Research Strategies for Quality Standards of Famous Classical Formula Based on Standard Decoction (Material Reference) / 中国实验方剂学杂志

The inheritance of traditional clinical value of famous classical formulae is an important direction for the development of traditional Chinese medicine industry.Compared with the previous research and development of new drugs, the management requirement of " material reference" was introduced into the famous classical formulae research, which is used as the reference of process optimization and quality control.The characteristics of compound preparation of famous classical formulae are also reflected in the core concept of " quality inheritance of classics" in the road of industrial development.How to implement the above requirements and concepts into product development and industrial production? There are many specific common problems to be solved in practical research.How to effectively establish the " material reference" of famous classical formulae of different dosage forms? How to use " material reference" to guide the process optimization of compound preparation of famous classical formulae? How to determine the daily dose of famous classical formulae? How to take effective measures in the selection of raw material to reduce quality fluctuation range? This paper discusses the key issues such as production process and quality evaluation from the following aspects.Firstly, the management regulations and research and development guidelines are analyzed, and the specific implementation methods are given.Then, the possible problems in the Requirements for Declaration Documents (Draft for Opinions) are pointed out, and relevant suggestions are given.Finally, based on the research experience of standard decoction and famous classical formulae in the laboratory, an example is given to provide reference for the development of compound preparation of famous classical formulae.

Current situation and research strategy of quality control of health food containing Chinese materia medica / 中国中药杂志

Health food containing Chinese materia medica has many advantages in health preservation and reducing the risk of disease occurrence,which meets people's demands for " great health" and " preventive treatment of disease". However,due to its complex ingredients,diverse quality of raw materials,as well as the vagueness and lack of integrity for existing quality standards,chaos is caused in the health food market,which restricts its healthy development and also poses new challenges to the quality control of healthy food. At present,the total component content or single component content is determined in most functional/marker component examinations. Safety and microbial detection methods fail to cover the contamination range of the raw materials of Chinese materia medica.Therefore,it is impossible to meet the purpose of ensuring authenticity,safety and efficacy. In recent years,a lot of Chinese materia medica extracts have been used as raw materials for food products,but many extracts lack standards. The author believes that the quality control of health food containing Chinese materia medicas should start with the quality control of Chinese materia medica extracts. In this way,product quality is controlled from source to ensure product consistency; secondly,the overall quality control should be strengthened to ensure the authenticity of the products; the scope of safety inspection shall be expanded to fundamentally ensure the safety of products. At the same time,we should strengthen the quality control of whole process and strengthen the overall quality control of raw materials to produce health food of high quality.

Some thoughts on health food formulated with traditional Chinese medicine / 中国中药杂志

The health food industry is an important support for the big health industry and the strategy of healthy China. The Chinese medicine prescription health food has exceeded 60% of the total declared health food. However,the main basis for its function evaluation,the Technical Specification for Inspection and Evaluation of Health Food,was abolished in 2018,and 27 of them were based on modern medical and nutritional theories. Quantitative efficacy evaluation methods in western pharmacology are short of function claims and function evaluation methods reflecting the characteristics of traditional Chinese medicine,which could affect the health food industry to a certain extent. Therefore,the establishment of the evaluation mechanism of Chinese medicine prescription health food which conforms to the positioning of health food and the theory of traditional Chinese medicine is helpful for the healthy development of health food industry. In this paper,this problem was explained from five aspects. First,how to differentiate the positioning of Chinese medicine prescription health food from ordinary food and medicine,and how to embody the characteristics of Chinese medicine. Secondly,the relationship between traditional Chinese medicine prescription health food and Chinese patent medicine. Thirdly,how to scientifically and reasonably determine the raw materials of traditional Chinese medicine prescription health food. Fourthly,how to explain the function claim of traditional Chinese medicine prescription health food,and how to evaluate its function scientifically and reasonably. Fifthly,the functional evaluation of Chinese herbal medicine prescription health food is connected with other national scientific and technological strategies. In this paper,a preliminary analysis of the Chinese medicine prescription health food was conducted from the above five aspects,and some personal views and suggestions were put forward,hoping to provide reference for the competent authorities and researchers.

Research Progress on Pharmacodynamic Material Basis and Quality Control of Danggui Buxue Tang / 中国实验方剂学杂志

Danggui Buxue Tang(DBT) is a famous classical formula of traditional Chinese medicine(TCM) for invigorating Qi and activating blood circulation.It is composed of Angelicae Sinensis Radix and Astragali Radix.It has the effect of enriching blood,invigorating Qi and regulating immunity,and has a high application value in clinical treatment.Because of its definite curative effect and simple compatibility,it has become a hot spot in the research field of TCM.This paper summarized and analyzed the research status of DBT from the pharmacological action,pharmacodynamic material basis,pharmacokinetics,quality control,compatibility and decoction process,so as to provide reference for the development of DBT and formulating its quality standard.

Quality evaluation of medicinal herb decoction--Forsythiae Fructus / 中国中药杂志

To establish the quality control methods for the standard decoction of Forsythiae Fructus. Twelve batches of representative Forsythiae Fructus were collected to prepare standard decoction of Forsythiae Fructus, and then the parameters such as extraction ratio, transfer rate of the index components and pH value of the solution were calculated to evaluate the stability of the process. The simultaneous determination method of target components and fingerprint method were established, and ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) was used to identify the main common peaks in the fingerprint to clarify the main chemical constituents in the decoction. The similarities of the fingerprints of standard decoction of Forsythiae Fructus were more than 0.9. The average extraction ratio of the standard decoction of Forsythiae Fructus was (15.53±6.27)%, and the transfer rate of forsythiaside A was(38.0±10.2)%. The method for evaluating the quality of standard decoction of Forsythiae Fructus was presented, providing reference for the quality control of products stemmed from the water extract of Forsythiae Fructus, with high similarity and uniform quality.

