目的: 建立枸橼酸咖啡因注射液包装完整性的测定方法。方法: 真空衰减法,采用双通道检测,通过设定通道1最大压力46 600 Pa,通道2最大压力100 Pa的限度进行试验;色水法,以亮蓝溶液为示踪液体,采用紫外-可见分光光度法631 nm波长检测和目测结合。结果: 真空衰减法表明泄漏量在0~1.20 mL·min-1范围内呈良好线性关系;色水法表明亮蓝-枸橼酸咖啡因溶液质量浓度在0.011~5.26 μg·mL-1范围内呈良好线性关系。2种检测方法对缺陷包装均能达到100%的检出率。结论: 真空衰减法测定枸橼酸咖啡因注射液包装完整性快速、简便,灵敏度高,无破坏性。
Objective: To develop a method for determining the package integrity of caffeine citrate injection. Methods: Vacuum decay method was used, using two-channel detection, by setting channel 1 with maximum pressure 46 600 Pa and channel 2 maximum pressure 100 Pa limit for testing. By color water method, brilliant blue solution was used as tracer liquid with UV visible spectrophotometry test and visual inspection together analysis. Results: The results showed that the leakage volume had a good linear relationship in the range of 0-1.20 mL·min-1. Color water method results showed that brilliant blue caffeine citrate solution has a good linear relationship in the range of 0.011-5.26 μg·mL-1 concentration. The detection rate of defective packaging can reach 100% by the two methods. Conclusion: Determination of package integrity of caffeine citrate injection by vacuum decay method is rapid, simple and sensitive.
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