| lschemic apoplexy ,the pathologic changes in cerebral blood vessel, containing transient ischemic attack (TIAS) and cerebral infarction ,is a kind of complex disease which commonly happened to middle-aged and old persons, usually cause severe neurologic impairment and even disability. Traditional Chinese Medicine hold that ACIS Originate from deficiency of Qi and blood stasis, and should be treated with tradition Chinese herbal medicine to promote circulation of Qi to remove blood stasis.QuTangHuoLuo concentrated pill comes from the famous recipes -BuYangHuanWu decoction, which made up of Rhizoma chuanxiong, Radix Astragali ,Radix Angenicae sinensis ,Radix salviae mictiorrhizae, pheretima aspergillum(E.perrier) etc.The medicine prepared with the process of extraction,purifying and formation techology,based on the characteristics of ACIS and active components of these herbal medicine. It has been proved the QuTangHuoLuo concentrated pill has remarkble clinical efficacy.In order to develop this medicine to a new drug as soon as possible. We complished a series of systematic studies according to the related standard of new drug research of SDA.In the respect of choosing new drug form, we determinded to choose the concentrated pill drug form.On the basis of the former test and many other factors,such as clinic demand, characteristics of TCM,practice of industrial production and so on.The study of extraction and purifying process: To study the water-extraction process of Radix Astragali, orthogonal design L9(34)was used in the experiments with the content of Astragaloside IV.Total polysaccharides of Astragalus and the dry extracta yield extracted with 80% ethanol as the detective markers. The optimum process is to add 8 times amount of water ,decocting for 3 times,once a hour. And the water extraction by precipitation with alcohol process of pheretima aspergillum(E.perrier)was studied by orthogoral design L9(34)with the result of pharacological activites which was determined to evaluate the factor levels. The optimum process is to add 14 times amount of water,decocting for 2 times,1.5hours one time.Using 70% ethanol to precipitate. On the other hand, we used clarificant to clarify the water-extracta of pheretima. The experiments were studied by Uniform design U6*(64),with the dry extracta yield as content index.The optimum chitosan clarifying conditions is to add 4% chitosan solution,when the water-extera concentration is 30%,and the temperatrue is 60℃.When choosing the ZTC-Ⅲ clarifying process,the single factor tests was also investigated and the results indecated that the process of adding 33% ZTC-Ⅲ solution.When the water —exteacta concentration is 25%,the temperature is 60℃,is better.Compareing the results of pharacological tests and the concentration of As and heavy metal.At last, we took the chitosan clarifying process as the optimum choose.Because it could lower cost,shorten production cycle,simplify production process,and effectively ratain active constituments in decoction.The study of formation technology:In order to reduce the dosage and make the formation technology easier,25% of amount of Radix Astragali,Radix Angelicaesinensis and Radix Salviae miltorrhizae shoule be made into powder to add to the extracta from the other herbal medicine.During the studying of coating process,by checking exterior, dissolve time and the humid absorption rate,the following conditions were proved to be avaible :the amount of talcum powder,activated charcoal powder,cera chinensis is 0.4%,0.5%,0.12% respectively.Three batches of QuTangHuoLuo concentrated pill prepared with the process on the experimental results mentioned above,conformed to the related standard of the Chinese pharmacopeia,and the quality is good.The study of quality standard :The indentifications of five chief herbal medicine were carried out by TLC,which have been proved very simple and specific.The method of HPLC-ELSD was established for the determination of the content of Astragaloside IV,is simple,accurate and has good repeatability,and can used for qual... |
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