硝苯地平片薄膜包衣生产工艺研究

Nifedipine piece of film coating production technology research

目的:研究适合硝苯地平片的薄膜包衣生产工艺方法。方法:用醇溶型薄膜包衣预混剂对该产品片芯进行包衣后,与该产品未包衣片芯同时进行稳定性考察对比。结果:用醇溶型薄膜包衣预混剂对该产品素片进行包衣后,当增重达到3.2%±0.3%时,本品加速试验6个月时的综合质量仍符合中国药典规定,而未包衣的片芯则呈现明显的质量变化。结论:按该工艺生产的硝苯地平片质量稳定可靠,该工艺适合大生产需要。

The method is suitable for the thin film coating production craft nifedipine tablets . Methods With alcohol soluble type thin film coating premix on the product core after coating , and the product is not coating tablet core stability test comparison at the same time . Results With alcohol soluble type thin film coating premix tablet after coating to this product , when the weight gain of 3 . 2% plus or minus 3 . 2%, the product the overall quality of accelerated test 6 months still conform to the requirement of Chinese pharmacopoeia , and did not show obvious coating of tablet core quality change . Conclusions According to the production of the nifedipine tablets is stable and reliable quality , the process is suitable for mass production needs .