三黄凝胶剂的研制及质量控制

SanHuang Gel Preparation and Quality Control

目的:研究三黄凝胶剂的制备及质量控制。方法:采用卡波姆等为基质制成凝胶剂,并建立质量控制方法,用HPLC法测定凝胶剂中大黄含量,检测波长为365 nm并进行稳定性实验。结果:大黄素进样量在0.002 57～0.051 40μg范围内,与峰面积积分值呈良好的线性关系(r=0.999 5);大黄酚进样量在0.008 61～0.172 20μg范围内,与峰面积积分值呈良好的线性关系(r=0.999 5);大黄素和大黄酚总量的加样平均回收率为98.4%(RSD为1.38%,n=5)。结论:该制剂处方合理,制备工艺简单,稳定性好,质量可控制。

Objective：To study SanHuang gel preparation and quality control.Method：Carbopol the matrix made as gel,and establish quality control methods,determined by HPLC gel content in rhubarb,detection at 365 nm and the stability test.Result：emodin sample volume 0.002 57-0.051 40 μg range,and peak area values showed a good linear relationship（r=0.999 5）;chrysophanol sample volume in the range of 0.008 61-0.172 20 μg,and the peak area values showed a good linear relationship（r=0.999 5）;emodin and chrysophanol plus the total average recovery was 98.4%（RSD of 1.38%,n = 5）.Conclusion：The prescription was reasonable preparation,preparation was simple,good stability,quality control.