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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 a qualitative and quantitative method for Ningxinbao Capsule. Methods: The free ergosterols and nucleosides in the preparation were qualitatively identified by TLC. The uridine, guanosine and adenosine were quantified by HPLC. A Lichrospher C18 (250 mm×4.6 mm, 5 μm) column with a mobile phase of methanol-0.05 mol.L-1 potassium dihydrogen phosphate solution (8:92) was used. The flow rate was 1.0 mL.min-1 and the detection wavelength was 260 nm. RESULTS: The qualitative identification of free ergosterols and nucleosides was particularly strong. The linear ranges of uridine, guanosine, adenosine and nucleosides were 0.13～1.90μg (r=0.9999, n=5) and 0.09～1.30μg (r=0.9999, n=5) respectively. The average recovery (n=9) was 100.8%, 99.4%, and 100.9%, respectively. Conclusion: This method is qualitative and specific, accurate and reliable, the method is easy to operate and has high sensitivity. It can be used to control the quality of Ningxinbao capsules.