噻托溴铵粉吸入剂中有关物质及其特性评价与比较  

Evaluation and comparison of related substances and characteristics in tiotropium bromide powder for inhalation

作　　者：张秀磊 钱江辉 任筱青 沙先谊 

机构地区：[1]教育部与全军智能化递药重点实验室复旦大学药学院药剂学教研室,上海201203

出　　处：《中国临床药学杂志》2017年第1期31-35,共5页Chinese Journal of Clinical Pharmacy

摘　　要：目的评价与比较2个厂家生产的噻托溴铵粉吸入剂中有关物质及其特性。方法根据《欧洲药典》噻托溴铵标准,采用HPLC法测定噻托溴铵粉吸入剂中有关物质;根据2015版《中国药典》第4部吸入制剂微细粒子空气动力学特性测定法来测定雾滴(粒)分布;以光散射法测定颗粒粒径及其分布。结果 A、B厂家的噻托溴铵粉吸入剂中有关物质总量均<1%,但在厂家之间差异具有统计学意义(P<0.05);在微细颗粒剂量上两厂间差异未见统计学意义(P>0.05),但在微细颗粒剂量/每喷递送剂量上差异具有高度统计学意义(P<0.01)。B厂在非有效部位的药物沉积剂量显著高于A厂(P<0.01)。A厂的胶囊填充颗粒平均粒径显著小于B厂(P<0.05),批间差异较小。结论 2种噻托溴铵粉吸入剂中在有关物质、颗粒粒径及其分布上可能存在一定的区别。AIM To evaluate and compare related substances and its characteristics in tiotropium bromide powder for inhalation from different manufacturers. METHODS Related substances of tiotropium bromide powder for inhalation were determined by HPLC according to European Pharmacopoeia. The droplet （grain） distribution was determined by inhalation preparation fine particle aerodynamic characteristics measurement according to Chi- nese Pharmacopoeia （2015 edition）. The particle size and its distribution were determined by light scattering meth- od. RESULTS The total amount of related substances were both less than 1% from two manufacturers, but there were significant differences about total amount of related substances between two manufacturers （P 〈 0.05）. There were not clear differences on dose of fine particles between two manufacturers（P 〉 0.05 ） , but there were significant differences in dosage of fine particles/delivery dose per spray （P 〈 0.01 ） ; the non-effective parts drug deposition dose of B manufacturer was more than that of A manufacturer（P 〈 0.01 ）. The average size of B manufacturer was bigger than that of A manufacturer （P 〈 0.05） , and there was a big difference between different lot numbers from B manufacturer. CONCLUSION There were certain differences of quality in terms of related substances, particle size and its distribution.

关 键 词：噻托溴铵 高效液相色谱法 有关物质 雾滴(粒)分布 颗粒粒径及其分布 质量评价 

分 类 号：R927.1[医药卫生—药学]