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目的:建立氯雷他定二元醇质体包封率的测定方法。方法:采用凝胶微柱离心法分离游离药物与二元醇质体,以HPLC测定氯雷他定的药物含量,计算二元醇质体的包封率。结果:氯雷他定浓度在10.2~102.0μg·ml-1内线性关系良好(r=0.999 5)。3批次氯雷他定二元醇质体的包封率分别为86.75%,87.26%,86.00%。结论:该方法简便、迅速,可准确测定氯雷他定二元醇质体的包封率。
Objective: To establish a method for determination of entrapment efficiency of loratadine dihydric alcohol. Methods: Free drug and dihydric alcohol were separated by gel micro-column centrifugation. The drug content of loratadine was determined by HPLC, and the entrapment efficiency of dihydric alcohol was calculated. Results: The linearity of loratadine was 10.2 ~ 102.0 μg · ml-1 (r = 0.999 5). The entrapment efficiencies of three batches of loratadine dihydric alcohol were 86.75%, 87.26% and 86.00%, respectively. Conclusion: This method is simple and rapid and can accurately determine the entrapment efficiency of loratadine dihydric alcohol.