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3 - (so it is methyl) - 5, 5 - two benzene of the pagan natives is the sodium salt of the ester of the stability of a medicament of water science

机译:3-(所以是甲基)-5、5-异教徒本地人的两个苯是水科学稳定药物酯的钠盐

摘要

Described is a stable pharmaceutical composition of 3-(hydroxymethyl)-5,5-diphenylhydantoin disodium phosphate ester, the produg of 5,5-diphenylhydantoin (phenytoin) a commonly used drug for the treatment and management of epilepsy and other types of convulsive states. It has been found that degradation of the produg to phenytoin can be controlled by controlling the pH of the composition. Controlling the pH to between 8.3 to 9.4 results in the production of diphenylglycinamide as the primary degradant and minimization of degradation to phenytoin. If the pH is maintained at a lower or higher value, then the degradation pattern changes, with earlier than expected product failure.
机译:描述了3-(羟甲基)-5,5-二苯基乙内酰脲磷酸二钠酯的稳定药物组合物,5,5-二苯基乙内酰脲(苯妥英)的前药是治疗和管理癫痫和其他类型惊厥状态的常用药物。已经发现,可以通过控制组合物的pH来控制前药降解为苯妥英。将pH值控制在8.3至9.4之间可产生作为主要降解剂的二苯基甘氨酰胺,并将降解为苯妥英的降解降至最低。如果将pH值保持在较低或较高的水平,则降解模式会发生变化,从而导致产品故障早于预期。

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