Combretastatin A4栓剂的处方及工艺研究

Study on prescription and preparation technology of Combretastatin A4 suppositories

目的建立CA4栓剂的质量评价方法,制备符合质量要求的CA4栓剂。方法通过正交试验考察半合成脂肪酸甘油酯浓度、PEG浓度、PEG种类、聚山梨酯-80种类等因素对栓剂的影响,确定CA4栓剂的处方,并参考《中国药典》进行质量评价。结果按选定处方及制备方法制得的CA4栓剂为白色鱼雷形栓剂,平均栓重为1.1956 g,融变时限在30 min内,含药量为每枚10 mg,溶出曲线符合Weibull方程,T50=51.2 min,Td=67.1 min。结论筛选的CA4栓剂的处方及工艺可行,质量评价指标明确,质量评价方法准确可靠。

OBJECTIVE To establish the quality evaluation method for CA4 suppositories.METHODS The effects of the half synthetic fat diethylene glycol dinitrate concentration,the PEG concentration,the PEG type,the tween-80 type on the formulation were studied using the orthogonal test.The quality of the formulation was evaluated based on the Pharmacopoeia of China.RESULTS The prepared CA4 suppositories showed a white torpedo shape,with the average hitch was 1.1956 g again,changed friendly the time limit within 30 min,drug content of 10 mg,dissolution curve T50=51.2 min,Td=67.1 min.CONCLUSION The prescription and preparation technology of CA4 is feasible.The quality evaluation method is accurate and reliable.