肾达欣胶囊颗粒的制备工艺改进

Study on Improvement of Preparing Process for Shendaxin Soft-gel Capsule

目的:简化肾达欣胶囊颗粒制备流程,减少生产用时,减少受热对有效成分的破坏,降低能耗,降低劳动量,降低物料损耗率,提高制剂均一性。方法:将处方中需要粉碎的中药饮片粉碎后与提取浓缩好的稠浸膏经过分次混合制粒干燥,粉碎整粒制成符合要求的颗粒,作为颗粒制备工艺Ⅰ;将提取浓缩好的流浸膏直接干燥粉碎成浸膏细粉,再与中药细粉混匀,加适量乙醇润湿制粒,整粒制成符合要求的颗粒,作为颗粒制备工艺Ⅱ。分别制得各3个批次的肾达欣胶囊。将二种工艺制备的半成品和成品从干燥粉碎次数、生产用时、物料损耗率、微生物限度检查和崩解时限等5个方面进行比较。结果:工艺Ⅱ生产用时和物料损耗均少于工艺I。二种工艺生产的成品其卫生学检测结果及崩解时限无显著差异,均合格。结论:改进工艺优于原工艺,可以作为肾达欣胶囊的制备工艺。

Objective ： To study a method of simplified preparing process for shendaxin capsule granules. Methods： After TCM pieces of the prescription that need to be crushed are crushed, they are mixed graded with good thick extract paste made by extraction and concentration, The mixture is granulated and dried. To crush the complete pieces and to make the granules met the requirements, as preparation process for granules Ⅰ. The concentrated fluidextract is directly dried and crushed to the powder of extract, and mixed with the powder of traditional chinese medicine evenly, then added appropriate amount of ethanol so as to wet and granulate. To make directly the granules met the requirements, as preparing process for granules Ⅱ. According to Ⅰ and Ⅱ. respectively to make shendaxin capsule for each three batches. The by two kinds of process semi-finished and finished products were compared from the times of dry and grinding process, production time, material loss rate, microbial limit tests and disintegration time etc. five respects. Results： Production time and material losses of production process Ⅱ were less than the process Ⅰ. For the finished products from two kinds of process, their test results of hygiene and disintegration time have no significant differences, and were qualified. Conclusion： The improved technology can reduce production time, the heat damage to the active compositions, energy consumption, labor and material loss rate, and improve the uniformity of preparation, and can be used as preparing process for shendaxin capsule.