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目的制备散结膏,建立散结膏的质量控制方法。方法以大黄、当归、香附、柴胡、黄芪等为组方制备散结膏;采用薄层色谱(TLC)法对当归、香附、柴胡、黄芪进行鉴别,并利用高效液相色谱(HPLC)法测定大黄中的大黄素的含量。结果所制制剂为棕黑色软膏,各项检查均符合《中国药典》相关规定,大黄素检测的线性范围0.04~0.40μg/m l(r=0.999 9),平均回收率为100.29%(RSD=1.79%,n=6)。结论该制剂制备工艺简单可行,所建立的质量控制方法可靠,制剂质量稳定。
Objective To prepare Sanjie cream and establish the quality control method of Sanjie cream. Methods Radix Angelicae Sinensis, Radix Angelicae Sinensis, Radix Bupleuri and Astragalus membranaceus were identified by thin layer chromatography (TLC), and rhubarb, Angelica sinensis, Cyperus rotundus, Radix Bupleurum, Radix Astragali, HPLC) Determination of emodin in rhubarb content. Results The preparation was brown black ointment. All the tests were in accordance with the relevant regulations of Chinese Pharmacopoeia. The linear range of emodin was 0.04 ~ 0.40μg / ml (r = 0.999 9) and the average recovery was 100.29% (RSD = 1.79 %, n = 6). Conclusion The preparation process of the preparation is simple and feasible, the quality control method established is reliable and the preparation quality is stable.