醋酸布舍瑞林缓释纳米粒灭菌粉末的处方工艺研究及质量评价  

Formulation Process and Quality Evaluation of Buserelin Acetate Sustained-release Nanoparticles Sterile Powder

作　　者：胡蕾[1] 刘松青[1] 戴青[1] 

机构地区：[1]第三军医大学西南医院药学部,重庆市400038

出　　处：《中国药房》2010年第41期3895-3897,共3页China Pharmacy

摘　　要：目的:优化醋酸布舍瑞林缓释纳米粒(BA-PLGA-NP)灭菌粉末的处方,并评价其质量。方法:先对影响处方工艺的因素进行单因素试验,再在此基础上以包封率为考察指标,投药量、PLGA浓度、内水相-油相的体积比、超声功率为主要考察因素进行正交试验筛选最佳处方;同时考察其在4℃及-20℃条件下放置3个月的稳定性。结果:最佳处方为投药量0.5mg·mL-1、PLGA2.0%、内水相-油相体积比1∶10、超声功率40W;所制制剂粒径呈单峰分布,平均粒径为127～132nm,Zeta电位为-64.8～-67.3mV,包封率为(63.37±0.29)%。制剂在考察期内各指标均无明显变化。结论:该优化处方质量稳定,可行性较强。OBJECTIVE：To optimize the formulation of Buserelin acetate sustained-release nanoparticles（BA-PLGA-NP） sterile powder and to evaluate its quality.METHODS：Single-factor experiment was used to confirm influencing factors of formulation technology.The formulation of BA-PLGA-NP sterile powder was optimized by orthogonal experiment with drug dosage,concentration of PLGA,volume ratio of water phase to oil phase and supersonic power as factors,and with encapsulation efficiency as index.The stability of BA-PLGA-NP sterile powder at 4 ℃ and-20 ℃ within 3 months was investigated.RESULTS：Optimized formulation of it was as follows：drug dosage 0.5 mg·mL^-1,PLGA 2.0%,volume ratio of water phase to oil phase 1：10,supersonic power 40 W.The particle size of preparation showed unimodal distribution with mean particle diameter of 127～132 nm.Zeta potential was-64.8～-67.3 mV and encapsulation efficiency was（63.37±0.29）%.No changes of parameters were found during the investigation period.CONCLUSION：The optimized formulation is stable in quality and feasible.

关 键 词：醋酸布舍瑞林 纳米粒 处方优化 稳定性 

分 类 号：R927[医药卫生—药学] R977.1