CN113559218A - Traditional Chinese medicine composition for treating chronic hepatitis and application thereof - Google Patents
Traditional Chinese medicine composition for treating chronic hepatitis and application thereof Download PDFInfo
- Publication number
- CN113559218A CN113559218A CN202110996816.4A CN202110996816A CN113559218A CN 113559218 A CN113559218 A CN 113559218A CN 202110996816 A CN202110996816 A CN 202110996816A CN 113559218 A CN113559218 A CN 113559218A
- Authority
- CN
- China
- Prior art keywords
- parts
- extract
- traditional chinese
- chinese medicine
- medicine composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/233—Bupleurum
-
- 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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- 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
- A61K36/484—Glycyrrhiza (licorice)
-
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
-
- 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)
- A61K36/58—Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
-
- 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)
- A61K36/62—Nymphaeaceae (Water-lily 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/68—Plantaginaceae (Plantain 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)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/718—Coptis (goldthread)
-
- 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)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8998—Hordeum (barley)
-
- 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)
- A61K36/9064—Amomum, e.g. round cardamom
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Biotechnology (AREA)
- Mycology (AREA)
- Botany (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Alternative & Traditional Medicine (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Virology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Oncology (AREA)
- Gastroenterology & Hepatology (AREA)
- Communicable Diseases (AREA)
- Molecular Biology (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention provides a traditional Chinese medicine composition for treating chronic hepatitis, which is prepared from the following raw material medicines: radix bupleuri, radix scutellariae, rhizoma coptidis, szechwan chinaberry fruit, lotus leaf, fortune eupatorium herb, tuckahoe, fructus amomi, angelica, plantain seed, malt and liquorice.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition and application thereof, in particular to a traditional Chinese medicine composition for treating chronic hepatitis and application thereof, and belongs to the field of traditional Chinese medicines.
Background
In the course of chronic hepatitis, it is often manifested as a complicated and complicated syndrome, with the pathogenesis of both deficiency and excess of the healthy qi and mixed deficiency and excess. Due to the invasion of damp-heat pathogen, depression and improper diet, stagnation of liver qi, liver qi loss, and spleen transportation and transformation, damp pathogen is blocked and accumulated in the body for a long time to transform into heat. Therefore, clinically, patients with chronic hepatitis B are very common with complex syndromes of liver depression, qi stagnation, damp-heat obstruction and spleen deficiency.
In literature reports, a liver soothing tendon spleen method is adopted to treat a lot of patients with chronic liver diseases, and the Xiaoyao powder is often used as a representative formula for soothing liver and strengthening spleen in traditional Chinese medicine. Xiaoyao powder is prepared from licorice, Chinese angelica, tuckahoe, white peony root, white atractylodes rhizome and bupleurum root, and has the functions of soothing liver, relieving depression, nourishing blood and strengthening spleen. It is used for treating chronic hepatitis, liver cirrhosis, cholelithiasis, gastric and duodenal ulcer, chronic gastritis, gastrointestinal neurosis, premenstrual tension, and mammary gland lobular hyperplasia with symptoms of liver depression, blood deficiency, and spleen weakness. In the formula, the Chinese angelica root, the white peony root and the bupleurum root are used together to tonify the liver body and assist the liver, blood harmonizes the liver, and blood replenishes the liver to soften the liver. The medicines are used together to lead liver depression to be relieved, blood deficiency to be nourished, spleen weakness to be recovered, qi and blood to be taken into consideration, the body is adjusted, and the liver and the spleen are treated simultaneously. However, in the aspect of treating liver diseases, from the aspect of differentiation of defense, qi, nutrient and blood, liver disease patients do not enter nutrient and blood; from the differentiation of syndromes of the triple energizer, it is still in the upper, middle and secondary energizers, so blood-based herbs are not used. Besides, the spleen has the functions of governing transportation and transformation and governing blood, so the Xiaoyao powder is mainly used by ancient people for treating liver depression and blood deficiency, while liver disease patients show liver depression and spleen deficiency, mainly digestive tract symptoms, and anemia is not obvious. Therefore, Xiaoyao powder has no specific effect on treating liver diseases.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides the traditional Chinese medicine composition for treating chronic hepatitis, especially chronic hepatitis B, the traditional Chinese medicine composition has the effects of soothing liver, regulating qi, and clearing and resolving dampness and heat, and has a remarkable effect in treating chronic hepatitis, especially chronic hepatitis B.
As one aspect of the present invention, the present invention provides a traditional Chinese medicine composition for treating chronic hepatitis, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: radix bupleuri, radix scutellariae, rhizoma coptidis, szechwan chinaberry fruit, lotus leaf, fortune eupatorium herb, tuckahoe, fructus amomi, angelica, plantain seed, malt and liquorice.
Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 30-180 parts of radix bupleuri, 30-180 parts of radix scutellariae, 20-120 parts of coptis chinensis, 30-180 parts of szechwan chinaberry fruit, 30-180 parts of lotus leaf, 30-180 parts of fortune eupatorium herb, 30-180 parts of poria cocos, 25-140 parts of fructus amomi, 30-180 parts of Chinese angelica, 30-180 parts of plantain seed, 50-280 parts of malt and 12-72 parts of liquorice.
Further preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 50-150 parts of radix bupleuri, 50-150 parts of radix scutellariae, 32-90 parts of coptis chinensis, 50-150 parts of szechwan chinaberry fruit, 50-150 parts of lotus leaf, 50-150 parts of fortune eupatorium herb, 50-150 parts of poria cocos, 40-110 parts of fructus amomi, 50-150 parts of Chinese angelica, 50-150 parts of plantain seed, 75-220 parts of malt and 18-57 parts of liquorice.
More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 80-120 parts of radix bupleuri, 80-120 parts of radix scutellariae, 42-65 parts of coptis chinensis, 80-120 parts of szechwan chinaberry fruit, 80-120 parts of lotus leaf, 80-120 parts of fortune eupatorium herb, 80-120 parts of poria cocos, 52-80 parts of fructus amomi, 80-120 parts of Chinese angelica, 80-120 parts of plantain seed, 95-180 parts of malt and 25-43 parts of liquorice.
Most preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 100 parts of radix bupleuri, 100 parts of radix scutellariae, 50 parts of coptis chinensis, 100 parts of szechwan chinaberry fruit, 100 parts of lotus leaf, 100 parts of fortune eupatorium herb, 100 parts of tuckahoe, 60 parts of fructus amomi, 100 parts of angelica, 100 parts of plantain seed, 150 parts of malt and 30 parts of liquorice;
or 95 parts by weight of radix bupleuri, 105 parts by weight of radix scutellariae, 45 parts by weight of rhizoma coptidis, 105 parts by weight of fructus toosendan, 92 parts by weight of lotus leaf, 105 parts by weight of herba eupatorii, 92 parts by weight of poria cocos, 70 parts by weight of fructus amomi, 95 parts by weight of angelica sinensis, 105 parts by weight of semen plantaginis, 135 parts by weight of malt and 34 parts by weight of liquorice;
or 105 parts of radix bupleuri, 92 parts of radix scutellariae, 55 parts of rhizoma coptidis, 95 parts of szechwan chinaberry fruit, 105 parts of lotus leaf, 95 parts of fortune eupatorium herb, 105 parts of poria cocos, 58 parts of fructus amomi, 105 parts of Chinese angelica, 92 parts of plantain seed, 160 parts of malt and 28 parts of liquorice.
