【作者】 刘敏；

【导师】 王永生；

【作者基本信息】 吉林大学 ， 药剂学， 2020， 硕士

【摘要】 近年来,社会经济迅猛发展,人们面临着各种竞争压力,心神难安、睡眠障碍往往使人们享受家庭生活的能力下降,工作表现变差,也会产生更多的消极情绪。复方益眠片是由刺五加、人参和灵芝孢子粉组成,该复方制剂可以起到补肾安神,益气健脾,辅助睡眠的作用,且副作用小。目的:筛选复方益眠片科学合理的工艺条件,并开发全面且准确可靠的质量检测方法,初步研究复方益眠片的稳定性。方法:经查阅刺五加药材中含有药理活性的物质所具有的性质,选择乙醇为提取溶剂。紫丁香苷是刺五加药材中发挥药理活性的主要成分,以其提取率作为检测标准,采取正交试验的方法选择提取刺五加药材的最优工艺。然后通过对制剂过程中所需要的辅料进行选择,以单因素考察的方法筛选复方益眠片最优成型工艺。参考2015版药典对本片剂中的人参和刺五加进行定性鉴别。通过高效液相色谱法分析本片剂中主要活性物质的含量,以本片剂中的四种成分（人参皂苷Rb₁、Re、Rg₁和紫丁香苷）作含量分析的目标,建立复方益眠片的质量标准,并通过试验完成方法学验证。结果:称取适量刺五加药材,使其与6倍量的60%乙醇溶液混合,回流2h,操作此步骤3次,回收乙醇并干燥提取物,得干膏。将刺五加提取物粉末（96g）与人参粉末（252g）、灵芝孢子粉（252g）混匀,将羧甲基淀粉钠（7.5g）和糖粉（150g）添加其中,搅拌均匀,水为润湿剂制粒,将湿颗粒放入35℃真空烘箱中2小时,整粒。将硬脂酸镁（1%）添加到所获得的干颗粒中,充分混合,压片,得复方益眠片。经试验考察,本试验所得制剂的重量差异,硬度,脆碎度和崩解时限都满足药典要求。本文对片剂中人参皂苷Rb₁、Re、Rg₁和紫丁香苷所使用的高效液相条件及含量计算方法,能够准确测定人参皂苷Rb₁、Re、Rg₁和紫丁香苷在复方益眠片中的含量,对片剂中的刺五加和人参所使用的薄层色谱法亦可完成准确的定性鉴别。结论:本文得出复方益眠片中刺五加的最优提取工艺,并确定出制备复方益眠片的最优成型工艺,考察的工艺参数均符合规定,制得的复方益眠片工艺稳定性良好。本文为检测有效成分建立的液相色谱条件准确可靠,能够准确地检测复方益眠片中有效成分的含量,使得进一步生产有可靠的研究基础。更多还原

【Abstract】 In recent years,the social economy has developed rapidly,and people are facing various competitive pressures.Uneasy feelings and sleep disturbances often make people’s ability to enjoy family life decline,and their work performance deteriorates,which will also produce more negative emotions.Compound Yimian tablets is composed of Acanthopanax senticosus,Ginseng and Ganoderma lucidum spore powder.The compound preparation can play the role of invigorating the kidney and calming the mind,invigorating the qi and strengthening the spleen,and aiding sleep,with little side effects.Objective:To screen the scientific and reasonable process conditions of compound Yimian tablets,and to develop a comprehensive and accurate and reliable quality detection method to preliminary study the stability of compound Yimian tablets.Method:After reviewing the properties of the substances containing pharmacological activity in Acanthopanax senticosus,ethanol was selected as the extraction solvent.Syringin is the main component in the pharmacological activity of Acanthopanax senticosus,and its extraction rate is used as the detection standard,and the optimal process for extracting Acanthopanax senticosus is selected by orthogonal test.Then,through the selection of the auxiliary materials needed in the preparation process,the optimal molding process of compound Yimian tablets is screened by the method of single factor inspection.Refer to the 2015 edition of the Pharmacopoeia for qualitative identification of ginseng and Acanthopanax senticosus in this tablet.Analyze the content of the main active substances in this tablet by high performance liquid chromatography,taking the four components in this tablet（ginsenosides Rb₁,Re,Rg₁ and syringin）as the objective of content analysis,the quality standard of compound Yimian tablets was established,and the methodological verification was completed through experiments.Results:Weigh an appropriate amount of Acanthopanax senticosus,mix it with 6times the amount of 60%ethanol solution,reflux for 2h,operate this step 3 times,recover the ethanol and dry the extract to obtain a dry paste.Mix Acanthopanax senticosus extract powder（96g）with Ginseng powder（252g）and Ganoderma lucidum spore powder（252g）,add sodium carboxymethyl starch（7.5g）and powdered sugar（150g）to it,stir and mix well to granulate the wetting agent,the wet granules are placed in a vacuum oven at 35°C for 2 hours to complete the granulation.Magnesium stearate（1%）was added to the obtained dry granules,mixed thoroughly and compressed to obtain compound Yimian tablets.After experimental investigation,the weight difference,hardness,friability and disintegration time limit of the preparation obtained in this experiment all meet the requirements of the Pharmacopoeia.In this paper,the high-performance liquid phase conditions and content calculation methods used for ginsenosides Rb₁,Re,Rg₁ and syringin in tablets can accurately determine the content of ginsenosides Rb₁,Re,Rg₁ and syringin in compound Yimian tablets,The thin layer chromatography method used for Acanthopanax senticosus and Ginseng in tablets can also complete accurate qualitative identification.Conclusion:This article obtained the optimal extraction process of Acanthopanax senticosus in compound Yimian tablets,and determined the optimal molding process for preparing compound Yimian tablets,the process parameters investigated were in compliance with the regulations,and the prepared compound Yimian tablets had good process stability.The liquid chromatographic conditions established for the detection of active ingredients in this paper are accurate and reliable,and can accurately detect the content of active ingredients in compound Yimian tablets,making a reliable research basis for further production.更多还原