Study On The Quality Control Of The Compound Danshen Tablets

The Compound Danshen Tablet,which is consist of Salvia miltiorrhiza Bge.,Panax notoginseng and borneol and widely used clinical in China,has a good curative effect on coronary heart disease,angina,chest stuffiness and pain before the district and other diseases.The drug,which was developed in 1975 by the second Shanghai pharmaceuti-cal factory,is a huge market for generic drugs varieties,while more than six hundred enterprises approved for production currently.However,in recent years,the provincial Food and Drug Administration sampling Compound Danshen Tablet announced that the quality of Compound Danshen Tablet is uneven in the market.In view of the current quality problems of Compound Danshen Tablet,the study analysis focused on the analysis of Salvia miltiorrhiza in the planting area,origin processing,extraction of ingredients,extract drying,tabletting coating process treatment on the effective components of its drug,discussing from the point of quality control of the whole industry chain of medicine production inspection and giving summary on the detection items and detection techniques of Compound Danshen Tablet in Chinese Pharmacopoeia.The results are as follows:(1)The quality of Salvia miltiorrhiza is mainly affected by the way of harvesting,the processing mode of producing area and the geographical conditions of producing area.Different harvesting methods,origin drying methods and phenological geographical factors have different effects on the effective components of medicinal materials.(2)The extraction process,drying method and the retention degree of borneol have significant influence on the quality stability of Compound Danshen Tablet.(3)In recent years,the quality evaluation system of Compound Danshen Tablet in China has the defects of less testing items and incomplete detection components-it can not reflect the true quality of Compound Danshen Tablet.Focusing on the shortcomings of the existing quality evaluation system of Compound Danshen Tablet in China,the study puts forward corresponding suggestions and prospects.This study has a promoting role on improving the quality control of Compound Danshen Tablet,ensuring the clinical efficacy,solving the problem of product quality difference existing in many present manufacturers.