1.Exploration of the application of extraction method in the preparation of drug sterility test solution
Fan SHE ; Yamin LIU ; Hong MIN ; Rui ZHOU ; Zhange XU
Drug Standards of China 2025;26(2):227-231
Objective:Investigating the migration pattern of microorganisms in the oil-water phase during the prep-aration of sterile test solutions for drugs by extraction method,providing reference for the pre-treatment of oil-based matrix test samples.Methods:Inoculate 6 strains of test bacteria separately into sterile isopropyl tetradecanoate,simulate the sample preparation process of extraction method,and detect the growth status of microorganisms in oil-water phase;Detect the recovery ratio of each test bacterium in the aqueous phase using the extraction method.Select semi-solid oily matrix samples and prepare the test solution using extraction method.Establish a sterility test method according to Part 1101 of the 2020 edition of the Chinese Pharmacopoeia.Results:After extraction,the recovery ratio of each test bacteria in the water phase is in the range of 0.64-0.89.After the oily matrix sample is extracted,the water phase is taken for microbial test,which effectively solves the problems of filter membrane blockage and difficult antibacterial removal,and is beneficial to the subsequent microbial inspection.Conclusion:The extraction method can improve the accuracy and sensitivity of microbial detection in the prepara-tion of test solutions for oily matrix samples.The applicability test of the established sterile inspection method meets the requirements of the Chinese Pharmacopoeia.
2.Exploration of the application of extraction method in the preparation of drug sterility test solution
Fan SHE ; Yamin LIU ; Hong MIN ; Rui ZHOU ; Zhange XU
Drug Standards of China 2025;26(2):227-231
Objective:Investigating the migration pattern of microorganisms in the oil-water phase during the prep-aration of sterile test solutions for drugs by extraction method,providing reference for the pre-treatment of oil-based matrix test samples.Methods:Inoculate 6 strains of test bacteria separately into sterile isopropyl tetradecanoate,simulate the sample preparation process of extraction method,and detect the growth status of microorganisms in oil-water phase;Detect the recovery ratio of each test bacterium in the aqueous phase using the extraction method.Select semi-solid oily matrix samples and prepare the test solution using extraction method.Establish a sterility test method according to Part 1101 of the 2020 edition of the Chinese Pharmacopoeia.Results:After extraction,the recovery ratio of each test bacteria in the water phase is in the range of 0.64-0.89.After the oily matrix sample is extracted,the water phase is taken for microbial test,which effectively solves the problems of filter membrane blockage and difficult antibacterial removal,and is beneficial to the subsequent microbial inspection.Conclusion:The extraction method can improve the accuracy and sensitivity of microbial detection in the prepara-tion of test solutions for oily matrix samples.The applicability test of the established sterile inspection method meets the requirements of the Chinese Pharmacopoeia.
3.Review on the effects of TCM on chronic exertional compartment syndrome, and signaling pathways of CaN-NFAT or PPAR/PGC-1 in muscle fiber type conversion
Chongyi XU ; Renfang YIN ; Zhange YU ; Rongguo WANG
International Journal of Traditional Chinese Medicine 2015;(1):83-86
The anti-fatigue ability decline is one of the most important clinical symptoms of chronic exertional compartment syndrome (CECS). The percentage change of type-I and II skeletal-muscle fiber is an important reason for anti-fatigue ability decline after intracompartmental pressure increase. There is a close relationship between CaN-NFAT or PPAR/PGC-1 signaling pathways and muscle fiber type conversion. Studies have confirmed that Traditional Chinese medicine can protect the body tissue by activing CaN-NFAT or inhibiting PPAR/PGC-1 signaling pathways. Therefore, we wrote the review in order to better analyze the research progress in this field.

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