跌打止痛巴布剂质量标准的研究

Quality Standard of DieDaZhiTong Cataplasm

目的建立跌打止痛巴布剂的质量标准。方法采用薄层色谱法对处方中丁香罗勒油、八角茴香油、桉油、川芎、大黄、蛇床子、独活等7味药材进行定性鉴别,采用高效液相色谱法对制剂中的丁香酚和蛇床子素进行含量测定。结果薄层色谱法能定性检出丁香罗勒油、八角茴香油、桉油、川芎、大黄、蛇床子、独活,斑点清晰,且阴性对照无干扰;高效液相色谱法测定丁香酚在0.712~7.120μg范围内线性关系良好;蛇床子素在0.055 8~0.558 0μg范围内线性关系良好。结论所建立的定性、定量检测方法操作简便,结果准确可靠,重复性好,能有效地控制跌打止痛巴布剂的质量。

Objective To establish a quality standard for DieDaZhiTong Cataplasm（DC）.Methods The qualitative identification of Oleum Ocimi Gratissimi,Anisestaroil,Eucalyptus Oil,Rhizoma Chuanxiong,Radix et Rhizoma Rhei,Fructus Cnidii,Radix Angelicae Pubescentis in DMS was carried out by TLC,and the contents of Eugenol and Osthole were determined by HPLC.Results The relevant spots of Oleum Ocimi Gratissimi,Anisestaroil,Rhizoma Chuanxiong,Radix et Rhizoma Rhei,Fructus Cnidii,Radix Angelicae Pubescentis on TLC plates were clear without the interference of blank control.The content of Eugenol showed a good linearity in the range of 0.712～7.120μg.The content of Osthole showed a good linearity in the range of 0.0558μg～0.5580μg.Conclusion These qualitative and quantitative detection methods are simple,accurate,reliable and reproducible,and can be effectively used for the quality control of DieDaZhiTong Cataplasm.