Practice and development of structural characteristics and quality control of multi-dimensional structure of basic components of genuine material of Moutan Cortex / 中国中药杂志

Traditional Chinese medicine is the product of clinical medication practice of the Chinese nation for thousands of years. Its material basis is the key to reveal the essence of the roles of traditional Chinese medicine, and the fundamental guarantee to solve the difficulties in the quality control of traditional Chinese medicine. However, the material basis of traditional Chinese medicine is to exert the overall pharmacodynamic effect through multi-targets, multi-approaches and mutual cooperation, resulting in unclear quality control index. In recent years, the quality control standards of traditional Chinese medicine have experienced great changes by shifting the focus from the appearance characteristics to the internal material basis, which however is limited to the control of a single com-ponent or multiple components. In other words, the intrinsic effectiveness and safety could not be guaranteed without the characteristics of the integrity of traditional Chinese medicine. With Moutan Cortex as an example, this paper analyzed the evolution of Moutan Cortex quality standards based on Chinese Pharmacopoeia, and comprehensively summarized the material basis of Moutan Cortex. Based on the theory of "component structure", this study analyzed current quality control of the material basis of Moutan Cortex and its preparations, and expounded the development trend of multi-dimensional quality control, so as to lay a foundation for establishing a more rational quality control system for traditional Chinese medicine in the future.

Structural characteristics of pharmacodynamical components in genuine Moutan Cortex / 中国中药杂志

Guided by the theory of "component structure", we analyzed the structural characteristics of pharmacodynamical components in genuine Moutan Cortex. The compositions of organic small molecules were determined by high performance liquid chromatography(HPLC) for 20 batches of genuine Moutan Cortex and 12 batches of non-genuine Moutan Cortex. By means of similarity analysis, clustering analysis(CA), principal component analysis(PCA) and orthogonal partial least-squares discriminant analysis(OPLS-DA), the elements in structural characteristics of the pharmacodynamical components were extracted as follows: terpene glycosides components(oxidized paeoniflorin, paeoniflorin,galloyl paeoniflorin, benzoyloxy paeoniflorinand benzoyl paeoniflorin), tannin components(1,3,6-tri-O-galloside acyl glucose, pentagalloyl glucose), and phenolic acid components(methyl gallate, paeonol). The contents and quantity ratios of terpene glycoside component, tannin component and phenolic acid components in genuine Moutan Cortex were determined as 14.1, 12.5, 21.7 mg·g~(-1), 1.00∶0.89∶1.54. The contents and quantity ratios of the oxidized paeoniflorin, paeoniflorin and benzoylpaeoniflorin in the terpene glycoside components were characteristic and determined as 2.05, 7.05, 3.30 mg·g~(-1), 1.00∶3.44∶1.61. The unique structural characteristics of genuine Moutan Cortex provide scientific basis for the formulation of quality standards.

Comparative analysis and study on component characteristics of inorganic elements in genuine Moutan Cortex and their differences from other areas / 中国中药杂志

Based on the theory of "component structure", the component structure characteristics of 17 inorganic elements in 20 batches of genuine Moutan Cortex and 12 batches of non-genuine Moutan Cortex were analyzed. The analytical method of inductively coupled plasma mass spectrometry(ICP-MS) for inorganic elements in Moutan Cortex was established, and the fingerprint of inorganic elements was drawn. Through correlation analysis and principal component analysis, the constituent elements of inorganic elements in Moutan Cortex were excavated, namely characteristic elements As, Cr, Pb, Se, K, Cu and Cd. The amount and the quantity relative ratio between the components of genuine and non-genuine Moutan Cortex samples were analyzed. It was found that the amount of characteristic elements in the bulk genuine Moutan Cortex samples was 0.33, 1.42, 1.33, 0.11, 4 385.78, 4.87, 0.49 mg·kg~(-1), with the quantity relative ratio of 1.00∶4.30∶4.03∶0.33∶13 290.24∶14.76∶1.48. The amount of characteristic elements in sub-packaged genuine Moutan Cortex was 0.24, 1.96, 0.36, 0.05, 5 122.01, 4.81, 0.05 mg·kg~(-1), with the quantity relative ratio of 1.00∶8.17∶1.50∶0.21∶21 341.71∶20.04∶0.21. The unique structural characteristics of inorganic elements in genuine Moutan Cortex are studied to provide a basis for the quality control and safety evaluation of Moutan Cortex.

Structure characteristics and quality control of Liuwei Dihuang Concentrated Pill from different manufacturers / 中国中药杂志

In this paper, we aim to control and evaluate the quality of Liuwei Dihuang Concentrated Pill by using the model of fingerprint technique and "component structure" theory. Agilent 5 TC-C_(18) column(4.6 mm×250 mm,5 μm) was used, with 0.1% formic acid solution-acetonitrile as mobile phase at a flow rate of 1.0 mL·min~(-1). The column temperature was 30 ℃, with detection wavelength of 242 nm and the sample volume of 10 μL. The characteristic fingerprint of Liuwei Dihuang Concentrated Pill was established by high performance liquid chromatography(HPLC) for its quality control. Seventeen common peaks were identified, and the similarity was 0.550-0.997 in 29 batches of samples, indicating that the quality difference among batches of Liuwei Dihuang Concentrated Pills was significant. The structural characteristics of the Moutan Cortex components in Liuwei Dihuang Concentrated Pills were characterized. On this basis, combined with the structural characteristics of genuine components of Moutan Cortex, the structural characteristics of components in Liuwei Dihuang Concentrated Pills were further analyzed. The results showed that there were significant differences in the contents and quantity ratios of 9 representative components(components) of Moutan Cortex in Liuwei Dihuang Concentrated Pills from different manufacturers, indicating internal quality differences among different batches of products. The fingerprint technique and the "component structure" theory established by the above research provide an analytical method and a research foundation for the quality evaluation of Liuwei Dihuang Concentrated Pills.

Quality analysis of Moutan Cortex Formula Granules based on structural characteristics of genuine components / 中国中药杂志

To evaluate the quality of Moutan Cortex Formula Granules from different manufacturers based on the structural characteristics of the genuine components of Moutan Cortex. High performance liquid chromatography(HPLC) fingerprint analysis method of Moutan Cortex Formula Granules was established to characterize the elements of the structural characteristics for genuine Moutan Cortex. Nineteen common peaks were determined and the similarity between the Moutan Cortex Formula Granules of each batch and the control fingerprint was 0.856-0.981. The results showed that there were differences in the internal quality of Moutan Cortex Formula Granules from three manufacturers. The contents of components as well as inter-component and intra-component quantity ratio for Moutan Cortex Formula Granules from different manufacturers were analyzed. It was found that the inter-component quantity ratio of G1 and G2 produced by manufacturer A was close to that of G4 produced by manufacturer B; the inter-component quantity ratio of G3 from manufacturer B was close to that of G7 from manufacturer C; and the inter-component ratios of samples G5, G6, G8-G11 produced by manufacturer C were closer to each other. The results of the study guided by the theory of "component structure" provide a new analytical method and basis for the quality evaluation of Moutan Cortex Formula Granules.