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红药气雾剂质量标准的研究
引用本文:张春玲,周晓琳,郑霞. 红药气雾剂质量标准的研究[J]. 实用中医内科杂志, 2010, 24(5): 25-26. DOI: 10.3969/j.issn.1671-7813.2010.05.13
作者姓名:张春玲  周晓琳  郑霞
作者单位:1. 辽宁省沈阳红药制药有限公司,辽宁沈阳,110044
2. 辽宁省中医药研究院,辽宁沈阳,110034
摘    要:[目的]建立红药气雾剂的现代质量控制方法。[方法]分别采用薄层色谱、高效液相色谱法,对红药气雾剂进行质量控制研究。[结果]薄层色谱斑点清晰;人参皂苷Rg_1进样量在3.96μg~9.24μg范围内呈良好线性关系,平均样品回收率为100.2%(n=6),RSD为1.95%,经三批测定,本品每1mL药液含人参皂苷Rg_1均不低于1.50mg。[结论]本方法可作为红药气雾剂的质量控制方法。

关 键 词:红药气雾剂  质量标准  薄层色谱法  高效液相色谱法  含量测定

Study on Quality Standard for HongYao Aerosol
ZHANG Chun - ling,ZHOU Xiao - lin,ZHENG Xia. Study on Quality Standard for HongYao Aerosol[J]. , 2010, 24(5): 25-26. DOI: 10.3969/j.issn.1671-7813.2010.05.13
Authors:ZHANG Chun - ling  ZHOU Xiao - lin  ZHENG Xia
Affiliation:1. Shenyang Hongyao Pharmaceutical Co. , Ltd, Shenyang 110044, Liaoning, China ; 2. Traditional Chinese Medicine Research Institute of Liaoning Province, Shenyang 110034, Liaoning,China)
Abstract:[ Objective] To establish the modern quality control standard of HongYao Aerosol. [ Methods ] The quality control of HongYao Aerosol was determined by TLC and high performance liquid chromatography (HPLC). [ Results ] The characteristic identification by TLC was distinct and highly specific. The calibration curves of ginsenoside Rgt were linear in the range of 3.96μg - 9.24μg. The average recovery of ginsenoside Rgl was 100.2% (n =6) (RSD = 1.95% ). To test the three batches of samples, the content of Ginsenoside Rgl did not less than 1.50 mg/mL. [ Conclusion]The method may be served as the quality control of HongYao Aerosol.
Keywords:HongYao aerosol  quality standard  TLC  HPLC  determine
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