Investigation of microorganism contamination in the whole production chain of three kinds of TCM formula granules
10.19778/j.chp.2024.03.008
- VernacularTitle:3种中药配方颗粒全生产链的污染微生物考察
- Author:
Wenjing LI
1
;
Yanfei ZHONG
;
Huanmin ZHU
Author Information
1. 广东省药品检验所,广州 510000
- Keywords:
traditional Chinese medicine formula granules;
decoction pieces;
microorganism contamination;
Cur-cumae Radix;
Mori Folium;
Cicadae Periostracum;
whole process control
- From:
Drug Standards of China
2024;25(3):265-272
- CountryChina
- Language:Chinese
-
Abstract:
Objective:The contaminated microorganisms in the whole production process of Yujin,mulberry leaf and cicada were investigated,and a database was established to explore the microbial key control points and control measures in the production process of traditional Chinese medicine(TCM)formula granules,in order to provide demonstration research for enterprises,provide basis for formulating standards and improving production processes,and fill the blank of the whole.Methods:The raw materials,intermediate products and final products of three kinds of TCM formula particles were analyzed according to the Chinese Pharmacopoeia 2020,and the supporting mi-croorganisms were identified by mass spectrometry technology.The degree of exogenous polluting microorganisms from raw materials to finished products of TCM formula particles and the types of microorganisms easily contamina-ted were analyzed and studied.Results:The raw materials(TCM decoction pieces)of the three TCM formulations granules had serious microbial pollution,and the thermostable bacillus of the raw materials could still be detected in the intermediate products and final products even after the process treatment,and the total number of aerobic bacte-ria in some batches exceeded the limit.Enterococcus faecium from human and animal intestines was also detected in intermediate products and finished products.Conclusion:①Strengthening the control of microbial contamination of TCM decoction pieces is conducive to reducing the microbial load of final products;②There are risks of spore microorganism contamination in the production technology of 3 kinds of formula granuleshas,and the production process parameters should be optimized to reduce the microbial load;③Pharmaceutical companies need to strength-en the whole process of product control to reduce the risk of microbial contamination.
