APAS-600型智能化自动配液机对药品配置残留量的控制验证

Validation of Intelligent Automatic Dispensing Machine APAS-600 for the Control of Drug Residues

目的验证APAS-600型智能化自动配液机对药品配置残留量限度标准的可控性。方法采用APAS-600型智能化自动配液机自动调配注射用浓溶液剂型药物(2 m L维生素C注射液、5 m L维生素C注射液、10 m L浓氯化钠注射液),以及注射用无菌粉末剂型药物(0.48 g注射用青霉素钠、0.50 g注射用头孢唑林钠),每种规格随机选取30组数据,统计并比较其自动化调配药品配置的残留量。结果 2 m L维生素C注射液、5 m L维生素C注射液、10 m L浓氯化钠注射液的平均药品配置残留量分别为0.06,0.14,0.24 m L,较对应规格调配残留限度值分别降低60.00%,53.33%,52.80%;0.48 g注射用青霉素钠、0.50 g注射用头孢唑林钠的平均药品配置残留量分别为0.29 m L和0.30 m L,较限度值降低15.71%。所有剂型药品配置残留量均在限度内。结论 APAS-600型智能化自动配液机对药品配置残留量具有可控性。

Objective To verify the controllability of Intelligent Automatic Dispensing Machine APAS-600 to the limit standard of drug residues.Methods Intelligent Automatic Dispensing Machine APAS-600 was used to automatically dispense concentrated solution for injection(2 mL of Vitamin C Injection,5 mL of Vitamin C Injection,and 10 mL of Concentrated Sodium Chloride Injection),sterile powder drug for injection(0.48 g of Penicillin Sodium for Injection,0.50 g of Cefazolin Sodium for Injection),30 groups of data were randomly selected from each specification to record the drug residues caused by intelligent automatic dispensing machine.Results The average residual quantity of dispensing 2 mL of Vitamin C Injection,5 mL of Vitamin C Injection and 10 mL of Concentrated Sodium Chloride Injection were 0.06,0.14,0.24 mL respectively,which were 60.00%,53.33%,52.80%lower than the corresponding residual limit value.The average residual quantity of dispensing 0.48 g of Penicillin Sodium for Injection and 0.50 g of Cefazolin Sodium for Injection were 0.29 mL and 0.30 mL respectively,which were 15.71%lower than the arresponding residual limit value and all dosage form were within the limits of drug residues.Conclusion The intelligent automatic dispensing machine APAS-600 has controllability for the residual quantity of dispensing drugs.