复方布洛肾素那敏片的开发及体外溶出评估

Formulation Development and in Vitro Dissolution Evaluation of Chlorpheniramine Maleate,Ibuprofen,Phenylephrine HCl Tablet

目的:制备复方布洛肾素那敏片,优化处方组成与制备工艺,评价自制制剂和参比制剂溶出曲线的相似性。方法:将布洛芬与马来酸氯苯那敏组合进行湿法制粒,盐酸去氧肾上腺素单独进行湿法制粒,考察崩解剂交联羧甲基纤维素钠、粘合剂羟丙甲纤维素、润滑剂硬脂酸镁用量,以及布洛芬原料粒径等影响因素对溶出的影响,确定最终处方组成。结果:经过处方筛选,在片剂总重480 mg条件下,确定布洛芬原料粒径范围为170μm≤D90≤190μm,崩解剂交联羧甲基纤维素钠用量为25.2 mg,粘合剂羟丙甲纤维素用量为4.2 mg,润滑剂硬脂酸镁用量为4.2 mg,自制制剂与参比制剂在4种溶出介质中溶出曲线的相似因子(f2)值高于50。结论:成功制备复方布洛肾素那敏片,制剂处方简单,工艺稳定,重现性好,溶出曲线与参比制剂相似,为后期生产布洛肾素那敏片剂提供理论依据。

Objective:To optimize formulation composition and process condition and evaluate the similarity of dissolution curve between tested formulation and reference formulation of chlorpheniramine maleate,ibuprofen,phenylephrine HCl tablet.Methods:The mixture of chlorpheniramine maleate and ibuprofen is granulated by wet method,and phenylephrine HCl is granulated by wet method separately.The percentage of the disintegrant croscarmellose sodium,the adhesive hypromellose,the lubricant magnesium stearate and particle size of ibuprofen on the dissolution are investigated,and the final formulation composition is determined.Results:After formulation screening,at a total tablet weight of 480 mg,the particle size range of ibuprofen is 170μm≤D_(90)≤190μm,the amount of the disintegrant croscarmellose sodium is at 25.2 mg,the adhesive hypromellose 4.2 mg and the lubricant magnesium stearate 4.2 mg.The similarity factor(f2)value of dissolution curve between tested formulation and reference formulation is higher than 50 in the four dissolution media.Conclusion:Chlorpheniramine maleate,ibuprofen,phenylephrine HCl tablet are successfully developed,with simple formulation,robust process,and good similarity of dissolution behavior,which provided a solid foundation for the later manufacturing of chlorpheniramine maleate,ibuprofen,phenylephrine HCl tablet.