穿膜肽修饰紫杉醇和他莫昔芬脂质体中主药含量测定

Determination of Content of TAT Modified Paclitaxel Plus Tamoxifen Liposomes

目的:测定穿膜肽(TAT)修饰的紫杉醇和他莫昔芬脂质体中的主药含量。方法:采用薄膜分散法和硫酸铵梯度法制备穿膜肽修饰紫杉醇和他莫昔芬脂质体;通过高效液相色谱法测定脂质体中紫杉醇和他莫昔芬的含量。结果:TAT修饰的空白脂质体对主药含量的测定无干扰;TAT修饰的紫杉醇和他莫昔芬脂质体中紫杉醇和他莫昔芬分别在0.13~1.3μg和0.16~1.6μg范围内线性关系良好,回收率均在97%以上,RSD均小于1.0%,精密度的相对标准偏差均小于2.0%;脂质体中紫杉醇的平均含量为23.6μg/m L,他莫昔芬的平均含量为8.6μg/m L。结论:所建立的HPLC方法准确可靠、简便快速、重复性好,可用于TAT修饰紫杉醇和他莫昔芬脂质体的质量控制。

Objective To measure main component contents of TAT modified paclitaxel plus tamoxifen liposomes. Methods The TAT modified paelitaxel plus tamoxifen liposomes were prepared by a thin - film dispersion method followed by an ammonium sulfate gradient method. The contents of paclitaxel and tamoxifen in the liposomes were measured via a HPLC method. Results Under the es- tablished chromatographic condition, the TAT modified blank liposomes had no interference on the determination of drugs. The paelita- xel and tamoxifen were 0. 13 - 1.3 μg and 0. 16 - 1.6 μg in good linear ranges; recovery rates were over 97% , RSD of recovery rates were less than 1.0% , RSD of precision tests were less than 2. 0%. The average content of paclitaxel and tamoxifen in the TAT modi- fied paclitaxel plus tamoxifen liposomes were 23.6 μg/mL and 8.6 μg/mL, respectively. Conclusion The established HPLC method was simple, precise, replicable, and can be used for the quality control of TAT modified paclitaxel plus tamoxifen liposomes.