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目的:制备氨来呫诺口腔生物黏附软膏并建立其质量控制方法。方法:以卡波姆-940和羧甲基纤维素钠为黏附剂,单硬脂酸甘油酯、白凡士林、液状石蜡为油相基质。参照《中国药典》一部(附录ⅫE第一法)贴膏剂初黏力的测定方法测定软膏的黏附力,采用高效液相色谱法测定其主药含量。结果:所制备软膏均匀细腻,能粘住5号钢球。氨来呫诺在1.0～24.0μg·ml-1范围内峰面积和浓度线性关系良好(r=0.999 8),平均回收率100.3%,RSD为1.7%。结论:制剂制备工艺简便可行,质量控制方法可靠。
OBJECTIVE: To prepare amlionoxan oral bioadhesive ointment and to establish its quality control method. Methods: Carbomer-940 and sodium carboxymethylcellulose were used as adhesive, glycerol monostearate, white petrolatum and liquid paraffin as oil phase matrix. With reference to the “Chinese Pharmacopoeia” (Appendix Ⅻ E first method) Determination of the initial adhesion of adhesive paste ointment adhesion, using high performance liquid chromatography determination of the main drug content. Results: The prepared ointment is fine and delicate, can stick No. 5 ball. The linear relationship between the peak area and the concentration of amiloxanide was 1.0 ~ 24.0μg · ml-1 (r = 0.999 8). The average recovery was 100.3% and the RSD was 1.7%. Conclusion: The preparation process is simple and feasible, the quality control method is reliable.