三康胶囊制备工艺的研究

Study on Preparation Process of Sankang Capsules

目的对三康胶囊的制备工艺进行研究。方法以出膏率和指标成分的含量进行正交设计,对三康胶囊的提取工艺进行优选;通过剂型、物料形式、润湿剂、制粒条件的选择以及颗粒流动性、吸湿性、临界相对湿度、堆密度的考察,优选制剂工艺。结果确定三康胶囊的提取工艺为:醇提部分提取两次,第1次用10倍量70%乙醇回流提取2.0 h,第2次用8倍量70%乙醇回流提取1.5 h;水提部分用适量水浸泡1.0 h,第1次用12倍量水回流提取1.5 h,第2次加10倍量水回流提取1.0 h。制备工艺为按一定比例加入相对密度为1.35(60℃)的醇提物和相对密度1.13(60℃)的水提物、药材细粉,混匀,真空干燥,粉碎,过孔径0.18 mm(80目)筛,用90%乙醇做润湿剂,加适量淀粉制软材,过孔径0.85 mm(20目)筛,装0号胶囊。临界相对湿度44.2%,堆密度为0.659 9 g·(cm3)-1。结论所选择的制备工艺合理,稳定可行。

Objective To study the optimal preparation process of Sankang capsules.Methods The optimum extraction process of shengxue capsules was determined by the orthogonal design with paste-forming rate and contents of the special ingredients.The preparation process was optimized through the selection of formulation,materials,wetting agents and conditions for granlunation,and investigation of flowability of particles,hygroscopicity,relative humidity and bulk density of the granules.Results The best extraction technology was as follows：the ethanol extraction was carried out twice,with 10 times volume of 70% ethanol for 2.0 h circumfluence reflux and 8 times of it for 1.5 h,respectively.The water extracted parts were soaked with some water for 1.0 h,refluxed with 12 times volume of water first for 1.5 h and 10 times water for 1.0 h later.The preparation technology was that mixed the ethanol extract with 1.13 relative density,water extract with 1.35 relative density and powder at a certain proportion,vacuumly dried,ground and passed through 80 mesh sieve,and formed softmaterials by using 90% ethanol as wetting agent,then crushed through 20 mesh sieve and loaded into No.0 capsules.The bulk density was 0.659 9 g·（cm3）-1 and the critical relative humidity was 44.2%.Conclusion The preparation process is reasonable,stable and practicable.