In the above technical scheme, the traditional Chinese medicine composition can be in any form composed or prepared from the above raw material medicines, including: the raw materials are respectively crushed and then mixed to form the composition; or, the composition is obtained by mixing and crushing the raw material medicines; or mixing the above raw materials, extracting by conventional extraction method to obtain extract, refining and purifying to obtain effective components, and making into conventional oral dosage form.
The conventional extraction method comprises soaking extraction, decocting extraction, reflux extraction, percolation extraction, ultrasonic extraction, microwave extraction, etc.; the extraction solvent comprises water or conventional organic solvent such as ethanol, methanol, ethyl acetate, petroleum ether, isopropanol, etc.; the refining and purifying process comprises extraction, column chromatography separation, high performance liquid chromatography separation and the like.
The conventional oral dosage forms include tablet, capsule, granule, pill, powder, and oral liquid. The preparation of the dosage form needs to be added with common pharmaceutically acceptable auxiliary materials, including: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, and the like. The filler comprises: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; the disintegrating agent comprises: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crospolyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.; the lubricant comprises: magnesium stearate, sodium lauryl sulfate, talc, silica, and the like; the suspending agent comprises: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and the like; the binder includes starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.
The traditional Chinese medicine composition can be fed in the form of raw material medicines, and also can be fed in the form of extracts or prepared into granules according to the proportion.
As another aspect of the present application, the present application further provides a traditional Chinese medicine composition for treating chronic hepatitis, the traditional Chinese medicine composition comprises the following raw materials: bupleuri radix extract, Scutellariae radix extract, Coptidis rhizoma extract, fructus Toosendan extract, folium Nelumbinis extract, herba Eupatorii extract, Poria extract, fructus Amomi extract, radix Angelicae sinensis extract, semen plantaginis extract, fructus Hordei Germinatus extract, and Glycyrrhrizae radix extract.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 30-180 parts of bupleurum extract, 30-180 parts of scutellaria extract, 20-120 parts of coptis extract, 30-180 parts of szechwan chinaberry fruit extract, 30-180 parts of lotus leaf extract, 30-180 parts of fortune eupatorium herb extract, 30-180 parts of poria extract, 25-140 parts of fructus amomi extract, 30-180 parts of angelica extract, 30-180 parts of plantain seed extract, 50-280 parts of malt extract and 12-72 parts of liquorice extract.
Further preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 50-150 parts of bupleurum extract, 50-150 parts of scutellaria extract, 32-90 parts of coptis extract, 50-150 parts of szechwan chinaberry fruit extract, 50-150 parts of lotus leaf extract, 50-150 parts of fortune eupatorium herb extract, 50-150 parts of poria extract, 40-110 parts of villous amomum fruit extract, 50-150 parts of angelica extract, 50-150 parts of plantain seed extract, 75-220 parts of malt extract and 18-57 parts of liquorice extract.
More preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 80-120 parts of bupleurum extract, 80-120 parts of scutellaria extract, 42-65 parts of coptis extract, 80-120 parts of szechwan chinaberry fruit extract, 80-120 parts of lotus leaf extract, 80-120 parts of fortune eupatorium herb extract, 80-120 parts of poria extract, 52-80 parts of villous amomum fruit extract, 80-120 parts of angelica extract, 80-120 parts of plantain seed extract, 95-180 parts of malt extract and 25-43 parts of liquorice extract.
Most preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 100 parts of bupleurum extract, 100 parts of scutellaria extract, 50 parts of coptis extract, 100 parts of szechwan chinaberry fruit extract, 100 parts of lotus leaf extract, 100 parts of eupatorium extract, 100 parts of poria extract, 60 parts of fructus amomi extract, 100 parts of angelica extract, 100 parts of plantain seed extract, 150 parts of malt extract and 30 parts of liquorice extract.
In the above technical scheme, the extract may be an aqueous extract or an organic solvent extract of each crude drug, or a refined product obtained by further refining and purifying the aqueous extract/organic solvent extract, or a further prepared formula granule.
The organic solvent is selected from one or more of methanol, 20-95% ethanol solution and acetone;
the extraction method for preparing the extract comprises any one of reflux extraction, immersion extraction, ultrasonic extraction or percolation extraction, or the combination of different extraction methods.
The raw material medicaments of the invention, namely bupleurum, scutellaria, coptis, szechwan chinaberry fruit, lotus leaf, fortune eupatorium herb, tuckahoe, amomum fruit, angelica, plantain seed, malt and liquorice, all conform to the record of Chinese pharmacopoeia (2020 edition).
As another aspect of the invention, the invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating chronic hepatitis.
Preferably, the traditional Chinese medicine composition is applied to preparation of medicines for treating chronic hepatitis B.
Preferably, the traditional Chinese medicine composition is applied to preparation of a medicine for improving the nonspecific immunity function of an organism.
The invention has the beneficial effects that:
the prescription of the invention takes radix bupleuri and radix scutellariae as the monarch: radix bupleuri, radix and radix bupleuri, wherein the radix bupleuri, the radix bupleuri, the radix, the bitter, the radix bupleuri, the radix bupleuri, the radix bupleuri, the radix bupleuri, the radix is bitter and the radix, so as to sooth; huang Qin is bitter and cold in property and can clear stomach heat and dry dampness to eliminate damp-heat in middle energizer. The toosendan fruit, the coptis root, the eupatorium and the lotus leaf are taken as ministers: wherein the szechwan chinaberry fruit can sooth the liver, promote qi circulation and relieve pain, and can strengthen the function of the monarch drug bupleurum root for flowing liver and regulating qi; coptis root, rhizoma Coptidis, being bitter and cold in property, has the effects of clearing stomach heat and relieving vomiting, and is combined with Huang Qin to strengthen the heat-clearing function of the recipe; eupatorium fortunei and lotus leaf have fragrant smell, and have the functions of resolving dampness and activating spleen, and are used together with Qinlian; to clear and resolve the damp-heat of the middle energizer. Poria cocos, fructus amomi, angelica sinensis, semen plantaginis and roasted malt as adjuvants: wherein Poria is sweet and neutral, and has effects in invigorating spleen and eliminating dampness; fructus Amomi, pungent in flavor and warm in property, promoting the circulation of qi and regulating the middle warmer; semen plantaginis, sweet and cold in nature, can seep water and induce diuresis; chinese angelica is sweet and warm, and has the functions of nourishing blood and promoting blood circulation so as to nourish and soften the liver; stir-frying malt to eliminate food stagnation. Raw licorice root, radix Glycyrrhizae Praeparata, coordinates the effects of the other drugs in the recipe. The medicines of the formula are used together to play the roles of dispersing stagnated liver qi, regulating qi-flowing, and clearing damp-heat. Compared with the existing liver-soothing and spleen-strengthening formula, the formula of the invention focuses on soothing the liver and strengthening the spleen, and reduces the use of spleen-strengthening medicines. On the basis of the curative effect of treating chronic hepatitis B, the curative ratio is improved, the curative effect is more durable, and the clinical curative effect is still 100% after the medicine is stopped for three months.
