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XE Effervescent Tablets, prepared from the drugs of Bupleuri Radix, Scutellariae Radix, Puerariae Radix,Rhei Radix et Rhizoma, etc. possesses the functions of carambola detoxification, and swallow purging fire, and is indicated for the treatment of pediatric diseases, headache, sore throat and high nose, sore throat, cough, defecate, runny nose, tongue is red, dry coating thin white or yellow, purple or pulse etc. Under the guidance of Traditional Chinese Medicine theories, and with the help of the modern pharmaceutical technology, XE Effervescent Tablets was studied on pre-clinical pharmaceutical reasearch.Based on the functions and indications and the characteristics of the ingredients in the herbs,the optium extraction technology of essential oil is using 8-fold volume of water to erxtract 4 h; collect volatile oil, and the mixed oil was included by P-CD. According to the actions and indications as well as the physico-chemical properties of the ingredients included in the herbs, by means of the multiple guidelines grading method and the orthogonal test, the optimum extraction technology was determined as follows:Extract Scutellariae Radix, Puerariae Radix,Rhei Radix et Rhizoma, etc. with water for 2 times, using 8-fold volume of ethanol for 2 hour each time, combine the extract for use, filter, then concentrate to a thin extract with a relative density of 1.30～1.35 (60℃), Combine the above-mentioned thin extract, then arescent under reduced pressure and pulverize it to powder, Add the lactose, tartaric acid, pvpp,and PEG 6000, then prepare it to 1000 tablets.According to the guiding principles of Chinese medicine new drug research, the quality standard research was carried out. TLC was used to identify the 8 ingredients in prescription respectively, among which Bupleuri Radix, Scutellariae Radix, Puerariae Radix,Rhei Radix et Rhizoma,and Loniceae japonicar flos had comparatively better results, thus the methods were included into the normal test of quality standard. The contents of baicalin in Scutellariae Radix was determined using HPLC as indicators of internal quality control, and the systematic methodology were accomplished. All results complied with the specified standards concerned, thus the method was included into the normal test of quality standard. According to the experimental results of multi-batch samples, the total count of baicalin should not be lower than 15.0mg 1 tablet.The results of above tests indicate that the preparation technology is reasonable and practical, the standard is controllable, and the quality of the sample is stable on the whole as well.
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