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目的:评价改装滚轮微针用于曲安奈德经皮给药的力度可控性、释药重现性和皮肤刺激性。方法:改装市售滚轮微针;石蜡切片、HE染色法观察不同微针使用力度(2.5,5.0,7.5,10.0,12.5,15.0,17.5,20.0N)时的皮肤微孔深度,探讨改装前后其力度可控性;以离体裸鼠皮肤为屏障,Franz扩散池法考察改装前后曲安奈德经皮渗透特性;评分法测定皮肤刺激性。结果:皮肤微孔深度随微针使用力度的增加而加大,微孔深度范围由65.28~106.25μm收窄为改装后的71.53~97.92μm,其RSD范围由10.45%~19.69%显著下降至改装后的2.33%~9.21%。在相同微针使用力度下,曲安奈德的累积释药量RSD范围由改装前的34.75%~55.92%,显著下降至改装后的14.29%~29.73%。改装滚轮微针用药1 h时出现轻度皮肤刺激性,之后消失。结论:与市售滚轮微针相比,改装滚轮微针具有较好的力度可控性、释药重现性,以及较小的皮肤刺激性。
OBJECTIVE: To evaluate the strength controllability, drug release reproducibility and skin irritation of triamcinolone acetonide transdermally modified roller microneedles. Methods: The microneedle of modified roller was modified; paraffin section and HE staining were used to observe the micropore depth of the skin when using different microneedles (2.5,5.0,7.5,10.0,12.5,15.0,17.5,20.0N) Strength and controllability. Taking the skin of nude mice as the barrier, the Franz diffusion cell method was used to investigate the transdermal permeation characteristics of triamcinolone acetonide before and after modification. The scoring method was used to determine the skin irritation. Results: The depth of skin microcosm increased with the increase of microneedle usage. The depth of micropore narrowed down from 65.28 ~ 106.25μm to 71.53 ~ 97.92μm, and the range of RSD decreased significantly from 10.45% to 19.69% After 2.33% ~ 9.21%. Under the same microneedle application, the cumulative RSD of triamcinolone acetonide decreased significantly from 34.75% to 55.92% before modification to 14.29% to 29.73% after modification. Modification roller microneedle 1 h mild skin irritation, then disappear. Conclusion: Compared with the commercially available roller microneedle, modified roller microneedle has better strength controllability, drug release reproducibility, and less skin irritation.