Jing Wen Guangcheng Xianlong liminghua guoxiaohan Weifeng mashuangcheng
National Institutes for Food and Drug Control (NIFDC)
. Methods: the quality connotation of traditional Chinese medicine was analyzed, the basic principles and common problems of the formulation of quality standards of traditional Chinese medicine were summarized, the shortcomings of the selection of existing quality control indicators were clarified, and the basic principles of the establishment of quality indicators of traditional Chinese medicine were explained based on the formation process of quality attributes of traditional Chinese medicine. Results: the establishment of quality indicators of traditional Chinese medicine should be based on the material base research and combined with the existing clinical efficacy, focusing on the correlation between the natural factors (genuine) and artificial factors (production standardization) of the quality formation of traditional Chinese medicine and the quality attributes (quality) of traditional Chinese Medicine. Conclusion: the establishment of quality indicators of traditional Chinese medicine should highlight the traditional authenticity, conform to production norms, reflect safety and effectiveness, ensure stability and controllability, strengthen the specificity of identification and highlight the internal quality relevance.
As a part of traditional Chinese medicine culture, traditional Chinese medicine is the material basis for TCM clinical prescription and treatment. Its quality not only affects the clinical efficacy of TCM, but also directly relates to the medication safety of the public. . For example, some Chinese medicinal materials are introduced blindly, the growth years are not enough, the processing in the production area is not standardized, and the storage and maintenance are improper; The phenomenon of non-standard processing of decoction pieces is still prominent; Quality problems such as illegal feeding and adulteration of Chinese patent medicines have not been completely eliminated. The reason lies in the lack of in-depth understanding of the quality connotation of traditional Chinese medicine and the lack of attention to the quality formation process of traditional Chinese medicine, resulting in unclear key quality indicators and unclear quality. At present, the quality of traditional Chinese medicine is only qualified according to the Chinese Pharmacopoeia, but there is no evaluation standard for its advantages and disadvantages. There is an embarrassing situation that "the authenticity is easy to identify, and the advantages and disadvantages are difficult to evaluate".
In recent years, the quality evaluation mode of traditional Chinese medicine has shown the phenomenon of many methods and wide ideas. The evaluation technology has covered many fields such as spectrum, chromatography, biological evaluation, multi omics analysis, and the evaluation indicators have also shifted from single indicators to diverse indicators. However, most research work on the quality attributes of traditional Chinese medicine focuses on the static analysis of existing indicators of end products (such as traditional Chinese medicine, decoction pieces or proprietary Chinese Medicine), which relatively isolated the impact of dynamic factors in each link of the production process (such as planting or breeding) on the quality, resulting in insufficient analysis of the formation process and characteristics of the quality attributes of traditional Chinese medicine. The established "quality indicators" are not strongly correlated with product quality, and the formulated standards can not effectively guide the actual production, nor can they effectively control and evaluate the quality. Like all products, the quality of traditional Chinese medicine originates from production, and the level of process control and production standardization are the guarantee of quality. In addition, the quality of Chinese medicinal materials is also affected by the origin, natural environment and other factors, so it is known as "genuine Chinese medicinal materials". Traditional authenticity has also become the core factor in the formation of the quality of Chinese medicinal materials[1]Therefore, in the current situation that the research on the material basis of the efficacy of traditional Chinese medicine is not in-depth, and the efficacy and mechanism of action of traditional Chinese medicine are not clear, the quality evaluation of traditional Chinese medicine should be based on the "material basis" research and combined with the existing "clinical efficacy", focusing on the correlation between the natural factors (authenticity) and artificial factors (production standardization) of the formation of the quality of traditional Chinese medicine and the quality attributes (quality). Among them, how to establish the internal quality indicators that can reflect the authenticity and production standardization of traditional Chinese medicine has become the focus of research. This paper discusses the basic principles and common problems of the formulation of quality standards of traditional Chinese medicine, and expounds the principles of establishing quality indicators based on the formation process of quality attributes of traditional Chinese medicine, in order to provide references for other scientific researchers.
