消炎止痛膏质量标准新研究

摘要

Objective:To establish new quality standard for XiaoYan ZhiTong ointment. Methods:DaiHuang (Rheum palmatum L.), HuangBo (Cortex Phellodendri Chinensis) and BanXia [Pinellia ternata (Thunb.) Breit.] were identified qualitatively by TLC, limited quantity of aconitine contained in processed CaoWu (Aconitum sp.) was de-termined, the contents of brucine and strychnine in processed MaQianZi(Strychnos nux-vomica L.) were identified by HPLC. Results:TCL spots were clear with high resolution;brucine and strychnine showed better linear relationship in the range between 0.20 and 2.0 μg and integral value of peak area (r=1.00 0), average recovery rate of brucine was 97.8%, RSD was 0.86%(n=6);average recovery rate of strychnine was 96.6%, RSD was 1.20%(n=6). Conclu-sion:The standard could be used for quality control of XiaoYan ZhiTong ointment.%目的：建立消炎止痛膏的新质量标准。方法：采用薄层色谱(TLC)法对方中大黄、黄柏、半夏进行定性鉴别以及对制草乌含乌头碱进行限量测定；用高效液相色谱(HPLC)对制马钱子中的马钱子碱和士的宁进行含量测定。结果：TLC斑点清晰，分离度好；马钱子碱和士的宁进样量都在0.20～2.0μg之间与峰面积积分值呈良好的线性关系(r=1.000)，马钱子碱的平均回收率为97.8%，RSD为0.86%(n=6)；士的宁的平均回收率为96.6%，RSD为1.20%(n=6)。结论：所建立的标准适用于院内制剂消炎止痛膏的质量控制。