CN106902223A - A kind of pharmaceutical composition for treating hepatitis B, liver fibrosis and preparation method thereof - Google Patents

A kind of pharmaceutical composition for treating hepatitis B, liver fibrosis and preparation method thereof Download PDF

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CN106902223A
CN106902223A CN201710152858.3A CN201710152858A CN106902223A CN 106902223 A CN106902223 A CN 106902223A CN 201710152858 A CN201710152858 A CN 201710152858A CN 106902223 A CN106902223 A CN 106902223A
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parts
hepatitis
root
liver fibrosis
pharmaceutical composition
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王海燕
王启琴
鹿汝亮
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    • 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)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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    • 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)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/284—Atractylodes
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    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/288—Taraxacum (dandelion)
    • A—HUMAN NECESSITIES
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    • 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
    • A61K36/481—Astragalus (milkvetch)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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    • 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)
    • A61K36/57—Magnoliaceae (Magnolia family)
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61K36/79—Schisandraceae (Schisandra family)
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

It is more particularly to a kind of that there is treatment chronic hepatitis B, the active drug of liver fibrosis and preparation method by main component of natural animal and plant medicinal material the present invention relates to a kind of Traditional Chinese medicine composition and preparation method thereof.The present invention is made up of the raw material of following weight parts：15 20 parts of prepared fleece flower root, 16 20 parts of the fruit of Chinese wolfberry, 14 20 parts of the Radix Astragali, 16 21 parts of Radix picrorrhizae, 16 20 parts of desmodium, 15 20 parts of dandelion, 8 14 parts of the root of herbaceous peony, 15 21 parts of Poria cocos, 13 19 parts of teasel root, 13 18 parts of the fruit of Chinese magnoliavine, 14 19 parts of oldenlandia diffusa, 14 21 parts of Paris polyphylla, 14 19 parts of Fructus meliae toosendan, 15 17 parts of rhizoma atractylodis macrocephalae.Chinese medicine composition of the invention has regulation immunologic function, enhancing to the immunity of hepatitis B, suppresses hepatitis B virus duplication and prevent liver damage from acting on, and has certain curative effect to hepatitis B, liver fibrosis.

