CN107050281A - It is a kind of to treat Chinese medicine composition of arrhythmia cordis and preparation method thereof - Google Patents

It is a kind of to treat Chinese medicine composition of arrhythmia cordis and preparation method thereof Download PDF

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CN107050281A
CN107050281A CN201710094847.4A CN201710094847A CN107050281A CN 107050281 A CN107050281 A CN 107050281A CN 201710094847 A CN201710094847 A CN 201710094847A CN 107050281 A CN107050281 A CN 107050281A
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parts
powder
chinese medicine
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范茜
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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
    • A61K36/10Bryophyta
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/60Fish, e.g. seahorses; Fish eggs
    • 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
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/07Basidiomycota, e.g. Cryptococcus
    • A61K36/076Poria
    • AHUMAN NECESSITIES
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    • 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
    • A61K36/11Pteridophyta or Filicophyta (ferns)
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/16Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
    • 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)
    • A61K36/27Asclepiadaceae (Milkweed family), e.g. hoya
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/72Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A61K36/725Ziziphus, e.g. jujube
    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8967Lilium, e.g. tiger lily or Easter lily
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    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A61K9/08Solutions
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    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
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    • 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
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    • 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
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • 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
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    • 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
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Abstract

The invention discloses a kind of Chinese medicine composition for treating arrhythmia cordis, it includes:Small pigeon-wheat, ginseng rhizome, rose rhodobryum herb, spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, Le fish, drymoglossum subcordatum Fee, Poria cocos, radix cynanchi bungei, lily, the invention also discloses the preparation method of above-mentioned Chinese medicine composition.Such a Chinese medicine composition is prepared with pure Chinese medicine, with natural drug small toxicity, eutherapeutic characteristic, for arrhythmia cordis curative effect clearly, treat both principal and secondary aspect of disease, it is cheap, simple for production, have a good application prospect.

Description

It is a kind of to treat Chinese medicine composition of arrhythmia cordis and preparation method thereof
Technical field
The present invention relates to a kind of medicinal preparation, more particularly to a kind of Chinese medicine composition for being used to treat arrhythmia cordis and its Preparation method.
Background technology
Clinically it is divided into rapidity and the major class of slow arrhythmia two by the speed of rhythm of the heart during arrhythmia episode, the former See Premature contracfion, tachycardia, auricular fibrillation and ventricular fibrillation etc.;The latter is with sinus bradycardia and various conduction Block to be common.Arrhythmia cordis refers to any different of origin position, cardiac frequency and the rhythm and pace of moving things and the impulse conduction of cardiac impulse Chang Eryan.It can be caused by factors such as various organic cardiovascular diseases, drug poisoning, electrolyte and acid-base imbalances, the part heart Rule is not normal also can be because caused by vegetative nerve functional disturbance.
Chinese medicine be used for treat arrhythmia cordis i.e. will not habituation, will not also produce dependence.There are large quantities of high-tech traditional Chinese medicines Achievement is played an important role in arrhythmia cordis field, such as wild jujube cannabis capsule, pseudo-ginseng ginseng tea, lily wild jujube cannabis capsule, These medicines have certain curative effect to arrhythmia cordis, but there is also some problems, such as some drug effects are slow, and flavour of a drug are more, It is not easy to preparation to use, effect is not fairly obvious, Time of Administration is long.
The content of the invention
In order to solve the above problems, the present invention provide one kind prepared with pure Chinese medicine, small toxicity, good effect, for the rhythm of the heart lose Normal curative effect clearly, treat both principal and secondary aspect of disease, cheap, the simple for production, Chinese medicine composition that has a good application prospect.
The technical solution adopted by the present invention is:A kind of Chinese medicine composition for treating arrhythmia cordis, the Chinese medicine composition Each component be small pigeon-wheat, ginseng rhizome, rose rhodobryum herb, spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, strangle fish, drymoglossum subcordatum Fee, Poria cocos, radix cynanchi bungei, Lily.
