抗坏血酸氯化钠注射液的制备及质量控制

Preparation and Quality Control of Ascorbic Acid and Sodium Chloride Injection

目的:制备100mL装量抗坏血酸氯化钠注射液并建立其质量控制方法。方法:以抗坏血酸为主药制备注射液;采用紫外-可见分光光度法测定其中主药的含量。结果:所制制剂检查、鉴别等均符合2005年版《中国药典》相关规定;抗坏血酸检测浓度的线性范围为4.0～12.0μg·mL-1(r=0.9999);平均回收率为99.85%(RSD=0.75%,n=6)。结论:本制剂组方合理,制备工艺简单可行,质量稳定可控。

OBJECTIVE： To prepare ascorbic acid and sodium chloride injection （100mL） and to establish its quality control. METHODS： The injection was prepared with ascorbic acid as the main ingredient; and the content of ascorbic acid was determined by ultraviolet- visible spectrophotometry. RESULTS： The examination and identification etc of ascorbic acid and sodium chloride injection were all in line with the corresponding standards stated in China Pharmacopoeia （2005 edition）. The linear concentration range of ascorbic acid was 4.0-12.0/1g · mL^-1（r = 0.999 9） and the average recovery was 99.85% （RSD = 0.75%, n = 6）. CONCLUSION The prepared ascorbic acid and sodium chloride injection had reasonable formulation, simple preparation technology, and its quality was stable and controllable.