芦荟软胶囊通便功能研究

Study on Facilitating Feces Excretion Function of Aloe Soft Capsule

目的评价芦荟软胶囊对通便功能的影响。方法按卫生部《保健食品检验与评价技术规范》(2003年版)中润肠通便功能检验方法开展实验。动物实验中,经口给予小鼠0.133、0.267、0.800 g/kg.bw剂量的芦荟软胶囊内容物14 d,采用不同剂量的复方地芬诺酯制备肠蠕动抑制模型和便秘模型。测定肠蠕动抑制模型小鼠小肠墨汁推进率、便秘小鼠排便时间、排粪便粒数和粪便重量。人体试食试验中,采用自身和组间对照两种试验设计,将受试者按便秘症状随机分为受试组和对照组,分别按推荐剂量服用样品或安慰剂,连续7 d。观察、记录受试者试食前后排便次数、排便状况、粪便性状的变化并评分。结果动物实验中,0.800 g/kg.bw剂量可显著提高肠蠕动抑制模型小鼠的小肠墨汁推进率(P<0.05),可显著缩短便秘小鼠排首粒黑便时间(P<0.05),显著增加便秘小鼠排便粒数(P<0.05),各剂量对便秘小鼠的粪便重量无显著影响(P>0.05)。人体试食试验中,试食组受试者试食后与试食前比较,排便次数明显增加,排便状况和粪便性状明显改善(P<0.05),总有效率为76.47%;试食后试食组与对照组比较,排便次数、排便状况、粪便性状亦有明显改善,差异有统计学意义(P<0.05)。试验前后对照组和试食组均未见不良反应,各项安全性指标均未见异常。结论芦荟软胶囊具有润肠通便功能。

Objective To assess the effect of aloe soft capsule on facilitating feces excretion function. Methods The study was conducted in accordance with the methods for the assessment of facilitating feces excretion function in Technical Standards for Testing ＆ Assessment of Health Food （2003 version）. In the animal experiment, after the mice were orally ad- ministered with substance of aloe soft capsule at 0. 133, 0.26？, and 0. 800 g/kg· bw doses for 14 days, the propulsion rate of ink in small intestine, the time when the first black feces granule was excreted, the number and the weight of black feces granules were tested and recorded in mice with inhibited peristalsis and constipation induced by different doses of diphenoxy- late. In the human feeding trial, 102 volunteers were assigned to the trial group and the control group randomly based on their constipation symptoms. The trial group was given aloe soft capsule while the control group was given the placebo for seven days continuously. Then the defecation frequency, condition and excrement character were observed. Results In the ani- mal experiment, as compared with the control mice, 0. 800 g/kg＇bw dose could significantly raise small intestine ink propel- ling rate in mice model with inhibited peristalsis （P〈 0.05）, could significantly shorten the time to excrete first black feces granule and increase the number of black feces granules in constipated mice model （P〈 0.05）. It did not affect the weight of black feces granules. In the human feeding trial, for the trial group, when compared with those before administration, the defecation frequency was significantly increased （P〈 0.05）, the defecation condition and excrement character were significantly improved （P〈 0.05）. The above indices were also improved when compared with the control group （P 〈 0.05）. The total ef- fective rate for improving constipation was 76.47%, which was significantly higher than that of the controls. No adverse effect was observed and every safe index was normal during the trial. Conclusion Aloe soft capsule could improve feces excre- tion function.