Benson H A, McElnay J C, Harland R
Department of Pharmacy, Queen's University of Belfast, Northern Ireland, United Kingdom.
Phys Ther. 1989 Feb;69(2):113-8. doi: 10.1093/ptj/69.2.113.
The influence of ultrasound on the percutaneous absorption of benzydamine hydrochloride from a gel base was investigated in a double-blind, placebo-controlled clinical study of 10 healthy volunteers. Using two similar experimental protocols, the effect of both 1:1 (2 msec on, 2 msec off) pulsed-output ultrasound (3.0 MHz at 1.0 W/cm2 and 0.0 W/cm2 [control]) and continuous-output ultrasound at a range of frequencies (0.75, 1.5, and 3.0 MHz at 1.5 W/cm2) were investigated. A placebo control (benzydamine gel massaged with ultrasound applicator switched off) was incorporated into each protocol. Percutaneous absorption of benzydamine was assessed by measurement of the residual amount of drug in the formulation base after treatment. Drug assay was by reversed-phase high-performance liquid chromatography and ultraviolet detection. Statistical analysis of the results for both continuous and pulsed ultrasound treatment showed that no significant differences existed between data for ultrasound treatment versus no ultrasound. In conclusion, although phonophoresis has been alleged to enhance percutaneous absorption of numerous drugs, ultrasound did not enhance the percutaneous absorption of benzydamine under the experimental conditions of this study.
在一项针对10名健康志愿者的双盲、安慰剂对照临床研究中，研究了超声波对盐酸苄达明从凝胶基质中经皮吸收的影响。采用两种相似的实验方案，研究了1:1（开2毫秒，关2毫秒）脉冲输出超声波（3.0兆赫，1.0瓦/平方厘米，以及0.0瓦/平方厘米[对照]）和一系列频率（0.75、1.5和3.0兆赫，1.5瓦/平方厘米）的连续输出超声波的效果。每个方案都纳入了一个安慰剂对照（在关闭超声治疗仪的情况下用超声按摩苄达明凝胶）。通过测量治疗后制剂基质中药物的残留量来评估苄达明的经皮吸收情况。药物分析采用反相高效液相色谱法和紫外检测法。对连续和脉冲超声治疗结果的统计分析表明，超声治疗组和无超声组的数据之间不存在显著差异。总之，尽管声透疗法据称可增强多种药物的经皮吸收，但在本研究的实验条件下，超声波并未增强盐酸苄达明的经皮吸收。
