复方电解质葡萄糖MG3注射液制备及质量研究-药学资料文档

摘  要

复方电解质葡萄糖MG3注射液，为电解质补充药剂，被临床医生广泛用于腹泻、手术前后、烧伤、烫伤、外伤出血、骨折、严重感染、重症糖尿病昏迷及肾炎等引起的脱水、电解质紊乱及酸中毒等的治疗。本品可作为组织液的补充调整剂，对电解质紊乱及酸中毒有很强的纠正作用，是治疗代谢性酸中毒、失血、手术时出血、失水症及电解质紊乱时的理想药物。本课题主要是对复方电解质葡萄糖MG3注射液制备工艺和质量进行了研究，对处方的筛选、制备中影响质量的主要因素、主要成分的含量测定及相关的质量标准进行了探讨，为今后大批量的工业生产提供参考依据。

关键词：复方电解质葡萄糖MG3注射液，电解质补充药剂， 制备工艺，质量控制

Abstract

Compound Electrolytes And Glucose Injection MG3 has been widely used clinician diarrhea, before and after surgery, burn, burn, trauma, bleeding, fractures, serious infections, severe diabetic coma, and nephritis caused by dehydration, electrolyte imbalance and acid poisoning and treatment. Glucose electrolyte compound to compound sterile injection MG3 colorless, transparent aqueous solution containing sodium lactate, sodium chloride, potassium chloride and glucose, pH 3.5 ~ 7.0, partial acid, by adjusting the body fluid volume, osmotic pressure, supplementary potassium, sodium and chloride ion and the supply of heat. When the in vivo circulating blood volume and tissue fluid reduction, the product can be adjusted as the tissue fluid complement agent, on the electrolyte imbalance and acidosis has a strong corrective role in the treatment of metabolic acidosis, blood loss, surgical bleeding, dehydration and disease When electrolyte disturbance ideal drug. This issue mainly for compound electrolyte glucose MG3 injection preparation process and quality were studied.

Keywords: Compound Electrolytes And Glucose Injection MG3， Electrolyte supplement pharmaceutical, preparation technology, quality control

目   录

1  引言 …………………………………………………………………………………1

1.1  复方电解质葡萄糖MG3注射液的临床作用………………………………………1

1.2  国内外有关该类产品研发、生产、临床使用情况…………………………………1

2  实验材料与仪器……………………………………………………………………3

2.1  实验材料………………………………………………………………………………3

2.2  实验仪器………………………………………………………………………………3

3  处方研究与工艺研究………………………………………………………………4

3.1  原料药的选择…………………………………………………………………………4

3.2  辅料的选择……………………………………………………………………………4

3.3  处方筛选………………………………………………………………………………4

3.4  最终处方………………………………………………………………………………7

3.5  制备工艺的确定……………………………………………………………………… 7

3.6  处方、工艺的验证…………………………………………………………………… 8

3.7  处方工艺结论…………………………………………………………………………11

4  质量研究……………………………………………………………………………… 12

4.1  pH值检查…………………………………………………………………………… 12

4.2  注射液的装量检查…………………………………………………………………… 12

4.3  可见异物检查…………………………………………………………………………13

4.4  不溶性微粒检查………………………………………………………………………13

4.5  重金属检查……………………………………………………………………………13

4.6  砷盐检查………………………………………………………………………………13

4.7  热原检查………………………………………………………………………………14

4.8  无菌……………………………………………………………………………………14

4.9  有关物质5-羟甲基糠醛的检查………………………………………………………14

4.10 含量测定……………………………………………………………………………15

5  实验结果的总结及评价………………………………………………………… 21

5.1  处方和制备工艺……………………………………………………………………… 21

5.2  质量研究与质量标准的综述………………………………………………………… 21

5.3  稳定性试验综述……………………………………………………………………… 22

参考文献 ………………………………………………………………………………… 23

致谢……………………………………………………………………………………… 25