化橘红微生物限度检查方法适用性研究

Method Suitability Test for Microbial Limit Test of Citri Grandis Exocarpium

目的建立化橘红微生物限度检查方法。方法依据《中华人民共和国药典》2020版四部中的中药饮片微生物限度检查法,进行方法适用性试验研究。结果微生物计数方法适用性试验:采用溶液稀释法将化橘红按1∶50稀释后,进行需氧菌、耐热菌总数试验,各菌株回收率均达到《中华人民共和国药典》要求;采用常规法进行霉菌和酵母菌总数试验,各菌株回收率均达到《中华人民共和国药典》要求。采用直接接种法开展控制菌试验,试验组均能检出试验菌。结论进行化橘红微生物限度检查时,溶液稀释法可用于需氧菌总数、耐热菌总数检查;常规法可用于霉菌和酵母菌总数检查;直接接种法可用于控制菌检查。

Objective To establish a microbial limit test method for Citri grandis exocarpium.Methods According to the microbial limit test method of Chinese herbal decoction pieces in the fourth part of Pharmacopoeia of the People's Republic of China(2020 edition),the applicability of the method was studied.Results The results showed that the recovery rate of Citri grandis exocarpium meet the requirements of Chinese Pharmacopoeia When solution dilution method(1:50)was used to test the aerobic bacteria count and the thermoduric bacteria count.When routine method was used to test the total number of mold and yeast,all the recovery rate met the requirements of Chinese Pharmacopoeia.When the direct inoculate method was used to test the control bacteria,all the positive bacteria could be detected.Conclusion In the microbial limit test of Radix bupleur,solution dilution method can be used to test the aerobic bacteria count and the thermoduric bacteria count,routine method can be used to test the total number of mold and yeast and direct inoculate method can be used to test the control bacteria in Citri grandis exocarpium.