摘要
目的 制定龙蛭胶囊质量控制方法.方法 用纤维蛋白平板法检测龙蛭胶囊纤溶活性,用全自动血凝仪测定该药体外抗凝效应,用薄层色谱（TLC）法鉴别阿魏酸、红花黄色素,用高效液相色谱（HPLC）法测定阿魏酸和羟基红花黄色素A含量.结果 纤溶活性为73万U·g-1,体外活化部分凝血酶时间、凝血酶原时间、凝血酶时间显著延长,TLC法鉴别专属性强,斑点清晰,分离度好,阿魏酸在进样量0.04～0.40 μg呈良好线性关系,平均回收率为99.32%,羟基红花黄色素A在进样量0.5～5.0 μg呈良好线性关系,平均回收率为99.14%.结论 该法可有效地控制龙蛭胶囊质量,方法简便快速、准确可靠,重复性好.
Objective To study the quality control method for longzhi capsule. Methods Fibrin plate method wasused to detect the drug fibrinolytic activity. Anticoagulantion effect of the drug in vitro was measured by using Automaticcoagulation analyzer. Ferulic acid and safflor yellow in the drug were identified by thin-layer chromatography （TLC）. The contentsof ferulic acid and hydroxysafflor yellow A in longzhi capsules were determined by high performance liquid chromatograghy （HPLC）. Results Longzhi capsule had obvious fibrinolytic effect. It could obviously prolong activated partial thromboplastintime （APTT）, prothrombin time （PT） and thrombin time （TT）. The calibration curve of ferulic acid was linear in the range of0. 04-0. 40 μg （r =0. 999 9）, the average recovery was 99. 3%. The calibration curve of hydroxysafflor yellow A was linear inthe range of 0. 5-5. 0 μg （r =0. 999 8）, the average recovery was 99. 1%. Conclusion This method is simple, accurate andcapable to effectively control the quality of longzhi capsules.
出处
《医药导报》
CAS
北大核心
2014年第2期240-245,共6页
Herald of Medicine
基金
广西壮族自治区卫生厅资助项目(GZYZ-10-32)
关键词
龙蛭胶囊
纤溶活性
阿魏酸
羟基红花黄色素A
质量控制
Longzhi capsule
Fibrinolytic activity
Ferulic acid
Hydroxysafflor yellow A
Quality control
