正交试验优选丹参片片芯制备工艺

目的:选择适宜的制粒工艺,提高丹参片的片芯质量,利于薄膜包衣进行。方法:采用正交试验,以片芯硬度、脆碎度和外观为考察指标,以预胶化淀粉用量、聚乙烯吡咯烷酮(PVP)-30用量、乙醇用量、乙醇浓度为考察因素,优选丹参片片芯制备工艺。结果:以20g·kg-1PVP-30为黏合剂,以40mL·kg-175%乙醇为湿润剂,预胶化淀粉用量为50g·kg-1,通过高效湿法混合制粒机制粒,可使压制的片芯外表光洁,硬度达到(46.6±21.8)N,脆碎度为(0.72±0.19)%。结论:该工艺制得的片芯可达到薄膜包衣的要求,有利于该制剂的进一步研究。

Optimization of the Preparation Technology of the Core of Salvia miltiorrhiza Tablet by Orthogonal Test

OBJECTIVE：To select appropriate granulating process and enhance the quality of the core of Salvia miltiorrhiza tablet so as to improve film coating.METHODS：The preparation of S.miltiorrhiza tablet was optimize by orthogonal test with hardness,friability and appearance of tablets as index with amount of pregelatinized starch,polyvinylpyrrolidone（PVP-30） and ethanol and the concentrations of ethanol as factors.RESULTS：The tablets were prepared by high efficient damp mixing granulator using 20 g·kg^-1 PVP-30 as binder and 75%ethanol as wetting agent 50 g·kg^-1 pregelatinized storch.Surface of prepared tablets was clean with hardness of（46.6±21.8） N,friability of（0.72±0.19） %.CONCLUSION：Prepared tablets core conforms to the requirement of film coating.It contributes to the further study of S.miltiorrhiza tablet.