CN100349597C - Chinese medicinal preparation for treating virus myocaraitis, its preparation method and quality control method - Google Patents
Chinese medicinal preparation for treating virus myocaraitis, its preparation method and quality control method Download PDFInfo
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Abstract
The present invention discloses a traditional Chinese medicine preparation for treating viral myocarditis, a preparation method thereof and a quality control method. The traditional Chinese medicine preparation is prepared from 10 flavors of Chinese medicinal plants of astragalus roots, ophiopogon roots, rehmannia roots, honeysuckle flowers, coptis, ledebouriella roots, schisandra fruits, red sage roots, spina date seeds and prepared liauorice roots. The quality control method is scientific and reasonable. Compared with the prior art, the present invention has the advantage of significant curative effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and method for making thereof and method of quality control, particularly a kind of Chinese medicine preparation and method for making and method of quality control for the treatment of viral myocarditis.
Background technology
Viral myocarditis sickness rate in recent years increases year by year, and the most common in teenager especially, most state of an illness are touching, the course of disease is long, easily repeatedly.Even the person of being in a bad way easily causes arrhythmia, cardiac dilatation, heart failure, cardiogenic shock sudden death, have a strong impact on people's study, work and healthy, threaten patient's life, it is one of important topic of present medical research, western medicine does not still have special effective Therapeutic Method, and it is also comparatively tired to treat this sick Chinese medicine.Chinese patent gazette disclosed name to be called " tablets against viral myocarditis ", publication number was 1406616 patent application on April 2nd, 2003, and the weight proportion of making each crude drug of the described Chinese medicinal tablet of invention is: Radix Salviae Miltiorrhizae 100g-120g, Radix Scutellariae 50g-70g, Radix Isatidis 30g-50g, Folium Isatidis 30g-40g, Radix Codonopsis 30g-50g, Poria 30g-50g, Rhizoma Atractylodis Macrocephalae 20-40g, river a kind of reed mentioned in ancient books 30g-50g, Radix Astragali 20g-40g, Semen Platycladi 20g-40g, Semen Ziziphi Spinosae 20g-40g, Flos Lonicerae 20g-40g, Radix Bupleuri 20g-40g, Radix Ophiopogonis 20g-40g, Fructus Schisandrae Chinensis 20g-40g.But its flavour of a drug are many, and curative effect and quality are all not ideal enough.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine preparation and method for making and method of quality control of treatment viral myocarditis evident in efficacy.
Technical solution of the present invention is achieved in that
According to the components by weight percent meter, Chinese medicine preparation of the present invention by following materials of weight proportions routinely prepared form, wherein: Radix Astragali 250-750 part, Radix Ophiopogonis 150-500 part, Radix Rehmanniae 120-370 part, Flos Lonicerae 120-370 part, Rhizoma Coptidis 100-300 part, Radix Saposhnikoviae 80-230 part, Fructus Schisandrae Chinensis 80-230 part, Radix Salviae Miltiorrhizae 120-370 part, Semen Ziziphi Spinosae (parched) 120-370 part, Radix Glycyrrhizae Preparata 80-230 part; Preferably: 500 parts of the Radixs Astragali, 333 parts of Radix Ophiopogonis, 250 parts of Radix Rehmanniae, 250 parts of Flos Loniceraes, 200 parts of Rhizoma Coptidis, 150 parts of Radix Saposhnikoviaes, 150 parts of Fructus Schisandrae Chinensis, 250 parts of Radix Salviae Miltiorrhizaes, 250 parts of Semen Ziziphi Spinosae (parched)s, 150 parts of Radix Glycyrrhizae Preparatas.
Chinese medicine preparation of the present invention has supplementing QI and nourishing YIN, the effect of heat-clearing and toxic substances removing.Cure mainly the viral myocarditis deficiency of both QI and YIN, pyretic toxicity is invaded heart card.Card is seen cardiopalmus, breathes hard, and discomfort uncomfortable in chest, weak, low grade fever, the dry pharynx pharyngalgia, dysphoria with feverish sensation in the chest palms and soles, vexed, hyperhidrosis, insomnia, light red tongue or red tongue, yellow and thin fur or thin white, deep-thready pulse or knot are for the person.
Chinese medicine preparation of the present invention can be an acceptable forms on the pharmaceutics, comprises granule, hard capsule, soft capsule, tablet, drop pill, oral liquid, injection etc., the preferred particulates agent.
