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作 者:颜冬梅[1] 屠凌岚[1] 李文钧[1] 彭小英[1] 沈正荣[1]
机构地区:[1]浙江省医学科学院,杭州310013
出 处:《药物分析杂志》2006年第5期680-682,共3页Chinese Journal of Pharmaceutical Analysis
摘 要:目的:观察不同粒度的赛特铂胶囊的体外溶出度。方法:采用高效液相色谱法,按照中国药典2005年版附录转篮法,测定2种不同粒度的赛特铂胶囊的体外溶出度。结果:小颗粒胶囊(d_v=2.04μm,d_(50)=1.04μm,d_(90)=4.89μm)的溶出速度及程度明显高于大颗粒胶囊(d_v=27.87μm,d_(50)=16.45μm,d_(90)=53.25μm)。测定转速为50r·min^(-1)时,30min 时胶囊Ⅰ的溶出为42%,胶囊Ⅱ的溶出仅18%;60min 时胶囊Ⅰ溶出83%,胶囊Ⅱ仅53%。半数溶出时间 T_(50)分别为35.82min 和42.79min。结论:药物粒度大小可影响药物的溶出速率,大颗粒赛特铂的溶出度小于小颗粒赛特铂的溶出度。Objective: To compare the dissolution of satraplatin capsules with different particle sizes in water. Methods:The dissolution study of satraplatin was analyzed by ZRS - 8G dissolution analyzer and Angilent 1100 high performance liquid phase chromatograph, following the standard ChP procedure. Results:Capsule satraplatin Ⅰ ,with smaller particles ( mean volume particle diameter dv = 2.04 μm, half particle diameter d50 = 1.04 μm, 90% particle diameter d90 = 4. 89 μm ), dissolved much faster than capsule satraplatin Ⅱ , with larger particles (dv =27. 87 μm,d50 = 16. 45 μm,d90 =53.25 μm). The dissolution at 30 min is 42% or 18% ,at 60 min 83% or 53% and the half time of dissolution 35.82 min or 42. 79 min for capsule satraplatin Ⅰ or capsule satraplatin Ⅱ, respectively. Conclusion:Particle size had a dramatic effect on the drug dissolution in vitro. The smaller particles dissolved more rapidly and more efficiently than the larger ones.
分 类 号:R917[医药卫生—药物分析学]
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