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目的:评价国产加替沙星注射剂的质量现状及存在问题。方法:按照2009年度国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果对国产加替沙星注射剂的质量现状进行评价。结果:法定检验显示70批样品中69批合格,有1批因可见异物不合格;探索性研究显示部分生产企业产品的渗透压测定结果明显低于各国药典规定的限度规定,而采用HPLC法分析了加替沙星注射剂和原料中杂质的分布情况,结果表明注射液中的杂质主要源于原料;对不同生产工艺的加替沙星注射液的光照稳定性进行了比较,结果表明如生产中以稀盐酸代替乳酸助溶,加替沙星注射剂的光稳定性更好。结论:加替沙星注射剂按各执行标准检验,总体合格率较好。但是还存在一些问题,如细菌内毒素限度需要规范统一、100℃30 min灭菌工艺能否保障无菌等。通过探索性研究还建议生产企业改进生产工艺,提高产品质量;同时改进并统一现行质量标准,进一步加强对加替沙星注射剂的监管。
Objective: To evaluate the quality status and existing problems of domestic gatifloxacin injection. Methods: According to the general requirements of national appraised sampling plan in 2009, the statistic test method combined with exploratory research was used to test the samples. The statistical analysis of the test results was used to evaluate the quality status of domestic gatifloxacin injection. Results: The statutory test showed that 70 batches of samples were qualified in 69 batches, and one batches of batches failed due to the visible foreign matters. The exploratory research showed that the osmotic pressure of some products was significantly lower than that stipulated by Pharmacopoeia in each country. However, Gatifloxacin injection and raw materials in the distribution of impurities, the results show that the injection of impurities mainly from raw materials; different production processes of gatifloxacin injection of light stability were compared, the results show that as in the production With dilute hydrochloric acid instead of lactic acid solubilization, gatifloxacin injection better light stability. Conclusion: Gatifloxacin injection according to the implementation of the standard test, the overall pass rate is better. However, there are still some problems, such as bacterial endotoxin limits need to be standardized and uniform, 100 ℃ 30 min sterilization process can guarantee sterilization and so on. Through exploratory research, manufacturers are also advised to improve the production technology and improve the quality of products. At the same time, the existing quality standards should be improved and unified to further strengthen the regulation of gatifloxacin injection.