| Objective:as a Chinese herbal medicine commonly used in treatment of cardiovascular and cerebrovascular disease,Danshen has a natural advantage.It is widely used clinically in treatment of coronary heart disease, angina, ischemic stroke, and other diseases. Water-solubility components in Danshen---salvianolic acids composition has goog prospect in treatment of cardiovascular and cerebrovascular disease. Salvianolic acids Orally Disintegrating Tablets are prepared to be a new preparation with modern fast-release technology. Drugs can disintegrate fast in buccal cavity,and they taste good by fast-release system.It is expect to increase the dissolution rate of drugs and improve drug bioavailability and improve patient medication compliance by this system.And to lay the foundation for Chinese medicine for further research and development of innovative drugs.Methods:①The preparation of salvianolic acids and the stability of preparation technology.The traditional technology condition of the extraction of water-soluble components in Danshen is optimized and improved.Salvianolic acids and salvianolic acid B are considered as detecting indicators respectively which are determined by ultraviolet spectropHotometry and high performance liquid spectropHotometry.②Study on preparation formula and preparation technology The category of disintegrants is screened and preparation formula is designed by multi-level and multi-factor orthogonal design.The experiment is arranged by the assistant of orthogonal design V3.0 with the content of disintegrants and the concentration of adhesive and some fators are chosen to be investigation agents.Disintegration time is investigated and considered as investigation fators,and the time is smaller ,the ratio of preparation formula is better.The test data of orthogonal design is regression analysized by EXCEL software.③Study on quality standard of preparation.The qualitation appreciation of preparation is done by chemical structure and property of principal agent.Salvianolic acid B is effective component in Salvianolic acids orally disintegrating tablet which is determined by high performance liquid chromatograpHy to definite the quality standard of preparation.④The initial stability study of salvianolic acids orally disintegrating tablet is undertaken by accelerated stability test and chronic stability test to investigate the stability of salvianolic acids orally disintegrating tablet.Results:①The 12 times volume 30% ethanol solution considered as extraction solvent,at 80℃,extracted three times,0.5 hour each time;the extract is flocculated,concentrated,extracted,adsorbed on a macroporous resin colume, decompression enrichment,arescented and the content of salvianolic acid B is above 60% in the final product.②The best disintegrants are PVPP,MCC,and L-HPC.The preparation fomula is 12% salvianolic acids, 20% MCC, 5% L-HPC,7% PVPP,50% manicol,0.5% magnesium stearate,5% aspartame and 0.5% fruit essence.The tablets prepared have good disintegrability,and the average disintegrating time is 23.5s.③The calibration curve shows good linearity over the range of 410.4～2052.0μg/ml(R2=0.9994).The average recovery is higher than 99%.④The mensurated results accord with quality standard.Compared with the results of initial month ,there is no any obvious change.Conclusions:①The best preparation technology of salvianolic acids is definited and the product can meet with demand of preparation.②The screened formula is the best formula.③The quality standard of salvianolic acids orally disintegrating tablet is initially established and the methods have good sensitiveness,accurance, reproducibility and strong specificity.④The results of stability study shows:the quality of salvianolic acids orally disintegrating tablet is stable and the expiration date is initially set to be two years.
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