Chinese medicine formula granules are granules made of single flavor Chinese medicine pieces by water extraction, separation, concentration, drying and granulation, under the guidance of Chinese medicine theory, according to the clinical prescription of Chinese medicine, can be used by patients, belonging to the management category
of Chinese medicine pieces.
It is reported that since the State Food and Drug Administration and other four departments jointly issued the "Announcement on the End of the Pilot Work of Traditional Chinese Medicine Formula Granules", the state has been accelerating the formulation of
national drug standards for traditional Chinese medicine formula granules.
From the perspective of more than 200 national standards for traditional Chinese medicine formula granules that have been promulgated, in order to ensure product quality, the characteristic map, extract and content determination of traditional Chinese medicine formula granules have been required
.
At present, all localities are also accelerating the formulation of
provincial standards for traditional Chinese medicine formula granules.
On November 8, the Jiangxi Provincial Bureau issued the Wuzhu (Shihu) formula granule standard, which is the first Wuzhu (Shihu) formula granule standard issued in China, and it is also the first self-developed authentic medicinal material formula granule standard in Jiangxi Province, marking a new level in the research of traditional Chinese medicine formula granule standard in Jiangxi Province
.
In the next step, the relevant departments of Jiangxi Province also said that they will continue to steadily promote the normalization of the formulation of provincial standards for traditional Chinese medicine formula granules, encourage the research on Jiangxi characteristics and clinically urgently needed traditional Chinese medicine formula granules, so that the standard varieties of traditional Chinese medicine formula granules in the province will be more complete, and the processing and medication habits of special Chinese medicine pieces in the province will continue to be carried forward, so as to promote the innovative development
of traditional Chinese medicine.
On August 19, the website of Hubei Provincial Institute of Drug Supervision and Inspection released the "Announcement on the Quality Standards of Traditional Chinese Medicine Formula Granules in Hubei Province (Third Batch)", which showed that the Hubei Provincial Drug Administration Bureau had organized and completed the third batch of 126 varieties of traditional Chinese medicine formula granule standard review
.
In July, the Guangdong Provincial Institute of Drug Inspection issued a notice on the quality standards of 23 varieties of lentil flower formula granules, strigogold formula granules, plum blossom formula granules, and dongling grass formula granules as the quality standards of traditional Chinese medicine formula granules in Guangdong Province (No.
4 of 2022).
In addition, the Shanghai Municipal and Hainan Provincial Food and Drug Administration have also issued more than 340 quality standards for traditional Chinese medicine formula granules, and the Guangxi Zhuang Autonomous Region, Shandong Province and Jiangsu Provincial Food and Drug Administration have issued more than 200 quality standards for traditional Chinese medicine formula granules.
.
.
The industry believes that under the acceleration of the standard switching progress, the development of the industry will move towards standardization and standardization, which will be more conducive to those enterprises with long-term accumulation in formula granules, such as Red Sun Pharmaceutical, China Resources Sanjiu, etc
.
Taking Red Sun Pharmaceutical as an example, its formula granule products have more than 600 kinds, basically covering varieties with high frequency of clinical use of traditional Chinese medicine, and basically forming barrier advantages
in product types, production processes, quality control and other aspects.
It is worth mentioning that Red Sun Pharmaceutical has also continuously built eight traditional Chinese medicine formula granule production bases
in China.
The intelligent manufacturing base project of traditional Chinese medicine formula granules, which previously invested 750 million yuan in local construction, is expected to have an annual sales scale of more than 3 billion yuan
after completion.
In general, with the gradual promulgation and implementation of the new standard and the steady progress of the company's filing, the future development prospects of traditional Chinese medicine formula granules will be very broad
.
But at the same time, the production capacity of formula granule manufacturers, reserve varieties, etc.
will also put forward higher requirements, related enterprises need to improve the technical level, to ensure that the products meet the national and local standards, of course, in this process enterprises need to be prepared to invest a lot of costs and time
.
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