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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,0.25μm),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1μL。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。
OBJECTIVE: To investigate the in vivo absorption characteristics of oral and oral mucosa in healthy volunteers with ZCPDP and two reference preparations of menthol. Methods: The content of menthol was determined by GC with Agilent HP-1 column (0.25 mm × 30 μm, 0.25 μm), column temperature 110 ℃, inlet temperature 250 ℃, detector temperature 250 ℃, carrier gas nitrogen, flow rate 0.80 mL · min-1, injection volume 1μL. The oral mucosal absorption capacity of menthol in three kinds of preparations was measured by self-made oral mucosal absorption and circulation device, and the absorption characteristics of menthol in oral mucosa of healthy volunteers in different preparations were evaluated. Results: The oral mucosal absorption parameters T50 and Td of ZCPDP were (4.734 ± 0.406) and (8.528 ± 1.783) min, respectively, and the osmotic coefficient (5.108 ± 0.384) cm · min-1, The parameters have significant differences. Conclusion: The established method for determination of content is stable and reliable, and meets the determination requirements. The absorption rate of menthol in oral mucosa of three kinds of preparations was different, which was related to the release characteristics of different dosage forms and provided a reference for the clinical rational application of cough medicine.