It is preferred that, the ratio of weight and number of various components is small pigeon-wheat 25-35 parts, 15-25 parts of ginseng rhizome, rose rhodobryum herb 15- 25 parts, 10-20 parts of spina date seed, 10-20 parts of Rhizoma soulieae vaginatae, 5-15 parts of folium ginkgo bilobae, strangle 5-15 parts of fish, 5-15 parts of drymoglossum subcordatum Fee, Poria cocos 5- 15 parts, 5-15 parts of radix cynanchi bungei, 5-15 parts of lily.
It is furthermore preferred that the ratio of weight and number of various components is small pigeon-wheat 30-35 parts, 20-25 parts of ginseng rhizome, rose rhodobryum herb 20-25 parts, 10-15 parts of spina date seed, 10-15 parts of Rhizoma soulieae vaginatae, 5-10 parts of folium ginkgo bilobae, strangle 5-10 parts of fish, 5-10 parts of drymoglossum subcordatum Fee, Poria cocos 5-10 parts, 5-10 parts of radix cynanchi bungei, 5-10 parts of lily.
Wherein, the formulation of the Chinese medicine composition is:Film coated tablet, sublimed preparation, emplastrum, syrup, oral liquid, mouth containing Agent, granule, powder, injection, sugar coated tablet, capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, when the formulation of the Chinese medicine is capsule, bag Include:
The first step, ginseng rhizome, rose rhodobryum herb are mixed in proportion, are 70- with determining alcohol of 2-3 times equivalent to mixture quality 80% normal propyl alcohol refluxing extraction 2-4 times, merging filtrate is concentrated under reduced pressure, dries and be ground into powder, then uses ethyl alcohol purification 1- 2 times, merge extract solution, ethanol is recovered under reduced pressure and the lotion that relative density at 60 DEG C is 1.21-1.24 is concentrated into, dries and crushes Into powder;
Second step, the normal propyl alcohol for being 80-90% with determining alcohol by spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, Le fish is extracted 2-3 times, Merge extract solution, be concentrated under reduced pressure and be dried, be ground into powder, it is 2-4 that the powder after crushing, which is added relative to its quality, The water dissolving of times amount, static 1-3 hour, filtering, filtrate decompression concentrate be relative density is 1.21-1.24 at 60 DEG C lotion simultaneously It dry, pulverize into powder;
3rd step, remaining component is smashed and mixed in proportion, is added water to cook 2 times, each 2-3 hours, is filtered respectively, Merging filtrate, filtrate is condensed into lotion and dry, pulverize into powder, and the quality of the water added is the mixture quality of the 3rd step 2-4 times;
4th step, above-mentioned powder and starch are mixed, pelletization treatment and drying is then carried out, obtains compound particles, then Magnesium stearate is added into compound particles, the magnesium stearate and the compound particles mass ratio are 0.25-100: 0.5-100, obtains capsule 's content, described capsule 's content is fitted into capsule housing and produces capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, when the formulation of the Chinese medicine is injection, bag Include:
The first step, ginseng rhizome, rose rhodobryum herb are mixed in proportion, are 70- with determining alcohol of 2-3 times equivalent to mixture quality 80% normal propyl alcohol refluxing extraction 2-4 times, merging filtrate is concentrated under reduced pressure, dries and be ground into powder, then uses ethyl alcohol purification 1- 2 times, merge extract solution, ethanol is recovered under reduced pressure and the lotion that relative density at 60 DEG C is 1.21-1.24 is concentrated into, dries and crushes Into powder;
Second step, the normal propyl alcohol for being 80-90% with determining alcohol by spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, Le fish is extracted 2-3 times, Merge extract solution, be concentrated under reduced pressure and be dried, be ground into powder, it is 2-4 that the powder after crushing, which is added relative to its quality, The water dissolving of times amount, static 1-3 hour, filtering, filtrate decompression concentrate be relative density is 1.21-1.24 at 60 DEG C lotion simultaneously It dry, pulverize into powder;
