be triptolide, had few contribute to the inhibition of mice spleen cells proliferation. The study of relationship between the HPLC fingerprint and the IC50 by GRA could help to investigate mechanism of bioactive and provide an evidence for the quantification of multi-constituents.

Objective: To observe the effects of electroacupuncture (EA) on circadian rhythm of temperature and melatonin (MT) in depression rats model induced by chronic stress, so as to explore the biological mechanism of EA for depression., Methods: Twenty-four SD rats were randomly divided into a control group, a model group and an EA group, 8 cases in each one. Rats in the control group were treated with normal diet for 21 days without any treatment. In the model and EA group, rat model was established by chronic unpredictable stress combined with solitarily feeding method, and rats in the EA group was treated with EA at "Baihui" (GV 20), "Yintang" (GV 29) 1 h before stress stimulation everyday, 2 Hz in frequency and intensity was favorable with the head of rat slightly shivering. The needles were retained for 20 min, once a day for totally 21 days. After EA treatment, open-field experiment was adopted to observe the behavioral improvement; the rats temperatures were monitored at six time points (2:00, 6:00, 10:00, 14:00, 18:00, 22:00) and orbital blood sampling was collected. The level of serum MT was tested by enzyme linked immunosorbent assay. The circadian rhythm changes of temperature and serum MT in each group were compared., Results: The numbers of horizontal movement and vertical movement in the model group were obviously lower than those in the control group (both P < 0.05), while those in the EA group were significantly improved compared with those in the model group (both P < 0.01). The circadian rhythm of temperature and MT disappeared in the model group, which was improved into normal level after EA treatment., Conclusion: The electroacupuncture has regulation effects on circadian rhythm of temperature and melatonin in depression rat model induced by chronic stress.

Objective: To evaluate the efficacy and security of propranolol gel in treatment of Infantile hemangiomas., Methods: 51 consecutive infants with hemangiomas from October 2010 to September 2011 in Department of General Surgery Fuzhou General Hospital of Nanjing Military Command were treated with propranolol hydrochloride 3% gel. Changes in hemangioma size, texture, color, tumor blood flow peak were recorded., Results: The results were evaluated using Achauer system, responses of IHs to propranolol were considered scale I (poor) in 4 patient (17.24%), scale II (moderate) in 18 patients (24.14%), scale III (good) in 22 patients (44.83%) and scale IV (excellent) in 7 patients (13.79%). The response of superficial hemangiomas was significantly better than other hemangiomas (P < 0.05), and no significant differences in response among different primary sites (P > 0.05)., Conclusions: Topical use of propranolol hydrochloride 3% gel is an effective option for superficial hemangiomas.

Objective: To assess whether the existing three types of pharmacogenetics-based Warfarin dosing algorithms appropriately predict the actual maintenance dose in Han Chinese mechanical heart valve replacement patients (n = 130)., Methods: The patients' CYP2C9 and VKORC1 genetic polymorphisms were detected by PCR-RFLP. The genotype of CYP2C9, VKORC1 and other information were used to calculate predicted doses. Accuracy of the models was assessed using the absolute value of the difference between predicted dose and actual dose, calculated on both an absolute and percentage basis. Actual weekly dose was also regressed on predicted weekly dose, from which we obtained R(2) values. Clinical accuracy of the predictions was assessed by computing the proportion in which the predicted dose was 20% or more below the actual dose (under dosed), within 20% of the actual dose (ideally dosed), or 20% or greater above the actual dose (over dosed)., Results: The average absolute error is the smallest for the predictions made by the Wen model (3.74 mg/wk), followed by the Ohno model (4.07 mg/wk) and IWPC model (5.05 mg/wk). R(2) was 40.2% in the Wen model, 38.2% in the Ohno model and 26.7% in the IWPC model. When comparing the percentage of patients for whom the predicted doses were ideal, the Wen model works the best (50.0%) in low-dose group (≤ 21 mg/wk), but the Ohno model works the best (85.29%) in middle-dose group (21 - 49 mg/wk), followed by the Wen model., Conclusion: The best accuracy is achieved by the Wen model and the best clinical accuracy is obtained by the Ohno model for predicting the actual maintenance dose in Han Chinese mechanical heart valve replacement patients.

