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目的建立新型的中空纤维离心超滤法分离脂质体中游离药物,并结合HPLC法用于注射用两性霉素B脂质体的包封率的表征。方法采用新型中空纤维微量离心超滤(HF-CF-UF)装置,在离心力的作用下,利用中空纤维超滤膜分离游离药物和包封药物。色谱条件:色谱柱为Diamonsil C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-20 mmol·L-1乙二胺四乙酸二钠(体积比38∶62),流速为1.0 mL·min-1,检测波长为405 nm,柱温为30℃。结果两性霉素B质量浓度在0.670~21.4 mg·L-1内与峰面积呈良好的线性关系(r=0.999 7),回收率均在97%以上,RSD不大于2%。结论中空纤维离心超滤装置基本保持了脂质体处方的原始的、稳定的存在环境(物理化学环境),最大限度地减少了脂质体的泄露,结果准确且简便快速,为脂质体包封率的表征提供了一种新方法。
OBJECTIVE To establish a novel hollow fiber centrifugal ultrafiltration method for the separation of free drug in liposomes and to characterize the entrapment efficiency of amphotericin B liposomes for injection by HPLC. Methods A new type of hollow fiber ultrafiltration (HF-CF-UF) device was used to separate free drugs and encapsulate drugs under the action of centrifugal force. Chromatographic conditions: a Diamonsil C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-20 mmol·L -1 disodium ethylenediaminetetraacetate (38:62 by volume) at a flow rate of 1.0 mL · min-1, the detection wavelength was 405 nm, the column temperature was 30 ℃. Results The amphotericin B had a good linear relationship with the peak area in the range of 0.670-21.4 mg · L-1 (r = 0.999 7). The recoveries of amphotericin B were above 97% and the RSD was no more than 2%. Conclusion The hollow fiber centrifugal ultrafiltration device basically maintains the original and stable environment (physicochemical environment) of the liposomal prescription, minimizes the leakage of the liposomes, and the result is accurate and simple and rapid. Characterization of the seal rate provides a new method.