摘要
目的制备高渗氯化钠右旋糖酐70注射液,建立其质量控制标准。方法拟定处方及制备工艺。依据《中国药典》2000年版建立质量标准并对3批产品进行检查。结果3批产品均符合所建立的质量标准。结论处方及制备工艺合理,质量控制方法可靠。
Abstract
OBJECTIVE To prepare hypertonic sodium chloride dextran 70 injection and establish its standard for quality control.METHODS The composition and manufacturing technique were designed.Quality standard was established according to ChP2000 and 3 batches of product were tested.RESULTS 3 Batches of product complied with the requirements of quality standard.CONCLUSIONS The composition and manufacturing technique is rational in formula and the method of quality control is suitable.
关键词
高渗氯化钠右旋糖酐70注射液 /
制备工艺 /
质量标准
{{custom_keyword}} /
Key words
hypertonic sodium chloride dextran 70 injection /
manufacturing technique /
quality standard
{{custom_keyword}} /
赵莲;王波;王广义;赵敬湘;赵晓宇;张玉华;周虹.
高渗氯化钠右旋糖酐70注射液的制备及质量标准研究[J]. 中国药学杂志, 2006, 41(16): 1237-1239
ZHO Lin;WNG o;WNG Gung-yi;ZHO Jing-xing;ZHO Xio-yu;ZHNG Yu-hu;ZHOU Hong.
Study on Preparation and Quality Standard of Hypertonic Sodium Chloride Dextran 70 Injection [J]. Chinese Pharmaceutical Journal, 2006, 41(16): 1237-1239
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] LU D X.Preparation of Neoteric Injection（近代输液剂的制备）[M]. Beijing: Chinese Medical Science and Technology Press，1990：358-359.
[2] GRADY J J， KRAMER G C， YOUNES R N，et al. Individual patient cohort analysis of the efficacy of hypertonic saline/dextran in patients with traumatic brain injury and hypotension[J]. J Trauma，1997， 42(5 Suppl)：S61-S65.
[3] ROTSTEIN O D. Novel strategies for immunomodulation after trauma：revisiting hypertonic saline as a resuscitation strategy for hemorrhagic shock[J].J Trauma，2000，49(4)：580-583.
{{custom_fnGroup.title_cn}}
脚注
{{custom_fn.content}}
基金
军队“十五”指令性课题(010L43)
{{custom_fund}}
