注射用硝普钠的研制(1)
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[摘要] 目的:制备注射用硝普钠,建立其质量控制方法并考察其稳定性和安全性。方法:优化处方组成与制备工艺,并进行性状、鉴别、检查质量研究,采用电位滴定法测定硝普钠的含量,影响因素试验、加速试验和长期试验考察其稳定性,血管刺激性试验、溶血性试验以及过敏性试验评价其用药的安全性。结果:硝普钠称样量在0.08～0.16 g范围内与硝酸银滴定液消耗体积呈良好线性关系(r=0.999 9),其平均回收率为99.5%,RSD为0.37%。恒温加速试验6个月和长期留样试验12个月,其性状、pH值、氰化物、铁氰化物、亚铁氰化物、可见异物、含量等均未见明显改变。结论:该制剂处方合理,制备工艺简便可行,质量可控,稳定性良好,用药安全。
[关键词] 注射用硝普钠;制备;质量控制;稳定性;安全性
[中图分类号] R943[文献标识码]A [文章编号]1673-7210(2010)06(c)-069-04
The study on SodiumNitroprusside for Injection
XU Fanghui1, LI Jianhe2, WANG Qiang1, CAO Junhua2
(1.Yiyang Medical College,Yiyang 413000, China; 2.Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha 410011, China)
[Abstract] Objective: To prepare Sodium Nitroprusside for Injection, establish its quality control and investigate its stability and safety. Methods: Some work was done to optimize the prescription and preparation technology. The character, identification and examination were tested. The content of sodium nitroprusside was determined by the method of potentiometric titration. Stress testing, accelerated testing and long-term testing were done to study its stability. The safety was evaluated by testing the vessel stimulation, haemolyticus and hypersensitivity. Results: The linear relation of sodium nitroprusside with the used titration solution of silver nitrate was excellent within the range of 0.08-0.16 g (r=0.999 9), and the mean recovery was 99.5% with a RSD of 0.37%. No obvious changes were observed at 6 month of an accelerated test or 12 month of long-term storage test. Conclusion: The preparation was reasonable in formulation, simple and convenient in preparation technique, accurate in quality control, good in stablility, and safe in application.
[Key words] Sodium Nitroprusside for Injection; Preparation; Quality control; Stability; Safety
硝普钠为一种速效和短时作用的血管扩张药,临床上用于高血压急症,如高血压危象、高血压脑病、恶性高血压、嗜铬细胞瘤手术前后阵发性高血压等的紧急降压,也可用于外科麻醉期间进行控制性降压。此外,也可用于急性心力衰竭,包括急性肺水肿;亦用于急性心肌梗死或瓣膜(二尖瓣或主动脉瓣)关闭不全时的急性心力衰竭[1-5]。现将注射用硝普钠的制备、质量控制、稳定性、安全性研究的结果报道如下:
1 仪器与试药
1.1 仪器
FA1004N型电子分析天平(上海精密科学仪器有限公司);pHS-3C型精密酸度计(上海雷磁仪器厂);GWJ-3智能微粒检测仪(天津大学精密仪器厂);YB-Z型澄明度检测仪(天津大学精密仪器厂);全封闭式HTY-2000型集菌仪(杭州高得医疗器械有限公司);KSF集菌培养器(杭州高得医疗器械有限公司);生化培养箱(广东医疗器械厂) ......
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