Compatibility of Sodium Ferrous Citrate Improved-Granules in Combination with Other Preparations.

Y. Arai, T. Nakane, A. Kubota, N. Mizushima, T. Shibata
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Abstract

Sodium Ferrous Citrate formulatio, Ferromia®granule was originally supplied as film-coated granules. However, some problems have been pointed out with this formulation regarding awkwardness in handling and unpleasantness during consumption.Therefore, corrigent was added while the film conting was removed in order to improve it.We investigated influence of changing the formilative method, and carry out the incompatibility test and hygroscopic test on 29 powders which can be admixed together. Furthermore, we also carried out a ferrous ion dissolution test on 11 powders which are likely to have an ionic interaction with iron. As a result, the modified granuls were incompatible when combined with ascorbic acid powder, Cinal ®granule, sodium bicarbonate and fblic acid powder (10%).The modified granules demonstrated no water-vapor sorption at 25°C, 75% RH at 30 days. Hygroscopicity was not considered to be related to incompatibility, and no noticeable difference was found due to the modification of the formulation.In the compounding the sample, dissolution property demonstrated only a slight difference in the ferrous ion elution.
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柠檬酸亚铁钠改良颗粒与其它制剂的配伍性。
柠檬酸亚铁钠配方,铁®颗粒最初作为薄膜包覆颗粒供应。然而,这一配方也存在一些问题,如操作笨拙和消费过程中不愉快。因此,在去除含膜物的同时加入correct,以改善其性能。考察了不同制备方法对其的影响,并对可混合的29种粉末进行了不相容试验和吸湿试验。此外,我们还对11种可能与铁离子相互作用的粉末进行了亚铁离子溶解试验。结果表明,改性颗粒与抗坏血酸粉、Cinal®颗粒、碳酸氢钠和10%的硫酸粉配伍时不相容。改性颗粒在25°C, 75% RH条件下,30天无水蒸气吸附。吸湿性不被认为与不相容有关,并且由于配方的修改而没有发现明显的差异。在复合样品中,亚铁离子洗脱的溶解性能仅表现出轻微的差异。
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