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Study on the Preparation and the Quality Standards of the Wuhuo Depressurization Dripping Pills

Author: WenYaPing
Tutor: GuiHui
School: Hunan University of Traditional Chinese Medicine
Course: Of Pharmacy
Keywords: Wu hopane buck Dripping Pills Evodia total alkaloids Icariin Preparation Process Orthogonal test Macroporous resin HPLC Quality control standards
CLC: TQ461
Type: Master's thesis
Year: 2010
Downloads: 27
Quote: 0
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Abstract


Objective: Wu the hopane buck Dripping Pills preparation conditions, in order to get the best preparation conditions, the inspection and quality standards, and to provide a reference for its industrial production. Methods: Wu the hopane buck dropping pills preparation process and quality control standards to provide experimental evidence for its practice of production. 1, extract: herbs the Evodia using ethanol extracted by high performance liquid chromatography (HPLC) method for the determination of total alkaloid content in the extract, as the marker of a of Evodia total alkaloid content and extract yield variance results analysis to determine the optimum extraction conditions; using ethanol reflux extraction Icariin Epimedium herbs, and to extract Icariin solution and extract yield as the marker of the results of analysis of variance, obtained the most The best extraction conditions. Purification: comparative analysis of the three purification methods Evodia extract, acid-base extraction, alcohol sedimentation, and water precipitation method, filter out the best purification methods and to determine the optimal process conditions was purified; Epimedium liquid DM-130 macroporous resin purification to extract Epimedium Flavonoids in content as index to establish the optimum purification conditions. 3, molding: Wu the hopane buck dropping pills best established through experimental matrix types, types of coolant, condensate meter temperature, and the drip rate and dropping distance, Dripping Pill dissolution time, the quality and appearance of the pill weight difference The coefficient of variation as a comprehensive assessment indicators, the the Orthogonal Test out dropping pills molding process conditions. Quality control standards: Evodia and Epimedium Wu the hopane buck Dripping Pill in the qualitative identification by thin-layer chromatography; HPLC method was used to determine the content of different batches of the product, and the methodological study. Results: By experimental study, established Evodia optimum extraction and purification conditions were as follows: 10-fold amount of 75% ethanol was extracted three times, 1.5 hours each time, the extract was precipitated with water 2 times, each 1-fold amount of water and precipitated with 95% ethanol was dissolved, filtered, and 30.18% total alkaloids Evodia concretes under the process conditions can be obtained. Epimedium best conditions for the extraction and purification: 10 times the amount of 50% ethanol reflux extraction three times, each time 1.5h extract DM-130 macroporous adsorption resin purification dynamic adsorption capacity 19.25mg/ml, on sample concentration is 0.2g/ml (unit volume Zhongyuan herbs amount), the sample volume is 2.0 times the column volume, the eluent was 60% ethanol in an amount of 3 times the column volume, after purification extraction matter content of total flavonoids can be achieved 74.42% Icariin also reached 10.5%. Optimal molding conditions of the of Wu Huo buck dropping pills: matrix, drug and matrix PEG4000: PEG6000 = 1:2 ratio is 1:3, the liquid temperature of 95 ° C, dimethyl silicone oil: liquid paraffin ( 3:1) as the coolant, the coolant temperature is 15 ℃, drip rate for 18d/min, the dropping distance 6cm the best drip system conditions. Wu the hopane buck Dripping Pill TLC method, and IIPLC assay their Dripping Pills the Evodia total alkaloids and Icariin measuring method is feasible and reproducible. Conclusion: The process is reasonable and feasible, quality control standards are built is sensitive, accurate, fast and can be used for the preparation of quality control, to provide a reference for its industrial production.

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