Medicine Network December 24th, 2020 - On December 3rd, 2020, the National Group Information Platform released the General Standard for the Production of Chinese Medicine Formula Particles (T/SHPPA008-2020), jointly drafted by the Shanghai Drug Review and Verification Center of the Shanghai Drug Administration and the Shanghai Pharmaceutical Industry Association. From The 28th of January, the group standard of the General Specification for the Production of Chinese Medicine Formula Particles follows the requirements of the Code of Quality Management of Pharmaceutical Production (revised in 2010), which describes the general norms of the whole process of the production of Chinese medicine formula particles, covering the cultivation and cultivation of medicinal herbs, harvesting and initial processing of origin, the preparation of Chinese medicine tablets, the production of Chinese medicine formula particles and other links.
provides a group standard with operaability for Chinese medicine formula particle production enterprises, which, while improving the production capacity of the industry, also greatly improves the regulatory efficiency of regulatory agencies and fills the gaps in the production and supervision of Chinese medicine formula particles in China.
, Chinese medicine formula particles how much do you know? Chinese medicine formula particles are also called Chinese medicine free of frying particles, single-flavored Chinese medicine concentrated particles, Chinese medicine new particles drink tablets, fried drink tablets, etc. , is through modern pharmaceutical technology, Chinese medicine drink tablets as raw materials, by extraction, filtering, concentration, drying, granulation and other series of processes prepared by the granules, is based on the modernization of Chinese medicine, international situation of traditional Chinese medicine a usage supplement.
Chinese medicine formula particles follow the characteristics of Chinese medicine four gas five taste, rise and fall, follow the overall concept of Chinese medicine, dialectical treatment, inherited the basic theory of Chinese medicine, is the heritage of Chinese medicine, easy to save, carry, take, expand the use of Chinese medicine population;
currently, Chinese medicine formula particles are a supplement to traditional Chinese medicine tablets, providing clinicians and patients with options.
II, "General Specification for the Production of Chinese Medicine Formula Particles" standard information III, "General Specification for the Production of Chinese Medicine Formula Particles" drafting unit 4, when will the national standard for Chinese medicine formula particles land? Chinese medicine formula particles in Taiwan and Hong Kong and Japan, South Korea, Singapore application is relatively common, but also achieved good efficacy, and the application in China started relatively late, a large number of basic work needs to start from scratch, in order to strengthen the management of Chinese medicine formula particles, guide the healthy development of the industry, better meet the clinical needs of Chinese medicine, in December 2015, the former State Food and Drug Administration drafted the "Chinese medicine formula particle management measures (draft for comments)," but has not yet been officially released.
2016, the State Pharmacopeia Commission issued the "Chinese medicine formula particle quality control and standard-setting technical requirements (draft for comments)", for the production of Chinese medicine formula particles quality control provides guidance.
November 2019, the State Pharmacopeia Commission promulgated the "Public Notice on the Pilot Uniform Standards for Chinese Medicine Formula Particle Varieties" for a period of three months to regulate the particle quality of 160 Chinese medicine formulations.
Publicity standards are from the source, method, characteristics, identification, feature map and fingerprint map, inspection, leaching, content determination, specifications, storage 10 aspects of 160 kinds of Chinese medicine formula particles for the establishment of quality standards, so that it is more standardized, unified, conducive to the production and sale of these 160 kinds of Chinese medicine formula particles, all along, people outside the industry have called for the landing of Chinese medicine formula particles as soon as possible national regulations.
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