The promulgation and implementation of the national standard for Chinese medicine formula granules helps the vigorous development of Chinese medicine

On April 29, 2021, the National Pharmacopoeia Commission issued the "Notice on Matters Concerning the Implementation of National Drug Standards for Chinese Medicine Formula Granules", and forwarded the first batch of 160 national standards for Chinese medicine prescription granules approved and promulgated by the State Food and Drug Administration.
It marks that China has finally ushered in the implementation of the national standard of traditional Chinese medicine formula granules after the "Announcement on the Pilot Uniform Standards for the Varieties of Traditional Chinese Medicine Formula Granules" promulgated on November 5, 2019
.

After nearly two decades of pilot production of traditional Chinese medicine formula granules, a large number of studies and discussions have been carried out on the formulation of Chinese medicine formula granules standards from manufacturers to national standards management departments.

Traditional Chinese medicine formula granules are granules prepared through a series of processes such as extraction, filtration, concentration, drying, and granulation using Chinese herbal medicine pieces as raw materials.
It is based on the modernization and internationalization of traditional Chinese medicine.
A usage supplement
.

The promulgation and implementation of the national standards for traditional Chinese medicine formula granules will significantly raise the market threshold and put forward higher requirements for the scale and quality control of enterprises

Among them, in terms of scale , the production of traditional Chinese medicine formula granules should follow the concept of whole-process control.
Manufacturers should give priority to using Chinese medicinal materials from Chinese medicinal planting and breeding bases that meet the requirements of Chinese medicinal material production quality management specifications.
The use of authentic medicinal materials is encouraged.
Self-contained Chinese herbal medicine pieces for the production of Chinese herbal medicine formula granules, with complete production capacity of Chinese medicine processing, extraction, separation, concentration, drying, and granulation.
At the same time, enterprises must have supporting Chinese herbal medicine planting bases to strengthen the processing technology of Chinese herbal medicine pieces.
Research, construction of Chinese herbal medicine planting bases and source control
.

In terms of quality control , the national standard of Chinese medicine formula granules not only introduces the concept of "standard decoction" in the technical requirements, but also stipulates the application of characteristic map quality control technology, which strengthens the overall quality control level of Chinese medicine formula granules

The development and formation of the standard of traditional Chinese medicine formula granule

       2001

       The State Drug Administration promulgated the "Interim Regulations on the Management of Chinese Medicine Formula Granules", which puts forward specific requirements for the formulation of standards for Chinese medicine prescription granules
.

       2002-2004

       Guangdong Yifang Pharmaceutical Co.
, Ltd.
, Jiangyin Tianjiang Pharmaceutical Co.
, Ltd.
, China Resources Sanjiu Pharmaceutical Co.
, Ltd.
, Beijing Kangrentang Co.
, Ltd.
, Peili (Nanning) Pharmaceutical Co.
, Ltd.
and Sichuan New Green Pharmaceutical Technology Development Co.
, Ltd.
The pilot qualification has been approved, and no new pilot enterprises have been approved at the national level since then
.

       2015

       The state issued the "Administrative Measures for Chinese Medicine Formula Granules (Draft for Solicitation of Comments)", each province has the right to approve, and more than a dozen provinces have successively introduced their province's pilot policies for Chinese medicine formula granules
.

However, for pharmaceutical companies that have obtained qualifications from provincial government departments, their products can only be sold and used within the province

       2016.
8

       The National Pharmacopoeia Commission issued the "Technical Requirements for Quality Control and Standard Establishment of Chinese Medicine Formula Granules (Draft for Solicitation of Comments)", which provides guidance for the production quality control of Chinese medicine formula granules
.

       2019.
11

       The National Pharmacopoeia Commission promulgated the "Publicity on the Pilot Uniform Standards for the Varieties of TCM Formula Granules" to standardize the quality of 160 types of TCM formula granules
.

       2021.
2.
10

       The State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the National Health Commission, and the National Medical Insurance Administration jointly issued the "Announcement on Ending the Pilot Work of TCM Formula Granules", announcing that the pilot work of TCM formula granules, which has continued from 1993 to the present, will be launched in November this year.
It ends on the 1st, and the implementation of the national drug standard for traditional Chinese medicine formula granules is connected with this
.

       The characteristics of the standard of Chinese medicine formula granule

       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:

       ● Clarify the varieties of multi-base raw medicinal materials, so that the source of Chinese medicine bases can be controlled more accurately
.

In principle, the standard distinguishes between different origins and establishes an exclusive quality standard
.

       ● Fully embody the traditional technique of decoction and ensure sufficient feeding of decoction pieces
.
The standard formulation process fully considered the amount of decoction determined by research, the decoction process, the method of drying and concentration, the extraction rate of the extract, and the volume of the prepared extract
.

       ● It can effectively distinguish the authenticity of formula granules and realize the overall quality control of Chinese medicine
.
The national standards for formula particles have set up items such as thin-layer identification, feature/fingerprint spectrum, extract, content determination, etc.
, which can reflect the authenticity of formula particles, as well as 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, 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 particles 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 maintain rapid growth 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.
Discussing the formation mechanism of national drug standards from the study of traditional Chinese medicine formula 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).