复方氨酚美敏混悬剂的处方工艺优化

Optimization of the formulation and preparation process of compound paracetamol suspension

制备复方氨酚美敏混悬剂,并进行处方工艺优化.以沉降体积比、再分散性、0.1 mol/L盐酸介质中对乙酰氨基酚(APAP)的溶出度、APAP晶型变化为评价指标,单因素考察助悬剂及用量、APAP原料粒径、胶态微晶纤维素(cMCC)剪切速度和时间、转速、温度,采用Box-Benhnken响应面法优化制剂处方工艺.优化的处方为:cMCC 0.12%、黄原胶0.064%、羧甲基纤维素钠(CMCNa) 0.097%.工艺筛选结果为:cMCC剪切速度1 2000 rpm、时间6 min,制剂搅拌速度为600 rpm,温度60℃.复方氨酚美敏混悬剂的处方工艺简单可行、稳定性较好.

The aim of this experiment was to optimize the formulation and preparation process of compound paracetamol suspension.The sedimentation volume ratio, redispersibility, the dissolution of paracetamol(APAP) in 0.1mol/L hydrochloric acid medium, and the change of APAP crystal form were used as evaluation indicators.The type and amount of suspension, size of APAP raw material, shear rate and time of colloidal microcrystalline cellulose(cMCC),rotational speed and temperature were investigated by single factor;Box-Benhnken response surface methodology was used to optimize the formulation and preparation process.The optimized formulation was as follows: cMCC 0.12%,xanthan gum 0.064%,sodium carboxymethyl cellulose(CMCNa) 0.097%.The preparation process screening results were as follows: the shearing speedand time of cMCC are 12 000 rpm and 6 min, the stirring speed of preparation is 600 rpm, and the temperature is 60 ℃.The formulation and preparation process of compound paracetamol suspension is simple, feasible and stable.