摘要
目的用正交设计方法优选甘草酸二铵注射液的制备工艺。方法采用正交设计,选择活性炭用量,中间品的pH值,微孔滤膜孔径,活性炭吸附温度四个因素,每个因素安排四个水平,按L16(45)安排正交实验,用2个指标的加权评分值判定工艺优劣,实验结果进行方差分析。结果实验证明,活性炭对甘草酸二铵有明显吸附作用;影响该药成品率的主要因素为活性炭及pH值;在主药浓度、吸附时间固定的条件下:加炭0.025%、中间品pH值为7.5、吸附温度为70℃、滤膜孔径为0.45μm的优化条件下,活性炭对甘草酸二铵吸附最小、热原检查合格、澄明度、成品率最高。结论配制甘草酸二铵注射液要对上述各因素进行控制,避免原料损失,提高成品率及产品质量。
OBJECTIVE To investigate the optimum techniques for preparation of diammonium glycyrrhizinate injection by orthogonal test.METHODS The influencing factors such as dosage of activated charcoal,pH value of intermediate product,pore size of micro-porous membrane and temperature of adsorption were studied,and each of them was arranged of 4 levels according to L16（45）orthogonal table,to assess the techniques by the sum of two indexes. RESULTS The Optimum techniques was that dosage of activated charcoal was 0.025%,pH of intermediate product was 7.5,temperature of adsorption was 70℃.and the pore size of the membrane was 0.45 μm.Using the technique,the adsorption is the least,the examination of pyrogen meets the requirement,and the clearance and the qualification rate are the highest.CONCLUSION It＇s feasible to seek the optimum techniques for preparing diammonium glycyrrhizinate injection by orthogonal test.The influence of those factors must be regarded in productive process.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2007年第5期421-423,共3页
Chinese Journal of Modern Applied Pharmacy
关键词
正交设计
甘草酸二铵
注射液
制备工艺
orthogonal test
diammonium glycyrrhizinate
injection
techniques of making
