匹莫范色林片的制备及其体外溶出度评价

Preparation and in vitro dissolution evaluation of pimavanserin tablets

目的:研究匹莫范色林片(pimavanserin)的处方,为仿制药的开发提供依据。方法:以片剂的外观、硬度、含量均匀度及溶出度等为考察指标,通过单因素实验考察筛选处方。结果:选用微晶纤维素(microcrystalline cellulose,MCC)及预胶化淀粉(pregelatinized starch,PS)为稀释剂,硬脂酸镁(magnesium stearate,MS)为润滑剂,采用粉末直接压片法得到片剂。微晶纤维素为每片138 mg,预胶化淀粉为每片20 mg,硬脂酸镁为每片2 mg。片剂在溶出介质中15 min的溶出度大于85%。结论:匹莫范色林片的制备方法简单可行,符合《中华人民共和国药典》要求,且为仿制药的开发提供了依据。

Objective： To study the formulation of pimavanserin tablets and provide the basis for the development of generic drugs. Methods： The prescription was screened by single factor experiment,through observing and studying the appearance,hardness,weight difference and dissolution of tablets. Results： Microcrystalline cellulose and pregelatinized starch were used as diluents,magnesium stearate as lubricant,and the tablets were obtained by direct compression method. The strengths of MCC,pregelatinized starch（ PS） and magnesium stearate（ MS） were 138,20 and 2 mg for each tablet respectively. Within 15 min,the dissolution of self-made preparations in the dissolution media were greater than 85%. Conclusion： The preparation method of pimavanserin tablets is simple and feasible,which meets the requirements of Ch P,and provides the basis for the development of generic drugs.