5种大黄制剂微生物限度检查法的建立  

Establishment of microbial limit test method for five Rhubarb preparations

作　　者：李思[1] 方李[1] 吴晶晶[1] 陆崟[1] 苏华[1] 王曙东[1] 

机构地区：[1]南京军区南京总医院制剂科,江苏南京210002

出　　处：《中国医药导报》2015年第24期9-13,共5页China Medical Herald

基　　金：全军医疗机构制剂标准提高科研专项课题重点项目(13ZJZ13)

摘　　要：目的建立5种大黄制剂(保肾片、新保肾片、肾炎宁片、新肾炎胶囊、炎黄保肾胶囊)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、薄膜过滤法对5种大黄制剂的细菌、霉菌和酵母菌进行回收率测定,通过回收率试验测定制剂的抑菌性;采用直接接种法对制剂控制菌进行测定。结果 5种大黄制剂均有抑菌作用,均不可用常规法进行细菌、霉菌和酵母菌测定;2种大黄制剂(保肾片、新保肾片)对枯草芽孢杆菌有较强的抑菌作用,可采用培养基稀释法(0.2 m L/皿)进行细菌数测定,霉菌和酵母菌可采用常规法检查;1种大黄制剂(肾炎宁片)对枯草芽孢杆菌和白色念珠菌有较强的抑菌作用,可采用培养基稀释法(0.2 m L/皿)进行细菌、霉菌和酵母菌数测定;2种大黄制剂(新肾炎胶囊、炎黄保肾胶囊)对枯草芽孢杆菌和金黄色葡萄球菌有很强的抑菌作用,需采用薄膜过滤法对细菌数进行测定,对白色念珠菌有较强的抑菌作用,可采用培养基稀释法(0.2 m L/皿)进行霉菌和酵母菌数测定。结论大黄具有明显的抑菌性,严格按照《中国药典》(2010年版)规定,建立合理适用的5种大黄制剂微生物限度检查方法,以有效控制其质量。Objective To establish a method of microbial limit test for five Rhubarb preparations （Baoshen Tables, Xinbaoshen Tablets, Shenyannin Tablets, Xinshenyan Capsules, Yanhuangbaoshen Capsules）. Methods According to the microbial limit test method set forth in Chinese Pharmacopoeia of 2010 edition, the conventional method, medium dilution method and membrane filtration method were used for the recovery determination of bactria, mould and yeast of five Rhubarb preparations, the antibacterial property of drugs were tested through the recovery determination, and con- trol bacteria was determined by direct inoculation method. Results All of the five Rhubarb preparations showed strong bacteriostasis, and conventional method couldn＇t be used to determine the varieties of bacteria, mould and yeast. Two Rhubarb preparations （Baoshen Tablets, Xinbaoshen Tablets） of them had strong bacteriostasis on Bacillus subtilis, and culture medium dilution method （0.2 mL/plate） could be used for the bacteria number count, and molds and yeasts could be checked by conventional method. One Rhubarb preparation （Shenyanning Tablets） had strong bacteriostasis on Bacillus subtilis and Candida albicans, and culture medium dilution method （0.2 mL/plate） could be used for the bac- teria, molds and yeasts number count. Two Rhubarb preparations （Xinshenyan Capsules, Yanhuangbaoshen Capsules） had very strong bacteriostasis on Bacillus subtilis and Staphylococcus aureus, and membrane filtration method should be used for the bacterial number count. Two preparations had strong bacteriostasis on Candida albicans, and culture medi- um dilution method （0.2 mL/plate） could be used for the molds and yeasts number count. Conclusion Rhubarb has obvious antibacterial activity. In strict accordance with the provisions of 2010 edition in Chinese Pharmacopoeia, suitable method of microbial limit test for five Rhubarb preparations should be established in order to effectively control the quality.

关 键 词：大黄制剂 微生物限度检查 方法验证 回收率 

分 类 号：R927.1[医药卫生—药学]