黄秋葵胶囊的制备及质量控制

Preparation and Quality Control of Okra Capsules

关键词:  黄秋葵胶囊  制备  质量控制

Key words:  okra capsules  preparation  quality control

摘要:

目的 研究黄秋葵胶囊的制备工艺，建立其质量控制方法。方法 采用UV测定多糖含量；以加水量、提取次数、提取时间、提取温度为影响因素，采用L₉(3⁴)正交试验，以多糖含量为指标，优选黄秋葵提取工艺；将提取液过滤、浓缩、加辅料、一步制粒、填充胶囊。结果 最佳提取工艺为：加水量10 倍，提取时间2 h，提取温度100 ℃，提取次数3次；多糖标准曲线为：Y=5.746 0X+0.084 1，r=0.999 7，线性范围为：0.007~0.036 mg·mL^-1，平均回收率为99.54％(RSD为1.29％)；处方辅料为：黄秋葵浸膏-淀粉-硬脂酸镁(300 g∶300 g∶3 g)；该制剂各项检查均符合2005年版中国药典的相关规定，胶囊多糖平均含量为8.1%。结论 黄秋葵胶囊制备工艺简单可行、合理，质量稳定可控。

Abstract:

OBJECTIVE To study the preparation of okra capsules and establish methods for its quality control. METHODS Polysaccharide content was detected by UV. Water volume, extracting times, extraction time, extraction temperature were taken for factors, L₉(3⁴) orthogonal test was used with polysaccharide content as indicators, to choose the best extraction process for okra capsules. Extract from filtration, concentrate, adding accessories, granulate and fill the capsule. RESULTS The best extraction process was 10 times the volume of water, extraction for 2 h, extraction temperature of 100 ℃, extraction 3 times. The standard curve of the polysaccharide was Y=5.746 0X+0.084 1, r=0.999 7, the linear range was 0.007-0.036 mg·mL^-1. The average recovery was 99.54％(RSD 1.29%). Accessories prescription was as follows: okra extract-starch-magnesium stearate(300 g∶300 g∶3 g). The results of the checks of this preparations were fit the relevant provisions of Ch.P(2005). CONCLUSION The preparation process of okra capsules is simple and feasible and reasonable. The quality is stable and controllable.