Study On Preparation Technology And Quality Standard Of Danshenfentong

Danshenfentong includes tanshinone and salvianolic acid, which the Salvia miltiorrhiza was used as main material. It could improve microcirculation, anti-atherosclerotic effects. At the same time, This has significant pharmacological effects in antitumor, prevent the myocardial ischemia, myocardial Infarction, etc.This paper adopted the methods of diacolation extraction and macroporous resin purification prepared by Danshenfentong. With the extraction rate of tanshinone ⅡA and salvianolic acid B as indexes, the effects of ethanol concentration, ethanol volume and percolation rate on extraction technology of tanshinone ⅡA and salvianolic acid B were investigated by orthogonal test. Types of macroporous resin, pH of sample solution, volume of eluent and ethanol concentration were observed by using the single factor investigation method. The results were as follows:took Dan Shen crushed 10 mesh, percolated at 4 mL/min·kg with 80% ethanol, collected 10 times amount of percolating liquid, recovered ethanol, diluted the solution to 0.5 g/mL of crude drug with water, filtrated and got tanshinone. The sample solution was djusted pH to 3.0 by HC1 and purified with HPD100 macroporous adsorption resin, washed with 2 BV of water, then eluted with 3 BV of 50% ethanol. The eluent was collected, tanshinone precipitation was added,there covery of ethanol,concentrated, decompression drying and got Danshenfentong. The result showed good effect of separation and high contents in the optimum extraction-purification conditions. The technique is simple, stable and reliable and is suitable for popularization and application in large scale production.Refering to the Chinese Pharmacopoeia 2010 Edition (a) of tanshinones and salvia total phenolic acids quality standards to Danshenfentong of character, differential diagnosis,examination, fingerprints, determinationfor a more comprehensive study. Water, residue of ignition, heavy metals, macroporous resin residue were examined; Danshenfentong fingerprints was established by studying of the mobile phase, wavelength, column temperature, flow rate. Evaluated by similarity of chromatographic fingerprint evaluation system(2004A),the fingerprint similarity was greater than 0.90; The UPLC method was established by determination of rosmarimic acid, lithospemic acid, salvianolic acid B. established the HPLC method of cryptotanshinone, tanshinone I, tanshinone IIA and the UV method of salvia total phenolic acids. According to the determination results, the product was calculated on dry goods, the contents of tanshinone was less than 4.5%, the contents of Salvia total phenolic acids least 55.0%.