中药饮片三七粉微生物限度检查方法适用性试验

Applicability test and result analysis of microbial limit test for Sanqi Powder of traditional Chinese medicine

目的按照《中华人民共和国药典》2020年版分别对3个厂家的三七粉进行微生物限度检查方法适用性试验研究并建立其方法,为粉状中药饮片微生物限度检查方法研究提供参考。方法按照《中华人民共和国药典》2020年版四部通则1108,采用平皿法进行需氧菌总数、霉菌和酵母菌总数的计数方法适用性试验,并对沙氏葡萄糖琼脂培养基、沙氏琼脂(含氯霉素)、孟加拉红培养基进行培养基适用性检查试验,采用增菌液常规法和稀释法进行控制菌检查方法适用性试验。结果3个厂家三七粉的需氧菌总数计数方法分别为1∶100、1∶50、1∶20平皿法,霉菌和酵母菌总数计数方法分别为1∶20、1∶10、1∶10平皿法。大肠埃希菌、耐胆盐革兰氏阴性菌均为增菌液常规法,沙门菌增菌液胰酪大豆胨液体培养基最大体积量为200 ml。结论所建立的3个厂家的三七粉微生物限度检查方法符合《中华人民共和国药典》2020年版四部通则的有关规定,方法可行。三七粉对细菌有一定的抑制作用,不同厂家的三七粉微生物限度检查方法并不完全相同。

Objective To establish a microbial limit test and the applicability test for Sanqi Powder from three manufacturers based on Chinese Pharmacopoeia in 2020,and to provide reference for the study of the microbial limit test method of powdered traditional Chinese medicine.Methods According to the four general rules 1108 of Chinese Pharmacopoeia in 2020,the plate method was used to determine the total number of aerobic,mold,and yeast.The applicability of methods for Sabouraud Dextrose Agar,Sabouraud Agar(containing chloramphenicol),and Rose Bengal Agar was studied.The conventional method and dilution method were used to test the applicability of control bacteria.Results The total number of aerobic bacteria in Sanqi Powder from three manufacturers were 1∶100,1∶50,1∶20 by plate method,the total number of molds and yeasts were 1∶20,1∶10,1∶10 by plate method.Escherichia coli and Gram-negative bacteria were both detected by conventional method,and the maximum volume of Salmonella enrichment liquid tryptophan soybean peptone liquid medium was 200 ml.Conclusion The microbial limit test methods of Sanqi Powder from three manufacturers conforms to the relevant provisions of the fourth general rule of Chinese Pharmacopoeia in 2020,and the method is feasible.Sanqi Powder has a certain inhibitory effect on bacteria.The microbial limit test methods of Sanqi Powder from different manufacturers are not identical.