Substitution mode of rare and endangered Chinese medicinal materials and research strategy of multi-component replacement / 中国中药杂志

Rare and endangered Chinese medicinal materials are the material basis for innovation and development of Chinese medicinal materials and their curative effects are remarkable. However, the resources are in shortage due to various man-made or natural factors such as rising demand, overexploitation and environmental degradation. Therefore, finding alternatives is a feasible and effective solution. This study systematically sorted out the list of rare and endangered Chinese medicinal materials, and combed relevant policies and regulations. According to existing research, the substitution model of rare and endangered Chinese medicinal materials was constructed from the theoretical level. In view of the slow search for substitutes, the failure to follow the basic theory of traditional Chinese medicine in the process of research and development, the difficulty in breaking through technologies and the incomplete guarantee of the clinical efficacy of substitutes, a multi-component replacement was proposed to replace the originals with more effective components from a wide range of sources. This study was expected to promote the study on the substitutes of rare and endangered Chinese medicinal materials to step into a new stage.

Dynamic two-dimensional characterization technique and influencing factors analysis of the hygroscopicity of Chinese medicine extracts / 药学学报

This study aims to construct a dynamic two-dimensional characterization technique for the hygroscopicity of traditional Chinese medicine extracts and investigate the effect of material properties of powders on hygroscopicity. The dynamic hygroscopicity-time curves of the powders were measured at 25 ℃ and 75% humidity, and the semi-equilibrium hygroscopicity time (t1/2) and equilibrium hygroscopicity (F∞) were derived as two-dimensional evaluation indicators. Finally, the correlation between the material properties and the hygroscopic behavior was analyzed by principal component analysis (PCA) and partial least squares analysis (PLS). The results showed that the dynamic two-dimensional characterization system of hygroscopicity constructed with 1/t1/2 = 0.1 h-1 and F∞ = 15% as the center can classify the hygroscopic behavior of traditional Chinese medicine extracts into four categories: fast hygroscopicity with strong hygroscopicity, slow hygroscopicity with strong hygroscopicity, fast hygroscopicity with weak hygroscopicity and slow hygroscopicity with weak hygroscopicity. The moisture absorption was negatively correlated with D50, D90, ρb and ρt; the moisture absorption rate was negatively correlated with D10, D50, D90, ρb, ρt, and positively correlated with moisture content. The hygroscopicity dynamic two-dimensional characterization indicators of Chinese medicine extracts (CMEs) constructed in this study matched with the physical properties. The method of dynamic multi-dimensional characterization technology is feasible and scientific, and the idea has strong promotional value.

Protective effects of Moutan Cortex polysaccharides components on renal injury in diabetic nephropathy rats / 中国中药杂志

This study investigated the protective effects of Moutan Cortex polysaccharides components(MCPC) on the renal tissues of diabetic nephropathy(DN) rats and explored their regulation effect on inflammatory response and oxidative stress. The DN rat model was induced by high-glucose and high-fat diet combined with streptozotocin(STZ), and then the rats were randomly divided into control group, model group, positive group and MCPC high(120 mg·kg~(-1)·d~(-1)), low(60 mg·kg~(-1)·d~(-1)) dose groups. After 12 weeks treatment, blood was taken from the orbit of the rats, and then they were sacrificed before the kidney tissues were collected. The serum and tissues were detected for related biochemical indicators and pathological changes of the kidney. Immunohistochemical methods were used to determine the expression of FN and ColⅣ in the kidney tissue of DN rats. Compared with the model group, blood glucose, serum creatinine, blood urea nitrogen and 24 h urine protein in the MCPC high-dose group were significantly reduced(P<0.01). The results of HE, PAS, Masson staining showed that glomerular basement membrane thickening, Bowman's capsule narrowing and inflammatory cell infiltration in DN rats were improved in the MCPC high-dose group; the activity of T-SOD and GSH-Px in serum significantly increased(P<0.001), and the expression level of FN significantly decreased(P<0.001). The high-dose MCPC treatment could effectively inhibit the abnormal expression of Col Ⅳ(P<0.001) and significantly reduce the levels of AGEs and RAGE in serum(P<0.001), the content of VCAM-1 and IL-1β in serum(P<0.001), and the levels of IL-1β mRNA in kidney tissue(P<0.001), but failed to effectively reduce VCAM-1 mRNA levels in kidney tissues. The high-dose MCPC could significantly improve pathological injury of renal tissue and related renal indicators in DN rats, and achieve renal protection in DN rats mainly by regulating oxidative stress and inflammatory factors.

