20 December 2024, Volume 38 Issue 12
    

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    Supervision & Administration
  • A Comparative Analysis and Reflection on the PIC/S GMP Annex for Herbal Medicinal Products Production with the Chinese GMP Appendices for Traditional Chinese Medicine Decoction Pieces and Preparations, and Related Regulations
    Wu Jing, Wang Han, Sun Wen, Li Na, Yang Xifan, Wang Lin
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1345-1350. https://doi.org/10.16153/j.1002-7777.20240172
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Objective: To identify the advantages and disadvantages of the regulations related to the production of traditional Chinese medicine (TCM) by conducting a benchmarking study on the annex of PIC/S GMP for herbal medicine production, and to provide a theoretical basis for China's smooth accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Methods: A comprehensive comparison was conducted among Chinese GMP decoction pieces, Chinese medicinal preparations annex, relevant regulations and the PIC/S GMP annex for Herbal Medicines production. An analysis and discussion were carried out on certain advantages and differences. Results: The requirements of China's GMP appendices for TCM decoction pieces and preparations, as well as related regulations, were essentially consistent with those of the PIC/S GMP annex for Herbal Medicines in all aspects. Moreover, China's TCM regulatory regulations were more comprehensive and specific in terms of plant and facilities and equipment, personnel, confirmation and verification, production management, and quality control and other requirements compared to the PIC/S GMP Herbal Medicines. Conclusion: China's relevant laws and regulations related to TCM production have a solid foundation and already meet the requirements of the PIC/S GMP annex for Herbal Medicines. Moving forward, it is essential to maintain confidence, clarify the direction, and further refine the regulatory requirements for TCM production in China.
  • General Considerations for Pharmaceutical Issues in the Communication of Innovative Chemical Drug at Different Application Stages for Registration
    Ren Feng, Jiang Tao, Chen Aiping, Liu Juan, Ren Lianjie, Fan Yi
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1351-1356. https://doi.org/10.16153/j.1002-7777.2024-08-0033
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    Objective: To further improve the quality and efficiency of communication on innovative chemical drugs, and to increase support for innovative drug research and development, as well as strengthen technical guidance and services for applicants. Methods: Based on the relevant technical guidelines and review practices of pharmaceutical at different application stages of innovative drugs for registration, this paper puts forward suggestions on the pharmaceutical problems existing in relevant communication. Results and Conclusion: Solutions and focus points for the common problems in the communication of innovative chemical drug at different application stages for registration are proposed, hoping to provide references for drug registration applicants, improve the quality and efficiency of communication, and better serve drug innovation and development.
  • Analysis of the Current Situation and Existing Problems of Drug Import Filing
    Li Lijie, Chen Jijian, Gao Qingquan, Qi Yaqiao
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1357-1362. https://doi.org/10.16153/j.1002-7777.20240214
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    Objective: To summarize and analyze the current situation of drug import filing work, explore the trend of fine-tuning the current drug import filing system in China, and provide reference for future policy formulation and optimization reform. Methods: By using literature review, data statistics, and comprehensive analysis methods, the problems existing in drug import filing were sorted out, and the main causes management status of various problems were found out. The policy trend in recent years regarding the announcement of relevant documents for drug import filing in China was studied. Results: Solutions were proposed for the existing problems, and the implementation of the new method effectively improved the current situation of drug import filing. Conclusion: This study helps to enhance understanding of the relevant laws and policies on drug import registration, and facilitates their rational application in practical work. It is suggested to flexibly adjust the review rules for the implementation of drug import filing in accordance with international development trends, in order to ensure compliance declaration by enterprises and improve the efficiency of imported drug clearance.
