论文部分内容阅读
目的:研究影响静脉药物复配液中微粒含量的因素,探讨减少不溶性微粒的最佳方法。方法:以≥10μm和≥25μm不溶性微粒数为指标,采用光阻法对注射用氨苄西林钠在不同配液器具(一次性注射器、自制新型溶药器)、配液环境(治疗室、静脉配置中心(PIVAS))、药物剂量(3、6支)下的复配液进行微粒测定。结果:相同条件下,溶药器组比注射器组微粒数目明显更少(P<0.001);用注射器配置时,PIVAS组比治疗室组在配置相同剂量的复配液时微粒数目明显更少(P<0.001);在相同配液环境中3支组比6支组微粒数目明显更少(P<0.05或P<0.001);用溶药器配置时,PIVAS组与治疗室组、3支组与6支组比较无明显差异(P>0.05)。结论:新型溶药器能明显减少复配液中的不溶性微粒,同时不易受配液环境、药物剂量的影响。
Objective: To study the factors influencing the content of microparticles in intravenous drug compound solution and to explore the best method to reduce the insoluble particles. Methods: With the number of insoluble particles ≥10μm and ≥25μm as index, the effects of ampicillin sodium for injection in different dosing devices (disposable syringes, new drug-dissolving device), dosing environment (treatment room, vein configuration Center (PIVAS)) and drug dose (3, 6). RESULTS: Under the same conditions, the number of particles in the drug-dissolving device group was significantly less than that of the syringe device (P <0.001). When using the syringe, the number of particles in the PIVAS group was significantly less than that in the treatment group when the same dose of compounding solution was configured (P <0.001 or P <0.001). The number of particles in three groups was significantly less than that in six groups (P <0.05 or P <0.001) in the same solution environment. No significant difference with the six groups (P> 0.05). Conclusion: The new drug-dissolving device can significantly reduce the insoluble particles in the compound solution, and is not easily affected by the dosing environment and the dose of the drug.