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7. Spectrophotometric Methodologies Applied for Determination of Pharmaceuticals

Author

Jangra Surender, Hu Jianping, Bhakri Gaurav, Luo Qing, Mazumder Rupa, Liu Jiang, Duan Huai-Chuan, Yuen Lew Sze, Wan Hua, Zhao Gang, Nie Lixing, K. Sharma Raj, Wei Lim Lee, Ağin Fatma, Gan Ya, Pothuraju Ramesh, Padhi Swarupanjali, Shi Hu-Bing, Li Shiying, Peng Lianxin, Cai Shaohui, Kaplan Ozan, Gan Xia, Sun Xin, Jiang Zhounan, Kumar Kashyap Pankaj, Lin Teoh Seong, Qian Xiuyu, Garg Varun, Celebier Mustafa, Liu Wei, Xu Jun, Cini Nejla, Ma Shuangcheng, Gölcü Ayşegül, Izat Nihan, Dai Zhong, Liu Xin-Yu, Huah Lim Siew, Liang Li, Bisth Shradha, Chen Lexing, Hu Yi-Chen, Hui Wong Kah, Sahin Selma, and Mittal Neeraj

Subjects
Analytical Chemistry
Abstract

Background: The development of innovative approaches in drug analysis is a challenging task for medicine, pharmacy, and engineering sciences. For instance, the requirement of proper dosage forms in releasing active ingredients is crucial. It is essential to analyze drugs in biological liquids for early diagnosis and treatment purposes. Drug analysis is also of great importance to control the quality of pharmaceutical products, test their efficacy, and develop novel drug formulation. The present review is aimed to highlight the most recent spectrophotometric approaches applied to analyze various classes of drugs in biological media and/or dosage forms. Methods: Direct and derivative UV/UV-Vis spectrophotometry and a combination of various techniques with spectrophotometry, such as injection analysis and chemometrics, have most widely been applied in the analysis of dosage forms. In addition, emerging technologies, such as UV imaging allows to obtain the distribution of drug concentration in time-resolved 2D images based on UV light absorption, utilization of nanotechnology, self-assembled nanomaterials, and aptamer-based nanoparticles have gained interests to investigate drug assays and to quantify the proper drug release. Results: Due to their high versatility, ease of application, low cost, and fast response, spectrophotometric methods are one of the most preferable methods providing high accuracy and precision with a wide linear range in drug analysis. Conclusion: Selected examples demonstrating the applicability of spectrophotometric methods in pharmaceutical assays in this review might contribute to the overall importance of the analytical test used in modern pharmaceutical analysis.

Published
2021
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8. Bioanalytical Method Validation of an RP-HPLC Method for Determination of Rifampicin in Liver Perfusion Studies

Author

Vijakumaran Ubashini, Kouhsari Ebrahim, Mazumder Rupa, F. Al Marjania Mohammed, Azarkan Mohamed, Bisth Shradha, Kaplan Ozan, Kumar Das Sumon, Liu Jiang, Gee Jun Tye, Abdul Hamid Zariyantey, Habib Jibona Rayhan, Chen Lexing, Calvo Esposito Rafaèle, Nordin Fazlina, Marta González Mariana, Bellal Hossain, H. Authman Sawsan, Priya S. Sathya, Jiang Zhounan, Mohapatra Hitesh, Abdullah Maha, Celebier Mustafa, Li Shiying, Al-Mamun Bulbul Abdullah, Gan Xia, Roy Tonmoy, Cai Shaohui, M.K. Sandhya, Izat Nihan, Xu Jun, Eugenia Errasti María, Kumar Rath Amiya, Sahin Selma, Avijit Saha Md., S. Ali Fatima, and Padhi Swarupanjali

Subjects
Bioanalysis, Liver perfusion, Chromatography, Chemistry, Biophysics, medicine, Pharmaceutical Science, Molecular Medicine, Biochemistry, Rifampicin, medicine.drug
Abstract