Basic principles and common problems in formulating quality standards of traditional Chinese Medicine
1. connotation of quality of traditional Chinese Medicine
The quality of traditional Chinese medicine is a systematic and integral concept, which is a set of attributes of traditional Chinese medicine products to meet the purpose of disease prevention and treatment, and meet the national drug standards and relevant requirements. The formation of quality attributes of traditional Chinese medicine covers multiple links and process factors, including origin, origin, planting / breeding, harvesting, processing, processing, production, packaging, storage, transportation, sales, use, etc., and safety and effectiveness are the ultimate embodiment of its quality.
According to the national drug sampling inspection work in recent years[2]The quality and safety level of traditional Chinese medicine in China has made gratifying progress, and the qualification rate has been steadily improved. However, the qualified rate is only an evaluation index for the general quality basically in line with. The real quality of traditional Chinese medicine should be reflected in the standardization and standardization of the whole chain, and its quality should be determined by the standardization degree of the production process. As a national compulsory standard, Chinese pharmacopoeia is only the most basic standard. However, in order to reduce production costs and increase production, some enterprises deliberately shorten the planting cycle, use growth regulators, cut corners and so on. Although the Chinese medicine produced barely meets the standard of Chinese Pharmacopoeia, its quality is self-evident. .
2. basic principles for formulating quality standards of traditional Chinese Medicine
National drug standards are mainly composed of Chinese Pharmacopoeia, ministerial (bureau) standards and registration standards. Among them, Chinese pharmacopoeia is the most frequently used in the industry and is the legal basis for drug development, production, operation, use, supervision and management. The quality standards of traditional Chinese medicine mainly include three categories: Traditional Chinese medicine and decoction pieces, traditional Chinese medicine extracts and Chinese patent medicine. In general, the basic principles for the formulation of quality standards of traditional Chinese medicine should be the same as those of Chinese Pharmacopoeia, mainly including the following four points[3]: ① adhere to the principle of ensuring the safety of public medication. National drug standards are important technical regulations for the country to ensure drug quality and maintain public health. We must adhere to the purpose of ensuring the safety of public medication as the work of drug standards, adhere to the principles of safety, effectiveness and quality control, effectively ensure drug quality and medication safety, and maintain public health. ② Adhere to the principles of being scientific, advanced, practical and standardized. The quality standards of traditional Chinese medicine should fully reflect and reflect the advanced level and development trend of quality control of traditional Chinese medicine at this stage, effectively support the scientific supervision of traditional Chinese medicine, and the established standards can guide the actual production and pay attention to practicality. ③ Adhere to the principles of inheritance, development and innovation. Drug standards are historical and developing. In different periods, the contents and items carried by the standards are not static. The quality standards of traditional Chinese medicine should constantly adapt to the needs of the development of traditional Chinese medicine industry and meet the requirements of inspection and detection. ④ Adhere to the principle of internationalization. We should use the advanced technology and methods of international drug standards for reference, and combine the use history, function characteristics and application forms of traditional Chinese medicine to guide and promote the internationalization of quality standards of traditional Chinese medicine.
3. common problems in the formulation of quality standards for traditional Chinese Medicine
The research and formulation of quality standards of traditional Chinese medicine is the core issue of the development of traditional Chinese medicine. For a long time in the past, the quality standard of traditional Chinese medicine has used the quality evaluation model of chemical drugs for reference, and has experienced the development process from scratch, from simple to gradually perfect. The model of "finding ingredients, measuring content, and setting the lower limit" has been used for more than half a century. However, compared with chemical drugs with single ingredients and clear efficacy and mechanism of action, traditional Chinese medicine is a multi-component, multi-target synergistic effect, and single or several ingredients are difficult to fully reflect the quality of traditional Chinese medicine. The 2020 edition of Chinese Pharmacopoeia adopts a combination of character, identification, inspection and content determination of index components to determine whether the traditional Chinese medicine is qualified. Some varieties have relatively single index components; The selected index components of some varieties have little relationship with drug efficacy; Other varieties only select high content ingredients as detection indicators for content determination, the correlation between indicators and quality is not clear, and even illegal manufacturers in Chinese patent medicine illegally add indicator ingredients and muddle through. In addition, only a few animal traditional Chinese medicines contain exact index ingredients, such as bufalin, cinobufagin and lipobufalin ligand of bufalin. Most of them still lack key index ingredients, and the quality standards are not perfect, so the quality cannot be effectively controlled. Therefore, at this stage, most quality evaluations of traditional Chinese medicine mainly emphasize more single chemical composition indicators and less consideration of integrity; More qualitative indicators and less quantitative indicators; .