The effect of CYP3A4*18B and CYP3A5*3 on concentration/dosage x body surface area ratios (C/D'), adverse effects and acute rejection of tacrolimus in renal transplant patients were investigated. The CYP3A4*18B genotypes of 227 renal transplant patients were determined by PCR-RFLP method. The differences of C/D' ratios, adverse reactions and acute rejection were compared among all of the genotype groups treated with tacrolimus. The frequencies of CYP3A4*18 and CYP3A5*3 alleles in renal transplant patients were 30.8% and 74.2%, respectively. No significant association was found between the C/D's of tacrolimus and CYP3A4*18B genotypes when they were classified by two CYP3A5 genotypes (P > 0.05). While after the effects of CYP3A4*18B genotype were eliminated, the C/D' ratio of tacrolimus in patients with CYP3A5*1/*1 and *1/*3 genotype group was significantly lower than those with CYP3A5*3/*3 genotype groups (P < 0.01). There is no significant difference in adverse effects and acute rejection among different genotypes (P > 0.05).

Objective: To study the chemical constituents from aerial parts of Gynura divaricata., Methods: The constituents were isolated on silica gel column chromatography, preparative TLC and Sephadex LH-20 column chromatography, identified by physicochemical properties and the structures were elucidated by spectral analysis., Results: 10 compounds were isolated and identified as 2-(1', 2', 3', 4'-tetrahydroxybutyl)-6-(2", 3", 4"-trihydroxybutyl)-pyrazine (1), 2-(1', 2', 3', 4'-tetrahydroxybutyl)-5-(2", 3", 4"-trihydroxybutyl) -pyrazine (2), nicotinic acid (3), 5-hydroxy-picolinic acid(4), methyl-5-hydroxy-2- pyridinecarboxylate (5), adenosine (6), uridine (7), stigmasterol-5-O- beta-D-glucoside (8), dibutyl terephthalate (9), methyl chlorogenate (10)., Conclusion: Compounds 1, 2, 5, 9, 10 are obtained from this genus for the first time, Compounds 3, 4 are obtained from this plant for the first time.

Objective: To describe a series of patients with multiple canal involvement in benign paroxysmal positional vertigo (BPPV), with respect to diagnosis and management., Methods: Ninety-five individuals with symptoms of BPPV and positional nystagmus were included in this study. The diagnosis was based on a history of brief episodes of vertigo and the presence of multiple positional nystagmus as confirmed by video-oculographic examination. Patients were treated by means of different particle repositioning manoeuvres according to the affected canal., Results: Ninety-five patients showed multiple positional nystagmus during the examination corresponding to simultaneous multi-canal BPPV. Fourteen patients (14.7%) had bilateral canal BPPV. Six patients had bilateral posterior canal. Six patients had bilateral horizontal canal, and two patients had bilateral anterior canal. Fifty-three patients (55.8%) had torsional, up-beating nystagmus with down-beating nystagmus, which suggested possible affected both of posterior and anterior canals. Twenty patients (21.1%) had torsional up-beating nystagmus and horizontal direction nystagmus, which suggested possible affected both of posterior and horizontal canals. Five patients had down-beating nystagmus with horizontal nystagmus, which suggested affected both of anterior and horizontal canals. Three patients had torsional up-beating with down-beating and horizontal nystagmus, which suggested possible affected multiple canals. Treatment given to the patients varied according to the canal affected, started with the canal that elicited a strong positional nystagmus and vertigo, and 93.7% (89/95) of patients were symptom free or improved., Conclusions: It has been found that multi-canal BPPV is not a rate observation in clinic, and most of them affected posterior and anterior canals. Treatment of multi-canal BPPV can be effective using repositioning maneuver.

