摘要
目的制备匹多莫德注射液,并建立其质量研究的方法。方法通过对匹多莫德原料药理化性质的研究,注射液pH、活性炭用量及灭菌条件对制剂质量影响的考察,确定了处方并对制备工艺进行了优化。质量分析方法采用HPLC法,以匹多莫德及有关物质含量、装量差异、溶液的澄清度和颜色、酸度、无菌、热源等为指标对制剂的质量进行控制,并对其与其他制剂的配伍稳定性进行考察。结果匹多莫德注射液的处方及制备工艺为:匹多莫德400g,加至5L注射用水中,制成1000支匹多莫德注射液。使用该处方和工艺制备的3批制剂各项指标均符合标准。质量研究方法中所建立的方法学试验结果均良好。流动相、辅料及各破坏条件下产生的有关物质对匹多莫德的含量测定无干扰。制剂经稳定性试验后各项指标依然符合标准。结论该质量分析方法专属性好、方法可靠;处方及制备工艺可行;制剂稳定性良好,可长期放置。
Objective To prepare the pidotimod injection and establish the quality evaluation method.Methods To determine the formulation and preparation technology through the investigation of physicochemical properties of pidotimod,pH of injection,content of activated carbon and sterilization condition.HPLC method was applied in quality analysis,and for quality control,the injection was evaluated in terms of the content of pidotimod and impurities,content uniformity,clarity and color of solution,acidity,sterility,heat source and so on.Results Three batches products made by the formulation and preparation process all meet the standards.The experimental results of methodology all were well.Mobile phase,excipients and impurities obtained by failure condition would not interfere with the measurement of pidotimod.The products after stability tests were still qualified.Conclusions The specificity of quality investigation method is good,and the method is reliable;formulation and preparation technology are practical;the stability of pidotimod is good enough to store for a long time.
出处
《中国药剂学杂志（网络版）》
2012年第6期93-98,共6页
Chinese Journal of Pharmaceutics：Online Edition
基金
辽宁省教育厅基金资助项目(NO.L2010531)
辽宁省高等学校优秀科技人才支持计划资助项目(LR20110028)
