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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。
Objective To evaluate and compare the related substances and their characteristics in tiotropium bromide powder inhalers produced by 2 factories. Methods According to the “European Pharmacopoeia” tiotropium standard, the determination of tiotropium bromide powder inhalation by HPLC related substances; according to 2015 edition of “Chinese Pharmacopoeia” Part 4 aerosol inhalation microspheres Determination of aerodynamic properties to determine the fog Droplet (particle) distribution; Determination of particle size and distribution by light scattering. Results The total amount of related substances in tiotropium bromide powder inhalers of manufacturers A and B were all less than 1%, but there was a statistically significant difference between manufacturers (P <0.05). There was no difference in the dosage of fine granules between the two plants (P> 0.05). However, the difference was statistically significant (P <0.01) in the fine particle dose / spray delivery dose. Plant B in non-effective parts of the drug deposition dose was significantly higher than the A plant (P <0.01). The average particle size of capsule-filled granules in factory A was significantly smaller than that in factory B (P <0.05), with no significant difference between batches. Conclusions There may be some differences between the two tiotropium bromide inhalers in the related substances, particle size and distribution.