阿苯达唑混悬剂的质量评价及其含量检测方法的建立

Quality Evaluation of Albendazole Suspension and the Establishment of Its Content Detection Method

目的:对自制阿苯达唑混悬剂的质量进行评价,考察稳定性的影响因素,并建立混悬剂中阿苯达唑的含量测定方法。方法:利用沉降体积比和再分散性试验考察制剂的性状稳定性,利用粒度测定仪对粒径的大小和分布进行测定,利用高温、冷冻和光照试验研究阿苯达唑混悬剂的影响因素,利用高效液相色谱方法建立阿苯达唑的含量检测方法。结果:自制阿苯达唑混悬剂室温条件下静置24h未发生沉降,平均粒径541.21nm,pH值6.20~6.40,物理性状良好,分散性好,质量可控,稳定性影响因素试验证实高温是影响混悬剂最主要的影响因素。含量测定方法结果表明阿苯达唑在10~100μg/mL的质量浓度范围内与峰面积呈良好的线性关系,回收率高,稳定性及精密度良好,适用于混悬剂中阿苯达唑的含量的测定。

Objective:to evaluate the quality of self-made albendazole suspension,study its physical and chemical properties and establish a method for the determination of its content.Methods:the stability of the preparation was investigated by sedimentation volume ratio and redispersibility test,the size and distribution of particle size were determined by laser particle size tester,and the content determination method of albendazole was established by HPLC.Results:Self-made albendazole suspension did not sedimentation after standing for 24 hat room temperature,with an average particle size of 541.21 nm,and the pH was 6.20~6.40.The physical properties were good,the dispersion was good,the mass was controllable,and the stability was controlled.The test confirmed that the high temperature was the most important factor affecting the suspension.The results of the content determination method showed that albendazole showed a good linear relationship with the peak area within the mass concentration range of 10~100μg/mL.High recovery,good stability and precision,suitable for the determination of albendazole suspension content.