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发明公开
CN101563057A 溶解氧减少的液体制剂及其制备方法、以及溶解氧含量减少的药液收容体 有权

溶解氧减少的液体制剂及其制备方法、以及溶解氧含量减少的药液收容体
摘要：
本发明的目的在于提供减少溶解氧含量、不易产生由氧化引起的变质、经时稳定性优异的液体制剂及其制备方法和使药液的溶解氧的含量维持在较低状态、不易产生由氧化引起的变质、经时稳定性优异的药液收容体。用于实现上述目的的溶解氧减少的液体制剂通过以如下方式进行调整来得到，即，将液体制剂收容、密封在由塑料构成的药液容器(15)中，然后，实施蒸汽灭菌处理或热水灭菌处理，再在具有脱氧装置的环境下保存，从而使上述塑料的透氧率达到稳定状态时，液体制剂的溶解氧的浓度为2ppm以下，所述塑料在蒸汽灭菌处理或热水灭菌处理后12小时以内、在25℃、60％RH下的透氧率为200cm3/m2·24h·atm以上，当透氧率处于稳定状态时，在25℃、60％RH下的透氧率为100cm3/m2·24h·atm以下。
摘要（英）：

The present invention is intended to provide a drug solution which has a reduced dissolved oxygen content and therefore suffers from little degradation caused by oxidation and has a high stability with the passage of time; a method of producing the same; and a drug solution containing unit wherein a drug solution can be stored while maintaining a low dissolved oxygen content and therefore suffers from little degradation caused by oxidation and has a high stability with the passage of time. A drug solution having a reduced dissolved oxygen content for achieving the object as described above canbe obtained by containing a drug solution in a drug solution container (15) made of a plastic material, which has an oxygen permeability at 25 DEG C and 60%RH of 200 cm<3>/m<2> 24.h.atm or more withi n 12 hours after steam sterilization or hot water sterilization and an oxygen permeability at 25 DEG C and 60%RH of 100 cm<3>/m<2> 24.h.atm or less in a steady state of oxygen permeability, sealing the container, then subjecting it to steam sterilization or hot water sterilization, storing it in an environment provided with a deoxidation means and, when the oxygen permeability of the above-described plastic material attains the steady state, regulating the dissolved oxygen concentration of the drug solution to 2ppm or less.

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