国产克林霉素制剂相关信息分析与评价

发布时间：2018-11-02 08:02

【摘要】：目的:了解国产克林霉素制剂的现状及存在的问题,为完善仿制药审批、生产及临床合理应用提供参考。方法:以"克林霉素"为关键词,在国家食品药品监督管理总局网站,查询1994-2013年国产克林霉素制剂的名称、批准文号、剂型、规格、生产企业等;从药品说明书原件、生产企业网站,查询储存条件和有效期。将相关信息录入Excel表进行统计、分析。结果:1994-2013年国内批准上市的克林霉素制剂有4种给药途径、18种剂型(注射制剂4种、口服制剂5种、外用制剂4种、阴道用制剂5种)、28个通用名、547个批准文号(注射制剂341个、口服制剂168个、外用制剂28个、阴道用制剂10个)、52个规格、262个生产企业。结论:国产克林霉素制剂剂型、规格过多,一方面让药品生产这一高科技产业蜕化为以低水平重复劳动获取利润的制造业;另一方面,给临床用药的选择带来了较大困难,难以达到合理用药的目的。建议应加强药品批准文号的审批及发放政策研究;进一步完善克林霉素制剂的质量标准,尽量避免因标准之间的偏差而影响药品的质量;进行临床用药的循证研究。
[Abstract]:Objective: to understand the current situation and existing problems of clindamycin preparations in order to provide reference for the approval, production and clinical application of generic drugs. Methods: with clindamycin as the key word, the name, approval document number, dosage form, specification, production enterprise of clindamycin preparation made in China from 1994 to 2013 were queried on the website of State Food and Drug Administration. From the original drug specification, production enterprise website, query storage conditions and validity. Input relevant information into Excel table for statistics and analysis. Results: there were 4 ways of administration of clindamycin in China from 1994 to 2013, 18 kinds of dosage forms (4 kinds of injection preparations, 5 kinds of oral preparations, 4 kinds of external preparations, 5 kinds of vaginal preparations). 547 approved symbols (341 for injection preparations, 168 for oral preparations, 28 for external use and 10 for vaginal preparations), 52 specifications and 262 manufacturing enterprises. Conclusion: the formulation of clindamycin in China has too many specifications. On the one hand, the high-tech industry of drug production has been transformed into a manufacturing industry with low level of repeated labor. On the other hand, it brings great difficulty to the choice of clinical medication, and it is difficult to achieve the purpose of rational use of drugs. It is suggested that we should strengthen the research on the approval and issuance policy of drug approval number, further improve the quality standard of clindamycin preparation, and try our best to avoid the influence of the deviation between the standards on the quality of drugs, and conduct evidence-based research on clinical drug use.
【作者单位】：昆明医科大学第二附属医院;
【基金】：“十二五”国家科技支撑计划课题(No.2013BAI06B04)
【分类号】：R978.1

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