摘要
目的 :制备磷酸川芎嗪氯化钠注射液 ,并对其质量进行控制。方法 :磷酸川芎嗪 1.0g ,氯化钠 9.0g ,纯化水溶解并加至 10 0 0mL定容制备磷酸川芎嗪氯化钠注射液。采用高效液相色谱法测定磷酸川芎嗪含量 ,银量法测定氯化钠含量。结果 :磷酸川芎嗪在 2 0 .0～ 2 0 0 .0 μg·mL 1 浓度范围内线性关系良好 (r=0 .9999) ,平均回收率 10 0 .13 % ,RSD =0 .5 6% (n =9) ;氯化钠平均回收率 10 0 .2 7% ,RSD =0 .3 9% (n =9)。结论 :该制剂处方合理 ,制备工艺简便 ,质量易于控制。
Objective:To prepare and control the quality of ligustrazine phosphate sodium chloride injection. Methods:Briefly,the injection was prepared by dissolving 1.0 g of ligustrazine phosphate and 9.0 g of sodium chloride in water for injection added gradually until a final volume of 1 000 mL was reached. The content of ligustrazine phosphate in the injection was determined with HPLC and that of sodium chloride,with silver nitrate titrimetry. Results:Linear relationship was found when the ligustrazine phosphate concentrations ranged from 20.0 μg·mL -1 to 200.0 μg·mL -1. The average rate of recovery of ligustrazine phosphate was 100.13%, RSD =0.56%( n =9). The average rate of recovery of sodium chloride was 100.27%,RSD =0.39%( n =9). Conclusion:The formula of this preparation is reasonable and the technology was simple and convenient. Moreover,its quality control is easy to handle.
出处
《医药导报》
CAS
2004年第8期575-577,共3页
Herald of Medicine
关键词
磷酸川芎嗪氯化钠注射液
药物制备
质量控制
Ligustrazine phosphate sodium chloride injection
Drug Preparation
Quality control
