5种淀粉类辅料吸湿行为初步研究

Preliminary Study on the Hygroscopic Behavior of 5 Kinds of Starch Excipients

目的初步研究5种淀粉类辅料的吸湿行为,为防潮辅料优选及其生产包装储存湿度提供依据。方法按相应方法,分别测定5种辅料在25℃9种相对湿度下的吸湿率,绘制吸湿率-时间曲线和平衡吸湿率-相对湿度曲线。结果糊精、可溶性淀粉、玉米淀粉、预胶化淀粉、羧甲淀粉钠等辅料在25℃(下同)、相对湿度3.5%～81.0%环境下放置120 h后,吸湿(含水量变化)均达平衡,其平衡吸湿率(平衡含水量)分别为2.26%～13.81%、1.62%～14.48%、2.15%～16.20%、1.62%～15.16%、1.58%～21.97%;在相对湿度100.0%环境下放置120h后,吸湿率(含水量)分别为27.44%、24.00%(平衡)、24.06%(平衡)、25.96%(平衡)、42.11%,其中可溶性淀粉、玉米淀粉、预胶化淀粉吸湿达到平衡,糊精、羧甲淀粉钠吸湿接近平衡;吸湿率-时间曲线和平衡吸湿率-相对湿度曲线均直观反映了5种辅料在9种相对湿度下的吸湿行为(含水量变化规律)。结论该研究初步表征了5种淀粉类辅料的吸湿行为,为防潮辅料优选及其生产包装储存条件提供参考。

OBJECTIVE To study the hygroscopic behavior of 5 kinds of starch excipients and provide reference for the selection of moisture-proof excipients and the conditions for packaging and storage.METHODS According to the corresponding method,determinating the moisture absorption rate of 5 kinds of excipients respectively under 25℃ and 9 kinds of relative humidity,drawing hygroscopic rate-time curve and equilibrium hygroscopic raterelative humidity curve.RESULTS The 5 kinds of excipients such as dextrin,soluble starch,corn starch,pregelatinized starch,sodium carboxymethyl starch were placed at 25℃(the same below),relative humidity 3.5%-81.0%,after 120 h,the moisture absorption(change of water content) had reached equilibrium.The equilibrium moisture absorption rate(equilibrium water content) were 2.26%-13.81%,1.62%-14.48%,2.15%-16.20%,1.62%-15.16%,1.58%-21.97%,respectively.After being placed in the environment with a relative humidity of 100.0%for 120 hours,the moisture absorption rate(water content) were 27.44%,24.00%(balanced),24.06%(balanced),25.96%(balanced) and 42.11%,respectively.Among them,soluble starch,corn starch and pregelatinized starch were balanced in moisture absorption,the moisture absorptions of dextrin and carboxymethyl starch sodium were near the balanced.Moisture absorption-time curve and equilibrium moisture absorption-relative humidity curve directly reflected the hygroscopic behavior of 5 kinds excipients under 9 kinds of relative humidity(change law of water content).CONCLUSIONS This study preliminarily characterized the moisture absorption behaviour of the five types of starch excipients.It provided reference for the selection of moisture-proof excipients and the conditions for packaging and storage.