Objective To provide suggestions for optimizing the sampling management of Chinese herbal pieces and improving the quality Chinese herbal pieces.Methods Logical reasoning method was used to analyze the problems in the...Objective To provide suggestions for optimizing the sampling management of Chinese herbal pieces and improving the quality Chinese herbal pieces.Methods Logical reasoning method was used to analyze the problems in the drug spot check of Chinese herbal pieces based on the data of drug quality published by the National Medical Products Administration from 2013 to 2021,combined with the current provisions and implementation of drug spot check management in China.Results and Conclusion At present,there are some problems in the drug spot check of Chinese herbal pieces,such as fewer varieties of Chinese herbal pieces in the national drug spot check,the unreasonable sampling links,the insufficient territorial management in some areas,and error-prone sample extraction.It is suggested that the actual quantity and overall quality of Chinese herbal pieces should be fully considered in the formulation of sampling plan.Besides,the variety coverage of drug spot check of traditional Chinese medicine should be strengthened.In the planning,the sampling links shall be made as a whole,and the credit rating and distribution of drug production,operation and use units within the jurisdiction shall be fully combined.While strengthening the sampling management at the production end in areas with concentrated industries,regional special drug spot check should be carried out or the administrative forces at the provincial,municipal and county levels should be fully mobilized to avoid local protection.In the assigned tasks,the name of Chinese herbal pieces should be accurately expressed to avoid the sampling errors of Chinese herbal pieces with the same original medicinal materials and different processing methods.展开更多
文摘Objective To provide suggestions for optimizing the sampling management of Chinese herbal pieces and improving the quality Chinese herbal pieces.Methods Logical reasoning method was used to analyze the problems in the drug spot check of Chinese herbal pieces based on the data of drug quality published by the National Medical Products Administration from 2013 to 2021,combined with the current provisions and implementation of drug spot check management in China.Results and Conclusion At present,there are some problems in the drug spot check of Chinese herbal pieces,such as fewer varieties of Chinese herbal pieces in the national drug spot check,the unreasonable sampling links,the insufficient territorial management in some areas,and error-prone sample extraction.It is suggested that the actual quantity and overall quality of Chinese herbal pieces should be fully considered in the formulation of sampling plan.Besides,the variety coverage of drug spot check of traditional Chinese medicine should be strengthened.In the planning,the sampling links shall be made as a whole,and the credit rating and distribution of drug production,operation and use units within the jurisdiction shall be fully combined.While strengthening the sampling management at the production end in areas with concentrated industries,regional special drug spot check should be carried out or the administrative forces at the provincial,municipal and county levels should be fully mobilized to avoid local protection.In the assigned tasks,the name of Chinese herbal pieces should be accurately expressed to avoid the sampling errors of Chinese herbal pieces with the same original medicinal materials and different processing methods.
