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目的:建立伤湿止痛热熔压敏贴膏的质量控制方法。方法:采用薄层色谱法对伤湿止痛热熔压敏贴膏中颠茄流浸膏进行定性鉴别;采用高效液相色谱法对贴膏中马钱子碱和士的宁进行含量测定。结果:在薄层色谱中能检出颠茄流浸膏中硫酸阿托品的特征斑点;高效液相色谱法测定贴膏中马钱子碱和士的宁的含量,士的宁在0.53～53.0 mg.L-1线性关系良好(r=0.999 5),其平均回收率为95.57%,RSD 2.91%(n=6);马钱子碱在0.50～50.0 mg.L-1线性关系良好(r=0.999 5),其平均回收率为97.95%,RSD 1.43%(n=6)。结论:方法简便、专属性强、重复性好,可用于控制伤湿止痛热熔压敏贴膏的质量。
Objective: To establish a method of quality control of hot-melt pressure-sensitive plaster for damp-wetting pain relief. Methods: The TLC was used to qualitatively identify the belladonna flow extract in the wet-heat analgesic and hot-melt pressure sensitive plaster. The content of brucine and strychnine in the plaster was determined by HPLC. Results: The characteristic spots of atropine sulfate in Atropa belladonna extract could be detected by TLC. The content of brucine and strychnine in the patch was determined by high performance liquid chromatography. The contents of strychnine at 0.53-53.0 mg (R = 0.999 5). The average recovery was 95.57% and the RSD was 2.91% (n = 6). The linear relationship between strychnine and 0.50-50.0 mg.L-1 was good (r = 0.999 5), the average recovery was 97.95%, RSD 1.43% (n = 6). Conclusion: The method is simple, specific and reproducible. It can be used to control the quality of the wound wet analgesic hot-melt pressure-sensitive adhesive plaster.