Nomenclature standardization of Chinese medicine extracts and components / 中国中药杂志

Chinese medicine extracts are the important pharmaceutical materials of Chinese medicinal preparations, but their nomenclature still needs improvement in the field of traditional Chinese medicine(TCM). By the analysis of the evolution rules of names of Chinese medicine extracts recorded in the Chinese Pharmacopoeia, this study proposed a three-level nomenclature of "Chinese medicine name+chemical information+extract" based on the standardization problems involved in the existing nomenclature, striving to accurately suggest the material basic information on extract names. Meanwhile, the basic elements of Chinese medicine components, the special case from Chinese medicine extracts, were clarified, and the core connotations of the professional names were discriminated to arouse attention and discussions of researchers, facilitate the standardization of Chinese medicine terminology, and promote the scienti-fic development of Chinese medicinal preparations, and the modernization and internationalization of Chinese medicine.

Twenty years in the 21st century: identification technologies for and multimodal research on chemical changes in exploration of processing mechanism of Chinese medicine / 中国中药杂志

Chinese medicine undergoes complex chemical changes during processing and identifying these changes is the key to the processing mechanism. In the past 20 years of the 21 st century, research on the chemical changes in Chinese medicine after processing has focused the changes in the biopharmaceutical process in addition to the variation during processing. With the surging of information technologies, various identification technologies(instrumental analysis techniques, molecular biological techniques, data mining techniques, and biotransformation techniques) have developed rapidly and been widely applied to the research on processing mechanism. Thus, based on the chemical changes in the processing and biopharmaceutical process, the author suggested a research tactic of multimodal identification as the core by reorganizing key technologies for chemical identification from studies of the processing mechanism of Chinese me-dicine, aiming at establishing an interdisciplinary multi-dimensional research model for the processing mechanism of Chinese medicine.

Twenty years in the 21st century: research hotspots and frontier analysis on Chinese medicine processing mechanism / 中国中药杂志

The research on the processing mechanism of Chinese medicine is the key and core foundation to improve processing technologies of Chinese medicine, formulate the quality standards of Chinese medicinal pieces, enhance the clinical efficacy of Chinese medicine, enrich Chinese medicine processing theories, and promote the development of Chinese medicine processing. Many researc-hers have conducted in-depth exploration on the processing mechanism of Chinese medicine in the 20 years in the 21 st century. Significant progress has been made in the transformation of chemical components during the processing, the change of active components in the body, the law of toxicity attenuation in the processing of toxic Chinese medicine, the mechanism of efficacy enhancement and toxicity attenuation of processing with auxiliary materials, and the application of new biomedical technologies. At present, the processing mechanism of multiple Chinese medicines has been preliminarily clarified, which has greatly promoted the development of Chinese me-dicine processing. The development of the processing mechanism of Chinese medicine reveals that the in vitro transformation of chemical components is combined with the in vivo absorption, transport, and metabolism, and the macroscopic biological effects of the organism are combined with the cells, molecules, targets, and pathways in the study of the processing mechanism of Chinese medicine. More attention has been paid to exploring the processing mechanism from the overall level, and a modern systematic research system on the processing mechanism of Chinese medicine has been initially formed. To further promote the scientific development of Chinese me-dicine processing, the present study proposed that the research on the processing mechanism of Chinese medicine should take Chinese medicine properties into account, focus on the influence of disease condition on the mode of action and effect strength of the drugs, comply with the characteristics of clinical compound compatibility of Chinese medicine, use the holistic view research strategies of systems bio-logy, and deeply explore the processing mechanism of Chinese medicine from traditional Chinese medicine theories and the characteristics of clinical medication of Chinese medicine.

