羟甲香豆素制剂溶出度测定方法的研究

Dissolution determination for hymecromone preparation

目的建立羟甲香豆素制剂的溶出度测定方法。方法依照《中国药典》（2005年版）附录溶出度项下第二法，以硼酸缓冲液1000mL为溶出介质，转速为75r·min^-1；紫外分光光度法测定，测定波长360nm。结果30min内产品的溶出率达到80％以上，辅料对主药测定无干扰，羟甲香豆素线性范围为2．0002～10．0010μg·mL^-1（r=0．9999），回收率为100．3％（RSD=0．8％，n=9）。结论本法操作简便、准确可靠，填补了羟甲香豆素制剂质量标准的空白。

Objective To develop a method for determination of dissolution of hymecromone preparation. Methods According to the dissolution test （ Pharmacopoeia of the Peoples Republic of China （ 2005 Edition, volume 2, supplemental method 3 ） , 1 000 mL boric acid buffer solution was selected as release medium, rotate speed was 75 r · min^-1 , and determined by UV with the detection wavelength at 360 nm. Results The dissolution rate of hymecromone preparation was over 80% in 30 min. The exeipients did not interfere with the determination. The calibration curve was linear in the range of 2. 000 2 - 10. 001 0 μg· mL^-1 （r =0. 999 9）. The average recovery （ n = 9） was 100.3% （ RSD =0. 8% ）, Conclusions The method was simple, accurate and precise, and might be used in dissolution determienation of hymecromone preparation