CN106267019B - Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof - Google Patents

Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof Download PDF

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CN106267019B
CN106267019B CN201610864104.6A CN201610864104A CN106267019B CN 106267019 B CN106267019 B CN 106267019B CN 201610864104 A CN201610864104 A CN 201610864104A CN 106267019 B CN106267019 B CN 106267019B
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parts
pharmaceutical composition
preparation
raw material
chronic hepatitis
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CN106267019A (en
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张传涛
黄金珠
郭尹玲
辜海英
杨鸿�
张技
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Chengdu University of Traditional Chinese Medicine
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704—Polygonum, e.g. knotweed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/489—Sophora, e.g. necklacepod or mamani
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/85—Verbenaceae (Verbena family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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  • Alternative & Traditional Medicine (AREA)
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  • Medical Informatics (AREA)
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  • Mycology (AREA)
  • Medicines Containing Plant Substances (AREA)
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Abstract

The invention discloses a pharmaceutical composition for treating chronic hepatitis B, which is a preparation prepared from the following raw material medicines in parts by weight: 10-20 parts of giant knotweed, 15-25 parts of penthorum chinense pursh, 10-20 parts of verbena, 19-29 parts of phyllanthus urinaria, 10-20 parts of sophora flavescens and 10-20 parts of curcuma aromatica. Also disclosed are methods of making and uses of the aforementioned compositions. The pharmaceutical composition of the invention can effectively treat chronic hepatitis B and has good application prospect.

