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Chinese patent medicine (CPM) is an important part of traditional and Chinese medicine (TCM). Its quality has direct impact on the safety and effectiveness of clinical use. The quality standard is the pivotal approach to guarantee the quality of CPM. Due to the complex material basis, multitudinous quality influencing factors and unveiled active ingredients, dose-effect relationship and action mechanism, the investigation on quality standard faces many difficulties. This paper surveys the current quality status of CPM and the general situation of CPM standards. At present, the dosing problem has the crucial impact on the quality of CPM. The current quality standard system of CPM is confirmed and the limitations are indicated. Based on the above analysis, the principles and considerations on investigation of quality standard are proposed as follows: ① Adhere to safety as the bottom line, strengthen the risk-control ability of the standard of CPM; ② Adhere to theory of TCM and comprehensive quality, improve the integrative control level of the CPM standard; ③ Emphasize technological development and innovation, promote the quality control competence of CPM standard; ④ Facilitate planning and coordination, optimize the management of the CPM standard system; ⑤ Reinforce investigation on evaluation method, develop grade evaluation standard, accelerate high-quality development of CPM. Finally, the future perspective on investigation of CPM quality standard is prospected.
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ObjectiveTo explore the effect and mechanism of Xiaojindan extract (XJD) on macrophage polarization. MethodLipopolysaccharide (LPS) and interleukin-4 (IL-4) were used to induce M1 and M2 polarization of RAW264.7 cells. The influence of 10-80 mg·L-1 XJD on cell proliferation was detected by Cell Counting Kit-8 (CCK-8) assay. Nitric oxide (NO) and interleukin-6 (IL-6) release was explored by Griess assay and enzyme-linked immunosorbent assay (ELISA), respectively. The mRNA expression of M1 and M2 macrophage markers was measured by real-time quantitative polymerase chain reaction (Real-time PCR), and the CD206+ expression was determined by flow cytometry. The activation of phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt) pathway was analyzed by western blot. Result10-80 mg·L-1 XJD showed no marked cytotoxicity in LPS (0.5 mg·L-1)- or IL-4 (20 μg·L-1)-induced RAW264.7 cells. Compared with the control group, LPS significantly promoted the expression of M1 macrophage markers (P<0.01), including increased NO and IL-6 release (P<0.01) and upregulated mRNA expression of interleukin-1β (IL-1β), inducible nitric oxide synthase (iNOS), cyclooxygenase-2 (COX-2) and tumor necrosis factor-α (TNF-α) (P<0.01). Compared with LPS-induced group, 20-80 mg·L-1 XJD decreased the release of NO and IL-6 in a dose-dependent manner (P<0.01), and similarly 10-80 mg·L-1 XJD suppressed the mRNA expression of IL-1β, iNOS, COX-2 and TNF-α (P<0.01). Compared with the control group, IL-4 obviously increased the expression of M2 macrophage markers (P<0.01), including increased CD206+ cell population and upregulated mRNA expression of arginine-1 (Arg-1), interleukin-10 (IL-10), interleukin-13 (IL-13) and transforming growth factor-β1 (TGF-β1). Compared with IL-4-induced group, 10-80 mg·L-1 XJD dose-dependently decreased CD206+ cell population (P<0.01) and inhibited the mRNA expression of Arg-1, IL-10, IL-13 and TGF-β1 (P<0.01). Western blot showed that XJD significantly downregulated the activation of PI3K/Akt pathway as compared to LPS- and IL-4-induced groups (P<0.05, P<0.01). ConclusionXJD significantly inhibited the macrophage polarization in the LPS- and IL-4-induced RAW264.7 cells by targeting PI3K/Akt pathway.
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OBJECTIVE: To investigate the stability of baicalein-7-O-diglucoside. METHODS: The chromatographic purity of baicalein-7-O-diglucoside and its solution in different condition was analyzed by HPLC-DAD. The degradation products of baicalein-7-O-diglucoside in its solvent were identified by LC-MS. Three degradation products in the solvent of baicalein-7-O-diglucoside were identified with applying electrospray ionization(ESI) source in the positive ion mode.RESULTS: ① Baicalein-7-O-diglucoside was stable with light and in 40, 80 and 105 ℃ within the inspection time in solid state. ②Baicalein-7-O-diglucoside in water was stable in room temperature and degrades quickly in 50%methanol and 50% ethanol. ③The degradation products of baicalein-7-O-diglucoside in solvent were 7-methoxy baicalein, 7-ethoxy baicalein and baicalein. The above research provides that baicalein-7-O-diglucoside is stable in solid state. Baicalein-7-O-diglucoside degrades in 50% methanol and 50% ethanol. CONCLUSION: Water should be used as the solvent for solution of baicalein-7-O-diglucoside. The solution of baicalein-7-O-diglucoside should be made up before use or stored in the refrigerator immediately after preparation.
