丁姜和胃膏贴剂体外透皮释药研究

张伟，曹嘉，王慧，曹云飞，王玮*

(1. 青岛市海慈医疗集团，山东 青岛 266033；2. 山东中医药大学，山东 济南 250355)

丁姜和胃膏贴剂体外透皮释药研究

张伟1，曹嘉1，王慧1，曹云飞2，王玮1*

(1. 青岛市海慈医疗集团，山东 青岛 266033；2. 山东中医药大学，山东 济南 250355)

采用体外透皮扩散池法，以离体大鼠腹部皮肤为屏障，对丁姜和胃膏贴剂透皮释药液中的丁香酚含量测定方法和不同时间段单位面积透皮累积释药量进行实验研究。结果表明，采用Agilent Zorbax SB-C18(150 mm×4.6 mm，5μm)色谱柱，甲醇-水(65∶35，V/V)为流动相，检测波长280 nm的色谱条件，丁香酚含量测定的重复性相对标准偏差为0.932%，24 h内样品溶液稳定性相对标准偏差为1.843%，平均加样回收率为97.419 2%，相对标准偏差为1.426%。透皮释药呈现一种先快后慢趋势，10 h以内累积释药总量占20 h内累积释药总量的76.71%,10～20 h内累积释药总量仅占23.29%。

丁姜和胃膏贴剂；体外透皮扩散池法；离体大鼠皮肤屏障；丁香酚含量测定；单位面积累积渗透量

Abstract∶The in vitro transdermal diffusion cell method was applied, the abdominal skin of rats in vitro was taken as the barrier, and the content determination of eugenol in transdermal solution of Dingjiang Hewei plaster and the cumulative release amount of transdermal drug per unit area in different time periods were researched. Experimental results showed the chromatographic conditions were as followed: Agilent Zorbax SB-C18column (150 mm×4.6 mm, 5 μm), methanol-water(65∶35,V/V) as mobile phase, detection wavelength was 280 nm, the RSD of the repeatability of eugenol content was 0.932%, the RSD of sample solution stability within 24 h was 1.843%, the average recovery was 97.4192%，and its RSD was 1.426%. Eugenol transdermal drug release showed a trend of first fast, then slow. The total cumulative drug release within the first 10 h accounted for 76.71% of the total cumulative drug release within 20 h, while the accumulative release total amount within 10～20 h was only 23.29%.

Key words∶Dingjiang Hewei plaster; in vitro transdermal diffusion cell method；isolated rat skin as barrier；the content determination of eugenol；cumulative transdermal amount per unit area

丁姜和胃贴膏为青岛市中医医院外用中药制剂，具有疏通经络、扶正祛邪、降逆止呕、行气安胎之功效[1-2]，丁香酚作为丁香的主要活性成分[3-4]，是该贴膏剂中主要生物活性成分之一。本实验以丁香酚为指标，进行丁姜和胃膏贴剂离体透皮释药液中的丁香酚成分含量测定方法以及膏贴剂的离体透皮药效学研究，为临床合理选择用药方法提供参考依据。

1 仪器与材料

RYJ-6B型药物透皮扩散实验仪(上海黄海药检仪器有限公司)；Agilent1100型高效液相色谱仪(美国安捷伦公司)；HHW-4 型双显恒温水浴锅( 金坛市双捷实验仪器厂)。……