Detailed Description
Example 1
The formula is as follows: 100g of radix bupleuri, 100g of radix scutellariae, 50g of rhizoma coptidis, 100g of szechwan chinaberry fruit, 100g of lotus leaf, 100g of fortune eupatorium herb, 100g of tuckahoe, 60g of fructus amomi, 100g of angelica, 100g of plantain seed, 150g of malt and 30g of liquorice;
the preparation method comprises the following steps: extracting volatile oil from the twelve medicines, namely fructus amomi, angelica sinensis and eupatorium, and collecting the distilled aqueous solution in another container; decocting the residue and the rest radix bupleuri in water, filtering, mixing the filtrate with the above distilled water solution, concentrating, centrifuging, adjusting pH of the centrifugate to 4-6 with sodium bicarbonate, adding the above volatile oil such as fructus Amomi, polysorbate-802 ml and 0.5g ethyl p-hydroxybenzoate, adding water to adjust total volume to 1000ml, stirring, packaging, and sterilizing.
Specification: the product contains crude drug 1.09g per ml, and 50ml per bottle.
The usage and dosage are as follows: orally administered 50ml at a time, 2 times a day.
Example 2
The formula is as follows: 95g of radix bupleuri, 105g of scutellaria baicalensis, 45g of coptis chinensis, 105g of szechwan chinaberry fruit, 92g of lotus leaf, 105g of fortune eupatorium herb, 92g of poria cocos, 70g of fructus amomi, 95g of Chinese angelica, 105g of plantain seed, 135g of malt and 34g of liquorice;
the preparation method, specification and usage amount are the same as those of example 1.
Example 3
The formula is as follows: 105g of radix bupleuri, 92g of scutellaria baicalensis, 55g of coptis chinensis, 95g of szechwan chinaberry fruit, 105g of lotus leaf, 95g of fortune eupatorium herb, 105g of poria cocos, 58g of fructus amomi, 105g of Chinese angelica, 92g of plantain seed, 160g of malt and 28g of liquorice;
the preparation method, specification and usage amount are the same as those of example 1.
Example 4
The formula is as follows: 83g of radix bupleuri, 112g of scutellaria baicalensis, 44g of coptis chinensis, 117g of szechwan chinaberry fruit, 85g of lotus leaf, 117g of fortune eupatorium herb, 85g of poria cocos, 65g of fructus amomi, 83g of Chinese angelica, 112g of plantain seed, 110g of malt and 38g of liquorice;
the preparation method comprises the following steps: extracting volatile oil from the twelve medicines, namely fructus amomi, angelica sinensis and eupatorium, and collecting the distilled aqueous solution in another container; adding water into the residue and the rest of radix bupleuri and other nine ingredients, percolating and extracting, filtering, mixing the filtrate with the distilled water solution, concentrating, centrifuging, adjusting the pH value of the centrifugate to 4-6 with sodium bicarbonate, adding the above fructus Amomi and other volatile oil, polysorbate-802 ml and 0.5g of ethyl p-hydroxybenzoate, adding water to adjust the total amount to 1000ml, stirring, bottling, and sterilizing to obtain the final product.
Specification: the medicine contains 1.05g crude drug per ml, and 50ml in each bottle.
The usage and dosage are as follows: orally administered 50ml at a time, 2 times a day.
Example 5
The formula is as follows: 117g of radix bupleuri, 85g of radix scutellariae, 60g of coptis chinensis, 83g of szechwan chinaberry fruit, 112g of lotus leaf, 83g of fortune eupatorium herb, 112g of tuckahoe, 55g of fructus amomi, 117g of angelica sinensis, 85g of plantain seed, 175g of malt and 26g of liquorice;
the preparation method, specification and usage amount are the same as those of example 4.
Example 6
The formula is as follows: 75g of radix bupleuri, 128g of scutellaria baicalensis, 38g of coptis chinensis, 125g of szechwan chinaberry fruit, 72g of lotus leaf, 125g of fortune eupatorium herb, 72g of poria cocos, 92g of fructus amomi, 75g of Chinese angelica, 128g of plantain seed, 90g of malt and 48g of liquorice;
the preparation method, specification and usage amount are the same as those of example 4.
Example 7
The formula is as follows: 125g of radix bupleuri, 72g of scutellaria baicalensis, 75g of coptis chinensis, 75g of szechwan chinaberry fruit, 128g of lotus leaf, 75g of fortune eupatorium herb, 128g of poria cocos, 48g of fructus amomi, 128g of Chinese angelica, 72g of plantain seed, 200g of malt and 22g of liquorice;
the preparation method comprises the following steps: extracting the above twelve raw materials with 70% ethanol under reflux, filtering, concentrating the filtrate under reduced pressure, centrifuging, adjusting pH of the centrifugate to 4-6 with sodium bicarbonate, adding the above volatile oil such as fructus Amomi, polysorbate-802 ml and ethyl p-hydroxybenzoate 0.5g, adding water to adjust the total amount to 1000ml, stirring, bottling, and sterilizing.
Specification: the product contains crude drug 1.14g per ml, and 50ml per bottle.
The usage and dosage are as follows: orally administered 50ml at a time, 2 times a day.
Example 8
The formula is as follows: 58g of radix bupleuri, 135g of scutellaria baicalensis, 35g of coptis chinensis, 140g of szechwan chinaberry fruit, 55g of lotus leaf, 140g of fortune eupatorium herb, 55g of poria cocos, 105g of fructus amomi, 58g of Chinese angelica, 135g of plantain seed, 85g of malt and 55g of liquorice;
the preparation method, specification and usage amount are the same as those of example 7.
Example 9
The formula is as follows: 140g of radix bupleuri, 55g of scutellaria baicalensis, 83g of coptis chinensis, 58g of szechwan chinaberry fruit, 135g of lotus leaf, 58g of fortune eupatorium herb, 135g of poria cocos, 43g of fructus amomi, 140g of Chinese angelica, 55g of plantain seed, 215g of malt and 20g of liquorice;
the preparation method, specification and usage amount are the same as those of example 7.
