注射用盐酸丙帕他莫与5种临床常用注射液的配伍稳定性考察

Compatible Stability of Propacetamol Hydrochloride with 5 Kinds of Representative Infusion Solution

关键词:  盐酸丙帕他莫  配伍禁忌  高效液相色谱法

Key words:  propacetamol hydrochloride  compatible stability  HPLC

摘要:

目的 通过建立盐酸丙帕他莫含量测定的HPLC法，研究注射用盐酸丙帕他莫与5种临床常见的注射液配伍稳定性。方法 用HPLC检测盐酸丙帕他莫分别与果糖注射液、葡萄糖氯化钠注射液、0.9%氯化钠注射液、5%葡萄糖注射液和10%葡萄糖注射液配伍后盐酸丙帕他莫的含量变化，观察配伍后溶液的pH值及外观变化。结果 盐酸丙帕他莫与5种注射液配伍后，含量在6 h内均下降至<90%；在0 h时仅盐酸丙帕他莫与0.9%氯化钠注射液的配伍溶液pH值为4.52，与其他4种注射液的配伍溶液pH值均在4.0左右；在0.5 h内pH值均下降至<4.0。结论 注射用盐酸丙帕他莫在5种常用的注射液中均不稳定，临床应首选0.9%氯化钠注射液与之配伍，且应现配现用。

Abstract:

OBJECTIVE To establish an HPLC method for the assay of propacetamol hydrochloride, and to investigate the compatible stability of propacetamol hydrochloride with 5 kinds of infusion solution. METHODS The variance of propacetamol hydrochloride content in fructose injection, glucose saline injection, 0.9% sodium chloride injection, 5% glucose injection and 10% glucose injection was determined by HPLC. Meanwhile, the changes of color and pH value were observed. RESULTS The content of propacetamol hydrochloride was <90% within 6 h; only the pH value of propacetamol hydrochloride with 0.9% sodium chloride injection was 4.52, and the pH value of the other 4 kinds of infusion solution was near 4 at 0 h; the pH value decreased to <4.0 within 0.5 h in all infusion solution. CONCLUSION Propacetamol hydrochloride is unstable in 5 kinds of infusion solution. The 0.9% sodium chloride injection should be used as preferred infusion solution, and it should be used immediately after configured.