Background: The number of validated quantification methods for rifampicin, a prototypical Oatp inhibitor, in biological rat samples was limited. Objective: This study was conducted to validate a modified reversed-phase liquid chromatographic method for the determination of rifampicin in rat liver tissue according to the current ICH M10 Bioanalytical Method Validation Draft Guideline (2019) for application to samples of in situ rat liver perfusion studies. Methods: Liver tissue samples were obtained from recirculatory in situ rat liver perfusion studies. The analysis was performed on a C18 column with a mobile phase composed of 0.05 M phosphate buffer (pH 4.58): acetonitrile (55:45, v/v). The assay was validated for selectivity, calibration curve and range, matrix effect, carry-over, accuracy and precision, reinjection reproducibility, and stability. Results: he method was considered selective and stable, without having carry-over and matrix effects. The calibration curve was linear (R2: 0.9983) within the calibration range (0.5-60 ppm). Accuracy and precision values fulfilled the required limits. Liver concentrations of rifampicin in liver tissue, obtained after 60 min perfusion with 10 μM and 50 μM of rifampicin, were 45.1 ± 11.2 and 313.4 ± 84.4 μM, respectively. Conclusion: The bioanalytical method validation was completed and the method was successfully applied for the determination of rifampicin in rat liver tissue.

Published
2021
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9. Evaluating Pharmacokinetic and Distribution Characteristics for A New Antitumor Activity Ortho-aryl Chalcone Compound of OC26 in Rats by LC-MS/MS Method

Author

Jiang Zhounan, Cai Shaohui, Gan Xia, Xu Jun, Chen Lexing, Liu Jiang, and Li Shiying

Subjects
Antitumor activity, Chalcone, chemistry.chemical_compound, Chromatography, Pharmacokinetics, Chemistry, Aryl, Lc ms ms, Biophysics, Pharmaceutical Science, Molecular Medicine, Distribution (pharmacology), Biochemistry
Abstract

Introduction: OC26, an ortho-aryl chalcone compound, shows excellent antitumor activity in vitro and vivo. However, the pharmacokinetic characteristics of OC26 have not been comprehensively reported. It is essential to investigate the correlation of pharmacological response. Objective: To further explore OC26, this study aims to develop an ultra-performance liquid chromatography- tandem mass spectrometric (UPLC-MS/MS) method to reveal the pharmacokinetics and distribution characteristics in rats of OC26. Methods: An UPLC-MS/MS method was developed to detect OC26 in plasma and various tissues. The protein precipitation method was applied to process the biological samples. After intravenous injection 12.5mg/kg of OC26 in rats, plasma and tissue samples were collected from rats and the method was applied to investigate pharmacokinetic and distribution characteristics of OC26. Results: Calibration curve samples of OC26 concentration range from 20 to 2000 ng/mL with the goodness of fit (r2> 0.99). The precisions for the method were within 12.3%, while the accuracies for the method were within ±11% (bias). The matrix effect had no influence on the accuracy and precision of the method. After intravenous injection 12.5mg/kg of OC26 in rats, OC26 was rapidly eliminated (t1/2=31.39±7.87min, MRT0→∞=15.03±2.55min) from rat plasma and widely distributed (Vd=4.83±0.96L/kg) in tissues. The highest concentration of OC26 was detected in the brain in which peak content (~8962.78ng/g at 15min) was over 5-fold higher than that of in other tissues, which prompted new potential targets in the brain. Besides, lung and heart also detected quite a high level of OC26. Benefited from quick elimination in the collected tissues and plasma, long-term accumulation was not observed as chronic toxicity might be less. Conclusions: This UPLC-MS/MS method was successfully applied to detect OC26 and provide a theoretical basis for the further study of OC26.

Published
2021
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13. Meta-analysis and Clinical Evaluation of the Relationship Between FAPα Expression and Malignant Degree of Solid Tumors

Author

Mo, Enpan, Tan, Qiutong, Cai, Shaohui, Shi, Mingjie, and Xu, Jun

Subjects
Fibroblast activation protein α, Solid tumor, Meta-analysis, Immunohistochemistry
Abstract