Example 10
The formula is as follows: 46g of radix bupleuri, 160g of scutellaria baicalensis, 28g of coptis chinensis, 155g of szechwan chinaberry fruit, 45g of lotus leaf, 155g of fortune eupatorium herb, 45g of poria cocos, 120g of fructus amomi, 46g of Chinese angelica, 160g of plantain seed, 70g of malt and 65g of liquorice;
the preparation method comprises the following steps: percolating the above twelve materials with 70% ethanol, filtering, recovering ethanol from filtrate, concentrating, drying under reduced pressure (or spray drying), pulverizing into fine powder, adding dextrin, granulating with ethanol, drying, tabletting, and making into tablet.
Example 11
The formula is as follows: 155g of radix bupleuri, 45g of radix scutellariae, 100g of rhizoma coptidis, 46g of szechwan chinaberry fruit, 160g of lotus leaf, 46g of herba eupatorii, 160g of tuckahoe, 35g of fructus amomi, 155g of angelica, 45g of semen plantaginis, 240g of malt and 16g of liquorice;
the preparation method is the same as that of example 10.
Example 12
The formula is as follows: 35g of radix bupleuri, 175g of radix scutellariae, 24g of rhizoma coptidis, 170g of szechwan chinaberry fruit, 33g of lotus leaf, 170g of fortune eupatorium herb, 33g of tuckahoe, 135g of fructus amomi, 35g of angelica, 175g of plantain seed, 58g of malt and 70g of liquorice;
the preparation method is the same as that of example 10.
Example 13
The formula is as follows: 170g of radix bupleuri, 33g of radix scutellariae, 115g of coptis chinensis, 35g of szechwan chinaberry fruit, 175g of lotus leaf, 35g of fortune eupatorium herb, 175g of tuckahoe, 28g of fructus amomi, 170g of angelica sinensis, 33g of plantain seed, 265g of malt and 14g of liquorice;
the preparation method is the same as that of example 10.
Example 14
The formula is as follows: 100g of radix bupleuri particles, 100g of scutellaria baicalensis particles, 50g of coptis chinensis particles, 100g of szechwan chinaberry fruit particles, 100g of lotus leaf particles, 100g of eupatorium particles, 100g of poria cocos particles, 60g of fructus amomi particles, 100g of angelica sinensis particles, 100g of semen plantaginis particles, 150g of malt particles and 30g of liquorice particles;
wherein, the fructus amomi granules, the angelica granules and the eupatorium granules are prepared by the following methods: extracting volatile oil from fructus Amomi, radix Angelicae sinensis, and herba Eupatorii respectively, and collecting the distilled water solution in another container; decocting the residue with water, filtering, mixing the filtrate with the above distilled water solution, adding the volatile oil, concentrating under reduced pressure, drying under reduced pressure (or spray drying), pulverizing into fine powder, adding dextrin, and making into granule with ethanol.
The other granules are prepared by decocting and extracting the raw materials with water respectively: for example, bupleuri radix granule is prepared by decocting bupleuri radix with water, filtering, concentrating the filtrate under reduced pressure, drying under reduced pressure (or spray drying), pulverizing into fine powder, adding appropriate amount of dextrin, and granulating with ethanol.
Example 15
The formula is as follows: 95g of radix bupleuri particles, 105g of scutellaria baicalensis particles, 45g of coptis chinensis particles, 105g of szechwan chinaberry fruit particles, 92g of lotus leaf particles, 105g of eupatorium particles, 92g of poria cocos particles, 70g of fructus amomi particles, 95g of angelica sinensis particles, 105g of semen plantaginis particles, 135g of malt particles and 34g of liquorice particles;
the above particle preparation method is the same as example 14.
Example 16
The formula is as follows: 105g of radix bupleuri particles, 92g of scutellaria baicalensis particles, 55g of coptis chinensis particles, 95g of szechwan chinaberry fruit particles, 105g of lotus leaf particles, 95g of eupatorium particles, 105g of poria cocos particles, 58g of fructus amomi particles, 105g of angelica sinensis particles, 92g of semen plantaginis particles, 160g of malt particles and 28g of liquorice particles;
the above particle preparation method is the same as example 14.
Example 17
The formula is as follows: 100g of radix bupleuri extract, 100g of scutellaria baicalensis extract, 50g of coptis chinensis extract, 100g of szechwan chinaberry fruit extract, 100g of lotus leaf extract, 100g of eupatorium extract, 100g of poria cocos extract, 60g of fructus amomi extract, 100g of angelica sinensis extract, 100g of semen plantaginis extract, 150g of malt extract and 30g of liquorice extract;
wherein, the fructus amomi extract, the angelica sinensis extract and the eupatorium extract are prepared by the following method: extracting volatile oil from fructus Amomi, radix Angelicae sinensis, and herba Eupatorii respectively, and collecting the distilled water solution in another container; decocting the residue with water, filtering, mixing the filtrate with the above distilled water solution, adding the volatile oil, concentrating under reduced pressure, and drying under reduced pressure (or spray drying).
The other extracts are prepared by decocting the raw materials with water respectively.
Example 18
The formula is as follows: 83g of radix bupleuri extract, 112g of radix scutellariae extract, 44g of rhizoma coptidis extract, 117g of szechwan chinaberry fruit extract, 85g of lotus leaf extract, 117g of herba eupatorii extract, 85g of poria cocos extract, 65g of fructus amomi extract, 83g of angelica sinensis extract, 112g of semen plantaginis extract, 110g of malt extract and 38g of liquorice extract;
the above extracts were prepared in the same manner as in example 17.
Example 19
The formula is as follows: 117g of radix bupleuri extract, 85g of radix scutellariae extract, 60g of coptis extract, 83g of szechwan chinaberry fruit extract, 112g of lotus leaf extract, 83g of eupatorium extract, 112g of poria cocos extract, 55g of fructus amomi extract, 117g of angelica sinensis extract, 85g of semen plantaginis extract, 175g of malt extract and 26g of liquorice extract;
the above extracts were prepared in the same manner as in example 17.
Example 20
The formula is as follows: 58g of bupleurum extract, 135g of scutellaria extract, 35g of coptis extract, 140g of szechwan chinaberry fruit extract, 55g of lotus leaf extract, 140g of eupatorium extract, 55g of poria extract, 105g of fructus amomi extract, 58g of angelica extract, 135g of plantain seed extract, 85g of malt extract and 55g of liquorice extract;
the above extracts were prepared in the same manner as in example 17.
Example 21
The formula is as follows: 140g of bupleurum extract, 55g of scutellaria extract, 83g of coptis extract, 58g of szechwan chinaberry fruit extract, 135g of lotus leaf extract, 58g of eupatorium extract, 135g of poria extract, 43g of fructus amomi extract, 140g of angelica extract, 55g of plantain seed extract, 215g of malt extract and 20g of liquorice extract;
the above extracts were prepared in the same manner as in example 17.