After Radix Salviae Miltiorrhizae adopts alcohol extraction; Medicinal residues are again with the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata water extract-alcohol precipitation; Radix Rehmanniae, Flos Lonicerae and Semen Ziziphi Spinosae adopt water extract-alcohol precipitation; Rhizoma Coptidis, Fructus Schisandrae Chinensis are with alcohol extraction; Add suitable adjuvant at last, be prepared into different preparations respectively.
Adjuvant among the present invention can be acceptable any excipient or a carrier on the pharmaceutics.
The preparation method of granule of the present invention: with tanshinone liposoluble constituent, filtration in a kind of extraction Radix Salviae Miltiorrhizae in supercritical extraction, ethanol refluxing process or the alcohol percolation method, filtrate recycling ethanol and concentrating under reduced pressure become clear paste; The medicinal residues and the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata decoct with water, and filter, and filtrate decompression concentrates; Radix Rehmanniae, Flos Lonicerae, Semen Ziziphi Spinosae decoct with water, and filter, and filtrate decompression concentrates; Merge above-mentioned two kinds of concentrated solutions, add ethanol, filter, filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste; Rhizoma Coptidis, Fructus Schisandrae Chinensis, alcohol reflux filters, filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste; Merge above-mentioned three kinds of clear paste, press the medicament common process and add corresponding auxiliary material, make the granule agent.Preferably: get Radix Salviae Miltiorrhizae, add 70% alcohol reflux secondary, each 1h, merge extractive liquid, filters, and filtrate recycling ethanol also is evaporated to the clear paste that relative density is 1.28～1.30 (60 ℃); The medicinal residues and the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata decoct with water secondary, and the 1st time 2 hours, the 2nd time 1 hour, collecting decoction filtered, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.14～1.16 (60 ℃); Other gets Radix Rehmanniae, Flos Lonicerae, Semen Ziziphi Spinosae and decocts with water secondary, and each 1 hour, collecting decoction filtered, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.14～1.16 (60 ℃); Merge above-mentioned concentrated solution, add ethanol, make to contain the alcohol amount and reach 70%, cold preservation (2～2 ℃) 24 hours filters, filtrate recycling ethanol, and being evaporated to relative density is the clear paste of 1.25～1.30 (60 ℃); All the other Rhizoma Coptidis, Fructus Schisandrae Chinensis add 70% alcohol reflux secondary, and each 2 hours, merge extractive liquid, filtered, filtrate recycling ethanol, and being evaporated to relative density is the clear paste of 1.25～1.30 (60 ℃); Merge above-mentioned three kinds of clear paste, the low-temperature reduced-pressure drying is pulverized, and sieves; Add dextrin and cane sugar powder is an amount of, make granule, drying promptly gets granule.
Viral myocarditis is many because diseases caused by exogenous pathogenic factor are evil malicious, especially based on damp and hot evil poison.Evil poison is invaded human body, can defend table and goes into from the nose larynx, attacks lung and decreases the heart; Also can go into from mouth, impairing the spleen and stomach accumulates damp-stagnancy heat, on violate in the heart; Or exopathogen attacks table, causes disharmony of nutrient QI with defensive QI earlier, after go into QI and blood, from outward appearance to inner essence, stay and do not remove to import into lung, be contained in the heart (pericardium).
" in healthy energy deposited, heresy can not be done, and the institute of heresy gathers, and its gas must be empty ".The positive QI-insufficiency of primary disease, relevant with plain body deficiency of qi and yin, pathogenic warmth just is the cardiopulmonary deficiency of both vital energy and Yin by the key of lung " adverse transference " pericardium.On this basis, the evil poison of impression, and then heat-transformation in going into are invaded heart arteries and veins, make negative and positive of qi and blood further impaired, and the damp and hot evil poison of exopathogen causes a disease, and very easily consumes impairment of QI the moon again.Opening Bai Yu says: " the pathogenic warmth seasonal noxious pathogen, the cloudy blood body fluid of hurting sb.'s feelings is normal for it, and the yang-energy consume is its change." invade the heart (pericardium) in the pyretic toxicity, the damage motive is burnt bright the heart-yin, has both decreased heart body, decreases heart usefulness again, the heart foster symptom of becoming homeless occurs, as cardiopalmus, breathe hard, uncomfortable in chest, weak etc.Therefore, deficiency of both QI and YIN is not only the endogenous cause of ill of viral myocarditis morbidity, and is that main pathogenesis lapses to, through the course of disease all the time.