  • Exploring the Importance of Quality Control of Pharmaceutical Excipients from the Pollution Incident of Ethylene Glycol and Diethylene Glycol
    Lu De, Xu Wenyan, Pei Yusheng, Xiao Yan
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1363-1370. https://doi.org/10.16153/j.1002-7777.2024-09-0032
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    Objective: To clarify the importance of quality control of pharmaceutical excipients by reviewing the incidents of ethylene glycol and diethylene glycol pollution and related regulatory requirements. Methods: Through sorting out the pollution incidents of ethylene glycol and diethylene glycol, as well as the relevant regulatory requirements issued by the United States and the World Health Organization, and combining with the warning letters of ethylene glycol and diethylene glycol pollution issued by the FDA, this paper puts forward some suggestions on the quality control of pharmaceutical excipients. Results and Conclusion: Glycerin and other pharmaceutical excipients by ethylene glycol, diethylene glycol pollution will produce more serious drug pollution events. The World Health Organization has repeatedly issued global medical alerts, FDA has also repeatedly warned against ethylene glycol, diethylene glycol pollution. The quality of pharmaceutical excipients and the quality of drugs is closely related. This paper analyzes the causes of ethylene glycol and diethylene glycol pollution, and puts forward suggestions on the quality system construction of excipient manufacturers, the control of excipient circulation links, the quality responsibility of drug manufacturers, the development and improvement of testing methods and equipment, and the coordination and cooperation of global regulatory authorities. It hopes to provide references for the industry to further improve the quality management and control of pharmaceutical excipients.
  • Research on Optimizing Early-Warning Strategies for Supply of Reference Drug Based on Data Analysis
    Xie Jingxin, Cheng Xianlong, Qiao Jing, Wei Feng, Zhao Zongge, Sun Huimin
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1371-1378. https://doi.org/10.16153/j.1002-7777.2024-08-0028
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    Objective: To improve the production and supply efficiency of reference drug and ensure the market and regulatory needs. Methods: The usage of reference drug in the document standards involving the National Reimbursement Drug List and the National Essential Medicines List was sorted out. The trend relationship between the frequency of use and supply of reference drug in the Chinese Pharmacopoeia was analyzed, and representative influencing factors for risk assessment were selected. Results: The optimizing early-warning strategies can quickly focus on in-short-supply reference drug, improve the supply of reference drug, and ensure the accurate seamless connection between batches. Conclusion: Through the identification of risk factors influencing the early-warning, and the analysis of the data of the use in the national standards and market demand of reference drug, the aim of optimizing the early-warning work is achieved, which provides a reference for effectively enhancing the production and supply efficiency of herbal reference drug.
  • Exploration of Radiation Safety Management in Radioactive Drug Testing Laboratories
    Pei Yunfei, Zhang Wenzai, Wang Quanzhu, Zhang Wei, Ni Xunsong, Guo Yaxin
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1379-1386. https://doi.org/10.16153/j.1002-7777.2024-09-0035
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    Objective: To provide constructive suggestions for the radiation safety management of radioactive drug testing laboratories in drug inspection institutions. Methods: A brief analysis was conducted on the demand for radioactive drugs in the market and the current development status of inspection laboratories. The relevant concepts, classifications, and regulations of radiation safety management were outlined, and the requirements for the construction, licensing, retirement, and daily radiation safety management of radioactive laboratories were summarized. The common causes of radiation accidents in recent years were statistically analyzed, and the risks of radiation safety management in radioactive drug inspection laboratories were discussed. Targeted solutions were proposed. Results and Conclusion: The radioactive drug testing laboratory should aim at the forefront of international construction, strictly implement the "three simultaneities" of radiation project construction, continuously improve the radiation safety management system, adhere to strict education, training and assessment, equip with high standard facilities and equipment, continuously consolidate the foundation of radiation safety management, and promote the rapid development of new quality and safety productivity in radioactive drug inspection.
