CAJ | 학술논문

目的：建立玉涎胶囊的质量标准控制方法。方法采用TLC法对制剂中的浙贝母、党参、桔梗、甘草进行鉴别；采用ELSD-HPLC法测定制剂中贝母素甲和贝母素乙的含量，采用Agilent1260高效液相色谱仪，Agilent380蒸发光散射检测器检测，ZORBAX SB-C18色谱柱（5μm，4．6 mm ×25 cm）；流动相：乙腈-水-二乙胺（70∶30∶0．03），流速：1．0 g· L-1；柱温：30℃；漂移管温度90℃；进样量：20μL。结果用薄层色谱法能较好的鉴别制剂中浙贝母、党参、桔梗和甘草。用ELSD-HPLC法测定制剂中贝母素甲和贝母素乙的含量，贝母素甲、贝母素乙的线性范围分别是0．0185～0．185 g · L-1（ r＝0．9998），0．0188～0．188 g· L-1（r＝0．9997）。平均加样回收率为98．59％，RSD为1．27％（n＝6）。结论该法操作简便、结果准确，重现性好，可用于玉涎胶囊的质量控制。
목적：건립옥연효낭적질량표준공제방법。방법채용TLC법대제제중적절패모、당삼、길경、감초진행감별；채용ELSD-HPLC법측정제제중패모소갑화패모소을적함량，채용Agilent1260고효액상색보의，Agilent380증발광산사검측기검측，ZORBAX SB-C18색보주（5μm，4．6 mm ×25 cm）；류동상：을정-수-이을알（70∶30∶0．03），류속：1．0 g· L-1；주온：30℃；표이관온도90℃；진양량：20μL。결과용박층색보법능교호적감별제제중절패모、당삼、길경화감초。용ELSD-HPLC법측정제제중패모소갑화패모소을적함량，패모소갑、패모소을적선성범위분별시0．0185～0．185 g · L-1（ r＝0．9998），0．0188～0．188 g· L-1（r＝0．9997）。평균가양회수솔위98．59％，RSD위1．27％（n＝6）。결론해법조작간편、결과준학，중현성호，가용우옥연효낭적질량공제。
Objective To establish the quality standard of Yuxian Capsules .Methods Fritillariae thunbergii bulbus.,Codonopsis ra-dix,Platycodonis radix and Glycyrrhizae radix et rhizoma were identified by TLC .The contents of peimine and peiminine were deter-mined by ELSD-HPLC (Agilent380,Agilent1260).The optimal conditions of the separation and detection were achieved on a ZORBAX SB-C18 column with a mobile phase consisting of acetonitrile-water-diethylamine(70∶30∶0.03) at the flow-rate of 1.0 g· L-1 .The tem-perature for the detector drift tube was set at 90℃and the nitrogen flow-rate was at 2.2 L· min-1,20 μL as the injection volume.Re-sults TLC was effective for discrimination of Fritillariae thunbergii bulbus.,Codonopsis radix,Platycodonis radix and Glycyrrhizae ra-dix et rhizoma.The calibration curves for peimine and peiminine were linear over the range of 0.018 5 ~0.185 g· L-1(r=0.999 8) and 0.018 8~0.188 g· L-1(r=0.999 7),respectively.The average recovery was 98.59%,RSD=1.27%(n=6).Conclusions The method is simple ,accurate ,reproducible and suitable for the quality control of Yuxian Capsules .