Background Aim This study aimed to identify the prognostic significance of Fibroblast activation protein α (FAPα) in solid tumor. Method A literature search was performed by using Pubmed, EMbase and CNKI for relevant articles published with the following key words “fibroblast activation protein” or “seprase”, “clinical” and “cancer” or “carcinoma”. Pooled effects with 95% confidence interval (CI) for outcomes (age, gender, positive ratio, histological differentiation, depth of tumor invasion, lymph node metastasis, clinical stage and overall survival) were calculated. Besides, immunohistochemical analysis was performed to evaluate FAPα positive ratio in normal, benign and malignant tumor tissues as well as in different degrees of differentiation, clinical stages and lymph node metastasis tissues. Results Finally, 28 articles with different types of solid tumors were included in the meta-analysis. Results revealed that solid tumors had a higher positive ratio of FAPα expression (OR: 39.51, P < 0.001), and FAPα overexpression also indicated higher degree of tumor depth invasion (OR: 2.82, P = 0.010), lymph node metastasis (OR: 2.52, P = 0.003), clinical stage (OR: 3.36, P = 0.003) and worse overall survival (HR: 2.03, P < 0.001). Results from immunohistochemistry demonstrated that FAPα expressed higher in malignant solid tumors than that in benign solid tumors (P = 0.022), and it significantly overexpress in lymph node metastasis tissues (P = 0.04). Conclusion Our findings indicate that FAPα expression is associated with worse prognosis in solid tumors and may be a promising prognosis predictor., This article aimed to identify the prognostic significance of Fibroblast activation protein α (FAPα) in solid tumor, we conducted by meta-analysis to found that solid tumors had a higher positive ratio of FAPα expression, which indicated higher degree of tumor depth invasion, lymph node metastasis, clinical stage and worse overall survival. The results from immunohistochemistry demonstrated that FAPα expressed higher in malignant solid tumors than that in benign solid tumors, and it significantly overexpress in lymph node metastasis tissues. Our findings indicate that FAPα expression is associated with worse prognosis in solid tumors and may be a promising biomarker in tumor diagnosis.

Published
2021
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29. Mixed nanomicelles as potential carriers for systemic delivery of Z-GP-Dox, an FAPα-based doxorubicin prodrug: formulation and pharmacokinetic evaluation

Author

Zhang,Yuchen, Zhang,Xingwang, Liu,Hongming, Cai,Shaohui, Wu,Baojian, Wang,Huang, Zhang,Yuchen, Zhang,Xingwang, Liu,Hongming, Cai,Shaohui, Wu,Baojian, and Wang,Huang

Abstract

Yuchen Zhang,1,* Xingwang Zhang,2,* Hongming Liu,2 Shaohui Cai,1 Baojian Wu21Department of Pharmacology, 2Division of Pharmaceutics, College of Pharmacy, Jinan University, Guangzhou, People’s Republic of China*These authors contributed equally to this workAbstract: Z-GP-Dox, the FAPα (fibroblast activation protein-α)-based doxorubicin prodrug, demonstrates excellent tumor targeting effects and a favorable toxicokinetic profile. However, the insoluble nature of Z-GP-Dox becomes a significant barrier to drug administration, particularly when it comes to the clinical stage. Here we developed a nanomicelle system to facilitate the systemic delivery of Z-GP-Dox, and evaluated its disposition in rats following administration of the micelles using a physiologically-based pharmacokinetic model. Z-GP-Dox-loaded mixed nanomicelles (ZGD-MNs) were prepared by dispersion of an ethanol solution of Z-GP-Dox, lecithin, and sodium oleate in water. The obtained ZGD-MNs were 86.6 nm in size with a drug loading of 14.03%. ZGD-MNs were fairly stable in phosphate-buffered saline and simultaneously showed satisfactory physical and chemical stability over a 2-week observation period. Accumulative drug release was more than 56% within 24 hours. Further, the physiologically-based pharmacokinetic rat model consisting of various organs (ie, heart, liver, spleen, lung, kidney, and intestine) was fitted to the experimental data following administration of ZGD-loaded cosolvent (control) or micelles. Derived partition coefficient values revealed that the nanomicelles significantly altered the biodistribution of Z-GP-Dox. Of note, drug distribution to the lung, liver, and spleen was greatly enhanced and the fold change ranged from 2.4 to 33. In conclusion, this is the first report of a mixed micelle system being a viable carrier for delivery of Z-GP-Dox. Also, the pharmacokinetic behavior of Z-GP-Dox was satisfactorily described by the physiologically-based pharmacokin

Published
2015

45. Homology Modeling of -Glucosidase and its Interactions with Andrograpolide Derivatives

Author

Xu, Jun, Lu, Yijing, Shen, Weizai, Luo, Haibin, Huang, Sichao, Bao, Jiaolin, Cai, Shaohui, and Wang, Yuqiang

