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Daclatasvir film coating tablet preparation and preparation method thereof

A film coating, daclatasvir technology, applied in the directions of pill delivery, antiviral agents, sugar-coated pills, etc., can solve the problems of high cost, large side effects, complex preparation process, etc., to break the price monopoly, small individual differences, simple craftsmanship

Inactive Publication Date: 2015-04-29
ANHUI YELLEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Compared with the traditional treatment of HCV with high cost, complicated process, low cure rate and large side effects, the new polymerase inhibitor has good selectivity, can be taken orally, and has no side effects. Small and other advantages, and SVR24 is better, the existing daclatasvir preparation process is complicated, the cost is relatively high, because we have a huge breakthrough in the preparation process of daclatasvir, greatly reducing its production cost, so for For the majority of patients living in underdeveloped areas, complete cure of HCV will be possible at low cost in the near future
[0008] At present, domestic research on daclatasvir film-coated tablet formulations is still blank

Method used

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  • Daclatasvir film coating tablet preparation and preparation method thereof
  • Daclatasvir film coating tablet preparation and preparation method thereof
  • Daclatasvir film coating tablet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] prescription:

[0045] Composition Prescription amount (mg / tablet)

[0046] Daclatasvir 60

[0047] Croscarmellose Sodium 21

[0048] Microcrystalline cellulose 273

[0049] Magnesium Stearate 3

[0050] According to above-mentioned prescription quantity, preparation process is as follows:

[0051] (1) Material pretreatment: sieve daclatasvir, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate for later use;

[0052] (2) Mixing: Weigh the active drug daclatasvir, croscarmellose sodium, microcrystalline cellulose and magnesium stearate in the prescribed amount and mix them evenly;

[0053] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0054] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of croscarmellose sodium and magnesium stearate;

[0055] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;

[0056] (6) ...

Embodiment 2

[0058] prescription:

[0059] Composition Prescription amount (mg / tablet)

[0060] Daclatasvir 60

[0061] Hypromellose 21

[0062] Microcrystalline Cellulose 270

[0063] Magnesium Stearate 6

[0064] According to above-mentioned prescription quantity, preparation process is as follows:

[0065] (1) Material pretreatment: sieve daclatasvir, hypromellose, microcrystalline cellulose, and magnesium stearate for later use;

[0066] (2) Mixing: Weigh the active drug daclatasvir, hypromellose, microcrystalline cellulose and magnesium stearate in the prescribed amount and mix them evenly;

[0067] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0068] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of hypromellose and magnesium stearate;

[0069] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;

[0070] (6) Film coating: film-coat the qualified ...

Embodiment 3

[0072] prescription:

[0073] Composition Prescription amount (mg / tablet)

[0074] Daclatasvir 60

[0075] Croscarmellose Sodium 21

[0076] Anhydrous lactose 270

[0077] Magnesium Stearate 6

[0078] According to above-mentioned prescription quantity, preparation process is as follows:

[0079] (1) Material pretreatment: sieve daclatasvir, croscarmellose sodium, anhydrous lactose, and magnesium stearate for later use;

[0080] (2) Mixing: Weigh the prescription amount of the active drug daclatasvir, croscarmellose sodium, anhydrous lactose, and magnesium stearate and mix evenly;

[0081] (3) Place the mixed powder in (2) in a dry granulator for granulation;

[0082] (4), total mixing: uniformly mix the dry granules prepared in (3) with the prescribed amount of croscarmellose sodium and magnesium stearate;

[0083] (5) Press plain tablets: place the granules prepared in (4) in a high-speed rotary tablet press;

[0084] (6) Film coating: film-coat the quali...

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Abstract

The invention discloses a daclatasvir film coating tablet preparation. The preparation is prepared from the following active ingredients in percentage by mass: 12.0-20.0 percent of daclatasvir, 2.0-8.0 percent of a disintegrating agent, 50.0-80.0 percent of a diluting agent and 0.5-1.5 percent of a lubricating agent, wherein the disintegrating agent is one or more of croscarmellose sodium, hydroxypropyl methylcellulose and sodium carboxymethyl starch, one or two of sodium carboxymethylcellulose and hydroxypropyl methylcellulose as first choice, and preferably sodium carboxymethylcellulose; the diluting agent is one or more of microcrystalline cellulose, lactose anhydrous, mannitol and polyethylene glycol, one or two of microcrystalline cellulose and mannitol as first choice, and preferably microcrystalline cellulose; and the lubricating agent is one or more of magnesium stearate, talcum powder, aerosil and calcium stearate, one or two of magnesium stearate and aerosil, and preferably magnesium stearate. The daclatasvir film coating tablet preparation has the advantages of simple process, high yield, good stability and the like, and is easy for large-scale industrial production.

Description

technical field [0001] The invention discloses a daclatasvir film-coated tablet preparation and a preparation method thereof, which are applied in the field of preparation of therapeutic preparations for hepatitis C virus. Background technique [0002] Hepatitis C virus, referred to as hepatitis C or hepatitis C, is a viral hepatitis caused by hepatitis C virus (Hepatitis C Virus, HCV) infection, mainly through blood transfusion or injection. [0003] Daclatasvir film-coated tablet preparation (Daclatasvir), its trade name is Aklinza ? , originally created by Bristol-Myers Squibb, is a class of anti-hepatitis C nucleoside NS5A polymerase inhibitors. Research data shows that the combination of daclatasvir and daclatasvir in the treatment of hepatitis C has a cure rate of 100%. In Asia, the population is infected with the gene: type II (Simmonds 1b) hepatitis C virus is the most, this type of hepatitis C virus is a Daclatasvir has a significant effect on the treatment of vir...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4178A61K47/38A61P31/14A61P1/16
Inventor 顾世海
Owner ANHUI YELLEN PHARMA
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