穿心莲内酯滴丸溶出度测定方法的研究

Dissolution determination of Andrographolide Dropping Pills

目的建立穿心莲内酯滴丸的体外溶出度测定方法。方法依据《中国药典》2010版溶出度测定法第1法(转篮法),以0.1 mol·L-1盐酸-乙醇(3∶2)为溶出介质,转速为100 r·min-1。采用紫外-可见分光光度法,以穿心莲内酯含量为指标,在225 nm条件下测定穿心莲内酯滴丸在不同时间的累积溶出百分率。结果穿心莲内酯在浓度范围5.6～28.0 mg·L-1内,线性关系良好,平均回收率为96.67%,RSD为1.30%。穿心莲内酯滴丸在15 min时平均累积溶出百分率为94.96%,30 min左右可完全溶出。结论该文所建立的溶出度测定方法操作简单,准确可靠,重现性好,可用于穿心莲内酯滴丸的溶出度的测定方法。

Objective To establish a method of dissolution determination of Andrographolide Dropping Pills. Methods According to the Chinese Pharmacopoeia, hydrochloric acid（0.1 mol . L-1 ） -Anhydrous ethanol solution was used as dissolution medium, with speed of 100 r . min-l. Andrographolide as the indicator, the accumulated dissolution rate of Andrographolide Dropping Pills was calculated at a wavelength of 225nm by UV-Vis spectrum method. Results The calibration curve of Andrographolide was linear in the range of 5.6 -28.0 mg . L- 1. The average recovery rate was 96.67 % with the RSD 1.30 %. The average accumulated dissolution rate of Andrographolide Dropping Pills reached 94.96% in 15 min and reached 100% in about 30 min. Conclusion The method is simple, accurate and repeatable,which can be used for the quality control of Andrographolide Dropping Pills.