宁心宝胶囊定性定量方法研究

Study on qualitive and quantitative methods of Ningxinbao capsules

目的:建立宁心宝胶囊的定性定量方法。方法:采用TLC法对该制剂中的游离麦角甾醇类成分及核苷类成分分别进行定性鉴别;采用HPLC法对3种核苷类成分尿苷、鸟苷及腺苷进行定量分析,色谱柱为Lichrospher C18(250mm×4.6mm,5μm)柱,流动相为甲醇-0.05moL·L-1磷酸二氢钾溶液(8∶92),流速1.0mL.min-1,检测波长260nm。结果:游离麦角甾醇类及核苷类成分的TLC定性鉴别专属性强。HPLC法测定的尿苷、鸟苷、腺苷3种核苷类成分的线性范围分别为0.13～1.90μg(r=0.9999,n=5),0.09～1.30μg(r=0.9999,n=5),0.08～1.21μg(r=0.9999,n=5);平均回收率(n=9)分别为100.8%,99.4%,100.9%。结论:本方法定性专属性强,定量准确可靠,方法操作简便,灵敏度高,可用于控制宁心宝胶囊的质量。

Objective：To establish the quality and quantity methods of Ningxinbao capsules. Methods： Ergosterins and nucleosides in Ningxinbao capsules were identified by TLC. The contents of three nucleosides （uridine, guanosine, adenosine） in Ningxinbao capsules were determined simultaneously by HPLC. The chromatographic col- umn was Lichrospher Cts column（250 mm ×4. 6 mm ,5 μm） ;The mobile phase was methanol -0. 05 mol · L-1 po- tassium dihydrogen phosphate solution （8：92） at the flow rate of 1.0 mL ·min-1 , and the detecting wavelength was 260 nm. Results：The method of identifying ergosterins and nucleosides was specific. The calibration curves were linear in the ranges of 0. 13 - l. 90 μg（r =0. 9999,n =5） for uridine,0. 09 - 1.30 μg（r =0. 9999,n =5） for guanosine, and 0. 08 -1.21μg（r =0. 9999,n =5） for adenosine;The average recoveries（n =9） were 100. 8%, 99. 4% and 100. 9% respectively. Conclusion： The method is specific, effective, sensitive and accurate. It can be used for quality control of Ningxinbao capsules.