Description

A kind of pharmaceutical composition for treating hepatitis B, liver fibrosis and preparation method thereof
Technical field
The present invention relates to a kind of Traditional Chinese medicine composition and preparation method thereof, more particularly to one kind is with natural animal and plant medicine Material is that main component has treatment chronic hepatitis B, the active drug of liver fibrosis and preparation method.
Background technology
Chronic hepatitis B (HBV) infection is a global health problem, and the whole world is estimated to there are about 3.5 hundred million people infection hepatitis B Virus, wherein 75% lives in the Asian-Pacific area, there are about 1.2 hundred million people in China is hepatitis carrier, and hepatitis B patient is 2800 Ten thousand, illness rate is up to 27,70/,100,000, wherein, 1/3rd hepatitis B patient will develop into chronic hepatitis, cirrhosis or liver Cancer.The whole world in 1998 there are about 2,000,000 people and die from the viral liver cancer for causing, and the death toll of China is 300,000 people, and the world defends Hepatitis B is classified as the ninth-largest cause of the death in the world by raw tissue.And, people once infect hepatitis viruse, just necessary Long-term taking medicine, Medical expense about 300-500 hundred million RMB of the annual China for various virus hepatitis.
Liver fibrosis is the problem and problem that a domestic and international medical domain pays high attention to, current Western medicine interferon, nucleosides Class antiviral drugs achieves certain progress, and traditional Chinese medicine promotes liver cell regeneration and effectively in antiviral, liver protection, protect liver Liver fibrosis aspect is reversed to make significant progress, to enliven result gratifying hepatopathy area research is prevented and treated for traditional Chinese medicine, has opened up Wide prospect is shown.Wu Qi hepatitis B medicament be for many years clinical liver disease experience prescription, by a large amount of clinical researches and checking, grinding There are numerous expert and R＆D institution to participate in supporting during hair, it is hard treatment chronic hepatitis B, liver fibrosis, liver Change, liver cancer, the effective medicine of fatty liver.The product confirms that Wu Qi hepatitis B medicament is a kind of peace by multiple hospitals clinical trial Effectively control liver medicine entirely.
The content of the invention
Regarding to the issue above, it is an object of the invention to provide a kind of drug regimen for treating hepatitis B, liver fibrosis Thing and preparation method thereof, is used to solve above-mentioned technical problem.
The present invention has preferable therapeutic action to chronic hepatitis B, liver fibrosis.
Treatment hepatitis B of the invention, the pharmaceutical composition of liver fibrosis are to slow based on traditional Chinese medicine traditional Chinese medicine Property hepatitis B, liver fibrosis, pathogenetic understanding and principle of reatment, with reference to modern pharmacology research achievement, from motherland doctor Learn filter out in treasure-house with nourishing the liver and kidney, removing toxic substances dissipates the natural animal and plant medicine of stasis of blood function.The present invention is according to theory of traditional Chinese medical science group Side, and according to the property and taste of each herbal medicine, its effective ingredient is extracted, the preparation convenient to take for developing, it is after several Treatment chronic hepatitis B, the effective medicine of liver fibrosis that the research and clinical verification of 10 years is developed.
The technical scheme that its technical problem of solution of the invention is taken includes：
Present invention treatment hepatitis B, the pharmaceutical composition of liver fibrosis are mainly made up of the raw material of following weight parts：System Fleece-flower root 15-20 parts, fruit of Chinese wolfberry 16-20 parts, Radix Astragali 14-20 parts, Radix picrorrhizae 16-21 parts, desmodium 16-20 parts, dandelion 15- 20 parts, root of herbaceous peony 8-14 parts, Poria cocos 15-21 parts, teasel root 13-19 parts, fruit of Chinese magnoliavine 13-18 parts, oldenlandia diffusa 14-19 parts, Paris polyphylla 14-21 parts, Fructus meliae toosendan 14-19 parts, rhizoma atractylodis macrocephalae 15-17 parts.
Further, above-mentioned treatment hepatitis B, the pharmaceutical composition of liver fibrosis is made up of following raw materials and weight is matched somebody with somebody Than the medicament being made：18 parts of prepared fleece flower root, 18 parts of the fruit of Chinese wolfberry, 17 parts of the Radix Astragali, 18 parts of Radix picrorrhizae, 18 parts of desmodium, dandelion 18 Part, 12 parts of the root of herbaceous peony, 18 parts of Poria cocos, 16 parts of teasel root, 15 parts of the fruit of Chinese magnoliavine, 16 parts of oldenlandia diffusa, 17 parts of Paris polyphylla, 17 parts of Fructus meliae toosendan, 16 parts of rhizoma atractylodis macrocephalae.
Further, described pharmaceutical composition is oral formulations.
Further, the oral formulations are granule.
Further, the granule is sugar-free type granular formulation.
Above-mentioned treatment hepatitis B, the preparation method of the pharmaceutical composition of liver fibrosis, comprise the steps of：
S1, take prepared fleece flower root, Fructus Schisandrae Chinensis powder and be broken into meal, 85% ethanol heating and refluxing extraction is secondary, 2 hours every time, Supernatant, concentration, drying, medicinal extract are standby；
