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目的:探讨临床胰岛素类注射剂经反复穿剌抽取后稳定性变化。方法:按中国药典2005年版附录细菌内毒素检查法凝胶限量试验测定细菌内毒素,按微生物限度检查法薄膜过滤做细菌培养,按不溶性微粒检查法中显微计数测定不溶性微粒,用高效液相色谱法测定胰岛素含量。结果:启封后各胰岛素类注射液细菌内毒素均符合规定,而细菌培养约有20%样品有细菌生长,不溶性微粒有不同程度的增加,使用过程中2~30d胰岛素的液相色谱图无变化。结论:此类注射剂的包装量太大,反复穿剌抽吸可导致细菌污染和微粒变化。
Objective: To investigate the stability of clinical insulin injection after repeated puncture extraction. Methods: Bacterial endotoxin was determined according to the Chinese Pharmacopoeia 2005 appendix bacterial endotoxin test gel limit test, according to the microbial limit test membrane filtration bacterial culture, according to the insoluble particle test microscopic count determination of insoluble particles, with high performance liquid chromatography Determination of insulin content by chromatography. Results: The bacterial endotoxin of each insulin injection was in conformity with the regulations after opening, but about 20% bacteria in the bacterial culture had the bacteria growth and the insoluble particles increased in varying degrees. There was no change in the liquid chromatogram of insulin during 2 ~ 30d . Conclusion: The injection volume of this kind of injection is too large, repeated puncture and suction can lead to bacterial contamination and particle changes.