Process Optimization And Technological Procedure Design Of Azelnidipine Tablet

Antihypertensive drugs (antihypertensive) can be used to treat hypertension. WHO recommendations hypertensive diagnostic criteria for adult blood pressure of more than21.3/12.6kPa (160/95mmHg). According to the onset of the disease,it is further divided into primary hypertension and secondary hypertension. Primary hypertension, accounted for about90%, is under the influence of various factors, blood pressure regulation function disorder. Secondary hypertension, about5%～10%, the blood pressure elevation is a manifestation of some diseases, such as secondary to renal artery stenosis, renal parenchymal disease, pheochromocytoma, pregnancy, or due to drug induced. Normal systolic blood pressure increased with age, so the primary hypertension incidence varies with the age increase gradually.40years old-50years old or more often, our country adult hypertension prevalence rate is about3.5%-10.0%.Azelnidipine is a new dihydropyridine calcium channel antagonist,which has been used for the treatment of hypertension. Azelnidipine tablet can reduce blood pressure to safety range in daytime, meanwhile without negative consequence, it is an ideal antihypertensive drugs.in this paper,we will study on Azelnidipine tablet of8mg.Azelnidipine tablets in our country at present (when this paper studies began) has not yet listed, also not imported, belong to the three class of new drugs in first small class.Based on literature research and preliminary test, we choosed the main influence on the dissolution rate of polysorbate80, croscarmellose sodium, microcrystalline cellulose, in Azelnidipine45min dissolution index, we screened the prescriptions by the L9(34) orthogonal test. we choose the dissolution of Azelnidipine tablet in vitro as the index, Orthogonal experimental design was applied to decide the best prescription and process, three batches of tablets prepared by optimized formulation were carried out. Subsequently,Factors influencing the stability by high temperature and high humidity and strong light of one sample was carried out,meanwhile, The quality was stable according to the results of6month Accelerated test and36month long-term test. According to the " standards for quality control of pharmaceutical production (2010Revision)" requirement, preparation process specification should include at least the production prescription (including product name, product type, specification and quantity; used in raw materials inventory, elucidation of each material of the specified name, code and content; such as the raw materials of the dosage required conversion, it should also state calculation method), production operation requirements (including the equipment used; key cquipment preparation methods and corresponding operation specification; detailed production steps and process parameters; the intermediate control methods and standards; the expected final yield limit, when necessary, should also state intermediate products yield limit, as well as the material balance calculation and limits; unpackaged product storage requirements, including containers, labels and special storage conditions; note note), packaging operation requirements (to final packaging of the product in the container number, weight or volume packaging format)Based on optimizing process and pilot equipment, we design the process parameters and technological procedure。We prepare the sample by the pilot equipment,the technological verification of the process parameters and technological procedure was carried out, In view of Azelnidipine tablets each step of a different nature and requirements, we used a variety of methods and means of detection, such as the mixing process, the main verification material is mixed uniformly, we used visual method, HPLC method,--Determination of bulk density and so on methods and means; drying process, main show moisture after drying index if qualified, we applied the determination of water content; pressing process, main show tablets can meet quality standards, we used a dissolution method, HPLC method, visual method etc. method; packaging process, main show packaging is qualified, mainly by visual method.The results showed that The preparation technology is feasible andthe quality control method is reliable.