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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 Jiaojiao gel patch and to establish the quality standard of Jiaojiao gel patch. Methods: The extract of the extract and pepper powder as the main drug, carbopol and sodium polyacrylate gel composition of the gel patch preparation. The pepper was qualitatively identified by thin-layer chromatography (TLC method). The content of piperine in the pepper was determined by high performance liquid chromatography (HPLC). Results: The prepared Jiaojiao gel patch paste creamy texture, has good formability, adhesion and moisture retention. TLC identification of pepper identification, and clear spots, good resolution, specificity, negative control without interference; HPLC quantitative identification of piperine in the range of 0.054 ~ 0.32μg and peak area showed a good linear relationship, the average recovery Was 101.79% with a RSD of 1.19% (n = 6). Conclusion: The preparation technology of Jiaojiao Gel Paste is reasonable and stable. The established quality standard is reliable, accurate and specific. It can be used for the quality control of Jiaojiao Gel Paste.