CN107260856B - A Chinese medicinal composition for treating hepatitis B, and its preparation method - Google Patents

A Chinese medicinal composition for treating hepatitis B, and its preparation method Download PDF

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CN107260856B
CN107260856B CN201710602706.9A CN201710602706A CN107260856B CN 107260856 B CN107260856 B CN 107260856B CN 201710602706 A CN201710602706 A CN 201710602706A CN 107260856 B CN107260856 B CN 107260856B
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臧星
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/47Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The invention discloses a traditional Chinese medicine composition for treating hepatitis B and a preparation method thereof. The traditional Chinese medicine composition for treating hepatitis B comprises the following components in parts by weight: 20-60 parts of cimicifuga foetida, 20-60 parts of bistort rhizome, 15-50 parts of sun euphorbia herb, 2-15 parts of sappan wood, 15-60 parts of hairyvein agrimony, 6-30 parts of green tangerine peel and 3-30 parts of liquorice. The traditional Chinese medicine composition for treating hepatitis B is reasonably compatible with seven pure natural Chinese herbal medicines, mainly aims at clearing heat and promoting diuresis, killing virus, expelling toxin, ascending the clear and descending the turbid, is assisted by improving the liver function, is named as 'Rumbizhu' because the five elements of the liver belong to wood, and is prepared by combining the traditional pharmaceutical technology and the modern pharmaceutical technology, so that the traditional Chinese medicine components are released to the maximum extent, the liver function can be effectively improved, and the hepatitis B virus can be inhibited or killed, and the effect is obvious.

Description

A Chinese medicinal composition for treating hepatitis B, and its preparation method
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating hepatitis B and a preparation method thereof.
Background
Hepatitis B is the inflammatory damage of liver caused by hepatitis B virus, and is one of the most popular and serious infectious diseases. At present, hepatitis B virus carriers in China are more than one hundred million, which exceeds 10% of the total population, wherein the number of people with virus detection indexes HBV-DNA capable of turning negative naturally to achieve self-healing is only 8-10%, about 80% of people can maintain the state of carrying chronic viruses, and 3-4% of people (3500-4500 ten thousand) can evolve to the slow migrating liver or the slow living liver. Still 10% of the patients can be self-healed, about 80% of the patients are in chronic stage for a long time, and 15% of the patients develop liver cirrhosis or liver cancer under the influence of adverse factors such as immune mechanism disorder, drug abuse, serious psychological stress, life law imbalance and the like.
At present, in the aspect of western medicines for resisting hepatitis B virus, various long-short-acting interferons, lamivudine, entecavir and the like are commonly used. The interferon can inhibit the replication of virus during administration, and promote the negative conversion of quarantine marker. The disadvantages are that: the price is high, and the cost of the whole treatment course is about ten thousand yuan. The disease condition is repeated after stopping taking the medicine, so the long-term curative effect is not ideal. The lamivudine, entecavir and the like can better inhibit the replication of viruses during the medication period, and the effect of reducing transaminase is also more ideal. The disadvantages are that: the side effect is great, the liver function is often worsened rapidly after the medicine is stopped, for example, the Qianfshan hospital clinically sees that several patients have virus replication rapidly rebounding after the medicine is stopped, and the liver function is worsened rapidly in a short time and leads to death. Even the authoritative and experienced doctor does not know how to stop the medicine.
The traditional Chinese medicine and the western medicine are greatly different in the concept of treating diseases, and the traditional Chinese medicine and the western medicine have no difference between the advantages and the disadvantages. Western medicine treats infectious diseases, and the aim of treatment is to treat pathogenic microorganisms. The main focus of TCM is human immunity. The traditional Chinese medicine can regulate the functions of viscera on the whole, support vital qi of a human body, and eliminate viruses (without providing a culture medium for the viruses to grow) by means of a method for improving the immunity of the human body.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating hepatitis B and a preparation method thereof, which have good inhibition and treatment effects on the replication of hepatitis B virus by restoring vital qi of a human body and improving the virus resistance, and have less medicine consumption and low cost.
