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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 in vitro dissolution curve of domestic loratadine tablets by optical fiber drug dissolution real-time monitor FODT-601 to evaluate the quality of each manufacturer. Methods: The determination wavelength was 278 nm, the reference calibration wavelength was 550 nm, the temperature was 37 ℃, the rotational speed was 50 r · min -1, the data acquisition interval was 30 s, and the concentration of hydrochloric acid (9 → 1000) was 500 ml For the media, pulp method, with a 5 mm optical fiber probe probe loratadine tablets dissolution curve. Results: Loratadine tablets were in compliance with the national standards, but there was a difference in the dissolution process among different manufacturers. Differences in the dissolution process and dissolution homogeneity were observed even for products of different lot sizes from the same manufacturer. Conclusion: The optical fiber drug dissolution real-time monitor can accurately and continuously reflect the dissolution process of the drug. The data obtained are more complete and real. It can be used to evaluate the dissolution process difference of different manufacturers with different varieties and different batches of the same manufacturer.