五味子软胶囊制剂成型工艺研究

Optimization of the Preparation Technology of Schisandra chinensis Soft Capsules

目的:优选五味子软胶囊的最佳成型工艺。方法:以明胶、甘油、水的用量及溶胶温度为考察因素,以崩解时限和加速试验崩解时限的综合评分为评价指标,采用正交试验优选软胶囊囊壳工艺;利用单因素试验考察药物粒度、基质种类及用量、助悬剂种类及用量。结果:最佳软胶囊囊壳工艺为甘油、明胶、水的用量分别为100、220、200g,溶胶温度为80℃;成型工艺为药物细粉与大豆油的比例1∶1.2,蜂蜡占药粉用量的15%,药物粒度为100目。结论:所得工艺稳定、质量可控,适合工业化生产。

OBJECTIVE： To optimize the preparation technology of Schisandra chinensis soft capsules. METHODS： The preparation technology of S. chinensis soft capsules was optimized by orthogonal test using the amount of gelatine, glycerin and water and temperature for gel formation as factors and with disintegration time limited and score of accelerated test as index. Single factor test was used to investigate the granularity of drug, type and amount of matrix and suspending agent. RESULTS： The optimized formula of envelope was as follows： gelatine 100 g, glycerin 220 g and water 200 g, temperature for gel formation of 80℃; The optimized preparation formula was as follows： ratio of drug fine powder to soybean oil was 1 ∶ 1.2; amount of beeswax was 15% of drug powder; granularity of drug was 100 mesh. CONCLUSION： Established preparation technology of S. chinensis soft capsules is stable and controllable for industrial production.