注射用甘草酸二铵的制备、质量控制及稳定性考察  

Diammonium Glycyrrhizinate for injection:preparation,quality control and stability study

作　　者：李柱 李健和[2] 易利丹[2] 阳巧凤[2] 曾小慧[2] 曹俊华[3] 

机构地区：[1]长沙市三医院药剂科,湖南长沙410015 [2]中南大学湘雅二医院药学部,湖南长沙410011 [3]湖南省马王堆医院,湖南长沙410016

出　　处：《中国现代医学杂志》2011年第26期3258-3263,3267,共7页China Journal of Modern Medicine

摘　　要：目的制备注射用甘草酸二铵,建立其质量控制方法并考察其稳定性。方法对处方中填充剂的种类、用量进行选择,并制备注射用甘草酸二铵;采用高效液相色谱法测定有关物质,用紫外分光光度法测定甘草酸二铵的含量,影响因素试验、加速试验和长期试验考察其稳定性。结果确定了以甘露醇为填充剂的制剂处方,甘草酸二铵检测浓度在24.12～56.28μg/mL范围内线性关系良好(r=0.9999),其平均回收率为99.6%,RSD为0.66%。恒温加速试验6 mo和长期留样试验12 mo,其性状、pH值、溶液的澄清度与颜色、有关物质、可见异物、干燥失重、含量等均未见明显改变。结论该制剂处方工艺合理可行,质量可控,稳定性良好。【Objective】 To prepare Diammonium Glycyrrhizinate for injection,establish its quality control and determine its stability.【Methods】 The type and dosage of the adjuvant in the formula were optimized and Diammonium Glycyrrhizinate for injection was prepared.Its related materials determined by HPLC and its content determined by UV.Stress testing,accelerated testing and long-term testing were done to study its stability.【Results】 Mannitol was determined as the adjuvant in the formula.The linear relation of Diammonium Glycyrrhizinate was excellent within the range of 24.12~56.28（μg/mL）（r =0.9999）,and the mean recovery was 99.6% with RSD was 0.66%.No obvious changes were observed at 6 month of an accelerated test or 12 month of long-term storage test.【Conclusion】 The preparation is reasonable and feasible in techniques,controllable and stable in quality.

关 键 词：注射用甘草酸二铵 制备 质量控制 稳定性 

分 类 号：R927.11[医药卫生—药学]