CAJ | 학술논문

　　目的建立参苓白术颗粒的微生物限度检查法，对3个生产厂家54个批次产品的微生物限度检查结果进行分析。方法细菌计数，霉菌和酵母菌计数、大肠埃希菌和大肠菌群检查采用常规法。结果选取的3个生产厂家6个批次的产品进行方法验证，5种验证菌的回收率均大于70%。结论3个生产厂家54个批次的参苓白术颗粒微生物限度检查结果均符合规定，结果较为满意。
　　목적건립삼령백술과립적미생물한도검사법，대3개생산엄가54개비차산품적미생물한도검사결과진행분석。방법세균계수，매균화효모균계수、대장애희균화대장균군검사채용상규법。결과선취적3개생산엄가6개비차적산품진행방법험증，5충험증균적회수솔균대우70%。결론3개생산엄가54개비차적삼령백술과립미생물한도검사결과균부합규정，결과교위만의。
Objective The method of microbial limit test of Shenlingbaizhu granules was established, and the test results of 54 batches from 3 manufacturers were analyzed. Methods Routine method was used for bacterium count,total combined molds and yeasts count,detection of Escherichia coli and Coli form bacteria.Results The validation of method test of 6 batches product s from 3 manufacturers has been processed, and the recovery of five validation strains was more than 70%. Conclusion It is satisfactory that results of microbial limit tests of 54 batches Shenlingbaizhu granules from 3 manufacturers were complies.