This paper studied the accumulation and scavenging of active oxygen radicals, injury of photosynthetic system and membrane system, and changes of antioxidant enzyme system in Thuidium cymbifolium cells under single and combined stress of Pb and Ni. Under low concentration of Pb and Ni (Pb < 0.1 mmol x L(-1), Ni < 0.01 mmol x L(-1)), the chlorophyll content of T. cymbifolium increased; while under high concentration of Pb and Ni (Pb > 0.1 mmol x L(-1), Ni > 0.01 mmol x L(-1)), it was in adverse. There was a dose-dependent accumulation of reactive oxide species (ROS) and malondialdehyde (MDA) under combined Pb and Ni stress. The superoxide dismutase (SOD) and catalase (CAT) activities decreased while the peroxidase (POD) activity increased with increasing Pb and Ni concentration, indicating the important role of POD in eliminating ROS under Pb and Ni stress. The dose-dependent change of MDA content and CAT activity under Pb and Ni stress suggested that T. cymbifolium could be used as a biomarker in pollution monitoring of these two heavy metals.

Objective: To attempt to visualize the endolymph in patients with Meniere's disease by applying non-invasive intratympanic gadolinium through eustachian tube and three-dimensional fluid-attenuated inversion recovery magnetic resonance imaging (3D-FLAIR MRI)., Methods: With a 3 Tesla magnetic resonance imaging (MRI) unit, 3D-FLAIR imaging was performed 24 hours after intratympanic gadolinium through eustachian tube in two patients with medically active and intractable Meniere's disease. Pure tone test and tympanometry were performed 24 hours before and after the administration of gadolinium., Results: The gadolinium appeared in almost all parts of the perilymph inside the inner ear; moreover, the border between the perilymph and the endolymph was visible so endolymphatic space was clearly shown on 3D-FLAIR. No change in pure tone test and tympanometry was noted., Conclusions: 3D-FLAIR MRI with intratympanic gadolinium through eustachian tube can clearly reveal the visualization of endolymph in patients with Meniere's disease. Intratympanic gadolinium therapy through eustachian tube is a safe and effective.

The in situ gel systems can form gel in situ after administration to achieve sustained release, thus provides a promising strategy for drug delivery systems. The aim of this study was to design and prepare in situ gel systems for the oral delivery of ibuprofen (IBU-ISG) and study its pharmacokinetics in Beagle dogs. The characteristics of the basic material of gellan gum (Kelcogel, Kel) and sodium alginate (Manugel, M) were studied through investigating the complex viscosity of the Kel or M solution with or without different concentrations of calcium ion or sodium citrate to ascertain the amount range of the excipients. The measurement of complex viscosity of the solution (0. 5% Kel and 1% M) with different concentrations of sodium citrate and calcium ion was carried out to select the suitable proportion of calcium ion and sodium citrate. The formulation of binary IBU-ISG was optimized by monitoring the complex viscosity before gelling in vitro release property. The optimized formulation contains 1.0% sodium alginate, 0.5% gellan gum, 0. 21% sodium citrate and 0.056% calcium chloride. A single oral dose of IBU-ISG and reference formulation (IBU suspension) were given to each of the 6 healthy Beagle dogs, ibuprofen in plasma at different sampling times was determined by RP-HPLC. The pharmacokinetics parameters in 6 Beagle dogs were calculated. The Tmax of IBU-ISG and reference formulation were (1.8 +/- 0.6) and (0.4 +/- 0. 1) h. The Cmax values were (29.2 +/- 7.6) and (37.8 +/- 2.2) microg x mL(-1). The T(1/2) were (2.3 +/- 0.5) and (2.0 +/- 0.9) h, and the AUC(0-t) were (131.0 +/- 38.6) and (117.3 +/- 23.1) microg x mL(-1) x h, respectively. The binary IBU-ISG was successfully prepared.

