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Compound The Baicalensis Chlorine Buck Piece Of Pharmaceutical Research

Posted on:2005-01-08Degree:MasterType:Thesis
Country:ChinaCandidate:R B ShiFull Text:PDF
GTID:2204360122987022Subject:Pharmacy
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High Blood Pressure is clinic ordinary disease. These diseasers were over ten millions at present in our country. So it is important to select drugs. The purpose of this project is to research a safety effective medicament that can prevent and cure such disease.Fufang Qinglv Jiangya Tablets is made up of Radix Scutellariae Fructus Sophorae Radix Puerariae, Hydrochlorothiazide etc and has the actions of clearing away heat and ptotecting live and lowering blood pressure. The tablets ofresearch was based on the clinical soup dosage. This project mainly deals with the preparation procedure, qual i ty standard and stability of the prepration.The optimum extraction process of Radix Scutellariae that is the most important was investigated by L9(34) orthogonal experimental design as the baicalin content index. The optimum extraction process was as follows: Radix Scutellariae was extracted with water for 2 times, with the solvent volume 12 times amount and extraction time 2h each time.The optimum extraction process of Fructus Sophorae and other two drugs was selected with the L9 (34) orthogonal experimental design as the rutin content index. The final process was as follows: 10 times amount of water for the first time and 8 times for the second time and the third time, and extracting for 2 hours each time.The method of fluid bed granulation can simplify the procedure and reduce the demage of drugs and contact the work time. To select the best condi t ions for fluid bed granulat ion, orthogonal experimental design L?(34) was done. The results of the study were that the blast temperature and the aeration temperature were notable effect. The optimum process: the rate of spraying was 20g/min, the spraying press was 2kg,the blast temperature was 90±2℃ and the aeration temperature was 50±2℃.To select the optimum adjuvants for the formulation process of Fufang Qinglv Jiangya Tablets, Starch , Carboxymehtyl starch sodium Microcrystalline cellulose were investigated in the hardness, breakage, the disintegration time indexes. It was feasible that the combined excipients of Starch Microcrystal1ine cellulose. Carboxymehtyl starchsodium (in a rate of 5: 5: 6) was mixed with granulation. However, the price of such three adjuvants was lower.To improve the process, the other three batches drugs were done .The result showed that the batches were good and showed that the process was feasible.In the quality control study, Thin Layer Chromatography was used for identification of Fructus Sophorae , Radix Puerariae. These methods of TLC were simple, rapid and with a good reappearance, and available for quality control of the preparation. The content of baicalin Hydrochlorothiazide and Pargylini Hydrochloridum in Fufang Qinglv Jiangya Tablets were determined by Rp-HPLC. It was limited that the content of baicalin wasn't lower than 8. 5mg per tablet and the other two contents were from 85% to 115% in theory per tablet.Finally the stabi1ity of the preparation was investigated. The result showed that these drugs were stable.
Keywords/Search Tags:Fufang Qinglv Jiangya Tablets, Preparation procedure, Quality standard, Stability
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