At the etiology and pathogenesis of above-mentioned viral myocarditis, on dialectical and the basis that differential diagnosis of diseases combines, established the Therapeutic Principle of strengthening vital QI to eliminate pathogenic factors, giving consideration to both the incidental and fundamental, so supplementing QI and nourishing YIN, invigorating heart and lung are its fundamental law, simultaneously, pay attention to the heat-clearing and toxic substances removing dispeling disease and evil.
Chinese medicine preparation of the present invention is made up of the Radix Astragali, Radix Ophiopogonis, Radix Rehmanniae, Flos Lonicerae, Rhizoma Coptidis, Radix Saposhnikoviae, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Semen Ziziphi Spinosae, Radix Glycyrrhizae Preparata.
The Radix Astragali, the sweet temperature of property, benefiting QI for strengthening the superficies, strengthening vital QI to eliminate pathogenic factors.To the viral myocarditis supplementing QI and nourishing YIN, in the heat-clearing and toxic substances removing strengthening vital QI to eliminate pathogenic factors method of treatment, the Radix Astragali is a monarch drug.The Radix Astragali is not only set upright in the side, and still residence has eliminating evil profound meaning of protecting the heart.Modern study also shows that the Radix Astragali has tangible antiviral, protection cardiac muscle, improves cardiac function and regulates immune effect.
Ministerial drug, Radix Ophiopogonis, Gan Hanzhi profit, the cloudy gentle property of tool, YIN nourishing and oiliness stagnating, the void of the moon that nourishes heart and hemopoietic be arteries and veins again, clear away heart-fire through heat and relieving restlessness is calmed the nerves.Modern experimentation shows can improve myocardial contraction and pumping function Radix Ophiopogonis, significantly reduces the infringement of myocardial cell anoxia, promotes its healing, and the ARR effect of pair anti-experimental character is arranged.The Radix Rehmanniae, sweet, bitter, cold.GUIXIN Liver and kidney warp.Clearing away heat and cooling blood, YIN nourishing and the production of body fluid promoting.In the indication epidemic febrile disease later stage, waste heat to the greatest extent, do not hinder by cloudy Tianjin; Or the warm febrile disease blood of joining the army, the fever of the body xerostomia, its indication and viral myocarditis are very identical, cooperate YIN nourishing and the production of body fluid promoting, clearing heat and relieving fidgetness with Radix Ophiopogonis, nourish heart and protect the heart and have good effect.Flos Lonicerae, Rhizoma Coptidis heat-clearing and toxic substances removing think to have " eliminating heart-fire " with the Rhizoma Coptidis ancients especially, and " main cardiopathia is contrary and contain, and the heart amass fullness in the epigastrium especially referring to the abcess of the abdomen in ancient times " " controls five kinds of strain and seven kinds of impairment, QI invigorating, only heart pain in the skin.Palpitation with fear is irritated, the profit cardiopulmonary ... " etc. multiple efficacies.Modern clinical and discover that Rhizoma Coptidis is the good medicine of cardiovascular system, have blood pressure lowering, coronary artery dilator, treatment tachycardia, ventricular premature contraction reduce multiple curative effects such as blood high viscosity and high coagulant state, and do not have untoward reaction such as negative inotropic action.That the Radix Saposhnikoviae expelling pathogenic wind from the body surface wins is wet, pain relieving, spasmolytic, embellish but not dry, and the title of " moistening agent in the wind medicine " is arranged, more than three flavors play the eliminating evil merit of heat-clearing and toxic substances removing, vital QI recovered after pathogens eliminated altogether.
Adjuvant drug, Radix Salviae Miltiorrhizae, property bitter cold tepor is gone into the cardiopulmonary warp, and merit is arrogated to oneself blood circulation promoting and blood stasis dispelling, mind tranquilizing and the heart calming.This medicine be at viral myocarditis because deficiency of both QI and YIN, invade in the evil poison and cause the pathogenesis of deficiency of heart-blood, the easy stasis of blood of painstaking effort and establish.Fructus Schisandrae Chinensis, the pathogenic fire reducing of astringing the lung, the controlling nocturnal emission with astringent drugs arresting sweating, heart tonifying and tranquilizing, the compatibility Radix Astragali are strengthened the merit of QI invigorating, to improve cardiopalmus, insomnia is useful.And the effect that reduces myocardium enzyme is arranged.Semen Ziziphi Spinosae, tranquilizing by nourishing the heart, the arresting sweating the moon that can nourish heart, the liver benefiting blood and mind tranquilizing and the heart calming.This three flavor assistants principal drug assistance Radix Astragali tranquilizing by nourishing the heart, uncomfortable in chest, cardiopalmus, insomnia, hyperhidrosis, myocardium enzyme increased etc. remarkable result.
