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在制剂成型工艺的微观层面,广东家之和药业采用流化床制粒技术实现粒径分布控制。通过api微粉化处理和共研磨工艺的结合,确保活性成分的固态分散度达到usp标准。实验数据显示,采用热熔挤出技术制备的固体分散体,其溶出度曲线在ph1.2介质中符合零级动力学模型。
在包衣工序参数优化方面,公司引入质量源于设计(qbd)理念。通过薄膜包衣增重率与崩解时限的响应面分析,确定最优的雾化压力和进风温度组合。特别在
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