Novel medicine composition for treating hepatitis B virus and preparation method

A hepatitis B virus and new drug technology, applied in the field of new drug combination and preparation for the treatment of hepatitis B virus, can solve the problems of poor anti-liver and anti-viral activity, prone to nephrotoxicity, drug resistance and the like, and achieves protection of the liver and a simple preparation method. Convenient, fast-acting results

Inactive Publication Date: 2019-10-22
苏州扬厉医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Nowadays, clinical anti-HBV drugs have many adverse reactions after patients take them, and they are prone to relapse after drug withdrawal. Long-term use will produce drug resistance, prone to adverse reactions such as nephrotoxicity and bone marrow suppression, and have poor anti-hepatic and anti-viral activities. , poor security

Method used

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  • Novel medicine composition for treating hepatitis B virus and preparation method

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Comparison scheme
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Embodiment I

[0045] Embodiment 1, a kind of preparation method of treating hepatitis B virus new drug combination of the present invention comprises the following steps:

[0046] S1. Micronize the bulk drug of the compound of formula I or its pharmaceutically acceptable salt to obtain micropowder A;

[0047] S2, uniformly mixing the filler and the disintegrant to obtain a mixture a;

[0048] S3 adding the binder into the wetting agent to obtain the mixture b;

[0049] S4. After the mixture a and the mixture b are mixed, the granules are granulated by wet method, and then the granules are sized and dried to obtain the granules B;

[0050] S5. Spray the micropowder A evenly on the particle B, and then dry to obtain the dry particle C;

[0051] S6. Add lubricant to dry granules C, mix evenly, and then compress to obtain bare chips;

[0052] S7. After adding the coating agent to the bare tablet, perform a coating process to obtain a tablet, thereby obtaining a tablet of the new drug combina...

Embodiment II

[0053] Embodiment II, a kind of preparation method for the treatment of hepatitis B virus drug combination of the present invention comprises the following steps:

[0054] (1) Micronize the crude drug of the compound of formula I or its pharmaceutically acceptable salt to obtain micropowder A, and micronize tenofovir disoproxil to obtain micropowder B;

[0055] (2) Mix the filler and the disintegrant uniformly to obtain mixture a, and add the adhesive to the wetting agent to obtain mixture b;

[0056] (3) After mixture a and mixture b are mixed, granulate by wet method, then granulate and dry to obtain granule B;

[0057] (4) Spray micropowder A evenly on particle B, and then dry to obtain dry particle C;

[0058] (5) Add a lubricant to the dry granule C and mix to obtain a mixture D, add micropowder B to the mixture D and mix evenly, and then press into tablets to obtain a bare chip;

[0059] (6) After adding the coating agent to the bare tablet, perform a coating process to ...

Embodiment 1

[0062] A new drug combination for the treatment of hepatitis B virus, consisting of 50% filler, 0.4% lubricant, 1% binder, 6% disintegrant, 4% coating agent, 25% wetting agent, 5% tenofo Viril dipivoxil, prepared into a new drug drug combination oral tablet whose specification is 0.5mg / tablet.

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PUM

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Abstract

The invention discloses a novel medicine composition for treating the hepatitis B virus and a preparation method. The novel medicine composition comprises a compound shown in a formula I or medicinalsalt of the compound and pharmaceutically acceptable auxiliary materials. The novel medicine composition is prepared into oral tablets, is convenient to take, has the advantages of a high dissolutionrate and a quick effect, has the dual effects of inhibiting the hepatitis B virus, stabilizing illness states, reducing toxicity and enhancing efficacy, has a significant inhibition effect on secretion of S antigens and e antigens of hepatitis B by HepG2.2.15 cells and significant effects of reducing toxicity and enhancing efficacy, and is safe, reliable and beneficial for application and popularization.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a combination of new drugs and a preparation method for treating hepatitis B virus. Background technique [0002] Hepatitis B virus, referred to as hepatitis B virus, is a DNA virus that belongs to the Hepadnaviridae family and belongs to the Department of Infection; the genome is about 3.2kb long and is partially double-stranded circular DNA; HBV can be inactivated within 10 hours, boiled for 10 minutes or high-pressure steam; chlorine-containing preparations, ethylene oxide, glutaraldehyde, peracetic acid and iodophor also have good inactivation effects; according to current knowledge, HBV It is only susceptible to humans and orangutans, causing hepatitis B virus disease; the complete hepatitis B virus is granulated, and it is also called Dana particles. [0003] The infection rate of hepatitis B virus in my country is about 60%-70%; the carrier rate of hep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/506A61K31/675A61K9/28A61P1/16A61P31/20
CPCA61K31/506A61K31/675A61K9/28A61P1/16A61P31/20A61K2300/00
Inventor 沙薇杨艳丽苑来旗
Owner 苏州扬厉医药科技有限公司
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