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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。
Objective: To compare the stability of tanshinone emulsion and tanshinone freeze-dried emulsion. Methods: The appearance of tanshinone emulsion and tanshinone freeze-dried emulsion, the content of tanshinone IIA and the reconstitution of freeze-dried emulsion were investigated by long-term retention test and influencing factor test. Results: The stability of tanshinone emulsion was significantly decreased at 25 ℃ for long-term retention test and thermal cycling test. The content of tanshinone IIA decreased to different extents in 4,25 ℃ long-term retention test and high temperature and high light test. Tanshinone freeze-dried emulsion showed good systemic stability in all long-term sample retention tests and influencing factors test. The content of tanshinone IIA decreased in varying degrees in long-term retention test and high temperature and high light test at 25 ℃ Decreased significantly lower than the same conditions tanshinone emulsion. CONCLUSIONS: Tanshinone freeze-dried emulsions were significantly better than tanshinone emulsions in improving the stability of the emulsion system and tanshinone IIA components.