棓丙酯注射液与不同输液配伍的稳定性研究

Study on Stability of Propylgallate Injection Combined with Different Transfusions

目的考察棓丙酯注射液与不同输液配伍后的稳定性,探讨棓丙酯注射液最适配伍溶媒,为临床安全应用提供依据。方法实验分为对照组与实验组,按照临床常用剂量与不同的输液配伍,分别在0、0.5、1、2、4、8 h时间点观察溶液的澄明度、测定溶液的p H值,按照《中国药典》2015版四部不溶性微粒检查法中光阻法测定不溶性微粒。结果棓丙酯注射液与不同的输液配伍后,在不同时间点溶液均为透明液体,无显著性差异,澄明度符合规定,p H值的变化符合要求。不溶性微粒数随时间增加微粒数量上下浮动,与5%和10%葡萄糖注射液配伍时≥10μm和≥25μm的微粒数最少,符合2015版《中国药典》规定。与0.9%氯化钠注射液配伍时≥10μm微粒数不符合规定。与葡萄糖氯化钠注射液配伍时≥10μm的微粒在0 h时不符合规定,其他时间点符合规定。结论棓丙酯注射液最适配伍溶媒为5%和10%葡萄糖注射液。

Objective To study the stability of the solution after compatibility of the propylgallate injection with different transfusions, so as to provide favorable experimental basis for the clinical application of the propylgallate injection. Methods According to the requirements for simulation of clinical medicine, the transfusions were divided into experimental group and control group, and the changes of color, pH values, and panicle numbers of compatible solutions at 0, 0.5, 1, 2, 4 h and 8 h were investigated. The numbers of particles were detected by light blockage method specified in Chinese Pharmacopeia （2015 edition, No 4）. Results The compatible solutions of propylgallate injection at different time were transparent liquid, no obvious change, and there were no differences between the groups. The pH value remained stable. The numbers of particles increaseed or decreaseed with time, which reached the minimum floating when propylgallate injection combined with 5% and 10% glucose injection, conformed to the 2015 edition of Chinese Pharmacopoeia standards. The numbers of ≥ 10 μm particles quickly increased and exceeded the limitation of the Chinese Pharmacopoeia after combined with 0.9% sodium chloride injection. The numbers of ≥10 μm particles reached the maximum floating at 0 hour when propylgallate injection combined with glucose- sodium chloride injection. At other times, the numbers of insoluble particles were qualified. Conclusion The most compatible suitable solvents for propylgallate injection were 5% glucose injection and 10% glucose injection.