莫慧贞,许则省
MO Hui-zhen,XU Ze-sheng(1. Yangjiang Institute for Drug Control

• 1:广东省阳江市药品检验所
• 2:广东阳江制药厂有限公司

摘要(Abstract)：

目的完善注射用盐酸克林霉素的无菌检验方法。方法通过确定稀释量、冲洗量、选择阳性对照菌等,以注射用盐酸克林霉素(0.6g)为例,说明无菌检查法建立在验证试验基础上的必要性。结果注射用盐酸克林霉素的验证试验,保证无菌检查方法的科学性和检验结果的准确性,证明方法可行。结论将中国药典2005年版二部样品项下无菌检验方法进一步完善。
Objective To improve the sterility test of clindamycin hydrochloride for injection. Methods By determining the amount of dilution and flushing volume,the positive control was selected. The clindamycin hydrochloride for injection (0.6 g) was used as an example to show the necessity of sterility test based on a basis of verification test. Results The verification test of clindamycin hydrochloride for injection could ensure the scientific character of sterility test and the accuracy test results. Conclusion The result can further improve the sterile test methods in Chinese Pharmacopoeia (Edition 2005,Vol II).

关键词(KeyWords)： 注射用盐酸克林霉素;薄膜过滤法;无菌验证
clindamycin hydrochloride for injection; membrane-filter; sterility test

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 莫慧贞,许则省
MO Hui-zhen,XU Ze-sheng(1. Yangjiang Institute for Drug Control

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