Résumé
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 and α-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 and α-asarone was (81.798 6 ± 14.872 6), (72.110 2 ± 17.776 1), (146.390 6 ± 33.794 1), (5.522 6 ± 1.279 6) 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.