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目的:用饱和磷脂制备了20(S)-原人参二醇药质体,并建立20(S)-原人参二醇氢化豆磷脂药质体中20(S)-原人参二醇含量及包封率的测定方法。方法:以氢化豆磷脂为膜材,采用薄膜超声法在65℃超声30 min制备了20(S)-原人参二醇的药质体。采用反相高效液相色谱法,色谱柱为COSMOSIL5 C18-MS-Ⅱ(250 mm×4.6 mm,5μm);流动相为甲醇-水(95∶5);流速为1.0 mL.min-1;检测波长为203 nm;柱温为25℃;进样量50μL。结果:药质体易于制备,稳定性好。在上述色谱条件下氢化豆磷脂和试剂对药物的测定无干扰,20(S)-原人参二醇在0.1~0.5 mg.mL-1范围内,PPD浓度与峰面积呈良好的线性关系,r=0.999 9,回收率在103.11%~104.78%之间,日内及日间RSD均小于2%(n=3)。结论:本方法操作简便,结果准确,重现性好,可用于药质体中20(S)-原人参二醇的含量及包封率测定。
OBJECTIVE: To prepare 20 (S) - protopanaxadiol protoplast from saturated phosphatide and to establish the content and package of 20 (S) - protopanaxadiol in 20 (S) - protopanaxadiol hydrogenated soya phospholipid. Determination of the rate of closure. Methods: The protoplast of 20 (S) - protopanaxadiol was prepared by using hydrogenated soya lecithin as membrane material and ultrasonicated at 65 ℃ for 30 min. The column was COSMOSIL5 C18-MS-Ⅱ (250 mm × 4.6 mm, 5 μm) using reversed-phase high performance liquid chromatography. The mobile phase consisted of methanol-water (95: 5) Wavelength of 203 nm; column temperature of 25 ℃; injection volume 50μL. Results: The drug body is easy to prepare and has good stability. Under the above chromatographic conditions hydrogenated soya lecithin and reagent did not interfere with the determination of the drug. The concentration of 20 (S) -protopanaxadiol in the range of 0.1-0.5 mg.mL-1 showed a good linear relationship between the concentration of PPD and the peak area. = 0.999 9. The recovery rates ranged from 103.11% to 104.78%. The intra-day and inter-day RSDs were less than 2% (n = 3). Conclusion: The method is simple, accurate and reproducible. It can be used to determine the content and entrapment efficiency of 20 (S) - protopanaxadiol in drug body.