HPLC-DAD-CAD法应用于药用丁基胶塞与疫苗注射液的相容性研究

Compatibility Between Medicinal Rubber Stoppers and 13-valent Pneumococcal Polysaccharide Conjugate Vaccine by HPLC-DAD-CAD

目的考察药用丁基胶塞与13价肺炎球菌多糖结合疫苗的相容性。方法采用高效液相色谱-二极管阵列检测器-电雾式检测器(HPLC-DAD-CAD)同时测定胶塞和疫苗中抗氧剂、硫化剂、软脂酸和硬脂酸的含量,以抗氧剂BHT、抗氧剂1010、抗氧剂1076、对叔戊基苯酚、2-氯-4-叔戊基苯酚、硫磺以及软脂酸和硬脂酸含量为指标,通过提取试验和迁移试验研究胶塞和疫苗的相互作用,并评价其相容性。结果测定胶塞和疫苗中抗氧剂、硫化剂、软脂酸和硬脂酸含量的方法易操作、快速、灵敏,各试验指标均符合方法验证技术要求。3批胶塞提取液中的可提取物均未高于分析评价阈值水平,迁移试验未检出抗氧剂、硫化剂、软脂酸和硬脂酸。结论 13价肺炎球菌多糖结合疫苗与药用丁基胶塞具有良好的相容性。

OBJECTIVE To investigate the compatibility between medicinal rubber stoppers and 13-valent pneumococcal polysaccharide conjugate vaccine(PPCV 13). METHODS HPLC-DAD-CAD method was developed for determination of antioxidants, vulcanizates, palmitic acid and stearic acid in medicinal rubber stoppers and PPCV 13 injection. Taking antioxidant BHT, antioxidant 1010, antioxidant 1076, 4-tert-amylphenol, 2-chloro-4-(tert-pentyl)-phenol, sulfur, palmitic acid and stearic acid as indicators, extraction and migration tests were carried out to study the interaction between medicinal rubber stoppers and PPCV 13 and evaluate the compatibility. RESULTS HPLC-DAD-CAD method had the advantages of simple operation, fastness and sensitivity, which can meet the test requirements. In the extraction test, the investigated substances were lower than the analytical evaluation thresholds, the contents of leachables were not found in the migration test. CONCLUSION The antioxidants, vulcanizates, palmitic acid and stearic acid in the medicinal rubber stoppers have good compatibility with PPCV 13 injection.