Messenger drug, Radix Glycyrrhizae Preparata, property is sweet flat, goes into cardiopulmonary taste warp.Get Radix Glycyrrhizae Preparata and relax the property of medicine, coordinating the actions of various ingredients in a prescription and for making.
Take a broad view of full side, at the viral myocarditis pathogenesis, supplementing QI and nourishing YIN Zhi Qiben, heat-clearing and toxic substances removing, mind tranquilizing and the heart calming are controlled its mark, adopting both clearing heat method and tonification method, refinforce each other giving consideration to both the exterior and interior, treating both the principal and the secondary aspects of a disease at the same time, QI invigorating is not loved heresy, not eliminating evil just the wound, and prescription is concise, make a distinction between the important and the lesser one, compatibility is precise and appropriate, plays supplementing QI and nourishing YIN altogether, heat-clearing and toxic substances removing, the merit of mind tranquilizing and the heart calming.
Chinese medicine preparation main pharmacodynamics experimental result of the present invention is as follows:
Every milliliter heavy 1.3g of extractum of the present invention is equivalent to primary crude drug 3.34g.
1. in the body, the extracorporeal antivirus effect result of the test shows: but the outer cardiac muscle cells film of the present invention's protective is complete, keeps the rhythm and pace of moving things of beating of myocardial cell, suppresses virus multiplication and has direct inactivation of viruses effect.Body inner virus myocarditis model test results suggest, 4.83g of the present invention, 9.66/kg can suppress the propagation of virus at mouse heart, thereby make animal hearts reduce virus infraction, alleviate the pathology damage that viral infection causes.
2. the present invention shows the hemodynamic result of the test of anesthetized dog: the present invention 0.97,1.93,3.86g/kg duodenal administration all do not have obvious influence to anesthetized dog heart rate, blood pressure, left ventricular pressure, the maximum rate of change of left ventricular pressure, and the visible coronary flow of 60min obviously increases behind the 3.86g/kg medicine.
3. to CaCl
2Bringing out the ARR result of the test of animal with aconitine shows: 2.90g/kg of the present invention can obviously improve CaCl
2Cause the survival rate of rat ventricular; 1.45-5.80g/kg of the present invention can postpone time of origin, the shortening arrhythmia persistent period that aconitine causes rat ventricular.Be that the present invention truly has the certain protection effect to the animal arrhythmia.
4. mouse immune mechanism being regulated result of the test shows: 4.83g of the present invention, 9.66/kg have the leukocyte of promotion and produce interferon, promote LT effect.Show that the present invention has the effect of raising combination of syndromes poison minimizing cardiac damage in the body's immunity.
Granule quality standard of the present invention:
One, character:
This product is the brownish red granule, bitter in the mouth, little suffering.
Two, differentiate:
(1) get this product 6g, add water 30ml, heating makes dissolving, adds 1.5ml hydrochloric acid, and heated and boiled 10 minutes is put coldly, adds water and complements to 30ml, and add chloroform and extract 3 times, each 30ml, merge extractive liquid, is concentrated into about 2ml, as need testing solution; Other gets control medicinal material 2g Radix Ophiopogonis, adds water 30ml, decocts 20 minutes, filters, and filtrate adds hydrochloric acid 0.5ml, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 4 μ l, control medicinal material solution 8 μ l, putting respectively on same silica gel g thin-layer plate, is developing solvent with chloroform-acetone (7: 1), launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color.
