平哮颗粒质量标准

Quality Standards of Pingxiao Granules

摘要:

目的: 建立平哮颗粒的质量标准。方法: 采用TLC对平哮颗粒中麻黄、白芍、蛇床子进行定性鉴别;采用HPLC测定盐酸麻黄碱含量,色谱条件为Hedera ODS2色谱柱(4.6 mm×200 mm,5 μm),流动相乙腈-0.1%磷酸溶液(3:97),流速1.0 mL·min^-1,检测波长207 nm,柱温30℃。结果: 平哮颗粒中麻黄、白芍、蛇床子的薄层色谱斑点清晰,盐酸麻黄碱线性范围0.069 6~0.417 6 μg(r=0.999 0),加样回收率99.35%(RSD 1.84%),3批样品中盐酸麻黄碱质量分数量分别为0.202 2,0.209,0.207 2 mg·g^-1,暂拟定本品每1 g含盐酸麻黄碱不得少于0.17 mg。结论: 建立的方法操作简便、专属性强、灵敏度高、重复性好,可作为该颗粒的质量控制标准。

Abstract:

Objective: To establish quality standardS of Pingxiao granules. Method: Ephedrae Herba,Paeoniae Radix Alba and Cnidii Fructus in Pingxiao granules were identified by TLC;The content of ephedrine hydrochlorid was determined by RP-HPLC,chromatographic conditions were as follows:Hedera ODS2 column(4.6 mm×200 mm,5 μm),mobile phase of acetonitrile-0.1% phosphoric acid(3:97),flow rate of 1.0 mL·min^-1,detection wavelength 207 nm,column temperature at 30℃. Result: Spots of Ephedrae Herba,Paeoniae Radix Alba and Cnidii Fructus in Pingxiao granules on TLC could be well separated.Ephedrine hydrochlorid showed a good linear relationship at the range of 0.069 6-0.417 6 μg (r=0.999 0),the average recovery was 99.35% with RSD 1.84%,the contents of ephedrine hydrochlorid in three batches of Pingxiao granules were 0.202 2,0.209,0.207 2 mg·g^-1,respectively;Temporarily intended the content of ephedrine hydrochlorid should more than 0.17 mg per 1 g of this product. Conclusion: This established method was simple,specific,sensitive and reproducible,it was suitable for quality control of Pingxiao granules.