S2, take the fruit of Chinese wolfberry, the Radix Astragali, Radix picrorrhizae, desmodium, dandelion, the root of herbaceous peony, Poria cocos, teasel root, oldenlandia diffusa, Paris polyphylla, Fructus meliae toosendan, the taste Chinese medicine of rhizoma atractylodis macrocephalae 12, water are extracted 2 times, 2 hours every time, supernatant, filtering, concentration, the second of medicinal extract addition 57% Alcohol, static alcohol precipitation 6 hours, reclaim ethanol, and extract dry is standby：
More than S3, merging 1,2 medicinal extract are mixed, and add appropriate honey element and dextrin, are mixed, and routinely technique is made orally system Agent.
The pharmacology of medicine of the present invention, clinical test experiment：
(1), pharmacological toxicology：The animal experiment result of study prompting of medicine：The chmice acute that this product causes to carbon tetrachloride Hepatic injury, the subacute hepatic injury of rat, rat chronic hepatic injury, the acute liver that D-Gal causes, 2,4, The experimental liver injury model animal such as immunological liver injury caused by 6- trinitro-chlorobenzenes has the work for reducing serum transaminase With, and mitigate the degeneration of liver cells of liver injury model animal and downright bad situation, and promote liver cell regeneration, suppress the subacute liver of rat The loss of damage model hepatic glycogen, strengthens mouse reticuloendothelial cell phagocytic function, promotes the generation of mice serum hemolytic antibody.
(2), clinical test：II, III clinical trial phase of medicine.Object of observation chronic hepatitis B, liver fibrosis, in Doctor is dialectical to belong to " liver-kidney Yin deficiency " person.Experiment is using random, double blinding, simulation, masculine parallel comparison, multicenter design.Observation Index includes symptom and sign, liver function serological biochemical markers and virology index, the course for the treatment of 5 months.After treatment, test group ALT Normalization rate is 83.48%, and higher than control group, difference is statistically significant.
The beneficial effects of the invention are as follows：
Chinese medicine composition of the invention has immunity, the suppression B-type hepatitis of regulation immunologic function, enhancing to hepatitis B Poison is replicated and prevents liver damage from acting on, and has certain curative effect to hepatitis B, liver fibrosis.
Specific embodiment
The present invention is expanded on further below by way of specific embodiment, but is not limited to following embodiments.
Embodiment：1
(1) 180 grams of the fleece-flower root, 150 grams of the fruit of Chinese magnoliavine, are taken and is ground into meal, 85% ethanol heating and refluxing extraction is secondary, often Secondary 2 hours, supernatant, concentration, drying, medicinal extract were standby.(2) 180 grams of the fruit of Chinese wolfberry, 170 grams of the Radix Astragali, 180 grams of Radix picrorrhizae, gold, are taken 180 grams of money grass, 180 grams of dandelion, 120 grams of the root of herbaceous peony, 180 grams of Poria cocos, 160 grams of teasel root, 160 grams of oldenlandia diffusa, Paris polyphylla 170 Gram, 170 grams of Fructus meliae toosendan, 160 gram of 12 taste Chinese medicine of rhizoma atractylodis macrocephalae, water extract 2 times, 2 hours every time, filtering, supernatant, concentration, leaching The ethanol of cream addition 57%, static alcohol precipitation 6 hours, reclaim ethanol, and extract dry is standby.(1) more than merging, (2), medicinal extract are mixed It is even, it is made granule agent according to common process preparation method after adding appropriate honey element and dextrin.
Embodiment：2
(1) 170 grams of the fleece-flower root, 145 grams of the fruit of Chinese magnoliavine, are taken and is ground into meal, 85% ethanol heating and refluxing extraction is secondary, often Secondary 2 hours, supernatant, concentration, drying, medicinal extract were standby.
(2) 175 grams of the fruit of Chinese wolfberry, 176 grams of the Radix Astragali, 186 grams of Radix picrorrhizae, 175 grams of desmodium, 168 grams of dandelion, the root of herbaceous peony, are taken 135 grams, 165 grams of Poria cocos, 155 grams of teasel root, 165 grams of oldenlandia diffusa, 165 grams of Paris polyphylla, 185 grams of Fructus meliae toosendan, 155 gram ten of rhizoma atractylodis macrocephalae Two taste Chinese medicines, water is extracted 2 times, and 2 hours every time, filtering, supernatant, concentration, the ethanol of medicinal extract addition 57%, static alcohol precipitation 6 were small When, ethanol is reclaimed, extract dry is standby.(1) more than merging, (2), medicinal extract are mixed, according to common process after the appropriate dextrin of addition Preparation method is made tablet.
Presently preferred embodiments of the present invention is the foregoing is only, is not whole embodiments of the invention, be not used to limit The system present invention, all any modification, equivalent substitution and improvements within the spirit and principles in the present invention, made etc., should be included in Within protection scope of the present invention.
In addition to technical characteristic described in specification, remaining technical characteristic is technology known to those skilled in the art, in order to prominent Go out innovative characteristicses of the invention, above-mentioned technical characteristic will not be repeated here.

