CN118203586A - Use of curcumin and TDO2 inhibitor in combination for preventing and/or treating non-alcoholic fatty liver disease - Google Patents

Use of curcumin and TDO2 inhibitor in combination for preventing and/or treating non-alcoholic fatty liver disease Download PDF

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CN118203586A
CN118203586A CN202410335433.6A CN202410335433A CN118203586A CN 118203586 A CN118203586 A CN 118203586A CN 202410335433 A CN202410335433 A CN 202410335433A CN 118203586 A CN118203586 A CN 118203586A
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curcumin
tdo2 inhibitor
fatty liver
liver disease
tdo2
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朱亚玲
马金虎
王毅
唐云书
崔明珠
王丹红
裴星月
朱勇
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Anhui Medical University
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Anhui Medical University
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Veterinary Medicine (AREA)
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  • Life Sciences & Earth Sciences (AREA)
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  • General Chemical & Material Sciences (AREA)
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  • Gastroenterology & Hepatology (AREA)
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Abstract

The invention discloses application of a combination of curcumin and a TDO2 inhibitor in preventing and/or treating nonalcoholic fatty liver disease (NAFLD). The invention constructs a rat model, and combines the curcumin and the TDO2 inhibitor to find that the two medicines have synergistic effect in preventing and treating nonalcoholic fatty liver disease, and the combined effect of the two medicines is obviously superior to that of singly administering the curcumin or the TDO2 inhibitor. The curcumin and the TDO2 inhibitor can be combined to effectively improve liver steatosis, mitochondrial injury and liver inflammation of the non-alcoholic fatty liver disease rats, reduce blood fat and weight, and provide a new choice for preparing the non-alcoholic fatty liver disease prevention and treatment drugs.

