玫瑰活心胶囊的质量标准研究

The Study on the Quality Standard for Meigui Huoxin Capsule

目的建立玫瑰活心胶囊的质量标准。方法采用薄层色谱法对玫瑰花进行了定性鉴别,采用高效液相色谱法测定了胶囊中没食子酸的含量,采用Lichrospher C18柱(5μm,200mm×4.6mm);检测波长273;流动相:甲醇-水-磷酸(5:95:0.4);流速:1.0ml/min;柱温:30℃。结果此法线性范围8.51～272.4μg/ml,r=0.9997;没食子酸的平均回收率为101.12%(RSD=2.09%,n=5)。结论该方法稳定、可靠,可作为该制剂的质量控制方法。

Objective To develop a quality standard for Meigui Huoxin Scapsule. Methods TLC was used to identify the ingredient of Flos Rosae Rugosae. Meanwhile, the content of gallic acid in Meigui Huoxin capsule was determined by HPLC with Lichrospher C18 column（5 um,200 mm×4.6 mm）. The detection wavelength was 273 nm; methanol-water- H3PO4 solution（5：95：0.4） was used as mobile phase,the rate of 1.0ml/ minand the colum temperature was at 30℃. Results The method was linear with in the range of 8.51-272. 4？ g/ml（ r = 0. 9997 ）. The average recovery of gallic acid was 101.12% , （ RSD = 2. 09% , n = 5 ）. Conclusion The method is accurate, reliable, and can be used for quality control of the production.