盐酸溴己新滴鼻剂的研制及含量测定与透皮性能评价
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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37.44～187.2μg/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。
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.
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.
引文
[1] 中华医学会呼吸病学分会《雾化吸入疗法在呼吸疾病中的应用专家共识》制定专家组. 雾化吸入疗法在呼吸疾病中的应用专家共识[J]. 中华医学杂志,2016,96(34):2696-2708.
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[5] 周密,徐晓勇,马凤森,等.雷公藤涂膜剂的制备及其体外透皮试验[J].中成药,2015,37(3):526-529.
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[2] 金伟华,陈华,于波涛,等. 盐酸溴己新栓剂的制备及含量测定[J].解放军药学学报,2017,12(30):542-544.
[3] 于波涛,范开华,金伟华,等.氮酮用量对马尼地平乳膏离体透皮吸收影响的研究[J].西南国防医药,2011,21(3):250-252.
[4] 宋玉华,杜光焰, 隋广志,等.不同浓度的氮酮对鼻宁滴鼻剂透皮吸收的影响[J].解放军药学学报,1999,15(5):53-54,封三.
[5] 周密,徐晓勇,马凤森,等.雷公藤涂膜剂的制备及其体外透皮试验[J].中成药,2015,37(3):526-529.
[6] 国家药典委员会.中华人民共和国药典(四部)2015年版[S]. 北京:中国医药科技出版社,2015:9-10.
[7] 王烽,方东伟,谢展鹏. 高效液相色谱法测定盐酸溴己新片的含量[J].中国药业,2007,16(19):19.