目的 建立磷酸川芎嗪滴丸新的溶出度测定方法,为修订标准提供参考。方法 通过比较6批磷酸川芎嗪滴丸在pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水4种溶出介质中的溶出曲线,确定溶出度检查方法:桨法,50 r·min-1,溶出介质为水500 mL,20 min取样,HPLC测定,限度为标示量的80%。结果 本品6批样品在4种溶出介质中的溶出曲线均相似,在15 min 内达到全部溶出。结论 该方法重现性好、准确、可靠,能客观地反映本品的溶出情况,为本品现行药品标准中溶出度项的合理统一、修订提供了依据。
Abstract
OBJECTIVE To establish a new dissolution method of Ligustrazine Phosphate Pills, which provides reference for revising the quality standard. METHODS The dissolution media were hydrochloric acid solution(pH 1.2), acetate buffer solution(pH 4.5), phosphate buffer solution(pH 6.8) and water. The dissolution curves of six batches of Ligustrazine Phosphate Pills in the four kinds of dissolution media were compared to establish the dissolution method. Apparatus 2 was used for the new method of dissolution test,using 500 mL water as the dissolution medium,at the rate of 75 r·min-1. The dissolution solution was taken at 20 min and analyzed by HPLC. The dissolution limit was set at 80%. RESULTS The dissolution curves of the six batches of samples were similar in the four kinds of dissolution media. The pills were dissolved completely within 15 min. CONCLUSION The determination method is highly reproducible, accurate and reliable, which can objectively reflect the dissolution of ligustrazine phosphate pills, and provides a basis for the reasonable unification and revision of the dissolution test of the current quality standard.
关键词
磷酸川芎嗪 /
磷酸川芎嗪滴丸 /
溶出度 /
溶出曲线 /
高效液相色谱法
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Key words
tetramethylpyrazine phosphate /
Ligustrazine Phosphate Pills /
dissolution /
dissolution curve /
HPLC
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中图分类号：
R917
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参考文献
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脚注
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基金
江西省食品药品监督管理局科研资助项目(2016YP19)
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