Risk analysis and control strategies of prescription drugs and production process of Xiaojin Pills
Xiaojin Pills is the first choice of Chinese patent medicine for the clinical treatment of mammary glands hyperplasia in Chinese medicine.In recent years,with the in-depth study of Xiaojin Pills,reports on quality control problems and adverse reactions have gradually increased.The comprehensive superposition of multiple factors,such as complex drug sources,variable medicinal material quality,different material properties and special production processes,seriously affects the stability,controllability,uniformity and consistency of Xiaojin Pills'quality and the safety and efficacy of clinical application.This is also a common bottleneck problem in the quality improvement of traditional Chinese medicine preparations.Based on theoretical analysis and production process,this article analyzes and summarizes the quality influencing factors and control risk points of Xiaojin Pills from the two perspectives of drug quality in prescriptions and process control of production,and proposes improvement strategiesand suggestions.It is expected to provide a scientific basis for the quality assurance of Xiaojin Pills and a reference for the fine manufacturing and innovation of other traditional pills.
Xiaojin PillsQuality controlRisk assessment and controlSafetyConsistencyPrescription drugsProduction processStrategies
NETL
NSTL
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