为促进降血糖功能食品的开发，本研究确定了降糖软胶囊中绿茶提取物、葛根提取物、苦瓜提取物的最佳配伍，优选软胶囊制备工艺并分析其稳定性。在单因素试验基础上通过α-葡萄糖苷酶抑制活性试验确定三种天然提取物的最佳配伍；以均匀性、流动性和沉降体积比为考察指标，考察内容物的性状；以色泽和透光率为判断指标，考察囊壳性状。通过稳定性试验考察软胶囊是否具有稳定的性质。当绿茶提取物、葛根提取物、苦瓜提取物的比例为1:3:30时抑制α-葡萄糖苷酶的效果最佳，IC50值为0.92 mg/mL；以该比例配制复合物，并发现复合物:大豆油:蜂蜡:大豆磷脂=1:1.5:0.025:0.07，制得的内容物混悬效果最好；根据1:0.45:1的明胶、甘油、水比例制备胶皮，并加入甘油用量2%的苋菜红色素和0.30%的二氧化钛，得到具有遮光效果好、硬度及黏性适中的红色囊壳。经过6个月的加速试验，发现软胶囊的性状、装量差异、崩解时限均符合中国药典要求，且抑制α-葡萄糖苷酶活性的IC50值仅降低5.33%。综上所述，含三种天然提取物的复方软胶囊具有良好抑制α-葡萄糖苷酶功效，且性质稳定，所得工艺参数可为后期该胶囊的生产提供依据。

In order to promote the development of anti-diabetic functional food, this research determined the optimal formula of green tea (Camellia sinensis) extract, kudzu root (Puerariae lobatae Radix) extract and bitter gourd (Momordica charantia L) extract for soft capsules, the optimal processing process, and the stability of soft capsules. Based on the single factor tests, the optimal formula of the three natural extracts was determined by the α-glucosidase inhibitory activity assay, based on the indicators like uniformity, fluidity and sedimentation volume ratio, and the properties of the capsule shell like the color and light transmittance. The stability of the soft capsules was investigated by a stability test. The inhibition of α-glucosidase was the greatest when the ratio of green tea extract, kudzu root extract and bitter gourd extract was 1:3:30, with the IC50 value being 0.92 mg/mL. The compound was prepared according to this ratio. It was found that the content of the prepared compound led to the most desirable suspension, when the three extracts were at the optimal ratio and the ratio of soybean oil: beeswax: soybean phospholipid was 1:1.5:0.025:0.07. The capsule shell was prepared at a ratio of 1:0.45:1 for gelatin, glycerin and water, with the addition of the amaranth red pigment containing 2.00% of glycerin and 0.30% of titanium dioxide. As a result, a red capsule shell with good light-blocking effect and moderate hardness and viscosity. The 6-month accelerated test revealed that the properties, loading difference, and disintegration time of the soft capsules all met the requirements of the Chinese Pharmacopoeia, with the IC50 value for the inhibition of α-glucosidase activity decreased only by 5.33%. In summary, the compound soft capsules containing the three natural extracts had a significant inhibitory effect on α-glucosidase and were stable in nature. The obtained technological parameters can provide a basis for the production of the capsules in the future.

欧阳康乐产学研用创新基金项目（201601003）