CAJ | 학술논문

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。
목적：연구괄합초분지평편적박막포의생산공예방법。방법：용순용형박막포의예혼제대해산품편심진행포의후，여해산품미포의편심동시진행은정성고찰대비。결과：용순용형박막포의예혼제대해산품소편진행포의후，당증중체도3.2%±0.3%시，본품가속시험6개월시적종합질량잉부합중국약전규정，이미포의적편심칙정현명현적질량변화。결론：안해공예생산적초분지평편질량은정가고，해공예괄합대생산수요。
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 .