摘要
目的建立心脉通软胶囊的质量控制方法,考察其稳定性。方法采用薄层色谱法鉴别心脉通软胶囊中的荭草、山楂叶和三七;采用高效液相色谱法对君药荭草中的异荭草素、荭草素进行含量测定;运用加速试验和长期试验方法对心脉通软胶囊的稳定性进行考察。结果薄层色谱法均检出了心脉通软胶囊中的主要药材,异荭草素、荭草素的质量浓度分别在11.05~88.40μg/mL(r=0.9999)和10.83~86.60μg/mL(r=0.9997)范围内与峰面积积分值线性关系良好,且3批心脉通软胶囊经6个月加速试验和24个月长期试验考察,各项指标均符合质量标准要求。结论心脉通软胶囊质量可控,稳定性好。
Objective To establish a quality control method for Xinmaitong Soft Capsules and investigate its stability. Methods The Polygonum orientale,Crataegi Folium and Notoginseng Radix et Rhizoma in Xinmaitong Soft Capsules were identified by TLC method,the content of isogenistin and urticarin in Polygonum orientale was determined by HPLC method,and the stability of Xinmaitong Soft Capsule was studied by accelerated test and long-term test. Results The main medicinal materials in Xinmaitong Soft Capsules all could be detected by TLC method. The isorientin and orientin showed good linear relationship with peak area in the ranges of 11. 05-88. 40 μg/m L( r = 0. 999 9) and 10. 83-86. 60 μg/m L( r = 0. 999 7). After 6 months of accelerated test and 24 months of long-term test,all the indexes of three batches of Xinmaitong Soft Capsules met the requirements of quality standards. Conclusion Xinmaitong Soft Capsules have controllable quality and good stability.
作者
郑林
刘丽娜
李月婷
李勇军
黄勇
王永林
兰燕宇
ZHENG Lin;LIU Lina;LI Yueting;LI Yongjun;HUANG Yong;WANG YongUn;LAN Yanyu(Guizhou Medidae University, Gnizhon Proviadal Key Labor airy of Pharmaceutics, State Key Laboratory of Functions ang Applications of Medicinal Plant i, Engiaeering Reseurcd Ceriro fno oOr Duiopmug and Application tn EiOnin Medicigr ang TCM < Ministry U EdncaiioO, Guiyaag, Guizhon, China 550004)
出处
《中国药业》
CAS
2019年第17期11-14,共4页
China Pharmaceuticals
基金
国家自然科学基金[81360664]
贵州省科技计划项目[黔科合平台人才[2017]5601
[2016]5613
[2016]5677]
贵阳市科研创新团队项目[筑科合同[2017]30-29号]
