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Paying Attention to the Standardization and Standardization of Traditional Chinese Herbal Medicine and Optimizing Industrial Structure
Chinese herbal medicines, Chinese Herbal Medicines, and proprietary Chinese medicines are three parts that are essential to support the development of traditional Chinese medicine. However, the industry has always failed to pay due attention to Chinese herbal medicines, especially Chinese herbal medicines. Judging from the current progress, the decoction pieces have been placed in an important position in the revision of the new edition of the Pharmacopoeia. There has been a leap in terms of quantity and specific indicators. The issue of unification of the quality control of medicinal herbs and the concoction of traditional Chinese medicines has received unprecedented attention in this revision.
The reporter learned that there are a total of 4,886 scientific research projects in the new edition of the Pharmacopoeia. Among them, there are about 1,000 scientific research projects for Chinese herbal medicines and Chinese herbal medicines. These projects can be divided into three levels: First, they have exemplary, good research foundations, and can reach international model standards through advancement of advanced technologies; second, they can improve one step and maintain the domestic average level on the basis of the original; Weak, poor basic research needs to be filled with materials.
According to experts, the “Guide to Clinical Medications of Chinese Medicinal Materials and Pieces of Herbal Medicine†currently being prepared will fill in the blank areas of clinical drug guidance.
Medicinal materials: comprehensive consideration of new varieties
At present, approximately one-third of the varieties of Chinese herbal medicines in the revision of the Pharmacopoeia have completed the formulation and drafting of standards, and have partially entered the review procedures of the Institute of Drug Control.
Tu Pengfei, a member of the 9th National Pharmacopoeia Committee Committee on Traditional Chinese Medicines and Chinese Herbal Pieces, told the “Medicine Economic News†reporter that the 2010 edition of the Pharmacopoeia Programme had added 150 new medicinal herbs and revised 318. The preparation mainly focused on the new varieties of medicinal materials and the addition and amendment of old varieties, the separate listing of multi-source medicinal materials, the revision of the original plant Latin name, and the application of new technologies and new methods.
“The main targets for the selection of new varieties of Chinese herbal medicines include: 'upside down' varieties (Chinese herbal medicines in the Pharmacopoeia containing traditional Chinese medicine prescriptions, and currently not yet included in the Pharmacopoeia of Chinese herbal medicines), have been included in the 1977 edition of the Pharmacopoeia or local Chinese herbal medicine standards. Commonly used varieties of Chinese herbal medicines, varieties with good research base, etc., said Zhou Chaofan, executive member of the 9th National Pharmacopoeia Commission.
Tu Pengfei revealed that in the selection of revised varieties, wild species and endangered species are no longer included in the new varieties of medicinal herbs, taking into account resource issues. For some ethnic medicines and new Chinese herbal medicines to be unclear or chaotic, it is necessary to conduct in-depth herbal textual research. After clarifying the original sources and clarifying the original sources, it is necessary to formulate standards. It is indeed difficult to clarify the primordial species and are not included in the Pharmacopoeia.
For the revision of the old varieties, Tu Pengfei said that the focus is on the research of varieties with weak standards, such as varieties with only basic sources and traits, to promote the improvement of the quality standards of Chinese medicine as a whole. At the same time, amendments have been made that are erroneous or have poor reproducibility of the original standard methods.
The single column of multi-source herbal medicine is also discussed in the revision of calendar edition pharmacopoeia. Zhou Chaofan said that the amendment will separate the varieties of Chinese herbal medicines with large differences in traits, identities, and chemical compositions. Difficult to identify the basic source of Chinese herbal medicines with the same chemical composition.
The quality control of medicinal materials has always been a difficult problem. According to the new version of the Pharmacopoeia Chinese herbal medicine standard plan, more mature new technologies and new methods will be adopted to solve the problems of identification and quality control of some medicinal materials. For example, the identification method of some animal medicines is established using DNA molecular marker technology; the qualitative identification and quantitative analysis methods of medicinal materials are established by biological methods such as auto-autography, cell membrane technology, and bioactivity determination; and multi-components are established using the “one label multi-measurement†technique. Content determination method; The use of fingerprint analysis method to establish part of the overall quality control of medicinal materials.
