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目的考察小儿止咳颗粒的加速稳定性,初步确定其有效期限。方法以性状、鉴别、溶化性、含量为质量指标,通过加速试验观察其质量变化情况。结果各项考察指标符合药品质量规定。结论本品在加速试验条件下稳定,加速试验6个月内其含量无明显变化,初步确定该制剂有效期为2年。
Objective To investigate the accelerating stability of pediatric cough granules and to determine its expiration date. Methods The traits, identification, solubility and content were taken as quality indexes, and their quality changes were observed through accelerated test. Results of the inspection indicators in line with the quality of drugs. Conclusion This product is stable under accelerated test conditions, its content did not change significantly within 6 months of accelerated test, and the preparation is validated for 2 years.