参加咀嚼片的研制及其对小鼠的抗疲劳作用

Development and anti-fatigue function of Shenjia chewable tablet

目的研制一种具有抗疲劳作用的新型营养剂参加咀嚼片,探讨参加咀嚼片对小鼠的抗疲劳作用。方法以人参多糖、刺五加提取物、牛磺酸为原料按6∶8∶1的比例混合作为主药,甘露醇作填充剂、蔗糖作矫味剂、硬脂酸镁作润滑剂。采用正交试验法,以甘露醇、蔗糖、硬脂酸镁用量为考察因素,通过外观、硬度、口感等指标评分对处方组成进行筛选。将60只雄性ICR小鼠随机分为参加咀嚼片低、中、高剂量组(200、600、1 800mg/kg)和空白对照组(给予生理盐水),每组15只,持续给药7d,通过小鼠负重游泳实验记录小鼠的负重游泳时间,游泳结束后检测小鼠体质量与血清生化相关指标三磷酸腺苷(ATP)、乳酸(Lac)、游离三碘甲状腺原氨酸(FT3)、游离甲状腺激素(FT4)、皮质醇和褪黑素(MT)。结果参加咀嚼片的优选处方为人参多糖30%、刺五加提取物40%、牛磺酸5%、甘露醇19%、蔗糖5%、硬脂酸镁1.0%;制得片剂呈土黄色圆形、光滑细腻、口感清凉味甜。与空白对照组相比,不同剂量参加咀嚼片均能延长小鼠的负重游泳时间(P<0.01),中、高剂量组小鼠血清ATP、FT3、FT4和MT的水平均升高(P<0.05,P<0.01),高剂量组小鼠的血清Lac水平升高(P<0.05),低、中、高剂量组小鼠血清皮质醇含量增加(P<0.05,P<0.01)。参加咀嚼片对小鼠体质量增长无明显影响。结论参加咀嚼片的处方组成合理,制备工艺简单,载药量高、口感好,具有抗疲劳作用,是一种理想的抗疲劳营养剂。

Objective To develop a new type of anti-fatigue nutrient chewable tablet and to explore its anti-fatigue effect in mice.Methods Ginseng polysaccharide,acanthopanax extract and taurine were mixed together in a proportion of 6∶8∶1as remedium cardinale,mannitol was used as filler,sucrose as a correctant and magnesium stearate as a lubricant.Hardness,appearance and taste were utilized as score indexes,the dosage of mannitol,sucrose,and magnesium stearate were used as study factors.The orthogonal test was applied to screen the best proportion of raw materials to create the formulation according to the mouse behaviors.A total of 60 male mice were randomly divided into control group（normal saline）and three doses of Shenjiachewable tablet groups（200,600 and 1 800mg/kg）.Lavage administration was lasted for 7days.We then carried out the weight loading swimming test to record the swimming time of mice,and also recorded the body mass and the serum biochemical indexes,including adenosine triphosphate（ATP）,lactic acid（Lac）,free triiodothyronine（FT3）,free thyroid hormone（FT4）,cortisol and melatonin（MT）.Results The formulation was optimized as 30% ginseng polysaccharide,40% acanthopanax extract,5% taurine,19%mannitol,5% sucrose,and 1.0% magnesium stearate.The Shenjia chewable tablet tasted cool and sweet,round in shape,yellow in color and smooth in appearance.Compared with the control group,there were significant increases in the loaded-swimming time in the three doses groups（P〈0.01）,in the levels of ATP,FT3,FT4 and MT in middle and high dosage groups（P〈0.05,P〈0.01）,and in Lac level in high dosage group（P〈0.05）.Cortisol was increased in the three doses groups（P〈0.05,P〈0.01）.All mice in three doses groups had no significant increase in body weight.Conclusion The Shenjiachewable tablet is an ideal anti-fatigue nutrient with reasonable formulation,simple preparation technology,high drug loading and good taste.