In order to achieve the above object, the present invention provides a Chinese medicine composition for treating hepatitis B in a first aspect. Specifically, the traditional Chinese medicine composition for treating hepatitis B comprises the following components in parts by weight: 20-60 parts of cimicifuga foetida, 20-60 parts of bistort rhizome, 15-50 parts of sun euphorbia herb, 2-15 parts of sappan wood, 15-60 parts of hairyvein agrimony, 6-30 parts of green tangerine peel and 3-30 parts of liquorice.
Preferably, the traditional Chinese medicine composition for treating hepatitis B comprises the following components in parts by weight: 30-50 parts of cimicifuga foetida, 30-50 parts of bistort rhizome, 30-40 parts of sun euphorbia herb, 7-10 parts of sappan wood, 30-45 parts of hairyvein agrimony, 16-20 parts of green tangerine peel and 13-20 parts of liquorice.
Preferably, the traditional Chinese medicine composition for treating hepatitis B comprises the following components in parts by weight: 40 parts of cimicifuga foetida, 40 parts of bistort rhizome, 35 parts of sun euphorbia herb, 9 parts of sappan wood, 38 parts of hairyvein agrimony, 18 parts of green tangerine peel and 16 parts of liquorice.
Preferably, the traditional Chinese medicine composition for treating hepatitis B is a solid or liquid preparation, the solid preparation is a tablet, an ointment, a powder, a pill, a capsule, a granule or a spray, and the liquid preparation is an oral liquid.
Preferably, the solid or liquid formulation consists of a Chinese medicinal composition and an acceptable carrier.
Preferably, the acceptable carrier is a binder, filler, diluent, tableting agent, lubricant, disintegrant, surfactant, flavouring agent or wetting agent.
Preferably, the binder is one of a cellulose derivative, alginate, gelatin or polyvinylpyrrolidone.
Preferably, the filler is one of starch, sucrose, lactose, mannitol, sorbitol, xylitol, microcrystalline cellulose or glucose.
The second aspect of the invention provides a preparation method of a traditional Chinese medicine composition for treating hepatitis B. Specifically, the method comprises the following steps:
firstly, taking cimicifugae foetidae, bistort rhizome, sun euphorbia herb, sappan wood, hairyvein agrimony, green tangerine peel and liquorice, washing with clear water once, transferring to a decoction pot, adding clear water until the decoction surface is 1-2 cm higher than the medicinal surface, soaking for 1-2 h, heating to boil, decocting for 30-50 min at 80-120 ℃, and filtering while the decoction is hot to obtain dregs and a first decoction;
step two, adding clear water at 100 ℃ into the medicine residues until the medicine residues are flush, heating to boiling, continuing to decoct at 80-120 ℃ for 20-40 min, and filtering to obtain medicine residues and a secondary decoction;
and step three, squeezing out the liquid medicine in the medicine residues by using a squeezer, mixing the liquid medicine with the primary decoction liquid and the secondary decoction liquid, filtering the mixture by using a 200-mesh sieve, transferring the filtered mixture into a concentration tank, and concentrating the filtered mixture under reduced pressure until the filtered mixture is dried to obtain the traditional Chinese medicine composition for treating the hepatitis B, and adding different pharmaceutical formulations of auxiliary materials.
The medicinal properties and pharmacology of the selected Chinese herbal medicines are as follows:
cimicifugae foetidae: sweet, pungent and slightly cold in flavor. It enters lung, spleen and stomach meridians. The functional indications are as follows: seasonal pestilence, headache, cold and heat, laryngalgia, aphtha and macula impetigo; sinking of middle qi, chronic diarrhea, dysentery, rectocele, metrorrhagia, leukorrhagia, and metrostaxis; abscess, swelling and sore. It is indicated for exterior syndrome, eruption, clearing away heat and toxic material, and ascending yang and sinking. Modern pharmacological research finds that the rhizome of the cimicifuga foetida contains cimicifuga foetida alkali, salicylic acid, Tannin (Tannin), resin, caffeic acid, ferulic acid, isoferulic acid, cimicifuga glycoside, cimicifuga alcohol xyloside and the like, and has the functions of reducing blood pressure, resisting bacteria, calming, relieving fever and cooling, and preventing liver injury.
