藻酸双酯钠氯化钠注射液制备-质量控制-稳定性及安全性考察.docVIP

藻酸双酯钠氯化钠注射液制备\质量控制\稳定性及安全性考察[摘要] 目的:制备藻酸双酯钠氯化钠注射液,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、检查等质量研究,采用滴定法测定藻酸双酯钠和氯化钠的含量,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:藻酸双酯钠和氯化钠的平均回收率分别为99.73%、100.93%,RSD分别为0.34%、0.17%。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、不溶性微粒、无菌、热原、主药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] 藻酸双酯钠氯化钠注射液;制备;质量控制;稳定性;安全性 [中图分类号] R943 [文献标识码]C [文章编号]1674-4721(2010)07(a)-173-03 Alginic sodium diester and sodium chloride injection:preparation,quality control,stability and safety study XU Fanghui1,LI Jianhe2*,WANG Qiang1,CAO Junhua2 (1.Yiyang Medical College,Hunan Province,Yiyang 413000,China;2.Department of Pharmacy,The Second XiangYa Hospital, Central South University, Hunan Province,Changsha 410011,China) [Abstract] Objective: To prepare alginic sodium diester and sodium chloride 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 et al were tested. The content of alginic sodium diester and sodium chloride were determined by the method of 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 mean recovery and RSD of alginic sodium diester and sodium chloride were 99.73%,0.34% and 100.93%, 0.17% respectively.No obvious changes were observed at 6 months of an accelerated test or 12 months of long-term storage test. Conclusion: The preparation is reasonable in formulation,simple and convenient in preparation technique,accurate in quality control,good in stablility,and safe in application. [Key words] Alginic sodium diester and sodium chloride injection;Preparation;Quality control;Stability;Safety 藻酸双酯钠是以海藻提取物为基础原料,经引入有效基团精制而得的多糖类化合物,属类肝素药。具有抗凝血、降低血黏度、降血脂、抑制红细胞和血小板聚集和改善微循环作用,是近年来常用的预防心脑血管疾病和改善微循环药物之一[1