金鸡系列制剂质量的初步评价  

Preliminary Evaluation of Jinji Series Preparations Quality

作　　者：黄云 杨艳模[2] 林海 

机构地区：[1]湖南食品药品职业学院,湖南长沙410208 [2]常德市第一人民医院,湖南常德415003 [3]湖南省中药不良成分快速检测及脱除工程技术研究中心,湖南长沙410001 [4]湖南省食品药品检验研究院,湖南长沙410001

出　　处：《湖南中医药大学学报》2014年第9期31-34,共4页Journal of Hunan University of Chinese Medicine

基　　金：湖南省科技计划资助项目(湘科计[2012]93号)

摘　　要：目的对金鸡系列制剂的质量进行分析,为其他简单改剂型制剂的质量评价提供参考。方法采用薄层色谱鉴别、含量测定及特征谱图比对方法检测金鸡颗粒、薄膜衣片、糖衣片、胶囊、分散片5种剂型。结果薄层色谱显示,薄膜衣片、糖衣片与原研药颗粒剂色谱图比较接近,而胶囊剂和分散片色谱图比较接近;含量检测显示,同一厂家不同剂型颗粒剂所含生物碱总量最低,不同厂家不同剂型,含量差异悬殊;特征图谱显示,薄膜衣片、糖衣片所含成分与原研药颗粒剂基本一致,而胶囊剂和分散片的色谱图中,少了一个特征峰。结论几种简单改剂型的金鸡制剂的质量跟原研药颗粒剂存在较大差异,且不同剂型间也存在差异,提示对已上市简单改剂型的中成药质量有必要进行再评价。Objective To provide the reference for quality evaluation of other simple change dosage forms by analyzing quality of the Jinji series preparations. Methods To detect the Jinji granules, film-coated tablets, sugar-coated tablets, capsules, dispersible tablets, five kinds of dosage forms by thin-layer chromatographic（TLC） identification, content determination as well as comparison of characteristic chromatogram. Results TLC results showed film-coated tablets,sugar-coated tablets and reference listed drug（RLD） granules chromatogram were similar, nevertheless, the capsules and dispersible tablets chromatograms were resemble.Content detection displayed total alkaloids was lowest in the granules produced in the same factory and varied dramatically in the different dosage forms. Characteristic chromatograms indicated that film-coated tablets and sugar-coated tablets contained basically the same ingredients as the RLD granules, while there was a missing peak in the capsules and dispersible tablets chromatograms.Conclusion The quality of several simple changed Jinji preparations have much difference with the RLD granules, and also differences between each other. Therefore, the reassessment on post-marketing Chinese generics medicine is necessary.

关 键 词：金鸡颗粒剂 金鸡胶囊 金鸡糖衣片 金鸡薄膜衣片 金鸡分散片 质量初步评价 特征图谱 

分 类 号：R284.1[医药卫生—中药学] R927.1[医药卫生—中医学]