去甲斑蝥素微乳的制备和质量评价

Preparation of Norcatharidin microemulsion and its quality evaiuatikm

目的 研究去甲斑蝥素微乳(NCID ME)的制备和质量评价方法。方法 通过滴定法绘制伪三元相图,根据相图优选处方,分别考察微乳制剂的稳定性、形态和对NCID的溶解性。用气相色谱法测定微乳中NCTD的含量。结果 NCTD ME稳定,透射电镜下呈圆球型,分布均匀。平均粒径45.1 nm,呈Gauss分布。NCTD在微乳中的溶解度为183.8 mg·ml-1。气相色谱测定回收率为99.54％,RSD=1.8％(n=5)。结论 微乳能显著提高NCTD溶解性,微乳制剂质量稳定,易于制备。检测方法可靠,重复性好。

OBJECTIVE To study the preparation of Norcatharidin - loaded microemulsion (NCTD ME) and its quality evaluation. METHODS NCTD ME was prepared by using the methods of titration to prepare the pseudotertiary phase diagram.The appearance,morphology,size distribution, stability of NCTD ME and solubility of NCTD in ME were tested. The contents of NCTD in ME was determined by GC method, RESULTS The stability of ME was good after 3 months storage. NCTD ME in electron microscopy were small spherical drops with a mean diameter of 44.5 nm.The solubility of NCTD in ME was 183.8 mg·ml-1.The methodological average recovery was 99.54% with RSD of 1.8%. CONCLUSION The solubility of NCTD was significant increased in ME and the stability of NCTD ME was good. The method to determine the contents of NCTD was accurate and reliable.