米诺地尔和非那雄胺复方制剂在治疗雄性激素性脱发中的药效学评价

Pharmacodynamic evaluation of the compound preparation of Minoxidil and Finasteride in the treatment of androgenetic alopecia

目的旨在开发一种米诺地尔和非那雄胺溶液的外用复方制剂,用于治疗雄性激素性脱发,以提高药物疗效并减少不良反应。方法研究通过体外渗透实验筛选出合适的处方,并建立雄性激素性脱发的动物模型来进行处方评价。结果处方筛选的结果显示5%(w)的米诺地尔、0.25%(w)的非那雄胺、22.32%(w)丙二醇、13.37%(w)的1,3-丁二醇、2.20%(w)的氮酮的处方,米诺地尔和非那雄胺24h的累计渗透率最高。动物实验表明,与其他治疗组相比,复方制剂组的小鼠毛发生长有所改善,毛发直径和长度明显增加。此外,稳定性数据表示此制剂至少在180天内是安全和稳定的。结论该复方制剂能有效改善雄性激素性脱发小鼠的毛发生长,具有较好的临床应用潜力和产品开发价值。

Objective The aim of this study was to develop a combination formulation of minoxidil and finasteride solution for topical administration of androgenetic alopecia to improve drug efficacy and to reduce adverse effects.Methods In this study,ethanol,propylene glycol,1,3-butanediol,nitrogen ketone and ultrapure water were used as solvents.Suitable prescriptions were screened by in vitro permeation assay and an animal model of androgenetic alopecia was established to evaluate the prescriptions.Results The results of prescription screening showed that the 24-hour cumulative penetration rates of minoxidil and finasteride reached the maximum values,with 39.17%and 24.73%,respectively,when minoxidil was 5%,finasteride was 0.25%,propylene glycol was 22.32%,1,3-butanediol was 13.37%,and azone was 2.20%.Compared to other treatment groups,the improvement on hair growth was observed with a significant increase in hair diameter and length in the mice in the compounded formulation group.In addition,the safety and stability of the formulation were evaluated for at least 180 days.Conclusion The results of this study indicate that the compound formulation of minoxidil and finasteride solution is effective in improving hair growth in mice with androgenetic alopecia,and it is promising to introduce this formulation to clinical application and product development.