灯盏花素微乳注射剂的制备

摘要

Objective To study the prescription and preparation technology of breviscapine microemulsion for parenteral injection,and to evaluate its quality.Methods The prescription was selected and optimized through single-factor test and the pseudo-ternary phase diagram method.The preparation technology was investigated,and the particle diameter,drug content,encapsulation efficiency and haemolyticus were evaluated.Results The prescription composition of breviscapine microemulsion was soybean oil:phospholipid:HS15:PEG400:water=1:0.1:0.55:0.55:6.64 (m/m),with the drug content of 4.01 mg·mL-1,the acquired breviscapine microemulsion exhibited light yellow,uniform and transparent,with average particle diameter of 92.1 nm and encapsulation efficiency of 96.8%.The compatibility test showed no drug precipitation and the preparation was no hemolytic crisis.Conclusion The preparation of breviscapine microemulsion injection is correspond to the main index of parenteral injection.%目的 探讨灯盏花素微乳注射液的处方及制备工艺,并进行质量评价.方法 通过单因素实验及伪三元相图法筛选并优化处方及制备工艺,并对其粒径、含量、包封率、溶血性及配伍稳定性进行评价.结果 筛选得到的灯盏花素微乳注射液处方为:大豆油:磷脂:聚乙二醇十二羟基硬脂酸酯(HS15):聚乙二醇400:水=1:0.1:0.55:0.55:6.64(质量比),药物含量为4.01 mg·mL-1,所得微乳为淡黄色澄清透明的液体,平均粒径92.1 nm,包封率96.8%.配伍实验显示无药物析出,制剂无溶血现象.结论 灯盏花素微乳注射液符合注射剂主要指标要求.