六味地黄丸(水蜜丸)微生物限度检查法适用性试验研究

Study on the Applicability Test of Microbial Limits Test of Liuwei Dihuang Pill

目的:对六味地黄丸(水蜜丸)进行微生物限度检查法适用性试验的研究。方法:按照2015版《中国药典》四部通则的要求检查,通过回收率的比较来确定适宜的检查方法。结果:需氧菌总数取1:100的供试液采用平皿倾注法,霉菌和酵母菌总数取1:10的供试液采用平皿倾注法,控制菌大肠埃希菌培养基用量为100ml,沙门菌培养基用量为200ml,耐胆盐革兰阴性菌培养基用量为10ml。结论:建立了六味地黄丸的微生物限度检查法,该方法有效可行。

Objective： To study the applicability test of microbial limits test of Liuwei Dihuang pill. Methods： The test was carried out according to Chinese Pharmacopeia （2015 edition, volume IV）,suitable method was confirmed by comparing recovery rate. Results： Ordinary pour dish method was used for the total amount of aerobe which need taking the 1：100 sample solution,ordinary pour dish method was also used for the total combined molds and yeasts count which need taking the 1：10 sample solution, the dosage of E. coli culture was 100ml,the dosage of salmonella was 200ml,the Culture and consumption of Bile salt resistant gram-negative bacteria was 10ml. Conclusion： The microbial limits test of liuwei dihuang pill was established,the method was effective and feasible.