目的 制定寒濕痹顆粒的質(zhì)量控制方法。方法 采用TLC法對處方中麻黃、白芍、甘草、黃芪進(jìn)行了定性鑒別。采用反相高效液相色譜法測定寒濕痹顆粒中芍藥苷，Diamonsil C18色譜柱（150 mm×4.6 mm，5 μm），以乙腈–0.1%磷酸溶液（14∶86）為流動相，檢測波長為230 nm。結(jié)果 TLC鑒別方法專屬性強(qiáng)，分離效果良好。芍藥苷在0.202 7～4.054 0 μg線性關(guān)系良好（r=0.999 8），平均回收率為96.2%，RSD為1.9%（n=6）。結(jié)論 本方法靈敏、簡便、準(zhǔn)確，重現(xiàn)性好，可作為寒濕痹顆粒的質(zhì)量控制方法。

Objective To establish the quality standard of Hanshibi Granula. Methods The TLC method was used for the qualitative identification of Ephedrae Herba, Paeoniae Alba Radix, Glycyrrhizae Radix et Rhizoma, and Astragali Radix in the formula. The contents of paeoniflorin in Hanshibi Granula were determined by RP-HPLC method with Diamonsil C18 (150 mm×4.6 mm, 5 μm). The mobile phase was acetonitrile-0.1% phosphoric acid (14∶86). The detection wavelength was 230 nm. Results The identification study showed strong specificity. The calibration curves were linear in the range of 0.202 7—4.054 0 μg (r=0.999 8) for paeoniflorin. The average recovery rate was 96.2% with RSD 1.9% (n＝6). Conclusion The method is sensitive, simple, and accurate, and has the specificity and good reproducibility. It could be used in the quality control of Hanshibi Granula.

國家藥典委員會2010版中國藥典一部標(biāo)準(zhǔn)研究課題