Study On Production Technology Of Salvia Miltiorrhiza Injection

With the improvement of the quality standard of Salvia miltiorrhiza injection, thesafety and effectiveness of the injection has been enhanced. Compared with the oldstandard, several modifications have been established to ensure security of Salviamiltiorrhiza injection. These modifications include increased operation processes forremoving impurities in production, improved control indexes and content of effectivecomponents, and additional inspection items.The thesis investigated the extraction technique of Salvia miltiorrhiza injection tooptimize its production technology. The contents of tanshinone IIAand salvianolic acid Bwere used as the index for the evaluation of the merits of Salvia miltiorrhiza produced inShandong and Henan respectively. HPLC was used to determine the content of activecomponents in Salvia miltiorrhiza. The contents of effective components and total solid inSalvia miltiorrhiza were used as the review indicators. The orthogonal test was used toinvestigate the effects of amount of added water and temperature on content of effectivecomponents and total solid during the decoction extraction. The effects of temperature and pHon the contents of effective components in Salvia miltiorrhiza and total solid content wereinvestigated in ethanol sediment and water sediment with single factor experiments. In thefollowing purification process, the effects of pH value and active carbon on the effectivecomponents were investigated.The contents of lipid soluble components and water soluble components in Salviamiltiorrhiza vary according to the different origin. Salvia miltiorrhiza of Shandong containsmore tanshinone IIAwhich is the representative of lipid soluble components than that ofHenan. Salvia miltiorrhiza of Henan contains more salvianolic acid B which is therepresentative of water soluble components than that of Shandong. So Salvia miltiorrhizashould be selected according to different producing area.In the water decoction extraction, the greatest impact on extraction yield of effective components and total solid is the liquid temperature. The second impact is the amount ofadded water in the first decoction. The minimum impact is the amount of added water in thesecond and third decoctions. So technological parameters are optimized as following:10time amount of water in the first decoction,7time amount of water in the second decoction,5time amount of water in the third decoction,95C of controlled liquid temperature.In ethanol sediment, the loss rate of effective components was far greater than thereduction rate of total solid with increasing temperature and pH. Technological parameters areoptimized as following: liquid temperature in the range of25C to30C and pH value in therange of8.0to8.6.In water sediment, temperature had not obvious effects on the contents of activecomponents and total solid. By the decrease of pH value, the loss rate of effectivecomponents was not severely impacted, but total solid content decreases. Technologicalparameters are optimized as following: liquid temperature at room temperature in the rangeof20C to25C and pH value in the range of2.0to2.2.During the process of refining Salvia miltiorrhiza liquid, the effective component ofsalvianolic acid B reduced with the increase of pH value. Active carbon can adsorb not onlypyrogen but also effective components. Therefore, the dosage of active carbon should bedecreased on the premise that pyrogen is removed effectively. Technological parameters areoptimized as following: pH value in the range of4.5to4.8and the dosage of active carbonaccounting for1percent of the liquid volume.After three batches of validation of industrial production, optimized extractiontechnology of Salvia miltiorrhiza injection was proved to be suitable for industrialproduction.