摘要
目的 制备尼扎替丁氯化钠注射液,建立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、检查等质量研究,采用高效液相色谱法测定尼扎替丁含量,滴定法测定氯化钠含量,影响因素试验、加速试验和长期试验考察其稳定性,并进行生物安全性评价。结果 尼扎替丁在0.55～1.31mg·mL^-1与峰面积线性关系良好,其平均回收率为99.9%,RSD为0.44%。恒温加速试验6个月和长期留样试验12个月,其性状、pH值、溶液颜色、有关物质、不溶性微粒、无菌、内毒素、主药含量等均未见明显改变,安全性良好。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 and sodium chloride injection, establish its quality control and investigate its stability and safety. Methods We optimized the prescription and preparation technology. The character, identification and examination were tested. The content of nizatidine and sodium chloride was determined by HPLC and titration. Stress test, acceleration test and long-term test were used for stability, and the biological safety was evaluated, Results A linearity be- tween the peak areas and nizatidine concentration was achieved at 0.55 - 1.31 mg·mL^-1. The mean recovery was 99.9% with RSD of 0.44%. No obvious changes were observed after 6 m nth acceleration test or 12 month long-term storage test. The preparation was safe. Conclusion The preparation has reasonable formulation, simple and convenient preparation, ac- curate quality control, stable, and safe.
出处
《中南药学》
CAS
2013年第12期885-889,共5页
Central South Pharmacy
关键词
尼扎替丁氯化钠注射液
制备
质量控制
稳定性
安全性
nizatidine and sodium chloride injection
preparation
quality control
stability
safety
