Production Process And Quality Standard Of Qianlie Shuan

Objective: To optimize the production process of Chinese Herb Qianlie suppository and to establish quality standards of the preparation.Methods: Using orthogonal design method, in order to optimize the best technological conditions on Amur Cork-tree Bark and Epimedium by ethanol extraction process which extract contains berberine hydrochloride as indicator; To study on extraction process by the extraction of essential oil for indicator optimization of by volatile oil of wild Chrysanthemum conditions ;To extract the flavonoids content in wild Chrysanthemum for indexes, the water decocting optimal process optimization; Using ethanol precipitation to wild chrysanthemum water frying liquid purify; Screening appropriate matrix, and the preparation of Qianlie suppository with powder's normal weight matrix of temperature, naphtha, shape of projects such as joining the temperature, the optimum preparation examined the molding process; Conduct quality inspection to finished product, including suppositories weight difference between the inspection, the melting variable time limit inspection ,the inspection of the microbial limits and so on; Using thin-layer chromatography to preparation of herbal medicines in a prescription for qualitative identification; A high performance liquid chromatographic method of berberine hydrochloride in preparations for the content determination, formulate the quality standard of the suppository.Results: The best extraction process for Amur Cork-tree Bark and Epimedium is add 10 times the amount 75% ethanol refluxing extraction three times, each 1.5 hours; Add 8 times wild Chrysanthemum extract water quantity steam distillation volatile 4 hours; Add 10 times the wild Chrysanthemum liquid water quantity, decoction 3 times, each 1 hour; Water fried fluid concentrated to the relative density measured about 1.10 (80℃measured), add ethanol makes containing alcohol volume reached 70%; The best molding process is synthesis of fatty acid glyceride in half for matrix, the ratio of matrix and powder for 1:0.75, molding temperature For 55℃, volatile oil joined temperature for 45℃, replacement price for 1.75; The TLC identification of three Chinese Herbs spots clear, strong specificity;The preparations containing Amur Cork-tree Bark to berberine hydrochloride, and each of shall not be less than 1.92mg. Conclusion: The production process used to make reasonable and preparation of finished product quality is stable and controllable.