4种大黄制剂微生物限度检查方法验证及分析  

Validation and Analysis of Microbial Limit Tests for Four Rhubarb Preparations

作　　者：易伟[1] 李思[1] 吴晶晶[1] 苏华[1] 王曙东[1] Yi Wei;Li Si;Wu Jingjing;Su Hua;Wang Shudong(Department of Preparation Division,Nanjing General Hospital of Nanjing Military Command,Nanjing,Jiangsu,China 210002)

机构地区：[1]中国人民解放军南京军区南京总医院制剂科,江苏南京210002

出　　处：《中国药业》2018年第22期33-37,共5页China Pharmaceuticals

基　　金：军队医疗机构制剂标准提高科研专项课题重点项目[14ZJZ08]

摘　　要：目的建立保肾片、新保肾片、炎黄保肾胶囊和新肾炎胶囊4种大黄制剂的微生物限度检查方法,并对该方法进行验证及分析。方法按2015年版《中国药典(四部)》通则1100生物检查法建立微生物限度检查方法并验证。结果保肾片和新保肾片有一定抑菌作用,但可通过稀释法消除;炎黄保肾胶囊和新肾炎胶囊的抑菌作用强,需采用薄膜过滤法才能消除。4种大黄制剂对金黄色葡萄球菌均有抑制作用,其回收率与大黄酸、大黄素和大黄酚的含量总和呈负相关。结论保肾片、新保肾片宜按培养基稀释法进行微生物限度检查,炎黄保肾胶囊、新肾炎胶囊则宜按薄膜过滤法进行微生物限度检查。Objective To establish the microbial limit test for Baoshen Tablets, Xinbaoshen Tablets, Yanhuangbaoshen Capsules and Xinshenyan Capsules,and to carry out the verification of the method. Methods The method of microbial limit test was established and validated according to Chinese Pharmacopeia（2015 edition, volume IV） General rule 1100. Results Baoshen Tablets and Xinbaoshen Tablets had a weak antibacterial effect,but could be eliminated by dilution. Yanhuangbaoshen Capsules and Xinshenyan Capsules had strong antibacterial effect,which need to be eliminated by using membrane filtration. Four kinds of rhubarb preparations had inhibitory effect on Staphylococcus aureus, the recovery rate had a negative correlation with the total content of rhein, emodin and chrysophanol. Conclusion The microbial limit tests of Baoshen Tablets and Xinbaoshen Tablets should be carried out according to the medium dilution method. The microbial limit tests of Yanhuangbaoshen Capsules and Xinshenyan Capsules should be carried out according to the membrane filtration method.

关 键 词：大黄制剂 微生物限度检查法 方法验证 抑菌作用 

分 类 号：R927.11[医药卫生—药学]