Study On The Preparation Technology And Quality Standard Of Danyin Dropping Pills

Objective: To study the extraction process, molding process, the quality standard and stability of Dan Yin dropping pills. To provide the preliminary preparation for the development of a new preparation of traditonal Chinese medicine for treating acute and chronic hepatitis.Methods: To optimize the extraction process of prescrition by orthogonal design method and multitarget ingredients, to optimize the optimal conditions of molding process of Dan Yin dropping pills by single factor and the central composite design-response surface method, to identificate Dan Yin dropping pills by TLC, to determine the content of Dan Yin dropping pills by HPLC, to study the atability of Dan Yin dropping pills by accelerated test and long-term test method.Results: To determine the extraction process of salvia miltiorrhiz was adding 12 times the 70% ethanol, reflux extracting 3 times, 1 hours per time, to concentrate the filtrate to 1 g/m L, adding 3 times ethyl acetate to the concentrated liquid for extration, extrated twice. To determine the extraction process of artemisia capillaris and radix isatidis were adding 12 times water, reflux extracting 3 times, 1.5 hours per time, to concentrate the filtrate to 1.1 g/m L, adding 95% ethanol to the concentrated liquid to contain it reach 70% and standing for 12 hours at 4 ?. The best prescription of Dan Yin dropping pills was: matrix was PEG4000: PEG6000(1:1), extractive: matrix(1:2), condensing agent: liquid paraffin. The final preparation technology was: dropping speed: 25 d/min, dropping distance: 7.1 cm, liquid temperature: 81.2 ?, condensing agent temperature: 5.3 ?, condensing agent height: 60 cm. The weight of dropping pill was 35 mg. The quality standard was established. The various indicators of Dan Yin dropping pills were conformed to the provisions at the accelerated test and long-term test method, the stability is good.Conclusion: The preparation technology of Dan Yin dropping pills is feasible, the stability of the dropping pill is good and the quality control method is accurate.