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该试验旨在测定止痛凝胶膏剂中有效成分的含量,研究其体外透皮吸收特性。以阿魏酸和欧前胡素为指标,用甲醇提取止痛凝胶膏剂中有效成分,以HPLC同时测定2种成分的含量。采用改良的Franz扩散池法,以裸鼠腹皮为体外模型,选择合适的接收液,测定接收液和皮中阿魏酸和欧前胡素的含量。止痛凝胶膏剂中阿魏酸和欧前胡素的质量分数分别为455.10,371.66μg·g-1。以20%乙醇-磷酸盐缓冲液(pH=8)做接收液,止痛凝胶膏剂中阿魏酸和欧前胡素透皮速率分别为1.29,0.15μg·h-1·cm-2,24 h的累积透过量分别为30.03,3.31μg·cm-2,累积透过率分别为41.45%,5.60%,在皮中的滞留量分别为0.69,2.60μg·cm-2,滞留率分别为0.95%,4.40%。止痛凝胶膏剂中,阿魏酸的体外透皮行为接近零级过程,皮肤角质层是其主要限速因素;欧前胡素的体外透皮行为符合Higuchi方程,渗透过程受药物释放和皮肤的限制。
The purpose of this test is to determine the content of active ingredients in analgesic gel plasters and to investigate the transdermal absorption characteristics in vitro. Taking ferulic acid and imperatorin as the indexes, the active ingredients in analgesic gel ointment were extracted with methanol, and the content of the two components was determined simultaneously by HPLC. A modified Franz diffusion cell method was used to determine the content of ferulic acid and imperatorin in the fluid and the skin of the nude mouse by using the abdominal cavity of nude mice as an in vitro model and selecting the appropriate receiving solution. Analgesic gel ointment in the ferulic acid and imperatorin mass fraction were 455.10,371.66μg · g-1. With 20% ethanol-phosphate buffer (pH = 8) as the receiving solution, the permeation rates of ferulic acid and imperatorin in analgesic gel plasters were 1.29 and 0.15 μg · h-1 · cm-2, respectively h were 30.03,3.31μg · cm-2 respectively, the cumulative transmission rates were 41.45% and 5.60%, respectively. The retention in the skin were 0.69 and 2.60 μg · cm-2, respectively, and the retention rates were 0.95 %, 4.40%. Analgesic gel ointment, ferulic acid in vitro transdermal behavior near zero process, the skin of the stratum corneum is the main rate-limiting factor; Imperatorin in vitro transdermal behavior in line with Higuchi equation, the process of penetration by the drug release and the skin limit.