Objectives: To investigate the mechanical properties of bilateral atlantoaxial trans-articular screws and atlas laminar hooks instrumentation with finite element method., Methods: There was a volunteer with age of 28 years old, body height 172 cm, body weight of 60 kg and without cervical deformity by X rays. The ligamentous, nonlinear, three-dimensional finite element models of normal upper cervical spine (C0-3) was developed and validated. The destabilized model with bilateral atlantoaxial trans-articular screws and atlas laminar hooks was evaluated for quasistatic loading., Results: The finite element model of upper cervical spine consists of 229,047 nodes and 152,475 elements, and correlated well with experimental data for all load cases and could be used for experiment. The finite model with bilateral atlantoaxial trans-articular screws and atlas-laminar hooks predicted that the maximum Von Mises Stress was in the region in which screws penetrated the atlantoaxial articular facet. The novel instrumentation resulted in sufficient stability., Conclusion: The bilateral atlantoaxial trans-articular screws and atlas laminar hooks instrumentation is useful and effective for atlantoaxial arthrodesis.

Objective: To analyse the video-oculographic findings of positional tests and evaluate the efficacy of canalith repositioning procedure (CRP) in patients with paroxysmal positional vertigo ( BPPV) of the anterior semicircular canal (ASC)., Methods: A retrospective study of 31 patients with ASC BPPV. Then the CRP was performed., Results: Twenty-two individuals (70.97%) presented a unilateral positional nystagmus during the Dix-Hallpike test, in 17 individuals had torsional nystagmus component, 5 individuals only had pure positional down beat nystagmus. Nine patients presented bilateral positional nystagmus, 7 individuals had torsional component positional nystagmus, in 2 patients the direction of the torsional component were the same during right and left Dix-Hallpike test, in 4 patients the torsional component were concurrent with positional down beat nystagmus but the direction could not be ascertained clinically, in 2 patients had pure positional down beat nystagmus. Nineteen patients (61.29%) had unilateral lesion, 11 patients had the left ASC BPPV, 8 patients had right ASC BPPV. Eleven patients had with both ASC and PSC BPPV in the ipsilateral. Twenty-one patients (67.74%) were cured, 29 patients (93.55%) were improved, 2 (6.45%) patients were inefficacy. CRP effectively resolved the nystagmus and vertigo in 14 patients (45.16%) when applied only once, The average number of CRP was 1.7 times, there were 5 patients recurrence during the follow-up., Conclusions: ASC BPPV was not a common condition. The torsional nystagmus component of ASC BPPV might be weak during the Dix-Hallpike test. The positional nystagmus of ASC BPPV was triggered bilaterally. Based on these findings, CRP could be one of the most effective treatment methods for ASC BPPV.

Objective: To prepare a sustained-release formulation of traditional Chinese medicine compound recipe by adopting time-controlled release techniques., Method: Shuxiong tablets were chosen as model drug. The prescription and technique of core tablets were formulated with selecting disintegrating time and swelling volume of core tablets in water as index. The time-controlled release tablets were prepared by adopting press-coated techniques, using PEG6000, HCO and EVA as coating materials. The influences of compositions, preparation process and dissolution conditions in vitro on the lag time (T(lag)) of drug release were investigated., Result: The composition of core tablets was as follow: 30% of drug, 50% MCC and 20% CMS-Na. The T(lag) of time-controlled release tablets was altered remarkably by PEG6000 content of the outer layer, the amount of outer layer and hardness of tablet. The viscosity of dissolution media and basket rotation had less influence on the T(lag) but more on rate of drug release., Conclusion: The core tablets pressed with the optimized composition had preferable swelling and disintegrating properties. The shuxiong sustained-release formulations which contained core tablet and two kinds of time-controlled release tablets with 3 h and 6 h of T(lag) could release drug successively at 0 h, 3 h and 6 h in vitro. The technique made it possible that various components with extremely different physicochemical properties in these preparations could release synchronously.

Objective: To prepare shuxiong micropellets., Method: Shuxiong micropellets were prepared by using a centrifugal granulator. The formulation composition and process factors were optimized investigated by adopting several indices such as size distribution, repose angle, bulk density and friability as indexes., Result: The optimal process parameters were as follows. The ratio of fine intermediate product and MCC was 3:1 (w/w), the adhesive agent was 3% HMPC solution, the rotating rate of plate was 200 r x min(-1), the blower rate was 15 x 20 L x min(-1), the rate of air flow was 15 L x min(-1), the spray air pressure was 0.5 MPa, the rotating of spray solution pump was 5-25 r x min(-1) and the rotating rate of powder feed machine was 5-25 r x min(-1)., Conclusion: Under the optimal conditions, micropellets prepared by using centrifugal granulator hadpossessed prefect shape and surface characteristics and the yield of shuxiong pellets was 90.5%.

