乙酰谷酰胺铝颗粒的制备与质量控制  

Preparation of aceglutamide aluminum granulesand its quality control

作　　者：边海勇[1] 邓树海[1] 徐文方[1] 袁玉梅[1] 祝伟伟[1] 

机构地区：[1]山东大学药学院,山东济南250012

出　　处：《中国医院药学杂志》2006年第4期439-442,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的：制备乙酰谷酰胺铝颗粒剂，并建立其质量控制标准。方法：以蔗糖为矫味剂制备乙酰谷酰胺铝颗粒剂，采用高效液相色谱法（HPLC）测定该颗粒剂中乙酰谷酰胺铝的含量与有关物质，并进行了稳定性试验。结果：HPLC线性关系起好，乙酰谷酰胺铝的线性范围为2．5～100mg·L^-1（r=0．9999），平均回收率为100．1％，RSD为0．45％（n=9）。结论：该颗粒剂处方合理，工艺简单，质量控制方法准确可靠，专属性好。OBJECTIVE To prepare aceglutamide aluminum granules and establish a standard for its quality control. METHODS Aceglutamide aluminum granules were prepared by using sucrose as a sweet excipient,aceglutamide aluminum and its related substances in granules was determinated by high performance liquid chromatography（HPLC）, and its stability test was also carried out. RESULTS A good linearity of calibration curve for the HPLC method was obtained, and the calibration curve of aceglutamide aluminum was linear in the concentration range of 2.5～100mg·L^-1（r = 0. 999 9）, the average recovery was 100. 1% and RSD was 0. 45% （n = 9）. CONCLUSION The recipe of aeeglutamide aluminum granules is suitable and the preparation is simple. The method of quality control is accurate, reliable and specific.

关 键 词：乙酰谷酰胺铝 颗粒剂 制备 质量考察 

分 类 号：R927.2[医药卫生—药学]