Claims (6)

1. a kind of pharmaceutical composition for treating hepatitis B, liver fibrosis, it is characterised in that by the raw material system of following weight parts Into：Prepared fleece flower root 15-20 parts, fruit of Chinese wolfberry 16-20 parts, Radix Astragali 14-20 parts, Radix picrorrhizae 16-21 parts, desmodium 16-20 parts, Pu Gong English 15-20 parts, root of herbaceous peony 8-14 parts, Poria cocos 15-21 parts, teasel root 13-19 parts, fruit of Chinese magnoliavine 13-18 parts, oldenlandia diffusa 14-19 parts, Paris polyphylla 14-21 parts, Fructus meliae toosendan 14-19 parts, rhizoma atractylodis macrocephalae 15-17 parts.
2. it is according to claim 1 to treat hepatitis B, the pharmaceutical composition of liver fibrosis, it is characterised in that by following The medicament that raw material is constituted and weight proportion is made：18 parts of prepared fleece flower root, 18 parts of the fruit of Chinese wolfberry, 17 parts of the Radix Astragali, 18 parts of Radix picrorrhizae, money 18 parts of grass, 18 parts of dandelion, 12 parts of the root of herbaceous peony, 18 parts of Poria cocos, 16 parts of teasel root, 15 parts of the fruit of Chinese magnoliavine, 16 parts of oldenlandia diffusa, Paris polyphylla 17 Part, 17 parts of Fructus meliae toosendan, 16 parts of rhizoma atractylodis macrocephalae.
3. treatment hepatitis B according to claim 1 or 2, the pharmaceutical composition of liver fibrosis, it is characterised in that described Pharmaceutical composition is oral formulations.
4. treatment hepatitis B according to claim 3, the pharmaceutical composition of liver fibrosis, it is characterised in that the mouth Formulation is granule.
5. treatment hepatitis B according to claim 4, the pharmaceutical composition of liver fibrosis, it is characterised in that described Granula is sugar-free type granular formulation.
6. it is a kind of to treat hepatitis B, the preparation method of the pharmaceutical composition of liver fibrosis, it is characterised in that by following steps group Into：
S1, take prepared fleece flower root, Fructus Schisandrae Chinensis powder and be broken into meal, 85% ethanol heating and refluxing extraction is secondary, every time 2 hours, supernatant Liquid, concentration, drying, medicinal extract are standby；
S2, take the fruit of Chinese wolfberry, the Radix Astragali, Radix picrorrhizae, desmodium, dandelion, the root of herbaceous peony, Poria cocos, teasel root, oldenlandia diffusa, Paris polyphylla, melia toosendan Son, the taste Chinese medicine of rhizoma atractylodis macrocephalae 12, water extract 2 times, 2 hours every time, supernatant, filtering, concentration, medicinal extract addition 57% ethanol, Static alcohol precipitation 6 hours, reclaims ethanol, and extract dry is standby：
More than S3, merging 1,2 medicinal extract are mixed, and add appropriate honey element and dextrin, are mixed, and routinely technique is made oral formulations.
CN201710152858.3A 2017-03-15 2017-03-15 A kind of pharmaceutical composition for treating hepatitis B, liver fibrosis and preparation method thereof Pending CN106902223A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109464454A (en) * 2018-11-29 2019-03-15 天津中医药大学 Purposes of the brown alga oligose in the drug that preparation treats or prevents hepatic injury

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Application publication date: 20170630