Dissertation
Dissertation > Medicine, health > Chinese Medicine > Of Pharmacy > In drugs

Hawthorn ginseng liver orally disintegrating tablets pharmacy part of the study

Author ZhangXiaoMei
Tutor LiuYouPing
School Chengdu University of Traditional Chinese Medicine
Course Medicinal Chemistry
Keywords Orally disintegrating tablet Preparation Process Quality Standards total Plavonids of Fructus Crataegi total saponins from Panax quinquefoliu
CLC R286
Type Master's thesis
Year 2007
Downloads 179
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Fructus Crataegi Panax quinquefolium Shugan orally disintegrating tablet is a compound preparation with total flavonids of Fructus Crataegi and total saponins from Panax quinquefolium.It’s best proportion compatibility of active fraction determined by effective screening of pharmacodynamic.It has the function of Jianpi with vitality,spleen qi Huayu Health-effectiveness,for the treatment of fatty liver caused by the Spleen and gas stagnation,stasis block.To develop into the treatment of fatty liver drug,the paper for the preparation of pharmaceutical research,and its contents are as follows.一、Preparation Process1.Preparation Process of total Plavonids of Fruetus Crataegi1.1 Extraction Process Systematically studied the total flavonids of Fructus Crataegi extraction process and the factors affecting the overall system,the single factor test and orthogonal test was adopted.The best extraction of total flavonids of Fructus Crataegi:9 times the amount of 75%ethanol and decocting 3 times,an hour for each time.1.2 Purification Process Using macronorous resin purification total flavonids of Fructus Crataegi and have a comprehensive and systematic study of its purification process parameters.The optimum purification of total flavonids:AB-8 macroporous resin,medicine liquid concentration 0.5mg/ml,medicine liquid pH 3-4,the adsorption flow rate 1BV/h,column on the amount of 3BV and 6BV75%ethanol in the rate of elution 4BV/h best effect.All the three samples of enlarge test,total flavonoid content was more than 50%,the results a met the request of standard.1.3 Quality Standards Quality standard of total flavonids of Fructus Crataegi in the three samples of enlarge sample was studied and developed total flavonoids sample content limits.Prescribe the total flavonoid content in Fructus Crataegi shall not be lower than 2.5%by Using ultraviolet(UV) spectrophotometry,the total flavonoid content in total Plavonids of Fructus Crataegi sample shall not be lower than 60%.The macroporous resin organic residues and the methodology in three test samples were examined and organic residues in test samples were not detected.2.Preparation Process of total total saponins from Panax quinquefolium2.1 Extraction Process Systematically studied the total saponins from Panax quinquefolium extraction proc ess and the factors affecting the overall system,the single factor test and orthogonalte st was adopted.The best extraction of total saponins from Panax quinquefolium:12 times the amount of 70%ethanol and decocting 2 times, an hour for each time.2.2 Purification Process Using macronorous resin purification total saponins from Panax quinquefolium and have a comprehensive and systematic study of its purification process parameters.The optimum purification of total saponins:D101 macroporous resin,medicine liquid concentration 0.2g/ml,medicine liquid pH 5-6,the adsorption flow rate 4BV/h,column on the amount of 8BVand 5BV70%ethanol in the rate of elution 4BV/h best effect.All the three samples of enlarge test,total flavonoid content was more than 50%,the results a met the request of standard.2.3 Quality Standards Quality standard of total saponins from Panax quinquefoliu in the three samples of enlarge sample was studied and developed total saponins sample content limits.Prescr ibe the total saponins content in Panax quinquefolium L shall not be lower than 2.4%by Using ultraviolet(UV) spectrophotometry,the total saponins content in total saponins from Panax quinquefoliu sample shall not be lower than 55% by Using ultraviolet(UV) spectrophotometry.Prescribe Ginsenoside Rg1,Ginsenoside Re,Ginsenoside Rb1 shall not be lower than 1.8%,7%,16%by HPLC.The macroporous resin organic residues and the methodology in three test samples were examined and organic resid ues in test samples were not detected.3.The Preparation Process of prodoct3.1 Choice of formulations This paper choice nearly 10 years of foreign research and development of new rapid-release formulations of solid-oral disintegrating tablets(or orally disintegrating tablet).Formulations is the main choice of rapid disintegration agent,may not use auxiliary water swallowing,15 seconds rapidly disintegrating into fine particles in oral,only a few moves swallowing medication process can be completed.It compared with ordinary solid oral formulations fast absorption, bioavailability,easy to take,especially for patients with drug problems,or special circumstances is not the water environment of the patients under treatment.At present, the clinic for specialized for the treatment of fatty liver drug formulations backward, mainly capsules,tablets,granules,pills,oral disintegrating tablets still in the blank,the formulations developed to fill this gap.3.2 Determination of prescription Using collapse of time and to look for indicators of sexual molding,select effective collapse of the types and its main drug ratio,Jiao propellants and their flow on the dosage,as well as hardness,and other parameters were optimized by single factor.The prepration orally disintegrating tablet appearance lightly yellow,the color of uniform,one-sided smooth,in an oral disintegrating within 1 minute,taste good,meet orally disintegrating tablet disintegration time of the request.According to the prescription formulations screening,the preparations of the prescription:90g main ingredients,L-HPC136.65g,MCC 45g,A Division Pakistan sweet 8.1g,menthol 25m,lactose 13.5g,magnesium stearate 1.35g.Experimental studies were prepared in line with provisions of the new solid preparation-orally disintegrating tablet,and was innovative dosage forms.二、Qquality standard of prodoctQuality standard of prodoct was studied and developed orally disintegrating tablet types of content limits.Prescribe the total flavonids shall not be lower than 35mg each tablet and the total saponins shall not be lower than 17mg each tablet by ultraviolet (UV)spectrophotometry.Prescribe Ginsenoside Rg1,Ginsenoside Re,Ginsenoside Rb1 shall not be lower than 1mg,4mg,10mg each tablet by HPLC.The materials used total flavonids,a total saponins and Ginsenoside Rg1,Ginsen oside Re,Ginsenoside Rb1 control the content of the product,have more effective guarantee of the quality of the product.In the determination of Ginsenoside Rg1,Ginsenoside Re,Ginsenosid e Rb1,compared with Pharmacopoeia and other samples,the 3 ingredients were effecti ve separation on the basis of changes in the proportion of the mobile phase and shorten the running time meanwhile.The results show that the method is simple and reproducible and can be used orally disintegrating tablet quality evaluation.

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