鼻用鲑降钙素粉雾剂与喷鼻剂的生物等效性试验  

Bioequivalence test of nasal salmon calcitonin powder spray and nasal spray

作　　者：张焱 葛庆华 张倩 李雪宁[3] 赵绪韬[4] 

机构地区：[1]中国医药工业研究总院,上海200040 [2]上海升正生物技术有限公司,上海201500 [3]复旦大学附属中山医院临床药理室,上海200032 [4]中国医药工业信息中心,上海200040

出　　处：《世界临床药物》2015年第4期251-255,268,共6页World Clinical Drug

摘　　要：目的研究鼻用鲑降钙素粉雾剂和喷鼻剂在健康受试者中的药动学及人体生物等效性。方法以鲑鱼降钙素喷鼻剂为参比制剂,在22例男性健康受试者进行鼻用鲑降钙素粉雾剂生物等效性试验。采用双周期自身交叉设计,清洗期为6 d,单次鼻腔给药,剂量为200 IU。应用酶联免疫吸附法(ELISA)测定血清鲑降钙素的浓度。结果 22例受试者单剂量使用200 IU受试剂及参比制剂后的平均Cmax分别为:(119.80±36.05)和(119.20±40.32)pg/ml;Tmax为:(8.40±2.80)和(8.90±2.60)min;T1/2为:(31.88±13.58)和(32.49±11.71)min;AUC0→t为:(2 204.0±585.30)和(2 392.0±836.0)pg/(ml·min)。自制鼻用鲑降钙素粉雾剂的平均相对生物利用度为:(97.72%±29.51%)。结论鼻用鲑降钙素粉雾剂和鲑降钙素喷鼻剂具有生物等效性。Objective To explore the pharmacokinetics and bioequivalence with nasal salmon calcitonin powder spray and nasal spray in healthy subjects. Methods The bioequivalence test in 22 healthy male subjects was performed with Miacalcic（salmon calcitonin nasal spray） as reference preparation and nasal salmon calcitonin powder as test preparation. A randomized crossover design, cleaning for a period of 6 days and the single nasal drug delivery at the dose of 200 IU were used. The determination of calcium in serum reduced concentration of salmon was used by Enzyme-Linked Immuno Sorbent Assay（ELISA）. Results In 22 subjects with single dose 200 IU of test nasal powder and reference nasal formulations, the average Cmax was respective（119.80±36.05） and（119.20±40.32）pg/ml; Tmax was（8.40±2.80） and（8.90±2.60） min; T1/2 was（31.88±13.58） and（32.49±11.71） min; AUC0→t was（2 204.0±585.30）and（2 392±836.0） pg/ml·min. The mean relative bioavailability of nasal salmon calcitonin powder mist agent was（97.72%±29.51%）. Conclusion The nasal salmon calcitonin powder spray and Miacalcic nasal spray are bioequivalent.

关 键 词：鲑降钙素 粉雾剂 喷鼻剂 酶联免疫吸附法(ELISA) 生物等效 

分 类 号：R943[医药卫生—药剂学] R98[医药卫生—药学]