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sunnybluesea

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苯磺酸氨氯地平(Norvasc,络活喜)制备工艺-辉瑞
API与羧甲淀粉钠、无水磷酸氢钙预混→过筛→再混合→过筛→加入微晶纤维素混合→过筛→再混合→加入硬脂酸镁混合→直接压片。

苯磺酸氨氯地平(Norvasc,络活喜)关键事项-辉瑞
原研片Norvasc的典型pH(加水制成20%混悬液)为7.05-7.35,高于或低于此pH范围过大,都会加速API的降解,从而引发稳定性问题。
由于原研工艺为粉末直压,无水磷酸氢钙作为填充剂和稳定剂需要提供良好的流动性和理想的pH环境,因此推荐使用Budenheim颗粒级的无水磷酸氢钙DI-CAFOS® A60。

A60的典型pH为7.1,能提供最理想的pH微碱性环境;A60的平均粒径为60μm,相比其他友商的直压型号,更小的粒径能提供API更多的接触保护面积;A60的松密度高达1.33g/ml,独特的球形外观,保证了大生产高速压片中极佳的流动性;A60的吸湿性极低,90%RH下吸湿小于0.15%,尤其适合对水分敏感的药物。

样品申请链接:https://www.wenjuan.com/s/rIFNFf/
提别提示:无水磷酸氢钙DI-CAFOS® A12是阿奇霉素最佳拍档!
微信:sunnyblue323
11楼2017-04-26 14:59:53
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