Example 22
The formula is as follows: 46g of radix bupleuri extract, 160g of scutellaria baicalensis extract, 28g of coptis chinensis extract, 155g of szechwan chinaberry fruit extract, 45g of lotus leaf extract, 155g of eupatorium extract, 45g of poria cocos extract, 120g of fructus amomi extract, 46g of angelica sinensis extract, 160g of semen plantaginis extract, 70g of malt extract and 65g of liquorice extract;
the above extracts were prepared in the same manner as in example 17.
Example 23
The formula is as follows: 155g of radix bupleuri extract, 45g of scutellaria baicalensis extract, 100g of coptis chinensis extract, 46g of szechwan chinaberry fruit extract, 160g of lotus leaf extract, 46g of eupatorium extract, 160g of poria cocos extract, 35g of fructus amomi extract, 155g of angelica sinensis extract, 45g of semen plantaginis extract, 240g of malt extract and 16g of liquorice extract;
the above extracts were prepared in the same manner as in example 17.
Effects of the embodiment
121 chronic hepatitis B patients are selected and divided into an observation group and a control group, and the statistical treatment on the aspect of the ratio of the experimental conditions to the sex, the age, the disease course and the disease distribution of the two groups has no significant difference p < 0.05.
(I) clinical Observation protocol
1 diagnostic criteria
According to the guidelines of clinical research on new drugs in TCM and the liver disease Committee of the medical society of TCM 1991, the standard of Tianjin conference, which conforms to the diagnosis of chronic hepatitis B and the syndrome differentiation of TCM, can be included in the experimental cases for patients with stagnation of liver qi, dampness and heat.
(1) Traditional Chinese medicine syndrome differentiation: stagnation of liver Qi due to stagnation of dampness and Heat in the middle energizer
The main symptoms are: firstly, distending pain in the ribs, secondly, eating less and anorexia, thirdly, sticky and uncomfortable mouth and fourthly, yellow, thick and greasy fur.
The B-time disease: firstly, abdominal fullness and distention, secondly, nausea and vomiting, thirdly, loose stool, fourthly, pale red tongue and fifth, wiry and slippery pulse.
The requirements of syndrome differentiation are as follows: the diagnosis can be carried out by taking any two of the main symptoms and other three symptoms or two of the main symptoms and two of the secondary symptoms.
(2) Etiology diagnostic criteria: chronic hepatitis B
2 observation index
(1) Safety observation
Routine test of blood, urine and excrement; ② electrocardiogram; ③ urea nitrogen.
(2) Observation of therapeutic effects
Clinical symptoms of chronic hepatitis; ② the physical signs of chronic hepatitis; ③ serum total bilirubin (TSB), alanine Aminotransferase (ALT), aspartate Aminotransferase (AST), serum Albumin (ALB) and glutamyl transferase (GGT);
3 criteria for therapeutic efficacy
According to the standard for judging the curative effect of the chronic hepatitis of the viral hepatitis in the guidelines of clinical research of new traditional Chinese medicines.
The method has the following advantages: the integral reduction value is 70 to 90 percent after the treatment of the primary and secondary symptoms of the traditional Chinese medicine; the hepatosplenomegaly is stable and unchanged or reduced, and no tenderness and percussion pain exist; the liver function is normal, and the above indexes are stable for more than one year.
Secondly, the method is effective: the integral reduction value is 50 to 70 percent after the treatment of the primary and secondary symptoms of the traditional Chinese medicine; the hepatosplenomegaly is stable and unchanged, and no obvious tenderness and percussion pain exist; the liver function test is normal or the original value is reduced by more than 50%, and the test lasts for three months.
③ invalid: the integral reduction value is less than 20% after the treatment of the primary and secondary symptoms of the traditional Chinese medicine, and ALT is not reduced after the treatment course is finished.
4 Experimental drugs
Observation group: the Chinese medicinal composition prepared in example 1 is orally taken 50 ml/time and 3 times/day.
Control group: instant powder for treating hepatitis B, 20 g/time and 3 times/day, and is orally taken
The formula is as follows: the Chinese medicinal composition is prepared into medicinal granules by processing radix bupleuri (processed with vinegar), fructus aurantii, radix paeoniae alba, radix salviae miltiorrhizae, radix astragali, radix codonopsitis, rhizoma coptidis and the like, wherein each bag is filled with 10g of the medicinal granules.
5 courses of treatment: all the time is three months; the subjects were followed up 3 months after the treatment course was over, and the follow-up requirements were the same as those of the clinical observation.
(II) results of the experiment
1 clinical efficacy
(1) The total effective rate of observation group and control group
The results are shown in Table 1.
TABLE 1 Total effective rate test results of observation group and control group
The results show that the total effective rate in the observation group is significantly different from the statistical treatment of the control group (P < 0.05). The traditional Chinese medicine composition can obviously improve the clinical curative effect.
Clinical symptoms: the clinical symptoms of an observation group and a control group after treatment are improved, and the observation group has significant differences in improvement of symptoms of hypochondriac distending pain, abdominal fullness and distention, anorexia, sticky mouth, unsmooth mouth and vomiting and nausea compared with the control group. The traditional Chinese medicine composition of the invention is better than a control group in improving clinical symptoms.
(2) Biochemical index investigation results of observation group and control group
The results are shown in Table 2.
TABLE 2 Biochemical index examination results (X + -SD) of the observation group and the control group
The results show that the liver function of the patients is obviously improved after the treatment of the observation group, and particularly the improvement of ALT, TSB and GGT is obviously different compared with the control group (P <0.05 and P < 0.01). The composition of the invention has better functions of benefiting gallbladder, removing jaundice and recovering liver function.
2 evaluation of safety
The results are shown in Table 3.
TABLE 3 Effect of the Chinese medicinal composition of the present invention on blood, urine, stool routine and renal function
The results show that the blood, urine and stool routine of the patients after treatment, the renal function BUN and the electrocardiogram are unchanged compared with those before treatment, and the clinical application of the Chinese medicinal composition has no toxic or side effect and adverse effect on the heart and kidney organs.
3 follow-up report
The results are shown in Table 4.
TABLE 4 comparison of efficacy of the observation groups after treatment and at follow-up visit
| n | Show effect | Is effective | Invalidation | |
| After treatment | 56 | 17 | 39 | 0 |
| Follow-up visit after 3 months | 56 | 17 | 39 | 0 |
The follow-up results show that the total effective rate of the traditional Chinese medicine composition is still stabilized at 100% 3 months after the medicine is stopped for treating chronic hepatitis B, and the comparative analysis between the treatment and the follow-up time has no obvious change. Meanwhile, the symptoms and signs of the patients are not repeated at the follow-up visit, and the symptoms and signs are not obviously different from the symptoms and signs after the treatment is finished (P is more than 0.05). The liver function index detection of the patients is further improved during follow-up visit, which shows that the medicine has stable and lasting curative effect.
(III) summary of
The research results of the clinical tests show that the traditional Chinese medicine composition is effective in treating chronic hepatitis B, and is specifically embodied in the following aspects:
1. the cure rate is improved: compared with the control group, the treatment is obviously different at the end of treatment, the clinical curative effect of the follow-up group is still 100 percent, and the curative effect is reflected to be positive.