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Objective: To establish an high performance liquid chromatography (HPLC) method for the simultaneous determination of four constituents in Niuhuang Qingwei pill (narirutin,naringin,hesperidin,and neohesperidin), and identify the source of Fructus Aurantii Immaturus. Method: The analysis was performed on a Waters CORTECS C18 column (4.6 mm×50 mm,2.7 μm), with acetonitrile-0.12% formic acid solution as the mobile phase for gradient elution. The flow rate was 0.5 mL·min-1, the detection wavelength was set at 283 nm, and the column temperature was 27℃. Result: 12 batches of Niuhuang Qingwei pills showed the different content of flavonoids as Citrus aurantium and C. sinensis. Narirutin,naringin,hesperidin and neohesperidin showed good linear relationships within the ranges of 5.47-2 735 ng (r=0.999 6),7.25-3 625 ng (r=0.999 5),8.41-4 205 ng (r=0.999 4) and 8.36-4 180 ng (r=0.999 5),and their average recoveries were 101.3% (n=6,RSD 2.9%),98.0% (n=6,RSD 1.8%),95.9% (n=6,RSD 0.8%) and 96.0% (n=6,RSD 1.1%), respectively. The contents of narirutin,naringin,hesperidin,neohesperidin and total flavonoids were 0.36-1.28,2.66-4.87,1.02-11.07,3.58-6.41,and 7.98-13.34 mg·g-1, respectively. Conclusion: The developed method was simple,accurate and reliable,which can be used to identify the source of Aurantii Immaturus Fructus and simultaneously determine the content of four flavonoids in Niuhuang Qingwei pills. It could provide basic research for quality control and composition comparison of 2 kinds of Niuhuang Qingwei pills, showing more comprehensive indicators and reference value for the quality standard improvement of Niuhuang Qingwei pill.
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We determined a component-target-disease network for Carthamus tinctorius L. and the key compounds, identified by topological analysis, were related to vasculitis, coronary heart and cerebrovascular disease. Based on these compounds, the chromatographic fingerprint of Carthamus tinctorius L. was established. Firstly, 132 compounds were obtained from TCMID and TCMSP databases. Their targets were predicted in the PharmMapp and HemMapper databases. CardioGenBase, Therapeutic Target Database and DisGeNET databases were used to collect targets of vasculitis, coronary heart disease and cerebrovascular disease. The corresponding relationships between component and target protein were established by mapping. Finally, the "component-target-disease" network was built with Cytoscape software. The core network and key nodes were analyzed with the Cytohubba plug-in. The results showed that the 24 key compounds were alpha-tocopherol, adenosine, quinone chalcone pigments such as hydroxysafflor yellow A, safflower yellow, quercetin, kaempferol and other flavonoids, organic acids such as stearic acid, linolenic acid, coumaric acid and cinnamic acid. This resulting chromatographic fingerprint of Carthamus tinctorius L. showed good consistency, and the core chemical compounds obtained by topological analysis of the network of "component-target-disease", could be used as quality control markers. Our research provides a new approach for the identification of quality control indicators in Chinese medicinal materials.
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Calculus Bovis is the dry gall-stone of Bos taurus domesticus Gmelin, which is the most precious traditional Chinese medicine for its incomparable therapeutic effects. In vitro cultured Calculus Bovis,cultured Calculus Bovis and artificial Calculus Bovis are developed as the substitutes of Calculus Bovis. The Chinese Pharmacopoeia 2015 edition includes 89 Chinese patent drugs containing cow-bezoar and its substitutes. In this paper, the standards of Calculus Bovis and its substitutes in 89 Chinese patent drugs were reviewed to provide suggestions and reference for improving the relative standards. The qualities of Calculus Bovis and its substitutes of several Chinese patent drugs were summarized and analyzed based on the quality research of these drugs in recent years to offer suggestions for the revision of quality standards of relevant drugs and regulatory policy.
