黄连上清丸微生物限度检查方法验证浅析  

Simple analysis on validation of method in microbial limit tests for Huanglian Shangqing pills

作　　者：特玉香[1] 刘鹏[1] 戴翠[1] 马仕洪[1] 苏德模[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2006年第11期1674-1677,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:黄连上清丸为中国药典品种,分析进行该品种微生物限度检查方法验证实验的必要性。方法:按2005年版中国药典的规定,采用7个生产企业生产的黄连上清丸进行该品种微生物限度检查方法的验证。结果:黄连上清丸对5株阳性代表菌株有不同程度的抗菌活性,但有的批无抗菌活性;即使同一厂家的不同批产品其抗菌活性亦有差异。结论:微生物限度检查方法验证是必要的;中成药质量的稳定性可能与原药材质量和工艺有关。Objective： Huanglian Shangqing pills has been recorded in the Chinese Pharmacopoeia. It is necessary for validation of microbial test with many batches of Huanglian Shangqing pills. Methods： According to the Chinese Pharmacopoeia 2005,the microbiological test method of Huanglian Shangqing pills from 7 corporations was valida- ted. Results： Huanglian Shangqing pills was antibacterial for 5 kinds of control bacteria of different grade, but some batches were not antibacterial; different batch appeared different antibacterial ability even from one corporation. Conclusion ： Validation of microbiological test is necessary. The stability of quality is based on the quality of medicinal materials and factors of production in Chinese patent medicine.

关 键 词：方法验证试验 微生物限度 回收率 中药材 

分 类 号：R917[医药卫生—药物分析学]