2. Biochemical indexes for improving liver functions: it is important to treat hepatitis and improve liver function. The traditional Chinese medicine composition effectively recovers the liver function of a patient, particularly has more prominent curative effect on reducing ALT, GGT and TSB, and has significant difference compared with a control group.
3. Improving the signs of clinical symptoms: after 2 weeks of treatment by applying the traditional Chinese medicine composition disclosed by the invention, the symptoms of a patient are relieved, the symptoms are obviously improved at the end of a treatment course, and the thick and greasy tongue coating disappears, so that the medicine can relieve the symptoms, and the symptoms of the patient are not repeated at the follow-up visit.
4. No obvious toxic or side effect: after the traditional Chinese medicine composition is taken, patients do not find adverse reactions such as fever, rash, abnormal heart rate and the like, and the electrocardiogram, blood, urine, excrement and kidney functions are normal, which shows that the traditional Chinese medicine composition has no toxic or side effect and adverse reactions when being applied.
Effect of embodiment two
(I) test materials
1 test drug: oral liquid prepared according to example 1, lot No. 991010.
2, dose design: the clinical daily dose of the traditional Chinese medicine composition is 103g of crude drugs for a human, the human is 1.72g of crude drugs/kg calculated according to 60 kg of the crude drugs, the dose for the test is converted according to the kg of the body weight of animals and the human, the middle dose is about equivalent to the clinical equivalent dose of the human, and then a dose group is respectively set according to 1/2 and 2 times of the clinical dose, namely the gavage dose of mice is 38, 19 and 9.5g of the crude drugs/kg of the body weight.
3, positive control drug: pikexin, produced by Jiangxi Jimin pharmaceutical Co., Ltd, batch number: 990620, the dose administered to the animal is 5.8g/kg (ig) in terms of kg body weight of the animal and human, and the clinically equivalent dose to the mouse.
4, reagent: sheep red blood cells, which are provided by the northern medicinal animal center, are washed with physiological saline for three times and diluted to the required concentration when in use; guinea pig serum (complement); hanks liquid; liquid A of Araliaceae; other reagents were all commercially available analytical grade.
5, animals: 18-22g of Kunming mouse, male and female, provided by animal research institute of Chinese academy of medical sciences, and animal qualification number is No. 01-3001.
6, instrument: UV-754 continuous spectrophotometer, product of Shanghai third analytical Instrument plant.
(II) Experimental methods and results
1 Effect on Normal mouse Small intestine advancing function
50 Kunming mice are taken, the weight is 18-22g, males are randomly divided into 5 groups, namely a normal control group, a positive control splenocophere group and a composition high, medium and low dose group, each group is 10, fasting is carried out for 24 hours, gastric lavage is carried out (0.2ml/10g, the normal control group is used for gastric lavage and distilled water with the same volume as the medicament), 5% of carbon powder (prepared by 10% of Arabic gum) is perfused after 1 hour, animals are killed after 20 minutes, the intestines and the intestines are immediately taken out by cutting open the abdominal cavity, a glass plate is paved, the moving distance of the carbon powder head end in an intestinal canal and the whole length of the small intestine (from the pylorus to the ileocecal part) are measured, and the propelling percentage is calculated and the propelling percentage (%) (the distance from the pylorus to the front edge of the carbon powder (cm))/(the distance from the pylorus to the ileocecal part (cm)) × 100%.
The results are shown in Table 5.
TABLE 5 influence of the Chinese medicinal composition on the propelling of charcoal dust in normal mice (X + -SD)
| Group of | Dosage (g/kg) | n | Push percentage (%) |
| Normal control group | - | 10 | 50.71±13.02 |
| Positive control group | 5.8 | 10 | 54.35±7.14 |
| High dose compositions | 38 | 10 | 47.50±8.06 |
| Dosage group in composition | 19 | 10 | 55.45±11.97 |
| Composition low dose group | 9.5 | 10 | 54.19±8.83 |
The results show that: the traditional Chinese medicine composition has no obvious influence on the intestinal propulsion function of normal mice.
2 Effect on the intestinal function of spleen deficiency mice
The Kunming mouse is taken, the weight is 18-20g, males are randomly divided into 6 groups, namely a normal control group, a model group, a positive drug splenoconazole group, a composition high, medium and low dose group, 10 mice in each group are administrated, 1 ml/100% rhubarb water decoction (distilled water with the same volume as the normal control group) is administrated by intragastric administration, and the symptoms of spleen deficiency such as loose stool, anorexia, emaciation, hypokinesia, hair withering and aversion to cold and the like appear after 8 days. On the fifth day of molding, the animals were gazed in the afternoon (0.2ml/10g, normal control group with the same volume of distilled water), weighed on the eighth day, fasted for 24 hours, gazed with 5% charcoal powder (formulated with 10% acacia) after the last administration for 1 hour, sacrificed after 20 minutes, immediately dissected open the abdominal cavity to take out the gastrointestinal tract, laid on a glass plate, the moving distance of the head end of the charcoal powder in the intestinal canal and the total length of the small intestine (from pylorus to ileocecal part) were measured, and the push percentage was calculated: percent (%) push is (distance (cm) from pylorus to carbon front edge)/(distance (cm) from pylorus to ileocecal part) x 100%.
The results are shown in Table 6.
TABLE 6 influence of the Chinese medicinal composition on the carbon powder propelling function of spleen deficiency mice (X + -SD)
Note: compared with the normal group#p<0.05，##p<0.01; in comparison with the set of models,*P<0.05，**p<0.01。
the results show that: the traditional Chinese medicine composition has an inhibiting effect on the increase of the carbon dust propulsion rate of the small intestine of a mouse with spleen deficiency caused by rheum officinale, and has a certain effect of improving the weight loss of the mouse caused by model building.
3 Effect on swimming time of spleen-deficient mice
The Kunming mouse is taken, the weight is 18-20g, males are randomly divided into 6 groups, namely a normal control group, a model group, a positive drug splenoconazole group, a composition high, medium and low dose group, 10 mice in each group are administrated, 1 ml/100% rhubarb water decoction (distilled water with the same volume as the normal control group) is administrated by intragastric administration, and the symptoms of spleen deficiency such as loose stool, anorexia, emaciation, hypokinesia, hair withering and aversion to cold and the like appear after 8 days. Gavage (0.2ml/10g) was administered every day afternoon starting on the fifth day of molding for three consecutive days, animals were weighed before the test, mice were placed in water 1 hour after the last dose (water temperature about 30, water depth about 40cm), and the time required for the mice to sink to the water surface from the time of immersion in water was recorded (1 hour per mouse observation).
The results are shown in Table 7.