3rd step, remaining component is smashed and mixed in proportion, is added water to cook 2 times, each 2-3 hours, is filtered respectively, Merging filtrate, filtrate is condensed into lotion and dry, pulverize into powder, and the quality of the water added is the mixture quality of the 3rd step 2-4 times;
4th step, above-mentioned powder is mixed, and is then dissolved in the water that quality is 2-4 times of mixture, and stirring is lower to add phase For powder quality 5%-15% sodium hydroxide hydrotropy, filtering, plus the salt acid for adjusting pH value that concentration is 1mol/L is 5-6, mistake Filter, precipitates standby, decontamination is first washed with water by polyamide column in filtrate, and the normal propyl alcohol for being then 80-90% with determining alcohol is washed It is de-, normal propyl alcohol eluent is collected, the normal propyl alcohol that precipitation is 80-90% with determining alcohol is extracted 2 times, filtered, filtrate and above-mentioned elution Liquid merges, and reclaims normal propyl alcohol, is concentrated under reduced pressure into lotion and is spray dried to powder, the powder of acquisition is added relative to its quality 1- 2 times of sodium chloride and appropriate water for injection, further injects water to the volume of needs after dissolving, filtering, embedding is gone out Bacterium, obtains the parenteral solution needed.
Small pigeon-wheat, pungent, warm-natured, tranquilizing and allaying excitement;Dissipate the stasis of blood;Hemostasis.Main palpitation and severe palpitation;Insomnia and dreamful sleep;Traumatic injury;Tell Blood.
Ginseng rhizome, sweet, slight bitter is warm-natured, return lung, stomach, the spleen channel, can yang invigorating.
Rose rhodobryum herb, pungent, hardship, mild-natured, mental-tranquilization is clear liver and improved vision.For palpitation and severe palpitation, neurasthenia;Mesh is controlled in external application It is red to swell and ache.
Spina date seed, sour, mild-natured, nontoxic, main trusted subordinate's fever and chills, heresy knot gas gathers, and has aches in the limbs, arthritis with fixed pain caused by dampness.Long term usage five viscera settling, gently Body, macrobiosis.
Folium ginkgo bilobae, sweet, bitter, puckery, mild-natured, invigorating heart is astringed the lung, dampness elimination antidiarrheal.Control uncomfortable in chest pained, palpitation and severe palpitation, asthma due to excessive phlegm is coughed Cough, rush down dysentery, leukorrhea.
Rhizoma soulieae vaginatae, bitter, cool in nature, purging intense heat and detonicating, relieving restlessness that clears away heart-fire.For eye conjunctivitis, stomatitis, pharyngitis, Vexed, Enteritis, dysentery, ulcerative carbuncle pyogenic infections.
Strangle fish, it is sweet, mild-natured, it is nontoxic, appetizing, it is warm in, qi-restoratives.
Drymoglossum subcordatum Fee, sweet, slight bitter is cold in nature, and clearing heat and detoxicating, cooling blood and hemostasis moistens the lung and relieve the cough.For cough with lung heat, pulmonary abscess, Hemoptysis of pulmonary tuberculosis, abscess of throat, parotitis, dysentery, scrofula, bleeding from five sense organs or subcutaneous tissue, hematuria is had blood in stool, uterine bleeding;External application is controlled furunculosis and swollen Poison, skin pruritus, tympanitis.
Poria cocos, sweet, light, mild-natured, the thoughts of returning home, lung, spleen, kidney channel, clearing damp and promoting diuresis, invigorating the spleen, calming heart;For oedema oliguria, phlegm Drink feel dizzy and heart palpitations, spleen eating less, loose stool diarrhea, confused and worried, insomnia of palpitating with fear.
Radix cynanchi bungei, bitter, sweet, puckery, slightly warm in nature, calms the nerves, enriches blood.For physically weak insomnia, forgetful dreaminess, skin itching.