Although some scholars[4]It is proposed to calibrate traditional Chinese medicine with its effective components and establish quality standards suitable for traditional Chinese medicine. However, the "component traditional Chinese medicine" must be verified by strict and large amounts of experimental data to ensure that the "component" is the core effective component of traditional Chinese medicine. Otherwise, it still cannot fully reflect the internal quality of traditional Chinese medicine, and the source of raw materials and preparation process have potential effects on the composition of components. The emergence of methods such as one test and multiple evaluation, fingerprint, multi-component content determination, and the development of serum medicinal chemistry, spectral efficacy, metabolomics and other technologies have gradually pushed the quality control of traditional Chinese medicine to the road of integrated, rational and comprehensive development, but there are still major deficiencies in the research.
4. the selection of quality indicators of traditional Chinese medicine is the key to standard formulation
. From the perspective of quality control and evaluation, based on material base research, we can find the ingredients or composition groups that can represent the quality (effectiveness and safety) from the numerous chemical components of each traditional Chinese medicine as indicators, which can open up the path of quality control and evaluation, so as to break through the bottleneck of traditional Chinese medicine quality evaluation. In recent years, scholars related to traditional Chinese medicine have continuously explored the selection and establishment of quality indicators of traditional Chinese medicine, and put forward many innovative and constructive ideas and methods.
Liuchangxiao et al[5,6,7,8]On the basis of studying the existing methods of quality evaluation and control of traditional Chinese medicine, this paper puts forward a quality evaluation model of traditional Chinese medicine based on the research of quality marker (q-marker) from the perspectives of the transmission and traceability of quality elements, the relationship between chemical components and drug efficacy, and the analysis of the specificity of components based on plant phylogeny and biogenic pathway, and compares the quality of Salvia miltiorrhiza and Panax notoginseng in Compound Salvia miltiorrhiza preparations[9,10,11], Rhizoma Corydalis[12]、 Corydalis yanhusuo Zhitong dropping pills[13], Leonurus japonicus and Phragmites repens[14]Quality marker of traditional Chinese medicine was studied, and the research path of quality marker of traditional Chinese medicine was elaborated in detail. Xiaoxiaohe et al[15]The quality control strategy of integrated quality view of traditional Chinese medicine (i.e. the quality view of traditional Chinese Medicine) is a diversified quality evaluation and control mode with biological evaluation as the core and traditional sensory evaluation and chemical evaluation as the same emphasis, highlighting the quality attributes of traditional Chinese medicine as a whole. Tanpeng et al[16]A quality evaluation and control mode of rhubarb based on multi-component chemical quantitative analysis weighted by biological titer weight coefficient was constructed. Liu An et al[17]The concept of mass constant of traditional Chinese medicine (TCM) was put forward through the combination of Appearance Traits and internal quality, and the calculation formula of TCM mass constant was established and applied to Scutellaria baicalensis Georgi[17], roasted licorice[18], jianghoupu[19], gardenia[20]And other quality evaluation of Chinese herbal pieces. The results showed that the quality constant of traditional Chinese medicine was directly proportional to the size of the decoction pieces and the content of the index components; Inversely proportional to the thickness of the decoction pieces; The greater the quality constant of traditional Chinese medicine, the higher the commodity specification of decoction pieces.
. Research on quality evaluation methods and standards mostly focuses on the analysis of static indicators of end products, ignoring dynamic factors such as environmental impact and process control. The established "quality indicators" are isolated and static. There is no reliable quality indicator quantity positive correlation with the authenticity and production standardization of traditional Chinese medicine, nor can they guide the production and processing of traditional Chinese medicine and decoction pieces and evaluate the quality of market products in various forms.
Authenticity and production standardization are the key to the formation of quality attributes of traditional Chinese medicine. Authenticity is the foundation of quality formation, production standardization is the guarantee of quality formation, the accumulation of effective ingredients is the foundation of quality formation, and safety and effectiveness is the ultimate embodiment of quality. Therefore, the authenticity and production standardization are the premise of clinical effectiveness. In the case of the existing lack of in-depth and unclear research on the material basis of efficacy, we must firmly grasp the authenticity and production standardization of traditional Chinese medicine, analyze in detail the impact of blind remote planting and non-standard production and processing on the quality of traditional Chinese medicine, and finally establish the real quality control indicators.
