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Title:
COMPOSITION FOR TREATING HEPATITIS B
Document Type and Number:
WIPO Patent Application WO/2019/193381
Kind Code:
A1
Abstract:
The invention used to kill of hepatitis B virus, comprising the concentrated essence of Adenosma Glutinosum; concentrated essence of Eclipta Prostrata; concentrated essence of Phyllanthus Urinaria; Ascorbic acid; Cyanocobalamin.

Inventors:
NGUYEN THI TRIEU (VN)
TRAN MINH DUC (VN)
Application Number:
PCT/IB2018/001473
Publication Date:
October 10, 2019
Filing Date:
December 24, 2018
Export Citation:
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Assignee:
NGUYEN THI TRIEU (VN)
International Classes:
A61K36/185; A61K31/375; A61K31/714; A61K36/28; A61P31/20
Domestic Patent References:
WO1998007437A11998-02-26
WO2003030929A12003-04-17
Other References:
NGUYEN THI TREU & TRAN MINH DUC: "Herbal medicaments, ascorbic acid, Tenofovir, treatment on HBeAg positive or HbeAg negative in chronic hepatitis B (A combination of treatment with herbals)", PEDIATRIC INFECTIOUS DISEASES, vol. 2, no. 1:32, 26 December 2016 (2016-12-26), pages 1 - 2, XP002790580, Retrieved from the Internet [retrieved on 20190412], DOI: 10.21767/2573-0282.100032
ANONYMOUS: "Tenofovir Disoproxil Fumarat , Herbal Medicaments, Vitamin C Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B (HBV)", 8 October 2015 (2015-10-08), XP002790581, Retrieved from the Internet [retrieved on 20190412]
WU YING ET AL: "Extract from Phyllanthus urinaria L. inhibits hepatitis B virus replication and expression in hepatitis B virus transfection model in vitro", CHINESE JOURNAL OF INTEGRATED MEDICINE /ZHONGGUO JIEHE YIXUE ZAZHI (ENGLISH), ZHONGGUO ZHONG-XIYI JIEHE YANJIUHUI, CN, vol. 21, no. 12, 13 April 2015 (2015-04-13), pages 938 - 943, XP035944013, ISSN: 1672-0415, [retrieved on 20150413], DOI: 10.1007/S11655-015-2076-7
DR NARENDRAKUMAR P. PALIWAL, DR BHARGAV M PUROHIT, DR C B TRIPATHI, DR HEMANGINI R ACHARYA, DR MAHENDRA K PATEL: "Evaluation of anti-inflammatory, analgesic and antipyretic activity of Eclipta alba (Linn.) Hassk. in experimental animals", EUROPEAN JOURNAL OF PHARMACEUTICAL AND MEDICAL RESEARCH, vol. 4, no. 3, 24 January 2017 (2017-01-24), pages 391 - 399, XP002790582
DATABASE WPI Week 199401, Derwent World Patents Index; AN 1994-000163, XP002790583
GRACE RATTUE: "Hepatitis C May Be Treated With Vitamin B12", 27 April 2017 (2017-04-27), XP002790584, Retrieved from the Internet [retrieved on 20190412]
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Claims:
Claims

The invention used to kill of hepatitis B virus, wherein the composition comprises the following ingredients (in% by weight):

Adenosium Glutinosum: 21.66

Eclipta Prostrata: 21.66

Phyllanthus Urinaria: 21.66

Ascorbic acid: 33.33

Cyanocobalamin: 0.02

Excipients: 1.67

The components required for protection consists of chemical components contained in 3 herbal ingredients: Flavonoid components, Phyllanthus alkaloids, Coumarin derivatives, Triterpenoid, Steroid, Sterol, and a combination of Ascorbic acid, Cyanocobalamin, according to the above registration rate.

AMENDED CLAIMS

received by the International Bureau on 11 June 2019 (11.06.19)

A composition for use in the therapeutic treatment of hepatitis B virus, composition includes will be killing hepatitis B virus in clinical trial of the therapeutic treatment.

A purified preparation after extracted from the plant parts herbal and ascorbic acid, cyanocobalamin (in% by weight):

Adenosma glutinosum: 21.66

Eclipta prostrata: 21.66

Phyllanthus urinaria: 21.66

Ascorbic acid: 33.33

Cyanocobalamin: 0.02

Excipients: 1.67

The components required for protection consists of chemical components contained in 3 herbal ingredients: Flavonoid components, Phyllanthus alkaloids, Coumarin derivatives, Triterpenoid, Steroid, Sterol, and combination of Ascorbic acid, Cyanocobalamin, according to the above registration rate.

