西甲硅油乳剂消泡能力评价方法的对比研究

Comparative Study on Evaluation Methods of Simethicone Emulsion's Defoaming Ability

目的对比考察了4种检测西甲硅油乳剂消泡性能的方法,选择出精密度高、区分力强的评价方法,为制剂研究和产品质量控制提供方便、可靠的评价手段。方法分别采用量筒法、手腕式振荡器法、通气鼓泡法和罗式泡沫法测定5批主药含量不同的西甲硅油乳剂的消泡性能,对各方法的精密度及变量变化条件的能力进行考察。结果4种方法检测,结果有相同的差异趋势,即主药含量越高的制剂消泡能力越强。精密度最好的是手腕式振荡器法,5份样品只有一份样品的变异系数大于5%,最差的是通气鼓泡法,5份样品的变异系数均大于5%;最能通过消泡能力的变化来反映乳剂主药含量变化的方法是罗氏泡沫法,相关系数为0.9729,最差的是手腕式振荡器法,相关系数为0.9074。在4种检测西甲硅油乳剂消泡能力的方法中,量筒法具有较高的精密度(60%的样品变异系数小于5%仅次于手腕式振荡器法)和较优的反映条件变化的能力(平均消泡时间与样品主药含量的相关系数为0.9518仅次于罗氏泡沫法),容易发现影响消泡能力条件的变化且数据可靠,对于西甲硅油乳剂的处方工艺改变及放置稳定性后变化有较好的评价效果,也更易发现批间差异,对成品也具有较好的质控效果。结论量筒法实验条件较简单,易操作,推荐在制备西甲硅油乳剂时,选用此法对其消泡性能进行检测。

Objective In this experiment,four methods for detecting the defoaming performance of simethicone emulsion were investigated with comparative methods,and the evaluation method with high precision and strong discrimination was selected to provide a convenient and reliable evaluation method for preparation research and product quality control.Methods The defoaming properties of simethicone emulsion with different contents of the 5 batches of drugs were determined by measuring cylinder method,wrist oscillator method,ventilation bubbling method and Luo foam method.Results The results of the four methods showed the same difference trend,that is,the higher the content of the main drug,the stronger the defoaming ability of the preparation.The best precision was the wrist oscillator method,and then the coefficient of variation of only one sample of 5 samples is greater than 5%.The worst was the ventilation bubbling method and the coefficient of variation of 5 samples is greater than 5%.The best way to reflect the change of emulsion's main drug content is the Roche bubble method and the correlation coefficient was 0.9729.The worst is the wrist oscillator method and the correlation coefficient was 0.9074.Among four methods for detecting the defoaming ability of simethicone emulsion,the measuring cylinder method has higher precision and better ability to reflect changes in conditions.It is easy to find changes in conditions that affect the defoaming ability and data are reliable.For simethicone emulsions,the formulation process changes and the changes after placing stability have a good evaluation effect.It is also easier to find differences between batches,and it also has a better-quality control effect on the finished products.Conclusion The experimental conditions of measuring cylinder method are simple and easy to operate.It is recommended to detect the defoaming performance of dimethylsilicone oil emulsionby this method.