Lily, sweet, mild-natured, nontoxic, main perverse trend, abdominal distension is pained, sharp stool and urine, bowl spares, QI invigorating.
Beneficial effects of the present invention:
Relative to the medicine of the prior art for having and treating arrhythmia cordis effect, such a Chinese medicine composition is with pure Chinese medicine Prepare, with natural drug small toxicity, eutherapeutic characteristic, for arrhythmia cordis curative effect clearly, treat both principal and secondary aspect of disease, it is cheap, It is simple for production, have a good application prospect.
Embodiment
Embodiment 1:
(1) a kind of Chinese medicine for treating arrhythmia cordis, is formed by following raw material medicaments in part by weight proportioning:
Small 30 parts of pigeon-wheat, 25 parts of ginseng rhizome, 20 parts of rose rhodobryum herb, 15 parts of spina date seed, 15 parts of Rhizoma soulieae vaginatae, 10 parts of folium ginkgo bilobae, Strangle 10 parts of fish, 10 parts of drymoglossum subcordatum Fee, 10 parts of Poria cocos, 5 parts of radix cynanchi bungei, 5 parts of lily.
(2) preparation method:
The first step, ginseng rhizome, rose rhodobryum herb are mixed in proportion, are 70% with determining alcohols of 2 times equivalent to mixture quality Normal propyl alcohol refluxing extraction 2 times, merging filtrate is concentrated under reduced pressure, dried and is ground into powder, then uses ethyl alcohol purification 1-2 times, merges Extract solution, is recovered under reduced pressure ethanol and is concentrated into the lotion that relative density at 60 DEG C is 1.21-1.24, dry and be ground into powder;
Second step, the normal propyl alcohol for being 80-90% with determining alcohol by spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, Le fish is extracted 2-3 times, Merge extract solution, be concentrated under reduced pressure and be dried, be ground into powder, it is 2 times that the powder after crushing, which is added relative to its quality, The water dissolving of amount, static 1 hour, filtering, filtrate decompression concentration was the lotion that relative density is 1.21-1.24 at 60 DEG C and done It is dry, it is ground into powder;
3rd step, remaining component is smashed and mixed in proportion, is added water to cook 2 times, 2 hours every time, is filtered respectively, is closed And filtrate, filtrate is condensed into lotion and dry, pulverize into powder, and the quality of the water added is the mixture quality of the 3rd step 2 times;
4th step, above-mentioned powder and starch are mixed, pelletization treatment and drying is then carried out, obtains compound particles, then Magnesium stearate is added into compound particles, the magnesium stearate and the compound particles mass ratio are 0.25: 0.5, are obtained Capsule 's content is obtained, described capsule 's content is fitted into capsule housing and produces capsule.
Embodiment 2:
(1) a kind of Chinese medicine for treating arrhythmia cordis, is formed by following raw material medicaments in part by weight proportioning:Be the same as Example 1.
(2) preparation method:
The first step, ginseng rhizome, rose rhodobryum herb are mixed in proportion, are 70% with determining alcohols of 2 times equivalent to mixture quality Normal propyl alcohol refluxing extraction 2 times, merging filtrate is concentrated under reduced pressure, dried and is ground into powder, then uses ethyl alcohol purification 1 time, and merging is carried Liquid is taken, ethanol is recovered under reduced pressure and the lotion that relative density at 60 DEG C is 1.21-1.24 is concentrated into, dries and is ground into powder;
Second step, spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, Le fish determining alcohol are extracted 2 times for 80% normal propyl alcohol, merged Extract solution, is concentrated under reduced pressure and is dried, is ground into powder, and it is 2 times of amounts that the powder after crushing, which is added relative to its quality, Water dissolves, static 1 hour, filtering, and filtrate decompression concentration is the lotion and drying, powder that relative density is 1.21-1.24 at 60 DEG C It is broken into powder;
3rd step, remaining component is smashed and mixed in proportion, is added water to cook 2 times, 2 hours every time, is filtered respectively, is closed And filtrate, filtrate is condensed into lotion and dry, pulverize into powder, and the quality of the water added is the mixture quality of the 3rd step 2 times;
4th step, above-mentioned powder is mixed, and is then dissolved in the water that quality is 2 times of mixture, and stirring is lower to be added relatively In the sodium hydroxide hydrotropy of powder quality 5%, filtering, plus the salt acid for adjusting pH value that concentration is 1mol/L is 5-6, is filtered, precipitation Standby, decontamination is first washed with water by polyamide column in filtrate, is then eluted with determining alcohol for 80 normal propyl alcohol, collects normal propyl alcohol Eluent, precipitation determining alcohol is extracted 2 times for 80 normal propyl alcohol, and filtering, filtrate merges with above-mentioned eluent, reclaims normal propyl alcohol, It is concentrated under reduced pressure into lotion and is spray dried to powder, the powder of acquisition is added to sodium chloride and injection of 2 times relative to its quality Appropriate amount of water, further injects water to the volume of needs after dissolving, filtering, embedding, and sterilizing obtains the parenteral solution needed.