Basic principles for establishing quality indicators of traditional Chinese Medicine
The traditional Chinese medicine industry chain is long and there are many influencing factors. The comprehensive superposition of the influence of each link leads to the complexity of the quality formation process. Fully excavate and analyze the key quality attributes of each link of the production and preparation of traditional Chinese medicine, analyze the quality risk points, select and establish the key quality indicators that can truly highlight the authenticity and production standardization of traditional Chinese medicine, and reflect the integrity of the role of traditional Chinese medicine, and establish the quality standards that conform to the development law of the traditional Chinese medicine industry, which is related to the inheritance, innovation and high-quality development of the whole traditional Chinese medicine. Therefore, based on the formation process of quality attributes of traditional Chinese medicine, the author discusses several principles for the establishment of quality indicators of traditional Chinese medicine for reference.
1. highlight the traditional authenticity
According to the "newly revised Materia Medica" of the Tang Dynasty, "the dynamic plant shape is born, because of the wrong nature of the square, the spring and Autumn Festival changes, and the feeling of Qi is different. Away from its native place, the quality is the same but the effect is different." it vividly expounds the relationship between the authenticity, quality and curative effect of traditional Chinese medicine, laying a solid foundation for the development of quality control and evaluation of traditional Chinese medicine. Genuine traditional Chinese medicine has been considered as the representative of "high-quality" traditional Chinese medicine since ancient times, and its "high quality and good effect" has been confirmed by the clinical practice of traditional Chinese medicine for thousands of years under the guidance of traditional Chinese medicine theory. Zhangminghua et al[21]. Xia Yunqing et al[22]Taking this as a guide, the authentic and non authentic samples of peony cortex were statistically analyzed, and the quantity and quantity ratio relationships among terpene glycoside components, tannin components, and phenolic acid components in the genuine peony cortex were summarized. The structural characteristics of the material base components of the genuine peony cortex were extracted, which provided a powerful method for the quantity index of peony cortex to highlight the authenticity.
The combination of HPLC-MS and chemometrics has been used to comprehensively analyze the differential secondary metabolites of genuine and non genuine Chinese medicinal materials, clarify the material basis of genuine, and understand the mechanism of the formation of genuine. A large number of experiments have been summarized, providing a technical means for the establishment of genuine quality indicators. Xuezhenzhen[23]Through the establishment of the database of secondary metabolites of Magnolia officinalis, it was found that there were significant differences in phenylethanolic glycosides, lignans and alkaloids in the samples of Magnolia officinalis from genuine and non genuine areas. Among them, the contents of arose phenylethanolic tetraglycoside, magnolignan E and 1,2-hydrazinedicarboxamide were significantly different between genuine and non genuine areas, which could be used as the key quality indicators of the authenticity of Magnolia officinalis. The quality indicators highlight the authenticity, and the quality standards can actively encourage and guide the planting of genuine Chinese medicinal materials in the producing areas, reflect the advantages of the authenticity and differentiation of Chinese medicinal materials, and ensure the high-quality supply of Chinese medicinal materials.