Aim: To prepare the compound danshen pH-dependent delayed release pellets and filled them in capsules and then study thier pharmacodynamics., Methods: The pH-dependent delayed release pellets were prepared by coating with HPMC, Eudragit L-30D-55 and Eudragit L100-Eudragit S100 (1:6), separately, and mixed in proper proportion to prepare the two pH-dependent delayed release systems T1 and T2. The release of delayed release pellets was determined according to the method of China Pharmacopoeia (2000) in the simulated gastrointestinal pH conditions. The pharmacodynamic,parameters were evaluated by serum pharmacology method., Results: The compound danshen pH-dependent delayed release pellets were prepared with the characteristics of pH dependent delayed release profile in vitro. In single oral dose, the pharmacodynamic parameters of rapid release tablets R Emax (%) and Tmax (h) were 34.63% and 0.58 h, respectively. Tmax S of delayed-release pellets T1 and T2 were extended to 2.42, 3.17 h and Emax S (%) were declined to 13.57%, 14.52%. The relative bioavailabilities of T1 and T2 were 99.3%, 133.6% , respectively. In multiple oral doses of R the pharmacodynamic parameter of DF was 7.32 and those T1, T2 DF were 3.40, 3.03, respectively., Conclusion: The compound danshen pH-dependent delayed release capsules have characteristics of pH dependent releasing in vitro and characteristics of delayed release in vivo. In multiple oral (loses the DF of delayed release capsules was lower than that of rapid release tablet at steady state.

Objective: To study the effect of tissue environment on the invasiveness of carcinoma cells and the implication of expression of matrix metalloproteinases., Methods: Tissue from a human gastric carcinoma was transplanted and passaged subcutaneously in nude mice. After the 3rd passage, the xenografts were also transplanted into the abdominal cavity of nude mice. The invasiveness of xenografts at the two locations were observed morphologically and the expressions of MMP-2, MMP-7, MMP-9, MMP-13, TM1-MMP, TM2-MMP and TM3-MMP were monitored by immunohistochemistry., Results: The subcutaneous xenografts of human gastric carcinoma in nude mice presented as expanding outgrowths with limited invasion. Except for MMP-7, the other 6 MMPs (MMP-2, MMP-9, MMP-13, TM1-MMP, TM2-MMP, TM3-MMP) were not expressed in the neoplastic cells nor in the tumor stroma. In contrast, the intra-peritoneal xenografts displayed an invasive growth pattern accompanied by more fibrous stroma. All MMPs examined were expressed in the tumor cells at the invasive fronts and in the adjacent stroma., Conclusions: Invasiveness and expression of MMPs were obviously diverse in human gastric carcinoma cells when grafted at different anatomic locations in nude mice, thus indicating: (1) There exists a close interaction between tumor cells and surrounding stromal cells. The tissue environment may play a definitive role in the tumor phenotype. (2) The expression of MMPs is closely related to the growth pattern and the invasiveness of tumor cells. MMPs produced by the stroma cells at the invasion front may be linked to the invasiveness of neoplastic cells.

Aim: To investigate the preparation of diclofenac sodium pulsatile release pellets (DS-PRP), the release in vitro and the pharmacokinetics of the drug., Methods: Diclofenac sodium (DS) core pellets prepared by extrusion-spheronization technology were coated in a mini-fluidized bed spray coater with swelling material as the inner coating swelling layer and ethylcellulose aqueous dispersion as the outer coating controlled layer. The effects of formulation and medium on pulsatile release of DS were investigated under release rate test. Pharmacokinetic and bioavailability study in eight human subjects were performed by HPLC method., Results: The delayed-release time and release rate of DS from DS-PRP were influenced obviously by the swelling material, the concentration of SDS in medium, the coating level of the inner swelling layer and the outer controlled layer. In vitro, the delayed-release time T0.1 was 3.1 h, and the pulsed-release time T0.1-0.2 was 1.2 h. In vivo, the delayed-release time Tlag was 2.8 h, and the bioavailability was (91 +/- 12)%., Conclusion: The release of drug from DS-PRP was shown to be in pulsed way both in vitro and in vivo.

