Pharmaceutical Research Of Xiefeipingchuanling Granules

The prescription of Xiefeipingchuanli is derived from clinical practice experience. It is a pure traditional Chinese medicine compound preparations which aims at the characteristics of asthma in the acute phase which keep phlegm and blood stasis loitering in lung,and combines with the classic theory of’lung associated with intestine’and’asthma must be activating blood and bowel’.Now by means of modern science and technology we are going to make it as granules. The efficacy of this Chinese material medica preparation is relieving asthma, activating blood and bowel, and it is used to treat children phlegm-heat type asthma. After years of clinical practice verification, curative effect is exact. This project had studied at preparation technology, quality standard, and preliminary research of stability of Xiefeipingchuanli Granules, according to the characters of the prescription, the pharmacological research of literatures, and requirements of clinical application.On the basis of the functions and treatments of the prescription and the characters of the component of the herbs to determine the drug’s extraction method, the optimal preparation process was designed by using the orthogonal experiment as well as quite a few assessing norms to evaluate them comprehensively. The optimum conditions are that extract Bitter Apricot Seed、Salvia Miltiorrhiza, White Mustard Seed,3 times, with 8- fold volume of 85% of ethanol,30 minutes each time, then filter it, decompress and reclaim the ethanol in 70℃,the liquid of the medicament will be put back to use. Fry and boil Ephedra, Snake Gourd fruit peel, Semen Lepidii, Giant Knotweed, Rhubarb, Licorice, and the dregs of the decoction which were mentioned above for 3 times,with 12-fold volume of water first time, with 10-fold volume of water left 2 times,1.5 hours each time, filter it, decompress and reclaim the water in 80℃ until the relative density of thick paste add to 1.07, make the thick paste’s Alcohol content reach to 50% by adopting alcohol deposition method, then let it stand for 12 hours, filter it, decompress and reclaim the ethanol. Combine these two kinds thick paste, add a third of dextrin. Dry it in vacuum and break it up. Blend the medical powder with starch and mannitol according to the proportion of 2:3, aspartame according to the percent of 0.3%, and citric acid according to the percent of 1.0%. Add the compound mentioned above, and then to granulate by extruding with water, dry it at 60℃, then pack it 8 gram respectively, and the Granule is made finally.In the study of the quality standard, Thin Layer Chromatograph was used to Identify Ephedra, Snake Gourd fruit peel, Salvia Miltiorrhiza, Giant Knotweed, Rhubarb, Licorice, and was taken as the text of the quality standard. The contents of the ephedrine hydrochloride were taken as an inherent index to estimate the products and accomplish the systematic methodology such as the extraction conditions of the sample, chromatographic conditions, linearity, precision, reproducibility, stability, family recovery, sample determination act. The results of the experiment were all in accordance with the demands. Therefore, the determination of the content was made as the text of the quality standard. According to the mensuration result of the samples, the ephedrine hydrochloride limitation was made, it was determined for the moment that each bag should contain no less than 3.60mg of the ephedrine hydrochloride.Preliminary stability research had kept on for 1 month,2 months,3 months; the three samples under the long experiment at room temperature and another three samples under the constant temperature and humidity. both of them were measured from characters, distinguishment, in section and the determination of the content. The results indicate that Xiefeipingchuanli Granules is stable and suitable to the quality standard.Result:This preparation process is reasonable and practical; the quality of the Sample is stable and controllable.