| 低装量注射用A型肉毒毒素与胶塞相容性研究 |
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| 引用本文： | 李小娟,田向斌,赵成梅,冯靖喻,王靖睿,张晓明,朱衍志.低装量注射用A型肉毒毒素与胶塞相容性研究[J].国际生物制品学杂志,2022,45(4):191-195. |
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| 作者姓名： | 李小娟 田向斌 赵成梅 冯靖喻 王靖睿 张晓明 朱衍志 |
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| 作者单位： | 1兰州生物技术开发有限公司质量检定室, 兰州 730030； 2甘肃省食品药品检定研究院化学药品检验研究室，兰州 730046 |
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| 摘 要： | 目的 评价进行工艺优化后的注射用A型肉毒毒素（0.1 ml分装量）与注射用冷冻干燥无菌粉末用氯化丁基橡胶塞（覆聚四氟乙烯/乙烯共聚物膜）的相容性。方法 完成包装的注射用A型肉毒毒素于（25±2）℃、相对湿度（60±5）%的条件下保存6个月，对元素杂质、抗氧剂、硬脂酸和棕榈酸、氟化物进行检测，考察胶塞成分是否会向制品中迁移；对制品进行效价、pH、水分、右旋糖酐和蔗糖、氧含量的测定及无菌检查，评价药品质量是否仍然可控。 结果 胶塞中元素杂质、抗氧剂、硬脂酸和棕榈酸、氟化物未见向制品中迁移，制品效价为104~119 IU/瓶，pH为5.94~6.07，水分最大值为2.5%，右旋糖酐和蔗糖含量稳定，氧含量最大值为3.4%，均无菌生长，符合质量标准。结论 注射用A型肉毒毒素与胶塞相容性良好，胶塞可用于生产。
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| 关 键 词： | 肉毒毒素 胶塞 相容性 |
The study on compatibility of botulinum toxin type A for injection and rubber stopper |
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| Affiliation: | 1Quality Control Department, Lanzhou Biotechnology Development Co., Ltd., Lanzhou 730030, China;2Chemical Medicine Control Department ,Gansu Institute of Food and Drug Control, Lanzhou 730046,China |
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| Abstract: | Objective To evaluate the compatibility of botulinum toxin type A for injection with polytetrafluoroethylene/ethylene copolymer membrane chlorinated butyl rubber stopper for freeze-dried sterile powder for injection. Methods Botulinum toxin type A for injection (0.1 ml) packaged with rubber stopper was stored at (25 ± 2) °C and (60 ± 5) % relative humidity for six months. Elemental impurities, antioxidants, stearic acid and palmitic acid, and fluoride were detected to investigate whether the rubber stopper’s components migrated to products. The titer, pH, water content, dextran, sucrose and oxygen content were determined and sterility test was performed to evaluate whether the quality of the drug was still controllable. Results Elemental impurities, antioxidants, stearic acid and palmitic acid, and fluoride did not migrate to the products. The titer was 104-119 IU per bottle, pH was 5.94-6.07, max water content was 2.5%, dextran and sucrose content was stable, max oxygen content was 3.4%, and all products, were aseptic, in line with the quality standards. Conclusion Botulinum toxin type A for injection has good compatibility with rubber stopper and the rubber stopper can be used for production. |
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| Keywords: | Botulinum neurotoxin Rubber stopper Compatibility |
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