盐酸溴己新滴鼻剂的研制及含量测定与透皮性能评价
投稿时间:2018-07-06  修订日期:2019-01-26  点此下载全文
引用本文:金伟华,蒲志强,陈华,于波涛,罗钰洁.盐酸溴己新滴鼻剂的研制及含量测定与透皮性能评价[J].药学实践杂志,2019,37(2):166~169
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金伟华 西部战区总医院药剂科, 四川 成都 610083  
蒲志强 西部战区总医院药剂科, 四川 成都 610083  
陈华 西部战区总医院药剂科, 四川 成都 610083  
于波涛 西部战区总医院药剂科, 四川 成都 610083 yu-bo-tao@sohu.comn 
罗钰洁 西南医科大学药学系, 四川 泸州 646000  
基金项目:四川省卫生厅面上项目(16PJ027)
中文摘要:目的 研究盐酸溴己新滴鼻剂的制备工艺,采用HPLC法测定主药盐酸溴己新的含量并考察其体外透皮效果。方法 采用分散法制备盐酸溴己新滴鼻剂;流动相为甲醇-醋酸溶液(55:45),流速1.0 ml/min,检测波长为247 nm,柱温30℃;以KM小鼠为模型进行体外透皮试验。结果 盐酸溴己新滴鼻剂为混悬型液体制剂,在37.44~187.2 μg/ml范围内,盐酸溴己新线性关系良好,回归方程为Y=11.996X+124.6(r=0.999 9),低、中、高三种浓度的平均回收率分别为104.00%、101.59%、98.51%,RSD为0.89%、1.35%、0.35%(n=9);24 h体外透皮试验累积透过率为60.29%。结论 该制剂处方合理,工艺可行,含量测定方法准确可靠。
中文关键词:盐酸溴己新  滴鼻剂  高效液相色谱法  体外透皮试验
 
Preparation and assay of bromhexine hydrochloride nasal dropand its transdermal performance evaluation
Abstract:Objective To study the preparation process of bromhexine hydrochloride nasal drop,develop the assay method for the main component in the drop and evaluate its transdermal penetration in vitro. Methods The bromhexine hydrochloride was prepared with dispersion method. HPLC was used for the assay. The flow phase is methanol-acetic acid solution (55∶45). The flow rate was 1.0 ml/min. The detection wavelength was 247 nm. The column temperature was 30 ℃. The in vitro transdermal test was carried out on KM mice.Results Bromhexine hydrochloride nasal drop was a suspension preparation. Bromhexine hydrochloride presented good linearity in the range of 37.44-187.2 μg/ml with the regression equation Y=11.996X+124.6 (r=0.9999). The average recoveries of low,medium and high concentrations were 104.00%,101.59%,98.51% respectively with RSD of 0.89%,1.35%,0.35%(n=9). The cumulative penetration rate of bromhexine hydrochloride in 24 h was 60.29%.Conclusion This nasal drop formulation was acceptable. The preparation process was feasible and assay method was accurate and reliable.
keywords:bromhexine hydrochloride  nasal drop  HPLC  in vitro transdermal performance
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