| 摘要: |
| 目的:分析低浓度硫酸阿托品滴眼液的稳定性参数,为药品的合理贮藏和安全用药提供参考。方法:以pH、硫酸阿托品
含量和有关物质作为评价指标进行溶液稳定性实验、影响因素实验、长期实验和加速实验。结果:硫酸阿托品在中性溶液(pH=7)
中稳定性较差,高温(>40 ℃)下硫酸阿托品降解明显,而光照和冻融无明显影响。在加速实验条件下[(25±2)℃,(40±5)%RH]
贮藏6 个月药液的杂质C(托品酸)和总杂质呈增长趋势,硫酸阿托品含量降低;在长期实验条件下[(5±3)℃]贮藏18 个月药
液的杂质C 和总杂质增长趋势缓慢,杂质C 最大值仅为0. 6%,总杂质最大值仅为0. 7%。结论:温度为影响制剂稳定性的关键
因素,低浓度硫酸阿托品滴眼液以(5±3)℃冷藏作为贮藏条件稳定性良好,效期可达24 个月。 |
| 关键词: 低浓度 硫酸阿托品 稳定性 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2025.06.005 |
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| 基金项目: |
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| Stability Study of Low-Concentration Atropine Sulfate Eye Drops for Children |
| Liu Zongyang, Fan Yunwei, Zhang Huan, Wang Hailun, Yang Shaopeng |
| (Beijing Children’s Hospital, Capital Medical
University, Beijing 100045, China) |
| Abstract: |
| Objective: To analyze the stability parameters of low-concentration atropine sulfate eye drops, and provide reference for the
rational storage and safe use of drugs. Methods: The solution stability experiment, influence factor experiment, long-term experiment
and accelerated experiment were carried out with pH, atropine sulfate content and related substances as evaluation indicators. Results:
The stability of atropine sulfate in neutral solution (pH=7) was poor, and the degradation of atropine sulfate at high temperature (>40 ℃)
was obvious, but there was no obvious effect on light and freeze-thaw. Under accelerated conditions at (25±2) ℃ and (40±5)%RH,
impurity C (tropic acid) and total impurities in the stored solution increased over 6 months, while the content decreased due to the
degradation of atropine sulfate. Under long-term conditions at (5±3) ℃, the growth trend of impurity C and total impurities in the stored
solution was slow over 18 months, with the maximum value of impurity C reaching 0. 6% and total impurities reaching 0. 7%.
Conclusion: Temperature is the key factor affecting the stability. Low-concentration atropine sulfate eye drops have good stability when
stored under refrigeration at (5±3) ℃, and the expiration date can reach 24 months. |
| Key words: low-concentration atropine sulfate stability |
