ABSTRACT
OBJECTIVE：To provide reference for r ational use of TCM decoction piece. METHODS ：Electronic questionnaire survey was conducted on the use （dose，ingredient number ）of TCM decoction piece prescriptions in 12 TCM hospitals from 10 provinces（regions，cities）. Through the hospital information system ，416 100 outpatient prescriptions of TCM decoction piece were collected from the First Affiliated Hospital of Henan University of TCM （our hospital ）during May 2016 to Apr. 2019，and were analyzed in terms of prescription dose ，the number of ingredients and use of TCM decoction pieces. At the same time ，the use of TCM decoction piece prescription were analyzed in different departments ，and the clinical application status of TCM decoction pieces prescription were investigated and relevant suggestions were put forward. RESULTS ：The average dose of TCM decoction piece prescriptions in 12 hospitals were 129.60-245.00 g，and the average number of ingredients were 11.90-18.25；the average dose of TCM decoction piece prescriptions in pediatric department was lower than other departments. The average dose of TCM decoction piece prescriptions in our hospital was 242.21 g；55.75％ of the prescription dose were distributed in 201-300 g，and 15.22％ were over 300 g. The average number of ingredients in prescriptions was about 15，and the prescriptions with 11-20 ingredients accounted for 87.75％，those with more than 20 ingredients accounted for 6.64％. Top 20 TCM decoction pieces in TCM prescriptions of our hospital had different degrees of overdose. Three decoction pieces with the highest frequency of overdose were Radix Curcumae processed by vinegar （85.51％），Atractylodes macrocephala stir-fried with bran （82.10％）and A. macrocephala（79.13％）. The number of TCM decoction piece prescriptions in internal medicine department accounted for 40.84％ in our hospital ；there were a lot of TCM prescriptions with dose exceeding 300 g（11.98％ and 18.69％）and the number of ingredients exceeding 18（14.60％ and 9.53％）in internal medicine department and surgery department. The proportion of pediatric TCM decoction piece prescriptions with more than 18 ingredients accounted for 24.09％. CONCLUSIONS ：The overall dosage of TCM decoction piece prescriptions is relatively high ，the number of ingredients is too much ，and the overdose of single-flavored TCM decoction piece is common. Internal medicine department and surgery department should focus on controlling the number of and the dosage of single-flavored decoction pieces of TCM prescriptions to standardize the prescribed dosage. Gynecology department needs to focus on controlling the dosage of single-flavored TCM pieces and pediatrics department should pay special attention to the use of prescription ingredients ，so as to ensure a more scientific and reasonable standard for the clinical application of TCM decoction piece.
ABSTRACT
OBJECTIVE：To compare the difference of microbiological limit test and criteria of TCM decoction pieces among 43 edition of United States Pharmacopeia （USP43），10.0 edition of European Pharmacopeia （EP10.0），17 edition of Japanese Pharmacopeia （JP17）and 2020 edition of Chinese Pharmacopeia （ChP2020），and to provide refernce for the revision and improvement of microbiological standards for TCM decoction pieces in China. METHODS ：The differences in the microbial enumeration tests method （including sampling and sample preparation ，selection of bacteria and culture medium ，count of microorganisms and heat-resistant bacteria ，etc.），tests for specified microorganisms （including sample pretreatment ，enrichment， separation and identification ，etc.）and microbial related limit criteria were compared among USP 43，EP10.0，JP17 and ChP 2020. RESULTS & CONCLUSIONS ：In terms of microbiological examination of TCM decoction pieces ，USP43，EP10.0，JP17 had their own independent provisions. Chp 2020 added“general rule 1108”. In terms of inspection items ，in addition to the total aerobic bacteria count and total combined yeasts and molds count ，ChP2020 and EP 10.0 provided three methods for the inspection of control bacteria （bile-resistant Gram-negative bacteria ， Escherichia coli ， Salmonella）. On the basis ， JP17 supplemented Staphylococcus aureus test；However，USP43 added Clostridium test method and put forward the concept of objectionable microorganisms risk assessment ；ChP2020 also added a new method for counting heat-resistant bacteria. In terms of microbial limit criteria，USP43 was the most detailed in the classification of TCM decoction pieces ，which was more strict than EP 10.0 and JP 17； ChP2020 had not set up a unified limit for the inspection of control bacteria of TCM decoction pieces. ChP 2020 revised the “microbial limit standard for TCM extracts and TCM decoction pieces ”，but it was not perfect compared with the Pharmacopoeia of the United States ，Europe and Japan. It is suggested that according to the current situation of microbial contamination and control of TCM decoction pieces ，the microbial limit test and criteria of TCM related products in Pharmacopoeia should be gradually improved ，and the microbial limit level of corresponding products should be reasonably refined.
ABSTRACT
OBJECTIVE:To promote quality control management of TCM decoction piece in secondary and tertiary TCM hospitals, integrated traditional Chinese and western medicine hospitals, and to guarantee the safety of drug use in patients. METHODS:According to 2016 TCM Decoction Piece Management Special Test Score of National Medical Institution made by quality control center of TCM in Shanghai,TCM decoction piece management of 22 secondary and tertiary TCM hospitals, integrated traditional Chinese and western medicine hospitals (14 and 8,respectively) in Shanghai were scored (the total score is 100),summarized and analyzed by on-site inspection from 7 modules,such as pharmaceutical management,acceptance and storage maintenance, dispensing, decocting or outside processing, prescription standardization and prescription review. The suggestions were put forward. RESULTS & CONCLUSIONS:Average score of 22 hospitals was 91.97, and hospitals with excellent(the secondary and tertiary hospitals are 11 and 5,respectively)and good(the secondary and tertiary hospitals are 2 and 3,respectively) score accounted for 95.45％. Those hospitals obtained good score in respect of pharmaceutical management (the total score is 12,scored 11.73). But in many hospitals,there are shortcomings in acceptance and storage maintenance,dispensing, outside processing,prescription standardization and prescription review management. It is suggested to control TCM decoction piece purchase and acceptance,strengthen TCM decoction piece maintenance and storage,enhance TCM decoction piece batch number management, effectively monitor TCM decoction piece outside processing, improve prescription standardization, implement TCM decoction piece prescription comment and standardize prescription name of TCM decoction piece so as to improve total quality of TCM decoction piece management.