The support of equipment is inseparable to improve the quality of Chinese medicine formula granules

[ Focus on Chemical Machinery and Equipment Network ] Traditional Chinese medicine formula granules are made from single-flavored Chinese medicine pieces that are extracted with water, concentrated, dried, and granulated.
After the clinical formula of Chinese medicine, they can be used by patients.
Chinese medicine formula granules are a supplement to traditional Chinese medicine decoction pieces.
They are simple to take and easy to carry, and are more suitable for the fast-paced life of modern people.

 

Status Quo of Traditional Chinese Medicine Formula Granule Industry
 

Many positive factors support development
 

Judging from the development status of the traditional Chinese medicine formula granule industry, many favorable factors such as the market, policies, and standards are supporting the rapid development of the industry.

 

Among them, on the demand side, with the intensification of aging, the upgrading of consumption levels, and the increase in people's recognition of Chinese medicine formula granules, the market demand for Chinese medicine formula granules will increase in the future.

 

In terms of policy, the "Outline of the Strategic Planning for the Development of Traditional Chinese Medicine (2016-2030)" clearly stated that the Chinese medicine formula granules were included in the content of the national Chinese medicine development strategic plan to support the development of the industry.

 

In addition, since the beginning of this year, under the influence of a special period, Chinese medicine has attracted attention from the industry.
Various localities have supported the Chinese medicine formula granule industry, and many provinces have carried out research.
For example, Qinghai Province has jointly formulated and issued the "Qinghai Province TCM formula granule research pilot work implementation plan", which aims to scientifically guide and standardize the improvement of the research level of Chinese medicine formula granules.
It satisfies the clinical medication needs of the Chinese Medicine Minority Hospital.
Starting from the completion of at least 200 kinds of traditional Chinese medicine formula granules production process and quality standards in a research cycle of 2 to 3 years, we strive to achieve the goal of forming reproducible and popularizing experience in technological innovation.

 

In terms of standards, in August 2016, the National Pharmacopoeia Commission issued the "Technical Requirements for Quality Control and Standardization of Traditional Chinese Medicine Formula Granules (Draft for Solicitation of Comments)", which fully launched the national standard study of Chinese medicine prescription granules.
Many companies have participated in the study of national standards; at the end of 2019, the National Pharmacopoeia Commission announced the first batch of national standards for 160 kinds of Chinese medicine formula granules.
With the national standardization and unification of the quality standards of traditional Chinese medicine formula granules, it will be beneficial to the longer-term development of the formula granule industry.

 

In terms of the market, the current Chinese medicine formula granule market is gradually liberalizing.
For example, this year Anhui Province* issued a document to select 290 types of Chinese medicine formula granules produced by Jiuzhou Fangyuan, including cinnamon, fangfeng, white peony, and dendrobium, into the third batch of Chinese medicine formula granules.
A catalog of the scope of medical insurance payment, and pilot clinical research and use in 209 medical institutions to provide medical insurance reimbursement.

 

　　In addition, the normalization of centralized drug procurement is the general trend.
In the future, biological drugs and proprietary Chinese medicines may be included.
The price reduction trend of medicines is becoming more and more intense.
Under the influence of this channel wave, Chinese medicine formula granules and Chinese medicine decoction pieces have become The hard rock in the market may be able to seize the opportunity.

 

　　In this context, many pharmaceutical companies have accelerated their investment in deployment.
According to incomplete statistics, there are currently over 60 pharmaceutical companies across the country that have obtained the qualifications for the production of traditional Chinese medicine formula granules, including the 6 preliminary Chinese medicine formula granule trial production enterprises approved by the state, and there are also more than 30 pharmaceutical companies in the A-share listed companies.
The company has already deployed or is about to deploy traditional Chinese medicine formula particles.

 

　　Improve the quality of traditional Chinese medicine formula granules
 

　　Inseparable from the support of the device
 

　　Although the market for TCM formula granules is considerable, many people still have doubts about TCM formula granules.
It is necessary for the industry and even enterprises to increase their efforts in production technology, quality standards, safety and effectiveness of TCM formula granules, and clinical application research.
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　　Among them, the improvement of product quality is inseparable from the support of various production and testing equipment.
It is understood that although the traditional Chinese medicine formula granules are convenient to take and seem to be very simple to produce, in fact, the manufacturing process needs to go through multiple links and strict checks at each level.

 

　　In the production process of Chinese medicine formulations particles, according to modern production and processing equipment such as a granule production lines, and also requires various detector holder and the control device to ensure product quality, such as laboratory equipped with Ultra Performance Liquid Chromatography Instrument , triple quadrupole liquid-mass spectrometer, high-resolution mass spectrometer, etc.

 

　　According to "Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules (Draft for Comment)", it is mentioned that since Chinese medicine formula granules no longer have the characteristics of decoction pieces, a characteristic map or fingerprint map with reference medicinal materials as accompanying control should be established.
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The characteristic map can be evaluated by using chromatographic peak retention time, peak area ratio, etc.

 

　　It is understood that high performance liquid chromatography, as the main separation tool for the establishment of fingerprints of traditional Chinese medicines, is also the * method for the publicity draft of Chinese medicine formula particles.
The high performance liquid chromatograph can determine the content of Chinese medicine raw materials and Chinese medicine formula particles according to certain quality indicators to ensure the uniformity and stability of product quality.

 

　　In addition, in accordance with the provisions of the National Pharmacopoeia, the production of traditional Chinese medicine formula particles requires strict testing of heavy metal content, pesticide residues, aflatoxin, sulfur dioxide and other external pollution to ensure the safety of clinical medication.
Therefore, the relevant heavy metal detection equipment also plays an important role in the quality control of traditional Chinese medicine formula granules.

 

　　Some formula granule manufacturers stated that all of their traditional Chinese medicine formula granules are automatically controlled from extraction, concentration, and spray drying, so that each medicinal material can be operated in accordance with a scientific and constant production process, ensuring the stable production of different batches of the same product.

 

　　It can be said that equipment plays an important role in the production process of Chinese medicine formula granules.
In the process of boosting product quality, equipment manufacturers need to seize downstream needs, innovate continuously, and create automated and intelligent equipment to meet the high-quality development needs of the Chinese medicine industry.

 

　　Concluding remarks
 

　　Generally speaking, Chinese medicine granules have a bright future.
At present, the overall scale of my country's traditional Chinese medicine industry has exceeded 800 billion yuan, of which the scale of traditional Chinese medicine decoction pieces has exceeded 200 billion yuan.
According to the data of the "Blue Book of the Development of Chinese Medicine Decoction Pieces Industry", the market size of domestic Chinese medicine formula granules from 2010 to 2018 The compound annual growth rate reached 30%.
Faced with such a huge space for development, the innovation of enterprises should be carried out around the improvement of product quality, and related production and testing equipment, as important "weapons" to improve product quality, also need continuous improvement and innovation to help the Chinese medicine formula granule industry more High-quality development.

 

　　Original title: Improving the quality of traditional Chinese medicine formula particles is inseparable from the support of equipment