  • Research and Establishment of the Quality Assessment Standard Method of Cosmetic Adverse Reaction Reporting in China Based on the International ADR Monitoring
    Shen Lu
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1387-1398. https://doi.org/10.16153/j.1002-7777.2024-08-0049
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    Objective: International ADR monitoring has developed for many years, and a mature drug reporting quality assessment method has been formed, but there has never been a scientific, systematic, and quantitative evaluation method for the quality of cosmetics adverse reaction reports, both domestically and internationally. In order to improve the quality of cosmetic adverse reaction report, strengthen the analysis evaluation, the basis of risk early warning, a standard method for assessing the quality of adverse reaction reports for cosmetics was established for the first time by drawing on international experience in monitoring adverse drug reactions. Methods: Based on the international quality assessment method of ADR reporting, this study established and operated the "manual sampling score addition" and "computer case-by-case multiplication weight reduction method", which enabled the method of cosmetics report quality assessment in China to achieve a leap from scratch and from existence to excellence. Results: After the application of the report quality evaluation method, the status quo and level of the report quality across the country were mastered by scoring, and the problems and deficiencies of the monitoring work were found out, and then targeted measures such as formulating technical guidelines and providing training guidance were taken to improve the quality of the report. Conclusion: Adverse reaction report is the foundation of adverse reaction monitoring work. Through quantitatively evaluating report quality, identifying the problems and deficiencies, continuously improving the quality of report, a true, complete and accurate information basis is provided for the subsequent analysis evaluation and risk early warning, which provide strong technical support for China's cosmetics regulation and public health safety.
    • Regulatory Tehnology
  • Suggestions for the Hygroscopic Chemical Reference Substances in Drug Regulatory Application
    Liu Yi, Wu Jingfang, Guo Xianhui, Ding Yi, Chen Hua, Ning Xiao, Cao Jin
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1399-1403. https://doi.org/10.16153/j.1002-7777.20240519
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    Objective: To introduce the problems of hygroscopic chemical reference substances in drug regulatory application and give suggestions, in order to provide reference for better application of national drug reference substances in drug regulation. Methods: Regulations related to pharmaceutical reference substances were expounded, and the problems encountered in the use were analyzed and the hygroscopic chemical reference substances by dynamic vapor absorption analysis (DVS) were studied. Suggestions from the aspects of standard implementation, instructions, packaging and storage, weighing and moisture determination were provided. Results and Conclusion: Chemical reference substances with hygroscopic properties are a relatively special type of reference standard. Due to their hygroscopic properties affecting the stability of measurement values, they has posed several problems and challenges to drug regulation. Through the achievements of research on hygroscopicity, the improvement of reference standard instructions, and the summary of practical work experience, all parties are working together to solve the problems and better improve the application of national reference substances, in order to ensure the effectiveness of drug regulation and the safety of drug.
  • Quality Risk Analysis of Human Prothrombin Complex Concentrate Extraction and Its Combination with Plasma for Blood Product Preparation
    Ma Yinlin, He Xuefeng, Gou Yangmei, Kong Liya, Shan Lin
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1404-1412. https://doi.org/10.16153/j.1002-7777.2024-09-0057
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    Objective: To analyze the potential quality risks in extracting human Prothrombin Complex Concentrate (PCC) from human plasma and producing other blood products, providing risk warnings and control measures to relevant enterprises and regulatory authorities to ensure public drug safety. Methods: Through a comprehensive review of literature and practical experience, the production process and quality control of PCC extraction from human plasma, along with its combination with plasma to manufacture other blood products, were analyzed. The safety and efficacy of producing human serum albumin (HSA) and intravenous immunoglobulin (IG) through the PCC process were also assessed. Additionally, the study compared the risks associated with switching from the direct production of HSA and IG to a process involving PCC extraction and its combination with plasma from the perspectives of process parameters, personnel, equipment, documents, and regulations. Based on this analysis, control measures were proposed. Results and Conclusion: The preparation process, raw material selection, and quality control of PCC, particularly the optimization of key process parameters, are crucial for the quality of both PCC and subsequent plasma-derived products. This study provides risk warnings and relevant recommendations for enterprises and regulatory authorities to refer to through the analysis of PCC preparation process, raw material characteristics and process change risk.
