Experts call for the establishment of a scientific standard system for Chinese patent medicines

The standard of Chinese patent medicine belongs to the component of the national drug standard Chinese patent medicine standards include Pharmacopoeia of the people's Republic of China, drug registration standards and other drug standards issued by the State Food and drug administration Other drug standards include Chinese patent medicine standards issued by the State Food and drug administration, new drug normalization standards, imported natural medicine standards, and traditional Chinese medicine prescription preparation standards of medical institutions The traditional Chinese medicine prescription preparation standards of medical institutions are approved by the provincial food and drug administration, which are only used by the approved medical institutions in their own units The rest are approved by the State Food and drug administration, which can be nationwide Internal circulation and use According to the standard practice, the product standard should be consistent For Chinese patent medicine, firstly, the expression should be consistent According to the provisions of the measures for the administration of drug registration, the contents of drug standards include technical requirements such as quality indicators, inspection methods and production processes Among them, the production process is the characteristic of Chinese patent medicine standard, and there is no production process regulation in the chemical medicine standard However, the standards for imported natural drugs and a considerable number of Chinese patent medicines do not stipulate the production process Even if the production process is stipulated, there are a considerable number of production processes that cannot be implemented This is because it is difficult for pharmaceutical manufacturers to implement unified regulations due to different production equipment The drafters of standards often make process conditions according to their own production equipment, while other pharmaceutical manufacturers are difficult to be exactly the same Even pharmaceutical manufacturers drafting standards are difficult to implement the production process according to the original standard due to the change of equipment For example, most pill production is replaced by pelletizing machine, and the amount of honey added is different from that of traditional technology In addition, due to different extraction equipment, the recovery rate of solid preparations such as tablets, capsules and granules is also different According to the production process, the amount of auxiliary materials with fixed proportion is different, so it is difficult to reach the same tablet weight, granule weight or bag weight (granules) specifications, In fact, some Chinese patent medicine tablet and capsule drug standards have cancelled the specification items, but there are still a considerable number of varieties to retain the specification items, which shows that the standard system is lack of coordination In addition, a considerable number of Chinese patent medicine standards do not have the preparation method, that is, the production process Most of these varieties are exclusive products and imported natural drugs There is a historical reason for the publication of the production process of Chinese patent medicine, mainly because the imitated drugs are imitated according to the standard process Since the State Food and drug administration has changed this wrong management concept, the significance of keeping it is worth studying Of course, it can also be considered to properly describe the production process in the standard of Chinese patent medicine, such as regulating solvents As we all know, the properties of traditional Chinese medicine are mainly summarized by Decoction and oral administration If there is an exception, it may affect the properties (functional indications) As for the differences or changes in the equipment of pharmaceutical production enterprises, they should apply for registration according to the supplement of drugs, or even may apply for registration Study according to the requirements of new drugs The standard of Chinese patent medicine should guarantee the fairness and justice of the market The so-called fairness is equal treatment in the same situation For example, in the case of the same prescription, the same route of administration, the same process and the same indications, the same requirements for identification and content determination should be implemented, that is, the same detection in the same situation For example, the content of tanshinone Ⅱ and borneol is regulated in the standard of Compound Danshen oral liquid, and the identification of Notoginsenoside R1, ginsenoside Rb1 and Rg1 is regulated; while the content of tanshinone Ⅱ and salvianolic acid is regulated in Compound Danshen tablet, and the identification of borneol, Notoginsenoside R1, ginsenoside Rb1 and Rg1 is obviously inconsistent Salvianolic acid is not only an effective component, but also an unstable prescription, which is greatly affected by the process and storage conditions As a drug standard, the most reasonable items of drug safety, effectiveness and quality control should be selected for identification and content determination The representative provisions of drug standards are the Chinese Pharmacopoeia The inspection indexes and methods determined by the standards should be the most reasonable when they are formulated or revised The same way of administration and the same prescription varieties of different dosage forms collected by other standards should be "in line" with them, of course, more than the items specified in the Chinese Pharmacopoeia, which can reflect the fairness and impartiality of drug standards It is the requirement of drug standard consistency Of course, there are many contents in the construction of Chinese patent medicine standard system, including drug name, function indications, usage and dosage, precautions, adverse reactions, drug interactions, taboos, storage, etc In addition, the examination and approval, promulgation, revision, implementation, adverse reaction monitoring and Drug Reevaluation of Chinese patent medicine standards also belong to the content of systematic construction.