复方丹参制剂质量控制研究  

Studies on Quality Control Method of Compound Radix Salviae Miltiorrhizae Preparations

作　　者：黄喜茹[1] 范桂敏[1] 冯媛媛[1] 杨亚军[1] 

机构地区：[1]河北医科大学药学院,河北石家庄050017

出　　处：《时珍国医国药》2006年第9期1628-1629,共2页Lishizhen Medicine and Materia Medica Research

基　　金：河北省卫生厅资助基金项目(No.04102);河北省中医药管理局资助基金项目(No.05057)

摘　　要：目的 建立复方丹参制剂中水溶性酚酸总量的测定方法，以其中酚酸总量做为质量控制指标全面控制药品质量。方法 利用丹参中水溶性酚酸类成分与NaNO2-Al（NO3），在碱性争件下的显色反应，比色法测定复方丹参制剂中水溶性酚酸（以原儿茶醛计）的总量。结果 原儿茶醛在3．336～14．46μg/ml范围内呈良好的线性关系，回归方程为：A=O．02777C＋O．01279（r=0.09996），加样平均回收率为99．95％，RSD为0.16％。结论 该法简便快速，结果准确．重现性好，可用于复方丹参制剂的质量控制。Objective To establish an assay for the determination of the total components of water - soluble phenolic acidity in compound Danshen preparation. Methods In the solvent of 1 mol/L NaOH,using the reaction of the total components of water - soluble phenolic acidity in Danshen and the NaNO2 -Al （NO3）3, the total components of water- soluble phenolic acidity in compound Danshen preparation （calculated with protocatechualdehyde ） were determincd by colorimetric spectrophotometry. Results The linear range of protocatechualdehyde was over 3. 336 - 14.46 μg/ml, the correlative equation was ：A = 0. 027 77 C ＋ 0. 012 79 （r = 0.999 6）. The average recovery and relative standard deviation were 99.95% and 0.16%, respectively. Conclusion The method was simple,quick and accurate,and it is usable on controling the quality of compound Danshen preparation.

关 键 词：复方丹参 制剂 原儿茶醛 水溶性酚酸总量 比色法 

分 类 号：R283[医药卫生—中药学]