注射用伊维菌素亚微乳的制备及其稳定性研究

Studies on preparation and stability of ivermectin submicron emulsion for injection

关键词:  伊维菌素  亚微乳  稳定性  局部刺激性

Key words:  ivermectin  submicron emulsion  stability  irritation

摘要:

以大豆磷脂S75、注射用大豆油和Poloxamer 188为辅料，采用高压匀质法制备注射用伊维菌素亚微乳。粒度/Zeta电位测定仪测得其粒径、多分散系数和Zeta电位分别为（174.9±8.7）nm、0.174±0.021和（-30.9±1.06）mV；加速稳定性试验后其外观、pH、粒径、电位和药物含量等均符合要求；局部刺激性较普通注射液轻。结果表明注射用伊维菌素亚微乳制备工艺简单、稳定性好、刺激性小。

Abstract:

Ivermectin submicron emulsion for injection was prepared by high-pressure homogeneous technique and soybean phospholipids S75, soybean oil and Poloxamer 188 were added as excipients. The particle size, polydispersity index and zeta potential were measured by Particle Size/Zeta potential analyzer. The particle size, polydispersity index and zeta potential was (174.9±8.7) nm, 0.174±0.021, and (-30.9±1.06) mV, respectively. After accelerated stability test, the appearance, pH, particle size, zeta potential and drug content of ivermectin submicron emulsions for injection accorded with the injection standard. The local irritant of ivermectin submicron emulsion for injection was less than the ordinary one. The results showed that the preparation of ivermectin submicron emulsion for injection was simple, and it had good stability and small irritation.