穴敷喘平凝胶贴剂质量标准研究

Study on Quality Standards of Xuefu Chuanping Gel Patch

目的:建立穴敷喘平凝胶贴剂的质量标准。方法:采用TLC法鉴别方中芥子、延胡索、细辛。采用HPLC法测定方中盐酸麻黄碱的含量。结果:定性鉴别中检出芥子、延胡索、细辛,且分离度好、专属性强,阴性对照无干扰。HPLC测定盐酸麻黄碱在0.032～0.096μg有较好的线性关系,平均回收率为98.12%,RSD为1.08%,凝胶贴剂中盐酸麻黄碱含量为4.25mg.g-1。结论:所建立的质量控制方法准确、可靠、专属性强,可以用于该制剂的质量控制。

Objective：To establish the quality standards of Xuefu Chuanping gel patch.Method：Semen Sinapis.Corydalis and Herba Asari were identified by thin layer chromatography（TLC）.The content of ephedrina hydrochloridum was determined by high performance liquid chromatography（HPLC）.Result：Semen Sinapis.Corydalis and Herba Asari were identified by thin layer chromatography（TLC）.The characteristic identification was distinct and highly specific.Ephedrina hydrochloridum was linear in the range of 0.032 ～ 0.096 μg.Average recovery was 98.12%,RSD was 1.08%.The content of ephedrina hydrochloridum in gels was 4.25 mg.g-1.Conclusion：The quality control method is reliable,accurate and specific.It can be used for quality control of Xuefu Chuanping gel patch.