微柱离心法测定紫杉醇脂肪乳的包封率

发布时间：2018-06-14 13:27

本文选题：紫杉醇 + 脂肪乳　；参考：《药物分析杂志》2017年11期

【摘要】：目的:建立一种微柱离心方法测定紫杉醇脂肪乳包封率。方法:采用Sephadex G-50微柱,分别以适量体积的水及乙醇为洗脱液分离脂肪乳中的包封药物和游离药物。通过考察洗脱过程中紫杉醇及脂肪乳中油相成分大豆油的含量(紫杉醇的含量测定采用HPLC法,大豆油的含量测定采用HPLC-ELSD法),并以外加法制备的包封不完全的紫杉醇脂肪乳的洗脱曲线确立包封药物和游离药物的分界点,确定了最终的洗脱方式及洗脱液用量:以1 m L水,共洗3次将脂肪乳中包封药物完全洗脱,以3 m L乙醇,共洗2次将脂肪中游离药物完全洗脱。并以方法的回收率和重复性,对方法进行了验证。最终以建立的方法测定了3批紫杉醇脂肪乳样品的包封率。结果:微柱离心法能有效实现紫杉醇脂肪乳中包封药物和游离药物的分离。方法的回收率为100.4%,RSD为0.60%(n=9);重复性为99.4%,RSD为0.58%(n=5)。3批样品的包封率分别为99.2%、99.3%、99.5%。结论:该法操作简便,回收率高,重复性好,能区分不同包封情况的紫杉醇脂肪乳,测定结果准确可靠。
[Abstract]:Objective: to establish a microcolumn centrifugation method for the determination of encapsulation efficiency of paclitaxel fat emulsion. Methods: Sephadex G-50 microcolumn was used to separate encapsulated drugs and free drugs in fat emulsion with proper volume of water and ethanol as eluant. The contents of taxol and soybean oil in fat emulsion were determined by HPLC, and the content of paclitaxel was determined by HPLC. The content of soybean oil was determined by HPLC-ELSD method, and the elution curve of incomplete paclitaxel fat emulsion prepared by the external method was used to determine the demarcation point between the encapsulation drug and the free drug, and the final elution method and the amount of elution solution were determined: 1 mL water. The encapsulated drugs in fat milk were completely eluted 3 times by co-washing, then completely eluted by 3 mL ethanol and 2 times by washing free drugs in fat. The method was verified by the recovery and repeatability of the method. Finally, the entrapment efficiency of three batches of paclitaxel fat emulsion was determined by the established method. Results: microcolumn centrifugation can effectively separate encapsulated and free drugs from paclitaxel fat emulsion. The recovery of the method was 100.40.The RSD was 0.60 and the repeatability was 99.4. The entrapment efficiency of 0.58%(n=5).3 was 99.2 and 99.3, respectively. Conclusion: the method is simple, high recovery, good reproducibility, and can distinguish paclitaxel fat emulsion with different encapsulation conditions. The determination result is accurate and reliable.
【作者单位】：中国医学科学院北京协和医学院药物研究所药物传输技术及新型制剂重点实验室;
【分类号】：R927.2

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