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目的:建立康乐鼻炎胶囊的质量标准。方法:采用TLC法对制剂中的白芷、麻黄、穿心莲、牡丹皮进行定性鉴别,采用HPLC法对制剂中的黄芩苷,马来酸氯苯那敏进行含量测定。结果:TLC法可检出白芷、麻黄、穿心莲、牡丹皮,黄芩苷在0.048 8~1.220 0μg范围内线性关系良好,相关系数为r=0.999 9,平均回收率为100.91%,RSD=1.24%,马来酸氯苯那敏在0.016 5~0.412 0μg范围内线性关系良好,相关系数为r=0.999 6,平均回收率为98.95%,RSD=1.61%。结论:本法简便,快速,重复性好,可作为本品的质量控制指标。
Objective: To establish the quality standard of Kangle Capsule. Methods: The qualitative identification of Radix Paeoniae Alba, Ephedra, Andrographis paniculata and Cortex Moutan were made by TLC. The contents of Baicalin and Chlorphenamine Maleate were determined by HPLC. RESULTS: The TLC method could detect white peony, ephedra, Andrographis paniculata, peony bark, and the baicalin had good linearity in the range of 0.048 8~1.220 0μg. The correlation coefficient was r=0.999 9, the average recovery was 100.91%, and the RSD was 1.24%. Chlorphenamine maleate had good linearity in the range of 0.016 5 to 0.412 0 μg. The correlation coefficient was r=0.999 6, the average recovery was 98.95%, and RSD was 1.61%. Conclusion: This method is simple, rapid, and reproducible. It can be used as the quality control index of this product.