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Study On The Pulsed Of Delayed Releasing Panax Notoginseng Saponins Tablet

Posted on:2013-06-16Degree:MasterType:Thesis
Country:ChinaCandidate:X X HuFull Text:PDF
GTID:2234330374493918Subject:Pharmacy
Abstract/Summary:PDF Full Text Request
Pulsed drug delivery system and also known as intelligent drug deli very system, is a new dosage form that based on time and hour drug dynamics pharmacology, regularly release effective doses of the drug, al so called Time clock or Controlled explosion systems; It can accordin g to some the biothythm characteristics of disease, release quantitative and timing of drug, in order to improve the treatment of the patient co mpliance.Panax Notoginseng (Burk.) F.H.Chen are plants of Araliaceae, its st em, leaf, flower all can be used to heal; Panax Notoginseng total sapon ins is the activity of the active ingredients extracted from Panax notoginsen g, it contain a varietyof monomer saponins, the main composition is gin seng saponins Rgl, ginseng saponins Rb1and Panax Notoginseng sapon ins R1; Panax Notoginseng total saponins have the effects on dilation of blood vessels, reducing blood fat, reduce the myocardial oxygenconsu mption, increase coronary blood flow, such as two-way adjusting heartra te pharmacological, it’s effective active ingredient to improve cardiovasc ular disease, alleviate the symptoms. This article chooses Panax Notogin seng total saponins drugs as a model durg, use the the dry coating that is current prevalent and mature technology made of pulsed of delayed releasing Panax Notoginseng Saponins tablet. With fullconsideration of the rhythm of cardiovascular disease, It’s regarded the Chinese medicine pharmacologyhour theory and hour drug science principles as the guide, the modern medicine dosage forms and the requirements of the need for clinical as the direction, made of Traditional Chinese medicine pulse tim ing drug release system.Panax Notoginseng total saponins as the active ingredients extracte d from Panax notoginseng of Traditional Chinese medicine Panax Notogi nseng, at present the main application is on cardiovascular system diseas eand in central nervous system diseases. In recent years, with the deepe ning of the research, we know more exactly on the pharmacological eff ects, of which also provide the basis for us to apply the drug reasonabl ely. Based on the pharmacology of the hour and hour drug action princ iples, we design the pulse timing drug delivery system, and do some st udy on absorption experiments in small intestine, preparation, quality co ntrol. The preparation of the study has an important significance for pre vention and treatment people who have cardiovascular disease, and provi des a theoretical basis for the purpose of using cardiovascular disease drug safely, rationally and efficiently as the guiding principle.1Study on the pulsed of delayed releasing tablet preparationPulsed of delayed releasing Panax Notoginseng Saponins tablet is composed of two parts of the core tablets and coating. The core tablet containing the main drug and high disintegrantand with a burst release effect; We use HPMC as a reinforcing material and combined with othe r accessories having a good late-release effect for the dry coating layer. We use suppress coating method made of the preparation of the entire tablet, use the powder squash method to suppress the core tablets, use wet granulation to process of the coating layer.2Screening the prescription of pulsed of delayed releasing tablet an d study in vitro releaseIn this study, we mainly use in vitro release studies to achieve the prescription screening of pulsed of delayed releasing Panax Notoginseng Saponins tablet. Screening prescription of the core tablets, we study the Influence of disintegrants, fillers, lubricants, and ultimately determine to use the CMS-Na disintegrant. We regard Ginsenoside Rgl of Panax not oginseng saponins as the index component, establish the method of puls ed of delayed releasing Panax Notoginseng Saponins tablet in vitro relea se ratedetermination, and investigated the impact of the dissolution condi tions of release. For mulation of the outer coating layer, we investigated the impact of HPMC viscosity and HPMC amount, filler types and fille r amount, coating layer amount and the impact of other factors on drug release. We prepared in vitro could delay the release of about4.5h, wh en taking6.5h, the drug release up to about90%.3Study on the quality control of pulsed of delayed releasing tabletTLC is used in qualitative identification of the preparation of ginsen oside Rgl and high performance liquid chromatography is used incontent determined too. We establish a method to analysis the the quality of in dicator composition of ginsenoside Rg1in the pulsed of delayed releasi ng Panax Notoginseng Saponins. Methodology studies have shown that the quantitative method is accurate, simple andprecision that can be use d for the determination of the appropriate ingredients in thepreparation.4Absorption experiments in rat small intestineIn Preformulation studies of the oral pharmaceutical preparations, it is necessary to predict the body’s absorption of drugs after oral administrati on. The small intestine is the main site of drug absorption, there a vari ety of research methods of drug absorbed in their parts:in vitro, in theb ody and in vivo. In the body method does not damage the research part s of the lymphatic and bloodcirculatory system, so it’s obviously superio r to the in vitro method. In this paper, we regard Ginsenoside Rg1as the target components. With absorption experiment in the small intestine, we have investigated drug pH, concentration and bowel in The impact of ginsenoside Rg1absorbing in the small intestine. The results show that, the pH of the circulating fluid in the impact of ginsenoside Rgl absorbin g in the small intestine has had nosignificant change in absorption, abso rption rate, the cumulative absorption percentage and t1/2;Ginsenoside R g1in the0.0214~0.1926mg/mL range, the absorption and drug concentra tion showed a good linear relationship. Sample liquid in the intestinal lo op perfusion180min, ginsenoside Rgl in the whole intestine are absorbe d, the absorption of ginsenoside Rgl are no significant difference in bow el loop solution. Experiments show that, absorption of ginsenoside Rgl are passive diffusion process, ginsenoside Rgl in rat intestinal have no sp ecific absorption site.
Keywords/Search Tags:Panax Notoginseng Saponins, Pulsed of delayed releasing tablet, Absorption experiments in small intestine, Preparation, quality control
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