The centralized collection and reporting of Chinese herbal pieces will end, and the core is still to establish quality control standards

Many people in the industry told reporters that, completely different from the centralized collection of chemical drugs, the evaluation standards of Chinese herbal pieces are difficult to unify, and the price of Chinese herbal pieces is affected by factors such as season and place of origin. This large-scale centralized collection of Chinese herbal pieces may have reference significance for the follow-up evaluation standards of the industry in this field.

Recently, Shanxi, Shandong, Ningxia and other provinces have successively issued the notice on filling in data related to some varieties of traditional Chinese medicine, and organized various medical institutions to fill in information such as purchase demand.

The deadline for volume reporting in the above provinces is 24:00 on March 16. After the completion of volume reporting in various regions, it is expected to enter the processes of enterprise declaration, qualification review and centralized purchase bid opening.

Many people in the industry told reporters that, completely different from the centralized collection of chemical drugs, the evaluation standards of Chinese herbal pieces are difficult to unify, and the price of Chinese herbal pieces is affected by factors such as season and place of origin. This large-scale centralized collection of Chinese herbal pieces may have reference significance for the follow-up evaluation standards of the industry in this field.

evaluation standard gradually standardized

Traditional Chinese medicine decoction pieces refer to the traditional Chinese medicine and processed products of traditional Chinese medicine that can be directly used for deployment or preparation under the guidance of traditional Chinese medicine theory. Traditional Chinese medicine decoction pieces include some traditional Chinese medicine slices processed in the place of origin (including sections, blocks and valves), prototype herbal medicine decoction pieces, and decoction pieces cut (on the basis of processing in the place of origin) and processed.

On March 10, Shanxi pharmaceutical equipment centralized bidding and procurement center issued a notice saying that according to the requirements of the notice on filling in relevant data of some varieties of traditional Chinese medicine decoction pieces issued by Sanming Procurement Alliance (National) office, Shanxi medical institutions were organized to carry out the filling in of procurement data of relevant varieties of traditional Chinese medicine decoction pieces.

According to the “list of varieties purchased by Sanming Purchasing Alliance for inter provincial Chinese herbal pieces with combined quantity” released along with the notice, a total of 21 varieties of Chinese herbal pieces are included, including Astragalus membranaceus, Codonopsis pilosula, honeysuckle, Angelica sinensis, safflower, Gastrodia elata, Ophiopogon japonicus, Coptis chinensis, Pseudostellaria, white peony root, licorice root, earthworm, Salvia miltiorrhiza, Scutellaria baicalensis, yam, dandelion, peony bark Platycodon grandiflorum and other common decoction pieces.

“This list basically includes the large varieties commonly used in traditional Chinese medicine, among which the first few with the largest dosage are Astragalus membranaceus, Codonopsis pilosula, Angelica sinensis, Atractylodes macrocephala and licorice. Astragalus membranaceus and Codonopsis pilosula are the most commonly used Qi tonics, while Scutellaria baicalensis, Coptis chinensis and honeysuckle are widely used in various fever diseases. Most of the proprietary Chinese medicine preparations related to covid-19 have these kinds.” A traditional Chinese medicine doctor in Shanghai said in an interview with China first finance and economics.

In recent years, the state has issued a number of documents to promote the purchase of drugs with quantity, but there has been no breakthrough in the joint mining of traditional Chinese medicine (materials). The key lies in the difficulty of solving the problem of standardization.

It is worth noting that the above list not only lists the variety name and the code included in the medical insurance, but also lists the specifications (selection and unified goods) and the grade requirements under the specifications (thick film, cutting section, diameter and color). For example, if Astragalus membranaceus is selected, it is required to have a thick piece with a diameter ≥ 0.8cm; Astragalus mongholicus is required to be thick, with a diameter of ≥ 0.5cm.

Shi lichen, a medical insurance policy research expert and head of Beijing Dingchen medical management consulting center, told reporters that from the quality level, the “unified goods” in the above specifications means that the large and small goods of traditional Chinese medicine are mixed together, regardless of quality, specification and grade, while the “selected goods” means that they have been screened and sorted, with clear grades, and the price of selected goods is higher than that of unified goods.

“But these are also two rough ways, with strong randomness and great human uncontrollable factors.” Shi lichen told reporters that at present, there are specifications and basic quality control indicators of traditional Chinese medicine decoction pieces in the 2020 edition of Chinese pharmacopoeia for reference. The Pharmacopoeia emphasizes the safety of traditional Chinese medicine, for example, it has comprehensively formulated the limit standards of heavy metals, harmful elements and pesticide residues in traditional Chinese medicine and decoction pieces; We will comprehensively formulate the limit standards for mycotoxins in Chinese medicinal materials and decoction pieces that are prone to mildew.