Embodiment 3:
1st, long term toxicity test process:
Experimental agents are set as using Wistar rats (Beijing Vital River Experimental Animals Technology Co., Ltd.'s offer) Capsule 8g/kg, 4g/kg, 2g/kg of high, medium and low three dosage, respectively embodiment 1 formula.Dosage 0.1g/ is used by people Kg/ sky-backings are calculated, and are 80 times, 40 times and 20 times of people's effective dose respectively;It is another to set a control group, continuous gavage administration 90 My god, after 180 days and Some Animals are discontinued 10 days, observe the influence to the every physiology of rat, biochemical indicator.Test result indicates that: With various dose to rat continuous oral 180 days, on the food-intake and body weight increase of rat without influence.To hepatic and renal function not It was found that overt toxicity is acted on.Blood routine, blood biochemistry, urine biochemistry and marrow piece etc. are showed no and significantly affected, between each group with it is right Compare no significant difference according to group.
2nd, acute toxicity test process:
Using ICR mouse (Beijing Vital River Experimental Animals Technology Co., Ltd.'s offer) 40, body weight at 25-30 grams, Carry out acute toxicity testing.Mouse is randomly divided into two groups, i.e. control group, administration group, fasting 12 hours before experiment, then give as Chinese medicine capsules suspension (capsule is dissolved in water acquisition suspension) gavage of the invention that embodiment 1 is prepared, To the median lethal dose (LD of administration50) experiment measure has been carried out, but LD is not measured50, therefore carried out mtd test. As a result:With Cmax (60%), maximum dosage-feeding (120ml/kg, part gives for four times in one day) 100g/kg gavages, equivalent to Crude drug amount 60g/kg, 300 times (pressing 75kg) for intending daily dosage clinical equivalent to adult, none death of mouse, puts to death in seven days Each internal organs of mouse anatomic observation do not find toxic reaction, and administration group is with control group mice without any difference.
Embodiment 4:
The clinical treatment observation of the present invention is as follows:
(1) Patients with 300 Cases, 150 are male, and 150 are women, the range of age 45-85 Sui.
(2) diagnostic criteria:
Diagnostic criteria:
Diagnostic criteria according to national arrhythmia cordis clinical speciality meeting:(1) angina pectoris, shortness of breath, peripheral vessels exhaustion, urgency DHF, acute myocardial infarction AMI;(2) dizzy, weak, blurred vision, temporary total blindness, even aphasia, paralyse, take out The transient or permanent cerebral lesion such as jerk, go into a coma.(3) the performance oliguresis of arteria renalis blood supply insufficiency, albuminuria, azotemia. (4) the performance abdominal distension of mesenteric artery blood supply insufficiency, stomachache, diarrhoea, or even occur bleeding, ulcer or paralysis.(5) heart function is not Full performance is mainly cough, expiratory dyspnea, burnout, weak etc..