Description:
COMPOSITION FOR TREATING HEPATITIS B

The technical field of the invention

The invention relates to the pharmaceutical composition, in particular, the invention to kill of human hepatitis B virus.

The invention consists of the following components: the concentrated essence of Adenosma Glutinosum; the concentrated essence of Eclipta Prostrata; the concentrated essence of Phyllanthus Urinaria; Ascorbic acid; Cyanocobalamin.

The technical state of the invention

Immunodeficiency and viral hepatitis are increasing. Currently, there are many preparations in the world for the treatment of hepatitis B, hepatitis C, and HIV. However, the disadvantages of these preparations are that they do not create a favorable environment have the presence of the necessary intermediates for the body to make antibodies against the virus, or to support beneficial effects such as nucleoside reverse transcriptase inhibitors; Does not promote the self-made antibody of the immune system. Does not to create superior cells it has the ability to prevent the penetration of viruses.

This is the only and latest drug that addresses the body condition of patients resistant to nucleoside reverse transcriptase inhibitors.

Resolves the condition of providing antibodies from outside the body into the patient's body. In order to meet this expectation, the composition will contain the following components: the concentrated essence of Adenosma Glutinosum; the concentrated essence of Eclipta Prostrata; the concentrated essence of

Phyllanthus Urinaria; Ascorbic acid; Cyanocobalamin.

The technical nature of the invention The purpose of the invention is to overcome the disadvantages mentioned above, which provide enzymes that help create the biochemical environment necessary to protect the body's cells from the entry of the virus. To achieve this goal, in one embodiment, the present invention provides a composition for the treatment of a hepatitis B virus in which the composition comprises the following components (in % by weight):

Adenosma Glutinosum 21.66

Eclipta Prostrata 21.66

Phyllanthus Urinaria 21.66

Ascorbic acid 33.33

Cyanocobalamin 0.02

Excipients 1.67

The detailed description of the invention

The invention is described in detail with specific embodiments. However, these embodiments are intended to clarify the nature of the invention and not to limit the scope of the claims claimed.

Concentrated essence of Adenosma Glutinosum, Eclipta Prostrata, Phyllanthus Urinaria are obtained by harvesting Adenosma Glutinosum, Eclipta Prostrata, Phyllanthus Urinaria during the flowering season and drying, high-boiling, makes maximum evaporation, makes concentrated substance create density to obtain the desired chemical composition.

Concentrated essence of Adenosma Glutinosum

In Adenosma Glutinosum has Saponin Triterpenoid; Saponin Steroid; Flavonoid; 6,7 - Dimethoxy; Coumarin; Cineol. It has anti-inflammatory, analgesic and anti-allergy properties, improve immunity and inhibit the development of cancer cells.

Concentrated essence of Eclipta Prostrata

Eclipta Prostrata has containing alkaloids ecliptic, nicotine and coumarin. Eclipta Prostrata tasks the protect blood vessels, anti-inflammation, analgesic, anti-allergy.

Concentrated essence of Phyllanthus Urinaria

Phyllanthus Urinaria has flavonoids; Phyllanthus alkaloid; Phyllanthus Urinaria has analgesic, anti-inflammatory, diuretic, has inhibitory properties DNA polymerase of the virus.

Adenosma Glutinosum; Eclipta Prostrata; Phyllanthus Urinaria contains Flavonoid components, Phyllanthus alkaloid, Coumarin derivatives, Triterpenoid, Steroid, Sterol, in which:

Flavonoids can act as a chemical transfer agent or physiological regulator. Flavonoids can also act as cell cycle inhibitors.

Alkaloid Phyllanthine restores the antioxidant capacity of the liver cells, protecting the liver cells.

Coumarin's derivatives have anti-fungal, anti-tumor, anti-coagulant, anti-viral effects.

Triterpenoid is synthesized by plants, is an anti-cancer agent that protects cells.

Steroids utilize two biological functions that are important components of cell membranes that alter cell membrane mobility and signal transfer at the cellular level.

