复方血栓通片的质量标准及其稳定性研究  

Quality Standard and Stability Research for Compound Thrombosis Tablets

作　　者：成伙清 李顺浓 

机构地区：[1]广东众生药业股份有限公司,广东东莞523325

出　　处：《中国中医药信息杂志》2011年第7期52-54,共3页Chinese Journal of Information on Traditional Chinese Medicine

摘　　要：目的制订复方血栓通片的质量标准并考察前3批产品的稳定性。方法采用薄层色谱法(TLC)对制剂中三七、黄芪、玄参、丹参进行鉴别,对人参皂苷Rg1、人参皂苷Rb1进行含量测定,并留样观察2年。结果制剂的TLC斑点清晰,重复性好;人参皂苷Rg1和人参皂苷Rb1浓度与吸收度呈线性关系,平均回收率为97.36%,精密度试验RSD=0.32%。留样考察2年,崩解时限最高为13 min,含量测定每片人参皂苷Rg1+人参皂苷Rb1总量最低为17.2 mg,各项指标均符合规定。结论复方血栓通片质量标准切实可行,产品在有效期2年内质量稳定。Objective To establish the quality standard of Compound Thrombosis Tablets and to investigate the stability of first three batches of product.Methods TLC was adopted to identify Panax Notoginseng,Radix Astragalus,Radix Scrophulariae and Sivia miltiorrhiza,and determine the content of ginsenoside Rg1 and ginsenoside Rb1.Samples were observed for 2 years.Results The TLC spots of the preparation were clear and reproducible.The relationship of concentration and absorbance of ginsenoside Rg1 and ginsenoside Rb1 was linear,the average recovery was 97.36%,and RSD of precision was 0.32%.After 2 years,disintegration time was up to 13 min,the total content of ginsenoside Rg1 and ginsenoside Rb1 was 17.2 mg,the indicators met the requirements.Conclusion The quality standard of Compound Thrombosis Tablets is feasible.The product quality is stable in the period of 2 years.

关 键 词：复方血栓通片 薄层色谱法 含量测定 留样观察 

分 类 号：R284.1[医药卫生—中药学]