明胶空心胶囊鉴别试验条件改进及修订操作步骤的建议

Improvement of condition of identification test about vacant gelatin capsules and the operating steps of proposed amendment

目的通过优化明胶空心胶囊鉴别试验中的某些条件,提高鉴别结果的准确性。方法在药典方法的基础上,鉴别试验(1)的母液加入一定量的活性碳进行脱色;鉴别试验(2)直接取用经脱色后的原液进行试验;鉴别试验(3)中用氢氧化钠代替钠石灰进行试验。结果鉴别试验(1)经改进后生成的絮状沉淀为真正的橘黄色,而原方法生成的颜色则为橘黄色与本底颜色的混合色;鉴别试验(2)取用经脱色后的原液进行试验的结果比原方法生成的浑浊更明显易判;鉴别试验(3)的两种方法均能使湿润的红色石蕊试纸变蓝色,但氢氧化钠更易于购买与保存。结论为确保结果准确性,建议修订药典中明胶空心胶囊鉴别试验操作过程中的不合理步骤。

Objective To improve the accuracy of results by optimizing the conditions of gelatin capsules identification test. Methods On the basis of the original method, the identification test （ 1 ） ： to the mother liquor add a certain amount of active carbon for decolorizing; identification test （2） ： directly take the decolorized concentrate to do experiment; identification test （3） ： use sodium hydroxide instead of soda lime. Results Identification test （ 1 ） the floccules generated by the improved method were of real orange color, while the floccules generated by the original method were of a mixture of orange color and background color; identification test （2） ： the turbidity generated by using decolorized concentrate was more marked and easier to distinguish ; the two methods of identification test （3） can both make the wet red litmus paper turn blue, but sodium hydroxide is easier to procure and preserve. Conclusions The results of this study show that in order to ensure the accuracy of results, economy and rationality, the unreasonable steps for vacant gelatin capsules identification test should be revised.