双氯芬酸钠缓释胶囊体外释放度考察
The comparison of dissolution rates of diclofenac sodium slow-released capsules
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摘要: 目的 考察国内不同厂家(4家)生产的双氯芬酸钠缓释胶囊体外释放度。方法 按中国药典 1995年版释放度测定法Ⅰ,测定双氯芬酸钠缓释胶囊的释放度。提取参数 (T50,Td,m),并对参数进行相关性研究。结果 各厂家产品的释放度参数具有极显著性差异 (P<0.01)。结论 每批产品须进行释放度检查以控制其质量。Abstract: OBJECTIVE To compare the dissolution rates of diclofenac(DCF) sodium slow-released capsules.METHODS According to Chinese Pharmacopoeia(1995) dissolution method I,the dissolution rates of DCF slow-released capsules made by lbur factories were meaaured. The correlation of paramctcrs(T50, Td, m)obtained from these samples was analysed. RESULTS The dissolution rates of DCF slow-released capsules from various domestic factories were remarkaly different(P<0.01).CONCLUSIONS The dissolution rates of per lot preparation is measured for controlling quality.
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Key words:
- diclofenac sodium /
- slow-released capsule /
- dissolution rate
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