当前位置: X-MOL 学术J. Mater. Sci. Mater. Med. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Preparation and preliminary quality evaluation of aspirin/L-glutamate compound pellets
Journal of Materials Science: Materials in Medicine ( IF 3.7 ) Pub Date : 2021-08-30 , DOI: 10.1007/s10856-021-06594-8
Mengchang Xu 1 , Fenglin Liu 2 , Wenhu Zhou 1, 2 , Binsheng He 1 , Songwen Tan 1, 2
Affiliation  

L-glutamate is an important component of protein. It can prevent gastrointestinal damage caused by NSAIDs. We constructed two-phase enteric-coated granules of aspirin and L-glutamate compound by extrusion spheronization method and fluidized bed coating. The subliminal effective dose of L-glutamate is 100 mg/kg tested by model of gastric ulcer of rats induced by aspirin and drug administration. HPLC-UV and UV–Vis methods were adopted to determine content and cumulative release of aspirin and L-glutamate as quality analysis method indexes. The prescription and process optimization were carried out with yield, sphericity and dissolution. The two-phase compound granules have good sphericity of 0.93 ± 0.05 (aspirin pellets) and 0.94 ± 0.02 (L-glutamate pellets), content of salicylic acid (0.24 ± 0.03)%, dissolution of aspirin (2.36 ± 0.11)%. Quality evaluation and preliminary stability meet the commercial requirements. The stored environment of compound preparation should be sealed in a cool and dark place.



中文翻译:

阿司匹林/L-谷氨酸复合微丸的制备及初步质量评价

L-谷氨酸是蛋白质的重要​​成分。它可以防止非甾体抗炎药引起的胃肠道损伤。我们通过挤压滚圆法和流化床包衣法构建了阿司匹林和L-谷氨酸复合物的两相肠溶颗粒。L-谷氨酸的阈下有效剂量为100mg/kg,通过阿司匹林致大鼠胃溃疡模型和给药试验。采用HPLC-UV和UV-Vis法测定阿司匹林和L-谷氨酸的含量和累积释放量作为质量分析方法指标。对收率、球形度和溶出度进行处方和工艺优化。两相复方颗粒具有良好的球形度,分别为0.93±0.05(阿司匹林微丸)和0.94±0.02(L-谷氨酸微丸),水杨酸含量(0.24±0.03)%,阿司匹林溶出度(2.36±0.11)%。质量评价和初步稳定性符合商业要求。复方制剂的储存环境应密封于阴凉避光处。

更新日期:2021-08-30
down
wechat
bug