Establishment Of Microbial Limit Test Methods For 10 Kinds Of Traditional Chinese Medicine Decoction Pieces And Research On Pollution

The diversity of source and the randomness of processing,transportation and storage make the prepared Chinese medicine in pieces highly susceptible to microbial contamination and affect the quality and safety of Pieces themselves and their downstream products.The microbiological examination methods and standards of Chinese medicine in pieces are still in a state of absence.In this paper,completed establishment of microbiological examination methods for 10 representative samples with reference to "Chinese Pharmacopoeia" 2015 edition(four)General rule 1105 microbiological counting method,general rule 1106 specified bacteria inspection method and other national standards.According to the established method in this paper,the TAMC and TYMC of 98 batches of 10 different samples were collected and specified bacteria were inspected.The relationship between microbial contamination and variety,medicinal parts and processing methods and heat treatment was got after the experimental data was statistically analyzed.First,different varieties have significant differences in microbial contamination,TAMC and TYMC of Daphne flower was the highest.Secondly,processing methods of medicinal parts are different.Flowers as medicinal parts(got after the net method,such as Daphne flower)is the most vulnerable to microbial contamination.Mineral herbal Pieces Natural copper(got after calcining and quenching)is less susceptible to microbial contamination.Thirdly,the quantity of thermophilic bacteria is still high(such as Daphne)after 120 min boiling water bath,suggest there are still risks for the patient.Specified bacteria testing results,among 98 batches samples,Salmonella in 2 batches,Escherichia coli in 1 batch,Pseudomonas aeruginosa in 1 batch,and other suspected bacteria such as Helicobacter baumannii,Acinetobacter baumannii,Klebsiella pneumoniae,Enterobacter cloacae,Pseudomonas putida Enterobacter sakazakii.This study shows that Prepared Chinese medicine in pieces is susceptible to microbial contamination.It's very important to improve the test methods and evaluation criteria,thereby reducing the risk of medication.