注射用哌拉西林钠/他唑巴坦钠(4∶1)的研制

Preparation of piperacillin sodium/tazobactam sodium(4∶1) for injection

目的:制备注射用哌拉西林钠/他唑巴坦钠(4∶1),并建立相应的质量控制方法。方法:采用无菌分装法制备注射用哌拉西林钠/他唑巴坦钠(4∶1),高效液相色谱法测定其有关物质和含量,并对其稳定性和安全性进行考察。结果:哌拉西林和他唑巴坦平均回收率分别为99.9%和99.8%,RSD分别为0.51%和0.40%。影响因素试验、加速试验、长期试验条件下样品稳定性良好。血管刺激性、肌肉刺激性、溶血性及全身过敏性试验结果表明其安全性良好。结论:该制剂处方工艺合理,质量可控,产品质量稳定,安全性良好。

Objective ：To prepare piperacillin sodium/tazobactam sodium （4：1 ） for injection and to establish the corresponding quality control method. Methods：Piperacillin sodium/tazobactam sodium （4：1 ） for injection was separately packed with the aseptic technology. The contents and the related substances were determined by the method of high performance liquid chromatograph （HPLC）and the stability and the safety were investigated. Results ： The average recovery of piperacillin and tazobactam were 99.9% and 99.8% with RSD 0.51% and 0.40% , respectively. The preparation showed good stability under the experimental conditions of stress test, accelerated test and long-ternl test. It showed good safety after blood vessel stimulation test, muscle stimulation test, haemolyticus test and system sensitivity test. Conclusion：The prescription and technology of the preparation are reasonable with controllable quality, satisfactory stability and good safety.