摘要
目的研究孟鲁司特钠咀嚼片体外溶出行为及其影响因素,为该品种新剂型开发和仿制药一致性评价提供参考。方法考察pH、胆盐、表面活性剂等因素对孟鲁司特钠咀嚼片溶出的影响。结果孟鲁司特钠在pH7.5的介质中,随着胆盐浓度的增加,溶解度明显上升;孟鲁司特钠咀嚼片在pH1.0盐酸溶液、pH4.0醋酸盐溶液、pH6.8磷酸盐溶液的溶出过程中,会迅速析出形成混悬液,而0.5%十二烷基硫酸钠水溶液会抑制其析出。结论孟鲁司特钠咀嚼片的体外溶出受pH、胆盐、表面活性剂的影响较大,可以为其新型给药系统的开发和质量一致性评价提供参考。
OBJECTIVE To investigate in vitro dissolution behavior and its influencing factors of montelukast sodium chewable tablets,to provide reference for the development of new dosage forms and consistency evaluation of generic drugs. METHODS The effects of pH,bile salts,surfactants and other factors on the dissolution of sodium chewable tablets were investigated.RESULTS In the medium with pH 7.5,the solubility of montelukast sodium increased significantly with the increase of bile salt concentration.The dissolution of montelukast sodium chewable tablets in pH 1.0 hydrochloric acid solution, pH 4.0 acetate solution and pH 6.8 phosphate solution rapidly precipitated to form a suspension,while 0.5% SDS aqueous solution inhibited its precipitation.CONCLUSION The dissolution of montelukast sodium chewable tablets is greatly affected by pH,bile salts and surfactant.It will be the reference and experience of formulation and quality consistency evaluation for generic drugs in future.
作者
许丽华
王乐健
吴惠芳
孙洁胤
XU Lihua;WANG Lejian;WU Huifang;SUN Jieying(Zhejiang Academy of Medical Sciences,Hangzhou 310013,China;Zhejiang Pharmaceutical College,Ningbo 315100,China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2019年第12期1498-1501,共4页
Chinese Journal of Modern Applied Pharmacy
关键词
孟鲁司特钠
体外溶出
溶解度
胆盐
montelukast sodium
in vitro dissolution
solubility
bile salt
