枸橼酸铋钾的物理吸附能力与其药理作用关系的初步研究-中国药房.PDF

枸橼酸铋钾的物理吸附能力与其药理作用关系的初步研究 ＊ 李秀梅 ，杨 柳，赵欣欣（重庆市食品药品检验所，重庆 401121） 中图分类号 R961 文献标志码 A 文章编号 1001-0408（2015）07-0918-04 DOI 10.6039/j.issn. 1001-0408.2015.07.16 摘 要 目的：初步探讨枸橼酸铋钾的药理作用是否与其物理吸附能力相关。方法：以14个厂家的枸橼酸铋钾胶囊、6个厂家的 枸橼酸铋钾片及6个厂家的原料药为试验样品，进行本品原料药和制剂溶液的丁达尔试验，以考察其是否为胶体溶液；对其胶囊 和片剂参照《美国药典》方法测定其中可溶性铋含量、参照《中国药典》方法测定其中总铋含量，以考察本品制剂中可溶性铋的含量 百分比以及本品的胶粒粒径；测定不同厂家原料药的黏度并进行所有样品在人工胃液中的沉降与挂壁试验。结果：本品溶液观察 到丁达尔现象发生；各厂家制剂中的可溶性铋含量与总铋含量均无明显差异，胶粒粒径小于10nm ；各厂家原料药的黏度均小于10 ml/g ，各厂家样品间无明显差异；各厂家原料药和制剂溶于人工胃液后均未出现明显的挂壁现象，各自所形成沉降物质的高度和 体积数不完全一致，K 值（最终沉降体积/起始体积50ml ）均在一定范围内。结论：本品溶液为胶体，但胶粒小；片剂和胶囊在水中 主要以可溶性铋存在；各厂家产品间及不同剂型间的物理吸附能力无明显差异。本品的药理作用与其物理吸附能力之间可能 无关。 关键词 枸橼酸铋钾；原料药；片剂；胶囊；物理吸附能力；药理作用 Preliminary Study on the Relationship between Physical Adsorption Capacity and Pharmacological Effect of Bismuth Potassium Citrate LI Xiu-mei ，YANG Liu ，ZHAO Xin-xin （Chongqing Institute for Food and Drug Control ，Chongqing 401121，Chi- na ） ABSTRACT OBJECTIVE ：To preliminarily explore whether the physical adsorption capacity of bismuth potassium citrate （BPC ） is related to its pharmacological effect. METHODS ：BPC capsules from 14manufacturers ，BPC tablets from 6 manufacturers ，and crude drug from 6manufacturers were used as samples to investigate whether the solution for crude drug and preparation was collo- idal solution by Tyndall test. The content of soluble bismuth in tablets and capsules were determined by the method stated in United States Pharmacopoeia （USP ），and the total content of bismuth was determined by the method stated in Chinese Pharmacopeia （CP ）to investigate the percentage of soluble bismuth and the particle size of colloidal preparation. The viscosity of crude drug from different manufacturers was determined and the settlement test and hanging wall test of all samples in artificial gastric juice were conducted. RESULTS ：Tyndall phenomenon happened in this product ；t