RESUMEN
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.
RESUMEN
Objective To prepare the reservoir patch of coumarins in Angelicae Dahuricae Radix and investigate its release and transdermal absorption characteristics in vitro. The efficient enhancers were chosen to improve the drug’s permeation rate. Methods The reservoir patch was prepared using hydroxypropyl methylcellulose (HPMC) as medium and ethylene vinyl acetate (EVA) membrane to control the release of drug. The Franz diffusion cells were used and HPLC was used to determine imperatorin content and permeation rate. The content of imperatorin was determined by HPMC. The effect of the gel consumption, the content of coumarins and penetration enhancer on the transdermal flux were investigated by selecting porcine skin as model. The release of the selected patch in vitro was investigated. Results 1% HPMC, 1% coumarins in Angelicae Dahuricae Radix, 1% Isopropyl Myristate (IPM) and 3% Azone were the best permeation of the patch. The permeation rate reached 0.713 μg/(cm2•h). The release mechanisms of the patch in vitro coincided with zero-order kinetic. Conclusion The reservoir patch of coumarins in Angelicae Dahuricae Radix had high transdermal rate and complete in vitro release. It was indicated that the patch could be expected to be an effective transdermal drug delivery system.