  • Establishment of the First Batch of National Drug Reference Standard of Escitalopram Oxalate Impurity A
    Ni Xue, Zhou Xiaoli, Sun Changying, Xu Hui, Yin Lihui
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1413-1420. https://doi.org/10.16153/j.1002-7777.2024-09-0036
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    Objective: To develop the first batch of national drug reference standard of Escitalopram Oxalate Impurity A, which will be used for quality control of escitalopram oxalate tablets and citalopram hydrobromide tablets and so on, in order to ensure the drug safe. Methods: The structure of Escitalopram Oxalate Impurity A was confirmed using LC-MS and NMR. HPLC was employed for purity analysis. The content of Escitalopram Oxalate Impurity A was calculated using the mass balance method, with DSC and qNMR methods used for auxiliary valuation. Results: The structure of the first batch of national drug reference standard of Escitalopram Oxalate Impurity A was characterized and its content was determined to be 97.5%. Conclusion: The first batch of national drug reference standard of Escitalopram Oxalate Impurity A was established, meeting the needs of the related substances inspection in the national standards for these relevant drugs.
  • Evaluation of Uncertainty in the Releasing Rate Determination of Fluvastatin Sodium Sustained-release Tablets
    Gao Zhaohui, Liu Jing
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1421-1428. https://doi.org/10.16153/j.1002-7777.2024-10-0033
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    Objective: To evaluate the contribution of uncertainty in the releasing rate determination process of fluvastatin sodium sustained-release tablets. Methods: The experiment was conducted according to General Rule 0931 in Volume Ⅳ of the 2020 edition of Chinese Pharmacopoeia, and a mathematical model was established to analyze the source of uncertainty in the determination of fluvastatin sodium sustained-release tablets and calculate the synthetic uncertainty and extended uncertainty with reference to the relevant provisions of JJF 1059.1- 2012. Results: The synthetic uncertainties of fluvastatin sodium sustained-release tablets at 0.5 h, 2 h, 4 h and 8 h were 0.02205, 0.03034, 0.03520 and 0.02979, respectively. The extended uncertainties were (5.9±0.26)%, (23.2±1.40)%, (54.8±3.86)%, (108.0±6.44)% (k=2, confidence interval 95%), respectively. Conclusion: At 0.5 h, 2 h, 4 h sampling points, the uncertainty contribution of fluvastatin sodium releasing rate in fluvastatin sodium sustained-release tablets comes mainly from the parallel determination of samples. At 8 h sampling point, it is mainly derived from the preparation of the test product solution. The uncertainty of the analysis method was quantified in this experiment, which provided a more scientific basis for the inspection of the releasing rate of controlled release tablets.
  • Exploring the Mechanism of Anti Prostate Cancer Effect of Proanthocyanidin A2 Based on Network Pharmacology
    Chang Xiuting, Chen Linlin, Cai Jiahui, Kou Lidan, Luo Xiaoju, Wang Bin
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1429-1437. https://doi.org/10.16153/j.1002-7777.2024-08-0051
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    Objective: To investigate the effects of proanthocyanidin A2 (PCA2) on the proliferation and migration of human prostate cancer cells (PC-3 cells) by cytological tests in vitro, and to elucidate its potential anti-cancer molecular mechanisms based on network pharmacology. Methods: The effects of varying concentrations of PCA2 on PC-3 cell proliferation were assessed using CCK8 assay. Colony formation and scratch assays were used to determine the effects of PCA2 on PC-3 cell proliferation and migration. Predicted targets of PCA2 and prostate cancer were identified through Similarity Ensemble Approach and other databases, and a protein-protein interaction network was constructed using String. GO and KEGG functional enrichment analyses were performed using the OmicShare Tools database to predict the mechanisms of action. Results and Conclusion: PCA2 significantly inhibited the proliferation and migration of PC-3 cells, and the inhibitory effect is positively correlated with the concentration of PCA2. Through network pharmacology, 95 targets were identified between PCA2 and prostate cancer, with EGFR, ALB, HSP90AA1, and MMP9 being the core targets. GO and KEGG functional enrichment analyses indicated that its main mechanism related to the PI3K/AKT signaling pathway.
