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目的:考察不同剂型,不同给药方式的金品肿痛系列药物体外经皮渗透特性,指导临床用药及市场销售。方法:采用改良Franz扩散池法,以雄性小鼠皮肤为屏障、30%乙醇生理盐水为接收液,收集各剂型及各给药方式不同时间点的接收液,采用高效液相色谱法测定,绘制累积透过曲线,对金品肿痛系列药物体外经皮渗透量、稳态透皮速率进行研究。结果:金品肿痛系列药物体外经皮渗透符合Higuchi方程。肿痛搽剂(涂搽给药)体外24 h累积透过量为57.3082μg/cm2;稳态透皮速率(J)为11.96μg/(cm2·h);肿痛气雾剂(喷射给药)体外24 h累积透过量为52.1414μg/cm2;稳态透皮速率(J)为7.444μg/(cm2·h);肿痛气雾剂(涂搽给药)体外24 h累积透过量为38.1809μg/cm2;稳态透皮速率(J)为9.737μg/(cm2·h)。结论:金品肿痛系列药物中搽剂为长效制剂,气雾剂为速释制剂,且喷射给药方式经皮渗透迅速。
Objective: To investigate the in vitro transdermal permeation characteristics of Jinpin Soreng Drugs of different dosage forms and administration modes to guide the clinical use of drugs and market sales. Methods: The modified Franz diffusion cell method was used to take the skin of male mice as the barrier and 30% ethanol normal saline as the receiving solution. The receiving solutions of different dosage forms and different time points were collected and determined by high performance liquid chromatography Accumulated through the curve, the series of drugs Jinyin swelling percutaneous penetration of drugs, steady-state transdermal rate of research. Results: Dermatitis series drugs in vitro transdermal penetration in line with Higuchi equation. The swelling transdermal rate (J) was 11.96μg / (cm2 · h). The swelling painkillers (spray-dosing) showed a cumulative transmission of 57.3082μg / cm2 in 24 h in vitro. The cumulative transdermal flux of 24 hours in vitro was 52.1414μg / cm2 and the steady-state transdermal rate (J) was 7.444μg / (cm2 · h) / cm2; steady-state transdermal rate (J) was 9.737μg / (cm2 · h). Conclusion: The drug of lingering pain in Jinpin Soreng series is a long-acting preparation, the aerosol is an immediate-release preparation, and the transdermal injection is rapid.