多指标优选银桑降糖颗粒辅料研究

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。

Optimize excipients for Yinsang hypoglycemic granules by using multiple indexes

Optimal excipients were screened by studying the effect of different excipients on the hygroscopicity of the extract, testing polysaccharide in the preparation and blood glucose value. Single factor tests were performed with hygroscopicity, formability and fluidity as the indexes, and the moisture content, granule yield and angle of repose were combined with physical characters of the materials to screen the proportioning and dosage of excipients. Then the critical relative humidity of preferred Yinsang granules were measured. The optimum excipients for Yinsang hypoglycemic granules were mulberry leaf paste-microcrystalline cellulose-mactra veneriformis crude polysaccharides (10:9:1.67). The obtained granules had good formability and fluidity, which were not easy to absorb moisture for liquefaction, with a critical relative humidity of 73%. This formation process was reasonable and feasible, suitable for industrial production, which can significantly improve hygroscopicity and liquefaction properties of extracts, improve stability of Yinsang granules, and provide reference for screening of excipients for other preparations.