The promulgation and implementation of the national standard for Chinese medicine formula granules helps Chinese medicine to develop

The characteristics of the standard of traditional Chinese medicine formula granules

The implementation of the national standard for Chinese medicine formula granules will help to fully realize the overall quality control of the safety and effectiveness of Chinese medicine formula granules.
It is a major milestone in the inheritance and innovation of the traditional Chinese medicine industry
.
Among the 160 national standards for TCM formula granules promulgated this time, the items, indicators, and limits set by each standard can better realize the quality control of the whole process from TCM materials, Chinese medicine decoction pieces to TCM formula granules, especially for the original The quality control in terms of, quality transfer, value relationship, stability and safety has pioneering characteristics
.

On the whole, the national standard of traditional Chinese medicine formula granules has the following characteristics:

● clear Dalkey original medicinal species, the base of the original source of the medicine more accurately controlled
.
In principle, the standard distinguishes between different origins and establishes an exclusive quality standard
.

● Fully embodies the traditional decoction technology to ensure adequate feeding of decoction pieces
.
The standard formulation process fully considered the research-determined amount of decoction pieces, water decocting process, drying and concentration method, extraction rate of extract and production volume and other information
.

● It can effectively distinguish the authenticity of formula granules and realize the overall quality control of Chinese medicine
.
The national standards of formula particles have set up items such as thin-layer identification, feature/fingerprint spectrum, extract, content determination, etc.
, which can not only reflect the authenticity of formula particles, but also reflect their advantages and disadvantages, and fully reflect the quality of the complex system of traditional Chinese medicine.
The control feature better guarantees the quality of Chinese medicine formula granule products
.

● Fully implement the requirements of the new version of "Chinese Pharmacopoeia" for foreign harmful residues, so that the formula particles are more safe
.
Based on the study of exogenous and other harmful residues in formula granules, unified requirements for pesticide residues, heavy metals and harmful elements, mycotoxins, etc.
, refer to the 2020 edition of the Chinese Pharmacopoeia, which greatly improves the safety of traditional Chinese medicines.

.

● Reasonably stipulate the conditions of storage and circulation links to better guarantee the quality of formula particles
.
The quality of formula granules is closely related to the conditions of storage and circulation.
In the drafting of the standard, the relevant aspects were fully investigated, and the factors affecting safety and effectiveness, such as the reasonable limit of moisture and storage methods, were fully considered
.

Development prospects of traditional Chinese medicine formula granules

In April, the 2020 transcripts of listed pharmaceutical companies were announced successively.
According to the company’s annual report statistics, leading pharmaceutical companies such as China Traditional Chinese Medicine, Hongri Pharmaceutical, Shenwei Pharmaceutical, China Resources Sanjiu, etc.
all stated that the sales of traditional Chinese medicine formula granules / decoction pieces continued to rise last year , The joint sales scale has exceeded 16.
8 billion yuan
.
From 2006 to 2016, the market size of traditional Chinese medicine formula particles increased from 200 million yuan to 10.
7 billion yuan, with a compound annual growth rate of 48.
9%.
In 2020, the overall market size of traditional Chinese medicine formula particles will reach 25.
5 billion yuan
.
The agency predicts that the market size of the traditional Chinese medicine formula granule industry will continue to grow rapidly in the next few years.
It is estimated that by 2023, the industry size will reach 49.
21 billion yuan
.

In the context of the rapid growth in demand for traditional Chinese medicine, traditional Chinese medicine formula granules are becoming a new blue ocean
.
With the continuous improvement of national policies and the implementation of this standard, the status of formula particles will become increasingly stable
.
Chinese medicine formula granule is a new Chinese medicine product of the 21st century Chinese medicine drink tablet reform
.
In clinical application, the convenience of using Chinese medicine formula granules has also been recognized by doctors and patients
.

  In addition, formula granules still belong to the category of Chinese herbal medicine, except for a few provinces, they are not included in centralized procurement
.
With the policy support of formula particles and the implementation of national standards, it is bound to usher in a new round of golden development period
.

references:

[1] Song Zonghua, Wang Hainan, Wang Lixin, Qian Zhongzhi, Yang Liwei.
Exploring the formation mechanism of national drug standards from the study of traditional Chinese medicine prescription granule standards[J].
Chinese Journal of Experimental Formulas, 2020, 26(13): 206-211.

[2] Ji Shen.
The national standard of Chinese medicine formula granules helps the development of Chinese medicine [N].
China Medical News, 2021-03-02 (003).