目的 制備兩親性聚合物β-環(huán)糊精-聚乙二醇-7-乙基-10-羥基喜樹堿（β-CD-PEG-SN38）納米膠束并進行質量評價。方法 采用自組裝法制備β-CD-PEG-SN38納米膠束，采用單因素變量法對影響納米膠束粒徑的因素進行了考察，并對β-CD-PEG-SN38納米膠束的粒徑、Zeta電位、形態(tài)和穩(wěn)定性進行評價。結果 膠束制備的最佳條件為丙酮作有機溶劑，β-CD-PEG-SN38在丙酮中的質量濃度為1 mg/mL，有機相和水相的體積比為1∶8。該納米膠束大小適中、粒徑分布均勻，為均勻的球形結構。β-CD-PEG-SN38納米膠束的臨界膠束質量濃度為7 μg/mL，在模擬的生理條件下具有良好的膠體穩(wěn)定性，在4℃條件下儲存6個月的粒徑未發(fā)生明顯變化。結論 β-CD-PEG-SN38在水中能自發(fā)形成納米膠束，粒徑均勻、穩(wěn)定性好，具有良好的膠體穩(wěn)定性和長期儲存穩(wěn)定性。

Objective To prepare β-cyclodextrin-polyethylene glycol-7-ethyl-10-hydroxycamptothecin nanomicelle and evaluate the quality. Methods β-CD-PEG-SN38 micelle was prepared in water with the self-assembly method. The single factor variable method was used to investigate the factors affecting the particle size of nanomicelles. The properties of β-CD-PEG-SN38 micelle were evaluated, including particle size, Zeta potential, appearance, and stability. Results The optimal conditions for preparation of β-CD-PEG-SN38 micelle were optimized. Acetone was used as the organic solvent, the concentration of β-CD-PEG-SN38 in acetone was 1 mg/mL, and the volume ratio of organic phase to aqueous phase was 1:8. The micelle displayed a moderate size, uniform particle size distribution, and a uniform spherical structure. The critical micelle concentration of β-CD-PEG-SN38 nanomicelles was 7 μg/mL, and it had good colloidal stability under simulated physiological conditions. The particle size of 6-month storage at 4℃ did not change significantly. Conclusion The particle size distribution ofβ-cyclodextrin-polyethylene glycol-7-ethyl-10-hydroxycamptothecin nanomicelle is uniform, and it has good colloidal stability and long-term storage stability.

R963

南昌市科技重大項目重大科技攻關項目（15）；江西中醫(yī)藥大學“1050青年人才工程”項目（5142001006）；江西中醫(yī)藥大學校級研究生創(chuàng)新專項資助項目（JZYC20S05）