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目的考察改装滚轮微针在人增生性瘢痕皮肤中对醋酸曲安奈德的促透作用。方法采用亚甲蓝和H-E染色法观察不同针长的微针刺入人增生性瘢痕皮肤的形态;建立高效液相色谱法测定醋酸曲安奈德含量;采用洗脱法、匀浆法分别考察给药1、12h时增生性瘢痕皮肤醋酸曲安奈德在体吸收特性;采用经皮水分流失(TEWL)测量法、激光多普勒血流量法考察其皮肤刺激性。结果所优选的针长500μm滚轮微针能有效穿透角质层,形成的微孔分布相对均匀;微针处理1、12h后,分别有27.42%、60.64%药物吸收进入皮肤。给药12h,皮内注射醋酸曲安奈德皮肤中滞留药量较给药1h下降至45.98%,而微针、直接涂布醋酸曲安奈德乳膏分别增加到2.73、4.18倍,微针组皮肤中滞留药量是直接涂布乳膏组的3.56倍(P<0.05)。皮内注射12h皮肤药量分布并不均匀,均值为(4.83±5.51)μg,微针组均值为(0.93±0.14)μg,分布相对均匀。TEWL法显示微针处理与皮内注射的皮肤刺激性差异无统计学意义,但激光多普勒血流量法显示皮内注射的皮肤刺激性是微针处理的8.40倍。结论改装滚轮微针处理后涂布醋酸曲安奈德乳膏较皮内注射醋酸曲安奈德在人增生性瘢痕中吸收均匀、皮肤刺激性较小,但其瘢痕治疗效果尚有待进一步验证。
Objective To investigate the effect of modified roller microneedles on the permeation of triamcinolone acetonide in human hypertrophic scar skin. Methods Methylene blue and HE staining were used to observe the morphological changes of human skin hypertrophic scars. The contents of triamcinolone acetonide acetate were determined by HPLC. The contents of triamcinolone acetonide acetate were determined by elution and homogenization The skin absorption characteristics of triamcinolone acetonide in hypertrophic scar skin were observed at 1 and 12 h after drug administration. The skin irritation was evaluated by TEWL and laser Doppler flowmetry. Results The microneedle needle with 500μm needles was able to penetrate the stratum corneum effectively and the distribution of micropores was relatively uniform. After microneedle treatment for 1 and 12 hours, 27.42% and 60.64% of drugs were absorbed into the skin respectively. Administration 12h, the intradermal injection of triamcinolone acetonide skin retention drug dose dropped to 45.98% 1h, while the microneedles, direct coating of triamcinolone acetate cream increased to 2.73,4.18 times the skin of the microneedle group The drug retention was 3.56-fold higher in the direct-coated cream group (P <0.05). The intradermal injection of 12h skin dose distribution is not uniform, mean (4.83 ± 5.51) μg, microneedle group mean (0.93 ± 0.14) μg, the distribution is relatively uniform. The TEWL method showed no significant difference in skin irritation between microneedle and intradermal injection. However, laser Doppler flowmetry showed that the skin irritation of intradermal injection was 8.40 times that of microneedle. Conclusion Triamcinolone acetate triamcinolone acetonide cream coated with microneedle modified roller is more uniform than human dermal triamcinolone acetonide in skin hypertrophic scars, but the skin irritation is smaller. However, its therapeutic effect on scar needs to be further verified.