(3) treatment method:1 group:Using the capsule 100g as made from the preparation method of embodiment 1, it is divided into 10 parts, daily Be administered at empty stomach portion in the morning, and 30 days are a course for the treatment of, continuously take two courses for the treatment of;2 groups:Using such as preparation method system of embodiment 2 The injection 100g obtained, is divided into 10 parts, injects a every morning on an empty stomach, is within 30 days a course for the treatment of, two courses for the treatment of of continuous injection; Separately set a control group.
(4) efficacy assessment standard:
Criterion of therapeutical effect:
Overall efficacy evaluation reference《New Chinese medicine guideline of clinical investigations》Relevant criterion:
Cure:Symptom and sign are obviously improved, >=10 beats/min of increase before 24h mean heart rates are relatively treated;
Effectively:Symptom and sign have been alleviated, >=5 beats/min of increase before 24h mean heart rates are relatively treated;
It is invalid:Symptom and sign are without improvement, 5 beats/min of < of increase before 24h mean heart rates are relatively treated.
(5) treatment results are shown in Table 1:
The treatment results of table 1
Group Recovery from illness Effectively It is invalid
Control group 0 0 100
1 group 98 1 1
2 groups 99 1 0
Above-described embodiment is simply to illustrate that the technical concepts and features of the present invention, the purpose is to be to allow in the art Those of ordinary skill can understand present disclosure and implement according to this, and it is not intended to limit the scope of the present invention.It is all It is the equivalent change or modification according to made by the essence of present invention, should all covers in protection scope of the present invention.

Claims (6)

1. a kind of Chinese medicine composition for treating arrhythmia cordis, it is characterised in that:The each component of the Chinese medicine composition is small golden hair Moss, ginseng rhizome, rose rhodobryum herb, spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, Le fish, drymoglossum subcordatum Fee, Poria cocos, radix cynanchi bungei, lily..
2. Chinese medicine composition as claimed in claim 1, it is characterised in that:The ratio of weight and number of various components is small pigeon-wheat 25-35 parts, 15-25 parts of ginseng rhizome, 15-25 parts of rose rhodobryum herb, 10-20 parts of spina date seed, 10-20 parts of Rhizoma soulieae vaginatae, 5-15 parts of folium ginkgo bilobae, Strangle 5-15 parts of fish, 5-15 parts of drymoglossum subcordatum Fee, 5-15 parts of Poria cocos, 5-15 parts of radix cynanchi bungei, 5-15 parts of lily.
3. Chinese medicine composition as claimed in claim 1, it is characterised in that:The ratio of weight and number of various components is small pigeon-wheat 30-35 parts, 20-25 parts of ginseng rhizome, 20-25 parts of rose rhodobryum herb, 10-15 parts of spina date seed, 10-15 parts of Rhizoma soulieae vaginatae, 5-10 parts of folium ginkgo bilobae, Strangle 5-10 parts of fish, 5-10 parts of drymoglossum subcordatum Fee, 5-10 parts of Poria cocos, 5-10 parts of radix cynanchi bungei, 5-10 parts of lily.
4. the Chinese medicine composition of arrhythmia cordis is treated as any one of claim 1-3, it is characterised in that the Chinese medicine group The formulation of compound is:Film coated tablet, sublimed preparation, emplastrum, syrup, oral liquid, mouth containing agent, granule, powder, injection, Sugar coated tablet, capsule.
