| 摘要: |
| 【目的】对研制的阿苯达唑混悬剂的品质进行评价，为扩大其临床应用奠定基础。【方法】采用分散法制备阿苯达唑混悬剂，以沉降体积比、再分散性和药物含量等混悬剂药剂学特性为指标，在单因素试验的基础上采用正交试验优选并确定最佳配方，对制备的阿苯达唑混悬剂进行品质评价。【结果】阿苯达唑混悬剂的最佳配方为：每25 mL混悬剂中含有1.75 g阿苯达唑，0.3 g羧甲基纤维素钠，0.012 5 mL聚山梨酯-80，0.3 g柠檬酸，0.075 g苯甲酸钠。制备的阿苯达唑混悬剂沉降体积比为0.94，再分散性良好，平均回收率（99.60±1.47）%，变异系数1.48%。【结论】确定的阿苯达唑混悬剂配方的药剂学特性稳定，制备的混悬剂物理稳定性良好，符合混悬剂的品质要求 |
| 关键词: 阿苯达唑 混悬剂 药物研制 质量控制 |
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| 基金项目:西北农林科技大学大学生创新创业训练计划校级重点项目（2201210712053） |
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| Preparation and quality control of Albendazole suspension |
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DANG Limei,CUI Yaoming,YE Dongyang,et al
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| Abstract: |
| 【Objective】The quality of prepared Albendazole suspension for veterinary use was evaluated to provide foundation for its application in clinical expansion.【Method】Albendazole suspension was prepared using dispersion method.The optimal dispersion characteristics such as sedimentation volume,re dispersibility and drug content were determined based on single factor experiments.Then the quality of prepared Albendazole suspension was evaluated.【Result】The optimal preparation conditions for Albendazole suspension were Albendazole 1.75 g,sodium carboxymethyl cellulose 0.3 g,poly yamanashi ester-80 0.012 5 mL,citrate 0.3 g and sodium benzoate 0.075 g in a volume of 25 mL.The prepared suspension had the subsidence volume ratio of 0.94,fine re-dispersibility,the average recovery rate of (99.60±1.47)% and the variation coefficient of 1.48%.【Conclusion】The prepared Albendazole suspension had good pharmaceutical and physical stability and meet the quality requirement of suspension. |
| Key words: Albendazole suspension drug development quality control |
