Study Of Atorvastatin Calcium Tablet

Atorvastatin calcium tablet is a type of best-selling anti-hyperlipidemia drug,and also is a reductase inhibitor for 3-hydroxy-3-methylglutaryl coenzyme A(HMG-CoA).At present,hyperlipidemia has gradually become the most invisible killer endangering human life.The research on atorvastatin calcium tablets is of great significance to patients,families and society.The key to this issue is whether atorvastatin calcium tablets with similar stability and original dissolution behavior can be prepared.This topic firstly carried out a prescription screening with reference to the original research prescription,and initially determined the composition and dosage of excipients.The prescription was composed of 7% of the main drug,28% of microcrystalline cellulose PH101,21.6% of lactose,29% of calcium carbonate,7% of low-substituted hydroxypropyl cellulose,and 6.4% of croscarmellose sodium,1% of magnesium stearate,and 1.5% to 3.0% of film clothing.Through the inspection of the preparation process,the granulation process parameters,the tableting process parameters and the coating process parameters were determined.Three batches of small test samples were prepared using the established prescription process and small test certificates were made.The dissolution,content and uniformity of the three batches of small test samples all met the requirements,and the growth trend of the related substances was similar to that of the original study.The quality standards for this product were established,and the items such as traits,identification,dissolution,content uniformity,and related substance content were set up.The chromatographic conditions for the determination of atorvastatin calcium tablet-related substances were established by HPLC.The results show that this method has good specificity,precision,high accuracy and good durability.Therefore,this method can effectively control the related substances of this product.The chromatographic conditions of the content determination are the same as those of the related substances.The test results show that the method has good specificity,precision,high accuracy,good durability.Ultraviolet spectrophotometry was used to detect the dissolution and content uniformity of atorvastatin calcium tablets.The stability of atorvastatin calcium tablets showed that under the influence of factors,accelerated conditions and long-term conditions,the self-made samples and the original research drugs were basically the same in terms of their traits,content,relate substances,and dissolution rate.And the atorvastatin calcium tablets have better stability.The quality standards developed for atorvastatin calcium tablets are of scientific,reliable.