Studies On The Preparation And Quality Control Of Total Salvianolic Acid

Using modern preparation technologies to extract active compound from Chinese herbs, and to establish widely accepted method for quality control, is an important task of Chinese medicine modernization. In our research, a kind of active compounds from Radix salviae named total Salvianolic acid, which has the function of activating blood circulation to dissipate blood stasis, was selected as the object. Producing area of Radix salviae was determined, preparation process of total Salvianolic acid was explored and a standard for quality control was established in this project.Traits, TLC analysis, chromatographic footprint, content of total Salvianolic acid were investigated to establish a standard for Radix salviae quality control. According this standard, Shanxi was selected as the fixed producing area in this project.Based on the characters of active compounds, the technologies of displacement and column chromatography were applied. By optimizing the conditions of displacement and column chromatography processes, the optimum condition of extraction and separation was determined: Radix salviae powder was marinated in 0.1mol/L HCl for through one night and dissipated with 14 time water(pH=2), the percolate was collected and applied to a column of AB-8 macroporous resin, then wash the column with 5 column volumes of water, 6 column volumes of 20% ethanol and 4 column volumes of 40% ethanol in sequence. The eluent of 40% ethanol was collected and condensed under 70 ℃, and then freez-dryied.The product obtained according to the process above will used for injection preparation, so a strict standard was established for quality control. In the standard, trait, TLC analysis, heavy metal, arsenic salt, resin residual, chromatographic footprint, content of totalSalvianolic acid and of Salvianolic acid B were investigated as controlled items. 3 batches of the product were examined according to the standard, and results showed that the process was stable, and meet the question of injection preparation very well.