小茴香挥发油贴剂体外释放和透皮性能的研究

Release and Transdermal Behavior of Fennel Oil Patch in vitro

本文主要对小茴香挥发油贴剂体外释放和透皮性能进行了研究。用高效液相色谱法(HPLC)测定小茴香挥发油在不同释放介质中的溶解度,选择30%聚乙二醇400-生理盐水作为满足漏槽条件的释放介质。按《中国药典》规定方法测定含不同稀释剂的小茴香挥发油贴剂体外释放量,24 h体外释放累积量依次为二乙二醇单乙基醚(Transcutol P)>己二酸二异丙酯>辛癸酸甘油酯>空白>肉豆蔻酸异丙酯,说明不同稀释剂对小茴香挥发油贴剂的释放影响较大。Transcutol P的释放效果最好,24 h体外释放百分含量为64.16%,其体外释放过程符合Higuchi方程,释放速率常数为1762.2μg/cm^2·h^2。因此,选择Transcutol P作为小茴香挥发油贴剂的稀释剂。用选定的稀释剂贴剂进行大鼠和小型猪腹部皮肤体外透皮性能的研究,体外透皮过程符合零级动力学方程,透皮速率分别为63.943μg/cm^2·h、6.134μg/cm^2·h,说明不同皮肤对体外透皮速率有影响。

The release and transdermal behavior of fennel oil patch in vitro was studied in this experiment. The fennel oil solubility in different release medium was measured by high performance liquid chromatography（ HPLC）,30%PEG400-saline was selected as the release medium which met sink conditions. The in vitro release of different dilutes fennel oil patch was studied according to the requirement of Chinese Pharmacopeia,the 24 h cumulative amount of release followed as the order of Transcutol P〉 Ceraphyl 230〉 O. D. O 〉Blank control〉 IPM. The results showed that different diluents on patch had a significant effect on release. Transcutol P was release best,in vitro release percentage content was 64. 16% in 24 h,the release mechanism coincided with the Higuchi equation,the release rate was1762. 2 μg / cm2·h2. Hence,Transcutol P was chosen as diluents. The selected diluent patch was used to study the transdermal behavior in vitro of the abdominal skin of rats and minipigs. The transdermal process coincided with zero-order kinetics equation,permeation rate was 63. 943μg / cm2·h and 6. 134μg/cm2·h,respectively. The result suggested that different skin have an effect on permeation rate.