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该文通过研究各辅料对提取物的吸湿性影响,对制剂内多糖测定的干扰以及对小鼠血糖值的影响筛选了辅料种类,采用单因素试验法,以吸湿性,成型性和流动性为指标,测定了吸湿量,颗粒得率以及休止角,结合物料外观性状,筛选了辅料配比及用量,并测定了颗粒的相对临界湿度。优选的银桑降糖颗粒最佳辅料为桑叶清膏-微晶纤维素-四角蛤蜊粗多糖10∶9∶1.67,所得颗粒成型性,流动性好,且不易吸潮液化,其相对临界湿度为73%。经研究优选所得银桑降糖颗粒制剂工艺和处方科学可行,可以明显改善提取物易吸湿液化的性质,提高制剂稳定性,适合工业化生产,并为其他制剂筛选辅料提供借鉴。
In this paper, through the study of various materials on the hygroscopicity of the extract, the interference of the determination of polysaccharide in the preparation and the influence on the blood sugar of the mice, the types of auxiliary materials were screened out. The single factor test was used to determine the hygroscopicity, formability and fluidity The moisture content, particle yield and angle of repose were measured. According to the appearance and appearance of materials, the ratio and dosage of auxiliary materials were screened, and the relative critical moisture of granules was measured. The best silver mulberry particles for the best excipient Mulberry leaf clear paste - microcrystalline cellulose - four-clam polysaccharides 10:9: 1.67, the resulting particles of good formability, good fluidity, and not easy to moisture absorption and liquefaction, the relative critical humidity Is 73%. The optimized preparation technology and prescription of silver Sang Jiangtang granule can be used to improve the property of liquefaction and liquefaction of extract, improve the stability of preparation, and be suitable for industrialized production, and provide reference for other preparations screening materials.