复方维生素E乳膏制备工艺改进

Process Improvement of Preparation of the Compound Vitamin E Cream

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)。

To enhance the storage stability of hydrocortisone butyrate（1） in the compound vitamin E cream, the formulation composition was improved. The storage stability and transdermal behaviors of the products before and after improvement were compared. Three batches of the improved product and one batch of the original product were stored under the accelerated conditions [（30±2）℃, relative humidity of（65±5）%] for 6 months and the long-term conditions [（25±2）℃, relative humidity of（60±10）%] for 12 months, respectively. The results showed that the content of 1 in the original product was significantly decreased but not remarkably changed in the improved product, which indicated that the storage stability of 1 was enhanced. The transdermal penetration of 1 and vitamin E, two active ingredients, from the products before and after improvement were investigated with mouse skin as the barriers. The results showed that the cumulative penetration amount at 18 h and the steady penetration rate of the improved product were also significantly higher than those of the original product（P0.05）.