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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 a method for the quality assessment of CA4 suppositories and prepare CA4 suppositories that meet the quality requirements. Methods The effects of different concentrations of semi-synthetic fatty acid glycerides, PEG concentration, PEG type and polysorbate-80 on the suppository were studied by orthogonal test. The formulation of CA4 suppository was determined and the quality was evaluated with reference to “Chinese Pharmacopoeia”. Results CA4 suppositories prepared by the selected prescription and preparation method were white torpedo-shaped suppositories with an average boll weight of 1.1956 g and a melting time limit of 10 mg per 10 min. The dissolution curves were in accordance with the Weibull equation and T50 = 51.2 min, Td = 67.1 min. Conclusion The prescription and technology of screening CA4 suppository are feasible, the quality evaluation index is clear and the quality evaluation method is accurate and reliable.