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Method for detecting dissolution rate of preparation containing colloidal bismuth pectin

机译:含胶态铋果胶的制剂溶出度的检测方法

摘要

A method for detecting the dissolution rate of a preparation containing colloidal bismuth pectin, according to the dissolution rate measurement in Appendix C, Part II, Chinese Pharmacopoeia 2010. The method comprises dissolving the preparation containing colloidal bismuth pectin in a dissolution medium, then directly taking the dissolved solution, adding a proton acid dissociation agent until the hydrogen ion concentration in the dissolved solution is 0.8-1.2 mol/L, separating the supernatant by centrifugation, adding a colour development solution of citric acid or ascorbic acid and potassium iodide for colour development, and measuring and calculating the dissolved amount of colloidal bismuth pectin in terms of bismuth by a spectrophotometric method. By the method for determining the dissolution rate of a colloidal bismuth pectin preparation established in the present invention, the dissolution curve and the dissolution rate of colloidal bismuth pectin in a preparation containing colloidal bismuth pectin can be determined well, meeting the requirements on quality control.
机译:一种根据中国药典2010年版第二部附录C中溶出度的测定方法,检测含有胶态铋果胶的制剂的溶出度的方法。该方法包括将含有胶态铋果胶的制剂溶入溶出介质中,然后直接服用。溶解溶液中,加入质子酸离解剂直至溶解溶液中氢离子浓度为0.8-1.2 mol / L,离心分离上清液,加入柠檬酸或抗坏血酸显色溶液和碘化钾显色。 ,并通过分光光度法测量和计算胶态铋果胶在铋中的溶解量。通过本发明建立的胶态铋果胶制剂溶出度的测定方法,可以很好地确定含有胶态铋果胶的制剂中的溶出曲线和胶态铋果胶的溶出率,满足质量控制的要求。

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