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Studies Of The Preparation And Quality Control For Shenshao Granules

Posted on:2005-09-18Degree:MasterType:Thesis
Country:ChinaCandidate:D D XuFull Text:PDF
GTID:2121360125960989Subject:Medicinal chemistry
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1. The Study of Extracting and Preparation process Objective: To investigate the extracting technology and inclusion technology of volatiling oil in Chuanxiong and Guizhi. To investigate the extracting technology of six Chinese medicinal herbs by alcohol(70%). To study the preparation technology of shenshao granule.Method: (1)The factors affecting extraction of the volatile oil were observed by screening tests. Two factors were excerpted and inspected: the weigh of water and the extracting time. The result was validated. (2)The factors affecting inclusion of the volatile oil were tested by L9(34) orthogonal test. Three factors were excerpted and investigated: the ratio of oil and -CD(A /ml:g) , the including time (B/h) , the including temperature (C/C) .The marker of orthogonal test was utilization ratio of inclusion compound. The result was validated. The quality of inclusion compound was examined. (3)The factors affecting extraction were observed by L9(34) orthogonal test. Three factors were excerpted and inspected: the weigh of solvent(A /times) , the extracting time (B/h) , the extracting temperature (C/ C) .The marker of orthogonal test was mass desiccant extraction. The result was validated. The quality of inclusion compound was examined. (4)The kind and the mass of accessories was excerpted in preparation process.Results and Conclusion: (1)The best extract process of volatile oil in Chuanxiong and Guizhi is to add 8 times water and to extract 10 hours. The mass of volatile oil can be 0.59ml (reach to 95% of all volatile oil). The result of three verification experiments demonstrated that the extract technology is stable and reliable. (2)The best inclusion process of volatile oil is to add 8times -CD and to include 4 hours at 40 C. The result of three verification experiments demonstrated that the extract technology is stable and reliable. To observe the structure of inclusion compound by microscope, the result proved that the volatile oil formed inclusion compound already.(3)The best inclusion technology of volatile oil is to add 8 times 70% ethanol and to extract 3 times for 1.5h every time. The result of three verification experiments demonstrated that the extract technology is stable and reliable.(4)The dextrin was excerpted in preparation process according to the solubility and the price of every kind of accessories. The results of experiment demonstrated that the proportion of extract powder and dextrin(include inclusion compound) was 1:1.12. Granules keep stable after six months at room temperature and appeared a small quantity block After 12 months. All of researches demonstrated that the granule is stable. 2. The Study of Quality StandardsObjective: To develop a sensitive and simple method to control the quality of shenshao granulesMethod: (1)Thin-layer chromatography(TLC) was applied to identification Chishao, Yanhusuo , Guizhi in shenshao granule. (2) Reverse phase high performance liquid chromatography(RP-HPLC) was applied to determine TanshinoneII A(Tan II A) in shenshao granule. Sinochrom C18 (4.6 250mm, 5um) was used; The mobile phase consisted of methanol-water(80: 20, v/v); The determined wave length was 270nm and flow rate was 1ml min-1.The column temperature was 40C and the volumes of simple injected was 20ul. The sensibility was 0.05AUFS.Results and Conclusion: (1) In identification experiment of Yanhusuo, outspread agent was skellysolve B-chlorogorm-methanol(10:6:l) and developer was KBiI4 solution. Contrast sample and examine sample display same yellow spot at same position (Rf=0.35). Negative experiment demonstrated that it was noninterference. In identification experiment of chishao, outspread agent was chlorogorm -methanol-water(5:3:1) and developer was 5% vanillin solution.Contrast sample and examine sample display same blue spot at same position (Rf=0.64). Negative experiment demonstrated it was noninterference. In identification experiment of guizhi, outspread agent was petroleum ether-ethyl acetate (17:3) and developer was 2,4-dinitrophenylhydra...
Keywords/Search Tags:Painful menstruation, drug granules, extracting technology, tanshinone ⅡA, content determination
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