Twenty years in the 21st century: research approaches and techniques in modern system biology for mechanisms of Chinese medicinal processing / 中国中药杂志

Clarifying the mechanisms of Chinese medicinal processing is pivotal to the modernization of Chinese medicine. Research on Chinese medicinal processing gives priority to the mechanisms of the processing in enhancing efficacy, reducing toxicity, and repurposing medicinals. During the past 20 years, scholars have carried out in-depth studies on the mechanisms of Chinese medicinal processing via modern system biology. They mainly focused on the changes of medicinal properties and efficacy caused by processing using techniques of modern pharmacology and molecular biology, spectrum-efficacy correlation, and biophoton emission. However, these techniques fail to reflect the holistic view of traditional Chinese medicine. With the introduction of system biology, multi-omics techno-logies(genomics, transcriptomics, proteomics, and metabolomics) have surged, which have been applied to the research on the mec-hanisms of Chinese medicinal processing. These multi-omics technologies have advantages in the research on holism. This study aims to summarize the research techniques and approaches in system biology for mechanisms of Chinese medicinal processing in the past 20 years and analyze the limitations and advantages of them. It is concluded that the multi-omics techniques of system biology can reconstruct the mechanisms of Chinese medicinal processing. This study provides a new direction for further research on the mechanisms of Chinese medicinal processing.

Twenty years in the 21st century: temporal and spatial evolution of Chinese medicinal processing equipment / 中国中药杂志

Against the backdrop of "Internet+" and Made in China 2025, Chinese medicinal processing equipment embraces various opportunities and develops to an unprecedented level. In the 20 years of the new century, the processing equipment has gradually developed in the direction of high efficiency, energy saving, environmental protection, integration, and automation, and this field has tended to highlight the establishment and application of the linkage production line for the processing of Chinese medicinal decoction pieces. Integrating automation control technology, online detection technique, and the internet of things technology, the online detection system of Chinese medicinal processing equipment and the computer information management system of Chinese medicinal proces-sing are the mainstream development trends of Chinese medicinal processing equipment. Standard Chinese medicine processing equipment is the prerequisite for the standardization of processing parameters. A standard system for processing equipment and processing parameters is the key to the modernization of Chinese medicinal decoction pieces. This paper summarized the research and application of Chinese medicinal processing equipment in the 20 years of the 21 st century and predicted the development trend, which is expected to serve as a reference for the technological innovation and development of the processing equipment.

Application of particle design technology in field of traditional Chinese medicine powder / 中国中药杂志

Solid preparations account for more than 50% of traditional Chinese medicines(TCM). TCM powder is an important raw material for solid preparations of TCM. Its powder properties directly affect the quality of solid preparations, and even clinical safety and effectiveness. Particle design technology based on the characteristics of powder in TCM is an important means to improve and enhance the quality of solid preparations. This study summarized the relevant principles, methods, characteristics, classification, equipment, and other elements of particle design technology in recent years, analyzed the difficulties in its application in the field of TCM powder, and proposed the strategies in conjunction with the development of computer data mining. The present study is expected to provide a reference for the suitability of particle design in the field of TCM powder.

Study on anti-hygroscopic technology based on correlations between particle spatial properties and hygroscopicity of Chinese medicinal extracts / 中国中药杂志

This study was designed to investigate the correlations of the spatial structure properties of Chinese medicinal extracts with hygroscopicity and the anti-hygroscopic techniques. With Poria extract used as the model drug, pregelatinised starch and microcrystalline cellulose at different ratios were added into Poria fluid extract for preparing powder particles with diverse spatial structures using different drying processes. Then, their hygroscopic behaviours were characterized by equilibrium hygroscopicity(F~∞) and semi-hygroscopic time(t_(1/2)). The correlations of the hygroscopicity of each powder with the spatial structure properties such as particle size(D_(90)), porosity(ε), true density(ρ_t), and surface element distribution were analyzed using partial least-squares method. The F~∞ and t_(1/2) values of Poria extract prepared by three drying methods were sorted in a descending order as follows: F~∞(spray drying>drying at ordinary pressure>drying at reduced pressure); t_(1/2)(drying at reduced pressure>drying at ordinary pressure>spray drying). The powder obtained by spray drying showed a spherical structure with the smallest particle size and intra-particle ε but relatively stronger hygroscopicity. The large-scale surface element enrichment of the powders dried by reduced pressure effectively reduced their hygroscopicity. F~∞ and t_(1/2) were negatively correlated with ε but positively with D_(90), and the interactive influence of each spatial structural properties was not significant. There existed a correlation between the spatial structure of the powder particles of Chinese medicine extracts and their hygroscopicity, and the hygroscopicity could be improved by designing the spatial structure. This study has provided some practical basis for developing the moisture-proof technology of Chinese medicinal preparations.

