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为增加复方维生素E乳膏中丁酸氢化可的松(1)的贮存稳定性,对原处方组成进行改进,并对比工艺改进前后制品的贮存稳定性和透皮行为。3批改进工艺产品和1批原工艺产品分别在加速试验[(30±2)℃、相对湿度(65±5)%]和长期试验[(25±2)℃、相对湿度(60±10)%]条件下放置6和12个月。结果表明,原工艺产品中1的含量显著下降,而改进工艺产品中1的含量无明显下降,提示其稳定性提高。以小鼠皮肤为屏障的透皮试验结果表明,改进工艺产品中2种主成分(1和维生素E)的18 h累积透过量和稳态渗透速率均显著高于原工艺产品(P<0.05)。
In order to increase the storage stability of hydrocortisone butyrate (1) in compound vitamin E cream, the composition of the original prescription was improved, and the storage stability and transdermal behavior of the products before and after the process improvement were compared. Three batches of improved products and one batch of raw products were tested under accelerated test [(30 ± 2) ℃, relative humidity (65 ± 5)%] and long term test [(25 ± 2) ℃, relative humidity (60 ± 10) %] Conditions for 6 and 12 months. The results showed that the content of 1 in the original process product decreased significantly, while the content of 1 in the improved process product did not decrease obviously, suggesting that its stability improved. The transdermal test with mouse skin as a barrier showed that the 18 h cumulative permeation and steady-state permeation rates of the two main components (1 and vitamin E) in the improved product were significantly higher than those of the original product (P <0.05) .