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Drug composition causing low drug resistance, and its preparation method and application

A composition and drug resistance technology, applied in the field of medicine, can solve problems such as limited antiviral drugs, and achieve the effect of reducing drug resistance

Active Publication Date: 2013-05-08
ANHUI BIOCHEM BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the antiviral drugs that have been marketed in my country are limited

Method used

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  • Drug composition causing low drug resistance, and its preparation method and application
  • Drug composition causing low drug resistance, and its preparation method and application
  • Drug composition causing low drug resistance, and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Example 1 Study on Drug Resistance of Different Doses of Lamivudine to Hepatitis B Virus in Patients Co-infected with HIV / HBV

[0055] To study the resistance rate of HBV to lamivudine when HIV / HBV co-infected patients received HAART treatment, the main time points and predictors of drug resistance.

[0056] (1) Research object

[0057] Inclusion criteria for AIDS patients with viral hepatitis B:

[0058] ① ELISA detects positive HIV-1 antibody and confirms it by Western Blot, and starts HAART treatment;

[0059] ②Before HAART, the patients who were HBsAg-positive or HBsAg-negative by nested PCR amplification were detected by microparticle enzyme-linked immunoassay (MEIA);

[0060] ③The HAART regimen includes lamivudine (only lamivudine has anti-HBV activity in this regimen);

[0061] ④Blood samples from other previous studies.

[0062] 100 patients (70 males and 30 females) who met the requirements of hospitalization or follow-up, 85 cases of HBsAg positive hep...

Embodiment 2

[0077] Example 2 Study on Drug Resistance of Different Doses of Lamivudine to Hepatitis B Virus in Patients Co-infected with HIV / HBV

[0078] To study the resistance rate of HBV to lamivudine in HIV / HBV co-infected patients receiving HAART.

[0079] (1) Research object

[0080] The inclusion criteria for AIDS patients with viral hepatitis B are the same as in Example 1.

[0081] 60 patients (48 males and 12 females) met the requirements of hospitalization or follow-up, 52 cases of HBsAg positive hepatitis B, and 8 cases of occult hepatitis B (see Table 3).

[0082] According to the dose difference of lamivudine in the HAART regimen, patients were divided into treatment group (300mg / day lamivudine+30mg / day d4T+200mg / day NVP) and control group (150mg / day lamivudine+30mg / day / day d4T+200mg / day NVP). Among them, in the treatment group, there were 28 cases of HBsAg-positive hepatitis B, 4 cases of occult hepatitis B, a total of 70 blood samples; in the control group, 14 case...

Embodiment 3

[0092] Example 3 A study of HAART containing lamivudine in the treatment of HIV / HBV infection-naive patients

[0093] To study the change of HBV virus replication level in patients with HIV / HBV infection treated with HAART regimen containing lamivudine (300mg / day 3TC+30mg / day d4T+200mg / day NVP) for one year.

[0094] 1. Research object

[0095] Screened 31 cases of newly diagnosed patients with HIV combined with HBV infection (HIV / HBV) (never received any antiviral treatment for HIV or HBV before), among them, 9 cases of large three positives and 22 cases of small three positives were given to the test subjects. Patients were treated with 3TC-containing HAART regimen (300mg / day 3TC+30mg / day d4T+200mg / day NVP) for 1 year, and the changes in plasma HBV viral replication before and after treatment were analyzed.

[0096] 2. Research methods

[0097] The venous blood of the patients was collected at baseline before treatment and 1 year after treatment (48 weeks), and the pla...

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Abstract

The invention relates to a drug composition causing low drug resistance. The drug composition is composed of lamivudine, one or more pharmaceutically-acceptable salts of lamivudine, one or more pharmaceutically-acceptable esters of lamivudine, or mixture of lamivudine and pharmaceutically-acceptable carriers. Based on proportioning of the drug composition, the drug composition is suitable for being dosed once a day according to a unit dosage and a dosage taken every time is 300 mg. The drug composition is utilized for anti-hepatitis treatment. The drug composition is utilized for reduction ofdrug resistance produced when lamivudine is utilized for treatment of hepatitis patients, hepatitis b patients, and AIDS-hepatitis b patients.

Description

technical field [0001] The invention relates to the field of medicines, in particular to an anti-hepatitis composition with significantly reduced drug resistance, a preparation method and application thereof. Background technique [0002] Hepatitis B virus (HBV) belongs to the hepadnaviridae family, and its genome is about 3.2kb in length, which is partially double-stranded circular DNA. HBV has strong resistance, but it can be inactivated by placing it at 65°C for 10 hours, boiling for 10 minutes, or high-pressure steam, and ethylene oxide, glutaraldehyde, peracetic acid and iodophor can also inactivate HBV better. live effect. [0003] After HBV invades liver cells, part of the double-stranded circular HBV DNA uses the negative-strand DNA as a template to extend the positive strand in the nucleus to repair the gap in the positive strand, forming a covalently closed circular DNA (cccDNA); Template, transcribed into several mRNAs of different lengths, which are respectivel...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7072A61K31/551A61K31/513A61P31/18A61P1/16A61P31/20
Inventor 卢洪洲李太生
Owner ANHUI BIOCHEM BIO PHARMA