Shi lichen also said that since the main purpose of centralized procurement is to promote the high-quality development of local traditional Chinese medicine industry and help the overall revitalization of rural areas, the price decline of traditional Chinese medicine slices will not be too large.

As for how to establish the quality control standard of decoction pieces of traditional Chinese medicine, Zhan Jifu, general consultant of Sanming Procurement Alliance (National) leading group, said that in the joint acquisition of traditional Chinese medicine (materials) of the alliance, the relevant joint acquisition transaction mechanism of high quality and good price will be established by Shandong Internet traditional Chinese medicine (materials) trading center to help the development of traditional Chinese medicine improve quality and efficiency.

Specifically, the joint purchase and trading mechanism of high quality and good price includes: formulating the standard of high-quality decoction pieces, participating in the competition of enterprises, optimizing and establishing the planting base, tracing the source of Chinese medicine decoction pieces with high quality and appropriate price in the whole process, and ensuring the quality and quantity of Chinese medicine decoction pieces through quality insurance, sample retention control and other measures.

In February this year, Shanghai also issued the notice on carrying out the pilot work of tracing the whole process of clinical application of traditional Chinese medicine decoction pieces in Shanghai, which said that it would select five well-known traditional Chinese medicine hospitals and eight pharmaceutical enterprises in Shanghai as the pilot, support the use of traceable decoction pieces, encourage high quality and good price, and improve the quality of traditional Chinese medicine decoction pieces.

production base is the key

Many industry experts believe that the key to the quality control of traditional Chinese medicine pieces still needs to start from the source of traditional Chinese medicine production base.

To this end, fan Jiping, former deputy director of the science and Education Department of the State Administration of traditional Chinese medicine and chairman of the Quality Assurance Expert Committee of traditional Chinese medicine decoction pieces of Shandong Internet traditional Chinese medicine (materials) Trading Center, once said that the formation of cross regional standard mutual recognition and price mutual recognition is the basis for the procurement of traditional Chinese medicine decoction pieces alliance. Through the big data traceability platform, the whole process data collection, recording and monitoring of traditional Chinese medicine decoction pieces from planting and harvesting to processing and processing, from finished product detection to finished product storage can be realized.

“The core of quality control of traditional Chinese medicine is the modernization of the transformation of traditional Chinese medicine planting industry.” Liang Jialin, Secretary General of the value medical advisory expert committee, told reporters that the quality of the origin of traditional Chinese medicine can be ensured only by promoting the whole process and systematic quality control system of traditional Chinese medicine decoction pieces, especially the fine control of the environment such as water, air and soil, and the continuous monitoring of the whole process of planting, transportation and spraying of traditional Chinese medicine decoction pieces.

Liang Jialin also said that as the centralized collection of traditional Chinese medicine pieces has been launched in various provinces, the market concentration of manufacturers and processing enterprises related to traditional Chinese medicine pieces is expected to gradually improve.

In fact, when the reporter visited the Bozhou traditional Chinese medicine professional market, the country’s largest distribution center of traditional Chinese medicine, he found that there are many cases of large price fluctuations of traditional Chinese medicine Pieces affected by raw materials. For example, yaotong.com shows that in Bozhou medicinal materials market, the medicinal materials with large increase in recent years include white lentils (847.5%), Eclipta (350%), raw land (327.3%), cooked land (324%), Mimeng flower (275.6%) and other varieties.

So, how to solve the possible price fluctuation of traditional Chinese medicine decoction pieces affected by the environment?

The reporter learned from China Resources Sanjiu Medical & Pharmaceutical Co.Ltd(000999) that the enterprise has successively established or cooperated to establish more than 30 standardized Chinese herbal medicine planting bases in recent years, of which the planting area of Gangmei, wild chrysanthemum and trigeminal bitter has exceeded 10000 mu. In addition, Tianjin Chase Sun Pharmaceutical Co.Ltd(300026) also said on the interactive platform that at present, the enterprise has more than 160 traditional Chinese medicine planting bases all over Gansu, Hubei, Anhui, Hebei, Guangxi, Inner Mongolia and other places, and is fully prepared for capacity control.

“The production enterprises of traditional Chinese medicine can also ‘iron out’ the output fluctuation between harvest years and disaster years through the disaster insurance promoted by the Ministry of agriculture, so as to ensure the stability and controllability of the output of traditional Chinese medicine, and there will be no sharp rise in the price of traditional Chinese Medicine raw materials.” Liang Jialin said.

Liang Jialin said that after the implementation of the above series of quality control methods one after another, it can realize that under the centralized purchase and price reduction of traditional Chinese medicine decoction pieces, its quality will not decline, the curative effect will not decline, and there will be no drug damage events caused by passing fake products off as real ones and shoddy products off as good ones.

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