灵芝多糖γ-氨基丁酸片制剂研究及其改善睡眠功能验证

Preparation of tablet composed of Ganoderma lucidum polysaccharide and γ-aminobutyric acid and its assessment of sleep improvement function

灵芝具有极高的药食两用价值,其现代化产品开发仍有较大空间。基于现代药理学和营养学理论,以富含灵芝多糖的灵芝提取物和γ-氨基丁酸为主要原料开发新产品,并验证其改善睡眠功能作用。通过湿法制粒压片法进行工艺研究,以制粒情况、压片情况、片剂硬度和崩解时限为考察指标,筛选出最优处方。以SPF级小鼠为实验研究对象,依据《保健食品检验与评价技术规范》进行功能学实验。结果得到最优处方工艺为将相应质量分数的灵芝提取物(12.5%)、γ-氨基丁酸(25%)、微晶纤维素(32.5%)、麦芽糊精(13.75%)、玉米淀粉(1.25%)、交联羧甲基纤维素钠(5%)混匀后,再加入浓度为650 g/L聚维酮K30溶液(10%,质量分数)制粒,最后加入硬脂酸镁(0.5%,质量分数),混匀后压片、包衣,制得呈棕褐色、光洁圆整的片剂。在延长戊巴比妥钠睡眠时间实验中,高、中剂量组极显著延长戊巴比妥钠睡眠时间(P<0.01);在戊巴比妥钠阈下剂量催眠实验中,与对照组相比,各剂量组均无明显协同作用;在巴比妥钠睡眠潜伏期实验中,高剂量组的睡眠潜伏期极显著缩短(P<0.01)。且其对小鼠无明显的直接睡眠作用。通过该研究可知,该片剂制备工艺稳定,质量可控,适合工业化生产。功能学实验研究表明,灵芝多糖γ-氨基丁酸片具有改善睡眠功能作用。

Ganoderma lucidum has shown a high dual-purpose value in medicine and food,and there are still great prospects for the development of its modern products.Based on the pharmacological and nutritional theories,the research aimed to design a new product with polysaccharide-rich Ganoderma lucidum extract and γ-aminobutyric acid and assessed its effect on sleep improvement.The tablets composed of Ganoderma lucidum polysaccharide and γ-aminobutyric acid were prepared by wet granulation.According to the results of granulation and tableting,as well as the tablet hardness and disintegration time,the optimal formulation was screened out.According to the “Technical Standards for Testing Assessment of Health Food”,the function assessment for the purpose of verifying its effect on sleep improvement was carried out with SPF mice.Results showed that the optimal prescription consisted of Ganoderma lucidum extract(12.5%,mass fraction),γ-aminobutyric acid(25%),microcrystalline cellulose(32.5%),maltodextrin(13.75%),corn starch(1.25%),croscarmellose sodium(5%),povidone K30 solution(10%) with a concentration of 65%,and magnesium stearate(0.5%).With the procedures of mixing,tableting,and coating,the tan,smooth,and round tablets were obtained.As for the assessment,the tablets significantly prolonged the sleep time of mice treated with pentobarbital sodium in the high-dose and medium-dose groups(P<0.01).Compared to the control group,there was no apparent synergistic effect on subthreshold dose hypnosis with pentobarbital sodium in the three experimental groups.The sleep latency of mice treated with barbital sodium was significantly shortened in the high-dose group(P<0.01).There was no obvious direct sleep effect on mice.It could be concluded that the preparation procedure of the tablets is stable and the qualities of the products are controllable,so it is suitable for industrial production.The functional experimental studies suggest that tablets composed of Ganoderma lucidum polysaccharide and γ-aminobutyric acid contribute to improving the quality of sleep.