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目的:琥珀酰明胶注射液是由健康牛骨、猪骨的明胶经水解后,加入丁二酸酐酰化交联改性制成,但目前没有测定交联剂含量的方法。本研究建立离子色谱法-电导检测器测定琥珀酰明胶注射液中琥珀酸(丁二酸)含量的方法。方法:本研究的离子色谱法以TSKgel super IC-AZ色谱柱分析,以Na HCO3(1.9mmol·L-1)+Na2CO3(3.2 mmol·L-1)溶液等度淋洗,流速为0.8 m L·min-1,进样量为30μL。以丁二酸标准品为对照,以峰面积计算供试品溶液中丁二酸的含量。结果:被测成份在浓度0.465 2~18.608 mg·L-1范围内呈良好线性关系(r=0.999 7),平均加标回收率为99.9%,RSD为1.3%。结论:该方法灵敏度高,精密度好,简单实用,适合琥珀酰明胶注射液生产工艺控制和质量标准的提高。
OBJECTIVE: Succinylated gelatin injection is made from healthy bovine and porcine bone gelatin hydrolyzed by succinic anhydride acylation and crosslinking. However, there is no method to determine the content of cross-linking agent. In this study, we established a method for the determination of succinic acid (succinic acid) in succinyl gelatin injection by ion chromatography-conductivity detector. Methods: The ion chromatography in this study was performed on a TSKgel super IC-AZ column with isocratic rinsing of Na HCO3 (1.9 mmol·L-1) and Na2CO3 (3.2 mmol·L-1) at a flow rate of 0.8 m L · Min-1, injection volume of 30μL. To succinic acid standard as a control, the peak area calculation for the test solution of succinic acid content. Results: The calibration curve showed good linearity (r = 0.999 7) in the concentration range of 0.465 2 ~ 18.608 mg · L-1 with an average recovery of 99.9% and RSD of 1.3%. Conclusion: The method has high sensitivity, good precision, simple and practical, suitable for the production process control and quality standard of succinyl gelatin injection.