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

Preliminary Study on the Relationship between Physical Adsorption Capacity and Pharmacological Effect of Bismuth Potassium Citrate

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10 nm;各厂家原料药的黏度均小于10ml/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50 ml)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。

OBJECTIVE： To preliminarily explore whether the physical adsorption capacity of bismuth potassium citrate （BPC） is related to its pharmacological effect. METHODS： BPC capsules from 14 manufacturers, BPC tablets from 6 manufacturers, and crude drug from 6 manufacturers 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; there were no significant differences between the content of soluble bismuth and total content of bismuth in the products from different manufacturers, and the particle size colloidal particles was less than 10 nm. The viscosity of crude drug from different manufacturers was less than 10 ml/g, and had no significant differ- ences among different manufacturers. There was no obvious hanging wall phenomenon of crude drug and preparation in artificial gastric juice. The sedimentation height and volume number were not consistent completely, and the K values （the final settlement volume/ initial volume 50 ml） were in a certain range. CONCLUSIONS： This product is colloidal solution, but the particles are small; the tablets and capsules mainly exist as soluble bismuth in water. The physical absorption capacity has no significant differ- ence among different manufacturers and different dosage forms. The pharmacological effects of BPC are possibly unrelated to its physical adsorption capacity.