气相色谱法与化学法测定羟乙基淀粉130注射液置换度的比较

• 作 者: 尚诚 华玉琴 张岚
• 机 构: 青岛首和金海制药有限公司,青岛市药品检验所,
• 出 处: 沈阳药科大学学报
• 发表日期: 2009年07期
• 关键词: 注射液 羟乙基淀粉 化学法测定 碘乙烷 置换度 滴定法测定 气相色谱法 羟乙基 烷氧基化 血液稀释

目的比较2种不同方法测定的羟乙基淀粉130的置换度的差异。方法分别采用气相色谱法和烷氧基化学滴定法测定10批羟乙基淀粉130注射液的置换度。结果气相色谱法测定的连续10批羟乙基淀粉130的平均置换度为0.405,标准偏差为1.8%,化学法的测定结果为0.426,标准偏差为2.5%。结论气相色谱法的测定羟乙基淀粉置换度的准确度优于化学法。

Objective To compare the differences in the degree of substitution of hydroxyethyl starch 130 measured by two different methods. Methods The degree of substitution of 10 batches of hydroxyethyl starch 130 injection was determined by gas chromatography and alkoxy titration, respectively. Results The average displacements of 10 batches of hydroxyethyl starch 130 determined by gas chromatography were 0.405 with a standard deviation of 1.8%. The chemical method was 0.426 and the standard deviation was 2.5%. Conclusion The accuracy of gas chromatography for the determination of hydroxyethyl starch substitution is better than that of chemical method.