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Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills was discussed. First, microscopic characteristics specified by the statutory standard of Niuhuang Qingxin pills were summarized. Then new identification method was established for Dioscoreae Rhizoma, Saigae Tataricae Cornu, Cinnamomi Cortex and Saposhnikoviae Radix. Finally, microscopic spectroscopy was used for test of Dioscoreae Rhizoma's adulterant Dioscoreae Fordii Rhizoma.It was the first time for this technology being applied in adulteration test of Chinese patent medicine.The results showed that Saigae Tataricae Cornu was not detected in 2 batches of Niuhuang Qingxin pills from 1 manufacturer while Dioscoreae Fordii Rhizoma was detected in 3 batches of samples from 2 manufacturers. The proposed methods were accurate, simple, rapid, objective and economic, which offered a more comprehensive approach for quality control of Niuhuang Qingxin pills. It was indicated that conventional technology such as microscopic spectroscopy could play an important role in identification of traditional Chinese medicine whose index ingredient was deficient or tiny.
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OBJECTIVE: To evaluate the quality status of Sanqi Shangyao tablets. METHODS: Based on the results of statutory inspection and exploratory research, the quality evaluation regarding authenticity, effectiveness, and safety, was carried out. RESULTS: The qualified rate of inspection was 98.8%. Some problems, such as inconsistency of preparation process of standards and illegal dying, were discovered in some samples. CONCLUSION: In general, the overall quality of Sanqi Shangyao tablets is good. Some deficiency in the quality standards deserves further concern.
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The paper is aimed to establish a methods for identication of pearl powder and conch powder from different origins. Hermetic aluminum pan was used to encapsulate samples. The optimal testing conditions were: heating rate 10 degrees C x min(-1), sample weight 3 mg and nitrogen gas flow rate 40 mL x min(-1). The enthalpy values of pearl powder and conch powder was obvious different. Identication of pearl powder and conch powder by DSC is a practical method for its accuracy, convenience and practificality.
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Animales , Exoesqueleto , Química , Rastreo Diferencial de Calorimetría , Métodos , China , Análisis Discriminante , Pinctada , Química , Clasificación , Polvos , QuímicaRESUMEN
OBJECTIVE: To study nucleosides in Safflower injection. METHODS: Nucleosides in Safflower injection were identified by LC-MS. The separation was performed on Phenomenex Gemini-C18 column. Gradient elution was carried out with mobile phase consisting of acetonitrile-0.05% trifluoroacetic acid. Electrospray ionization source was applied and operated in the positive ion mode. Four nucleosides in Safflower injection were simultaneously determined by ultra performance liquid chromatography (UPLC) with ACQUITY UPLC HSS T3 column. The mobile phase was 0.05% trifluoroacetic acid aqueous solution at the flow rate of 0.4 mL·min-1. The assay was carried out at 40 °C with detection at 260 nm. RESULTS: Adenosine, guanosine, uridine and cytidine in safflower injection were identified. The relationship between the injection quality and the peak areas of the four nucleosides was all linear. The average recoveries (n=6) were in the range of 99.0%-101.4% and the RSDS were all less than 1.5%. The contents of the four nucleosides in tested samples were in the field of 0.033-0.162, 0.008-0.052, 0.048-0.184 and 0.031-0.064 mg·mL-1. CONCLUSION: There are four nucleosides in safflower injection. The contents of adenosine and uridine are relatively high. There was significant difference in the contents of the tested samples.
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This paper summarizes the current research on chemical structure, pharmacology and structure-activity relationship of antitumor constituents, including quinoline and indole alkaloids, stilbenoids, diterpenes, pentacyclic triterpenes, flavones, lactones, amyloses, proteins et al, of chinese herbal. The prospect of studies of antitumor medicinal plants is discussed.
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Animales , Humanos , Antineoplásicos Fitogénicos , Química , Medicamentos Herbarios Chinos , Farmacología , Neoplasias , Quimioterapia , Plantas Medicinales , Química , Relación Estructura-ActividadRESUMEN
<p><b>OBJECTIVE</b>To study antibacterial chemical constituents of Sarcandra glabra.</p><p><b>METHOD</b>The constituents of the chloroform and EtOAc-soluble portions of the EtOH extract from the whole plant of S. glabra, which posses the antibacterial activities, were isolated and purified with column chromatography. The compounds were identified by physical and spectroscopic techniques.</p><p><b>RESULT</b>Six compounds were isolated and identified as 4, 4'-biisofraxidin (1), esculetin (2), fraxetin (3), scoparone (4), isofraxidin (5), scopoletin(6), respectively.</p><p><b>CONCLUSION</b>Compound 1 is a novel natural product. Compounds 24 were isolated from the plants of Chloranthaceae for the first time. The antibacterial activities of these six compounds were tested for the first time. Some compounds may have potential for future study and development as plant-derived oral antibacterial agents.</p>