风湿颗粒的质量标准研究

Quality Standard for Fengshi Granules

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 for Fengshi granules. Methods ： Stephania tetradras. Moore, angelica, At- ractylodes lancea were identified by TLC. Tetrandrine was determinated by HPLC, and chromatographic conditions were^as follows： column of Agilent Hypersil Ct8 （ 4.0 mm x 200 mm, 5 p^m）, mobile phase consisting of acetonitrile-water-triethylamine （50： 50： 0. 05）, flow rate of 1 mL ~ min, and detection wavelength of 280 nm. Results ： The characteristic identification by TLC was distinct and highly specific. Baicalin showed a good linear relationship at a range of 21.08 - 63.24 p^g（ r = 0. 9995 ）, the average recovery was 98.54% （ RSD = 0.52% ）, precision with RSD of 1.55% （ n = 6）, repetition with RSD of 2.66% （ n = 6） and stability with RSD of 2.05 %. Conclusion：The metll,,d is reliable, accurate, specific and can be used for quality control of the production.