[1]郭文宾,汪爱霞,刘峰,等.舒肝健胃丸质量标准研究[J].甘肃中医药大学学报,2016,33(06):47-52.[doi:10.16841/j.issn1003-8450.2016.06.15]
 GUO Wenbin,WANG Aixia,LIU Feng,et al.Quality control for Shugan Jianwei Wan[J].Journal of Gansu University of Chinese Medicine,2016,33(06):47-52.[doi:10.16841/j.issn1003-8450.2016.06.15]
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舒肝健胃丸质量标准研究()
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《甘肃中医药大学学报》[ISSN:1003-8450/CN:62-1062/R]

卷:
33卷
期数:
2016年06期
页码:
47-52
栏目:
技术与方法
出版日期:
2016-12-25

文章信息/Info

Title:
Quality control for Shugan Jianwei Wan
作者:
郭文宾1 汪爱霞2 刘峰2 张效祥2
1. 甘肃河西制药有限责任公司技术部, 甘肃 张掖 734000;
2. 甘肃河西制药有限责任公司质管部, 甘肃 张掖 734000
Author(s):
GUO Wenbin1 WANG Aixia2 LIU Feng2 ZHANG Xiaoxiang2
1. Technology Department of Hexi Pharmaceutical Co., Ltd, Zhangye, Gansu, 734000, China;
2. Quality Control Department of Hexi Pharmaceutical Co., Ltd, Zhangye, Gansu, 734000, China
关键词:
舒肝健胃丸薄层色谱高效液相色谱厚朴酚和厚朴酚含量测定
Keywords:
Shugan Jianwei WanTLCHPLCmagnololhonokiolcontent determination
分类号:
R284.2
DOI:
10.16841/j.issn1003-8450.2016.06.15
摘要:
目的 研究舒肝健胃丸的质量控制方法。方法 采用薄层色谱(TLC)法对舒肝健胃丸处方中的香附、白芍、柴胡、延胡索进行定性鉴别;采用高效液相色谱(HPLC)法对厚朴中的厚朴酚与和厚朴酚进行含量测定,色谱柱为Hypersil ODS2 C18柱(150 mm×4.6 mm,5 μm),流动相为乙腈-水-冰醋酸(60∶38∶2),检测波长294 nm,柱温35℃,流速1 mL/min,进样量10 μL。结果 TLC鉴别专属性强,斑点清晰,且阴性对照无干扰;含量测定中,厚朴酚与和厚朴酚的回归方程分别为Y=12 335X-4 745.1(r=0.999 1),Y=1 598.1X-3 569.4(r=0.999 3)。结果表明,厚朴酚与和厚朴酚分别在3.13~62.60 μg/mL,1.995~39.900 μg/mL范围内呈良好的线性关系;厚朴酚与和厚朴酚平均回收率分别为99.60%,98.54%。结论 所建立的方法操作简便,专属性强,稳定、准确,重现性好,可用于该制剂的质量控制。
Abstract:
Objective To study the quality control method for Shugan Jianwei Wan. Methods Cyperus rotundus,radix paeoniae alba,radix bupleuri,rhizoma corydalis were identified qualitatively by TLC; the contents of magnolol and honokiol were determined by HPLC. The HPLC separation was performed on the column of Hypersil ODS2 C18(200 mm×4.6 mm,2.5 μm) with the mobile phase of acetonitrile-water-glacial acetic acid (60:38:2),the detecting wavelength was 294 nm,the column temperature was 35℃,the flow rate was 1 mL/min,the sample size was 10 μL. Results Qualitative identification by TLC was specific,the spots were clear and the negative control showed no interference. The regression equations of magnolol and honokiol were Y=12 335X-4 745.1(r=0.999 1) and Y=1 598.1X-3 569.4(r=0.999 3) respectively. Their calibration curves were in good linearity in the range of 3.13 to 62.60 μg/mL,1.995 to 39.900 μg/mL with average recoveries of 99.60%,98.54% respectively. Conclusion The method is easy and simple,specific,accurate and reliable also with good reproducibility. It can be used to identify and evaluate the quality of Shugan Jianwei Wan.

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备注/Memo

备注/Memo:
收稿日期:2016-03-07
作者简介:郭文宾(1974-),男,主管药师,主要从事新药的研发与产品的工艺技术研究。
更新日期/Last Update: 1900-01-01