    • Research Progress
  • Current Status and Insights of Ethnic Medicine Scutellaria amoena C. H. Wright
    Song Wei, Yan Qianru, Wu Weikui
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1438-1446. https://doi.org/10.16153/j.1002-7777.2024-10-0054
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    Objective: To provide a theoretical foundation for the rational development and comprehensive utilization of Scutellaria amoena C. H. Wright which is a valuable ethnic medicinal resource, and to enhance the quality control and clinical safety of Scutellaria species. Methods: This study reviewed the chemical constituents, pharmacological activities, and potential biological effects of Scutellaria amoena C. H. Wright, evaluated its current applications in traditional medicine, identified existing issues, and proposed corresponding strategies. Results: The dried roots of Scutellaria amoena C. H. Wright primarily contain flavonoids, which are largely consistent with those in Scutellaria baicalensis, with higher levels of baicalin. Furthermore, Scutellaria amoena C. H. Wright demonstrates a range of potential biological activities, including anti-aging, anti-tumor, anti-atherosclerotic, lipid-lowering, blood glucose-lowering, immune-enhancing, and cognitive-improving effects. Conclusion: Due to its rich chemical profile and broad spectrum of biological activities, Scutellaria amoena C. H. Wright has substantial potential for further development. The strategies proposed in this study will support the advancement of research and clinical application of Scutellaria amoena C. H. Wright, thereby facilitating its effective development and clinical use.
  • Research on Family and Genus Classification and Development of Species Names of Chinese Medicine Hirudo
    Wang Wenyi, Zhao Weitao, Sun Xi, Yang Jinshen, Yang Yaojun
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1447-1452. https://doi.org/10.16153/j.1002-7777.20240138
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    Objective: To enable more relevant scholars to understand the development and record of the species of Hirudo (leeches) through a more clear historical context, and to use relevant Chinese names and nicknames more strictly in various scenarios in the future. Methods: By collecting domestic research literature related to three medicinal leeches included in pharmacopoeia from the early days of the founding of the People's Republic of China to the present day, as well as family and genus, combining with some earlier foreign records and the data of the present main shared database, the family and genus classification of several leeches, species merger and separation, and the corresponding Chinese names and Latin scientific names were sorted and analyzed. Results: Since the founding of the People's Republic of China, Hirudo has been included in the Pharmacopoeia of the People's Republic of China since 1963. With the in-depth research of leeches, the classification of leeches has been adjusted continuously. At present, the family and genus classification of leeches has gradually differentiated into two relatively independent usage habits, and there are some problems such as misuse of Chinese names. Conclusion: In order to ensure the accuracy of the source of species and prevent the ambiguity between research and use, it is suggested that pharmacopoeia should be supplemented by a variety of notes to confirm the original source. In addition, a new round of survey and sorting of leeches should be one of the important topics for leeches research.
    • Hospital Pharmacy
  • Construction of Evaluation Index System of Statins in Medical Institutions
    Pang Jingjing, Qian Yating, Yuan Dongdong, Liu Wei
    Chinese Pharmaceutical Affairs. 2024, 38(12): 1453-1460. https://doi.org/10.16153/j.1002-7777.2024-10-0055
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    Objective: To construct the evaluation index system of statins in medical institutions and promote the evaluation and selection of clinical statins more systematicly, scientificly and standardizedly. Methods: Referring to "Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (2021 version trial)", combined with the characteristics of statins and clinical experience, a multi-criteria and multi-dimensional evaluation index system for statins was constructed by using the Delphi method. Results: On the basis of the established initial evaluation index system, the evaluation index system of statins was finally determined through two rounds of expert questionnaire consultation, including 6 first-grade indexes, 23 second-grade indexes and 44 third-grade indexes. The familiarity of the two rounds of expert correspondence was 0.81, the coefficient of judgment was 0.94 and 0.95, and the coefficient of authority was 0.84 and 0.88, respectively. The reliability was 0.95 and 0.98, respectively. Conclusion: The evaluation index system of statins established in this study is scientific and authoritative, which can provide an important basis for the selection and rational use of statins catalog in medical institutions, accelerate the high-quality development of pharmaceutical services, and the control of unreasonable drug expenses.
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