Description

Use of curcumin and TDO2 inhibitor in combination for preventing and/or treating non-alcoholic fatty liver disease
Technical Field
The invention belongs to the technical field of biological medicines, and particularly relates to application of a curcumin and TDO2 inhibitor combination in preventing and/or treating non-alcoholic fatty liver disease.
Background
With the continuous improvement of living standard, non-alcoholic fatty liver disease (NAFLD, non-alcoholic FATTY LIVER DISEASE) has become one of the most common chronic liver diseases in our country. The global prevalence of NAFLD is statistically 25.24%, whereas chinese prevalence is as high as 29.2%, with a continuously increasing trend. NAFLD mainly refers to clinical pathological syndromes which are mainly characterized by excessive lipid deposition of liver and are caused by alcohol removal and other definite liver damage factors, and the clinical pathological syndromes comprise simple fatty liver, and fatty hepatitis, liver cirrhosis and liver cancer which are evolved from the clinical syndromes are important causes of liver transplantation. Meanwhile, NAFLD can also increase the incidence rate of liver cirrhosis and liver cancer of patients with chronic hepatitis B, chronic hepatitis C and the like, is related to various diseases such as obesity, type 2 diabetes, atherosclerosis, other cardiovascular and cerebrovascular diseases, malignant tumors related to metabolic syndrome and the like, and has great influence on human health and economic and social development. Several classes of NAFLD drug candidates are in clinical research phase, such as pioglitazone, statins, obeticholic acid, pentoxifylline, etc. Although clinical trial results suggest that these drugs can bring some benefit to NAFLD patients, no effective NAFLD therapeutic has been clinically approved so far.
Curcumin (Curcumin), also known as dimethoxy curcumin (DiferuloyMethane), is a fat-soluble casein extracted from dried rhizome of Curcuma longa, and has good anti-inflammatory and anticancer properties. Curcumin has been reported to increase the level of sIgA in the intestinal mucosa of rats with nonalcoholic steatohepatitis, reduce the level of malondialdehyde in the intestinal tissues of rats, raise the level of superoxide dismutase, and play roles in regulating immunity, resisting oxidation and scavenging free radicals.
Tryptophan 2,3-dioxygenase (TDO 2, tryptophan-2, 3-dioxygenase) is an important metabolic enzyme that participates in the metabolic process of tryptophan and converts it into various metabolites such as canine uric acid, xanthurenic acid, cinnabar acid, quinolinic acid, pyridine, and the like. These metabolites have a close relationship with the occurrence and development of NAFLD.
Methods for the combined prevention and/or treatment of nonalcoholic fatty liver disease using curcumin and TDO2 inhibitors have not been reported.
Disclosure of Invention
In view of the above, the present invention aims to provide a new combination pharmaceutical composition for preventing and/or treating non-alcoholic fatty liver disease, wherein the main components of the combination pharmaceutical composition are curcumin and TDO2 inhibitor, and the combination of the two drugs can improve hepatocyte lipid deposition, mitochondrial injury and inflammatory reaction, reduce blood lipid and reduce body weight, so as to achieve the effect of preventing and/or treating non-alcoholic fatty liver disease.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
in a first aspect, the present invention provides the use of a combination of curcumin and a TDO2 inhibitor in the manufacture of a medicament for the prevention and/or treatment of non-alcoholic fatty liver disease.
In a second aspect, the invention provides a combination pharmaceutical composition for preventing and/or treating non-alcoholic fatty liver disease, which consists of curcumin and a TDO2 inhibitor.
The third aspect of the invention provides application of the combination drug composition in preparing drugs for preventing and/or treating non-alcoholic fatty liver disease.
In a fourth aspect, the present invention provides a medicament for preventing and/or treating non-alcoholic fatty liver disease, which comprises the above-mentioned combination pharmaceutical composition.
The curcumin as used herein refers to curcumin and its derivatives, the curcumin refers to dimethoxy curcumin, and the curcumin derivatives refer to curcumin obtained by modifying the molecular structure of curcumin in various known ways, for example, curc-OEG, biphenyl difluoro ketone EF24, etc., but is not limited thereto. In some specific embodiments of the present invention, the curcumin is dimethoxy curcumin, and its specific chemical structural formula is as follows:
the TDO2 inhibitor as described herein refers to any component capable of inhibiting the expression of TDO2 or inhibiting the function of TDO2, and specifically, allopurinol (Allopurinol) may be mentioned as an example, but is not limited thereto. In some embodiments of the invention, the TDO2 inhibitor is allopurinol, which has the following chemical formula:
As used herein, "in combination with" means that two or more active substances can each be administered to a subject simultaneously as a single formulation, or sequentially in any order, each as a single formulation, or formulated into pharmaceutical compositions.
The ratio of the two active substances curcumin and TDO2 inhibitor can be determined according to the manner known in the art, and in some specific embodiments of the present invention, in a combination pharmaceutical composition composed of two active substances, the mass ratio of the curcumin and the TDO2 inhibitor is 2: 3-3: 2; preferably, the mass ratio of the curcumin to the TDO2 inhibitor is 1:1.
The medicine for preventing and/or treating the nonalcoholic fatty liver disease comprises the combined medicine composition and also comprises pharmaceutically acceptable auxiliary materials, excipients or carriers.
Specifically, the choice of auxiliary materials, excipients or carriers is selected according to the different dosage forms of the medicines, and the specific dosage forms of the medicines are adjusted according to the different administration modes. The combination pharmaceutical composition or the medicine can be prepared into corresponding dosage forms, preferably oral dosage forms, by oral administration, injection and other administration modes. The dosage forms which may be mentioned in particular are: powders, tablets (including various coated tablets, sustained-release or controlled-release tablets), capsules (including soft and hard capsules), granules, pills, dispersible powders, aqueous or oily suspensions, aqueous or oily solutions, emulsions, elixirs, syrups, and the like, but are not limited thereto. Depending on the dosage form, pharmaceutically acceptable carriers, excipients or excipients thereof include, but are not limited to, fillers (or diluents), binders, disintegrants, lubricants, wetting agents, auxiliary lipids, glidants, sweeteners, flavoring agents, solvents, dissolution aids, suspending agents, isotonic agents, buffers, preservatives, antioxidants, colorants, foaming agents and the like. The carrier, adjuvant or excipient may be selected by those skilled in the art according to actual needs. And will not be described in detail herein.
The medicament herein includes an effective amount of curcumin and an effective amount of a TDO2 inhibitor, where an effective amount is an amount that includes sufficient symptoms or diseases to prevent or treat a medical condition. After use in a particular patient or medical subject, the following changes may be made: the condition to be treated, the overall health of the patient/subject is improved. The effective amount can be determined by methods well known in the art, for example, the dosage of the drug is: curcumin 32-48mg/kg/d, TDO2 inhibitor 32-48mg/kg/d; preferably, the dosage of the medicine is as follows: curcumin 40mg/kg/d, TDO2 inhibitor 40mg/kg/d.
The invention has the beneficial effects that:
