注射用尼扎替丁的研制  

Preparation of nizatidine for injection

作　　者：向红菊[1] 李健和[2] 易利丹[2] 黎银波[1] 

机构地区：[1]湖南省桑植县人民医院药剂科,湖南张家界427100 [2]中南大学湘雅二医院药学部,长沙410011

出　　处：《中南药学》2011年第9期675-679,共5页Central South Pharmacy

摘　　要：目的制备注射用尼扎替丁,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,进行性状、鉴别、检查等质量研究,采用高效液相色谱法测定尼扎替丁的含量,并进行影响因素试验、加速试验和长期试验考察其稳定性,采用血管刺激性试验、溶血性试验以及过敏性试验评价其用药的安全性。结果确定了每支含主药尼扎替丁100 mg和辅料甘露醇50 mg的处方,尼扎替丁在0.571-1.331 mg.mL^-1与峰面积呈良好的线性关系,其平均回收率为99.8%,RSD为0.39%。恒温加速试验6个月和长期留样试验12个月,其性状、pH值、有关物质、可见异物、干燥失重、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。Objective To prepare nizatidine for injection,establish its quality control and investigate its stability and safety.Methods The prescription and preparation technology were optimized.The character,identification and examination were tested.The content of nizatidine was determined by HPLC.Stress test,accelerated test and long-term test were used to study its stability.The safety was evaluated by testing the vessel stimulation,haemolyticus and hypersensitivity.Results The formula that contained the primary medicine nizatidine 100 mg and accessories mannitol 50 mg per piece was established.A linearity between the peak area and nizatidine concentration was achieved at 0.571-1.331 mg·mL^-1,and the mean recovery was 99.8% with RSD 0.39%.No obvious changes were observed after 6 months of accelerated test or 12 months of long-term storage test.Conclusion The preparation is reasonable with simple and convenient preparation,accurate quality control,good stablility,and safe application.

关 键 词：尼扎替丁 制备工艺 质量控制 稳定性 安全性 

分 类 号：R944.1[医药卫生—药剂学] R927.1[医药卫生—药学]