Bistort rhizome: bitter and astringent taste, slightly cold in nature. It enters lung meridian, liver meridian and large intestine meridian. The functional indications are as follows: dysentery with diarrhea, cough due to lung heat, carbuncle, scrofula, aphtha on the mouth and tongue, hematemesis, epistaxis, hemorrhoid hemorrhage, and snake and insect bite. It has effects in clearing away heat and toxic materials, relieving swelling, and stopping bleeding. Modern pharmacological research finds that rhizoma Bistortae rhizome contains tannin, starch, saccharide, fruit acid, gum, mucilage, anthraquinone derivative, resin, etc., has antibacterial, analgesic, central nervous system inhibiting, immunity enhancing and antioxidant effects, and can be used for treating various cancers, such as nasopharyngeal carcinoma, rectal cancer, cervical cancer, etc. by decocting rhizoma Bistortae with other medicines in water or making into various preparations; can also be used for treating esophageal cancer, pancreatic cancer, head and neck malignant tumor, etc.
Euphorbia helioscopia: bitter in taste and slightly cold in nature. It enters lung, small intestine and large intestine meridians. The functional indications are as follows: edema of water and qi, phlegm retention, cough, asthma, malaria, bacillary dysentery, scrofula, tuberculous fistula, osteomyelitis. Is used for promoting diuresis and relieving swelling, eliminating phlegm and relieving cough, and removing toxic substance and killing parasite. Modern pharmacological research finds that herba Euphorbiae Helioscopiae contains quercetin-5, 3-di-D-galactoside, herba Euphorbiae Helioscopiae saponin, triterpene, butyric acid, alisol, beta-dihydrofucosterol, glucose, fructose, and maltose; the latex contains m-hydroxyphenyl glycine and 3, 5-dihydroxy benzoic acid, and the dry latex contains rubber hydrocarbon, resin and water-soluble substance; the seed contains fatty oil, protein, cellulose, sugar and glycoside, and has antitussive, expectorant, analgesic and anticancer effects.
Sappan wood: sweet, salty and neutral in nature. The functional indications are as follows: traumatic injury, fracture, tendon injury, swelling and pain due to blood stasis, amenorrhea, dysmenorrhea, puerperal blood stasis, thoracico-abdominal pain, carbuncle, cellulitis, and swelling and pain. Is used for promoting blood circulation, removing blood stasis, and relieving swelling and pain. Modern pharmacological research finds that the sappan wood contains colorless raw pigments, namely brazilein, phellandrene, ocimene, tannin and the like, has the effects of resisting cancers, improving immunity, promoting microcirculation, resisting platelet aggregation and resisting bacteria, can inhibit the proliferation, invasion and metastasis of tumor cells, promotes the apoptosis of the tumor cells, and inhibits the signal transduction pathway of tumor angiogenesis factors, thereby inhibiting the generation of tumor neovascularization.
Agrimony: bitter and astringent taste, mild in nature. It enters heart and liver meridians. The functional indications are as follows: hemoptysis, hematemesis, metrorrhagia and metrostaxis, malaria, bloody dysentery, carbuncle, swelling and sore toxin, pruritus vulvae, leukorrhagia and weakness and internal injury. It has astringent, hemostatic, antimalarial, dysentery stopping, toxic materials clearing away, and deficiency tonifying effects. Modern pharmacological research finds that the agrimony contains phenolic pinoresinoic acid, agrimonine A, agrimonine B, agrimonine C, tannin, vitamin K1 and the like, and has the effects of promoting blood coagulation, strengthening heart, resisting bacteria and expelling parasites.
Green tangerine peel: bitter and pungent in flavor and warm in nature. It enters liver and gallbladder meridians. The functional indications are as follows: stagnation of liver qi, chest distress, costalgia, mastalgia, hernia, food stagnation and abdominal distension. Is used for breaking qi, dispersing accumulation, soothing qi and relieving pain. Modern pharmacological research finds that the pericarpium citri reticulatae viride contains a large amount of volatile oil, the main component is limonene, the pulp contains aurantiin, citric acid and reducing sugar, and the pericarpium citri reticulatae viride has the effects of relaxing gastrointestinal smooth muscle, benefiting gallbladder, relieving spasm, strengthening heart, boosting pressure, eliminating phlegm, relieving asthma and resisting shock.