The invention provides a new application of a combination of curcumin and a TDO2 inhibitor in preventing and treating nonalcoholic fatty liver diseases, and the combination of the curcumin and the TDO2 inhibitor is superior to that of the curcumin or the TDO2 inhibitor alone by the synergistic effect of the curcumin and the TDO2 inhibitor on preventing and treating NAFLD.
According to the invention, by combined administration of curcumin and a TDO2 inhibitor, liver steatosis, mitochondrial injury and liver inflammation of NAFLD rats can be effectively improved, blood fat and body weight can be reduced, a new choice is provided for preparing NAFLD prevention and treatment medicines, and the NAFLD prevention and treatment medicines have important application values in research and development of new medicines.
Drawings
FIG. 1 is the experimental results of the body weight of rats in the examples;
FIG. 2 is the experimental results of liver weights of rats in the examples;
FIG. 3 is the hematoxylin-eosin staining results of rat livers in the examples;
FIG. 4 is the results of oil red O staining of rat livers in the examples;
FIG. 5 is a transmission electron microscopy result of rat liver in the example;
FIG. 6 is the results of experiments on serum triglyceride levels in rats in the examples;
FIG. 7 is the results of experiments on serum total cholesterol levels of rats in the examples;
FIG. 8 is the results of experiments on serum low density lipoprotein levels of rats in the examples;
FIG. 9 is the results of experiments on the glutamic pyruvic transaminase content of rat serum in examples;
FIG. 10 is the results of experiments on the content of glutamic oxaloacetic transaminase in the serum of rats in examples;
FIG. 11 shows the results of experiments on serum HDL levels of rats in the examples.
Detailed Description
The following detailed description of embodiments of the invention is exemplary and is provided merely to illustrate the invention and is not to be construed as limiting the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In addition, unless otherwise specified, the conditions or procedures are not specifically described and the reagents and materials employed are commercially available.
Examples combination of curcumin and TDO2 inhibitor for treatment of high fat diet induced non-alcoholic fatty liver disease
1. Experimental materials:
curcumin, cat No. S31628, available from shanghai source leaf biotechnology limited.
TDO2 inhibitors: allopurinol, cargo number: a8003, available from merck, germany.
Curcumin suspension: weighing 0.4g curcumin, adding 39.6ml 0.5% CMC, and preparing 40ml curcumin suspension with final concentration of 10 mg/ml;
TDO2 inhibitor suspension: 0.4g of TDO2 inhibitor is weighed and 39.6ml of 0.5% CMC is added to prepare 40ml of TDO2 inhibitor suspension with the final concentration of 10 mg/ml.
Male SD rats, 6 weeks old, weighing 210-240g, purchased from Nanjing division, peking Vitre Lihua Experimental animal technologies Co., ltd.
Normal feed, goods number: SWS9102, energy duty cycle: 20.6% protein, 12% fat, 67.4% carbohydrate, purchased from Jiangsu province collaborative medical bioengineering, inc.
High fat feed, cat No.: XTHF45-1, the energy supply duty ratio: 20% protein, 45% fat, 35% carbohydrate, purchased from Jiangsu province collaborative medical bioengineering, inc.
2. The experimental method comprises the following steps:
Establishment of NAFLD rat model: male SD rats of 6 weeks of age, after 1 week of normal feed-adapted feeding, were weighed and randomly divided into 3 groups of 5 animals each.
Control group: normal feed was fed for 8 weeks, and from week 3, 0.5% sodium carboxymethyl cellulose was administered by intragastric administration at the same time every day for 5 weeks, and body weight was recorded weekly.
Model group: high-fat feed was fed for 8 weeks, and from week 3, 0.5% sodium carboxymethylcellulose was administered by intragastric administration at the same time every day for 5 weeks, and body weight was recorded weekly.
Curcumin group: curcumin (40 mg/kg/d) was administered by intragastric administration at the same time daily for 5 weeks from week 3 on high-fat diet, and body weight was recorded weekly.
TDO2 inhibitor group: the high-fat diet was fed for 8 weeks, and the TDO2 inhibitor (40 mg/kg/d) was administered by intragastric administration at the same time every day from week 3 for 5 weeks, and the body weight was recorded weekly.
Curcumin + TDO2 inhibitor group: the high-fat diet was fed for 8 weeks, and curcumin (40 mg/kg/d) and TDO2 inhibitor (40 mg/kg/d) were administered in combination by intragastric administration at the same time every day from week 3, for 5 weeks, and body weight was recorded weekly.
3. Serum and liver samples were collected:
After 8 weeks of feeding, rats were sacrificed for anesthesia and serum and liver samples were collected, specifically, all rats were fasted for 12 hours, were anesthetized by intraperitoneal injection of pentobarbital sodium (100 mg/kg), were collected from the inferior vena cava, were left at room temperature for 2 hours, and were centrifuged at 4000 rpm for 10 minutes at 4℃to collect serum samples, and were stored at-80 ℃. Rapidly taking out liver, weighing, washing two small pieces of liver tissue at the same part of the right lobe of liver with 4 ℃ physiological saline, sucking the filter paper, fixing with 4% paraformaldehyde solution and 4 ℃ precooled 2.5% glutaraldehyde solution respectively, and preserving the rest at-80 ℃.
4. The pathological morphological characteristics, lipid deposition and mitochondrial injury of the livers of the rats of each group were examined by hematoxylin-eosin staining, oil red O staining and transmission electron microscopy. Detecting the contents of serum glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, total hepatic sterol, triglyceride, low density lipoprotein and high density lipoprotein by biochemical analyzer.
5. Analysis of results
The NAFLD model rats had significantly increased body weight and liver weight compared to the control rats, and the combined administration of curcumin and TDO2 inhibitor significantly reduced HFD-induced increases in body weight and liver weight of rats, with better effects than the curcumin alone or TDO2 inhibitor alone (fig. 1 and 2).
The results of hematoxylin-eosin staining, oil red staining and transmission electron microscopy show that the liver cells of the rats in the model group show obvious steatosis, inflammatory reaction and mitochondrial damage, while the liver cell steatosis, inflammatory reaction and mitochondrial damage of the rats in the curcumin plus TDO2 inhibitor group are obviously improved, and the effect is superior to that of the curcumin group alone or the TDO2 inhibitor group alone (figures 3,4 and 5).
The high fat diet resulted in significant increases in serum total cholesterol, triglycerides and low density lipoproteins, whereas the combined administration of curcumin and TDO2 inhibitor significantly reversed accumulation of these lipids in serum and was superior to the curcumin alone or TDO2 inhibitor alone (fig. 6, 7 and 8).
The rise in liver injury index (glutamic pyruvic transaminase and glutamic oxaloacetic transaminase) and fall in high density lipoprotein level in serum caused by HFD were also significantly reversed by the combined administration of curcumin and TDO2 inhibitor, and the effect was also superior to that of the curcumin alone group or the TDO2 inhibitor alone group (fig. 9, 10 and 11).
The research results show that HFD causes liver steatosis, induces inflammation and mitochondrial injury, and increases blood fat and weight, and the combined administration of curcumin and TDO2 inhibitor can effectively improve liver steatosis, liver inflammation and mitochondrial injury of NAFLD rats, reduce blood fat and weight, and the combined action of the two medicines shows a synergistic effect, and the effect is superior to that of independent administration of curcumin or independent administration of TDO2 inhibitor.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (10)

