Study On Quality Standard Of Beraprost Sodium Tablets

The beraprost sodium tablets are composed of beraprost sodium and its excipients.The content of beraprost sodium in each of the beraprost sodium tablets is 20 ?g.The beraprost sodium is mainly used to improve the chronic arterial occlusive disease.Related symptoms,chronic arterial occlusion can easily lead to ulcers,cold,pain and intermittent claudication.Beprostine sodium tablets are the world's first oral prostacyclin derivatives,which can effectively inhibit the expansion of blood vessels,and also inhibit platelet aggregation and adhesion,and have multiple effects that other drugs do not have.The aim of this study is to improve the quality standards of beraprost sodium tablets,to improve the quality standards of beraprost sodium tablets,to reduce the risk of beraprost sodium tablets in clinical use,and to better control the product quality of beraprost sodium tablets.Provide patients with better quality products.Based on the research on the quality standard of the current beraprost sodium tablets,this topic consults relevant literatures at home and abroad,optimizes the content determination method and increases the related substances and dissolution items of beraprost sodium tablets,which can make the shell more convenient and comprehensive.The product quality of prostaglandin sodium tablets reduces the risk of product quality control.In terms of content determination,the current import drug registration standard(standard number:JX20000170)uses high-performance liquid chromatography,using a fluorescence detector.This method has many steps and requires the use of chloroform.Chloroform is volatile and harmful to human health.The newly proposed method for the determination of content,using a UV detector,simplifies the experimental procedure without the use of chloroform.Through the methodological verification of the newly developed test method,and using this method to detect three batches of beraprost sodium tablets,the contents of the three batches of samples were 97.7%,100.5%,and 97.2%,respectively,and the results showed that the content was determined.It can be used as a method for determining the content of beraprost sodium tablets.In the aspect of related substances detection,this study determined the substance type and control limit by studying the synthesis and production process of beraprost sodium tablets,and using high performance liquid chromatography to detect related substances by referring to the method for determination of beraprost sodium tablets..Validation by methodologies such as specificity,linearity,limit of quantitation,detection limit,accuracy,repeatability,intermediate precision,solution stability,durability,and system suitability.Three batches of beraprost sodium tablets were tested by this method.The total contents of the three batches of samples were 0.9%,0.9%,and 0.7%,respectively.The content of the related substances in the single category was also within the control limit.The results showed that the related substances were detected.The method is effective and feasible,has high accuracy,excellent sensitivity,strong specificity,good precision and durability,and can be used as a detection method for related substances of beraprost sodium tablets.In terms of dissolution detection,this study was carried out by high performance liquid chromatography with reference to the Chinese Pharmacopoeia 2015 edition four(General Rule 0931).Three batches of beraprost sodium tablets were tested by this method.The average dissolution of the three batches was 88.3%,92.6%,95%,and the dissolution of the individual tablets was also in compliance with the standard.The results showed that the dissolution method could be tested.As a method for detecting the dissolution of beraprost sodium tablets.In summary,this subject has conducted in-depth research on the content of babeprost sodium tablets,related substances,and dissolution methods.The experimental results show that the newly developed detection method is superior to the current import drug registration standard and is a beraprost sodium tablet.The improvement of quality standards provides a reliable basis.