Study On Process And Quality Standard Of Compound Danshen Chewable Tablets

The compound danshen preparation as a traditional Chinese medicine has good effects of promoting blood circulation, removing stasis, and arresting pain.at same time, it also has role of the anti-aging, enhancing immune, protecting liver and nourishing gallbladder. The compound Danshen chewable tablet has been second developed on the basis of the original formulation, which made it have some benefits not found in other dosage forms, for example, its drug dissolution rapidly without disintegrating, absorption quick and high bioavailability; easy to take, especially for patients with swallowing difficulties.The best extraction process was determined by orthogonal experiment designed, secondly, the technological procedure was defined through study on forming of preparation and referenced to actual production processes, the studies on sample stability and quality standards indicated that the content of compound could been tested, the quality could controlable and stability was better in the Danshen chewable tablet.1. Study on extraction technology of Salvia MiltiorrhizaThe optimum extraction process of radix salviae miltiorrhizae was determined through the orthogonal experimental design in follow,the salviae miltiorrhiza8times95%ethanol at heating return1.5h,8times50%ethanol at heating return1.5h, last10times water contracted at100℃2h.2. Research on preparation forming processStudied on prescription and screening of process to determine the Stevia, Aspartame and mannitol, citric acid as a flavor agent,4%povidone K30solution for adhesive,1%magnesium stearate and0.5%silica powder as a lubricant, opadry for coating materials, β-Cyclodextrin inclusion to prevent the loss of Borneol.3. Study on Quality StandardTLC test results show that salvia miltiorrhiza, notoginseng, borneol have better characteristic chromatographic spots. The experimental results was specifical, without negative interference, repeatable and accurate. HPLC test results indicate that this method have a good future in linear relationship, Stability, precision, recovery, reproducibility, measuring results accurate, which could effectively control the product’s intrinsic quality.