3种治咳制剂中薄荷脑在健康志愿者口腔黏膜的吸收特性比较

Absorption Characteristics Comparison of Menthol from Three Different Cough Preparations in Healthy Volunteers Oral Mucosa

摘要:

目的: 考察治咳川贝枇杷滴丸(ZCPDP)及2种参比制剂中薄荷脑在健康志愿者口腔黏膜在体吸收特性的差异。方法: 采用GC测定薄荷脑含量,Agilent HP-1色谱柱(0.25 mm×30 m,0.25 μm),柱温110℃,进样口温度250℃,检测器温度250℃,载气氮气,流速0.80 mL·min^-1,进样量1 μL。通过自制口腔黏膜在体吸收循环装置,测定3种制剂中薄荷脑的口腔黏膜吸收量,评价不同制剂中薄荷脑在健康自愿者口腔黏膜的吸收特性。结果: ZCPDP中薄荷脑口腔黏膜吸收参数T₅₀及T_d分别为(4.734±0.406),(8.528±1.783) min,渗透系数(5.108±0.384) cm·min^-1,与2种参比制剂的吸收参数具有显著性差异。结论: 建立的含量测定方法稳定可靠,满足测定要求。3种制剂中薄荷脑口腔黏膜吸收速率不同,与不同剂型的释药特点有关,为止咳药物的临床合理应用提供参考。

Abstract:

Objective: To investigate in vivo absorption characteristics differences of menthol from Zhike Chuanbei Pipa dropping pills(ZCPDP) and two reference preparations in healthy volunteers oral mucosa. Method: The content of menthol was determined by GC,Agilent HP-1 column(0.25 mm×30 m,0.25 μm),column temperature 110℃,inlet temperature 250℃,detector temperature 250℃,with nitrogen as carrier gas,flow rate 0.80 mL·min^-1,injection volume 1 μL.Oral mucosal absorption amounts of menthol from three different preparations were determined by homemade oral mucosa in vivo absorption circulation equipment,and evaluated absorption characteristics of menthol from different preparations in healthy volunteers oral mucosa. Result: T_d,T₅₀ and permeability coefficient of ZCPDPwas (8.528±1.783),(4.734±0.406) min and (5.108±0.384) cm·min^-1,respectively;All of these parameters had significant differences from two kinds of reference preparations. Conclusion: This determination method was stable and feasible.Oral absorption rate of menthol was different in three preparations and it was related to release characteristics of different preparations,these results could provide a reference for clinical application of cough medicines.