肺结核丸质量标准研究
Study on quality standard for Feijiehe Pills
王亚娟 1谢光磊2
作者信息
- 1. 陕西华西制药股份有限公司，宝鸡 721013
- 2. 东盛科技股份有限公司西安制药厂，西安 710065
- 折叠
摘要
目的：建立肺结核丸的质量标准。方法采用TLC法对制剂中制何首乌、白及进行定性鉴别；采用 HPLC法对制何首乌中的2，3，5，4′‐四羟基二苯乙烯‐2‐O‐β‐D‐葡萄糖苷进行定量测定。结果薄层色谱鉴别何首乌、白及的斑点清晰，分离效果好，阴性对照无干扰；2，3，5，4′‐四羟基二苯乙烯‐2‐O‐β‐D‐葡萄糖苷在6．0～48．0μg·mL －1范围内线性关系良好（r＝0．9993）。平均回收率为99．0％，RSD为0．30％（n＝9）。结论该方法简单准确，专属性强，重复性好，可有效控制该制剂的质量。
Abstract
Objective To investigate the quality standard for Feijiehe Pills .Methods TLC was used to identify Radix Polygonum multiflorumPreparataandRhizomaBletillae,andHPLCwasusedtoquantitativelymeasure2,3,5,4′‐tetrohyoxystilbene‐2‐O‐β‐D‐glucoside.Results ByTLCidentificationof RhizomaBletillae,Polygonummultiflorum,thespotswereclear,andnointerfer‐ence was observed;Four hydroxyl 2 ,3 ,5 ,4′‐2‐2‐styrene&western‐beta‐D‐glucoside in the range of 6 .0‐48 .0μg · mL-1 (r=0 .999 3) demon‐strated good linear relationship .The average recovery was 99 .0% ,and RSD was 0 .30% (n=9) .Conclusion The method is sim‐ple ,accurate ,and with strong specificity and good reproducibility ,which shows the method can effectively control the quality of the preparation .
关键词
肺结核丸/质量标准/2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷/TLC/HPLCKey words
Feijiehe Pills/quality standard/2, 3, 5, 4′-tetrohyoxystilbene-2-O-β-D-glucoside/TLC/HPLC引用本文复制引用
出版年
2015
NETL
NSTL
维普
万方数据