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The Hidden Volvatus Capsule Preparation Process And Quality Standards

Posted on:2005-02-13Degree:MasterType:Thesis
Country:ChinaCandidate:H ZhaoFull Text:PDF
GTID:2191360125467640Subject:Pharmacy
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The fungus Cryptoporus volvatus was used by native peoples in China and recorded by ancient books and literatures, e.g. and , for treating the bronchitis and the asthma. Development of this new Chinese medicine has good prospect. We tried to develop it as a new anti-inflammatory traditional Chinese medicine. We made the ferment product to the stuff easy to preserve and did some works to extract and identify activity substance. We also conducted the study on extraction technology preparation technology and quality standard by advanced methods. After that we researched the stability of the drug. The product not only has the satisfactory effect, but also no significant toxicity. The drug provided an effective treatment to this disease.The stuff was made from the fermentation product of Cryptoporus sinensis growing widely in Yunnan province. For making it to the stuff easy to preserve, we researched the spray drier technics through the orthogonal design which was indicated by direct cross experiment, selected the best condition by moisture content and solid substances. The best condition was: relative density of extract was 1.15, in-temperature was 190 and out-temperature was 85. The process was quickly and easy, and the product was good to preseave.We extracted and identify alkaloid organic acid polysaccharide volatile oil and ergosterol. Polysaccharide and volatile oil had the strongest effect. Through the orthogonal design we decided the best condition of the volatile oil extraction was: soaking for 1h, adding 10 times amount of water and extracting for 8h. The solution was used in the next process. Becaues the volatile oil has not very stability, we tried to preparing the Cryptoporus volvatus oil- cyclodextrin inclusion compound. The optimal process was as follow: the consistence of alcohol as solvent was 20%, the duration of grinding was 15 minutes, and the proportion of the Cryptoporus volvatus oil to -cyclodextrin in the inclusion compound was 1:10. We check the new compound withDSC method.The rest drug was extracted by water for most activity substance. The best eatraction condiction was: extracting for 3 times, 1h once, first adding 12 times amount of water, next and last adding 9 times amount of water. Then liquid was centrifugate by high speed with 5000rpm for 30 min. The clean liquid was condensed and dried by spray. The spray drier condition was: in-temperature was 220 and out-temperature was 90, pressure was 3kg/cm2, speed was 1.3L/h.The drug powder was mixed with the cryptoporus volvatus oil- cyclodextrin inclusion compound, MC and C-pvp, prepared granules with 85% ethanol, then the finished product was obtained by repacked.To control the quality of drug effectively, the colorimetry of sulfuric acid anthrone was used to determine the content of polysaccharide. Analysis procedure: accurately weighed glucose standard substance (dried to weight coincidence at 105), added water and maked into to 0.1mg/ml contrast solution. Accurately transferred respectively the contrast solution 0.3ml 0.6ml 0.9ml 1.2ml, 1.5ml 1.8ml to 10ml test tube with stopper, added the sulfuric acid anthrone solution 6ml and mixed well, heated on water bath for 15min, cooling on ice bath. The above solution and blank reagent were assayed at 625nm. The absorption value was made a standard curve. Accurately weighed 1.2g to extractor, added 90ml water and reflu heated to lack of color, transferred to 100ml volumetric flask, diluted to volume and mixed well. Placed in 4 over night and centrifugated, discarded the solution, added water to solve the precipitation and transfer to 100ml volumetric flask. Accurately transferred 2ml sample solution to 10ml test tube with stopper, and then tested according to above-metioned. Calculate the content of glucose in sample solution according to standard curve. The polysaccharide content of each cryptoporus capsule should not be less than 10.0mg. The polysaccharide content of CFS should not be less than 4%.The HPLCwas used to determine the content...
Keywords/Search Tags:Cryptoporus volvatus, polysaccharide, β-cyclodextrin inclusion, uridine, the colorimetry of sulfuric acid anthrone, HPLC, the finger print
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