Licorice root: sweet in flavor and neutral in nature. They enter heart, stomach, spleen and lung meridians. The functional indications are as follows: invigorating spleen and replenishing qi, clearing away heat and toxic material, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the drugs. Can be used for treating weakness of spleen and stomach, asthenia, palpitation, short breath, cough, excessive phlegm, abdominal and limb spasm, pain, carbuncle, swelling, sore, and drug toxicity and strong nature. Modern pharmacological research finds that the liquorice contains various chemical components, the main components comprise glycyrrhizic acid, liquiritin and the like, the liquorice has the functions of resisting inflammation and allergy, can prolong the service life of epithelial cells, and has good effect on chronic adrenocortical insufficiency.
The invention has the following advantages:
the traditional Chinese medicine composition for treating hepatitis B has the advantages that the seven pure natural Chinese herbal medicines of cimicifugae foetidae, bistort rhizome, sun euphorbia herb, sappan wood, hairyvein agrimony, green tangerine peel and liquorice are reasonably compatible, so that the drug effects of the components generate synergistic effect, the treatment of symptoms and root causes are performed simultaneously, the effects of clearing heat and promoting diuresis, killing viruses, expelling toxin, ascending the clear and descending the turbid are achieved, the liver function can be effectively improved, and the hepatitis B virus can be inhibited or killed, so that the effect of treating the hepatitis B is achieved.
In addition, the traditional Chinese medicine composition for treating hepatitis B disclosed by the invention combines the traditional pharmaceutical technology with the modern pharmaceutical technology, not only comprehensively utilizes the advancement of the modern pharmaceutical technology, but also keeps the drug effect of the traditional decoction, and the prepared traditional Chinese medicine composition for treating hepatitis B is mild in drug property and quick in effect, and can recover normal values of more than 75% of patients with HBV-DNA abnormality and liver dysfunction in six to eight months.
Detailed Description
The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.
Example 1
The preparation method of the traditional Chinese medicine composition for treating hepatitis B of the embodiment comprises the following steps:
firstly, taking 30 parts of rhizoma cimicifugae, 40 parts of bistort rhizome, 50 parts of sun euphorbia, 10 parts of sappan wood, 45 parts of hairyvein agrimony, 20 parts of green tangerine peel and 30 parts of liquorice, washing once with clear water, transferring to a decoction pot, adding clear water until the clear water submerges the surface of the medicine for 1.5cm, soaking for 1.5h, heating to boiling, decocting for 40min at 100 ℃, and filtering while hot to obtain medicine residues and a first decoction;
step two, adding clear water with the temperature of 100 ℃ into the medicine residues until the medicine residues are leveled, heating to boiling, continuously decocting for 30min at the temperature of 100 ℃, and filtering to obtain medicine residues and a secondary decoction;
and step three, squeezing out the liquid medicine in the medicine residues by using a squeezer, mixing the liquid medicine with the primary decoction liquid and the secondary decoction liquid, filtering the mixture by using a 200-mesh sieve, transferring the filtered mixture into a concentration tank, and concentrating the filtered mixture under reduced pressure until the filtered mixture is dried to obtain the traditional Chinese medicine composition for treating the hepatitis B, and adding different pharmaceutical formulations of auxiliary materials.
Example 2
The preparation method of the traditional Chinese medicine composition for treating hepatitis B of the embodiment comprises the following steps:
step one, taking 20 parts of rhizoma cimicifugae, 20 parts of bistort rhizome, 40 parts of sun euphorbia herb, 15 parts of sappan wood, 60 parts of hairyvein agrimony, 18 parts of green tangerine peel and 13 parts of liquorice, washing once with clear water, transferring to a decoction pot, adding clear water until the decoction surface is submerged for 2cm, soaking for 1.2h, heating to boiling, decocting for 50min at 90 ℃, and filtering while hot to obtain decoction dregs and a first decoction;
step two, adding clear water with the temperature of 100 ℃ into the medicine residues until the medicine residues are leveled, heating to boiling, continuing to decoct at the temperature of 110 ℃ for 20min, and filtering to obtain medicine residues and a secondary decoction;
and step three, squeezing out the liquid medicine in the medicine residues by using a squeezer, mixing the liquid medicine with the primary decoction liquid and the secondary decoction liquid, filtering the mixture by using a 200-mesh sieve, transferring the filtered mixture into a concentration tank, and concentrating the filtered mixture under reduced pressure until the filtered mixture is dried to obtain the traditional Chinese medicine composition for treating the hepatitis B, and adding different pharmaceutical formulations of auxiliary materials.