Particle design for improving taste and homogeneity of traditional Chinese medicinal powder: taking Zhuhuang Chuihou Powder as an example / 中国中药杂志

Due to the complex source and different physical and chemical properties of traditional Chinese medicines(TCM) powder, there are many common pharmaceutical problems in its preparation, such as large particle size difference, poor mixing uniformity, and poor compliance with oral intake, which has directly affected the quality of solid preparations as well as their clinical efficacy and safety. This study observed the property of Zhuhuang Chuihou Powder and extract its pharmaceutical defects. It was found that realgar and calcined Borax in Zhuhuang Chuihou Powder were heavy in texture and toxic, and they were easy to be isolated, indicating the potential safety hazard. At the same time, Coptidis Rhizoma and Phellodendri Chinensis Cortex were the main sources of its bitterness. Therefore, based on the idea of "drug-excipients unity", the particle design technology was used to prepare core/shell-type composite particles with bitter medicines as the core and mineral medicines as shell. Both infrared spectroscopy and scanning electron microscopy results indicated the formation of composite particles, and the taste of these composite particles were improved. Compared with the physical mixtures, the composite particles exhibited significantly decreased RSD values in the content uniformity of berberine hydrochloride, arsenic disulfide, and sodium tetraborate and appearance uniformity. The introduction of particle design technology solved the problem of uneven dispersion of Zhuhuang Chuihou Powder, thus ensuring its uniform dispersion, stability, and control and improving the quality of the original preparation. This has provided a scientific basis for the quality control of TCM powder.

[Product improvement and secondary development of Pudilan Xiaoyan Oral Liquid based on clinical medication].

Pudilan Xiaoyan Oral Liquid is widely used in clinical applications, with safe and effective results. Its coverage rate in the national first, second and third grade hospitals is as high as 71%. In this study, we analyzed and summarized the research progress on the material basis, quality control, production process and clinical medication of Pudilan Xiaoyan Oral Liquid based on the clinical diseases(parotitis, tonsillitis, pharyngitis), and deeply explored the intrinsic quality improvement and secondary development of Pudilan product. Pharmacodynamic material basis of Pudilan Xiaoyan Oral Liquid was explored through the network pharmacology technology and quality control indicators of the production process were optimized by cell anti-inflammatory experiments. Through these techno-logies, it would be more specific, scientific and effective to carry out process optimization of each link and multidimensional quality control of the whole process. The dosage and oral compliance for special patients(children) were explored, providing a reference for clinical pediatric medication of Pudilan Xiaoyan Oral Liquid. Simultaneously, it is helpful to expand the application market by developing Pudilan daily chemical products, and promote the traditional Chinese medicine products in terms of curative effect and daily life.

[Investigation of active components and mechanism of Pudilan Xiaoyan Oral Liquid based on network pharmacology].

To investigate the active components/ingredients of Pudilan Xiaoyan Oral Liquid based on the network pharmacology technology, and analyze the network data of its potential targets and mechanisms. The active ingredient screening, protein interaction analysis and pathway annotation were used to further optimize its active components and potential targets, and clarify the pharmacodynamic substance basis and mechanism of Pudilan Xiaoyan Oral Liquid. Through this technique, we screened out 41 active ingredients in Pudilan Xiaoyan Oral Liquid, mainly including 16 alkaloid components, 13 organic acid components, 11 flavonoid components and 1 coumarin component such as chicoric acid, chlorogenic acid, oroxindin, rutin, corynoline, and esculetin. In addition, 6 targets for parotitis, 48 targets for tonsillitis, and 22 targets for pharyngitis were screened. A total of 22 disease signaling pathways are involved, including 4 pathways closely related to inflammation. The IL-17 signaling pathway had the highest D(degree) value and may be most closely related to inflammatory diseases. Through network data excavating, we initially explored the main active components/ingredients of Pudilan Xiaoyan Oral Liquid, clarified the pharmacodynamic basis of Pudilan Xiaoyan Oral Liquid treatment-related diseases and its key mechanism of action in this study, hoping to provide a theoretical basis for clinical research, and at the same time, lay the foundation for deep research and promotion of Pudilan Xiaoyan Oral Liquid product.

