Technology And Quality Standards Research Of Zi Jin Zhi Ke Tablet

Cough as one of the most common respiratory diseases, is always caused by upper respiratory tract infection, acute bronchitis, chronic bronchitis, pneumonia, chronic laryngitis, etc. A State Food and Drug Administration(SFDA) survey showed that the number of patients with cough was in high growth of 5 to 10 percent a year. Under the circumstances of atmospheric pollution, pharmaceutical experts predict medicines of the field for resolving phlegm and relieving cough and asthma will accounts for a large market share.Zijinzhike Tablets according to the theory of traditional Chinese medicine, includes eight ingredients of honeysuckle, rhubarb, hawthorn et al. The medicine has the effect of clear heat, detoxifcation, resolve phlegm, relieve cough. In this study, we studied the preparation process and quality standards of Zijinzhike Tablets according to the traditional Chinese medicine and Natural Medicine Registration requirements and Guidelines for New Drug Research and Development.For preparation process. Firstly, according to the compare results of extraction process the reasonable process route was selected:(1) honeysuckle, rhubarb, hawthorn was extracted with 10 times amount of 70% ethanol and each extraction 2 hours;(2) honeysuckle, rhubarb, hawthorn made water as solvent to extract 3 times, extraction solvent was 10, 6, 6 times, and each extraction by 2 hours;(3) The preparation parameters of basil leaves volatile was determined, while chosen β-cyclodextrin as the clathrate, and the final clathrate process was optimized;(4) According to the classical method, the best extract method of baicalin from Scutellaria herbs was determined. Afterwards, we studied the molding process of preparation, the parameters of spray drying process was determined: the relative density of concentrated solution was 1.10, the inlet temperature was 170℃, the exhaust temperature was 80℃. Last, at the mixed dried baicalin extraction and spray powder, add the volatile oil and appropriate amount of lubricant, blending them and make tablet and coating.Quality standard study:established the method with thin layer chromatography(TLC)identification of Scutellariae Radix,Gardeniae Fructus,Crataegi Fructus,Rhei Radix et Rhizoma,Glycyrrizae Radix et Rhizoma(英文名);adopt high performance liquid chromatography(HPLC)to assay the content of forsythin and chlorogenic acid.The detected results indicates that the above methods are highly accurate,reproducible,easy to operation,and it was a scientific quality control method for Zijinzhike Tablets.