九味生化颗粒制剂的稳定性试验研究  

Experimental Study on the Stability of Jiuwei Shenghua Granules

作　　者：赵丽萍 任建花 ZHAO Liping;REN Jianhua(Department of Pharmacy,Jiugang Hospital,Gansu Province,Jiayuguan 735100,China)

机构地区：[1]酒钢医院药学部,甘肃嘉峪关735100

出　　处：《中国中医药现代远程教育》2024年第6期145-148,共4页Chinese Medicine Modern Distance Education of China

摘　　要：目的通过对自制纯中药制剂九味生化颗粒的稳定性考察,确定其贮存方法及有效期。方法按照《中华人民共和国药典》(2015年版)四部中通则9001关于制剂的稳定性试验方法要求进行研究,以外观性状、水分、薄层鉴别、含量测定等为考察指标,通过进行高湿、高温、强光照射、加速及长期稳定性试验,对九味生化颗粒制剂进行稳定性考察。结果九味生化颗粒在高湿环境下具有一定的吸湿性,影响因素试验、加速及长期试验均表明本品各项指标均在质量标准范围内,质量稳定。结论中药制剂九味生化颗粒在制备、分装与贮存时要密封保存,并防止受潮;其在常温下,质量稳定。Objective To determine the storage method and expiry date of Jiuwei Shenghua granules by investigating the stability of the self-made pure Chinese medicine preparation.Methods The stability test of Jiuwei Shenghua granules was carried out in accor⁃dance with the requirements of the stability test method of the preparation in the general rule 9001 of the fourth part of the Chinese Pharmacopoeia(2015 edition),with the appearance,moisture,thin layer identification,and content determination as the inspection in⁃dicators,through the high humidity,high temperature,strong light irradiation,accelerated and long-term stability tests.Results The product has certain hygroscopicity in high humidity environment.The influence factor test,accelerated test and long-term test show that all indicators of Jiuwei Shenghua granules are within the quality standard range and the quality is stable.Conclusion The tradi⁃tional Chinese medicine preparation Jiuwei Shenghua granules should be sealed and stored during preparation,sub-packaging and storage,and should be protected from moisture.Under normal temperature,the quality is stable.

关 键 词：九味生化颗粒 稳定性 中药制剂 影响因素 

分 类 号：R286.0[医药卫生—中药学]