Development Of Xuesaitong Orally Disintegrating Tablets

Heart cardiovascular disease is one of chief enemies of beings. The prescription of Xuesaitong Orally Disintegrating Tablets(ODT) mainly contains panax notoginseng saponin(PNS).The effect is promoting blood circulation and detoxicating. Preparation forms of Xuesaitong in the market are tablets, capsules, granules, dropping pill, soft capsule and injection, etc.This paper mainly focused on the research of orally disintegrating tablets of Xuesaitong, researching on preparation process, quality control standards and initial stability of the pills, aiming to establish molding technological conditions, quality control standards and study the stability of the pill.The formula prescription is optimized by the single factor experiment to select the type and the proportion of disintegrants and fillers. We disscussed disintegrating time, palate, hardness and appearance of the tablet as criteria in the tests to get the optimum including conditions, at last the pressure is optimized. The final optimized tablet was mainly composed of panax notogineseng saponin 25 mg, lactose Tablettose 80 5 mg, microcrystalline cellulose 45 mg, colloidal silicon dioxide 150 mg, cross-linked polyvinyl pyrrolidone 50 mg, carbolymethyl starch sodium 15 mg, aspartame 1 mg, magnesium stearate1 mg. The Xuesaitong ODT were prepared under the optimum formulation by the techniques of direct compression, which was simple and feasible, and the Xuesaitong ODT were integrity and smooth with disintegrate in mouth were all less than 30 s and taste good, and tablet weight variation was in the limits range.According the influence factor tests, accelerated test and long-term experiment to preliminary investigation the stability studies. Evaluation the appearance, disintegrating time, identification, and content determination of tablet. The results show that this product can resist to light and temperature, but high humidity moisture affects the disintegration time. The period of validity is temporarily set at 24 months.The quality standards are established according to the guiding principles of drug research requirements, ODT of Xuesaitong quality standard including characteristics, identification, examination and determination of contented. The item of distinguishing has a good effect with TLC method according to pharmacopoeia of people’s Republic of China. We drafted the quality standard of PNS, and control their contents with radix notogiseng saponin R1, ginseng saponin Rgl, ginseng saponin Rb1. Subsequently we drawed up the quatity standard. 3 batches of samples were assayed, and the results showed that all samples complied with the quality standards effectively.