丹参酮Ⅱ_A微乳注射剂的制备及其质量评价  

Preparation and Quality Evaluation of TanshinoneⅡ_A Microemulsion for Parenteral Injection

作　　者：卢秀霞[1] 何琳[1] 邓细龙 许轶俊 龙晓英[2] 

机构地区：[1]广东药学院医药化工学院,广东中山528458 [2]广东药学院中药学院,广东中山528458

出　　处：《中药材》2014年第11期2070-2076,共7页Journal of Chinese Medicinal Materials

基　　金：国家自然科学基金资助(30973953C1909)

摘　　要：目的:研究丹参酮ⅡA微乳注射剂的处方与制备工艺,并对其进行质量评价。方法:通过单因素、配伍试验与伪三元相图法筛选并优化处方,考察制备工艺,并对乳滴形态、粒径、稳定性、溶血性进行评价。结果:筛选得到的丹参酮ⅡA微乳注射剂处方:MCT∶Solutol HS-15∶豆磷脂∶无水乙醇=9∶10∶5∶6(质量比),油相∶水相=1∶10,载药量1.0 mg/g。所得微乳橙红色、均一透明,粒径16.04 nm,动电位-11.57 m V,包封率98.53%。稳定性结果表明高温与光照影响丹参酮ⅡA在微乳注射剂中的含量,应低温避光保存,制剂无溶血现象。结论:丹参酮ⅡA微乳注射剂制备简单,符合注射剂主要指标要求,为开发丹参酮ⅡA新剂型提供依据。Objective： To study the prescription and preparation technology of tanshinoneⅡ Amicroemulsion for parenteral injection,and to evaluate its quality. Methods： The prescription was selected and optimized through single-factor test,compatibility experiment and the pseudo-ternary phase diagram method. The preparation technology was investigated,and the droplet morphous,particle diameter,zeta potential,stability and haemolyticus were evaluated. Results： The prescription composition of tanshinone ⅡAmicroemulsion was MCT： Solutol HS-15∶ fabaceous lecithin∶ absolute alcohol = 9∶ 10∶ 5∶ 6（ m / m）,oil phase∶ aqueous phase = 1∶ 10,with the drug-loaded of1. 0 mg / g. The acquired microemulsion exhibited salmon pink,uniform and transparent,with the average particle diameter of 16. 04 nm,Zeta potential of- 11. 57 m V,and the encapsulation efficiency of 98. 53%. The stability result showed that tanshinoneⅡ Acontent in microemulsion was influenced by high temperature and illumination,indicating tanshinone ⅡAmicroemulsion should to be stored at low temperature and protected from light. The preparation was without hemolytic crisis. Conclusion： The preparation of tanshinone ⅡAmicroemulsion is simple,corresponding to the main index of parenteral injection and offering the basis for new dosage form development of tanshinone ⅡA.

关 键 词：丹参酮ⅡA微乳 伪三元相图 粒径 包封率 

分 类 号：R283.6[医药卫生—中药学]