Abstract

Andrographolide derivatives have been reported as potential -glucosidase inhibitors. A more detailed investigation of active sites and key residues of -glucosidase, which can interact with andrographolide derivatives, is useful for the discovery of more effective -glucosidase inhibitors. To establish a virtual method predicting potential active sites and key residues, a 3D structure of -glucosidase from bakers yeast was first constructed by homology modeling (RMSD of alignment was 1.745Å). The SiteID program was then used to explore the potential binding sites of the homology model of -glucosidase. Based on these potential binding sites, 25 andrographolide derivatives were docked into the homology model of -glucosidase for determining the potential active sites. Results showed that the predicted strong inhibitors AR (accuracy rate) of the two potential active sites, P7 and P10, were 77.8 and 88.9 respectively. To further research the potential active sites, key residues of these predicted active sites were investigated through the virtual residues knockout method. VAL316 and THR307, residues of P7, and HIS258, LYS262, ILE271, MET272, THR273, ALA289, TYR292, and SER295, as well as residues of P10, were found to contribute greatly to the high ARs of their corresponding active sites. These results may be useful for design of new -glucosidase inhibitors.

Published
2011

46. Mixed nanomicelles as potential carriers for systemic delivery of Z-GP-Dox, an FAPα-based doxorubicin prodrug: formulation and pharmacokinetic evaluation.

Author

Zhang Y, Zhang X, Liu H, Cai S, and Wu B

Subjects
Animals, Endopeptidases, Rats, Tissue Distribution, Doxorubicin chemistry, Doxorubicin pharmacokinetics, Doxorubicin pharmacology, Drug Carriers chemistry, Drug Carriers pharmacokinetics, Gelatinases chemistry, Gelatinases pharmacokinetics, Membrane Proteins chemistry, Membrane Proteins pharmacokinetics, Micelles, Nanoparticles chemistry, Prodrugs chemistry, Prodrugs pharmacokinetics, Prodrugs pharmacology, Serine Endopeptidases chemistry, Serine Endopeptidases pharmacokinetics
Abstract

Z-GP-Dox, the FAPα (fibroblast activation protein-α)-based doxorubicin prodrug, demonstrates excellent tumor targeting effects and a favorable toxicokinetic profile. However, the insoluble nature of Z-GP-Dox becomes a significant barrier to drug administration, particularly when it comes to the clinical stage. Here we developed a nanomicelle system to facilitate the systemic delivery of Z-GP-Dox, and evaluated its disposition in rats following administration of the micelles using a physiologically-based pharmacokinetic model. Z-GP-Dox-loaded mixed nanomicelles (ZGD-MNs) were prepared by dispersion of an ethanol solution of Z-GP-Dox, lecithin, and sodium oleate in water. The obtained ZGD-MNs were 86.6 nm in size with a drug loading of 14.03%. ZGD-MNs were fairly stable in phosphate-buffered saline and showed satisfactory physical and chemical stability over a 2-week observation period. Accumulative drug release was more than 56% within 24 hours. Further, the physiologically-based pharmacokinetic rat model consisting of various organs (ie, heart, liver, spleen, lung, kidney, and intestine) was fitted to the experimental data following administration of ZGD-loaded cosolvent (control) or micelles. Derived partition coefficient values revealed that the nanomicelles significantly altered the biodistribution of Z-GP-Dox. Of note, drug distribution to the lung, liver, and spleen was greatly enhanced and the fold change ranged from 2.4 to 33. In conclusion, this is the first report of a mixed micelle system being a viable carrier for delivery of Z-GP-Dox. Also, the pharmacokinetic behavior of Z-GP-Dox was satisfactorily described by the physiologically-based pharmacokinetic model.

Published
2015
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47. [Construction of intrakine mutant SDF-1alpha/54/KDEL and its inhibiting effects upon CXCR4 expression on cell membrane].

Author

Chen H, Tan Y, Guo Z, Ma W, Cai S, Du J, Huang J, Hu H, and Cai S

Subjects
Animals, COS Cells, Chlorocebus aethiops, Cloning, Molecular, Electroporation, Gene Knockout Techniques, Genetic Vectors genetics, Humans, Receptors, CXCR4 genetics, Recombinant Proteins genetics, Stromal Cells metabolism, Transfection, Cell Membrane metabolism, Chemokine CXCL12 genetics, Mutation, Receptors, CXCR4 metabolism
Abstract

