摘要
目的:制备辅酶Q10亚微乳,并考察其稳定性及理化性质。方法:设计正交试验优选辅酶Q10亚微乳的处方及制备工艺并制备乳剂,以高效液相色谱法测定其含量及包封率,考察其粒径、ζ电位、pH值及稳定性等。结果:辅酶Q10亚微乳的最佳处方工艺为大豆油∶中碳链甘油三酸酯=1∶2,大豆磷脂∶泊洛沙姆188=3∶1,高速剪切乳化时间10min,制备温度60℃。所制备的乳剂包封率3批样品平均值为98.07%,ζ电位为—28.4mV,平均粒径为168nm。该制剂贮存时应避免光照和冻融,在4℃条件下稳定性较好。结论:所制备的辅酶Q10亚微乳满足静脉注射用制剂要求。
OBJECTIVE： To prepare coenzyme Q10 submicroemulsion and investigate its stability and physico- chemical properties. METHODS： Orthogonal experiment was designed to optimize the formulation and preparation procedure of coenzyme Q10 submicroemulsion. The content and entrapment efficiency of the preparation were determined by HPLC, and its properties such as particle size, ζ potential, pH value and stability were studied. RESULTS： The optimal formulation and preparation procedure of coenzyme Q10 submicroemulsion were as follows： the ratio of soybean oil to medium- chain triglyceride was 1 ： 2; the ratio of soybean phospholipids to poloxamer 188 was 3 ： 1; the high speed shearing emulsification time was 10min and the preparation temperature was 60℃. The mean entrapment efficiency of 3 batches of coenzyme 10 submi- croemulsions was 98.07%, with a t; potential of -28.4mV and a mean particle size of 168 nm. Illumination and freeze thawing should be avoided for the preparation in storing, which showed a satisfactory stability at 4℃. CONCLUSION： The prepared coenzyme Q10 submicroemulsion was up to the standards of intravenous injection preparations.
出处
《中国药房》
CAS
CSCD
北大核心
2007年第19期1476-1478,共3页
China Pharmacy
关键词
辅酶Q10
亚微乳
制备
理化性质
稳定性
Coenzyme Q10
Submicroemulsion
Preparation
Physico-chemical property
Stability