Description

Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof
Technical Field
the invention relates to a pharmaceutical composition for treating chronic hepatitis B and a preparation method and application thereof.
Background
HBV infection is prevalent worldwide, about 20 hundred million people are infected with HBV all over the world, wherein about 2.4 to 3.5 hundred million people are chronic HBV infected people, if the treatment is not timely, about 8 to 20 percent of CHB patients develop into cirrhosis within 5 years, and the survival rate of the cirrhosis in the decompensation period of 5 years is 15 to 40 percent. More than 78 million people die each year from complications caused by HBV infection, accounting for the 15 th cause of total human death, and being a major public health problem worldwide.
China is a high-prevalence area of HBV infection, and the number of chronic HBV infected people in China is still 9300 thousands, of which about 2000- & lt3000 ten thousands are Chronic Hepatitis B (CHB) which still needs to be treated, 100 thousands have been developed into cirrhosis, and 30 thousands have been developed into primary hepatocellular carcinoma. The direct economic loss of China caused by HBV infection-related liver diseases is as high as 260 billion yuan every day, and the indirect economic loss caused by the shortened life span is as high as 320 billion yuan. The total cost of the people with hepatitis B related diseases only in Beijing is respectively as follows: 22941.68 yuan for acute hepatitis B, 1007.90 yuan for hepatitis B virus carriers, 11777.28 yuan for chronic hepatitis B, 54473.94 yuan for cirrhosis and 128309.35 yuan for liver cancer, wherein the total annual cost of patients with cirrhosis and liver cancer is 2.04 times and 4.80 times of the dominant income of the same year, and huge economic burden is brought to individuals and society. Therefore, HBV infection is one of three major infectious diseases in China, which seriously endangers the life health of human beings, and the huge economic burden thereof also seriously influences the great target of the comprehensive well-being society in China, so that the positive prevention and treatment of HBV infection has important significance.
The first-line anti-HBV drugs still cannot completely eliminate viruses at present, the current global anti-HBV treatment faces serious dilemma due to increasingly serious drug resistance, side effects and other factors, and the active research and development of new drugs with strong effect, low toxicity and different action sites becomes an extremely urgent task in the field of prevention and treatment of chronic HBV infection.
Zhangtao et al, "research on anti-hepatitis B virus in HBV transgenic mice treated by HH Capsule", discloses a traditional Chinese medicine formula for resisting hepatitis B virus in Shizhen national medicine 2015, volume 26, phase 10, wherein the traditional Chinese medicine formula comprises 15g of giant knotweed, 20g of penthorum chinense pursh, 15g of agrimony, 24g of phyllanthus urinaria, 15g of radix sophorae flavescentis, 15g of radix curcumae, 30g of semen coicis and 20g of polyporus umbellatus, but the traditional Chinese medicine formula has a lot of medicinal flavors, and the effect is still to be further improved.
Disclosure of Invention
The invention aims to provide a novel pharmaceutical composition for treating chronic hepatitis B.
The invention relates to a pharmaceutical composition for treating chronic hepatitis B, which is a preparation prepared from the following raw material medicines in parts by weight:
10-20 parts of giant knotweed, 15-25 parts of penthorum chinense pursh, 10-20 parts of verbena, 19-29 parts of phyllanthus urinaria, 10-20 parts of sophora flavescens and 10-20 parts of curcuma aromatica.
Preferably, the traditional Chinese medicine composition is a preparation prepared from the following raw material medicines in parts by weight:
15 parts of giant knotweed, 20 parts of penthorum chinense pursh, 15 parts of verbena, 24 parts of phyllanthus urinaria, 15 parts of sophora flavescens and 15 parts of curcuma aromatica.
Wherein said Phyllanthus urinaria is dried whole plant of Phyllanthus urinaria L of Euphorbiaceae.
The preparation is prepared by taking medicinal powder of raw material medicines, water or organic solvent extract of the raw material medicines as active ingredients and adding auxiliary materials or auxiliary ingredients commonly used in pharmacy.
Wherein the formulation is an oral formulation. Preferably, the preparation is decoction, oral liquid, granules, capsules, powder, pills and tablets.
The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:
(1) Weighing the raw materials according to the proportion;
(2) Preparing medicinal powder of the raw materials, water or organic solvent extract of the raw materials, and adding pharmaceutically-used adjuvants or auxiliary components.
the invention also provides application of the pharmaceutical composition in preparing a pharmaceutical composition for resisting hepatitis B virus.
Wherein, the medicine composition is used for treating chronic hepatitis B.
The pharmaceutical composition has a precise and appropriate formula, has good anti-HBV effect on HepG2.2.15 cells, duck hepatitis B models and HBV transgenic mice, reduces the levels of HBsAg and HBVDNA, can effectively treat chronic hepatitis B, provides a choice for clinically treating chronic hepatitis B, and has a good application prospect.
The present invention is described in further detail with reference to the following embodiments, but the present invention is not limited thereto, and various other modifications, substitutions and alterations can be made without departing from the basic technical idea of the present invention based on the above-mentioned contents of the present invention and common technical knowledge and conventional means in the art.
Detailed Description
EXAMPLE 1 preparation of a pharmaceutical composition of the invention
the formula is as follows: taking 15g of giant knotweed, 20g of penthorum chinense pursh, 15g of verbena, 24g of phyllanthus urinaria, 15g of sophora flavescens and 15g of curcuma aromatica.
The preparation method comprises the following steps: the first step is as follows: the medicinal materials are put into an earthen pot, 1000ml of water is added, and the medicinal materials are soaked for half an hour. The second step is that: boiling with strong fire, decocting with slow fire until about 250ml is left, and pouring the decoction into a bowl. The third step: the first step and the second step can be repeated, and the medicine is taken twice.
EXAMPLE 2 preparation of pharmaceutical compositions of the invention
Taking 10g of giant knotweed, 15g of penthorum chinense pursh, 10g of verbena, 19g of phyllanthus urinaria, 10g of sophora flavescens and 10g of curcuma aromatica.
The preparation method comprises the following steps: the first step is as follows: the medicinal materials are put into an earthen pot, 1000ml of water is added, and the medicinal materials are soaked for half an hour. The second step is that: boiling with strong fire, decocting with slow fire until about 250ml is left, and pouring the decoction into a bowl. The third step: the first step and the second step can be repeated, and the medicine is taken twice.
EXAMPLE 3 preparation of a pharmaceutical composition of the invention
Taking 20g of giant knotweed rhizome, 25g of penthorum chinense pursh, 20g of verbena, 29g of phyllanthus urinaria, 20g of sophora flavescens and 20g of curcuma aromatica.
The preparation method comprises the following steps: the first step is as follows: the medicinal materials are put into an earthen pot, 1000ml of water is added, and the medicinal materials are soaked for half an hour. The second step is that: boiling with strong fire, decocting with slow fire until about 250ml is left, and pouring the decoction into a bowl. The third step: the first step and the second step can be repeated, and the medicine is taken twice.
the advantageous effects of the present invention are specifically described below by way of test examples.
Test example 1 study of the treatment of chronic hepatitis B with the composition of the present invention
1 Material
1.1 test articles and reagents
The composition of the invention (the composition of the invention prepared in example 1); control group: giant knotweed rhizome 15g, penthorum chinense pursh 20g, agrimony 15g, phyllanthus urinaria 24g, lightyellow sophora root 15g, curcuma aromatica 15g, coix seed 30g and polyporus umbellatus 20g, and the medicine is prepared according to the method in the embodiment 1. Positive drug: kurarinone capsules, available from Zhengda Ningqing pharmaceutical industry group, Inc., national drug Standard H20010763, product batch No. 131121102.
1.2 Experimental animals
HBV transgenic mice are purchased in the liver disease center of the general at hospital 458 of the Chinese people liberation force, and the license number is produced: SCXK (military) 2012 and 0018.
1.3 instruments
Quantitative PCR instrument: ABI Stepone plus; an enzyme-labeling instrument: thermo DENLEY DRAGON Wellscan MK 3.
2 method
2.1 grouping and Molding
36 HBV transgenic mice (6-8 weeks old, male and female halves) were randomly divided into 4 groups: a model group, a kurarinone control group, a control composition group and a composition group of the invention.
2.2 methods of administration
the mice in the model group are subjected to intragastric administration by physiological saline with the same volume, the mice in the oxymatrine control group are subjected to intragastric administration by physiological saline with the same volume and contain oxymatrine suspension with 150 mg/kg.d, the mice in the control composition group are subjected to HH suspension with the same volume and contain 7 g/kg.d, and the HH suspension with the same volume and the composition of the invention containing 7 g/kg.d is administered to the mice in the composition group of the invention, wherein the treatment course is 5 weeks.
3 results
The results are shown in tables 1 and 2.
Table 1: HBsAg condition in mice
Comparison with model groups: b. c, dP < 0.05; comparison with the oxymatrine control group: dP < 0.05; comparison with the composition of the invention: b. cP < 0.05.
Table 2: mouse HBVDNA status
Comparison with group M: b. c, dP is less than 0.05; comparison with the oxymatrine group: dP is less than 0.05; comparison with the composition of the invention: b. cP is less than 0.05;
As can be seen from tables 1 and 2, compared with the model group, the oxymatrine, the control composition and the composition of the invention can significantly reduce the levels of HBsAg and HBVDNA in the serum of HBV transgenic mice; compared with the oxymatrine and the contrast composition, the composition has better effect than the oxymatrine and the contrast composition, and has obvious difference.
the experimental result shows that the pharmaceutical composition can effectively treat chronic hepatitis B, and the effect is obviously better than that of oxymatrine and contrast group drugs.
Compared with the control group of medicines, the pharmaceutical composition provided by the invention has the advantages that the effect is obviously improved and the effect is excellent under the condition that two medicines are reduced.
In conclusion, the pharmaceutical composition can effectively treat chronic hepatitis B and has good application prospect.

