口服多烯紫杉醇纳米粒的制备及载药量测定

Preparation and determination of drug loading of docetaxel nanoparticles in oral solution

目的制备口服多烯紫杉醇纳米粒溶液并用HPLC法测定其载药量。方法采用乳化溶剂挥发法制备口服多烯紫杉醇纳米粒溶液,建立HPLC法测定纳米粒药物的含量,进行方法学验证并计算其载药量。结果多烯紫杉醇质量浓度在0.20~3.40mg·mL^-1(r=0.9998)范围内线性关系良好,仪器精密度良好。平均回收率为98.98%,RSD值为3.20%(n=5)。平均载药量为3.84%,RSD值为2.27%。结论HPLC法可用于测定该纳米粒多烯紫杉醇的载药量。

Objective To prepare the docetaxel nanoparticles for oral solution and determine its drug loading by HPLC method.Methods Emulsion solvent evaporation method was used to prepare the docetaxel nanoparticles.HPLC,which was checked by method validation,was established to determine the content so as to calculate the drug loading.Results The linear relationship of docetaxel was good within 0.20-3.40 mg·mL^-1(r=0.999 8)concentration range.The precision of the instrument was good.The average recovery was 98.98%with RSD of 3.20%(n=5).The average drug loading was 3.84%with RSD of 2.27%.Conclusion HPLC can be used to determine the drug loading of docetaxel nanoparticles.