溃平宁胃漂浮片的质量标准研究

Study on the quality standard of Kuipingning gastric floating tablets

目的建立溃平宁胃漂浮片的质量标准。方法制备溃平宁胃漂浮片,进行性状观察和重量差异、脆碎度考察,采用薄层色谱法对该制剂中的延胡索药材进行定性鉴别,采用高效液相色谱法测定该制剂中的大黄总蒽醌含量并规定其含量限度,然后再考察该制剂的漂浮性能以及释放度并对其释放动力学过程进行拟合。结果本研究所制得的溃平宁胃漂浮片为灰白色至灰色片剂,气微,味苦;重量差异及脆碎度均符合相关规定;建立的薄层色谱法专属性强,可准确鉴别延胡索药材;大黄总蒽醌的平均含量为17.95 mg/片,其含量限度不得少于14.36 mg/片;该片剂起漂时间不大于10 s,持漂时间大于8 h,且释放动力学过程符合Retger-Peppas释放模型。结论本研究建立的溃平宁胃漂浮片质量标准具有良好的可靠性、稳定性、可行性,可有效控制该制剂的质量。

OBJECTIVE To establish the quality standard of Kuipingning gastric floating tablets.METHODS Kuipingning gastric floating tablets were prepared and investigated in terms of property,weight difference and friability.Crydalis yanhusuo was identified qualitatively by thin layer chromatography(TLC)method.High performance liquid chromatography method was used to determine the content of total anthraquinones in Rheum palmatum,and set the content limit of total anthraquinones.The floating performance and release degree of the preparation were investigated,and the release kinetic process was fitted.RESULTS Kuipingning gastric floating tablets prepared in this study were gray white to gray tablets with slight smell and bitter taste;the weight difference and friability were all in line with relevant regulations;the established TLC method possessed strong specificity and could accurately identify C.yanhusuo.The average content of total anthraquinones in R.palmatum was 17.95 mg/tablet,and its content limit would not be less than 14.36 mg/tablet.The initial floating time of the preparation was no more than 10 s,and the holding time was more than 8 h.The release kinetics process accorded with the Retger-Peppas release model.CONCLUSIONS The method established in this study shows good reliability,stability and feasibility,and can effectively control the quality of Kuipingning gastric floating tablets.