The endo-1,4-xylanase gene from Bacillus pumilus HB030 was cloned into the Pichia pastoris expression vector, pPIC9k, the recombinant plasmid was named pHBM220. The digested recombinant plasmid pHBM220 was transformed into Pichia pastoris KM71, GS115, SMD1168, respectively. The recombinant Pichia pastoris KM71 (pHBM220), GS115 (pHBM220), SMD1168 (pHBM220) secreted functional endo-1,4-xylanase, and the enzymatic activities reached 10.80IU/mL, 11.63IU/mL, 9.68IU/mL, respectively. The temperature and pH optimum for the recombinant xylanase were 60 degrees C and pH5.5, respectively.

Objective: To study the preparation of Venenum Bufonis beta-cyclodextrin inclusion complexes., Method: An optimal condition was established by the uniform design. Under the optimal conditions the Venenum Bufonis beta-cyclodextrin inclusion complexes were prepared with 5 different methods., Result: The ball grinding method was superior to other four methods. The bufadienolide inclusion rate of Venenum Bufonis beta-cyclodextrin prepared with ball grinding method was 85.42%., Conclusion: Ball grinding method is the best method for the preparation of Venenum Bufonis beta-cyclodextrin inclusion complexes.

Aim: To prepare heart-protecting musk pH-dependent gradient-release pellets and investigate the drug release in vitro and in vivo., Methods: The pH-dependent gradient-release pellet system was prepared by using HPMC, Eudragit L-30D-55 and Eudragit L100-Eudragit S100 (1:5) combinations as coater. The release of borneol and total ginsenoside from pH-dependent gradient-release pellets were determined according to the method of Pharmacopoeia of the People's Republic of China (2000) in the simulated gastrointestinal pH conditions. The gastrointestinal transit and disintegration of pellets was investigated by using gamma-scintigraphic trace in volunteers. The pharmacokinetics of borneol of heart-protecting musk pH-dependent gradient-release pellets was studied in 6 healthy volunteers by GC methods., Results: The f2 value of release data of borneol and total ginsenoside of the heart-protecting musk pH-dependent gradient-release pellets was 79.6 in the simulated gastrointestinal pH conditions. The gamma-scintigraphic trace evaluation demonstrated that the pellets coated with HPMC, Eudragit L-30D-55 or Eudragit L100-Eudragit S100 (1:5) combinations can disintegrate in stomach, duodenum and jejunum or ileum. The gastrointestinal transit time of pellets was about 5 hours in fasted state and about 6 hours in fed state. The concentration-time curves of borneol of heart-protecting musk pills fit in two-compartment model. The pharmacokinetics data showed that borneol had a short time of absorption and elimination. The mean residence time (MRT) of borneol of heart-protecting musk pills was 2.61 hours. The plasma concentration of borneol of heart-protecting musk sustained-release capsule which consisted of three kinds of pellets coated with HPMC, Eudragit L-30D-55 or Eudragit L100-Eudragit S100 (1:5) combinations was steadier than those of heart-protecting musk pills, its Cmax was lower than and Tmax was near to those of heart-protecting musk pills, its MRT was 4.0 hours, and its relative bioavailability was 96%., Conclusion: The lipidsoluble borneol and watersoluble total ginsenoside of heart-protecting musk pH-dependent gradient-release pellets can release simultaneously while sustained-releasing in vitro. The heart-protecting musk pH-dependent gradient-release pellets had the characteristics of pH-dependent gradient-releasing and disintegration while transiting in gastrointestinal tract. A characteristic of gradient sustained-release was shown in the concentration-time curves of borneol of heart-protecting musk sustained-release capsule in volunteers.