青霉素皮试剂与0.9%氯化钠溶液的配伍稳定性研究

Compatibility Study of Penicillin for Skin Test with 0.9% Sodium Chloride

目的通过对青霉素皮试剂与0.9%氯化钠注射液的配伍稳定性研究,确认现有产品使用说明书的合理性。方法取3批青霉素皮试剂,按现有药品使用说明书配制溶液,在不同的温度下存放,采用HPLC考察不同时间青霉素皮试液的有关物质、含量指标的变化情况。结果青霉素皮试剂的有关物质在0.9%氯化钠注射液中随着时间的推移呈上升趋势:在25℃室温条件下存放,4 h后杂质总量接近1.0%;8 h后已经接近2.0%,明显超出企业内控标准(1.0%)。在2~8℃低温条件下,24 h后杂质总量仍<1.0%。结论青霉素皮试剂与0.9%氯化钠注射液的配伍稳定性与存放的温度和时间条件相关性大。在实际临床应用中,建议配制好的药液在25℃左右室温条件下存放≤4 h;在2~8℃低温条件下可以存放24 h。建议企业及时修订青霉素皮试剂的使用说明书,在说明书的用法用量中注明存放条件和存放时间,以确保皮试的准确性和用药的安全性。

OBJECTIVE To study the compatibility of penicillin for skin test with 0.9% sodium chloride, to verify the rationality of current drug use instruction. METHODS Three batches of penicillin for skin test were prepared into solution according to current drug use instruction, and stored for different period under different temperature, evaluating the change in related substances and assay for different storage period by HPLC. RESULTS The related substances in penicillin for skin test dissolved in 0.9% sodium chloride tend to rise over time： at the room temperature of 25 ℃ for 4 h, total impurities were close to 1.0%; at the room temperature for 8 h, total impurities were close to 2.0%, and obviously exceed the in-house specification（1.0%）; at the low temperature of 2-8 ℃ for 24 h, total impurities were 1.0%. CONCLUSION The compatibility stability of penicillin for skin test with 0.9% sodium chloride is closely related to storage temperature and time. It is suggested that during clinical use, prepared penicillin solution for skin test shall be used within 4 h at about 25 ℃ and within 24 h at 2-8 ℃. The enterprises shall revise the drug use instruction of penicillin for skin test in time, stating the storage temperature and time under the usage and dosage, in order to ensure the accuracy of skin test and safety of drug.