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目的:建立苏氏接骨胶囊中骨碎补和菟丝子的质量控制方法。方法:采用微乳薄层色谱法,以十二烷基硫酸钠-正丁醇-正庚烷-水组成的微乳体系为展开剂,聚酰胺薄膜为吸附剂,分离鉴定苏氏接骨胶囊中的骨碎补和菟丝子;应用高效液相色谱法测定柚皮苷的含量,色谱柱为Thermo C18柱(250mm×4.6mm,5μm);流动相为乙腈-水(21∶79);流速为1.0mL.min-1;柱温25℃;检测波长283nm;进样量20μL。结果:骨碎补的鉴别以含水量75%微乳液-甲酸(9∶1)为最佳展开剂,菟丝子的鉴别以含水量80%微乳液-甲酸(9∶1)为最佳展开剂;柚皮苷在64.8～162mg.L-1范围内呈良好的线性关系(r=0.999 7),平均回收率为99.69%,RSD为1.17%。结论:微乳薄层色谱联合高效液相色谱法可以简便、准确、高效地控制苏氏接骨胶囊中骨碎补和菟丝子的质量。
Objective: To establish the quality control method of Suxujiegu Capsule in Osteoporosis and Dodder. METHODS: The microemulsion system consisting of sodium dodecyl sulfate-n-butanol-n-heptane-water was used as developing solvent and the polyamide membrane was used as adsorbent. Micro-emulsion thin-layer chromatography (250mm × 4.6mm, 5μm). The mobile phase consisted of acetonitrile-water (21:79), the flow rate was 1.0, and the content of naringin was determined by high performance liquid chromatography. mL.min-1; column temperature 25 ℃; detection wavelength 283nm; injection volume 20μL. Results: The best nodular agent was identified as 75% microemulsion-formic acid (9:1) with the best water content of 80% and the best solvent was 9:1. Naringin had a good linearity (r = 0.999 7) in the range of 64.8 ~ 162 mg.L-1 with an average recovery of 99.69% and a RSD of 1.17%. Conclusion: The micro-emulsion thin-layer chromatography combined with high-performance liquid chromatography can be easily, accurately and efficiently control the quality of DRB and Dodder.