愈骨片制备工艺及质量标准研究

目的:研究愈骨片的制备工艺及质量标准。方法:采用半浸膏片的生产工艺制成制剂,使用显微和薄层色谱法进行鉴别,通过加速试验和常温考察两种方法对其初步稳定性进行预测。结果:制备工艺设计合理,可操作性强。成品各项检查均符合药典要求;薄层鉴别图谱斑点清晰,分离度好。成品置于温度37℃～40℃、相对湿度75%环境,分别于0,1,2,3月对其外观性状、鉴别、检查等稳定性项目进行测定,各项检测指标均无明显变化,表明该产品质量稳定。结论:制备工艺成熟稳定可行,操作简便;质量可控。

The study of the preparation and quality standards of Yu Gu Pian

Objective:To study the preparation and quality standards of Yu Gu Pian.Methods:Using production process of the semi-extract tablets to make preparations,microscopy and thin layer chromatography to identify,forecast by speeding up the trial and room temperature study two methods of its initial stability.Results:Preparation process design is reasonable and workable.The tests of finished were in line with pharmacopoeia requirements;TLC maps spots are clear,and separation degree is good.The finished product at 37℃～ 40℃,75% relative humidity environment,were respectively observed for 0,1,2,3 months of their appearance,identification,check the stability of the project,all indices had no significant change,indicating that the product quality is stable.Conclusion:Preparation process is mature,stable and practical,easy to operate;quality is controlled.