ABSTRACT
Adulterants and counterfeits were found in some of the commercial traditional Chinese medicine (TCM) decoctions in Hongjin Xiaojie Jiaonang, Hongjin Xiaojie Pian, and Chaihuang Keli during the national drug sampling inspection. However, it was difficult to determine the species of the adulterants and counterfeits by conventional testing methods. Therefore, a total of 184 samples of the TCM decoctions and raw materials belong to the prescriptions of above mentioned traditional Chinese patent medicines, including Bupleuri Radix, Bajiaolian, Heimayi, and Shufuchong, were collected and authenticated by DNA barcoding technology. 111 ITS2 sequences were obtained from 115 commercial TCM decoctions and raw materials of Bupleuri Radix, among which 71 were Bupleurum chinense, three were B. scorzonerifolium, and 31 were closely related species in the same genus. In addition, counterfeits derived from different genera, such as Ailanthus altissima (one sample), Saposhnikovia divaricate (two samples), and Solidago decurrens (three samples), were also detected. 21 ITS2 sequences were obtained from 22 commercial TCM raw materials of Bajiaolian, among which 15 were Diphylleia sinensis and six were Dysosma versipellis and other species in genus Dysosma. For 22 Heimayi samples, PCR amplification of COI sequence was failed due to genomic DNA degradation. Among 38 Shufuchong samples, 24 COI sequences were obtained and only nine of them were the genuine species (Armadillidium vulgare) recorded in the Chinese Pharmacopoeia, 11 were Porcellio laevis, two were Mongoloniscus sinensis, and two samples could not be identified due to the limitation of database. This study demonstrates that DNA barcoding technology is suitable for the species authentication of the decoctions of traditional Chinese patent medicine prescription. It is a conductive way for the establishment of traceability system for the whole TCM industrial chain.
ABSTRACT
OBJECTIVE: To analyze the main measures of the drug quality and safety risks management in the national drug sampling and testing, and provide reference for improving the drug sampling and testing after listing. METHODS: Using retrospective research methods to analyze the effects of the deadline management, special item (special topic) sampling and testing, serious quality risk disposal mechanism, nonserious quality risk warning mechanism, information disclosure on drug quality and safety risk management during the national drug sampling and testing in 2014-2019. RESULTS: A series of measures improved a timely, efficient and complete closed-loop response chain of risk identification-disposal-disclosure. CONCLUSION: The main measures can help reduce public drug safety risks and have good demonstration and guiding significance for local drug sampling and testing. It is recommended to continuously improve the risk management mechanism, such as learning from the US and EU drug regulatory experience, strengthening the sampling and testing of vaccines, imported drugs and consistency evaluated drugs, and personalized designing test and research strategies.
ABSTRACT
OBJECTIVEP: To explore the necessity and feasibility of organic combination of the national drug sampling and testing for quality evaluation and national drug standards improvement. METHODS: Through analysis of the similarities and differences of the two working modes and their complementarity, the problems that may arise in the connection of work were identified. The mechanism and counter measures to promote the organic combination of the two working modes were put forward. RESULT AND CONCLUSION: It was suggested that a communication mechanism should be established in time to strengthen the connection and interaction between the national drug sampling and testing for quality evaluation and national drug standard improvement, thus to avoid wasting resources and timely translate feasible suggestions into national drug standards.
ABSTRACT
OBJECTIVE: To provide a reference to the use of quality standards in national drug sampling and testing, and establish the implementation plan. METHODS: By carding the approval process and usage flow of drug standards, analyzing approval form, authorized department, revise and numbering methods of the standard, composition and influencing factors of standard serviceability were studied. RESULTS AND CONCLUSION: The correctness and accuracy of the quality standards have a tremendous impact on national drug sampling and testing which is a significant measure of post-marketing surveillance. The article focuses on three aspects including the correctness, accuracy and orderliness, and then some solutions are proposed such as establishing the implementation plan and multi sector coordination, which can solve the problem of using standards in national drug sampling and testing.
ABSTRACT
OBJECTIVE: To improve the method of national drug sampling and testing system, Enhance the work efficiency of national drug sampling and testing, improve early warning ability of drug quality risk. METHODS: By using relevant data of national drug sampling and testing in the past 3 years, to analysis the tredency of drug quality situation. Through summarizing the effect of national drug sampling and testing work, put forward suggestions and countermeasures. RESULTS AND CONCLUSION: Strengthening efforts on sampling and testing, improving the efficiency by using varied and flexible sampling form, enhancing the application effects of sampling and testing through multi forms and channels, further perfect drug quality announcement releasing mechanism, enriching the form and content of drug quality announcement, increasing the interpretation and analysis of sampling data, in order to enhance the effective cohesion between the sampling and testing work and supervision management.