Quality Difference Between Original And Generic Nifedipine And Its Slow-release And Controlled-release Agents

Hypertension is a common disease in modern clinical practice,which requires lifelong medication.Moreover,if it is not well controlled,multiple organs will be damaged,so it will cause greater psychological and economic burden to patients.With the development of modern medical technology,people have a deeper understanding of hypertension.According to relevant clinical studies,the risk of hypertension is different in different populations in different regions.The data show that the number and proportion of patients with hypertension are significantly higher in Asia than in other regions,and the incidence is higher in China,which is related to a variety of factors including heredity,dietary habits and aging population.There are five categories of drugs in the field of hypertension treatment,among which calcium antagonists are the most widely prescribed in China,and also the first-line recommendations of clinical guidelines.Nifedipine is a calcium antagonist.As a common drug in the treatment of hypertension,nifedipine is widely used in clinical practice.It can block calcium ion channels and achieve the effect of relaxing smooth muscles and blood vessels,thus reducing blood pressure.Nifedipine,on the other hand,significantly reduces sympathetic activity,reducing the release of epinephrine and further lowering blood pressure.The modern chemical drug nifedipine was developed in 1966 by bayer,a German enterprise.In the early stage,it was mainly applied to patients with coronary heart disease and angina pectoris.In the 1980s,with the clear efficacy of nifedipine in lowering blood pressure,it was widely used in the world.But the lack of nifedipine tablets to treat high blood pressure is also gradually revealed,nifedipine sustained-release dosage form application soon,sustained-release dosage form is divided into three generations in the market at present,namely the nifedipine?,nifedipine?,nifedipine ?(retard tablet).NifedipineImainly use relevant auxiliary material,according to the principle of drug correlation,namely drug related characteristics of difficult soluble,the particles were superfine pulverized and then tiled,so that the drug could reach a certain distribution pattern and achieve the effect of slow release as much as possible;On the basis of nifedipine?,nifedipine? had the obvious progress.It makes use of the molecular slow-release skeleton structure to make the drug molecules more uniform and more widely bound to the skeleton,and is locked in each network structure by the skeleton structure uniformly,achieving the effect of uniform and slow release from the inside.There are a lot of nifedipine ? products on the market,it is widely used in pharmacies,third-tier and fourth-tier city hospitals and county-level hospitals;Nifedipine ? has adopted the technology of osmotic pump,coating film,laser drilling,etc.,so that the drug components can be released at a constant speed or close to a constant speed,which greatly improves the efficacy and makes it more convenient to use.Among them,the original research product is the nifedipine controlled release tablet produced by bayer company,The name of this product is baixintong and it is the mainstream product in the market.The comparison between the original research drug and the generic drug in this paper is mainly the quality difference between baixintong and the domestic drug.The main contents of this study are as follows:the quality differences between the original nifedipine controlled release tablets and the generic drugs made by different domestic manufacturers,as well as the quality differences between the domestic sustained-release tablets.According to the pharmacopoeia,a series of experiments were carried out,including appearance quality,in vitro dissolution and release experiment,impurity content determination,active ingredient content determination,tablet fragility and so on.In addition,based on the collected real clinical data,the following conclusions were drawn:nifedipine controlled-release tablets were superior to sustained-release tablets(imitation controlled-release tablets)in terms of dissolution rate and total impurity content.In the actual clinical practice,the original research controlled release tablets(70%)were higher than the domestic controlled release tablets(30%)in the hypertension compliance rate,and lower than the domestic controlled release tablets in the incidence of adverse reactions.In this study,the correlation between in vivo and in vitro pharmacokinetics and pharmacodynamics was explored by investigating whether domestic imitation of nifedipine could completely achieve the same therapeutic and quality effect as the original developed drug.It provides laboratory data support for the quality of nifedipine generic drugs,and further provides a complete methodological reference for the improvement of China's generic drug production level,China's future evaluation standards for the application of generic drugs,and the re-evaluation of generic drugs before and after the market.On the other hand,the results of this study can guide doctors and patients to take medicine,and help patients to choose appropriate drugs and dosage forms in consideration of disease factors and economic factors.The research focus of this subject is to draw a conclusion on the difference between the original research drug baixintong and the generic drug by comprehensively and systematically comparing the quality difference between the original research drug baixintong and the domestic generic drug of different manufacturers.Based on this,the slow and controlled release tablets of nifedipine was studied.Finally,the quality difference between the studied nifedipine slow and controlled release tablets and the original research drug baixintong was analyzed to obtain a better prescription of domestic generic drug slow and controlled release tablets.