TABLE 7 influence of the Chinese medicinal composition on swimming time of spleen deficiency mice (X + -SD)
Note: compared with the normal group#p<0.05，##p<0.01; in comparison with the set of models,*P<0.05。
the results show that the traditional Chinese medicine composition can increase the weight of mice, has certain effect of increasing swimming time, and has significant difference compared with a model group in a high-dose group.
4 Effect on cellular immune function-delayed allergy (DTH) (plantar thickening)
The Kunming mouse is taken, the weight is 18-20g, the male sex is randomly divided into 5 groups, namely a normal control group, a splenomenine group, a composition high, medium and low dose group, and each group comprises 10 mice. The administration was performed once a day in the morning (the same volume of distilled water as that of the normal control group), and after 5 days of continuous administration, the mice were injected with 0.2 ml/mouse of 2% (V/V) Sheep Red Blood Cells (SRBC), and after 4 days of sensitization, the thickness of the left hind paw plantar was measured with a vernier caliper, and then 20% SRBC (20. mu.l/mouse) was injected subcutaneously at the measurement site, and the thickness of the left hind paw plantar was measured again 24 hours after the injection. The extent of DTH is expressed as the difference in plantar thickness (degree of swelling of the plantar surface) before and after the challenge.
The results are shown in Table 8.
TABLE 8 influence of the Chinese medicinal composition of the present invention on the delayed allergy in normal mice (X + -SD)
The result shows that the traditional Chinese medicine composition and the positive medicine pikexin have certain enhancing effect on the delayed hypersensitivity of the mice, but the statistical treatment has no significant difference.
5 Effect on phagocytic function of reticuloendothelial system in mice with spleen deficiency (carbon particle clearance method)
The mice are randomly divided into 6 groups according to weight, namely a normal control group, a rhubarb model group, a positive control drug splenoconazole group and a high, medium and low dose group of the invention, except the normal control group, the mice of each group are subjected to intragastric administration of 100 percent rhubarb water decoction 1 ml/day/one for 8 consecutive days, the administration is performed by intragastric administration in the afternoon, the weight is weighed once a day on the 8 th day, Indian ink diluent is injected into the tail vein of 0.1ml/10g of the weight, 20ul of blood is respectively taken from the retroorbital venous plexus by using a glass capillary pipette 1 minute and 5 minutes after the injection, and the blood is dissolved in 3ml of 0.1 percent NaCO3Shaking the solution uniformly, performing colorimetry at the wavelength of 650nm by using a spectrophotometer, and determining the Optical Density (OD). Finally, the mouse is killed by dislocation of cervical vertebra, and the weight of the liver and the weight of the spleen are respectively weighed. The clearance index K or corrected clearance index alpha is calculated according to the following formula, and the t test among groups is carried out.
The results are shown in Table 9.
TABLE 9 Effect of the Chinese medicinal composition of the present invention on the phagocytic function of reticuloendothelial system of spleen-deficient mice (X + -SD)
Note: compared with the normal group#p<0.05，##p<0.01; in comparison with the set of models,*P<0.05，**p<0.01。
the results show that: the clearance rate of blood carbon and the phagocytic coefficient of the liver-spleen reticuloendothelial system of the rheum officinale molding mouse are obviously lower than those of a normal mouse, the clearance rate of blood carbon and the phagocytic coefficient are obviously improved after the traditional Chinese medicine composition is administrated by gastric lavage, and compared with a model group, the significant difference shows that the medicine can improve the clearance rate of the spleen deficiency mouse on the carbon particles in blood and can enhance the phagocytic capacity of the liver-spleen reticuloendothelial system of the mouse.
(III) summary of
The above experimental results show that: the Chinese medicinal composition can inhibit the hyperfunction of small intestine propulsion caused by rhubarb, and has particularly remarkable large and medium dose groups; has strong recovery effect on light weight and low immunologic function caused by spleen deficiency, and is characterized by increasing weight, increasing the removal rate of carbon granules in blood, enhancing the phagocytic function of reticuloendothelial system and prolonging the swimming time of mice. Has no obvious effect on the delayed hypersensitivity of the mice. The medicine can improve the nonspecific immunity function of the organism, and has no obvious influence on the specific immunity function of the organism. The test results provide pharmacodynamic basis for clinical medication.
Claims (10)
1. The traditional Chinese medicine composition for treating chronic hepatitis is characterized by being prepared from the following raw material medicines: radix bupleuri, radix scutellariae, rhizoma coptidis, szechwan chinaberry fruit, lotus leaf, fortune eupatorium herb, tuckahoe, fructus amomi, angelica, plantain seed, malt and liquorice.
2. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 30-180 parts of radix bupleuri, 30-180 parts of radix scutellariae, 20-120 parts of coptis chinensis, 30-180 parts of szechwan chinaberry fruit, 30-180 parts of lotus leaf, 30-180 parts of fortune eupatorium herb, 30-180 parts of poria cocos, 25-140 parts of fructus amomi, 30-180 parts of Chinese angelica, 30-180 parts of plantain seed, 50-280 parts of malt and 12-72 parts of liquorice.
3. The traditional Chinese medicine composition of claim 2, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 50-150 parts of radix bupleuri, 50-150 parts of radix scutellariae, 32-90 parts of coptis chinensis, 50-150 parts of szechwan chinaberry fruit, 50-150 parts of lotus leaf, 50-150 parts of fortune eupatorium herb, 50-150 parts of poria cocos, 40-110 parts of fructus amomi, 50-150 parts of Chinese angelica, 50-150 parts of plantain seed, 75-220 parts of malt and 18-57 parts of liquorice.
4. The traditional Chinese medicine composition of claim 3, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 80-120 parts of radix bupleuri, 80-120 parts of radix scutellariae, 42-65 parts of coptis chinensis, 80-120 parts of szechwan chinaberry fruit, 80-120 parts of lotus leaf, 80-120 parts of fortune eupatorium herb, 80-120 parts of poria cocos, 52-80 parts of fructus amomi, 80-120 parts of Chinese angelica, 80-120 parts of plantain seed, 95-180 parts of malt and 25-43 parts of liquorice.
5. The traditional Chinese medicine composition of claim 4, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 100 parts of radix bupleuri, 100 parts of radix scutellariae, 50 parts of coptis chinensis, 100 parts of szechwan chinaberry fruit, 100 parts of lotus leaf, 100 parts of fortune eupatorium herb, 100 parts of tuckahoe, 60 parts of fructus amomi, 100 parts of angelica, 100 parts of plantain seed, 150 parts of malt and 30 parts of liquorice;
or 95 parts by weight of radix bupleuri, 105 parts by weight of radix scutellariae, 45 parts by weight of rhizoma coptidis, 105 parts by weight of fructus toosendan, 92 parts by weight of lotus leaf, 105 parts by weight of herba eupatorii, 92 parts by weight of poria cocos, 70 parts by weight of fructus amomi, 95 parts by weight of angelica sinensis, 105 parts by weight of semen plantaginis, 135 parts by weight of malt and 34 parts by weight of liquorice;
or 105 parts of radix bupleuri, 92 parts of radix scutellariae, 55 parts of rhizoma coptidis, 95 parts of szechwan chinaberry fruit, 105 parts of lotus leaf, 95 parts of fortune eupatorium herb, 105 parts of poria cocos, 58 parts of fructus amomi, 105 parts of Chinese angelica, 92 parts of plantain seed, 160 parts of malt and 28 parts of liquorice.