Pieces: concocted to select the mainstream
In response to various problems of traditional Chinese medicine decoction pieces, the revision of the quality standards for the new version of the Chinese medicinal herb decoction pieces will highlight two major features: First, the quality standards for more than 400 decoction pieces to be added; and second, improve the quality control indicators for decoction pieces.
Zhou Chaofan introduced that starting from the 2005 edition of the Pharmacopoeia (Part 1), the Pharmacopoeia committee will separately list some decoction pieces that require special concoctions and formulate corresponding quality standards. “But more than 92% of the pieces were included in the net system, cutting requirements or related processing methods. There were only 23 types of single-piece quality standards for the decoction pieces. Only 11 of them had content determination items, which was far from meeting the quality control requirements of the decoction pieces. â€
In addition, there are five or six or even more concocted methods for the same type of decoction pieces. The art of making decoction pieces varies from place to place and the standards vary. For the specifications of the concoctions of the decoctions, the differences between the north and the south are very different, and the doctors' medication habits are not the same. Therefore, for the concocted specifications of commonly used Chinese Herbal Medicines, the new edition of the Pharmacopoeia is only loaded into the most mainstream methods and has common content. The rest is supplemented by localities and does not insist on unity. Changes are made in the composition of the components that may have been changed after processing and functions have changed.
In terms of quality control, the new edition of the Pharmacopoeia emphasizes the selection of highly specific and sensitive identification methods; in terms of content determination, it establishes a quality standard system that meets the characteristics of traditional Chinese medicine, and gradually qualitatively quantifies active and active ingredients and bioassays from a single indicator component. The comprehensive examination of the transition to improve the specificity of Chinese medicine testing methods, the establishment of scientific and reasonable control indicators.
For example, the historical version of the pharmacopoeial description of the traditional Chinese medicine Maqinzi: Take the net horse money, according to the sand hot law to bulge and tan or dark brown. Calculated on dry products, the content of strychnine should be 1.2% to 2.2%. This description is very simple and does not involve artifacts. In this revision, it is proposed that the conversion of strychnine and strychnine into oxyfluoride during the processing of Strychnine nucifera as an indicator component of the content determination, and strychnine as a limited component, not only reflects the degree of concocting, but also guarantees The quality of processed products.
The reporter learned that the new edition of the Pharmacopoeia also pays attention to the improvement of methods and indicators for the safety testing of Chinese medicines, and will strengthen the detection of heavy metal, harmful elements and residual pesticides.
Tu Pengfei said that there are 325 flavored pieces that are uniformly processed. As of the end of October this year, there have been 37 kinds of pieces of kudzu which have been drafted for quality standards.
Impact: Industrial structure or change
As an old clinical expert of traditional Chinese medicine, Zhou Chaofan once lamented that the phenomenon of “the prescription of drugs is not working†often occurs. This phenomenon will be partially alleviated with the emphasis on quality standards and quality control of Chinese herbal medicines and decoction pieces in the revision of the new edition of the Pharmacopoeia.
Zhou Lushan, general manager of Guangzhou Cai Zhilin Pharmaceutical (formerly Guangzhou Medicinal Materials Co., Ltd.) believes that the current chaotic decoction industry pattern may change due to the improvement of the quality threshold. The improvement of the quality standards of the decoction pieces will eliminate a group of small-scale enterprises with weak technical strength. The enterprises that regulate the operation will usher in development opportunities, which will be conducive to the continued development of the Chinese medicine industry and further improve the safety and effectiveness of the Chinese medicine products.
Jiang Yun, chairman of the Sichuan New Lotus Herbal Medicine Piece Company, told reporters that the main problems affecting the export of Chinese herbal medicines and decoction pieces are the safety (heavy metals, pesticide residues, SO2 residues, etc.) and effectiveness (effective ingredient content, etc.). Jiang Yun believes that the new version of the Pharmacopoeia to increase and improve the safety standards of Chinese medicine quality standards, will be conducive to solving the common security problems in the export of Chinese medicine, and promote exports.
One of the supporting guidelines for the new edition of the Pharmacopoeia under preparation is “Prescriptions for the clinical use of Chinese herbal medicines and decoction piecesâ€, which will further regulate the clinical use of the pieces. "In the Pharmacopoeia revision, how much can be done," Zhou Chaofan said.