雾化器及辅助储雾罐对热毒宁注射液雾化性能的影响  

Influence of nebulizers and add-on spacers on nebulization performances of Re-Du-Ning injection

作　　者：李超逸 杨飞飞[1] 刘春雨[1] 廖永红[1,2,3] LI Chao-yi;YANG Fei-fei;LIU Chun-yu;LIAO Yong-hong(Institute of Medicinal Plant Development(IMPLAD),Chinese Academy of Medical Sciences and Peking Union MedicalCollege,Beijing 100193,China;JiangsuKanionPharmaceuticalCo.,Ltd.,Lianyungang 222001,China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process,Lianyungang 222001,China)

机构地区：[1]中国医学科学院、北京协和医学院药用植物研究所,北京100193 [2]江苏康缘药业股份有限公司,江苏连云港222001 [3]中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《药学学报》2021年第10期2676-2681,共6页Acta Pharmaceutica Sinica

基　　金：国家自然科学基金资助项目(82173983);中药制药过程新技术国家重点实验室开放基金资助项目(SKL2020M0201).

摘　　要：本文旨在评价不同雾化器在加装储雾罐后对热毒宁注射液雾化性能的影响。雾化性能评价以绿原酸和栀子苷为指标成分,测定热毒宁注射液经空气压缩雾化器和振动筛孔雾化器雾化后液滴的实时粒径分布和空气动力学粒径分布(aerodynamic particle size distribution,APSD)、可吸入递送速率(respirable drug delivery rate,RDDR)和可吸入递送效率(percentage of respirable delivered dose,RDD%)、雾化残留及雾化时长等性能。递送效率即为递送总量与雾化的热毒宁注射液中药物含量之比,在成人呼吸模式下,空气压缩雾化器雾化热毒宁注射液的递送效率约为30%,3种振动筛孔雾化器的递送效率在24%~35%。加装储雾罐后的振动筛孔雾化器的递送效率可显著提高到37%~68%,而空气压缩雾化器则降低。当两类雾化器产生的气溶胶可吸入粒子分数(fine particle fraction,FPF)和质量平均空气动力学粒径(mass median aerodynamic diameter,MMAD)相当时,加装储雾罐后的振动筛孔雾化器的可吸入递送效率是空气压缩雾化器未加装储雾罐的2倍以上。加装储雾罐可提高热毒宁注射液经振动筛孔雾化器雾化的递送效率。The objective of the study was to investigate the effects of nebulizers and add-on spacers on nebulization performances of Re-Du-Ning injection.Chlorogenic acid and geniposide were taken as the chemical markers of the injection.In vitro nebulization performances including real-time particle size distribution,aerodynamic particle size distribution(APSD),respirable drug delivery rate(RDDR)and percentage of respirable delivered dose(RDD%),residual rate and nebulization time were determined after nebulization of Re-Du-Ning injection via jet or mesh nebulizers.The delivery efficiency was the ratio of delivery dose to the drug content of the injection.The aerosol delivery efficiency of Re-Du-Ning injection for the jet nebulizer was about 30%of the nominal dose whereas those for mesh nebulizers varied from 24%to 35%in adult breathing pattern.Upon the inclusion of spacers,the delivery efficiencies of mesh nebulizers increased to 37%-68%whereas the presence of a spacer decreased the delivery efficiency of the jet nebulizer.When the aerosols of mesh nebulizer exhibited comparative fine particle fraction(FPF)and mass median aerodynamic diameter(MMAD)to those of the jet nebulizer,the RDD%of the former nebulizer with a spacer was more than two folds of the latter.These results indicated that the addition of spacer was demonstrated to significantly improve the delivery efficiency of Re-Du-Ning injection by mesh nebulizers.

关 键 词：热毒宁注射液 雾化器 储雾罐 空气动力学粒径分布 递送效率 

分 类 号：R943[医药卫生—药剂学]