Study on Microbiological Control Strategy of Non-sterile Traditional Chinese Medicine Preparation Based on Water Activity

OBJECTIVE To establish a microbiological control strategy for non-sterile Chinese medicine preparations based on water activity(a_w).METHODS The water activity and the total number of aerobic bacteria of 11 kinds of traditional Chinese medicines(TCM) were measured by the method of placing samples under series of water activity conditions 0.328, 0.529, 0.753, 0.902, 0.973, the water activity distribution and the change rule of the total number of molds and yeasts of 11 kinds of Traditional Chinese Medicines was figure out.RESULTS TCM preparations produced in GMP conditions could be classified into 4 categories according to a_w, assessing the risk of microbial growth and reproduction, and adopting scientific microbial control strategies. For the first type of product a_w≥0.90, test TAMC, TYMC and the prescribed control bacteria and other potentially harmful microbial tests, for the second type of product 0.90 > a_w≥0.85, test TAMC, TYMC and Staphylococcus aureus test, for the third type of product 0.85 > a_w≥0.60, test TAMC and TYMC, for the fourth type of products a_w < 0.60, could be combined with risk assessment, and gradually study the control plan to reduce the test.CONCLUSION The classification of TCM preparations based on a_w provides new ideas for microbial control. Under the premise of reducing the bioburden of TCM preparations, the risk of microbial growth and reproduction during the production, transportation, and storage of TCM preparations can be reduced by controlling the a_w, thereby increasing the level of microbiological control of non-sterile TCM preparations.