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ObjectiveTo establish the determination for index components in benchmark samples of Erdongtang， and clarify the content and transfer rate rages of index components in 15 batches of benchmark samples， and to explore the quantity transfer of index components of decoction pieces to benchmark samples. MethodFifteen batches of benchmark samples were prepared， the contents of mangiferin， baicalin and glycyrrhizic acid were determined by high performance liquid chromatography （HPLC）-diode array detector （DAD）， the mobile phase was acetonitrile （A）-0.1% formic acid aqueous solution （B） for gradient elution （0-10 min， 10%-17%A； 10-25 min， 17%-19%A； 25-28 min， 19%-25%A； 28-45 min， 25%-33%A； 45-46 min， 33%-45%A； 46-60 min， 45%-55%A）， detection wavelength was set at 254 nm. Contents of timosaponin BⅡ and the sum of protoneodioscin and protodioscin were determined by HPLC-evaporative light scattering detector （ELSD）， the mobile phase was acetonitrile （A）-water （B） for gradient elution （0-20 min， 24%A； 20-25 min， 24%-27%A； 25-33 min， 27%-28%A； 33-36 min， 28%-90%A； 36-41 min， 90%-24%A）. ResultThe methodological verification of the established method was good， which could be used for determination of five index components in benchmark samples. The content ranges of mangiferin， baicalin， glycyrrhizic acid， timosaponin BⅡ， and the sum of protoneodioscin and protodioscin in 15 batches of benchmark samples of Erdongtang were 0.14%-0.23%， 2.40%-3.37%， 0.07%-0.44%， 0.43%-0.95%， and 0.15%-0.47%， the transfer rate ranges of them were 33.90%-52.15%， 84.46%-105.61%， 22.59%-93.86%， 38.07%-61.43%， and 53.28%-96.11%， respectively. ConclusionThe consistencies of transfer rate of mangiferin， baicalin， timosaponin BⅡ and the sum of protoneodioscin and protodioscin （except glycyrrhizic acid） between decoction pieces and benchmark samples of Erdongtang are good， indicates that the transfer rates of 4 index components are stable during the preparation process of benchmark samples， which can provide data support for research and development of the compound preparation of this formula.
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Objective:Powders and decocted powders account for about 1/3 in the Catalogue of Ancient Famous Classical Formulas （the First Batch）， and have a very important position. Determination of preparation technology and particle size in the pulverization process is the key step in the research and development of powders and decocted powders following the original methods. However， there are many terms describing the preparation technology and particle size of powders and decocted powders in ancient Chinese medical books， and the parameters are not clear. Due to the lack of unified basis of particle size， the existing research results have not formed a uniform consensus. Based on ancient textual researches and experimental results， this article discusses the particle size of decocted powders and powders. Method:Through textual researches of the preparation technology and particle size of powders and decocted powders and powder classification in the 2020 edition of Chinese Pharmacopoeia， the specifications of pulverized particle size were suggested. In addition， Xiebaisan and Danggui Buxuetang were taken as examples to investigate the influence of different particle sizes （4， 10， 24 mesh） on the preparation process of decocted powders and the obtained decoction. Result:The particle size of 4 mesh was equivalent to that of ancient as big as hemp bean. The contents of index components in Xiebaisan and Danggui Buxuetang with particle size of 4 mesh were higher than that of 10 mesh and 24 mesh， but the particle size of 50 mesh was too fine to be filtered. Conclusion:The suggested particle sizes of powders and decocted powders are recommended as Cumo is the power through 10-mesh sieve， Mo is the power through 24-mesh sieve， Ximo is the power through 80-mesh sieve， as big as hemp bean is the power through 4-mesh sieve and not through 10-mesh sieve.