6. The traditional Chinese medicine composition of any one of claims 1-5, wherein the traditional Chinese medicine composition is: the raw material medicines are respectively crushed and then mixed to form the composition; or the raw material medicines are mixed and then crushed to obtain the composition; or mixing the above raw materials, extracting by conventional extraction method to obtain extract, refining and purifying to obtain effective components, and making into conventional oral dosage form.
7. The traditional Chinese medicine composition of claim 6, wherein the conventional oral dosage form comprises tablets, capsules, granules, pills, powders, oral liquids.
8. Use of the Chinese medicinal composition of any one of claims 1-5 in the preparation of a medicament for treating chronic hepatitis.
9. The use of claim 8, wherein the use of said composition in the manufacture of a medicament for the treatment of chronic hepatitis B.
10. The use of claim 8, wherein the use of the composition is in the preparation of a medicament for enhancing non-specific immune function.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110996816.4A CN113559218A (en) | 2021-08-27 | 2021-08-27 | Traditional Chinese medicine composition for treating chronic hepatitis and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110996816.4A CN113559218A (en) | 2021-08-27 | 2021-08-27 | Traditional Chinese medicine composition for treating chronic hepatitis and application thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113559218A true CN113559218A (en) | 2021-10-29 |
Family
ID=78172991
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110996816.4A Pending CN113559218A (en) | 2021-08-27 | 2021-08-27 | Traditional Chinese medicine composition for treating chronic hepatitis and application thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113559218A (en) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1634548A (en) * | 2004-11-23 | 2005-07-06 | 北京亚东生物制药有限公司 | Medicine composition for treating viral hepatitis and its preparation method |
| CN101099780A (en) * | 2007-07-20 | 2008-01-09 | 北京亚东生物制药有限公司 | Traditional Chinese medicinal composition for qi-benefiting, liver-nourishing, heat-clearing and antitoxic and preparation method thereof |
| CN101332284A (en) * | 2008-07-30 | 2008-12-31 | 佛山德众药业有限公司 | Chinese traditional medicine composition for treating ulcerative colitis and its preparation method |
| CN101357219A (en) * | 2008-09-04 | 2009-02-04 | 兰州佛慈制药股份有限公司 | Medicine for treating chronic hepatitis b |
| CN103301380A (en) * | 2012-03-13 | 2013-09-18 | 北京亚东生物制药有限公司 | Liver-soothing and qi-regulating traditional Chinese medicinal composition and preparation method thereof |
-
2021
- 2021-08-27 CN CN202110996816.4A patent/CN113559218A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1634548A (en) * | 2004-11-23 | 2005-07-06 | 北京亚东生物制药有限公司 | Medicine composition for treating viral hepatitis and its preparation method |
| CN101099780A (en) * | 2007-07-20 | 2008-01-09 | 北京亚东生物制药有限公司 | Traditional Chinese medicinal composition for qi-benefiting, liver-nourishing, heat-clearing and antitoxic and preparation method thereof |
| CN101332284A (en) * | 2008-07-30 | 2008-12-31 | 佛山德众药业有限公司 | Chinese traditional medicine composition for treating ulcerative colitis and its preparation method |
| CN101357219A (en) * | 2008-09-04 | 2009-02-04 | 兰州佛慈制药股份有限公司 | Medicine for treating chronic hepatitis b |
| CN103301380A (en) * | 2012-03-13 | 2013-09-18 | 北京亚东生物制药有限公司 | Liver-soothing and qi-regulating traditional Chinese medicinal composition and preparation method thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103990081B (en) | Traditional Chinese medicine composition and application thereof in preparation of medicine for treating infant jaundice | |
| CN101732683A (en) | Chinese medicinal preparation for treating facial chloasma and preparation method thereof | |
| CN104491801A (en) | Traditional Chinese medicine preparation for treating acute or chronic gastritis and preparation method thereof | |
| CN106421673A (en) | Traditional Chinese medicine composition for treating HPV (human papillomavirus) infection and preparation method thereof | |
| CN102247479B (en) | Antitumor strong medicine and preparation method thereof | |
| CN104352793A (en) | Traditional Chinese medicine preparation for treating gastrointestinal bleeding and preparation method thereof | |
| CN111714553A (en) | A Chinese medicinal composition for treating new coronary pneumonia and/or influenza, and its preparation method | |
| CN115252753B (en) | Traditional Chinese medicine composition for treating insomnia and application thereof | |
| CN111110735A (en) | Lipid-lowering pharmaceutical composition, preparation method and application | |
| CN113209194B (en) | Composition for treating chronic gastritis and preparation method and application thereof | |
| CN112274619B (en) | Composition for relieving dysmenorrhea and application of composition in preparation of medicines, health-care products or foods | |
| CN104547902A (en) | Application of traditional Chinese preparation in preparation of drugs used for treating chronic enteritis and appendicitis | |
| CN113559218A (en) | Traditional Chinese medicine composition for treating chronic hepatitis and application thereof | |
| CN109876127B (en) | Blood-nourishing angelica sinensis capsule and preparation method thereof | |
| CN112587645A (en) | Traditional Chinese medicine composition for treating infertility, traditional Chinese medicine preparation and traditional Chinese medicine product | |
| CN111686226A (en) | Traditional Chinese medicine composition for treating colon cancer and preparation method and application thereof | |
| CN104398975A (en) | Traditional Chinese medicinal preparation for treating fibroadenoma of breast and preparation method thereof | |
| CN108159150A (en) | A kind of Chinese medicine composition for treating rheumatic Bi syndrome and its preparation method and application | |
| CN115770279B (en) | Traditional Chinese medicine composition for treating chronic lower limb vein diseases, decoction and preparation thereof | |
| CN111388604B (en) | Traditional Chinese medicine composition for treating migraine and preparation method thereof | |
| CN111214584B (en) | Traditional Chinese medicine composition for tonifying kidney and benefiting liver as well as preparation method and application thereof | |
| CN116350731B (en) | Formula for clearing heat, removing dampness and relieving arthralgia as well as preparation and application thereof | |
| CN111759901B (en) | Traditional Chinese medicine composition for treating functional abdominal pain of children and preparation method thereof | |
| CN108524731B (en) | Traditional Chinese medicine composition for treating myasthenia gravis and preparation thereof | |
| CN108721572B (en) | A Chinese medicinal composition for treating hepatocarcinoma and liver cirrhosis |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20211029 |
|
| WD01 | Invention patent application deemed withdrawn after publication |