Quality Research Of San Huang Xie Xin Tang And Its Preparations

Chinese medicine prescription preparations is under the guidance of Chinese medicine theory, the fixed prescription medicine, mostly for classic Cuban side, select the appropriate route of administration and dosage forms, materials and preparation process made in accordance with the quality and stability of modern pharmaceutical technology, controllable, and approved by the production and application of a class of agents, commonly known as " Traditional Chinese Medicine Patent Prescription." Because of the complexity and preparation process large differences medicinal sources, mechanism of action and the physico-chemical properties of compound compatibility is not clear, the composition of the active ingredients of prescription drugs affect each other in the manufacturing process, resulting in the quality control of traditional Chinese medicine prescription preparations is difficult to control clinical pharmaceutical research preparations can not establish an objective evaluation system, causing the clinical application of Chinese medicine prescription preparations lack of strong data support. Traditional decoction for hundreds of clinical applications, its safety and efficacy can be guaranteed. Sanhuang Xiexintang is basis for the study, as a quality control standard. Safety and effectiveness in order to guarantee quality control standards Sanhuang series preparations, study quality three yellow series preparations whether homogeneity, and analysis of the factors that may affect the preparation of formulations of traditional Chinese medicine prescription preparations quality. The first partThe material foundation research of Sanhuang XiexintangObjective:Research Sanhuang Xiexintang material basis, the establishment of a multi-component determination method, curing quality standards lay the foundation for the research the of Sanhuang Series preparations.Methods:LC-MS analysis, chromatography and mass spectrometry combined with preliminary data for compound identification, established method for the determination of Sanhuang Xiexintang 14 index components.Results:In this study 14 indicators ingredients are quite different, the content of the largest baicalin, the average content of 78.469μg / mL, is 172 times the average content 0.456μg / mL of physcion. Good linearity, calibration curve r greater than 0.998. The precision relative error of each index component, is 0.239%, RSD values of each index component, were 0.610%, indicating good precision instrument. Repeatability RSD of each index component, were 1.62%, repeatability is good. Stability test RSD values of each index component, were 1.25%, good stability. The average recovery recovery test 97.45% ~ 100.76%, RSD values of each index component, were 1.68%. Sanhuang Xiexintang samples were analyzed in the positive ion mode, compounds were initially identified 23.Conclusion:The Sanhuang Xiexintang complex composition, with chromatography mass spectrometry for compound preliminary inference, but there are still many compounds can not be confirmed. The establishment of LC-MS to Sanhuang Xiexintang multi-component quantitative methods, get rid of the shackles of quantitative separation must first achieve a complete separation of the compound failed to multicomponent simultaneous quantification. Establish quality Sanhuang Xiexintang from the qualitative and quantitative multi-component, providing the basis for the quality control of Sanhuang series preparations. The second partQuality research of Sanhuang series preparationsObjective:Based on the quality of Sanhuang Xiexintang control standards, with multiple batches three pornographic films from different sources and the same side of different processes, Yiqing particle,Yiqing capsule, Kampo Sanhuang Xiexintang as the research object to investigate Sanhuang series formulations different manufacturers, different batches, the degree of approximation of different processes prescription preparations quality and decoction, as well as whether there are differences between the various formulations.Methods:LC-MS analysis 16 batches of different manufacturers, different batches of three yellow tablets, measuring three yellow tablets six index components and analysis of Yiqing particles, Yiqing capsule, Kampo Sanhuang Xiexintang three kinds of different processes Tongfang Three yellow prescription preparations, determination of 14 index components, and a variable component indicators, statistical data, and analyze the degree of approximation traditional decoction.Results:Different manufacturers commercially available Sanhuang tablets each ingredient significantly different, baicalin maximum 107.94 mg/g, the minimum 66.43 mg/g; berberine maximum 29.18 mg/g, minimum 14.85 mg/g; wogonoside content Maximum43.16mg/g, the minimum3.45mg/g; wogonin content Maximum 28.73mg/g, the minimum 0.38 mg/g; oroxylin A maximum content of 3.26 mg/g, the minimum 0.33 mg/g; emodin maximum 5.72 mg/g, a minimum 0.11 mg/g.Prescription index component content measured three Sanhuang preparations there is a big difference, we found the proportion of the index components differ in the same amount of crude drug inputs based assays, the indicator component content of Yiqing capsule and Yiqing granule is higher than the indicator component content of Kampo Sanhuang Xiexintang, but the certain large polar components of Kampo Sanhuang Xiexintang, is prominent.The degree of approximation with the traditional decoction of view, Yiqing capsule > Yiqing Granule > Kampo Sanhuang Xiexintang.Conclusion:The medicine Sanhuang side Yiqing granule, Yiqing capsule formulation Kampo Sanhuang Xiexintang three different processes with prescription system of law, the same amount of crude drug, the ingredients significantly different, and each different proportions, and the degree of approximation is not a traditional decoction. Sanhuang tablets from different manufacturers, different batches of content there is a big difference. The third partStudy to multi-factors of quality of Sanhuang series preparationsObjective:Given the quality of the Sanhuang series preparations differences, analyze the factors for the differences, during the preparation of study medicinal feed preparation, extraction temperature, extraction solvent, influence feeding mode and alcohol precipitation "purified" and other factors.Methods:Two batches of medicines from different sources, a combination of eight samples, measured 14 index components in the samples using LC-MS method, and for similarity evaluation; measured by dynamic extraction temperature 50 ℃ and high temperature boiled extract 14 index components samples and collection samples 30 minutes before total ion current data comparative analysis of anions mode; compare the percentage of each component of 50% ethanol extract and water extract content of 14 index components samples and; extracting 14 indicators measured separately co-extracted sample measured fried after statistical analysis content, and mass spectral data; weight of dry matter by ethanol precipitation contrast "purified" sample and without "refined" sample and the 14 index components content.Results:Two batches of medicinal differences single component after component content directly affect prescription decoction. But through fingerprint similarity evaluation, there is significant difference. Compared with the high-temperature extraction, low temperature extraction extraction rate is low, a small amount of each component extraction, high-temperature extraction of samples 58.9% ~ 96.5%, but there is a large unknown polar components increased. Compared with the water extraction, the organic solvent extraction extraction rate increased significantly, from 103.4%- 238.7%, and the composition of the polar smaller the greater the impact. Therefore, the proportion of each component is different from the organic solvent extract water extract ratio. Decoction and separate decoction extract only the presence of trace amounts of mass spectrometry data analysis differences, and each index components showed no significant difference. After ethanol precipitation, extract dry matter weight was significantly reduced by 927.24 mg to 454.12 mg, the content of each index component no significant difference.Conclusion:This experiment with Sanhuang Xiexintang traditional decoction preparation method as a reference, comparative study of feeding herbs, extraction temperature, extraction solvent, the impact of multiple factors in Preparation feeding mode, alcohol precipitation purification and the like, for the Sanhuang series preparations Further quality control and clinical studies provide data to support.