植物软胶囊的处方优化及加速稳定性考察

发布时间：2018-01-25 04:55

  本文关键词： 植物软胶囊 稳定性 黏度 胶皮强度 胶皮弹性 崩解时间　出处：《中国医药工业杂志》2017年02期 　论文类型：期刊论文

【摘要】：以明胶、变性淀粉、κ-卡拉胶、ι-卡拉胶、低酰基结冷胶为研究对象,分别考察浓度、温度和p H值对胶液黏度、胶皮强度和弹性的影响,筛选替代明胶的植物胶。选用变性淀粉,再配合甘油、山梨醇和水制备软胶囊胶皮,通过正交试验优选胶皮处方,并压制含液体石蜡的软胶囊,进行加速稳定性试验。结果表明,具有黏度低、耐高温、耐酸特性的变性淀粉在4种植物胶中最具优势。优选得到的优化软胶囊胶皮处方为:变性淀粉∶增塑剂为2∶1,变性淀粉∶水为1∶1,甘油∶山梨醇为1∶1。3批优化制品的胶液黏度、胶皮强度、胶皮弹性和崩解时间分别为(38.89±0.63)Pa·s、(242.51±4.91)g、(7.03±0.10)mm和(47.03±0.42)min。在40℃加速试验3个月,该优化软胶囊的外观及崩解时间均未发生显著改变。
[Abstract]:The effects of concentration, temperature and pH value on viscosity, strength and elasticity of gelatin, modified starch, 魏 -carrageenan, 1-carrageenan and low-acyl cold gel were investigated. The soft capsule rubber was prepared with modified starch, glycerol, sorbitol and water. The formulation of soft capsule was selected by orthogonal test, and the soft capsule containing liquid paraffin was pressed. The accelerated stability test was carried out. The results showed that it had low viscosity and high temperature resistance. The modified starch with acid-resistant properties had the most advantages among the four kinds of plant gum. The optimized formulation of soft capsule rubber was as follows: modified starch: plasticizer 2: 1, modified starch: water 1: 1. Glycerol: the viscosity, strength, elasticity and disintegration time of the products were 38.89 卤0.63 Pa 路s, respectively. It was 7.03 卤0.10mm and 47.03 卤0.42mm. accelerated test at 40 鈩，

本文编号：1462043