1. Use of curcumin in combination with a TDO2 inhibitor for the preparation of a medicament for the prevention and/or treatment of non-alcoholic fatty liver disease.
2. The use according to claim 1, wherein the curcumin has the following chemical formula:
3. The use of claim 1 wherein the TDO2 inhibitor is allopurinol.
4. A combination pharmaceutical composition for the prevention and/or treatment of non-alcoholic fatty liver disease, characterized in that it consists of curcumin and a TDO2 inhibitor.
5. The combination pharmaceutical composition of claim 4, wherein the curcumin has the following chemical formula:
6. The combination pharmaceutical composition of claim 4, wherein the TDO2 inhibitor is allopurinol.
7. The combination pharmaceutical composition according to claim 4, wherein the mass ratio of the curcumin and the TDO2 inhibitor in the combination pharmaceutical composition is 2: 3-3: 2;
Preferably, the mass ratio of the curcumin to the TDO2 inhibitor is 1:1.
8. Use of a combination pharmaceutical composition according to any one of claims 4-7 for the preparation of a medicament for the prevention and/or treatment of non-alcoholic fatty liver disease.
9. A medicament for preventing and/or treating nonalcoholic fatty liver disease, comprising the combination pharmaceutical composition according to any one of claims 4 to 7;
preferably, the medicament further comprises pharmaceutically acceptable auxiliary materials, excipients or carriers.
10. The medicament of claim 9, wherein the medicament is administered in an amount of: curcumin 32-48mg/kg/d, TDO2 inhibitor 32-48mg/kg/d;
preferably, the dosage of the medicine is as follows: curcumin 40mg/kg/d, TDO2 inhibitor 40mg/kg/d.
CN202410335433.6A 2024-03-22 2024-03-22 Use of curcumin and TDO2 inhibitor in combination for preventing and/or treating non-alcoholic fatty liver disease Pending CN118203586A (en)

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