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Objective:There were 92 kinds of compound preparations containing Ophiopogonis Radix in the 2015 edition of Chinese Pharmacopoeia， but there was no effective method to identify these compound preparations. Because Ophiopogonis Radix and Liriopes Radix are similar in appearance， it is easy to be confused in application. The aim of this study was to set up a thin layer chromatography （TLC） to identify compound preparations containing Ophiopogonis Radix and distinguish Ophiopogonis Radix and Liriopes Radix in the forms of decoction pieces and standard decoction. Method:In this study， decoction pieces of Ophiopogonis Radix and Liriopes Radix were collected and separately prepared as standard decoction. TLC was used to qualitatively identify decoction pieces and standard decoction of Ophiopogonis Radix and Liriopes Radix， and compound preparations containing Ophiopogonis Radix. In the TLC， the lower solution of chloroform-methanol-water （65∶35∶10） was selected as the developing agent and 10% sulfuric acid ethanol solution as the chromogenic agent. Result:The resolution of this TLC was good. Decoction pieces， standard decoction and preparations of Ophiopogonis Radix had the same characteristic strips， which were two bright white fluorescent strips under ultraviolet lamp （365 nm）. But these two characteristic strips were not existed in the TLC of decoction pieces and standard decoction of Liriopes Radix. The corresponding components of both of these two strips were identified as mixture containing saponins by LC-MSn， including ophiopogonin Ra， Tb， ophiopogonin D'， borneol glycoside， ophiopogonin C and Liriope muscari baily saponins C. Conclusion:The established TLC method， which has significant advantages such as high specificity and sensitivity， can be applied to the characteristic identification of decoction pieces and standard decoction of Ophiopogonis Radix， the identification of compound preparations containing Ophiopogonis Radix， and the distinction of Ophiopogonis Radix and Liriopes Radix， thus serving as an effective method to qualitatively identify Ophiopogonis Radix and its compound preparations.
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Objective:To establish the quality evaluation methods of Asparagi Radix decoction pieces and its standard decoction. Method:Ten batches of Asparagi Radix standard decoction were prepared. High performance liquid chromatography-evaporative light scattering detection method (HPLC-ELSD) was established for the determination of protodioscin and protoneodioscin in Asparagi Radix decoction pieces and its standard decoction, and the fingerprint detection of Asparagi Radix decoction pieces with acetonitrile-water as mobile phase for gradient elution. UHPLC-LTQ-Orbitrap-MS/MS was used to identify ten main common peaks in the fingerprint with acetonitrile-0.1% formic acid solution as mobile phase for gradient elution, electrospray ionization (ESI) and positive and negative ion mode scanning were employed, the detection range was m/z 100-1 400. Result:The total content of protodioscin and protoneodioscin in Asparagi Radix decoction pieces was 0.41%-0.72%, and their total content in Asparagi Radix standard decoction was 0.33%-0.59%, the transfer rate of these two components was 73.6%-98.3%. The dry extract yield of the standard decoction was 59.0%-73.0%, and its pH was 4.9-5.6. There were 10 common peaks in the fingerprint, and all of them were saponins, including protoneodioscin, protodioscin, aspacochioside A and its isomer, methyl protodioscin, asparagoside F, (25R)-26-O-β-D-glucopyranosyl-furostan-5, 20-diene-3β, 26-diol-3-O-[α-L-rhamnopyranosyl (1→2)]-[β-D-glucopyranosyl (1→4)-α-L-rhamnopyranosyl (1→4)]-β-D-glucopyranoside, 26-O-β-D-glucopyranosyl-furostan-20 (22)-ene-3β, 26-diol-3-O-[α-L-rhamnopyranosyl (1→2)]-[α-L-rhamnopyranosyl (1→4)]-β-D-glucopyranoside, pseudodiosgenin, aspacochioside C. Conclusion:In this paper, the quality evaluation methods of Asparagi Radix decoction pieces and its standard decoction are established, and these methods are stable and feasible, which can provide reference for the quality control of pharmaceutical preparations containing Asparagi Radix.
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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.
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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.
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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.
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China , Food , Food Industry , Medicine, Chinese TraditionalABSTRACT
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.
Subject(s)
Food , Reference Standards , Materia Medica , Reference Standards , Medicine, Chinese Traditional , Quality Control , Research DesignABSTRACT
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.
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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.
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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.
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The quality of Danshen extract granules on market is largely different from each other mainly due to the heterogeneous quality of raw materials of Salvia miltiorrhiza, various producing procedures and lack of good quality evaluation method. Formula granule and "standard decoction" have the same quality. In this paper, a systematic evaluation method for the quality of Danshen decoction was established from the perspective of "standard decoction", in order to explore the main factors affecting the quality uniformity of Danshen extract granules. Danshen standard decoction was prepared; then the fingerprint method was developed to determine the content of salvianolic acid B; and the main peaks in the fingerprint were identified with UPLC-QTOF/MS to clarify the chemical compositions of Danshen decoction. Three indexes were calculated to evaluate the stability of whole process, including the extraction ratio; transfer rate of index components and pH value. The results showed that the main components of Danshen decoction were phenolic acids, while the extraction rate, the transfer rate of salvianolic acid B and pH value were in a relatively stable level, and the similarity in the fingerprint of standard decoction was high, indicating that the preparation procedure was stable. The level of salvianolic acid B in the standard decoction was in a large range, which was mainly due to the difference in the quality of Salviae Miltiorrhizae Radix et Rhizoma.
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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.
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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.
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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.