生肌化瘀膏质量标准研究

Quality standard for Shengji Huayu Cream

目的：建立生肌化瘀膏（龙血竭、大黄、当归、等）的质量标准。方法：采用TLC法对处方中龙血竭、大黄和当归进行定性鉴别，采用HPLC法测定制剂中龙血素A和龙血素B的含量。结果：TLC能特异性地鉴别龙血竭、大黄和当归。龙血素A进样量在3．65～365μg／mL范围内，线性关系良好，回归系数r=0．9999（n=7），平均回收率为100．3％，RSD为1．33％（n=6）；龙血素B进样量在3．62—362μg／mL范围内，线性关系良好，回归系数r=0．9999（n=7），平均回收率为99．1％，RSD为1．50％（n=6）。结论：该法专属性强，简便，准确，可作为控制生肌化瘀膏质量的方法。

AIM ： To establish the quality standard for Shengji Huayu Cream （ Resina Draconis, Radix et Rhizoma Rhei, Radix Angelicae Sinensis, etc. ）. METHODS： Resina Draconis, Radix et Rhizoma Rhei, Radix Angelicae Sinensis were identified by TLC. Loureirine A and loureirineB were determined by HPI,C. RESULTS： Resina Draconis, Radix et Rhizoma Rhei, Radix Angelicae Sinensis in Shengji Huayu Cream were determined by TLC. The linear ranges were 3.65 - 365 μg/mL （ r = 0. 999 9 ） , for loureirine A, 3.62 - 362 μg/mL （ r = 0. 999 9 ） for loureirine B （n = 7 ） respectively. The average recoveries （ n = 6） of them were 100.3% （ RSD = 1.33% ） and 99.1% （RSD = 1.50% ）, respectively. CONCLUSION ： The methods is specific, simple and accurate. It can be used for the quality control of Shengji Huayu Cream.