Preparation And Quality Of Losartan Potassium Tablets

As a new generation of AT1receptor antagonist, Losartan Potassium has characteristics of effective, high affinity, good selectivity, specificity, no exciting activity, long-term, high efficiency and low toxicity. This product does not affect the physical reactions of cardiovascular system but helps the recovery of coronary heart disease and myocardial infarction. Meanwhile, it can reverse left heart hypertrophy of high blood pressure, restrain glomerular sclerosis, prevent and improve the organ damage caused by high blood pressure. As a member of Sartan drugs, Losartan Potassium not only has the widest experience accumulation but also has become commonly used first-line drug to hypertension and heart failure in clinical with broad market potential and application prospect. To meet the production requirements and more selections of drug dosage forms, we have copied Losartan Potassium tablets and done some research on the prescription and production, quality controls and stability study.Losartan Potassium tablets’ prescription and production:according to the reference of foreign product’s instruction, the prescription of microcrystalline cellulose, lactose and cross-linked PVP were taken respectively to mix with primary drug equality, screened, added aqueous3%povidone solution evenly mixing to make soft material, sifted, granulated, pelletized after drying, and then blended with prescriptions of magnesium stearate. Tested the content and pressed into piece, and then got the target. Through the dissolve degree examination and influence factor investigation tests (illumination tests, high temperature tests, and high humidity tests) of the prescription, we optimized the product, obtained the simple and mature production process of losartan potassium with good stability.Losartan Potassium tablets’ quality controls:according to the reference of Losartan Potassium tablets’ national drug standard [WS1-(X-144)-2003Z] issued by state food and drug administration. We have done some quality controls to this product such as content limitation, physical and chemical characteristics, content identification test, relevant material, dissolving degrees, weight difference examination and high performance liquid chromatograph (HPLC) method for the content determination. Methods are quick, easy and comply with relevant standardsLosartan Potassium tablets’ stability study: according to chemical drug stability research technique guiding principles and the relevant requirements of the appendix in two parts of the2010edition Chinese Pharmacopeia. We did some stability research to this product. The results showed that removing the outer packing, this product’s complete index test results had not significantly changed in the conditions of strong light, high temperature and high humidity. The product stimulated listed packaging sample, placed by40℃±2℃, RH75%±5%for6months and25℃±2℃, RH60%±10%long-term tests for9months. The index of examination results had no change, neither. The product has basic stable physical and chemical properties. According to the stability study results and the national drug standards of Losartan Potassium tablets, recommend that this product should be shading and sealing preservation.