西红花酸胶囊微生物限度检查方法学验证研究

目的：建立西红花酸胶囊微生物限度检查方法。方法：按2005年版中国药典，用大肠埃希菌、枯草芽胞杆菌、金葡菌、黑曲霉和白色念珠菌对3批次西红花酸胶囊进行微生物限度检查方法学验证试验。结果：采用常规法，仅有枯草芽胞杆菌试验组平均回收率为59％，其余各菌株试验组回收率均大于70％；采用培养基稀释法，所有验证菌试验组回收率均大于70％；控制菌检查试验组采用常规法，检出了大肠埃希菌。结论：本项研究提供了一个适用于西红花酸胶囊微生物限度检查的方法。

Study on Methodological Validation of Microbial Limit Examination of Crocetins Capsules

Objective： To establish a method for microbial limit examination of Crocetins capsules. Methods： Following the method for microbial limit examination in Chinese Pharmacopoeia 2005th edition, the microbial examination of 3 batches of Crocetins capsules were validated using Escherichia coli, Bacillus subtilis, Staphylococcus aureus, Aspergillus niger and Candida albicans. Results： It was found by conventional method that the mean recovery in Bacillus subtilis group was 59 % and the recoveries in the rest were above 70%. It was also found by culture meditun-diluting method that the recoveries in all test microbe groups were above 70%. Escherichia coli was detected in control bacteria examination by conventional method. Conclusion： A method suitable for microbial limit examination of Crocetins capsules has been obtained.