文献类型：期刊文献

中文题名：山楂叶颗粒剂的制备和质量控制

英文题名：Preparation and Quality Control of FOLIUM CRATAEGI Granules

作者：杨群[1];张锴[2]

机构：[1]绍兴文理学院元培学院;[2]太极集团浙江东方制药有限公司

年份：2012

卷号：40

期号：12

起止页码：7106

中文期刊名：安徽农业科学

外文期刊名：Journal of Anhui Agricultural Sciences

语种：中文

中文关键词：山楂叶颗粒剂;制备;质量控制

外文关键词：FOLIUM CRATAEGI granules; Preparation; Quality control

中文摘要：[目的]研究山楂叶颗粒剂的制备工艺,建立质量控制方法。[方法]将山楂叶用浓度50%乙醇提取,以颗粒休止角和吸湿性为指标,选择最佳处方辅料,并采用薄层色谱法鉴别颗粒中的总黄酮和金丝桃苷,以紫外分光光度法测定总黄酮含量。[结果]最佳处方辅料为:浸膏粉250 g,糖粉125 g,糊精125 g;此时,颗粒的休止角和吸湿性都最小,分别为33°和0.65%;总黄酮和金丝桃苷样品分离良好,薄层色谱斑点清晰;总黄酮标准曲线为:Y=25.455X+0.004 7,R=0.999 9,线性范围为0.016～0.024 mg/ml,平均回收率为100.57%(RSD为0.13%);颗粒的水分、粒度和溶化性均符合中国药典的相关规定,总黄酮平均含量为0.412 g/g(RSD为0.38%)。[结论]山楂叶颗粒剂制备工艺简单可行、合理,质量稳定可控。

外文摘要：[Objective] To study the preparation technology of FOLIUM CRATAEGI granules and to establish methods for its quality control.[Method] FOLIUM CRATAEGI was extracted by 50% ethanol.With granules＇ angle of repose and moisture absorption as the indices,the optimal auxiliary materials of prescription were selected.Total flavonoids and hyperin were detected by TLC.UV spectrophotometry was used to determine the content of total flavonoids.[Result] The optimal auxiliary materials of prescription were 250 g extracts,125 g sugar powder,and 125 g dextrin.Under this condition,the angle of repose and the moisture absorption were both the minimum,which were 33° and 0.65%,respectively.Total flavonoids and hyperin were well isolated from the samples,the TLC spots were clear.The standard curve of total flavonoids was Y=25.455X＋0.004 7 with R=0.999 9.Linear range was between 0.016 and 0.024 mg/ml,the average recovery rate was 100.57%（RSD=0.13%）.Moisture content,particle size and dissolvability of granules all met the requirements in Chinese Pharmacopeia.The average content of total flavonoids was0.412 g/g（RSD=0.38%）.[Conclusion] The preparation process of FOLIUM CRATAEGI granules was simple,feasible and reasonable,and the quality was stable and controllable.