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目的:考察氯霉素滴眼液在不同贮存条件下的稳定性,并确定其有效期。方法:取供试品3批分别于(25±2)℃与(4±2)℃条件下贮存9个月,以HPLC法考察贮存期间氯霉素含量的变化情况。结果:两种贮存条件下,氯霉素含量均逐渐降低,且(25±2)℃条件下降低更为明显,有效期分别为4.71个月和24.04个月。结论:贮存温度显著影响氯霉素含量,氯霉素滴眼液宜低温贮存。
Objective: To investigate the stability of chloramphenicol eye drops under different storage conditions, and to determine the validity period. Methods: Three batches of test samples were stored for 9 months at (25 ± 2) ℃ and (4 ± 2) ℃, respectively. The changes of chloramphenicol content during storage were determined by HPLC. Results: Under the two storage conditions, the content of chloramphenicol decreased gradually, and it was more obvious under the condition of (25 ± 2) ℃, the effective period was 4.71 months and 24.04 months respectively. Conclusion: The storage temperature significantly affected the content of chloramphenicol, chloramphenicol eye drops should be stored at low temperature.