注射用匹多莫德的研制与质量控制  

Study on Preparation and Quality Control of Pidotimod for Injection

作　　者：朱国龙[1] 孙彦甫[1] 石涛[1] 缪玉山[1] 

机构地区：[1]东南大学附属中大医院药剂科,江苏南京210009

出　　处：《中国医药导刊》2008年第7期1094-1095,共2页Chinese Journal of Medicinal Guide

摘　　要：目的:探讨注射用匹多莫德的处方、制备工艺及质量控制方法。方法:采用冷冻干燥法制备了注射用匹多莫德;采用HPLC测定其含量及有关物质。结果:本品处方以甘露醇与精氨酸为填充剂,制备的注射用匹多莫德在光照(4500lx)、高温(40℃)10d及室温留样考察12mo,物理及化学性质稳定。结论:研制的注射用匹多莫德性质稳定;质量控制方法准确可靠。Objective： To study the formulation, preparation, and quality control ffor pidotimod for injection. Method： Pidotmod for injection was prepared by freeze-dry, The contents of pidotimod was performed by HPLC.Results： The physico-chemical stability was good after storing 10d under illumination （4500lx）, 40℃ and 12 mo undr indoor temperature. Conclusions： The selected formulation and preparation technique are good and can contribute to the development of the product. The method of quality control was reliable.

关 键 词：匹多莫德 色谱法 高压液相 制备 质量控制 

分 类 号：TQ463[化学工程—制药化工]