注射用紫杉醇(白蛋白结合型)配制流程优化的研究

Study on Optimization of Preparation Process of Paclitaxel(Albumin Binding Type) for Injection

关键词:  注射用紫杉醇(白蛋白结合型)|流程优化|药物配制

Key words:  paclitaxel for injection(albumin binding type)|process optimization|pharmacy preparation

摘要:

目的 探讨智能称重仪应用于配制注射用紫杉醇(白蛋白结合型)流程优化的效果。方法 对注射用紫杉醇(白蛋白结合型)说明书中配制流程进行优化，具体的优化措施包括不限制溶媒注入速度、运用智能称重仪简化静止瓶身5 min和手工摇晃2 min 2个操作步骤，收集流程优化前后对照组和实验组药物溶解后产生的泡沫高度、药物配制耗时、药物稳定性3个结局指标，进行统计学分析。结果 实验组药物溶解后泡沫高度为2.80 mm，对照组为3.05 mm，实验组明显低于对照组(P<0.05)；2组数据统计结果显示，实验组平均每份化疗输液药物配制耗时539.79 s，对照组537.94 s，差异无统计学意义；实验组单位时间配置总量高于对照组；2组配制的药物稳定性差异无统计学意义。结论 智能称重仪应用于注射用紫杉醇(白蛋白结合型)配制，能确保药品配置质量，提高配置效率。

Abstract:

OBJECTIVE To explore the optimization effect of intelligent weighing instrument in preparing paclitaxel for injection(albumin binding type). METHODS Optimize the preparation process of paclitaxel for injection(albumin binding type) in the instruction manual, the specific optimization measures included no limit on the speed of solvent injection, simplify the static bottle for 5 min by using intelligent weighing instrument and manual shaking for 2 min. The foam height, drug preparation time and drug stability of the control group and the experimental group after drug dissolution were collected for statistical analysis before and after process optimization. RESULTS The foam height after drug dissolution was 2.80 mm in the experimental group and 3.05 mm in the control group, which was significantly lower in the experimental group than in the control group(P<0.05). The statistical results of two groups of data showed that average preparation time of each chemotherapy infusion drug was 539.79 s in the experimental group and 537.94 s in the control group, the difference was not statistically significant. The total amount per unit time was higher in the experimental group than in the control group. There was no significant difference in drug stability between the two groups. CONCLUSION The intelligent weighing instrument is applied to the preparation of paclitaxel for injection(albumin binding type), which can ensure the quality of drug configuration, improve the efficiency of configuration.