| It is believed that acute pharyngitis,a frequently-occurring disease,belongs to sthenic heat,caused by the invasion of exopathogens or excess heat of the lung and stomach by Traditional Chinese Medicine.Yanshuning(YSN) compound is a clinical prescription researched for many years by Huang Yi-qi chief physician, who enjoyed the special allowance of the State Council. YSN compound is comprised of Radix isatidis, Radix scrophulariae, Radix platycodonis, Radix et rhizoma glycyrrhizae, etc. It can clear away heat and toxic materials,relieve sore-throat and resolve phlegm, promote the production of the body fluid and nourish the throat. It can treat the acute and chronic pharyngitis significantly. In this studies YSN granules as a model drug, modern pharmacy and traditional Chinese Materia Medica medicine had been applicated on the research of preparation and quality standards of granules being good effect and easy to take.HPLC methods were used to detect the contents of Epigoitrin, effective anti-viral composition of Radix isatidis and Harpagoside, effective anti-inflammatory ingredient of Radix scrophulariae.With the contents of epigoitrin,harpagoside in the extract liquid and the rate of dried extracts as the indexes,orthogonal test method was used to optimize the conditions of the extraction. The optimal was:add water with 8 times weight of medicinal herbs, decoct 3 times,1 hour for each time.Through detecting the transfer rates of Epigoitrin and Harpagoside in membrane filtrate and the impurity rate,optimization of the membrane pore size was taken by single-factor test. The results showed that the optimal membrane pore size was 200 nm with the import pressure 0.2 MPa.When the liquid volume in the reservoir barrel is not enough to circulate,water with equal to the amount of dead volume was added to the barrel once. When the filtrate weight is equivalent to the original,it was end.By detecting the transfer rates of Epigoitrin and Harpagoside in the ethanol refined liquid and the impurity rate, optimization of ethanol precipitation technology was taken by othogonal design. The results showed that the optimal ethanol refining technology was that the extract concentration was 1.5g/mL, the ethanol concentration was 60% and the ethanol precipitation time was 6h.It was studied that the antibacterial effect of the original fluid,optimal refined fluids of membrane and ethanol,by the detecting of the MIC and MBC of five pathogens of acute pharyngitis. The results showed that the antibacterial effects have no significant difference. Both the two methods of refinement can maintain antimicrobial efficacy. Compared with the ethanol precipitation refining technology, the transfer rates of Epigoitrin and Harpagoside of the ethanol refining fluid were higher than that of the membrane filter. Ceramic membrane technology being having many advantages such as low-cost, short production cycle, easy operation and less pollution, etc. The ultimate refining technology was the optimal 200nm ceramic membrane microfiltration technology.The preparation technics studies of YSN granules showed that Epigoitrin had a large loss in the enrichment technics at 80℃and in drying process at 60℃on normal pressure,but little loss in the wet granulation and the drying process at 60℃.Through detecting the rates of moisture absorption, forming and solubilization of the YSN granules the optimization excipient was dextrin. With the wetting agent of 85% ethanol,the ratio of dried extracts powder to dextrin 1:0.5, granules can be obtained. It was showed that the fluidity was good and the CRH was 60% by the study of semifinished product quality control. Validation test showed that the effect of the YSN granules was stronger than the unilateral Radix isatidis granules.At last, the process flow chart and packing material were determined initially.Quality standards studies showed that thin-layer chromatography identification methods of Radix isatidis, Radix scrophulariae, Radix platycodonis, Radix et rhizoma glycyrrhizae in YSN granules were formulated. The methods are simple and specific. Content limit of Epigoitrin in YSN granules was determined initially. The content of Epigoitrin shall not be less than 0.35mg in each sack(5g). Results of general pharmacopoeia test on three batchs of YSN granules were in line with the provisions.So the studies of optimization technology were stable and feasible.It will be the foundation for the development of new drugs of the YSN granules... |
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