5. a kind of preparation method for the Chinese medicine composition that arrhythmia cordis is treated as any one of claim 1-3, its feature It is:When the formulation of the Chinese medicine is capsule, including:
The first step, ginseng rhizome, rose rhodobryum herb are mixed in proportion, are 70-80%'s with determining alcohol of 2-3 times equivalent to mixture quality Normal propyl alcohol refluxing extraction 2-4 times, merging filtrate is concentrated under reduced pressure, dried and is ground into powder, then uses ethyl alcohol purification 1-2 times, closes And extract solution, ethanol is recovered under reduced pressure and the lotion that relative density at 60 DEG C is 1.21-1.24 is concentrated into, dries and is ground into powder End;
Second step, the normal propyl alcohol for being 80-90% with determining alcohol by spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, Le fish is extracted 2-3 times, is merged Extract solution, is concentrated under reduced pressure and is dried, is ground into powder, and the powder after crushing is added and measured relative to its quality for 2-4 times Water dissolving, static 1-3 hour, filtering, filtrate decompression, which is concentrated, to be relative density is 1.21-1.24 at 60 DEG C lotion and does It is dry, it is ground into powder;
3rd step, remaining component is smashed and mixed in proportion, is added water to cook 2 times, each 2-3 hours, is filtered respectively, is merged Filtrate, filtrate is condensed into lotion and dry, pulverize into powder, and the quality of the water added is the 2- of the mixture quality of the 3rd step 4 times;
4th step, above-mentioned powder and starch are mixed, and then carry out pelletization treatment and drying, obtain compound particles, then to mixed Magnesium stearate is added in polymer beads, the magnesium stearate and the compound particles mass ratio are 0.25-100: 0.5- 100, capsule 's content is obtained, described capsule 's content is fitted into capsule housing and produces capsule.
6. a kind of preparation method for the Chinese medicine composition that arrhythmia cordis is treated as any one of claim 1-3, its feature It is:When the formulation of the Chinese medicine is injection, including:
The first step, ginseng rhizome, rose rhodobryum herb are mixed in proportion, are 70-80%'s with determining alcohol of 2-3 times equivalent to mixture quality Normal propyl alcohol refluxing extraction 2-4 times, merging filtrate is concentrated under reduced pressure, dried and is ground into powder, then uses ethyl alcohol purification 1-2 times, closes And extract solution, ethanol is recovered under reduced pressure and the lotion that relative density at 60 DEG C is 1.21-1.24 is concentrated into, dries and is ground into powder End;
Second step, the normal propyl alcohol for being 80-90% with determining alcohol by spina date seed, Rhizoma soulieae vaginatae, folium ginkgo bilobae, Le fish is extracted 2-3 times, is merged Extract solution, is concentrated under reduced pressure and is dried, is ground into powder, and the powder after crushing is added and measured relative to its quality for 2-4 times Water dissolving, static 1-3 hour, filtering, filtrate decompression, which is concentrated, to be relative density is 1.21-1.24 at 60 DEG C lotion and does It is dry, it is ground into powder;
3rd step, remaining component is smashed and mixed in proportion, is added water to cook 2 times, each 2-3 hours, is filtered respectively, is merged Filtrate, filtrate is condensed into lotion and dry, pulverize into powder, and the quality of the water added is the 2- of the mixture quality of the 3rd step 4 times;
4th step, above-mentioned powder is mixed, and is then dissolved in the water that quality is 2-4 times of mixture, the lower addition of stirring relative to Powder quality 5%-15% sodium hydroxide hydrotropy, filtering, plus the salt acid for adjusting pH value that concentration is 1mol/L is 5-6, is filtered, and is sunk Form sediment standby, decontamination is first washed with water by polyamide column in filtrate, the normal propyl alcohol for being then 80-90% with determining alcohol elution is collected Normal propyl alcohol eluent, the normal propyl alcohol that precipitation is 80-90% with determining alcohol is extracted 2 times, and filtering, filtrate merges with above-mentioned eluent, Normal propyl alcohol is reclaimed, lotion is concentrated under reduced pressure into and is spray dried to powder, the powder of acquisition is added to chlorine of 1-2 times relative to its quality Change sodium and appropriate water for injection, the volume of needs is further injected water to after dissolving, filter, embedding, sterilizing is needed The parenteral solution wanted.
CN201710094847.4A 2017-02-15 2017-02-15 It is a kind of to treat Chinese medicine composition of arrhythmia cordis and preparation method thereof Pending CN107050281A (en)

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Application publication date: 20170818