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目的考察促透皮吸收剂对菌克软膏中盐酸林可霉素、醋酸地塞米松透皮吸收的影响,并筛选最佳透皮吸收剂及用量。方法采用Franz扩散池法,以离体裸鼠皮肤为透皮屏障,HPLC法测定盐酸林可霉素、醋酸地塞米松含量,计算累积透皮量。结果累积透皮量表明,促透皮吸收剂对盐酸林可霉素的促透皮吸收强弱顺序依次为3%氮酮>5%丙二醇>1%氮酮>5%油酸>5%氮酮>3%薄荷脑>0.6%氮酮>不加促透剂;对醋酸地塞米松的促透皮吸收强弱顺序依次为1%氮酮>5%油酸>5%丙二醇>3%氮酮>0.6%氮酮>3%薄荷脑>不加促透剂,而高剂量5%氮酮则有抑制作用。结论本试验中3%氮酮对盐酸林可霉素具有显著的促透皮吸收作用,对醋酸地塞米松的促透皮吸收作用也强于原处方中0.6%氮酮,结合前期试验结果3%氮酮对硝酸咪康唑有较显著的促透皮吸收作用,综合评价建议将原处方中氮酮的浓度提高为3%,以发挥菌克软膏的最大药效。
Objective To investigate the effect of transdermal absorbers on the transdermal absorption of lincomycin hydrochloride and dexamethasone acetate in Mycoplasma ointment and to screen the best transdermal absorbers and the dosage. Methods The Franz diffusion cell method was used to determine the transdermal barrier of nude mouse skin. The content of lincomycin hydrochloride and dexamethasone acetate was determined by HPLC, and the cumulative transdermal volume was calculated. Results The cumulative transdermal dose showed that the transdermal absorbability of the transdermal absorbers on lincomycin hydrochloride was in the order of 3% azone> 5% propylene glycol> 1% azone> 5% oleic acid> 5% nitrogen Ketones> 3% menthol> 0.6% azone> no permeabilizing agent; the order of promoting percutaneous absorption of dexamethasone acetate is 1% azone> 5% oleic acid> 5% propylene glycol> 3% nitrogen Ketones> 0.6% Azone> 3% Menthol> without permeabilizing agent, while high dose of 5% Azone had inhibitory effect. Conclusion In this study, 3% Azone had a significant transdermal absorption effect on lincomycin hydrochloride, and also had a stronger percutaneous absorption effect on dexamethasone acetate than 0.6% azone in the original formulation. The results of the previous study 3 % Azone on miconazole nitrate has a more significant role in promoting transdermal absorption, a comprehensive evaluation suggests that the concentration of azone in the original prescription increased to 3%, in order to play the maximum efficacy of mycoplasma cream.