2. compliance with production norms
Quality comes from production. If authenticity is the core of quality formation of high-quality traditional Chinese medicine, production standardization is the guarantee of quality[1]The production of traditional Chinese medicine includes planting, harvesting, primary processing, and the formation of decoction pieces through net processing, cutting and processing. Good standard planting is the key to ensure the quality of traditional Chinese medicine, reasonable and legal processing and processing is the premise to ensure the quality of decoction pieces, and finding and establishing standardized quality indicators of production is to prevent the early harvesting of traditional Chinese medicine and the abuse of growth regulators; The processing of decoction pieces is not enough or too much, and inferior products are shoddy; The adulteration of Chinese patent medicine is the key to the industry problems such as fake and illegal feeding. Light Douchi is a fermented product of the dried mature seeds (black beans) of Glycine max (L.) merr., a legume plant. At present, there are some problems in the market, such as passing black kidney beans as light Douchi, incomplete fermentation and so on, which seriously affect the quality of light Douchi. However, the current standard cannot effectively distinguish black kidney beans from light Douchi, nor can it define whether light Douchi is fermented. Li Ningxin et al[24]Using traditional pharmacognostic identification methods, the characteristics of light Douchi and black kidney beans were compared. It was found that the fake black kidney beans could be distinguished from the navel characteristics; Daidzein and genistein were selected as the quality indicators, which could effectively distinguish the genuine and fake products from unfermented products, providing a reference for the establishment of standardized quality indicators and the revision of quality standards for the production of light Douchi. Sunxiurui et al[25]The study showed that there was a certain proportional relationship between flavonoid aglycones and flavonoid glycoside peak area in Astragalus membranaceus with different growth modes and growth years. This proportional relationship can be used as a quality index to distinguish Astragalus membranaceus with different growth years and growth modes. Quality indicators highlight the standardization of production, which is to guide growers not only to focus on the bottom line standard of Chinese Pharmacopoeia, but also to focus on strengthening the standardization of planting links. At the same time, researchers should build a quality grade evaluation system of traditional Chinese medicine with quality indicators as the core. Managers should promote the quality evaluation and quality grade certification of traditional Chinese medicine to ensure "high quality and good price, high quality first", so as to drive the adjustment and upgrading of industrial structure from the inside and promote the healthy development of the traditional Chinese medicine industry.
The standardization of production is not only reflected in the standard planting of traditional Chinese medicine, but also in the standard processing of decoction pieces. The characteristic and essence of the processing of decoction pieces is that "decoction pieces can be used as medicine, and different treatments can be used in different ways". Sometimes the quality indicators of decoction pieces cannot be completely copied from the quality indicators of traditional Chinese medicine. .
3. reflect safety and effectiveness
Safety and effectiveness is the eternal theme of drug quality. With the in-depth development of multiple disciplines, many effective ingredients of traditional Chinese medicine have been excavated and discovered, such as artemisinin as the effective ingredient of Artemisia annua for malaria interception, ephedrine as the effective ingredient of Ephedra for asthma relief, baicalein as the effective ingredient of Scutellaria baicalensis antibacterial, and tetrahydropalmatine as the effective ingredient of Corydalis for analgesia. The discovery of these active ingredients has laid the foundation for the establishment of effectiveness indicators, but there are still many components with similar structures and comparable activities in traditional Chinese medicine that have not been characterized. [26]. Therefore, we should use multi-disciplinary, new technology and new methods to establish more effectiveness indicators and evaluate the quality of traditional Chinese medicine products from the multi-dimensional aspects of chemical composition integrity, effectiveness and safety.
. Traditional Chinese medicine quality marker is a chemical substance inherent in traditional Chinese medicine or formed in the process of processing and preparation, which is closely related to the functional attributes of traditional Chinese medicine. It is used as a marker to reflect the safety and effectiveness of traditional Chinese medicine for quality control[5]It provides research ideas for the establishment of effectiveness indicators. Lu tulin et al[27]The research idea of quality control of decoction pieces based on quality marker of traditional Chinese medicine was put forward. For the key indicators of changes in decoction pieces, metabolomics method should be used to further explore the influence of different components on the overall quality of decoction pieces. . For example, if hawthorn is mainly used to fortify the stomach and digest food, organic acids are used as quality indicators; If the treatment of cardiovascular disease (promoting qi and dispersing blood stasis) is the main method, flavonoids are used as quality indicators.
Harmful substances are important factors affecting the safety of traditional Chinese medicine, including endogenous and exogenous harmful substances. Among them, endogenous harmful substances refer to the chemical components with toxic and side effects contained in traditional Chinese medicine itself; Exogenous harmful substances mainly include residual pesticides, heavy metals and harmful elements, aflatoxins, sulfur dioxide, etc. A comprehensive analysis of harmful substances affecting the quality of traditional Chinese medicine and the establishment of a limit standard for safety quality indicators are favorable measures to put an end to pesticide abuse, excessive sulfur fumigation, and inadequate processing of toxic traditional Chinese medicine. Polygonum multiflorum and its related preparations can cause liver injury, Yang Jianbo et al[28]The study found that CIS and trans emodin Dianthrone may be the main hepatotoxic components. After reasonable and standardized processing of Polygonum multiflorum, the content of the above Dianthrone components decreased significantly. After systematic evaluation, it was considered that the Dianthrone components can be used as the index components to control the hepatotoxicity of Polygonum multiflorum, which provided the basis for the establishment of the safety index of Polygonum multiflorum.
