Preparation Technology And Quality Standard Of Entecavir Dispersible Tablets

Entecavir is a new generation of hepatitis b virus drugs,for guanine nucleoside analogues,is efficient selective hepatitis b virus polymerase inhibitors,can effectively inhibit the hepatitis b virus replication,and resistant rate is low.Entecavir tablet for sino-american Shanghai squibb co.,LTD.,the development and production,entecavir dispersible tablets for jiangsu zhengda sunny pharmaceutical development.Because of entecavir its work fast,strong antiviral activity and low incidence of drug resistance,gradually in the hepatitis b virus include the treatment of chronic severe hepatitis has been widely clinical application.This topic research the entecavir dispersible tablets and entecavir tablet formulations,entecavir dispersible tablet is after normal slice and capsule and new dosage forms.Therefore this topic to entecavir dispersible tablets preparation technology and quality standards as the research object,to optimize the prescription and process,provide the basis for the quality and efficacy of the product stability,to establish dissolution,related substances,isomer,content determination method,through the research to improve the quality of existing product standards,producing stable quality,adapt to clinical demand,convenient for patients taking high quality drugs.Prescription process part,in order to make the entecavir dispersible tablet in water can spread out evenly mixed suspension particles as soon as possible,this article adopts the wet legal system grain.At the same time to analyze the nature of the raw materials,auxiliary materials,type and dosage of screened optimize the prescription,prescription was finally determined.Smaller due to the product specification,process was preparation of raw materials increasing amount hybrid method was used.And preparation process of preparation was studied by the three batch of pilot sample,and the stability of the prescription process validation.Also explored the influence factors of the product at the same time,the experimental results show that the homemade products of various indicators and reference preparation.So according to the technology preparation of the product quality control,the craft is simple,fast disintegration time,suitable for industrialized production of entecavir dispersible tablets.Quality research part,the establishment of the dissolution,the detection method for the determination of related substances,content and methodology verification.Its determination method is accurate,high sensitivity,and the product quality research on literatures and materials properties increased the isomer of detection,and to establish the methods for the methodology validation,this product did not check out after inspection isomer.Of this product based on the investigation to the three batch samples each index,compared with listed the reference preparation product,quality are basically identical.And this product did not detect the isomer.Product quality is relatively stable.Stability of experiment on the influence factors of three batch of pilot sample for 10 days;Accelerated 6 months,long term test,the indicators compared with 0 month had no obvious change.The product quality is stable,according to the drug stability test guidelines,to better control the quality of our products and with reference to the listed samples made the sample storage condition.This topic research the entecavir dispersible tablets,process stability,the establishment of a reliable testing method,can effectively control the quality of the products.Product quality is not lower than the reference preparation.