| 刘芸雅,刘哲鹏,王俊,等.艾塞那肽聚乳酸-羟基乙酸共聚物纳米粒的制备及其分析方法研究[J].安徽医药,2022,26(9):1729-1734. |
| 艾塞那肽聚乳酸-羟基乙酸共聚物纳米粒的制备及其分析方法研究 |
| Preparation and analysis of exenatide PLGA nanoparticles |
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| DOI：10.3969/j.issn.1009-6469.2022.09.008 |
| 中文关键词: 降血糖药 胰高血糖素样肽-1受体 工艺学，制药 艾塞那肽 纳米粒 Box-Behnken Design响应面分析 |
| 英文关键词: Hypoglycemic agents Glucagon-like peptide-1 receptor Technology, pharmaceutical Exenatide Nanoparticles Box-Behnken design response surface methodology Chromatography, high pressure liquid Method validation |
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| 中文摘要: |
| 目的以聚乳酸-羟基乙酸共聚物(PLGA)为载体，用乳化复乳法制备包载艾塞那肽(EX)的PLGA纳米粒(EX-PLGANPs)，并对其分析方法进行研究。方法2018年10月至2019年8月，采用Box-Behnken Design(BBD)响应面分析法对纳米粒制备的处方工艺进行优化，动态光散射技术检测EX-PLGA NPs粒径和Zeta电位；通过高效液相色谱法(HPLC)测定EX-PLGANPs中艾塞那肽含量并进行方法学验证。结果制备的EX-PLGA NPs粒径为(157.2±3.1)nm，Zeta电位为(119.5±2.6)mV；载药量和包封率分别为(4.41±0.28)%和(73.43±0.59)%，透射电镜图显示纳米粒外观圆整，分布均匀；EX-PLGA NPs体外稳定性良好，透析袋法释放结果显示其具有缓释效果。结论制备的EX-PLGA NPs粒径分布均一，包封率和载药量高，稳定性好，艾塞那肽含量分析方法科学有效，为艾塞那肽抗糖尿病口服缓释制剂的分析和开发提供了实验基础。 |
| 英文摘要: |
| Objective Exenatide (EX)-encapsulated poly (lactic-co-glycolic acid) (PLGA) nanoparticles (EX-PLGA NPs) were prepared by emulsification and the double emulsion method with PLGA as a carrier, and the analysis method was studied.Methods From October 2018 to August 2019, the Box-Behnken Design (BBD) response surface analysis method was used to optimize the nanoparticle preparation, and dynamic light scattering technology was used to detect the particle size and zeta potential of EX-PLGA NPs. The content of exenatide in EX-PLGA NPs was determined by high-performance liquid chromatography (HPLC), and the methodology was validated.Results The particle size of the prepared EX-PLGA NPs was (157.2±3.1) nm, the zeta potential was (119.5±2.6) mV, and the drug loading and encapsulation efficiency were (4.41±0.28)% and (73.43±0.59)%, respectively. The transmission electron microscope image showed that nanoparticles were round in appearance and evenly distributed. EX-PLGA NPs have good stability in vitro, and the release results of the dialysis bag method show that they had a sustained release effect.Conclusion The prepared EX-PLGA NPs have a uniform particle size distribution, high encapsulation efficiency and drug loading, and good stability, and the method for analyzing the content of exenatide is scientific and effective, which provides an experimental basis for the analysis and development of exenatide antidiabetic oral sustained-release preparations. |
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