辛伐他汀吸入粉雾剂的制备与质量评价  

Preparation and quality evaluation of Simvastatin Dry Powder Inhalation

作　　者：易蕾[1] 徐宁路[1] 

机构地区：[1]武汉科技大学附属天佑医院,武汉430064

出　　处：《西北药学杂志》2017年第3期345-349,共5页Northwest Pharmaceutical Journal

摘　　要：目的制备辛伐他汀吸入粉雾剂,并进行质量评价。方法采用冷冻干燥法制备辛伐他汀微粉,将微粉与乳糖载体混合制备吸入粉雾剂,并通过正交实验优化处方,测定其粒径、密度、含水量、排空率和有效沉积率。结果辛伐他汀微粉与乳糖Inhalac~70按照1∶1比例混匀制成的吸入粉雾剂,平均粒径在10μm以下,堆密度和振实密度分别为0.192±0.012和0.285±0.013g·mL^(-1),含水量为2.36%±0.22%,排空率为97.8%,有效沉积率为32.7%。结论按照选定的处方和制备方法制得的吸入粉雾剂流动性好、排空率合格、有效部位药物沉积量高,符合吸入粉雾剂要求。Objective To prepare Simvastatin Dry Powder Inhalation,and to evaluated its quality.Methods Simvastatin micro powder was prepared by freeze drying method,and the dry powder inhalation was prepared by mixing simvastatin micro powder with lactose which was used as a carrier.An orthogonal design was used to optimize the prescription.The grain size,density,moisture content,emptying rate and valid deposition rate were measured.Results Simvastatin Dry Powder Inhalation was prepared by mixing simvastatin micro powder with lactose Inhalac70in a ratio of 1∶1.The mean grain size was under 10μm,the bulk density and compaction density were 0.192±0.012 and 0.285±0.013g·mL-1respectively.The moisture content was 2.36%±0.22%,the emptying rate was 97.8% and the valid deposition rate was 32.7%.Conclusion The Simvastatin Dry Powder Inhalation was qualified in flowing nature,the emitted dose and fine particles fraction were conformed to the standard of dry power inhalation.

关 键 词：辛伐他汀吸入粉雾剂 排空率 有效沉积率 

分 类 号：R94[医药卫生—药剂学]