Quality evaluation of Rhei Radix et Rhizoma decoction / 中国中药杂志

Decoction of single medicinal herb is a reference for the standardization of different dosage forms of Chinese medicine and it provides a new direction for solving the problems existing in the quality of Chinese medicinal granules such as no uniform dosage form and no clear quality standard. In this paper, the quality evaluation method of standard decoction of rhubarb was established to provide reference for the quality control of common dosage forms such as clinical decoction and formula granule. 10 batches of representative Rhei Radix et Rhizoma were collected to establish UPLC fingerprints were established. The chemical structures of main peaks were identified with ultra-performance liquid chromatography with quadrupole-time-of-flight mass spectrometry (UPLC-Q-TOF-MS) and the main components in the decoction were Anthraquinones. The extraction ratio of the standard decoction was (28.1±3.8)% and the transfer rate was (19.9±6.3)%. The method for the quality evaluation of standard decoction of Rhei Radix et Rhizoma was established in this study, providing reference for the quality control method of terminal products from decoction of Rhei Radix et Rhizoma.

Establish quality evaluation system for standard Ephedrae Herba decoction / 中国中药杂志

To establish the quality control methods for the standard decoction of Ephedrae Herba, and provide the reference for quality evaluation method of all Chinese herbal medicine decoction.Standard decoction of Ephedrae Herba was prepared, and UPLC-UV fingerprint was established to determine the total contents of ephedrine and pseudoephedrine. Then UPLC-QTOF/MS was used to confirm the major common peaks in the fingerprint to clarify the main chemical constituents in the decoction. In addition, the stability of the process was evaluated by calculating the parameters such as the extraction ratio, transfer rate of the index components and the pH values.In the decoction of Ephedrae Herba, the total average concentration of ephedrine and pseudoephedrine was (2.11±0.70) g•L⁻¹; the similarities of all the fingerprints were more than 0.85; there were 10 major common peaks in the fingerprint, including alkaloids, flavonoids and organic acids; the extraction ratio was (17±3.2)%, and the overall transfer rate of ephedrine and pseudoephedrine was (32.4±8.1)%.The method for evaluating the quality of standard decoction of Ephedrae Herba was established in this article, providing reference for the quality control of products which were stemmed from the water extract of Ephedrae Herba.

Quality evaluation of decoction of single medicinal herb--a case of Lonicerae Japinicae Flos / 中国中药杂志

Decoction of single medicinal herb is a reference for the standardization of different dosage form of Chinese medicine and it provides a new direction for solving the problems existing in the quality of Chinese medicinal granules such no uniform dosage forms and no clear quality standard. There are few reports on the idea, method and preparation of single herb standard decoction. Our country is in urgent need of that information in order to improve the consistency and stability of traditional Chinese medicine products. Here, Lonicerae Japinicae Flos was selected as an example to elucidate the preparation and quality evaluation of Chinese single herbal medicine decoction. Twelve batches of representative Lonicerae Japinicae Flos were collected, UPLC fingerprints were established, and the chemical structures of main peaks were identified with UPLC-QTOF-MS and standard compounds. The main components in the decoction are organic acids and iridoids. The extract rate of the standard decoction was (34.2±2.9)% and the transfer rate is (78.6±8.4)% in the form of chlorogenic acid, within the range of 75%-125% of mean. This paper established a method for the quality evaluation of standard decoction of Lonicerae Japinicae Flos and provided reference for the quality control method of terminal products from decoction of Lonicerae Japinicae Flos.

Metabolomics research of medicinal plants / 中国中药杂志

Metabolomics is the comprehensively study of chemical processes involving small molecule metabolites. It is an important part of systems biology, and is widely applied in complex traditional Chinese medicine（TCM）system. Metabolites biosynthesized by medicinal plants are the effective basis for TCM. Metabolomics studies of medicinal plants will usher in a new period of vigorous development with the implementation of Herb Genome Program and the development of TCM synthetic biology. This manuscript introduces the recent research progresses of metabolomics technology and the main research contents of metabolomics studies for medicinal plants, including identification and quality evaluation for medicinal plants, cultivars breeding, stress resistance, metabolic pathways, metabolic network, metabolic engineering and synthetic biology researches. The integration of genomics, transcriptomics and metabolomics approaches will finally lay foundation for breeding of medicinal plants, R&D, quality and safety evaluation of innovative drug.

Research strategies in standard decoction of medicinal slices / 中国中药杂志

This paper discusses the research situation of the standard decoction of medicinal slices at home and abroad. Combined with the experimental data, the author proposes that the standard decoction of medicinal slices is made of single herb using standard process which should be guided by the theory of traditional Chinese medicine, based on clinical practice and referred to modern extraction method with a standard process. And the author also proposes the principles of establishing the specification of process parameters and quality standards and established the basis of drug efficacy material and biological reference. As a standard material and standard system, the standard decoction of medicinal slices can provide standards for clinical medication, standardize the use of the new type of medicinal slices especially for dispensing granules, which were widely used in clinical. It can ensure the accuracy of drugs and consistency of dose, and to solve current supervision difficulties. Moreover the study of standard decoction of medicinal slices will provide the research on dispensing granules, traditional Chinese medicine prescription standard decoction and couplet medicines standard decoction a useful reference.