14种中成药微生物限度检查方法研究

Study on the Microbial Limit Test Method for 14 Kinds of Chinese Patent Medicines

目的:建立14种中成药的微生物限度检查方法。方法:按照《中国药典》(2010年版)微生物限度检查法的规定,采用常规法、培养基稀释法及薄膜过滤法对各品种细菌、霉菌和酵母菌数进行回收率测定,通过回收率试验测定药物的抑菌性;采用直接接种法对各品种控制菌进行测定。结果:6种供试品(抗宫炎片、克咳胶囊、保济丸、夏桑菊颗粒、妇炎康复胶囊、小儿咽扁颗粒)无抑菌作用,细菌回收率均大于70%,可采用常规法对细菌数测定;4种供试品(藿香清胃片、护肝宁片、橘红丸、黄芩片)对细菌抑菌作用较强,可采用培养基稀释法(0.2mL/皿)进行细菌数测定;4种供试品(清热解毒片、鼻渊丸、冠心丹参胶囊、清喉利咽颗粒)对金黄色葡萄球菌和枯草芽孢杆菌有很强的抑菌作用,需采用薄膜过滤法测定细菌数;上述各品种的霉菌和酵母菌及各种必检控制菌均可采用常规法检查。结论:经验证的微生物限度检查方法适用于以上中成药的微生物限度检查,可有效控制其质量。

Objective ：To establish a method of microbial limit test for 14 kinds of Chinese patent medicines. Methods： According to the microbial limit test method set forth in the Chinese Pharm, acopoeia of 2010 edition, the conventional method, medium dilution method and membrane filtration method were used for the recovery determination of the varieties of bacteria, mould and yeast, the antibacterial property of drugs was tested through the recovery determination, and the different control bacteria were determined by the direct inoculation method. Results： Six testing samples （kanggongyan tablets, keke capsules, baoji pills, xiasangju granules, fuyankangfu capsules, and xiaoeryanbian granules） showed no bacteriostasis and their bacterial recovery rates were more than 70%, which showed that the conventional method can be used to determine the bacterial count. The testing samples of huoxiangqingwei tablets, huganning tablets, juhong pills and huangqin tablets showed strong bacteriostasis, and the culture medium dilution method （0.2 mL/plate） can be used for the bacterial count determination. The testing samples of qingre jiedu tablets, biyuan pills, guanxin danshen capsules and qinghou liyan granules presented very strong bacteriostasis on Staphylococcus aureus and Bacillus subtilis, and membrane filtration method should be used for the bacterial counting test. The conventional method can be used for the testing of mould and yeast and various control bacteria of above mentioned testing samples. Conclusion： The method of microbial limit test was verified suitable for the above mentioned Chinese patent drugs and the method was proved effective in the quality control of the drugs.