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目的验证金砂五淋丸的卫生学检查方法。方法按照《中国药典》(2010年版一部)附录卫生学限度检查法的规定,采用平皿法(1 mL/皿)对金砂五淋丸细菌数、霉菌和酵母菌数进行测定;采用直接接种法对金砂五淋丸控制菌进行测定。结果采用平皿法对细菌、霉菌和酵母菌进行检查,细菌回收率均大于70%;采用直接接种法对控制菌(大肠埃希菌、大肠菌群)进行检查,试验组、阳性对照组均验出控制菌;阴性对照组未检出试验菌。结论可采用平皿法(1 mL/皿)进行细菌、霉菌和酵母菌数检查;采用直接接种法进行控制菌(大肠埃希菌、大肠菌群)检查。
Objective To verify the method of hygiene examination of Jinsan Wu Lin Wan. Methods The number of bacteria, molds and yeasts in Jinsanwulian pill was determined by the plate method (1 mL / dish) according to the hygiene limit check method in the appendix of Chinese Pharmacopoeia (2010 edition). The direct inoculation method Determination of gold sand Wu Lin Wan control bacteria. Results Bacteria, molds and yeasts were examined by plate method, and the recovery rates of bacteria were all over 70%. The direct inoculation method was used to test the control bacteria (Escherichia coli and coliform bacteria). The test group and the positive control group were tested Control bacteria; negative control group did not detect test bacteria. Conclusion Bacteria, molds and yeasts could be checked by plate method (1 mL / dish). The control bacteria (Escherichia coli and coliforms) were examined by direct inoculation method.