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1. 发明授权

EP3315946B1 METHOD FOR DETECTING DISSOLUTION RATE OF PREPARATION CONTAINING COLLOIDAL BISMUTH PECTIN 有权
公开(公告)号：EP3315946B1
公开(公告)日：2020-07-08
申请号：EP16813640.6
申请日：2016-05-27
申请人： Shanxi Zhendong Ante Biopharmaceutical Co. Ltd.
发明人： LI, Anping , CUI, Feng , ZHU, Ping , QIN, Zhengguo , ZHENG, Tai , WU, Yuexia
IPC分类号： G01N21/33 , G01N21/78 , G01N33/15 , G01N13/00

2. 发明授权

EP3315945B1 METHOD FOR MEASURING BISMUTH CONTENT IN COLLOIDAL BISMUTH PECTIN OR COLLOIDAL BISMUTH PECTIN-CONTAINING PREPARATION 有权
公开(公告)号：EP3315945B1
公开(公告)日：2020-07-08
申请号：EP16813639.8
申请日：2016-05-27
申请人： Shanxi Zhendong Ante Biopharmaceutical Co. Ltd.
发明人： LI, Anping , CUI, Feng , ZHU, Ping , QIN, Zhengguo , ZHENG, Tai , WU, Yuexia
IPC分类号： G01N21/78 , G01N33/84 , G01N21/33

3. 发明公开

EP3315946A1 METHOD FOR DETECTING DISSOLUTION RATE OF PREPARATION CONTAINING COLLOIDAL BISMUTH PECTIN 有权
标题翻译：检测含胶体铋皮肤素制剂溶出率的方法
公开(公告)号：EP3315946A1
公开(公告)日：2018-05-02
申请号：EP16813640.6
申请日：2016-05-27
申请人： Shanxi Zhendong Ante Biopharmaceutical Co. Ltd.
发明人： LI, Anping , CUI, Feng , ZHU, Ping , QIN, Zhengguo , ZHENG, Tai , WU, Yuexia
IPC分类号： G01N21/33 , G01N21/78
摘要： A method for detecting a dissolution rate of a preparation containing colloidal bismuth pectin includes steps of: according to " Pharmacopoeia of the People's Republic of China, 2010 Edition, Volume 2, Appendix XC", dispersing the preparation containing the colloidal bismuth pectin into dissolution medium, and directly obtaining dissolution liquid; adding a protonic acid dissociation agent into the dissolution liquid until a hydrogen ion concentration reaches 0.8-1.2mol/L; centrifuging for separating a supernatant; coloring the supernatant by adding a chromogen solution of citric acid or ascorbic acid and potassium iodide to obtain a test solution; calculating a dissolution amount, which is accounted by bismuth, of the colloidal bismuth pectin with a spectrophotometry method. The method of the present invention well detects dissolution curves and rates of the colloidal bismuth pectin in the preparation thereof, satisfying quality control requirements.
摘要翻译：检测含胶体铋果胶制剂溶出度的方法包括：按照“中华人民共和国药典2010年版2卷附录XC”将含有胶体铋果胶的制剂分散到溶出介质，并直接获得溶解液; 向溶解液中加入质子酸解离剂，直至氢离子浓度达到0.8-1.2mol / L; 离心分离上清液; 通过加入柠檬酸或抗坏血酸和碘化钾的色原溶液使上清液着色以获得测试溶液; 利用分光光度法计算胶态铋果胶中溶解量，其由铋计算。本发明的方法很好地检测了胶体铋果胶在其制备过程中的溶解曲线和速率，满足了质量控制的要求。

4. 发明授权

EP3181140B1 DISPERSION PREPARATION CONTAINING COLLOIDAL BISMUTH PECTIN AND PREPARATION METHOD THEREFOR 有权
公开(公告)号：EP3181140B1
公开(公告)日：2020-07-15
申请号：EP15833729.5
申请日：2015-08-06
申请人： Shanxi Zhendong Ante Biopharmaceutical Co. Ltd.
发明人： LI, Anping , SHEN, Qi , ZHU, Ping , QIN, Zhengguo , WU, Yuexia , LI, Jing
IPC分类号： A61K31/732 , A61K47/02 , A61K47/12 , A61K9/20 , A61K9/28

5. 发明公开

EP3315945A2 METHOD FOR MEASURING BISMUTH CONTENT IN COLLOIDAL BISMUTH PECTIN OR COLLOIDAL BISMUTH PECTIN-CONTAINING PREPARATION 有权
标题翻译：测定胶体铋或胶态铋含蛋白制剂中铋含量的方法
公开(公告)号：EP3315945A2
公开(公告)日：2018-05-02
申请号：EP16813639.8
申请日：2016-05-27
申请人： Shanxi Zhendong Ante Biopharmaceutical Co. Ltd.
发明人： LI, Anping , CUI, Feng , ZHU, Ping , QIN, Zhengguo , ZHENG, Tai , WU, Yuexia
IPC分类号： G01N21/31
摘要： Provided is a method for measuring the bismuth content in a colloidal bismuth pectin or a colloidal bismuth pectin-contained preparation. A protonic acid is used to dissociate bismuth from a colloidal bismuth pectin, the principle of the characteristic reaction between bismuth and potassium iodide to produce yellow potassium bismuth iodide is used; ultraviolet-visible spectrophotometry is for measurement; an external standard method is for calculation. The method has strong specificity, a good linear relationship, high accuracy, good repeatability and high sensitivity. The method is able to act as a quality control method for bismuth in a colloidal bismuth pectin or a colloidal bismuth pectin-contained preparation to effectively control the product quality.
摘要翻译：本发明提供一种测定胶体铋果胶或胶体铋果胶制剂中的铋含量的方法。使用质子酸从胶体铋果胶中分离铋，使用铋和碘化钾之间的特征反应产生黄色钾碘化铋的原理; 紫外 - 可见分光光度法用于测量; 外部标准方法是用于计算。该方法特异性强，线性关系好，准确度高，重复性好，灵敏度高。该方法可作为胶体铋果胶或胶体铋果胶制剂中铋的质量控制方法，有效控制产品质量。

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