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乌参八味胶囊质量标准研究
引用本文:顾明业,吴琼,徐彬,胡北,安晔,史国兵.乌参八味胶囊质量标准研究[J].中国药师,2014(6):931-934.
作者姓名:顾明业  吴琼  徐彬  胡北  安晔  史国兵
作者单位:沈阳军区总医院药剂科 沈阳110016;沈阳军区总医院药剂科 沈阳110016;沈阳军区总医院药剂科 沈阳110016;沈阳军区总医院药剂科 沈阳110016;沈阳军区总医院药剂科 沈阳110016;沈阳军区总医院药剂科 沈阳110016
基金项目:军队医疗机构制剂标准提高科研专项重点课题(编号:13ZJZ02)
摘    要:目的:建立乌参八味胶囊的质量标准.方法:采用薄层色谱法,对该品种中的何首乌、川芎、赤芍进行专属性鉴别;采用高效液相色谱法对处方中君药何首乌中有效成分大黄素进行含量测定.色谱柱为Thermo Hypersil GOLD柱(250 mm×4.6 mm,5μm);流动相为甲醇-水(75∶25),流速为1.0 ml·min-1,检测波长为290 nm,柱温为室温,进样量为20出.结果:3味药材的TLC特征斑点清晰,分离度好,阴性对照无干扰.大黄素在10~1 280 μg·ml-1的浓度范围内呈良好线性关系,r=0.999 6.平均加样回收率为99.71%,RSD =2.16% (n =6).结论:所建立的质量标准准确可靠、重复性良好,可用于乌参八味胶囊的质量控制.

关 键 词:乌参八味胶囊  大黄素  高效液相色谱法  薄层色谱法  质量控制
收稿时间:2013/11/22 0:00:00
修稿时间:2014/2/17 0:00:00

Study on Quality Standard for Wushen Bawei Capsules
Gu Mingye,Wu Qiong,Xu Bin,Hu Bei,An Ye and Shi Guobing.Study on Quality Standard for Wushen Bawei Capsules[J].China Pharmacist,2014(6):931-934.
Authors:Gu Mingye  Wu Qiong  Xu Bin  Hu Bei  An Ye and Shi Guobing
Institution:Department of Pharmacy, General Hospital of Shenyang Military Area Command, Shenyang 110016, China;Department of Pharmacy, General Hospital of Shenyang Military Area Command, Shenyang 110016, China;Department of Pharmacy, General Hospital of Shenyang Military Area Command, Shenyang 110016, China;Department of Pharmacy, General Hospital of Shenyang Military Area Command, Shenyang 110016, China;Department of Pharmacy, General Hospital of Shenyang Military Area Command, Shenyang 110016, China;Department of Pharmacy, General Hospital of Shenyang Military Area Command, Shenyang 110016, China
Abstract:Objective:To establish the quality standard for Wushen Bawei capsules.Methods:Radix pplygoni multflori,Rhizoma Chizoma Chuanxiong and Radix Paeoniae Rubra were identified by TLC.The content of emodin was determined by HPLC.The determination was performed on a Thermo Hypersil GOLD (250 mm × 4.6 mm,5 μm) column with methanol-water (75∶25) as the mobile phase,the flow rate was 1.0 ml · min-1,the detection wavelength was 290 nm,the column temperature was room temperature and the injection volume was 20 μl.Results:The TLC spots were clear with good resolution and without interference from the negative samples.There was a good linearity within the range of 10 ~ 1 280 μg · ml-1 (r =0.999 6) for emodin.The average recovery of emodin was 99.71% (RSD =2.16%,n =6).Conclusion:The method is reliable,accurate and reproducible.It can be used as the quality control method for Wushen Bawei capsules.
Keywords:Wushen Bawei capsules  Emodin  HPLC  TLC  Quality standard
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