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建立了氟化钠缓释片的氟离子选择电极测定法,并考察了方法的回收率、精密度。试验结果表明,方法简便、准确可靠、重现性较好。进行了氟化钠缓释片在光照和简易加速试验条件下的稳定性考察。结果表明药物在3000LX光照10日条件下或在40℃,RH为75.28%环境中3个月,制剂的含量与释放度无显著变化,制剂的使用期可暂定为两年。
A fluoride ion selective electrode method for determination of sodium fluoride sustained release tablets was established. The recovery and precision of the method were also investigated. The test results show that the method is simple, accurate, reliable and reproducible. The stability of sodium fluoride sustained-release tablets under light and simple accelerated test conditions was investigated. The results showed that under the condition of 3000LX light on the 10th or at 40 ℃ and RH of 75.28% for three months, the content and the release of the drug did not change significantly, and the period of the drug could be tentatively scheduled for two years.