壮骨麝香止痛膏的质量标准研究

Study on the improvement of quality standard of Zhuanggu Shexiang Zhitong Ointment

目的修订并提高壮骨麝香止痛膏的质量标准。方法采用TLC法对马钱子、生草乌和生川乌进行限量控制;采用GC法同时测定壮骨麝香止痛膏中樟脑等4种成分的含量。结果士的宁和乌头碱斑点清晰,分离度良好,阴性对照无干扰;樟脑、水杨酸甲酯、冰片和薄荷脑的线性关系和分离度良好,线性范围分别为0.1273~2.5457(r1=0.9999),0.0803~1.6060(r2=0.9999),0.0786~1.5725(r3=0.9999)和0.1249~2.4984μg(r4=0.9999);回收率分别为101.72%(RSD=0.69%),100.73%(RSD=1.08%),101.57%(RSD=1.86%)和99.49%(RSD=1.18%)。结论改进和提升壮骨麝香止痛膏标准的方法可行,有利于提高和保障该药品的质量。

Objective To revise and improve the quality standard of Zhuanggu Shexiang Zhitong Ointment.Methods The contents of Semen Strychni,Radix Aconiti kusnezoffii and Radix Chuanwu were controlled by TLC,and the contents of 4 components like camphor in Zhuanggu Shexiang Zhitong Ointment were determined by GC.Results The spots of strychnine and aconitine were clear with good resolution and no interference was observed.The linearity and resolution of camphor,methyl salicylate,borneol and menthol were good with the linear ranges of 0.1273-2.5457(r1=0.9999),0.0803-1.6060(r2=0.9999),0.0786-1.5725(r3=0.9999)and 0.1249-2.4984μg(r4=0.9999),respectively.The recoveries were 101.72%(RSD=0.69%),100.73%(RSD=1.08%),101.57%(RSD=1.86%)and 99.49%(RSD=1.18%),respectively.Conclusion It is feasible to improve and enhance the standard of Zhuanggu Shexiang Zhitong Ointment,which is beneficial to improve the product quality of the drug.