摘要
目的研究3种中药制剂的抑菌作用,建立、验证其微生物限度检查方法。方法根据《中国药典》2010版之规定进行回收率试验,测定其是否对微生物有抑制作用。结果妇炎净合剂对金黄色葡萄球菌有一定抑制作用,但可通过培养基稀释法消除。丹药合剂、养血化瘀合剂对各试验菌种无明显抑制作用。结论丹芍合剂与养血化瘀合剂可按常规法进行微生物限度检查,妇炎净合剂可按培养基稀释法进行微生物限度检查,各种制剂控制菌检查可按常规法。
Objective To study the antimicrobial effect of 3 kinds of Chinese patent medicines and to establish microbial limit test method for them. Methods Common method and culture medium dilution method were used to do the recovery test in order to validate the method, according to Chinese Pharmacopeia,2010. Results Fu Yan Jing oral liquid shows inhibition effect on staphylococcus aureus to some extent. The effect can be eliminated by culture medium dilution method. Other 2 kinds show no obvious inhibition effect on bacterials. Conclusion The common method can be used for the microbial limit test of Dan Shao oral liquid and Yang Xue Hua Yu oral liquid. Dilution method can be used for the microbial limit test of Fu Yan Jing oral liquid. The common method is suitable for all kinds of specified microorganisms.
出处
《临床合理用药杂志》
2016年第23期21-22,共2页
Chinese Journal of Clinical Rational Drug Use
关键词
微生物限度检查方法验证
药品质量
回收率
Validation of method for microbial limit test
Drug quality
Recovery rate
