舒筋外洗颗粒微生物限度检查方法的验证  

Methodological Validation of Microbial Limit Test for Shujin Waixi Granules

作　　者：钟碧莲[1] 黄晓冰[1] 陈金兴[1] 

机构地区：[1]广州中医药大学附属骨伤科医院药剂科,广州510240

出　　处：《中国中医药现代远程教育》2015年第19期152-153,共2页Chinese Medicine Modern Distance Education of China

摘　　要：目的建立舒筋外洗颗粒的微生物限度检查方法。方法按《中国药典》2010年版微生物限度检查方法的要求进行验证实验。结果对舒筋外洗颗粒微生物限度检查方法采用常规法进行验证,细菌、霉菌和酵母菌试验组的回收率均大于70%;控制菌检查中,各阳性试验菌均检出,阴性无干扰。结论舒筋外洗颗粒可按常规法进行微生物限度检查。Objective To establish microbial limit test method for Shujin Waixi granules. Methods According to the requirements of microbial limit test method of the Chinese pharmacopoeia（ edition 2010） to verify the experiment. Results Using the routine method of Shujin Waixi granules microbial limit test method for validation, the recovery rates of bacteria, mold and yeast were higher than 70 %. The positive test bacteria were detected, and negative had no interference in the control bacteria test. Conclusion The microbial limit test of Shujin Waixi granules could be investigated by routine method.

关 键 词：舒筋外洗颗粒 微生物限度检查 

分 类 号：R286.0[医药卫生—中药学]