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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 the preparation and quality control of Sanhuang Gel. Methods: A gel was prepared by using carbomer as a matrix and a method of quality control was established. The content of rhubarb in the gel was determined by HPLC. The detection wavelength was 365 nm and the stability was tested. Results: The emodin injection volume was in the range of 0.002 57 ~ 0.051 40μg with a good linear relationship with the peak area integral value (r = 0.999 5). The injection volume of chrysophanol was in the range of 0.00861 ~ 0.172 20μg, with the peak area The integral value showed a good linear relationship (r = 0.999 5). The average recoveries of total emodin and chrysophanol were 98.4% (RSD 1.38%, n = 5). Conclusion: The preparation prescription is reasonable, preparation process is simple, good stability, quality control.