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Metacavir enteric-coated pellets and preparation method thereof

A technology of Cavir sausage and pellets, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. It can solve problems such as temperature instability, poor water solubility of ddG, and difficulty, and achieve Simple operation, avoiding the effect of electrostatic adsorption

Active Publication Date: 2016-04-27
GUANGZHOU YIPINHONG PHARMA +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is mainly due to the physical and chemical properties of ddG. ddG has poor water solubility and is extremely unstable to temperature. It generally needs to be stored at -20°C and is easily degraded in the body, so it is difficult to become a drug.

Method used

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  • Metacavir enteric-coated pellets and preparation method thereof
  • Metacavir enteric-coated pellets and preparation method thereof
  • Metacavir enteric-coated pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] A. Drug-containing pellets

[0052] Metacavir 70g

[0053] Microcrystalline Cellulose 105g

[0054] 25% ethanol aqueous solution 140ml

[0055] Preparation Process:

[0056] (1) Metacavir and microcrystalline cellulose are respectively passed through a 100-mesh sieve, mixed uniformly, and soft materials are prepared with 25% ethanol aqueous solution;

[0057] (2) Put the above-mentioned soft material in an extruding spheronizer, and extrude-spheronize-dry to form pellets. The extrusion speed was 15Hz, the spheronization speed was 26Hz (18 minutes), and finally dried at 40°C for 2 hours to obtain 0.6mm drug-containing pellets.

[0058] B. Isolation layer

[0059] Drug-containing pellets 175g

[0060] Hydroxypropyl Methyl Cellulose 14g

[0061] 70% ethanol aqueous solution 105ml

[0062] Preparation Process:

[0063] (1) Disperse the above-mentioned hydroxypropyl methylcellulose in absolute ethanol, then add water to dissolve, and get final product;

[0064] (2)...

Embodiment 2

[0077] A. Drug-containing pellets

[0078] Metacavir 65g

[0079] Lactose 30g

[0080] Microcrystalline cellulose 90g

[0081] 50% ethanol aqueous solution 200ml

[0082] Preparation Process:

[0083] (1) Metacavir, lactose, and microcrystalline cellulose are mixed evenly by the method of equal addition, passed through an 80-mesh sieve, and set aside;

[0084] (2) Use 50% ethanol aqueous solution as adhesive

[0085] (3) Start the centrifugal granulator to prepare drug-containing pellets. The spray speed changes with the granulation time, the first 2min is 100r.min -1 , so that the powder is wetted in a short time to avoid flying dust → adjust the spray speed to 40r.min -1， , continue until the material is in a flocculent flow state → supply powder and control the powder-slurry ratio to make the material flow in a flocculent state → grow into the target pellet core → dry → sieve to obtain drug-containing pellets;

[0086] B. Isolation layer

[0087] Drug-containing pe...

Embodiment 3

[0106] A. Drug-containing pellets

[0107] Metacavir 50g

[0108] Microcrystalline cellulose 50g

[0109] water 85g

[0110] Preparation Process:

[0111] (1) Mix metacavir and microcrystalline cellulose uniformly by equal addition method, and prepare soft material with water as binder;

[0112] (2) Put the above-mentioned soft material in an extruding spheronizer, and extrude-spheronize-dry to form pellets. The extrusion speed was 15Hz, the spheronization speed was 26Hz (18 minutes), and finally dried at 40°C for 2 hours, and the 0.6mm drug-containing pellets were sieved.

[0113] B. Isolate pellets

[0114] Drug-containing pellets 100g

[0115] Hypromellose 8g

[0116] 75% ethanol 80g

[0117] Preparation Process:

[0118] (1) Disperse hydroxypropyl methylcellulose in absolute ethanol first, and then add water to dissolve it;

[0119] (2) Start the fluidized bed, the inlet air temperature is 35°C, the outlet air temperature is 27°C, the material temperature is 30°C...

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Abstract

The invention belongs to the field of medicinal preparations and relates to a Metacavir enteric coating pellet. The Metacavir enteric coating pellet contains a medicine-containing micro-pellet consisting of Metacavir as an active component and a pharmaceutical excipient as well as an enteric-coating layer consisting of acrylic resin substances and other pharmaceutical excipients, wherein an isolating layer is arranged between the enteric-coating layer and a main medicinal layer. The Metacavir enteric coating pellet disclosed by the invention contains the medicine-containing micro-pellet, the isolating layer and the enteric-coating layer in the percentage by weight: in the medicine-containing micro-pellet, the content of the Metacavir is 20-50 percent and the content of the pharmaceutical excipient is 30-50 percent; in the isolating layer, the content of a coating agent is 2-7 percent and the content of an anti-sticking agent is 0-2 percent; and in the enteric-coating layer, the content of an enteric-coating material is 10-40 percent, the content of a stabilizing agent is 0-1 percent, the content of a plasticizer is 1-5 percent and the content of an anti-sticking agent is 3-10 percent. The Metacavir enteric coating pellet prepared by the preparation method disclosed by the invention has the advantages of strong acid resistance, stability in release speed and favorable stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a chemical drug metacavir enteric-coated preparation for treating viral hepatitis B and a preparation method thereof. Background technique [0002] Hepatitis B (hepatitis B), referred to as hepatitis B, is an infectious disease caused by hepatitis B virus (HBV), mainly liver lesions and can cause damage to various organs. More than 500,000 people die from primary liver cancer every year in the world, and as many as 80% of the primary liver cancers are caused by chronic hepatitis B. Of the 400 million chronic hepatitis B patients, 75% live in Asia, and my country is the country with the highest incidence of hepatitis B. The latest data show that the number of deaths due to liver disease in my country is close to 500,000 every year, and the loss to the society is as high as 100 billion yuan. [0003] Metacavir (6-methoxydideoxyguanosine) is a novel anti-hepa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/7076A61K47/32A61K47/38A61P1/16A61P31/20
Inventor 何红燕刘彩连朱丽君吴小涛钟雪斌
Owner GUANGZHOU YIPINHONG PHARMA
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