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乳疾灵胶囊质量标准研究
帅银花1, 王琼2, 刘敬3, 赵斌2
1.中山市中智药业集团有限公司 528436;2.中山火炬职业技术学院 528436;3.成都中医药大学 611731
摘要:
[目的] 建立乳疾灵胶囊质量标准。[方法] 采用薄层色谱法对方中淫羊藿、赤芍、丹参、青皮进行定性鉴别;采用高效液相色谱法对淫羊藿苷进行含量测定。[结果] 薄层鉴别均斑点清晰,阴性对照无干扰;含量测定中淫羊藿苷进样量在0.0928~0.4640μg范围内,与峰面积线性关系良好(r=0.9998),平均回收率为99.12%,RSD=1.54%(n=6)。[结论] 所建立方法操作简单、专属性和重复性良好,可作为该制剂的质量控制方法。
关键词:  乳疾灵胶囊  质量标准  淫羊藿苷  反相高效液相色谱法  薄层色谱
DOI:10.11656/j.issn.1673-9043.2009.03.19
分类号:
基金项目:
Quality standard for Rujiling Capsules
SHUAI Yin-hua,WANG Qiong,LIU Jing
Zhongshan Zeus Medicine Industry Group Co., LTD., Zhongshan 528437, China
Abstract:
[Objective] To establish the quality standard of Rujiling Capsules.[Methods] Radix Paeoniae Rubra,Radix Salviae Miltiorrhizae,Herba Epimedii,Pericarpium Citri Reticulatae Viride were identified by TLC.The content of icraiin was determined by RP-HPLC.[Results] The TLC sports developed were fairly clear,and the blank test showed no interference.The control content of icraiin was within the range of 0.092 8~0.4640 μg,and there was the fine linearship between the sample input and the peak area,the average recovery was 99.12%,RSD was 1.54%(n=6). [Conclusion] The methods are simple,accurate with good repeatability,which can be used for the quantity control of Rujiling Capsules.
Key words:  Rujiling Capsules  quality standard  icraiin  RP-HPLC  TLC
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