解郁安神凝胶贴膏剂的处方优选与质量评价

Optimization of prescription and quality evaluation of Jieyu Anshen Gel Plaster

目的优选解郁安神凝胶贴膏剂(JAGP)处方并对其进行质量评价。方法以黏力和感官评分为评价指标,采用正交试验设计法优化处方,对JAGP中的甲基丁香酚、榄香素、β-细辛醚、α-细辛醚含量进行测定,并采用改良的Franz扩散池法对其体外透皮性能进行评价。结果筛选出的空白凝胶贴膏剂最优处方为3%NP700、36%甘油、4%PVP K30及0.08%甘羟铝;所制备的凝胶贴膏含膏量为217.4 mg/cm2,凝胶贴膏剂中总指标有效成分为5.77 mg/贴;经皮给药24 h,甲基丁香酚、榄香素、β-细辛醚和α-细辛醚单位时间累积渗透量分别为(81.7986±14.8726)、(72.1102±17.7761)、(146.3906±33.7941)、(5.5226±1.2796)μg/cm2,甲基丁香酚、榄香素、β-细辛醚、α-细辛醚体外扩散均符合零级方程。结论制得的JAGP符合相关质量要求,具有良好的稳定性和释药性。

Objective To optimize the formulation of Jieyu Anshen Gel Plaster(JAGP)and evaluate its quality.Methods With the bonding strength and sensory evaluation scores as indicators,the formulation of JAGP was optimized by using orthogonal experiment design method.Then the content of methyl eugenol,elemicin,β-asarone andα-asarone in JAGP were determined by GC-MS and the in vitro transdermal properties were studied by modified Franz diffusion cells.Results The optimized blank matrix formulation was as following:NP700 of 3%,glycerol of 36%,PVP K30 of 4%and aluminium glycinate of 0.08%.The containing ointment of prepared gel plaster was 217.4 mg/cm2 and the effective component of the total index in gel paste was 5.77 mg/paste.Then the accumulated transdermal permeation of methyl eugenol,elemicin,β-asarone andα-asarone was(81.7986±14.8726),(72.1102±17.7761),(146.3906±33.7941),(5.5226±1.2796)μg/cm2,respectively within 24 h,which were all consistent with the zero-order equation.Conclusion The preparation of JAGP with good stability and drug-releasing properties conformed to the relevant quality requirement,And this study provides certain basis for the development of production.