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目的:考察全国11家企业生产的苯磺酸左旋氨氯地平片在光照、高温、高湿条件下放置5 d和10 d的有关物质及含量,以及样品中检出的氨氯地平乳糖加合物杂质量与环境温湿度的相关性。方法:采用Agilent XDB C18色谱柱(250 mm×4.6 mm,5μm);流动相:甲醇-乙腈-0.7%三乙胺溶液[取三乙胺7.0 m L,加水至1 000 m L,用磷酸调节p H值至(3.0±0.1),V甲醇∶V乙腈∶V三乙胺=35∶15∶50];检测波长:238 nm;流速:1.0m L·min-1;柱温:30℃;进样量:20μL。结果:11家生产企业均检出杂质脱氢氨氯地平,使用乳糖或糊精的3家企业检出氨氯地平乳糖加合物;光照、高温对脱氢氨氯地平和总杂质的含量影响较大,高温对左旋氨氯地平含量影响较大;氨氯地平乳糖加合物的量与环境温湿度和放置时间呈显著性正相关。结论:建议使用乳糖的生产企业变更处方工艺,生产过程应注意避光,车间控制温湿度,生产工艺如用湿法制粒应控制物料干燥温度不宜过高,包装应用避光、阻隔性好的材料,宜在避光、密封阴凉处保存。
OBJECTIVE: To investigate the related substances and contents of levamlodipine besilate tablets which were produced in 11 enterprises in China for 5 d and 10 d under light, high temperature and high humidity conditions, and the amlodipine lactose addition The correlation between the amount of impurities and the temperature and humidity of the environment. Methods: Agilent XDB C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was methanol-acetonitrile-0.7% triethylamine solution [triethylamine 7.0 m L and water to 1000 m L, pH 3.0 to 0.1, V methanol: V acetonitrile: V triethylamine = 35:15:50]; detection wavelength: 238 nm; flow rate: 1.0 m L · min-1; Injection volume: 20μL. Results: Eleven amoxicillin and amlodipine lactose adducts were detected in 11 enterprises with impurity dehydroamlodipine and lactose or dextrin respectively. The effects of light and temperature on the content of amniotic dextrins and total impurities Larger and higher temperatures had a greater effect on the content of levamlodipine. The amount of amlodipine lactose adduct was significantly and positively correlated with the temperature, humidity and storage time. Conclusion: It is recommended that the manufacturer of lactose should change the prescription process, the production process should be taken care to avoid light, temperature and humidity should be controlled in the workshop, the production process should be controlled by wet granulation, such as the drying temperature should not be too high, the package should be dark and good barrier material , Should be in the dark, sealed cool place to save.