Example 3
The preparation method of the traditional Chinese medicine composition for treating hepatitis B of the embodiment comprises the following steps:
firstly, taking 50 parts of rhizoma cimicifugae, 60 parts of bistort rhizome, 35 parts of sun euphorbia herb, 9 parts of sappan wood, 38 parts of hairyvein agrimony, 30 parts of green tangerine peel and 16 parts of liquorice, washing once with clear water, transferring to a decoction pot, adding clear water until the decoction surface is submerged by 1.6cm, soaking for 1h, heating to boiling, decocting for 35min at 120 ℃, and filtering while hot to obtain decoction dregs and a first decoction;
step two, adding clear water with the temperature of 100 ℃ into the dregs of a decoction until the dregs of a decoction are leveled, heating to boiling, decocting for 25min at the temperature of 80 ℃, and filtering to obtain medicine residues and a secondary decoction;
and step three, squeezing out the liquid medicine in the medicine residues by using a squeezer, mixing the liquid medicine with the primary decoction liquid and the secondary decoction liquid, filtering the mixture by using a 200-mesh sieve, transferring the filtered mixture into a concentration tank, and concentrating the filtered mixture under reduced pressure until the filtered mixture is dried to obtain the traditional Chinese medicine composition for treating the hepatitis B, and adding different pharmaceutical formulations of auxiliary materials.
Example 4
The preparation method of the traditional Chinese medicine composition for treating hepatitis B of the embodiment comprises the following steps:
step one, taking 60 parts of rhizoma cimicifugae, 50 parts of bistort rhizome, 30 parts of sun euphorbia herb, 2 parts of sappan wood, 15 parts of hairyvein agrimony, 16 parts of green tangerine peel and 20 parts of liquorice, washing once with clear water, transferring to a decoction pot, adding clear water until the decoction surface is submerged for 1cm, soaking for 1.4h, heating to boiling, decocting for 48min at 80 ℃, and filtering while the decoction is hot to obtain decoction dregs and a first decoction;
step two, adding clear water with the temperature of 100 ℃ into the medicine residues until the medicine residues are leveled, heating to boiling, decocting at the temperature of 115 ℃ for 28min, and filtering to obtain medicine residues and a secondary decoction;
and step three, squeezing out the liquid medicine in the medicine residues by using a squeezer, mixing the liquid medicine with the primary decoction liquid and the secondary decoction liquid, filtering the mixture by using a 200-mesh sieve, transferring the filtered mixture into a concentration tank, and concentrating the filtered mixture under reduced pressure until the filtered mixture is dried to obtain the traditional Chinese medicine composition for treating the hepatitis B, and adding different pharmaceutical formulations of auxiliary materials.
Example 5
The preparation method of the traditional Chinese medicine composition for treating hepatitis B of the embodiment comprises the following steps:
firstly, taking 40 parts of rhizoma cimicifugae, 30 parts of bistort rhizome, 15 parts of sun euphorbia, 7 parts of sappan wood, 30 parts of hairyvein agrimony, 6 parts of green tangerine peel and 3 parts of liquorice, washing once with clear water, transferring to a decoction pot, adding clear water until the clear water submerges the surface of the medicine for 1.1cm, soaking for 2 hours, heating to boiling, decocting for 30min at 105 ℃, and filtering while the medicine is hot to obtain medicine residues and a first decoction;
step two, adding clear water with the temperature of 100 ℃ into the medicine residues until the medicine residues are leveled, heating to boiling, continuously decocting at the temperature of 120 ℃ for 40min, and filtering to obtain medicine residues and a secondary decoction;
and step three, squeezing out the liquid medicine in the medicine residues by using a squeezer, mixing the liquid medicine with the primary decoction liquid and the secondary decoction liquid, filtering the mixture by using a 200-mesh sieve, transferring the filtered mixture into a concentration tank, and concentrating the filtered mixture under reduced pressure until the filtered mixture is dried to obtain the traditional Chinese medicine composition for treating the hepatitis B, and adding different pharmaceutical formulations of auxiliary materials.
