复方丹参制剂质量控制研究

Studies on Quality Control Method of Compound Radix Salviae Miltiorrhizae Preparations

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.