复方丹七郁胶囊质量标准及其稳定性研究

Quality Standard and Stability of Compound Danqiyu Capsules

目的探讨复方丹七郁胶囊的质量标准及其稳定性。方法采用薄层色谱(TLC)法对复方丹七郁胶囊中的丹参及三七的主要成分进行定性鉴别,采用高效液相色谱(HPLC)法测定主要成分丹酚酸B的含量,采用加速试验和长期试验考察其稳定性。结果丹参和三七的定性鉴别斑点圆整,分离度好,易于鉴别;丹酚酸B质量浓度在9.94~49.71μg/m L范围内与峰面积线性关系良好(r=0.9992);丹酚酸B平均回收率为99.81%,RSD为0.23%(n=6);3批复方丹七郁胶囊经6个月加速试验和12个月长期试验考察,各项指标均符合质量标准要求。结论本研究中建立的定性、定量方法操作简便、灵敏度高、重复性好,可作为该制剂的质量控制方法。该制剂在常温下保存稳定性良好。

Objective To investigate the quality standard and stability of Compound Danqiyu Capsules.Methods Qualitative identification was made by TLC method for Salvia Miltiorrhiza and Notoginseng Radix et Rhizoma in the Compound Danqiyu Capsules.Content determination for salvianolic acid B in the Compound Danqiyu Capsules was carried out by HPLC method.Accelerated test and long-term test were used for evaluating the stability of Compound Danqiyu Capsules.Results The results of qualitative identification of Salvia Miltiorrhiza and Notoginseng Radix et Rhizoma showed that the spots were round,good separation and easy to identity.The salvianolic acid B showed good linearity in the range of 9.94-49.71μg/m L(r=0.9992),the average recovery rate of salvianolic acid B was 99.81%with RSD of 0.23%(n=6).The results of six-month accelerated test and 12-month long-term test showed that the quality indexes of three batches of the Compound Danqiyu Capsules were consistent with the regulations of drug quality criteria.Conclusion The qualitative and quantitative methods established in this study are simple,highly sensitive and reproducible,which can be used for the quality control of this preparation.The preparation has good stability at room temperature.