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

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。

OBJECTIVE To establish an HPLC method for the assay ofpropacetamol 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 ofpropacetamol hydrochloride was 〈90% within 6 h; only the pH value ofpropacetamol hydrochloride with 0.9% sodium chloride injection was 4.52, and the pt-I 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 Propacetarnol 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.