Claims (9)

1. A pharmaceutical composition for treating chronic hepatitis B is characterized in that: the preparation is prepared from the following raw material medicines in parts by weight:
10-20 parts of giant knotweed, 15-25 parts of penthorum chinense pursh, 10-20 parts of verbena, 19-29 parts of phyllanthus urinaria, 10-20 parts of sophora flavescens and 10-20 parts of curcuma aromatica.
2. The pharmaceutical composition of claim 1, wherein: the preparation is prepared from the following raw material medicines in parts by weight:
15 parts of giant knotweed, 20 parts of penthorum chinense pursh, 15 parts of verbena, 24 parts of phyllanthus urinaria, 15 parts of sophora flavescens and 15 parts of curcuma aromatica.
3. The pharmaceutical composition of claim 1, wherein: the Phyllanthus urinaria L refers to dried whole plant of Phyllanthus urinaria L (Phyllanthus urinaria L.) of Euphorbiaceae.
4. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the preparation is prepared by taking medicinal powder of raw material medicines, water or organic solvent extract of the raw material medicines as active ingredients and adding auxiliary materials or auxiliary ingredients commonly used in pharmacy.
5. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the formulation is an oral formulation.
6. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the preparation is in the form of decoction, oral liquid, granule, capsule, powder, pill, or tablet.
7. A process for preparing a pharmaceutical composition according to any one of claims 1 to 6, characterized in that: the method comprises the following steps:
(1) Weighing the raw material medicines according to the proportion of claim 1 or 2;
(2) Preparing medicinal powder of raw materials, water or organic solvent extract of raw materials, and adding pharmaceutically-used adjuvants or auxiliary components.
8. Use of the pharmaceutical composition of any one of claims 1-6 for the preparation of a pharmaceutical composition against hepatitis b virus.
9. Use according to claim 8, characterized in that: the medicine composition is used for treating chronic hepatitis B.
CN201610864104.6A 2016-09-29 2016-09-29 Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof Expired - Fee Related CN106267019B (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101375951A (en) * 2007-08-29 2009-03-04 北京星昊嘉宇医药科技有限公司 Medicine composition for treating hepatitis B
CN102727633A (en) * 2012-07-20 2012-10-17 成都中医药大学 Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof
CN104840899A (en) * 2015-06-03 2015-08-19 江苏省中医院 Traditional Chinese medicine composition for regulating chronic hepatitis B, decoction and application thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101375951A (en) * 2007-08-29 2009-03-04 北京星昊嘉宇医药科技有限公司 Medicine composition for treating hepatitis B
CN102727633A (en) * 2012-07-20 2012-10-17 成都中医药大学 Pharmaceutical composition for treating chronic hepatitis B and preparation method and application thereof
CN104840899A (en) * 2015-06-03 2015-08-19 江苏省中医院 Traditional Chinese medicine composition for regulating chronic hepatitis B, decoction and application thereof

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
HH胶囊抗乙肝病毒的体外(2.2.15细胞)实验研究;张传涛 等;《时珍国医国药》;20111231;第22卷(第1期);第78-80页 *
HH胶囊治疗HBV转基因小鼠抗乙肝病毒研究;张传涛 等;《时珍国医国药》;20151231;第26卷(第10期);第2314-2315页 *
HH胶囊的HPLC指纹图谱研究;周道杰 等;《云南中医学院学报》;20150630;第38卷(第3期);第16-20页 *
复方叶下珠胶囊体内抗鸭乙型肝炎病毒作用的研究;李晖 等;《江苏中医药》;20121231;第44卷(第4期);第71-72页 *
新HH方对HBV转基因小鼠脾脏源DC相关的免疫耐受状态影响的研究;张传涛 等;《四川中医》;20131231;第31卷(第08期);第45-48页 *

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