风诃止咳颗粒的质量标准研究

Quality standard for Fenghe Zhike granules

目的建立风诃止咳颗粒质量标准。方法采用薄层色谱法对复方中诃子、栀子、山楂、甘草进行定性鉴别,采用高效液相色谱法测定制剂中防风药材升麻苷、升麻素、5-O-甲基维斯阿米醇苷、亥茅酚苷、花椒毒素含量,采用Kromasil 100-5C_(18)(250 mm×4.6 mm,5μm)柱;以水为流动相A,甲醇溶液为流动相B,梯度洗脱;检测波长为254 nm;流速为1.0 mL·min^(-1);进样量为10μL。结果薄层色谱斑点清晰且阴性样品无干扰,升麻苷、升麻素、5-O-甲基维斯阿米醇苷、亥茅酚苷、花椒毒素分别在0.1~2.0、0.016~0.32、0.07~1.4、0.018~0.36、0.002~0.04 mg·mL^(-1)与峰面积线性关系良好,平均回收率分别为95.3%~99.3%(RSD=2.2%)、96.2%~101.5%(RSD=2.0%)、95.4%~100.8%(RSD=1.3%)、95.6%~101.1%(RSD=2.7%)、97.3%~101.3%(RSD=2.7%)。结论所建立的方法准确、简便,可用于风诃止咳颗粒的质量控制。

Objective To establish the quality standard of Fenghe Zhike granules.Methords TLC was used to qualitatively identify the compound myrobalan,gardenia,hawthorn and liquorice respectively.HPLC method was used to determine the content of prim-O-glucosylcimifugin,cimicifugin,5-O-methylvisamminoside,hesperidin and zanthoxylin in Saposhnikovia divaricata.The determination was performed on Kromasil 100-5C_(18)(250 mm×4.6 mm,5μm)column with mobile phase consisting of water-methanol at the flow rate of 1.0 mL·min^(-1),the detection wavlength was 254 nm,and the sample size was 10μL.Results TLC spots were clear and well separated without negative interference.The linearity of prim-O-glucosylcimifugin,cimicifugin,5-O-methylvisamminoside,hesperidin and zanthoxylin was 0.1-2.0,0.016-0.32,0.07-1.4,0.018-0.36 and 0.002-0.04 mg·mL^(-1).The recoveries were 95.3%-99.3%(RSD=2.2%),96.2%-101.5%(RSD=2.0%),95.4-100.8%(RSD=1.3%),95.6%-101.1%(RSD=2.7%),and 97.3%-101.3%(RSD=2.7%)respectively.Conclusion method is simple and accurate,which can be used to control the quality of Fenghe Zhike granules.