Steroids have a variety of biological, pharmacological, and positive effects on human health. Sterols are special types of specific steroids found in plants with antioxidant properties, with evidence that sterols have an effect on inflammatory responses to hepatitis B virus, hepatitis C, HIV, stress reduction, etc.

Ascorbic acid

Ascorbic acid is an essential nutrient for humans. Ascorbic acid is readily distributed in high concentrations in immune cells, has natural antibacterial activity, promote increased bioavailability. Promotes the growth and reproduction of Lymphocytes, and are consumed rapidly during the infection, the effects showing a prominent role in regulating the immune system.

Cyanocobalamin

Cyanocobalamin is essential for the production of blood, carbohydrates, fats and proteins, and the production of DNA and RNA.

The components present will create the direction to destroy the virus in a new step, innovative way.

When some of the metabolites require the presence of these active ingredients, the active ingredient will play the role of producing the immune system against the virus, anti-inflammatory, and help the body fight the hepatitis B virus disease.

The metabolites obtained during the digestion process, undergoes alteration in the intestinal tract, by microorganisms and enterocyte enzymes being absorbed in the cellular and colon levels, this enhances beneficial effects treatment for the patient, including a series of protective effects against the entry of the virus, creating an unfavorable environment for the reproductive virus and developing, creating a viral rejection environment. The special environment when the presence of active ingredients substances in this composition increases the effectiveness of nucleoside reverse transcriptase inhibitors.

In one embodiment, the invention provides a composition for the treatment of hepatitis B virus, wherein the composition comprises the following components

(in % by weight):

Adenosma Glutinosum 21.66

Eclipta Prostrata 21.66

Phyllanthus Urinaria 21.66

Ascorbic acid 33.33

Cyanocobalamin 0.02

Excipients 1.67

This preparation is given in the form of 1500mg tablets at a dose of 1 capsule once daily.

Inclusion Criteria

• Male and female (> 18 years of age) with chronic or acute hepatitis B.

• Hepatitis B surface antigen (HBsAg) (+) for a minimum of 6 months prior to treatment.

• Hepatitis B envelope antigen (HBeAg) (+) or (-) at baseline.

• Patients cirrhosis with compensated liver function (Child-Pugh score < 6).

• Hepato-Celluar Carcinoma (+) or (-).

Exclusion Criteria

• Alcohol or drugs consumption. • Organs or bone marrow transplant recipients.

Study Design of implementing the invention Study Design 1

Procedure for preparing the compositions according to the invention in the form of tablets (100 tablets).

Herbs and vitamins

Adenosma Glutinosum 325g

Eclipta Prostrata 325g

Phyllanthus Urinaria 325g

Ascorbic acid 500g

Cyanocobalamin 325 mg

Excipients 24.675g

Mix well and then divide the doses and tablets.

Study Design 2

Testing demonstrates the effect of eradicating hepatitis B virus.

- To remove the virus from the patient’s body.

- Has to do liver cell regeneration.

- Prevents the recurrence of liver cancer.

To test the effect of the composition according to the invention, the trial was conducted with 50 volunteers aged 18-60.

Hepatitis B surface antigen (HBsAg)(+) for at least 6 months prior to application. HBeAg(+) or (-)

Patients with compensated liver function (Child-Pugh score < 6)

Test subjects are divided into two groups Group 1 : Control group, placebo.

Group 2: Application of the test composition according to the invention.

The trial period was 12 months.

The test data is based on

• Test HBsAg Cobas

• HBV-DNA Quantification

• HBeAg

• Liver enzymes (SGOT - SGPT)

• Fibroscan

• CT Scan

• Alpha-fetoprotein

Results showed that the placebo group did not show any positive signs. For the group using the composition of the present invention, 100% of the respondents were satisfied. It has been shown that the composition of the present invention has the effect of enhancing the ability to kill the virus, regenerating the liver cells.

The effectiveness of the invention

The first use of the combination of pharmaceutical will result in a chain reaction that is good in treating the disease. By studying the combination of chemical components in this composition, it will to action as interferon to remove the virus in the patient's body.

Provided the catalyst works well to prevent the multiplication of the virus, they can act as real enzymes or analogy protein enzymes.

Up to 100% effective in killing hepatitis B when combination with Nucleoside reverse transcriptase inhibitors.

No side effects were detected.

Reduce the death rate from cirrhosis, liver cancer.

Reduce the burden on medical expenses in treating the disease.