景天止痛膏质量标准研究
投稿时间:2021-09-09  修订日期:2022-01-20  点此下载全文
引用本文:胡丹,尹明,王习文,曹红,张贵英,苏传洋,张帅.景天止痛膏质量标准研究[J].药学实践杂志,2022,40(2):157~160,170
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作者单位E-mail
胡丹 中国人民解放军联勤保障部队药品仪器监督检验总站, 北京100166  
尹明 解放军总医院第二医学中心急诊医学科,国家老年疾病临床研究中心 北京 100853 ym301@163.com 
王习文 中国人民解放军联勤保障部队药品仪器监督检验总站, 北京100166  
曹红 中国人民解放军联勤保障部队药品仪器监督检验总站, 北京100166  
张贵英 中国人民解放军联勤保障部队药品仪器监督检验总站, 北京100166  
苏传洋 中国人民解放军联勤保障部队药品仪器监督检验总站, 北京100166  
张帅 中国人民解放军联勤保障部队药品仪器监督检验总站, 北京100166  
基金项目:全军医疗机构制剂标准提高重点课题(13ZJZ16)
中文摘要:目的 修订景天止痛膏质量标准中的测定方法。方法 采用薄层色谱法(TLC)对当归、川芎、元胡、三七总皂苷进行定性鉴别,应用高效液相色谱法(HPLC)测定制剂中三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1的含量。结果 TLC法鉴别专属性强,分离度好;三七皂苷R10.16042.0050μg (r=0.999)、人参皂苷Rg10.800310.0035μg (r=1.000)、人参皂苷Rb10.61827.7275μg (r=1.000) 范围内呈良好的线性关系,加样回收率分别为101. 43% 、98.75% 、100. 95% ,相对标准偏差(RSD)分别为2.56% 、2.71% 、2.75%。结论 本方法准确可靠、灵敏度高,可用于景天止痛膏的质量控制。
中文关键词:景天止痛膏  质量标准  高效液相色谱法  薄层色谱
 
Study on quality standard of Jingtian Zhitong cream
Abstract:Objective To revise the determination method in the quality standard of Jingtian Zhitong cream. Methods The total saponins of angelica sinensis, Ligusticum wallichii, Rhizoma corydalis, and Panax notoginseng saponins were qualitatively identified by thin-layer chromatography (TLC). The contents of notoginsenoside R1, ginsenoside Rg1, and ginsenoside Rb1 in the preparation were determined by high performance liquid chromatography (HPLC). Results TLC showed strong specificity and good resolution. The concentration of notoginsenoside R1 showed a good linear relationship in the range of 0.1604 and 2.0050μg (r=0. 999). The concentration of ginsenoside Rg1 showed a good linear relationship in the range of 0.8003 and 10.0035μg (r=1.000). The concentration of ginsenoside Rb1 showed good linearity in the range of 0.6182 and 7.7275μg (r=1.000). The sample recovery rates were 101.43%, 98.75% and 100.95%, respectively. The relative standard deviation (RSD) were 2.56%, 2.71% and 2.75%, respectively. Conclusion The developed method is accurate and reliable with high sensitivity, which can be used for the quality control of Jingtian Zhitong cream.
keywords:Jingtian Zhitong cream  quality standard  HPLC  TLC
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