内包材对醋酸奥曲肽注射剂质量的影响

Study on the effect of internal packing materials for the quality of octreotide acetate injection

目的:考察内包材对醋酸奥曲肽注射剂质量的影响。方法:以pH、溶液的澄清度、颜色、有关物质、含量及抗氧剂2,6-叔丁基-4-甲基-苯酚(BHT)迁移为指标,通过60℃下加速试验考察不同的胶塞及玻璃瓶对醋酸奥曲肽注射剂质量的影响。此外,采用电感耦合等离子体质谱(ICP-MS)法碰撞池技术,正向功率1 200 W,采样深度150 mm,雾化气流量0.97 L·min^(-1),冷却气流量13.0 L·min^(-1),对醋酸奥曲肽注射剂进行了铝、钡、铁、铬、锡、铅、镉、砷、汞、铜10种金属离子及有害元素迁移量测定,考察不同包材的金属离子及有害元素迁移情况。结果:覆膜溴化丁基胶塞与未覆膜溴化丁基胶塞对醋酸奥曲肽注射剂的pH、澄清度、颜色、有关物质及含量均无影响,2种胶塞的BHT迁移量无差异;中硼硅玻璃的金属离子及有害元素迁移量较低硼硅玻璃低。结论:中硼硅玻璃瓶相对低硼硅玻璃瓶更能保证醋酸奥曲肽注射剂产品的质量。

Objective:To study on the effect of internal packing materials for the quality of octreotide acetate injection. Methods:With the pH,clarification of the solution,colors,related substances,assay and butylated hydroxytoluene (BHT) as parameters,the effect of different stoppers and bottles on the quality of octreotide acetate injection by accelerated tests at 60 ℃ was studied. Meanwhile,the metal ion and harmful elements migration of Al、Ba、Fe、Cr、 Sn、Pb、Cd、As、Hg and Cu for octreotide acetate injection were determined by ICP-MS collision cell technology to study the metal ion migration of different packing materials. The ICP-MS parameters were as follows:the forward power was 1 200 W,the sample depth was 150 mm,the atomized air flow was 0.97 L·min^-1 and the cooling air flow rate was 13.0 L·min^-1. Results:The uncoated brominated butyl rubber stopper and the coated brominated butyl rubber stopper showed no impact on the pH,clarification of the solution,colors,related substances and assay of octreotide acetate injection. There is no difference of BHT migration between the two types of stoppers. The metal ion and harmful elements migration of borosilicate glass were less than that of low borosilicate glass. Conclusion:The borosilicate glass is better than low borosilicate glass for ensuring the quality control of octreotide acetate injection.