4. ensure stability and controllability
At this stage, the quality standards of traditional Chinese medicine decoction pieces Chinese patent medicine lack relevance and traceability, especially the stability and transmissibility of the indicators selected in the quality standards of traditional Chinese patent medicine are relatively insufficient, and the controllability of the indicators is poor. . For non transferable indicators, the transformation law should be studied, the transformation mechanism should be clarified, and the end-point indicators after transformation should be taken as the key reference. Therefore, when establishing the quality standard of Chinese patent medicine, we should focus on the "common material base" of Chinese herbal medicine decoction pieces Chinese patent medicine, identify and identify the "common material base" by means of fingerprint, knock-in and knock-out, liquid chromatography-mass spectrometry, etc., determine the key indicators of quality control of Chinese patent medicine from the principle of testability, and establish the quality standard that can reflect the consistency between batches. In addition, the different pretreatment methods of samples and the stability of reference materials should not be ignored to prevent misjudgment of the quality of traditional Chinese medicine due to the poor stability of indicators.
5. strengthen identification specificity
The characteristics of clinical use of traditional Chinese medicine are that one drug has multiple sources, one drug has multiple uses, and one drug has multiple effects. Most of the traditional Chinese medicines of polygenic origin have similar material basis and clinical efficacy, and the quality control indicators are basically the same. However, there are also some cases in which the material base and clinical efficacy of some Chinese medicinal materials are inconsistent with those of other original plants due to different growth environment, cultivation methods, processing methods, etc. Chinese Pharmacopoeia strengthens the specificity of identification by single listing of original plants and selecting different detection indicators. For example, Peucedanum praeruptorum and purple flower Peucedanum, epimedium and Wushan epimedium, Dryopteris crassipes and Osmunda japonica. . For example, mulberry leaves and Solidago decumbens detect rutin, honeysuckle and Eucommia ulmoides leaves detect chlorogenic acid, Prunella vulgaris and Perilla frutescens stem detect rosmarinic acid. Some of these ingredients are widely found in medicinal plants, and as quality control indicators, their specificity is slightly insufficient. For traditional Chinese medicines that are in serious shortage, expensive or adulterated, the establishment of specificity identification indicators and detection methods is of great significance to ensure the safety of people's medication. For example, for gum Chinese medicines such as donkey hide gelatin, antler gum and tortoise shell gum, screening the characteristic peptides that contribute to species identification is an important method to distinguish different gum Chinese medicines. Chengxianlong et al[29]Different kinds of Chinese medicinal materials were trypsinized to generate a mixture of multiple peptides, which were analyzed by liquid chromatography-mass spectrometry to obtain peptide map. . Pinellia ternata (Thunb.) Breit and Rhizoma typhonii are derived from plants of the same family and genus. Rhizoma typhonii Breit is often used instead of Rhizoma Pinelliae. Nielixing et al[30]A specific detection method for Pinellia ternata Thunb and its adulterant huzhangnanxing was established by using high resolution fast liquid chromatography triple quadrupole mass spectrometry and taking water aspartic acid as the specific identification index. . Zhang Wenjuan et al[31]PCR-RFLP technology was used to explore a semi quantitative method to detect the adulteration ratio in Fritillaria cirrhosa samples according to the intensity of enzyme digestion bands. For Chinese patent medicines containing less than 10 Chinese herbal medicines, we should try our best to find the exclusive identification indicators of each Chinese herbal medicine, so that there is no blind spot in the taste of prescription drugs, and the identification of key drug flavors (monarch drugs and Minister drugs) should highlight the key points.
6. highlight the internal relevance and comprehensiveness
Although Chinese medicinal materials have changed from wild to domestic species, some appearance traits have changed, the overall characteristics of Appearance Traits of Chinese medicinal materials should still be considered in the case of standardized planting. By judging the external "shape, color, gas and taste" of traditional Chinese medicine, the external character index with the most distinguishing characteristics is established. .