[Identification of quality markers for Pudilan Xiaoyan Oral Liquid].

On the basis of anti-inflammatory activity, combined with multiple indicators, the quality markers of Pudilan Xiaoyan Oral Liquid were screened and determined for quality control. Lipopolysaccharide(LPS) was used to induce normal human bronchial epithelial cell(NHBE) inflammation model. The anti-inflammatory effects of the main chemical components in Pudilan Xiaoyan Oral Liquid were examined one by one, and the pharmacodynamic basis for the overall anti-inflammatory efficacy of Pudilan Xiaoyan Oral Liquid was clarified to identify the quality markers of Pudilan Xiaoyan Oral Liquid and the contents of the quality markers were determined by high performance liquid chromatography(HPLC). The results showed that adenosine, epigoitrin, chlorogenic acid, caffeic acid, cichoric acid, corynoline, baicalin, wogonoside, wogonin and oroxylin A had a certain regulatory effect on inflammatory factor tumor necrosis factor(TNF-α), interleukin(IL-1ß) and IL-6 at specific concentrations in a dose-dependent manner. Considering the factors such as the IC_(50) value of each monomer component and the comprehensiveness of the quality control components, we proposed to use adenosine, cichoric acid, corynoline, baicalin and wogonin as quality markers of Pudilan Xiaoyan Oral Liquid. The contents of the five components were determined by HPLC, and the results showed that they were relatively stable in three batches of Pudilan Xiaoyan Oral Liquid. In this study, the quality control components selected by the anti-inflammatory activity test have a clear material basis, covering all four active pharmaceutical ingredients, which can fully reflect the quality of Pudilan Xiaoyan Oral Liquid, and effectively improve the quality control standard of Pudilan Xiaoyan Oral Liquid.

[Improvement of compliance of Pudilan Xiaoyan Oral Liquid based on comprehensive analysis of bad taste of traditional Chinese medicine oral liquid preparation].

From "good efficacy with a bad taste" to "good efficacy with no bitterness" and then to "good efficacy with a good taste" is the only way to develop oral liquid preparations of traditional Chinese medicine, and "good medicine is beneficial to disease" is the only way for the development of oral liquid preparations of traditional Chinese medicine. Based on the analysis of the causes, the sources of bitterness, the formation principles and their solutions of traditional Chinese medicine oral liquid preparations, we explored the causes of the bad taste and the material basis of bitterness of Pudilan Xiaoyan Oral Liquid, and applied the solutions in improving the taste of Pudilan products. The overall taste of Pudilan Xiaoyan Oral Liquid was improved by modifying the original product taste, enhancing the process and changing the dosage form, which improves the compliance of the patients who take the medicine, and better serve the clinical medication.

[Source control of Pudilan Xiaoyan Oral Liquid--research on quality of Taraxaci Herba based on ultra high performance liquid chromatography fingerprint].

Pudilan Xiaoyan Oral Liquid has been widely used in the clinical treatment of inflammatory diseases such as upper respiratory tract infections. Taraxaci Herba, as the monarch medicine in Pudilan Xiaoyan Oral Liquid, due to its multi-source, multi-origin characteristics, and the difference in the content of active ingredients in different medicinal parts, has become a potential factor for the unstable quality among different batches of Pudilan Xiaoyan Oral Liquid. In this paper, Thermo Scientific Vanquish ultra-high-performance liquid chromatography(UPLC) system was used, and the Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(2012 Edition) issued by National Pharmacopoeia Commission was used for processing and analysis. The main common peaks were identified and contents were determined by comparison with reference substances. Fingerprints of Taraxaci Herba medicinal materials from different origins were established. 13 common peaks were identified, and 29 batches of samples from five origins had similarities above 0.90. At the same time, an ultra-high performance liquid chromatography method was developed for the determination of monocaffeoyl tartaric acid, chlorogenic acid, caffeic acid, chicoic acid, and luteolin in Taraxaci Herba. The quantitative analysis conditions were verified by methodology, and the average sample recovery was 97.30%-101.8%. The results showed that the content of the same ingredient in Taraxaci Herba from different origins and different medicinal parts was obviously different, and the fluctua-tion range was also different for different ingredients. The establishment of UPLC fingerprints for Taraxaci Herba from different regions combined with multi-component content determination methods provides a reference for improving the quality control of Taraxaci Herba medicinal materials, and also provides a source guarantee for the quality improvement of Pudilan Xiaoyan Oral Liquid.