When the traditional Chinese medicine composition for treating hepatitis B is prepared into a pharmaceutical preparation, a pharmaceutically acceptable carrier can be added, and the traditional Chinese medicine composition is prepared according to the conventional technology of pharmaceutics. For example: diluents, excipients, and water, and the like, fillers such as starch, sucrose, lactose, microcrystalline cellulose, and the like; binders such as cellulose derivatives, alginates, gelatin, and polyvinylpyrrolidone; humectants such as glycerol; disintegrating agents such as sodium carboxymethyl starch, hydroxypropyl cellulose, crosslinked carboxymethyl cellulose, agar, calcium carbonate and sodium bicarbonate; absorption enhancers such as quaternary ammonium compounds; surfactants such as cetyl alcohol, sodium lauryl sulfate; adsorption carriers such as kaolin and bentonite; lubricants such as talc, calcium and magnesium stearate, micronized silica gel, polyethylene glycol, and the like. Other adjuvants such as flavoring agent, sweetener, etc. can also be added into the composition.
Commonly used adjuvant ingredients include: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin C, EDTA disodium, calcium sodium EDTA, monovalent alkali metal carbonates, acetates, phosphates or aqueous solutions thereof, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and derivatives thereof, alginates, gelatin, polyvinylpyrrolidone, glycerol, Tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, beta-cyclodextrin, phospholipid-based materials, kaolin, talc, calcium stearate, magnesium stearate, and the like.
The food and medicine dual-purpose traditional Chinese medicine composition for resisting fatigue and balancing yin and yang can be any medicinal dosage form, and the dosage forms comprise: tablet, capsule, granule, pill, powder, unguent, pellet, powder, solution, injection, suppository, spray, drop, patch, and oral liquid.
The efficacy of the traditional Chinese medicine composition for treating hepatitis B is proved in clinical application, and the treatment effect is as follows:
and (3) healing: the detection value of five major three positive of hepatitis B, namely three positive of hepatitis B to three positive of hepatitis B, HBV-DNA and main items of liver function is normal, and the main clinical symptoms disappear.
The effect is shown: the main items of liver function and HBV-DNA are normal, and the main clinical symptoms are obviously relieved.
The method has the following advantages: the main items of liver function and HBV-DNA are improved, and the main clinical symptoms are relieved.
And (4) invalidation: the five items of hepatitis B and HBV-DNA are not improved, and somatization symptoms are not reduced.
150 hepatitis B patients of 15-50 years old, half-year old or older are selected and randomly divided into five groups, and the traditional Chinese medicine composition (decoction) for treating the hepatitis B, which is prepared by the method of the embodiment 1-5, is taken one dose every day and is taken twice at nine am and three pm.
TABLE 1 treatment of 150 patients with the decoction of the Chinese medicinal composition for treating hepatitis B prepared in examples 1 to 5
Figure BDA0001357549820000091
As can be seen from Table 1, 150 patients with hepatitis B take the Chinese medicinal composition (decoction) for treating hepatitis B prepared in examples 1 to 5 for 180 days continuously, the effect is obvious, the proportion of the patients with hepatitis B is 60 to 80 percent, the proportion of the patients with hepatitis B is continuously increased along with the continuous taking of the Chinese medicinal composition (decoction) for treating hepatitis B, and the proportion of the patients with hepatitis B after the continuous taking of the Chinese medicinal composition (decoction) for treating hepatitis B is over 75 percent, so that the clinical cure standards at home and abroad are achieved, and the treatment effect is far superior to that of the existing products. In addition, in follow-up visits for three years after the medicine is stopped on the treatment object, only 6 percent of detection values are repeated, evidence related to the medicine stopping cannot be determined, and clinical cure is still achieved by adopting the treatment method again. Withdrawal symptoms of the existing western anti-hepatitis B virus medicines during withdrawal are not seen during withdrawal, corresponding western clinical biochemical and imaging tests are respectively carried out on the treatment objects before and after treatment, and front and back comparison is carried out, so that no obvious adverse effect is seen on main organs such as heart, liver, spleen, lung, kidney and the like.
