| 甲硝唑氯化钠注射液的冻融稳定性研究及质量控制图分析 |
| 投稿时间：2021-05-31 修订日期：2022-02-19 点此下载全文 |
| 引用本文：朱滇黔,李睿旻,李玲.甲硝唑氯化钠注射液的冻融稳定性研究及质量控制图分析[J].药学实践杂志,2022,40(6):532~535 |
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| 基金项目:2017年度后勤科研项目（BWS17J020） |
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| 中文摘要:目的 考察极端严寒环境及不同冻融条件对甲硝唑氯化钠注射液稳定性的影响。方法 模拟甲硝唑氯化钠注射液在极端寒冷环境下的冻结过程，并给予适当的条件使其融化。采用HPLC法测定甲硝唑的含量，分别考察室温和60 ℃水浴解冻及冻融次数对甲硝唑含量的影响，并对变化情况作质控图分析。结果 甲硝唑在0.01～1.00 mg/ml范围内线性关系良好，r=1.000，平均回收率101.38%（RSD=0.94%），符合方法学要求。样品在?20 ℃冷冻，60 ℃水浴解冻18次，稳定性良好；室温解冻时，容易形成针状结晶，含量降低。结论 在极端严寒环境下甲硝唑氯化钠注射液的稳定性会受冻融条件的影响，使用时应当尽量减少其冻融次数，避免室温解冻。 |
| 中文关键词:甲硝唑氯化钠注射液 冻融试验 高效液相色谱 极端严寒环境 质控图 |
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| Freeze/thaw stability and quality control chart analysis of metronidazole sodium chloride injection |
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| Abstract:Objective To investigate the effect of different freezing thawing conditions on the stability of metronidazole sodium chloride injection in extreme cold environment. Methods The freezing process of metronidazole sodium chloride injection in extremely cold environment was simulated and appropriate conditions were given to melt. The effects of room temperature, 60 ℃ water bath thawing and freeze-thaw times on the content of metronidazole were investigated by HPLC, and the changes were analyzed by quality control chart. Results The linear range of metronidazole was 0.01～1.00 mg/ml and the relationship was acceptable, r=1.000, the average recovery was 101.03% (RSD=1.17%), which met the requirements of methodology. The samples were frozen at ?20 ℃ and thawed in 60 ℃ water bath for 18 times with good stability. However, when thawed at room temperature, acicular crystals formed and the content decreased. Conclusion In extreme cold environment, the stability of metronidazole sodium chloride injection could be affected by freezing and thawing conditions. Therefore, in the use of Metronidazole and Sodium Chloride Injection, the number of freeze-thaw cycles should be minimized, and try to avoid thaw at room temperature. |
| keywords:metronidazole sodium chloride injection freeze/thaw test HPLC extreme cold environment quality control chart |
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