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MiRNA (micro ribonucleic acid) marker related to drug-induced liver injury and its detection kit

A drug-induced liver injury and microRNA technology, applied in the fields of biotechnology and pharmaceuticals, can solve the problems that cannot meet the needs of drug-induced liver injury diagnosis, and there is no detection of miRNA marker combinations and detection kits.

Inactive Publication Date: 2012-05-02
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, even the serum ALT and / or AST, which are the gold standard for clinical diagnosis of liver injury, cannot meet the needs of the diagnosis of drug-induced liver injury. Associated with myocardial and skeletal muscle injury; serum ALT activity is also associated with muscle necrosis
[0007] At present, there is no report on drug-induced liver injury-specific miRNA marker combinations and detection kits for detection of blood samples

Method used

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  • MiRNA (micro ribonucleic acid) marker related to drug-induced liver injury and its detection kit
  • MiRNA (micro ribonucleic acid) marker related to drug-induced liver injury and its detection kit
  • MiRNA (micro ribonucleic acid) marker related to drug-induced liver injury and its detection kit

Examples

Experimental program
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Effect test

Embodiment 1

[0066] Example 1 Time-dependent detection of markers

[0067] Establishment of DILI animal model: The animals in the normal group were male SD rats of SPF grade, weighing 250g±20g, and were directly given an equal volume of 5% CMC-Na solution. Animal model of liver injury caused by chemical drugs (acetaminophen): male SPF grade SD rats, high dose group (1600mg / kg body weight); animal model of liver injury caused by Chinese herbal medicine (Xanthophyll, water extract): For male SPF grade SD rats, the dosage is divided into high dosage group (70g / kg body weight) (the dosage is calculated by crude drug amount). Both drugs were dissolved in 5% CMC-Na solution.

[0068] Acquisition of study samples: In the time-dependent analysis of markers, blood and liver tissue samples were collected at 3 hours, 6 hours and 12 hours after administration, respectively. Blood was collected from the femoral artery (a large amount) or the orbital venous plexus (a small amount), and the serum / plasm...

Embodiment 2

[0075] The dose-dependent detection of embodiment 2 marker

[0076] Establishment of DILI animal model: The animals in the normal group were male SD rats of SPF grade, weighing 250g±20g, and were directly given an equal volume of 5% CMC-Na solution. Animal model of liver injury caused by chemical drugs (acetaminophen): male SPF grade SD rats, high dose group (1600mg / kg body weight), middle dose group (800mg / kg body weight) and low dose group (400mg / kg body weight); Chinese herbal medicine (Xantaozi, water extract) induced liver injury animal model: male SPF grade SD rats, the dosage is divided into high dose group (70g / kg body weight), middle dose group (35g / kg body weight) And low dose group (18g / kg body weight) (dosage is calculated according to crude drug amount). Both drugs were dissolved in 5% CMC-Na solution.

[0077] Acquisition of research samples: In the dose-dependent analysis of markers, blood and liver tissue samples were collected 24 hours after administration in...

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Abstract

Belonging to the technical field of biology and pharmacy, the invention relates to a serum / plasma miRNA marker related to drug-induced liver injury (DILI) and application of its detection kit in early detection of DILI as well as drug liver toxicity safety evaluation, etc. The marker can be one or more of miR-122, miR-192 and miR-193. The detection kit of the marker is conducive to early detection of DILI, and has better early sensitivity than traditional blood biochemical indexes. Thus, the detection kit has potentials to be applied in preclinical laboratories as well as clinical diagnosis of various hospitals nationwide, and simultaneously provides a powerful reference for liver toxicity safety evaluation during new drug development, as well as improves the detection rate of drug liver toxicity to a greater extent.

Description

Technical field: [0001] The invention belongs to the field of biotechnology and pharmaceutical technology, and relates to a drug-induced liver injury-related serum / plasma microRNA marker and its detection kit for the early detection of drug-induced liver injury and the safety of drug-induced liver toxicity. applications in performance evaluation. Background technique [0002] With the wide application of various new drugs and the increase of combination drugs, drug-induced liver injury (Drug-induced Liver Injury, DILI) has become an important problem faced by medical and health workers, the pharmaceutical industry and drug management departments. According to reports, drug-induced liver injury accounts for 10%-15% of adverse drug reactions, and the actual clinical cases of drug-induced liver injury are far more than the reported number. DILI is the most common reason for drug withdrawal from the market. Over the past few years, the FDA has withdrawn a number of drugs from ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68C12N15/113C12N15/11
Inventor 张陆勇江振洲苏钰文陈熹张辰宇
Owner CHINA PHARM UNIV
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