芒果苷-HP-β-CD包合物冻干粉针质量标准研究

Quality Standard of Mangiferin-hydroxypropyl-β-cyclodextrin Freeze-dried Powder

目的建立芒果苷-HP-β-CD包合物冻干粉针的质量控制方法。方法参照《中国药典》要求,对制剂的外观、再分散性、pH值、水分含量进行检查,并采用UV法测定制剂含量。结果制剂外观为淡黄色松块状物,表面细腻光洁、有一定强度,质轻不易碎裂;再分散性好,pH值及水分含量均符合药典规定;经含测方法学考察,确定了可采用UV法测定制剂中芒果苷的含量,制剂中芒果苷平均含量为(103.08±0.84)mg/ml,RSD为0.81%(n=6)。结论本文建立了芒果苷-HP-β-CD包合物冻干粉针制剂通项检查及含量测定方法,质控方法具有简便、可控、重复性好的优点,能准确评价该制剂的质量。

Objective To establish the quality standard of mangiferin-hydroxypropyl-β- cyclodextrin freeze-dried powder.Methods Reference to the Chinese Pharmacopoeia requirements,the appearance,the dispersion,pH and moisture content of this preparation were checked. The preparation content was determined by UV.Results The appearance of this preparation was as pale yellow loose lumps with delicate, a certain intensity and smooth surface,meanwhile it was light weight, easy to fragmentation and with good redispersibility. UV method was use to determine the content after the methodological study. The mean contents were （103.08±0.84）mg/ml, RSD=0.81%（n=6）.Conclusion Qualitative methods were simple, sensitive and specific. The quality standard could be used for the evaluation of the preparation.