摘要
目的制备多西他赛纳米乳注射液,并对其质量进行控制。方法采用高压均质法制备多西他赛纳米乳注射液;在最佳处方的基础上,考察工艺因素对纳米乳剂的性质及稳定性的影响,并对其理化性质进行考察。结果多西他赛纳米乳注射液载药量为2 g.L-1,粒径为(46.7±35.0)nm,含量质量分数为96.69%;与质量分数为0.9%的氯化钠配伍后24 h内使用安全;在(4±2)℃条件下,稳定性良好。结论该处方及工艺可行,所制备的多西他赛纳米乳注射液质量稳定,使用方便,具有临床应用价值。
Objective To prepare and characterize docetaxel nanoemulsion injection and investigate its physic-chemical properties. Methods The docetaxel nanoemulsion was obtained though a high pressure homogenizer, and processing factors were studied based on the optimized formulation. The particle size, zeta potential and content of the docetaxel nanoemulsion were also examined. Results Docetaxel nanoemulsion injection drug loading was 2 g.L-1 ,particle size was （46.7 ± 35.0） nm,content of the docetaxel was 96.69%, and its compatibility with 0.9% of NaCl aqueous solution was favorable in 24 h;the stability was good under （4 ± 2） ℃. Conclusions The prescription and technology is feasible, the quality of docetaxel nanoemulsion injection is stable. The injection is easy to use, and possesses good clinical application values.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2013年第7期501-505,共5页
Journal of Shenyang Pharmaceutical University
