在各种存储条件下分析0.04%的米托米辛C眼液的稳定性
Yuma Nonomiya1,2, Koki Yamaguchi2, Yuta Yokoyama2
1Department of Pharmacy, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
The Keio journal of medicine
|June 29, 2025
概括
医院准备的米托米C (MMC) 眼科溶液是不稳定的. 存储MMC溶液在寒冷和阴影下显著提高稳定性,确定其临床使用到期日期.
科学领域:
- 眼科医生 眼科 眼科
- 制药科学 制药科学
- 化学稳定性 化学稳定性
背景情况:
- 在医院中,0.04%的米托米辛C (MMC) 眼科溶液是临时准备的.
- 关于这种复合眼科制剂的物理性质和稳定性的数据有限.
研究的目的:
- 为了评估医院制备的米托米C (MMC) 眼科溶液的稳定性.
- 为了确定最佳的储存条件并确定临床使用的到期日期.
主要方法:
- 米托米辛C (MMC) 眼科溶液在各种条件下准备和储存:冷/阴光,室温/阴光,室温/散光.
- 使用高性能液态染色学 (HPLC) 来量化21天的MMC度.
- 进行了pH测量和细菌培养试验.
主要成果:
- 随着时间的推移,MMC度下降,最显著的降解发生在室温和暴露于光线下.
- 在冷条件下储存的溶液中观察到最低的降解率,保护免受光线的影响.
- pH从5.8增加到6.9,没有检测到细菌污染.
结论:
- 米托米辛C (MMC) 眼科溶液在冷条件下存储和保护免受光线影响时表现出最大的稳定性.
- 这项研究提供了关键的数据,以确定复合MMC眼科溶液临床应用的可靠到期日.
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