注射用醋酸奥曲肽产品包装材料及选择依据 Packaging materials of Octreotide Acetate Injection Products and the Evidences for Choosing Them
l、包装材料的选择 Selection of the packaging materials 选用符合国家药用标准的2毫升无色管制瓶及配套丁基橡胶瓶塞作为内包装材料。 The internal packaging materials should be 2 ml colorless tube vials and butyl rubber stoppers. 2、选择依据 Evidences for choosing them 注射用醋酸奥曲肽为醋酸奥曲肽加适量甘露醇的无菌冷冻干燥品,故直接接触药品的包装材料选用符合国家药用要求的标准管制瓶及配套丁基橡胶瓶塞作为内包装材料。2毫升西林瓶材质为硼硅酸盐玻璃,主要成份为NA2O-B2O 3-S2O 2。由于玻璃中有很大部分的碱和碱土阳离子被硼、铝、锌所代替,此类玻璃有较好的化学惰性。采用稳定性较好的氯丁基橡胶塞,具有较好密封性,保证保存过程中产品的稳定。 Octreotide acetate injection are aseptic freeze dried products of octreotide acetate and appropriate amount of mannitol. Therefore, the packaging materials used internally which will directly contact the drugs shall be standard tube vials and supporting butyl rubber stoppers consistent with the national standards. The material for 2ml vials are borosilicate glass with NA2O-B2O 3-S2O2 being the main component. Because a large portion of the alkali and alkaline earth cation in the glass are replaced by boron, aluminum, zinc, the glass is chemically inert. Butyl rubber stoppers with good stability will seal the drugs better and guarantee the stability of the products during the storage.
华译网 上海翻译公司曾经翻译过大量有关 注射用醋酸奥曲肽产品包装材料及选择依据资料文件。
选用此包装,可满足以下要求: This package will meet the following requirements: 2.1 密封性良好,保护产品不受环境条件的影响。冻干制品其密封性与产品稳定性密切相关,采用此包装,加上铝塑盖扎紧后,具有很好密封性。 With perfect sealing capacity, it will protect the products from affected by the environment. In freeze dried products, the product stability was highly relevant to the sealing. This packaging together with alumni-plastic cover will guarantee the good sealing. 2.2 与内容制品不发生反应。 It does not react with internal contents. 2.3对人体无毒。 Innocuous to human. 2.4 能满足生产工艺要求。在灌封时可进行半加塞,冻干结束后,可在一定真空度下全压塞,并维持瓶内一定的真空度。 Able to meet the requirements for production technics. After filling, it is half plugged. After freeze dried, it is fully tapped in vacuum and a certain degree of vacuum is maintained within the bottles. 制剂的稳定性试验证明采用此包装材料,可保证本品在贮藏期间性质稳定。 Stability test of the preparation proved that this packaging material was able to guarantee the stability of the products during the storage.
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