摘要
目的评价国内外已上市的不同生产厂家的吸入用布地奈德混悬液的雾化特性、理化特性及细胞转运、摄取情况。方法通过测定3个厂家吸入用布地奈德混悬液的递送速率、递送总量、空气动力学粒径分布、物理粒度、Calu-3细胞药物累积转运量等指标参数,对产品质量的共性进行评价。结果3种吸入用布地奈德混悬液在初始1 min的递送速率和空气动力学粒径指标差异无统计学意义(P>0.05);与A制剂相比,B制剂与C制剂在递送总量和可雾化剂量上差异有统计学意义B制剂与C制剂的递送总量分别为[(156.606±20.653)μg、(160.386±18.851)μg比(219.369±26.263)μg,P<0.05];可雾化剂量[(331.662±43.554)μg、(344.619±41.318)μg比(449.555±16.915)μg,P<0.05];B制剂的微粒粒子百分比与A制剂比较差异有统计学意义[(38.796±6.047)%比(32.319±1.773)%,P<0.05]。与A制剂相比,B制剂与C制剂的药物颗粒大小、物理粒径差异无统计学意义(P>0.05)。与A制剂相比,B与C制剂的药物细胞表观渗透系数(Papp)除低浓度的C制剂外,其他各组差异无统计学意义(P>0.05)。结论不同厂家生产的吸入用布地奈德混悬液各雾化特性检测指标符合雾化吸入药物的气溶胶颗粒的药学特性预期,在递送总量和可雾化剂量上存在一定内在差异;3种制剂总体表现出良好的体外雾化关键药学属性的共性特征。
Objective To evaluate the aerosol particles characteristics,physicochemical property,cell transport and uptake of budesonide suspension for inhalation from different productors in marketing.Methods By measuring the delivery rate,total delivery dosage,aerodynamic particle size distribution,physical particle size,Calu-3 cell drug cumulative transport volume and other index parameters were measured,and the generality of quality of products was evaluated.Results The 3 budesonide suspensions for inhalation had no significant difference in delivery rate and aerodynamic particle size at the initial 1 minute(P>0.05);compared with preparation A,there was a statistically significant difference between the doses of preparation B and preparation C.The total delivered amounts of preparation B and preparation C were[(156.606±20.653)μg,(160.386±18.851)μg to(219.369±26.263)μg,P<0.05];atomization dose[(331.662±43.554)μg,(344.619±41.318)μg compared with ratio(449.555±16.915)μg,P<0.05];the percentage of fine particles in preparation B was significantly different from that in preparation A[(38.796±6.047)% to(32.319±1.773)%,P<0.05].Compared with preparation A,there was no significant difference in drug particle size and physical particle size between preparation B and preparation C(P>0.05).Compared with preparation A,the apparent permeability coefficient(Papp)of drug cells between preparations B and C was not statistically significant(P>0.05),there was no statistically significant difference in other groups(P>0.05).Conclusion The detection indicators of the nebulization characteristics of budesonide suspensions for inhalation produced by different manufacturers are in line with the expected pharmaceutical properties of aerosol particles of nebulized inhalation drugs,and there are certain inherent differences in the total delivery volume and the nebulized dose;3 formulations overall show good common characteristics of key pharmaceutical properties of in vitro nebulization.
作者
王蕊
何文秀
沙先谊
WANG Rui;HE Wen-Xiu;SHA Xian-Yi(Department of Pharmacy,School of Pharmacy,Fudan University,Shanghai 201203,China)
出处
《中国药物经济学》
2021年第2期108-113,共6页
China Journal of Pharmaceutical Economics
关键词
吸入用布地奈德混悬液
雾化特性
理化特性
空气动力学粒径分布
Budesonide suspension for inhalation
Nebulization aerosol characteristic
Physicochemical property
Aerodynamic particle size distribution