Thereby providing strong evidence for the safety of the traditional Chinese medicine composition for treating hepatitis B.
Although the invention has been described in detail above with reference to a general description and specific examples, it will be apparent to one skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims (7)

1. A traditional Chinese medicine composition for treating hepatitis B is characterized in that: the traditional Chinese medicine composition for treating hepatitis B is prepared from the following raw materials in parts by mass: 20-60 parts of cimicifugae foetidae, 20-60 parts of bistort rhizome, 15-50 parts of euphorbia helioscopia, 2-15 parts of sappan wood, 15-60 parts of hairyvein agrimony, 6-30 parts of green tangerine peel and 3-30 parts of liquorice; the preparation method of the traditional Chinese medicine composition comprises the following steps:
firstly, taking cimicifugae foetidae, bistort rhizome, sun euphorbia herb, sappan wood, hairyvein agrimony, green tangerine peel and liquorice, washing with clear water once, transferring to a decoction pot, adding clear water until the decoction surface is 1-2 cm higher than the medicinal surface, soaking for 1-2 h, heating to boil, decocting for 30-50 min at 80-120 ℃, and filtering while the decoction is hot to obtain dregs and a first decoction;
step two, adding clear water at 100 ℃ into the medicine residues until the medicine residues are flush, heating to boiling, continuing to decoct at 80-120 ℃ for 20-40 min, and filtering to obtain medicine residues and a secondary decoction;
and step three, squeezing out the liquid medicine in the medicine residues by using a squeezer, mixing the liquid medicine with the primary decoction liquid and the secondary decoction liquid, filtering by using a 200-mesh sieve, transferring the mixture into a concentration tank, and concentrating the mixture under reduced pressure until the mixture is dried to obtain the traditional Chinese medicine composition for treating hepatitis B.
2. The traditional Chinese medicine composition for treating hepatitis B according to claim 1, which is characterized in that: the traditional Chinese medicine composition for treating hepatitis B is prepared from the following raw materials in parts by mass: 30-50 parts of cimicifuga foetida, 30-50 parts of bistort rhizome, 30-40 parts of sun euphorbia herb, 7-10 parts of sappan wood, 30-45 parts of hairyvein agrimony, 16-20 parts of green tangerine peel and 13-20 parts of liquorice.
3. The traditional Chinese medicine composition for treating hepatitis B according to claim 1, which is characterized in that: the traditional Chinese medicine composition for treating hepatitis B is prepared from the following raw materials in parts by mass: 40 parts of cimicifuga foetida, 40 parts of bistort rhizome, 35 parts of sun euphorbia herb, 9 parts of sappan wood, 38 parts of hairyvein agrimony, 18 parts of green tangerine peel and 16 parts of liquorice.
4. A formulation consisting of the Chinese medicinal composition for treating hepatitis b according to any one of claims 1 to 3 and an acceptable carrier, characterized in that: the preparation is a solid or liquid preparation, the solid preparation is tablets, paste, powder, pills, capsules and granules, and the liquid preparation is oral liquid.
5. The preparation of the traditional Chinese medicine composition for treating hepatitis B according to claim 4 and an acceptable carrier, wherein the preparation comprises: the acceptable carrier is a binder, filler, lubricant, disintegrant, surfactant, flavoring agent, or humectant.
6. The preparation of claim 5, which consists of the traditional Chinese medicine composition for treating hepatitis B and an acceptable carrier, and is characterized in that: the adhesive is one of cellulose derivative, alginate, gelatin or polyvinylpyrrolidone.
7. The preparation of claim 5, which consists of the traditional Chinese medicine composition for treating hepatitis B and an acceptable carrier, and is characterized in that: the filler is one of starch, sucrose, lactose, mannitol, sorbitol, xylitol, microcrystalline cellulose or glucose.
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