复方胃痛胶囊质量标准研究

目的：修订完善复方胃痛胶囊的质量标准。方法：修订原标准的显微鉴别和薄层鉴别；用高效液相色谱法对金果榄中的古伦宾和徐长卿中的丹皮酚进行含量测定。结果：显微鉴别增加了徐长卿、吴茱萸、拳参的显微特征；修订后的吴茱萸薄层色谱中斑点清晰，专属性强；含量测定中古伦宾在9．24～92．4μg·mL^-1范围内线性关系良好（r=0．9999），平均加样回收率96．3％（n=9），RSD为1．5％；丹皮酚在18．84～188．4μg·mL^-1范围内线性关系良好（r=0．9999），平均加样回收率100．8％（n=9），RSD为2．4％。结论：修订后的标准可有效控制复方胃痛胶囊的质量。

Study on Quality Standard for Fufang Weitong Capsules

Objective： To improve the quality standard for Fufang Weitong Capsules. Methods： Revising the micro-identification and TLC of the original standards. Determing the contents of columbin in Radix Tinosporae and paeonol in Radix Cynanehi Paniculati by HPLC. Results： The micro-characters of Radix Cynanchi Paniculati, Evodia rutaecarpa and Rhizoma Bistortae were added. The spots of Evodia rutaecarpa were clear and visible in TLC.. The calibration curves of columbin and paeonol were linear in the range of 9. 24- 92.4 μg·mL^-1 （r =0. 9999） and 18. 84-188.4 μg·mL^-1 （r =0. 9999） ,respectively. The average recoveries were 96. 3% with RSD 1.5% and 100. 8% with RSD 2.4% （n =9）. Conclusion： The revised standards can be used to control the quality of Fufang Weitong Capsules.