摘要
目的:设计治疗眼部表面细菌感染的妥布霉素和倍他米松混悬型滴眼液的处方和制备工艺,建立制剂质量控制及含量测定的方法。方法:将倍他米松与PVP制成固体分散体后加缓冲液制备成混悬液,对其粒度、稳定性进行考察。采用HPLC法测定含量。结果:制剂的粒度小,粒径分布范围窄,再分散性好,放置两年后稳定性好,无大于10 μm的粒子形成,无凝集现象发生。建立的分析方法能排除辅料的干扰,准确测定含量。结论:复方妥布霉素滴眼液制备工艺简单,贮藏稳定性好。
OBJECTIVE The prescription and preparation of tobramycin and betamethasone suspension eye drops were designed and studied. The method of qaulity control and the assay of the content were established . METHODS Betamethasone was made into solide dispersion with PVP. The particle size and stability were studied,and the content was determined by HPLC. RESULTS The preparation was homogeneous with small particles which were all smaller than 10μm after stored for two years. The assay was precises and specific without the disturbation of the additive and degration products. CONCLUSIONS The preparation of the tobramycin and betamethasone suspension eye-drops was simple. The product is stable.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2003年第11期673-675,共3页
Chinese Journal of Hospital Pharmacy
关键词
妥布霉素
倍他米松
固体分散法
混悬液
tobramycin
betamethasone
solid dispersion
suspension eye-drop
