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目的研究小容量注射剂亮蓝溶液检漏法灵敏度与风险性,掌握风险程度,寻找风险降低的方式,保证产品质量。方法对亮蓝溶液检漏法的肉眼识别浓度和分光光度法检测灵敏度进行测定,并对不同颜色的小容量注射液进行灵敏度测定,确定质量风险。结果亮蓝溶液肉眼可识别的浓度为0.03×10~(-6)g/g,在(629±2)nm有最大吸收,分光光度法检测的灵敏度为0.01×10~(-6)g/g;无色注射液肉眼可识别浓度为0.15~0.25×10~(-6)g/g,分光光度法检测的灵敏度为0.015×10~(-6)g/g;有色注射液肉眼可识别的浓度为0.25~2.5×10~(-6)g/g,分光光度法检测的灵敏度为0.015×10~(-6)g/g。结论小容量注射液采用亮蓝溶液进行检漏存在质量风险,可对不足之处进行适当补救,提高不良品的剔除率。
Objective To study the sensitivity and risk of small volume injection blue solution leak detection method, to master the degree of risk, to find ways to reduce risk and to ensure product quality. Methods The naked eye recognition concentration and spectrophotometric detection sensitivity of brilliant blue solution were determined, and the sensitivity of different color injection volumes was determined to determine the quality risk. Results The concentration of Brilliant Blue solution was 0.03 × 10 ~ (-6) g / g macroscopically and the maximum absorbance was at (629 ± 2) nm. The sensitivity of spectrophotometry was 0.01 × 10 -6 g / g; the identifiable concentration of colorless injection was 0.15 ~ 0.25 × 10 ~ (-6) g / g, the sensitivity of spectrophotometry was 0.015 × 10 ~ (-6) g / g; The concentration was 0.25 ~ 2.5 × 10 -6 g / g, the sensitivity of spectrophotometry was 0.015 × 10 -6 g / g. Conclusion Small volume injection with bright blue solution for leak detection poses quality risk. It can remedy the deficiencies and improve the reject rate of defective products.