基于近红外光响应性的盐酸阿霉素纳米脂质体的制备工艺优化
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篇名: 基于近红外光响应性的盐酸阿霉素纳米脂质体的制备工艺优化
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摘要: 目的:建立盐酸阿霉素纳米脂质体药物含量的测定方法,并优化其制备工艺。方法:采用紫外-可见分光光度法测定盐酸阿霉素纳米脂质体的药物含量;采用薄膜分散法制备盐酸阿霉素纳米脂质体。以粒径、包封率、载药量为指标,以磷脂与药物质量比(mg/mg)、磷脂与胆固醇质量比(mg/mg)、超声时间(min)为因素,采用星点设计-响应面法优化制备工艺;采用近红外光照射考察盐酸阿霉素纳米脂质体的光热转换效应。结果:盐酸阿霉素检测质量浓度的线性范围为1.01~16.16 μg/mL(r=0.999 7),精密度、稳定性、重复性均符合《中国药典》相关要求。最优制备工艺为磷脂与药物质量比13.30 ∶ 1(mg/mg)、磷脂与胆固醇质量比4.09 ∶ 1(mg/mg)、超声时间10 min。在此工艺条件下,所得的盐酸阿霉素纳米脂质体的粒径、载药量分别为(200.5±25.1)nm、(11.02±0.20)%,与预测值(196.3 nm、10.68%)的相对误差分别为1.82%、1.63%,实测值与预测值一致性良好。于808 nm近红外光照射下,盐酸阿霉素纳米脂质体具有浓度和时间依赖性的光热转换效应。结论:所建含量测定方法简便、准确度较好,优化所得工艺简单、可行。
ABSTRACT: OBJECTIVE: To establish a methaod for content determination of doxorubicin hydrochloride nano-liposomes, and to optimize its preparation technology. METHODS: The contents of doxorubicin hydrochloride nano-liposomes was determined by UV spectrophotometry. The membrane dispersion method was used to prepare doxorubicin hydrochloride nano-liposomes. Using particle size, encapsulation efficiency and drug-loading amount as indexes, the weight ratio of phospholipid to drug (mg/mg), the weight ratio of phospholipid to cholesterol (mg/mg) and ultrasonic time (min) as factors, central composite design-response surface methodology was used to optimize the preparation technology. The photothermal conversion effect of doxorubicin hydrochloride nano-liposomes was investigated by near infrared irradiation. RESULTS: The linear range of doxorubicin hydrochloride were 1.01-16.16 μg/mL(r=0.999 7); precision, stability and reproducibility tests were all in line with the requirments of Chinese Pharmacopoeia. The optimal preparation technology included that the weight ratio of phospholipid to drug was 13.30 ∶ 1(mg/mg); the weight ratio of phospholipid to cholesterol was 4.09 ∶ 1 (mg/mg); the ultrasonic time was 10 min. Under this technology, the particle size and drug-loading amount of doxorubicin hydrochloride nano-liposomes were (200.5±25.1) nm and (11.02±0.20)%, relative errors of which to predicted value (196.3 nm, 10.68%) were 1.82% and 1.63%. The consistency between measured value and predicted value was good. Doxorubicin hydrochloride nano-liposomes exhibited concentration- dependent and time-dependent photothermal conversion characteristics under near infrared irradiation at 808 nm. CONCLUSIONS: Established method is simple and good accuracy. The optimized preparation technology is simple and feasible.
期刊: 2019年第30卷第10期
作者: 祝侠丽,王莎莎,李玲华,巴妍妍,刘黎明,贾永艳
AUTHORS: ZHU Xiali,WANG Shasha,LI Linghua,BA Yanyan,LIU Liming,JIA Yongyan
关键字: 盐酸阿霉素;纳米脂质体;近红外光响应性;星点设计-响应面法;粒径;载药量
KEYWORDS: Doxorubicin hydrochloride; Nano-liposomes; Near-infrared light response; Central composite design-response surface methodology; Particle; Drug-loading amount
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