The first batch of national standard of traditional Chinese medicine granules is coming! Open the new pattern of formula granules!

Author: unharmed, Jiao Mengmeng On November 8, the State Food and drug administration again solicited opinions on the technical requirements for quality control and standard setting of traditional Chinese medicine formula granules, which put forward technical requirements for standardizing the standard research of traditional Chinese medicine formula granules and reflecting the quality control of traditional Chinese medicine formula granules On the same day, the national pharmacopoeia commission publicized 160 unified standards for the pilot varieties of traditional Chinese medicine formula granules The traditional Chinese medicine formula granule is a granule which is made of single Chinese medicine pieces by water extraction, separation, concentration, drying and granulation It is a supplement to traditional Chinese medicine pieces Under the guidance of the theory of traditional Chinese medicine, according to the clinical prescription formula of traditional Chinese medicine, for patients to take it, its clinical effect should be consistent with the corresponding pieces Compared with the traditional Chinese medicine pieces, the traditional Chinese medicine formula particles do not need to be tormented, just need hot water to brew can take In addition, the difference between traditional Chinese medicine formula granules and compound granules is that traditional Chinese medicine formula granules have only one medicine, while compound granules have several medicines at the same time Japanese changcang yinzang first applied granule preparation technology to traditional Chinese medicine In the 1950s, Xu Hongyuan worked in the Taiwan Provincial Health Laboratory He went to Japan's changcang pharmaceutical factory to see Japanese enterprises using large pots of decocting herbs to make granules and packaging them into commodities for sale The products did not need to be decoctified as ordinary pieces of Chinese herbal medicine to be taken immediately Xu Hongyuan brought this idea back to Taiwan But the earliest products in Taiwan were not granules Traditional Chinese medicine had never been decocted and was made into powder by grinding the medicine directly In contrast, this kind of traditional Chinese medicine powder has a large volume and can not be completely dissolved, so it is complained by doctors and patients In the mainland of China, after the economic reform and opening up, some pharmaceutical companies began to copy "Chinese herbal granules for compatibility", and the official name of the relevant products is "Chinese herbal formula granules" The development process of traditional Chinese medicine formula granules can be roughly divided into three stages: research and trial production (1992-2000), gradually standardized management (2001-2014) and pilot production to be released (2015-now) In 1993, the State Science and Technology Commission and the State Administration of traditional Chinese medicine listed the traditional Chinese medicine formula granules in the "spark plan" In March 1994, the State Administration of traditional Chinese medicine approved Guangdong Yifang and Tianjiang pharmaceutical industry as the "national pilot unit for the reform of traditional Chinese medicine preparation" In the stage of research and trial production, the State Administration of traditional Chinese medicine attached great importance to it and supported it by various ministries and commissions of the state, as well as through scientific research The cooperation between colleges and universities has made great achievements in technology, quality standard, efficacy, single decoction and co Decoction clinical comparative study In April 2001, the Interim Provisions on the administration of traditional Chinese medicine formula granules was promulgated, and then enterprises were successively approved to pilot the production of traditional Chinese medicine formula granules In September 2012, the national pharmacopoeia committee drafted the technical requirements for research and formulation of quality standards for granules of traditional Chinese medicine (Draft for comments) According to the requirements of this document, by 2015, the pilot production enterprises had completed the unification of 681 product process standards In December 2015, the former State Food and Drug Administration issued the measures for the administration of traditional Chinese medicine formula granules (Draft for comments), which is intended to liberalize the pilot production of traditional Chinese medicine formula granules; on February 26, 2016, the State Council issued the strategic planning outline for the development of traditional Chinese medicine (2016-2030), which clearly included traditional Chinese medicine formula granules in the national strategic plan for the development of traditional Chinese medicine Among them, traditional Chinese medicine formula granules have become a hot topic in the medical circle Since 2015, there have been many provinces in China, including Hebei, Zhejiang, Heilongjiang, Jilin, Anhui, Shaanxi, Henan, Chongqing, Jiangxi, Guangdong and other provinces, which have approved relevant enterprises to carry out scientific research and production pilot of traditional Chinese medicine formula granules and clinical use in medical institutions This also reflects the urgent demand of the whole industry for the release of traditional Chinese medicine formula granules from one side On August 5, 2016, the National Pharmacopoeia Committee issued the technical requirements for quality control and standard setting of traditional Chinese medicine formula granules (Draft for comments), comprehensively launched the research on the national standard of traditional Chinese medicine formula granules, and a number of enterprises including 6 national pilot enterprises participated in the research on the national standard, and the research and formulation of the national standard of traditional Chinese medicine formula granules, for the standardization of traditional Chinese medicine formula granules It is of great significance to promote the production of granules, to promote the unification of the standard of TCM formula granules, to speed up the establishment of overall marketization, and to promote the modernization process of TCM Since July 2001, the State Food and Drug Administration (SFDA) has issued the Interim Provisions on the management of traditional Chinese medicine formula granules, which clearly includes the traditional Chinese medicine formula granules into the category of Chinese medicine decoction piece management However, due to the inconsistency of production process and enterprise quality standards, the SFDA has strictly controlled the qualification of pilot production enterprises and only approved six enterprises for pilot production However, at the end of 2015, with the release of the management measures for traditional Chinese medicine formula granules (Draft for comments), Zhejiang, Heilongjiang, Henan, Anhui and other provinces successively issued documents to approve the provincial pilot enterprises of traditional Chinese medicine formula granules, and more than 30 pharmaceutical enterprises got "tickets" It is estimated that in 2018, the traditional Chinese medicine formula granule industry has reached 20 billion yuan, an increase of 30% year on year This market scale has attracted a lot of enterprises to join The leading enterprises of Chinese traditional medicine and other industries occupy the national market At present, there are more than 700 kinds of Chinese herbal formula granules, accounting for 50% of Chinese herbal pieces At present According to the management of Chinese herbal pieces, the Chinese herbal formula granules can keep the favorable policies such as drug addition, no two ticket system requirements, and no proportion of hospital drugs Although at present, the national level does not explicitly include the traditional Chinese medicine formula granules in the medical insurance management, some provinces and cities have explicitly included the formula granules in the territorial medical insurance or the management according to the pieces of decoction, and the medical insurance preferential policies will continue to promote the expansion of the formula granules market However, due to the fact that traditional Chinese medicine formula granules are still in the stage of scientific research pilot, there is no unified production process and quality standards for reference The enterprises in the pilot production of formula granules are limited by their own technical level, R & D investment and production scale, and basically explore their own production process and quality standards The market supervision department also supervises the products according to the standards of the production enterprises The supervision department does not have the corresponding standards to supervise the traditional Chinese medicine formula particles, and can only manage according to the enterprise standards.