Standardized Research On The Method Of Chinese Patent Medicine Standard

As an important part of Chinese medicine,Chinese patent medicines play an important role in the prevention,treatment and diagnosis of diseases.At present,China has approved more than 9,000 varieties of Chinese patent medicines.The manufacturing method is one of the contents of the Chinese patent medicine standard.For a long time,due to lack of deep understanding of the basic principles and functions determined by the manufacturing method,the research on the production process of Chinese patent medicine is weak and lagging.There are different levels of problems in timeliness and other aspects.There are some process steps and related parameters in the preparation method that are difficult to explain with traditional Chinese medicine theory.The fixed process parameters cannot take into account the objective differences in production between enterprises,the main process steps and related parameters specified between the same prescription and different dosage forms of the same administration route.There are large differences,and the fixed parameters specified in the manufacturing method have not been revised for a long time,and it cannot reflect the actual production and management issues.It affects the degree of standardization of the manufacturing method and limits the improvement of the quality of Chinese patent medicine preparations.Comprehensively summarize the issues and put forward standardized principles and suggestions.This topic is based on the current situation and existing problems of the national drug standard system regulations corresponding to the Chinese patent medicines that have been listed on the market in Sichuan Province as a breakthrough in research.A total of 1146 Chinese patent medicine varieties have been listed in Sichuan Province,and 333 varieties listed in the 2015 edition of the Chinese Pharmacopoeia are selected.Extract the corresponding standards of the 333 varieties in the form of computer program commands,including [prescription],[manufacturing method],[specification],[usage and dosage],[function indication],etc.,select and classify [manufacturing method] main process steps and related parameters recorded in it,and establish a database of Chinese patent medicine standards.Based on the data in the database,we summarize the current status of the steps of extraction,concentration,separation and purification,and the amount of preparation and related parameters in the standard manufacturing method of Chinese patent medicine.According to the current status of the regulations,research is carried out in conjunction with relevant laws and regulations,Chinese medicine theory,relevant research reports,and the use of Chinese patent medicine standard preparation method to demonstrate the problems in the Chinese patent medicine standard preparation method.Based on the problems found,corresponding improvement suggestions are proposed to provide a reference for the standardization of Chinese patent medicine standards.This thesis is composed of seven chapters.The first chapter is an introduction,which mainly describes the research background,current status,research content and ideas,research purpose and significance,and research methods of this topic;Chapter2 is an overview of the listed Chinese patent medicines in Sichuan Province,Record the distribution of the dosage forms of the Chinese patent medicines on the market in Sichuan Province,the collection of national drug standards(including the changes in the number of varieties and the changes in the system of legal items included in the Chinese Pharmacopoeia),and the regulations of the standard of Chinese patent drugs To provide data support for the development of the subsequent chapters;chapters three,four,five,and six are respectively the current status and problems of the process steps and related parameters of the extraction,concentration,separation and purification,and production volume of the standard preparation of Chinese patent medicines It mainly proposes that it is impossible and unnecessary to stipulate specific process parameters in the standard manufacturing method of Chinese patent medicine,only need to state the point of view of the process route.The specificprocess equipment and parameters should be recorded in the production process document.Approved by the supervisory and administrative department as the content of drug registration approval;Chapter VII is the standardization proposal for the standard system of Chinese patent medicine Suggests the correct distinction between proprietary standard system of law and medicine production technology,medicine ought to state clearly the standard system of law items.In the process of manufacturing and repairing the standard manufacturing method of Chinese patent medicine,it is necessary to deeply explore the scientific connotation of applying traditional Chinese medicine theory,and respect the practice of classic famous prescriptions and modern clinical prescriptions;Improve the principle of writing the content of the standard system,recommend the introduction of the "reference substance" control concept,and enhance the universality of the standard system of Chinese patent medicine;increase the principle of uniformity of the system of the same prescription with different formulations of the same prescription.