Key quality indicators can be a single attribute indicator in a certain aspect or a combination of multiple attribute indicators. Using entropy weight and other multi-attribute decision-making methods, multiple attribute indexes are objectively weighted, each attribute control index is refined, and each comprehensive score is taken as the score value of this attribute index. Finally, the quality comprehensive evaluation index (qcei) of traditional Chinese medicine was established by using multi-source data fusion. As a complex of quality indicators, the comprehensive quality evaluation index of traditional Chinese medicine can be used to judge the quality of traditional Chinese medicine, fully reflect the quality and quality centered on the material basis formed by authenticity and production standardization, interpret the effectiveness and safety of traditional Chinese medicine to play its traditional efficacy, and reflect the integrity and comprehensiveness of the quality evaluation of traditional Chinese medicine.
Establish a quality standard with the quality indicators of traditional Chinese medicine as the core and in line with the characteristics of traditional Chinese Medicine
. In terms of effectiveness and safety, first, the effectiveness and safety of traditional Chinese medicine have undergone thousands of years of clinical practice, and its clinical efficacy has been fully verified in practice; Second, the existing chemical research technology and methods are difficult to fully verify the effectiveness and safety of traditional Chinese medicine. The main reason is that the chemical composition of traditional Chinese medicine is complex, the content is mostly low, and the action intensity of each component is also different, and the apparent efficacy of many components through integration is more complex and diverse. In terms of quality control and evaluation, although relying on modern scientific and technological means, it has been found that many chemical components of traditional Chinese medicine monomers have various pharmacological activities, but they are not enough to represent the overall efficacy of traditional Chinese medicine. The quality standards established by taking these chemical components of monomers as indicators are often partial, not practical and easily misleading.
As the basic raw materials for the development of traditional Chinese medicine industry, the improvement and improvement of the quality and standards of traditional Chinese medicine are of decisive significance for the overall and series quality control of traditional Chinese medicine products. Therefore, to evaluate the quality of traditional Chinese medicine, especially the quality of traditional Chinese medicine, the establishment of quality indicators must not leave the natural attributes and humanistic attributes of traditional Chinese medicine. The natural attributes include the genuine quality proved by clinical practice, and the humanistic attributes contain the production standardization in the formation process of quality attributes. Based on the genuine and production normative quality assurance indicators, combined with the modern pharmacodynamic evaluation of the traditional core efficacy, further study the correlation degree of effectiveness material base quality indicators, so as to control the correlation quality of indicators, correlate the efficacy, be objective and reliable, and highlight the quality, so as to establish the quality standard that conforms to the characteristics of traditional Chinese medicine and the actual development of traditional Chinese medicine industry.
The proposal of the Central Committee of the Communist Party of China on formulating the 14th five year plan for national economic and social development and the long-term goals for the year 2035 clearly states that the theme of economic and social development during the "14th five year plan" period is to promote high-quality development. In terms of the high-quality development of the traditional Chinese medicine industry, how to adhere to the problem orientation, implement accurate strategies, establish a standard system, evaluation methods and management mode that meet the characteristics of traditional Chinese medicine and the quality connotation of traditional Chinese medicine, effectively solve the problem of unbalanced and insufficient development, and improve the quality supply of traditional Chinese medicine is the key to realize the high-quality development of the traditional Chinese medicine industry. The screening and establishment of key quality indicators of traditional Chinese medicine has great practical significance for solving the bottleneck problem of quality evaluation of traditional Chinese medicine, constructing quality standards and evaluation system of high-quality traditional Chinese medicine, standardizing market order, and boosting the high-quality development of traditional Chinese medicine industry.
As a part of traditional Chinese medicine culture, traditional Chinese medicine is the material basis for TCM clinical prescription and treatment. Its quality not only affects the clinical efficacy of TCM, but also directly relates to the medication safety of the public.
. Fully excavate and analyze the key quality attributes of each link of the production and preparation of traditional Chinese medicine, analyze the quality risk points, select and establish the key quality indicators that can truly highlight the authenticity and production standardization of traditional Chinese medicine, and reflect the integrity of the role of traditional Chinese medicine, and establish the quality standards that conform to the development law of the traditional Chinese medicine industry, which is related to the inheritance, innovation and high-quality development of the whole traditional Chinese medicine.
Copyright notice: the article is fromChina food and drug administration 2021, (09);
