摘要
目的:用光纤药物溶出度实时监测仪FODT-601实时监测国内氯雷他定片的体外溶出度曲线,评价各厂家的工艺质量。方法:测定波长为278 nm,基准校正波长为550 nm,温度为37℃,转速为50 r·min^(-1),数据采集间隔时间30 s,以盐酸溶液(9→1 000)500 ml为介质,浆法,用5 mm规格的光纤探头监测氯雷他定片的溶出曲线。结果:监测的氯雷他定片均符合国家标准规定,但各厂家品种的溶出过程存在差异,即使是同一厂家不同批号的产品,溶出过程和溶出的均一性也存在差异。结论:光纤药物溶出实时监测仪可准确连续反映药物的溶出过程,获得的数据更加完整、真实,可用于评价不同厂家同品种药品以及同一厂家不同批号产品的体外溶出过程差异。
Objective： To monitor the situ dissolution of loratadine tablets and to investigate the difference in qualities between the tablets by using fiber-optic dissolution tester FODT-601. Method： Each loratadine tablet was dissolved in 500 ml of hydrochloric acid solution （9→1 000） at 37 ℃ ,and the dissolution was monitored with 5 mm fiber optic probe. The paddle method was used at the rate of 50 r. min^-1 and signals were detected at 278 nm against the reference wavelength of 550 nm. Dissolution data were collected every 30 seconds. Result： The dissolutions of loratadine tablets produced by the different manufactors and different batches qualified to the national standards,but the significant difference was observed in their dissolution curves. Conclusion： The fiber-optic dissolution tester is capable of monitoring the real dissolution process of a drug and supplying more complete and accurate details of the dissolution process, and can be used to evaluate the quality of the same drug among different manufactories and among different batches in the same manufactor.
出处
《中国药师》
CAS
2010年第9期1289-1291,共3页
China Pharmacist
