复方紫草油微生物限度检查法的建立

Establishment of microbial limit test for Compound Zicao Oil

目的建立复方紫草油的微生物限度检查方法。方法采用无菌十四烷酸异丙酯、聚山梨酯80或混合中和剂溶解,制备供试液,按照中国药典2015年版第四部规定对复方紫草油进行微生物限度检查适用性实验。结果单独或混合无菌十四烷酸异丙酯和聚山梨酯80作为中和剂,无法得到稳定均一的供试液,使用无菌单硬脂酸甘油酯、聚山梨酯80和司盘80组成的混合中和剂可以得到性状稳定均一供试液,微生物回收率在0.5~2之间;控制菌检查中,各阳性试验菌均检出,阴性对照均无菌生长。结论复方紫草油的微生物限度检查方法可行。

Objective To establish the method for the microbial examination of Compound Zicao Oil.Methods According to the microbial limit test in the four books of Chinese Pharmacopoeia(2015 Edition),the applicability test for Compound Zicao Oil was conducted.The samples were dissolved by sterilized isopropyl myristate,polysorbita 80 or mixed neutralizer.Results Using isopropyl myristate or polysorbita 80 as neutralizer separately to mixed together couldn’t get a stable solution,however using sterilized glyceryl monostearate,polysorbita 80 and span 80 as mixed neutralizer could get a stable solution.The recovery ratio of applicability test of total count of aerobic bacteria and total count of molds were in the range of 0.5-2.0.Every positive test microorganism could be detected while negative control one could not grow in the examination of control microorganisms.Conclusion This method could be applied for the microbial limit test of Fufang Zicao Oil.