To investigate the impact of phenotypic knockout of CXCR4 on Molt-4 cells via intrakine technology,the C-terminal alpha-helix gene SDF-1alpha/54/KDEL of human stromal cell-derived Faceor-1 deletion is fused to a retention signal 4-peptide -KDEL that retains the newly synthesized receptor within the Molt-4 cells endoplasimc reticulum. Subsequently, PCR is used to amplify the target gene SDF-1alpha/54/ KDEL from the constructed plasmid SDF-WT-Gly x 4-Dec/PET-30a(+) at its C-terminal and subclone it into eukaryotic expression vectors pEGFP-C3 for generating recombinant vector cells by lipEGFP-C3/SDF-1alpha/54/KDEL, and then have it sequenced. After the transfection of recombinant plasmids into COS-7 posome, SDF-1alpha/54/KDEL protein is confirmed with Western blot. The recombinant plasmids pEGFP-C3/SDF-1alpha/54/KDEL are isolated and transiently transfected in Molt-4 cells by electroporation. Flow cytometric analysis shows a dramatic reduction of CXCR4 expression on Molt-4 cells. The conclusion is that SDF-1alpha/54/KDEL could assume a role in the phenotypic knockout of CXCR4, and the findings suggest that the inhibiting effect of SDF-1alpha/54 against CXCR4 is not influenced by the deletion of SDF-1alpha helix at the C terminal.

Published
2008

48. [The role of SDF-1 and its receptor CXCR4 in tumor metastasis].

Author

Chen H, Tan Y, Cai S, Ma W, Guo Z, Du J, and Cai S

Subjects
Breast Neoplasms pathology, Humans, Multiple Myeloma pathology, Signal Transduction physiology, Chemokine CXCL12 physiology, Neoplasm Metastasis, Receptors, CXCR4 physiology
Abstract

The chemokine SDF-1 (CXCL12) and its receptor, CXCR4, have been implicated in organ-specific metastases of several malignancies. CXCR4 expression has recently been characterized in many cancer cell types and is thought to play a pivotal role in directing the migration of metastasizing tumor cells to SDF-1-rich tissues. SDF-1, which is highly expressed in the organs where breast cancers preferentially metastasize, has been shown to promote cancer cell migration. The tumor cells use chemotaxis which occurred between CXCR4 and its ligand SDF-1 to direct migration from their primary sites via the circulation to the preferential sites of metastases, and further studies on the mechanism involved in a variety of cellular signaling pathways are beneficial to tumor therapy.

Published
2007

49. [The action of decorin in anti-fibrosis and anti-cancer].

Author

Ma W, Tan Y, Cai S, Chen H, Du J, and Cai S

Subjects
Animals, Decorin, ErbB Receptors antagonists & inhibitors, Humans, Recombinant Proteins pharmacology, Transforming Growth Factor beta1 antagonists & inhibitors, Antineoplastic Agents pharmacology, Extracellular Matrix Proteins chemistry, Extracellular Matrix Proteins pharmacology, Fibrosis prevention & control, Proteoglycans chemistry, Proteoglycans pharmacology
Abstract

Decorin (DCN) is a member of the small leucine-rich proteoglycan gene family. Many studies indicated that DCN inhibited fibrosis and scar-formation by neutralization of TGF-P and interfering the binding of TGF-beta with its receptor, which induced ectopic deposition of extracellular matrix. Additionally, DCN can prevent the proliferation and metastasis of tumor cells by activating EGFR/MAPK/p21 signal pathway and inhibiting the cell proliferation pathway mediated by EGF-EGFR. It is suggested that the recombinant DCN had potential pharmaceutical potency in treatment of chronic fibrosis and neoplasm for its critical biological activities and low immunogenicity.

Published
2007

50. [The cell micro-encapsulation techniques and its advancement in the field of gene therapy].

Author

Li X and Cai S

Subjects
Biomedical Engineering methods, Cell Transplantation methods, Humans, Miniaturization, Tissue Engineering methods, Biomedical Engineering trends, Cell Transplantation trends, Genetic Therapy trends, Tissue Engineering trends
Abstract

It is no doubt that the gene therapy using recombinant engineering cells provides a novel approach to many refractory diseases. However, the transplant rejection from the host's immune system against heterogeneous cells has been the main handicap of its clinical application. The modern cell micro-encapsulation technique with good immune isolation makes it possible to overcome this problem and has shown potential application foreground in clinical therapies for a lot of diseases such as Parkinson's disease and Hemophiliac disease. This article reviews mainly the relative materials and techniques in processing micro-encapsulation, the host cells used to construct the recombinant genetic engineering cells and application of cell micro-encapsulation technique in the field of gene therapy.

Published
2006

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