| 引用本文: | 汪鑫,范娅甜,晏菊姣,李苗,黄慧芬.基于吸入用布地奈德混悬液联合雾化配伍相容性的体外评估[J].中国现代应用药学,2025,42(8):39-46. |
| Wang Xin,Fan Yatian,YAN Jujiao,Li Miao,HUANG Huifen.Based on the in vitro evaluation of Compatibility of budesonide suspension for inhalation combined with nebulization[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(8):39-46. |
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| 摘要: |
| 目的：评估吸入用布地奈德混悬液与吸入用异丙托溴铵溶液、吸入用盐酸氨溴索溶液等药物联合雾化的体外配伍相容性。方法：采用高效液相色谱法结合呼吸模拟器与新一代撞击器(next generation impactor, NGI)研究联合雾化的递送速率与递送总量、空气动力学粒径分布(aerodynamic particle size distribution, APSD)，并考察其物理化学相容性。结果：吸入用布地奈德混悬液与不同吸入制剂联合雾化时，与单独雾化相比，递送速率和递送总量会发生不同程度改变。布地奈德的递送速率均会降低，除与异丙托溴铵以外的三种药物联合雾化的递送速率显著降低(大于15%)，但递送总量基本相同；此外，异丙托溴铵的递送速率减少33%，氨溴索的递送速率增加25%，氨溴索、特步他林和乙酰半胱氨酸的递送总量也显著增加，分别增加56%、48%、49%。微细粒子剂量(fine particle dose, FPD)、微细粒子分数(fine particle fraction, FPF)、质量中值空气动力学粒径(mass median aerodynamic diameter, MMAD)变化均小于10%；30分钟内混合药液的pH值、渗透压、活性成分含量均稳定。结论：本研究建立的评价方案可更全面地考察吸入溶液联合雾化的相容性，研究结果完善了吸入用布地奈德混悬液联合雾化配伍相容性数据，为临床合理地进行联合雾化用药提供数据支持。 |
| 关键词: 布地奈德 吸入溶液 联合雾化 相容性 空气动力学特性 |
| DOI： |
| 分类号:R284.1；R917.101 |
| 基金项目:国家药监局药物制剂质量研究与控制重点实验室开放课题 |
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| Based on the in vitro evaluation of Compatibility of budesonide suspension for inhalation combined with nebulization |
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Wang Xin, Fan Yatian, YAN Jujiao, Li Miao, HUANG Huifen
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Wuhan Institute for Drug and Medical Device Control
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| Abstract: |
| OBJECTIVE: To evaluate the in vitro compatibility of inhaled budesonide suspension combined with inhaled ipratropium bromide solution or inhaled ambroxol hydrochloride solution or others in combination with nebulization. METHODS: A high-performance liquid chromatography combined with a breath simulator and a new generation impactor (NGI) were used to study the delivery rate, total volume and aerodynamic particle size distribution (APSD) of the combined nebulization, and to investigate its physicochemical compatibility. RESULTS: When inhaled budesonide suspension is used in combination with four other inhaled drugs, such as ipratropium bromide, there are significant differences in the delivery rate and total drug substance delivered compared to nebulization alone. The delivery rate of budesonide was reduced in all cases, except for the combination of three drugs with ipratropium bromide, where the delivery rate was significantly reduced (> 15%), but the total delivery was essentially the same. In addition, the delivery rate of ipratropium bromide decreased by 33%, the delivery rate of ambroxol increased by 25%, and the total delivery of ambroxol, terbutaline, and acetylcysteine also significantly increased, by 56%, 48% and 49%, respectively. The fine particle dose (FPD), fine particle fraction (FPF), and mass median aerodynamic diameter (MMAD) changes are all less than 10%. The pH value, osmotic pressure, and active ingredient content of the mixed solution were stable within 30 minutes. CONCLUSION: The evaluation protocol established in this study can more comprehensively investigate the compatibility of inhaled solutions combined with nebulization. The research results improve the compatibility data of budesonide suspension for inhalation combined with nebulization, providing data support for clinical rational use of combined nebulization medication. |
| Key words: budesonide inhalation solutions simultaneous nebulization compatibility aerosol characteristics |
