Method for preparing entecavir tablets

Abstract

The invention discloses a method for preparing entecavir tablets, which comprises: preparing an auxiliary material for later use by uniformly mixing a filling agent, a disintegrating agent and a bonding agent in formula amount; dispersing entecavir in a formula amount into injection water to obtain a main medicine for later sue; and uniformly spreading the main medicine into the auxiliary material, adding lubricating agent, uniformly mixing, measuring the content of an intermediate, tabletting and obtaining entecavir tablets. The preparation of the entecavir tablets adopts a spray gun to spray the main medicine into the pre-mixed medicinal auxiliary material, so the uniformity problem of the tablets under a condition of low medicine content is solved. In addition, as the low-water-content microcrystalline cellulose PH-200LM as the filling agent of the entecavir tablets, tabletting can be performed without using a drying process; and the direct tabletting process is simpler and easier to implement than a wet-process granulation, fluidized bed granulation and spray drying processes and other processes, is suitable for industrial production and favorable for product quality control, energy conservation and consumption reduction, can reduce production cost and has high practicality.

Description

technical field

[0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a method for preparing entecavir tablets. Background technique

[0002] Entecavir is a deoxyguanosine analog that can effectively inhibit the replication of hepatitis B virus and has a strong anti-HBV effect. It can inhibit the three stages of HBV DNA replication initiation, retrovirus and DNA positive strand synthesis. The effect of Entecavir is to inhibit HBV DNA polymerase and retrovirus, thereby inhibiting the replication of HBV by pre-gene RNA retrovirus DNA negative strand, thereby inhibiting the synthesis of the positive strand, thereby blocking the elongation and assembly of the HBV DNA chain. It has been clinically proven to have a good inhibitory effect on hepatitis B virus. It is currently clinically used to treat chronic hepatitis B infection in adults with active virus replication and persistently elevated serum transaminases, or active liver hi...