清热神芎丸中大黄质量控制方法的研究

目的建立清热神芎丸中大黄质量控制方法,确保药品的质量。方法用HPLC法测定制剂中大黄酸、大黄素和大黄酚的含量。KromasilTMC18(250mm×4.6mm,5μm)柱;甲醇-0.1%磷酸溶液(85∶15)为流动相;检测波长254nm。结果大黄酸、大黄素和大黄酚分别在0.0508～0.5588μg、0.0409～0.4497μg和0.0418～0.4602μg范围内,进样量与色谱峰面积之间呈良好线性关系(r=0.9999)。平均加样回收率分别为100.18%、100.55%和99.93%;RSD分别为1.14%、1.29%和1.10%(n=6)。结论本法专属性强,准确度高,重现性好,可作为该产品质量控制的方法。

Study of the method for controlling the quality of Radix et Rhizoma Rhei in Qingre Shenxiong Pill

OBJECTIVE In order to control the qualilty of this drug,A RP-HPLC method was established to determine the active constituent-Radix et Rhizoma Rhei in Qingre Shenxiong Pill.METHODS The experiment were perform on Kromasil TMC18(4.6×250mm,5μm)column,methanol-0.1% phosphoric acid(85∶15)as mobile phase and detection wavelength was 254 nm.RESULTS The Iinear ranges of rhein,emodin and chrysophanol were 0.0508～0.5588μg,0.0409～0.4497μg,0.0418～0.4602μg,and their average recoveries were 100.18%,100.55% and 99.93%,respectively.CONCLUSION This mothod shows high accuracy,highly repeatable and can be used for quality control of Radix et Rhizoma Rhei in Qingre Shenxiong Pill.