典片剂通则下要求检查脆碎度的疑问

gg1234567890

剂通则“七、  片剂外观应完整光洁，色泽均匀，有适宜的硬度和耐磨性，以免包装、运输过程中发生磨损或破碎，除另有规定外，非包衣片应符合片剂脆碎度检查法(通则0923)的要求”这个意思是没有特殊规定，所有非包衣片都要检查脆碎度？



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邹生

对                                                                                       .

抗争少年

包衣片在包衣之前的素片也要测

13712754309

必须的！压片过程中，每小时最少一次检测

机智鼠

根据《中国药典》通则规定，非包衣片在无特殊规定时，需进行脆碎度检查。但实际操作中，是否所有非包衣片都强制检查，还需结合具体品种情况及注册批件要求综合判断。部分药品可能因工艺特性或质量属性，在注册时经监管部门认可豁免此项检查。建议查阅具体品种的注册标准或咨询药审部门，以明确个体化要求。法规依据可参考《中国药典》通则0923及药品注册相关技术指导原则。

【鼠鼠还在学习中，内容仅供参考（药搭GMP软件提供技术支持）】

叶老叁

这有什么纠结的，这又不难，仪器也不贵

抱琴揽风

脆碎度必须要测啊，有些看着好看的片子，脆碎度可不咋地。脆碎度不好的片子流向市场再经过运输颠簸，断片、裂片、碎片都会有。

胜利者

肯定