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Objective: To establish HPLC specific chromatograms of Puerariae Lobatae Radix(PLR) and Puerariae Thomsonii Radix(PTR), and make a distinction about their species and different habitats of PLR by chemical pattern recognition, provide reliable methods for scientific evaluation and effective control of their quality. Method: HPLC was employed to determine the contents of chemical ingredients in 23 batches of PLR and PTR.The similarity analyzed with "Similarity Evaluation System for Chromatographic Fingerprint of Chinese Materia Medica"(version of 2004A), then a common pattern was established.Based on its chemical fingerprint information, the quality of PLR and PTR was comprehensively analyzed by three kinds of chemical pattern recognition methods. Result: In addition to sample S22(from Shaanxi province), the similarities of 23 batches of samples were more than 0.9, which showed that similarity of PLR and PTR was good, this method can not differentiate them.Principal component analysis(PCA) could only identify PLR and PTR, but partial least squares-discriminant analysis(PLS-DA) could distinguish PLR from PTR and the producing areas of PLR with model interpretation of 96.4% and prediction of 74.6%.The result of hierarchical cluster analysis(HCA) was consistent with PLS-DA. Conclusion: Chemical pattern recognition method can make a distinction between PLR and PTR, as well as different habitats of PLR;it is suitable for quality control of their medicinal materials.
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Volatile oil is widely distributed in Chinese medicinal materials,which contains rich chemical compositions and has a variety of pharmacological activities such as anti-bacterial,anti-inflammatory,anti-oxidant,anti-tumor,transdermal absorption and antalgic activities,etc.In recent years,the research on the Chinese medicines containing volatile oil is increasing,showing a wide prospect of application in clinical medicine,health care,daily products development,etc.Volatile oil of traditional Chinese medicine has poor solubility,volatility and unstable properties.Factors such as species,harvesting seasons,extraction methods,processing technologies and storage conditions would affect the compositions and contents of volatile oil,thus directly affecting its efficacy,safety and quality stability.Hence,it is especially necessary to control the volatile oil content.The current 2015 edition of the Chinese Pharmacopoeia has made a lot of regulations on the quality control of Chinese medicines containing volatile oil,but generally does not provide the lowest and highest concentrations of volatile oil.As the volatile oil of traditional Chinese medicines has good biological activity and the quality standards are not yet perfect,this study would take the Fist Part of Chinese Pharmacopoeia 2015 Edition as the data source to determine the species of Chinese medicines containing volatile oils through literature research and pharmacopoeia description;the functions,indications,and sources of 196 kinds of traditional Chinese medicines containing volatile oil would be classified and the confusable species would be discriminated by using the Chinese pharmacy knowledge.In this study,the quality-influencing factors would be comprehensively analyzed and the content determination methods of volatile oil would be summarized to offer a reference for the development and application of Chinese medicinal materials containing volatile oil,as well as to lay the foundation for further reinforcing and improving their quality standards.
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Decoction pieces are important raw materials in the production of traditional Chinese medicine( TCM),and their quality could directly affect the clinical efficacy and medication safety. Research on the production and processing technology of TCM is the basis for the normalization and standardization of Chinese medicine decoction pieces. At present,the production and processing standards for Scutellaria baicalensis pieces are non-regulated,lacking data foundation. In this study,with baicalin,baicalein,wogonoside and wogonin contents as evaluation indicators,single factor experiment was designed to optimize the softening,drying and cutting processes of S. baicalensis,providing a basis for the standardization of their production and processing. The effects of different softening,drying and cutting processes on the contents of the main components in S. baicalensis were comprehensively analyzed by the summation of relative differences. RESULTS:: showed that the contents of the four components and comprehensive indexes were affected by different softening methods and drying temperatures. The content of wogonin in boiling method was higher than that in boiling with cold water,and the content of glycosides in 70 ℃ drying condition was higher than that in other groups. The content of baicalin was significantly affected by different cutting thicknesses,but not by comprehensive index. Eventually,the optimal preparation process for S. baicalensis was determined as follows: boiled in boiling water for 20 min,cut into thin slices( 1-2 mm),and then dried at 70 ℃ in blast drier. This process was close to the actual production,practical and feasible and meanwhile,it was of great significance to improve the quality of S. baicalensis pieces.
Subject(s)
Desiccation , Drugs, Chinese Herbal , Reference Standards , Flavonoids , Medicine, Chinese Traditional , Quality Control , Scutellaria baicalensis , ChemistryABSTRACT
"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development.
Subject(s)
China , Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese Traditional , Reference Standards , Quality Control , Technology, PharmaceuticalABSTRACT
Objective To identify the active components of Andrographis paniculata coupled with Caco-2 cells screened by UPLC-Q-TOF-MS. Methods The cell-combining compounds from A. paniculata were screened based on drug uptake and transport absorption experiment using Caco-2 cells, then the cell dissociation solution was detected before and after treating with A. paniculata by using UPLC-Q-TOF-MS method. The cell-combining compounds from the ethanol extracts of A. paniculata were identified based on the retention time and mass spectrometry information of each chemical composition combined with comparing the extracted ion chromatograms and mass spectrometry datas of reference substances and the related articles. Results A total of 10 compounds combined with Caco-2 cells in ethanol extract of A. paniculata, which were detected and identified as 12,13- dihydroandrographolide (1), skullcapflavone I-2'-O-glucoside (2), andrographolide (3), 14-deoxy-11,12-didehydro andrographiside (4), 7-hydroxy dehydroandrographolide (5), neoandrographolide (6), 3-deoxy dehydroandrographiside (7), deoxyandrographolide (8), dehydroandrographolide (9), and one unidentified component. Conclusion This research establishes a method of screening the active components of A. paniculata coupled with Caco-2 cells using UPLC-Q-TOF-MS analysis, which can be used to screen out the active components of the complex system on traditional Chinese medicines, as well as to lay the foundation for further study of the synergetic compatibility effects among active ingredients.
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Current evaluation method for astringency is mainly focused on human sensory evaluation. However, it is subjective, vague, and short of assessment indicators for objective quantification. In this paper, the quantification method for astringent intensity of traditional Chinese medicine was established based on the animal preference index and electronic tongue in vitro and in vivo. Firstly, the standard substance of astringency, tannic acid, was used for the methodology optimization and validation of two-bottle preference test. It was determined that the standard experimental animals were female rats of 140-180 g. The functional relationship between concentration of tannic acid and preference index was obtained Y= ln(1.682 6－0.441 66X), r=0.997 3. Then the typical astringent Chinese herbs Chebulae Fructus, Ardisiae Japonicae Herba, Canarii Fructus, Catechu, and Arecae Pericarpium were evaluated by the optimized method. Their corresponding concentration of tannic acid was converted by the concentration-preference index relationship through preference index. Their astringency was equivalent to 0.56, 0.29, 0.24, 0.34, 0.25 g•L⁻¹ tannic acid. Finally, the results were verified by electronic tongue. The correction analysis between Euclidean distance in PCA and preference index and concentration of tannic acid converted by samples showed a high correlation through pearson correlation analysis. The above results indicated that the method was objective, true and reliable. The method provided a reliable tool for the quantification of astringency and evaluation of taste masking effect for Chinese medicines, and also offered a new idea and model for the quantification of taste in the pharmaceutical and food fields.