丹参酮冻干乳剂的制备及其稳定性

目的:比较丹参酮乳剂和丹参酮冻干乳剂的稳定性.方法:通过长期留样试验和影响因素试验,对丹参酮乳剂和丹参酮冻干乳剂的外观、丹参酮ⅡA的含量以及冻干乳剂的复溶情况进行了考察.结果:丹参酮乳剂在25℃长期留样试验和热循环试验中,系统稳定性明显降低；在4,25℃的长期留样试验和高温、强光试验中,丹参酮ⅡA含量均不同程度降低.丹参酮冻干乳剂在所有长期留样试验和影响因素试验中,均表现出良好的系统稳定性；在25℃的长期留样试验和高温、强光试验中,丹参酮ⅡA含量均不同程度降低,但降低程度明显低于同等条件下的丹参酮乳剂.结论:在提高乳剂系统和丹参酮ⅡA成分的稳定性2方面,丹参酮冻干乳剂均明显优于丹参酮乳剂.

Preparation and Stability of Tanshinone Freeze-dried Emulsion

Objective:Comparative study on stability of tanshinone emulsion and tanshinone freeze-dried emulsion.Method: Appearance of tanshinone emulsion and tanshinone freeze-dried emulsion and the content of tanshinone and reconstitution of freeze-dried emulsion were investigated by influential factors test and long-term sample test.Result: System stability of tanshinone emulsion had significantly reduced in 25 ℃ long-term sample test and thermal cycling test;The content of tanshinoneIIA was reduced to varying degrees in 4,25 ℃ long-term sample test and high temperature and light test.System stability of tanshinone freeze-dried emulsion showed good in long-term sample test and influential factors test;The content of tanshinoneIIA was reduced to varying degrees in 25 ℃ long-term sample test and high temperature and light test,but reduced degree was lower than that of tanshinone emulsion in tha same conditions.Conclusion: Tanshinone freeze-dried emulsion showed significantly better than tanshinone emulsion in improving stability of emulsion system and tanshinoneIIA.