[Mechanism of Alisma orientale in treating nonalcoholic fatty liver disease].

In this study, network pharmacology technology was combined with molecular docking technology and experimental verification to clarify the active ingredients, potential targets and mechanism of Alisma orientale for nonalcoholic fatty liver disease(NAFLD), providing a basis for its clinical application. The active ingredients of A. orientale were screened through traditional Chinese medicine systems pharmacology database(TCMSP), and the potential targets related to both active ingredients and NAFLD were predicted through protein databases by considering the oral bioavailability(OB) and drug-likeness(DL). The "active ingredient-potential target" network was constructed by using Cytoscape software, and the molecular docking was performed between active ingre-dients and potential targets. KEGG pathway analysis and enrichment analysis were performed through DAVID biological information annotation databases. ClueGO software was used to analyze target GO annotation. Western blot and immunocytochemistry were used to detect the protein expression levels, and fluorescent probe was used to detect the reactive oxygen species(ROS) generation level. The results revealed that 7 active ingredients of A. orientale were obtained from TCMSP database and analysis platform, 140 ingredient-related targets were screened, and 59 potential targets were obtained by intersecting disease targets with ingredient-related targets. Molecular docking showed that 7 active ingredients of A. orientale could act on the potential targets including 3-hydroxy-3-methylglutaryl-coenzyme A reductase(HMGCR) and tyrosine-protein phosphatase non-receptor type 1(PTPN1). In addition, KEGG enrichment analysis showed that the potential targets were mainly enriched in inflammatory mediator regulation, insulin resistance, neuroactive ligand-receptor interaction, vascular smooth muscle contraction, FcγR-mediated phagocytosis and other related pathways of tryptophan(TRP) channel. GO enrichment analysis showed that potential targets mainly affected the biological processes of G-protein coupled receptor signaling pathway, organic hydroxyl compound transport, positive regulation of lipid biosynthesis process, positive regulation of lipid metabolic process. Western blot, immunocytochemistry and fluorescent probe confirmed that the extract of A. orientale could reduce HMGCR and PTPN1 protein expression levels effectively, and also could reduce ROS production level of HepG2 cells. This study systematically revealed the material basis and mechanism of A. orientale in regulating NAFLD through multi-component, multi-target, and multi-pathway characteristics, which provided a theoretical basis and scientific basis for the clinical application of A. orientale.

Characterization of oil/water partition coefficient of chishao terpene glucoside components based on contribution rate of representative components for myocardial ischemia / 中国中药杂志

The components of traditional Chinese medicine(TCMCs) are the basic unit of raw materials for Chinese medicines, and their physical and chemical properties directly affect the choice of dosage forms and the optimization of prescriptions. However, most of TCMCs are multi-component complex systems, and the characterization of their overall properties is still in the exploration stage. On the basis of biological activity, the representative components are determined, and then the individual characteristics are fitted with the weight coefficient of efficacy contribution rate, which may provide reference for characterizing the overall properties of TCMCs. In this study, with the pharmacological effects of isoproterenol(ISO)-induced myocardial ischemia in rats as the indicators, the pharmacodynamic contribution rates of three representative components of chishao terpene glucoside components(CSTGCs) were evaluated by the normalization weighting method. The contribution rates of paeoniflorin, paeoniflorin and benzoylpaeoniflorin were 54.87%, 32.46% and 12.67%, respectively. The oil-water partition coefficients of paeoniflorin, albiflorin, benzoylpaeoniflorin in water and buffer solutions with different pH values were measured, and the oil-water partition coefficients of CSTGCs were characterized by the weight of their pharmacodynamics contribution rate. The results showed that the apparent oil-water partition coefficient(log P) of CSTGCs in the phosphate buffer system such as n-octanol-water(pH 2.0, 2.5, 5.0, 5.8, 6.8) were 0.18-0.22, indicating that CSTGCs have common absorption and low permeability, providing basis for the preparation of CSTGCs.

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.

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.