| 韩程佳,刘 浩,王 彦,潘 颖,闫 超.药用丁基胶塞与注射用氨曲南相容性研究[J].,2020,(9):1624-1630 |
| 药用丁基胶塞与注射用氨曲南相容性研究 |
| Compatibility Study of Aztreonam for Injection and Rubber Stopper |
| 投稿时间：2019-09-28 修订日期：2019-10-24 |
| DOI：10.13241/j.cnki.pmb.2020.09.005 |
| 中文关键词: 注射用氨曲南 药用丁基胶塞 相容性 澄清度 |
| 英文关键词: Aztreonam for injection Rubber plug Compatibility Clarity |
| 基金项目:国家自然科学基金项目（21874088, 81874307）；上海市科委"科技创新行动计划"项目（16142200300，17142201000，18142200700）；上海市标准化推进专项(17DZ2201500) |
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| 中文摘要: |
| 摘要 目的：考察药用丁基胶塞与注射用氨曲南澄清度的相关性。因为胶塞中的挥发性成分易于迁移出瓶塞，在与药粉接触过程中会被药物表面所吸附，形成胶体或药粉团，进而影响澄清度。本文研究胶塞中的挥发性物质和抗氧化剂能否迁移至氨曲南粉末中，引起溶液浑浊，甚至超过中国药典规定的限度。方法：随机选取23家生产企业样品中的1批，分别对胶塞和粉末进行GC-MS分析，测定挥发物质。以Agilent HP-5 MS（30 m×0.25 mm，0.25 μm）色谱柱；载气：高纯氦气；流速：1.0 mL/min；柱温：50 ℃，保持5 min，以5℃/min速度升温到200 ℃，保持6 min；进样量：1.0 mL。顶空条件：110 ℃恒温40 min；采用HPLC法对6家单位25批样品进行十一种抗氧化剂的检测。色谱柱：Ultimate XB-C18，4.6×250 mm（Agilent），10 μm ；测定波长：200 nm；流动相水-乙腈(7:3，按梯度洗脱)；柱温：60℃；进样体积：20 μL。结果：胶塞和粉末中均检测出四种环硅氧烷类挥发物质。25批样品中测出了四种抗氧剂1076、BHT、TP、TBHQ。在溶液的澄清度不合格的样品中BHT的含量较高，影响了药品的质量。结论：样品溶液的澄清度与粉末中环硅氧烷类化合物的检出量有一定的相关性。胶塞中的挥发性物质和抗氧化剂会迁移到注射用氨曲南溶液中从而影响到澄清度。建议企业提高胶塞生产工艺，提高药品的质量，保障用药的安全。 |
| 英文摘要: |
| ABSTRACT Objective: To investigate the correlation of clarification between the aztreonam for injection and butyl rubber plug. The volatile components in the stopper are easily removed from the bottle plug, and will be adsorbed by the drug surface during contact with the powder, forming a colloid or powder group, and then affect the clarity. In this paper, we studies whether the volatile substances and antioxidants in the rubber plug can migrate into the drug powder and cause the solution to be cloudy, even exceeding the limit stipulated by Chinese pharmacopoeia. Methods: One batch of samples from 23 manufacturers was randomly selected and GC-MS analysis was performed on the rubber plugs and powder respectively to determine volatile substances. Agilent HP-5 MS (30 m×0.25 mm, 0.25 μm) chromatographic column was used. Carrier gas: high purity helium gas; Flow rate: 1.0 mL/min; Column temperature: 50℃, maintained for 5 min, at the rate of 5℃/min to 200 ℃, maintained for 6 min; Injection quantity: 1.0 mL. Headspace condition: 110 ℃ constant temperature for 40 min; HPLC method was also used to detect 11 kinds of antioxidants in 25 batches of samples from 6 units. Chromatographic column: Ultimate XB-C18, 4.6×250 mm (Agilent), 10 micron; Determination wavelength: 200 nm; Mobile phase water - acetonitrile (7:3, elution by gradient); Column temperature: 60℃; Injection volume: 20 μL. Results: Four kinds of cyclosiloxane volatile substances were detected in rubber plug and powder. Four antioxidants agents 1076, BHT, TP and TBHQ were detected in 25 batches of samples. The content of BHT was higher in the sample with unqualified clarification of solution, which affected the quality of medicine. Conclusion: There is a certain correlation between the clarification degree of the sample solution and the amount of cyclosiloxane compounds detected in the powder. Volatile substances and antioxidants in the plug can migrate to the aztreonam for injection and affect its clarification. It is suggested that enterprises must improve the production process of rubber plug and the quality of drugs to ensure the safety of drugs. |
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