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目的:建立风湿颗粒质量标准。方法:用TLC鉴别当归、防己和苍术,用HPLC测定粉防己碱含量,以依利柱C18(200 mm×4.6 mm,5μm,)柱为色谱柱,流动相为乙腈-水-三乙胺(50∶50∶0.05),流速为1.0 mL.min,检测波长280 mn。结果:定性鉴别分离度好、重现性好、专属性强;粉防己碱线性范围为21.08～63.24μg,r=0.9995,平均回收率为98.54%,RSD为0.52%,精密度RSD=1.55%(n=6),重复性RSD=2.66%(n=6)。结论:方法可靠、准确、专属性强,可用于该制剂的质量控制。
Objective: To establish the quality standard of rheumatism granules. Methods: Angelica, Rhizoma Dioscoreae and Rhizoma Corydalis were identified by TLC. Tetrandrine content was determined by HPLC. The column was C18 column (200 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile - water - triethylamine : 50:0.05) at a flow rate of 1.0 mL.min with a detection wavelength of 280 mn. Results The linearity of tetrandrine was 21.08 ~ 63.24μg with r = 0.9995, the average recovery was 98.54%, the RSD was 0.52% and the precision RSD was 1.55% (n = 6), repeatability RSD = 2.66% (n = 6). Conclusion: The method is reliable, accurate and specific and can be used for the quality control of the preparation.