葎椒凝胶贴膏剂制备工艺及质量标准研究

Preparation and Quality Control of Humulus scandens and Piper nigrum Gel Ointment

目的:制备葎椒凝胶贴膏剂,并建立葎椒凝胶贴膏剂的质量标准。方法:以葎草提取物和胡椒粉为主药,卡波姆和聚丙烯酸钠为凝胶骨架成分制备凝胶贴膏剂。采用薄层色谱法(TLC法)对制剂中胡椒进行定性鉴别;以胡椒中的胡椒碱含量为指标,采用高效液相色谱法(HPLC法)测定制剂中胡椒碱的含量。结果:制备的葎椒凝胶贴膏剂膏质细腻,具有较好的成型性、黏附性和保湿性。TLC定性鉴别中检出胡椒,且斑点清晰,分离度好、专属性强,阴性对照无干扰;HPLC定量鉴别中胡椒碱在0.054~0.32μg范围内与峰面积呈良好的线性关系,平均回收率为101.79%,RSD为1.19%(n=6)。结论:葎椒凝胶贴膏剂的制备工艺合理稳定,建立的质量标准可靠、准确、专属性强,可用于葎椒凝胶贴膏剂的质量控制。

Objective：To prepare Humulus scandens and Piper nigrum Gel Ointment,and establish its quality standard. Methods：Gel ointments was prepared with the extract of Humulus scandens and the powder of Piper nigrum as materials,carbomer and sodium polyacrylate as gel skeleton matrix. Piper nigrum was identified by thin layer chromatography（TLC）. The content of piperine was determined by high performance liquid chromatography（HPLC）. Results：Humulus scandens and Piper nigrum Gel Ointment had fine paste and good formability,adhesion as well as moisture retention. Piper nigrum was identified by TLC. The characteristic identification was distinct and highly specific. The linear range of piperine was 0.054-0.32μg with an average recovery of 101.79%,RSD for 1.19%（n=6）. Conclusion：The preparation technology is suitable and stable. The quality standard is reliable,accurate and specific which can be used for quality control of Humulus scandens and Piper nigrum Gel Ointment.