具有抗菌活性的中药固体制剂微生物限度检查计数方法研究  

Study on the Microbial Enumeration Tests for Solid Preparation of Traditional Chinese Medicine with Antimicrobial Activity

作　　者：徐晓洁 冷佳蔚 王志宏 丁勃 

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]龙口市出入境检验检疫局,龙口265700

出　　处：《中国药事》2015年第9期946-950,共5页Chinese Pharmaceutical Affairs

基　　金：中国食品药品检定研究院中青年发展研究基金(编号2013WA5)

摘　　要：目的：采用双层膜过滤方法,建立具有抗菌活性的中药固体制剂微生物限度检查微生物计数方法。方法：设计新型微生物检查用双层膜过滤器,以30~50μm作为预过滤膜,0.22μm作为终端滤膜,采用《中国药典》微生物计数适用性试验方法,进行验证试验,考察预过滤对供试液中微生物的影响情况。结果：双层膜过滤方法,可以有效避免颗粒物堵塞滤膜,利于消除供试液抗菌活性,降低实验过程对样品中微生物造成的损伤或损失。结论：双层膜过滤法实验过程符合《中国药典》相关规定,试验结果有效,可用于药品的无菌检查或微生物限度检查试验。Objectives： To develop a new method of two-membrane filtration in microbial enumeration tests for solid preparation of traditional Chinese medicine. Methods： New fi lters with double thin membranes were designed by using different pore-size membranes： pre-fi lter membrane with 30 μm-50 μm, and terminal fi lter membrane with 0.22 μm t. The effects of pre-fi ltration of test solution on several strains were evaluated by the methods described in Chinese Pharmacopoeia. Results： The established method of two-membrane fi ltration can eliminate the antibacterial activity of the samples, thus reducing the injury or loss of microorganisms in special samples. Conclusion： The two-membrane fi ltration method meets the requirements of Chinese Pharmacopoeia; the test results are valid and the method can be used for sterility test and microbial limit test for drug substances.

关 键 词：中药口服固体制剂 微生物计数检查 供试液处理 预过滤 双层膜过滤法 

分 类 号：R944.2[医药卫生—药剂学]