(2) get this product 4g, add water 30ml, heating makes dissolving, puts coldly, adds hydrochloric acid adjust pH=1～2, and with ethyl acetate extraction 3 times, each 15ml merges ethyl acetate extraction liquid, and evaporate to dryness, residue add methanol 5ml makes dissolving, as need testing solution; Extracting honeysuckle control medicinal material 0.5g adds methanol 15ml in addition, and supersound process 20 minutes filters, and filtrate evaporate to dryness, residue add methanol 5ml makes dissolving, in contrast medical material solution.Get the chlorogenic acid reference substance again, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 5 μ l, control medicinal material solution 3 μ l, reference substance solution 2 μ l put respectively on same polyamide film, are developing solvent (exhibition is apart from 6cm) with 25% glacial acetic acid solution, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, respectively with reference substance chromatograph and the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(3) get this product 1g, add ethanol 20ml, supersound process 20 minutes filters, and filtrate evaporate to dryness, residue add methanol 5ml makes dissolving, as need testing solution; Other gets Rhizoma Coptidis control medicinal material 0.5g, shines medical material solution in pairs with legal system; Get the berberine hydrochloride reference substance again, add methanol and make the solution that every 1ml contains 0.5mg, in contrast product solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B) test, draw each 5 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with n-butyl alcohol-glacial acetic acid-water (7: 1: 2), launch, take out, dry.Put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(4) get this product 10g, add water 40ml, heating makes dissolving, put cold, with water saturated ether extraction 2 times, 20ml at every turn, merge extractive liquid, is flung to ether, residue adds ethyl acetate 2ml makes dissolving, as need testing solution; Other gets the schisandrin B reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B) test, draw need testing solution 10 μ l, reference substance solution 4 μ l put in same silica gel G F respectively
254On the lamellae, be developing solvent, launch, take out, dry, put under the ultra-violet lamp (254nm) and inspect with toluene-ethyl acetate (9: 1).In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(5) get this product 8g, add hydrochloric acid solution (5 → 100) 40ml, heating in water bath 1 hour, with water saturated ether extraction 2 times, each 40ml merges ether solution, reclaim ether to about 15ml, with 2% aqueous sodium carbonate washing 2 times, each 10ml, merge alkali liquor, add hydrochloric acid and transfer pH value to 2, with water saturated ether extraction 3 times, each 15ml, merge extractive liquid, volatilizes, residue adds methanol 2ml makes dissolving, as need testing solution; Other gets the protocatechualdehyde reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 10 μ l, reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with toluene-ethyl acetate-formic acid (15: 10: 1) is developing solvent, launches, and takes out, dry, spray is with the mixed solution of freshly prepared 1% phloroglucinol ethanol-concentrated sulphuric acid (1: 1).In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Three, check:
(1) heavy metal: get this product 1.0g, check to contain (an appendix IX of Chinese Pharmacopoeia version in 2000 E second method) heavy metal and must not cross 20/1000000ths in accordance with the law.
(2) arsenic salt: get this product 1.0g, adding calcium hydroxide 1g mixes, and adds low amounts of water, stir evenly, dry back is earlier with little fiery calcination, blazingly makes complete ashing at 500～600 ℃ again, puts cold, add hydrochloric acid 5ml, add water 23ml, check (an appendix IX of Chinese Pharmacopoeia version in 2000 F) in accordance with the law, arsenic content must not cross 2/1000000ths.
(3) other: should meet every regulation relevant under the granule item (appendix IC of Chinese Pharmacopoeia version in 2000).
Four, assay:
Get this product 2.5g, the accurate title, decide, and adds hot water 20ml and make dissolving, adding chloroform extracts 3 times, each 20ml discards chloroform solution, and water liquid is with water saturated n-butanol extraction 4 times, each 20ml, merge n-butyl alcohol liquid, reuse 1% sodium hydroxide solution washing 3 times, (each washing all needs shake well to each 25ml, repetitive operation again behind the standing demix), discard alkali liquor, with n-butyl alcohol saturated be washed to neutrality (2 times, each 25ml), n-butyl alcohol liquid evaporate to dryness, residue makes dissolving with the about 10ml of mixed solution of ethyl acetate-methanol (10: 3), is added on the silicagel column [200-300 order, the 1.5g (with preceding 105 ℃ of baking 0.5h) that have handled well, internal diameter 9mm, the wet method upper prop is with ethyl acetate-methanol (10: 3) mixed solution 10ml prewashing] on, with ethyl acetate-methanol (10: 3) mixed solution 80ml eluting, collect eluent, water bath method, the residue dissolve with methanol, and be settled in the 2ml measuring bottle, shake up, as need testing solution.Other gets the astragaloside reference substance, and accurate the title decides, and adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 8 μ l～12 μ l, reference substance solution 1 μ l and 3 μ l, put respectively on same silica gel G precoated plate, lower floor's solution of placing 3h with chloroform-methanol-water (2: 2: 1) below 10 ℃ is developing solvent, presaturation below 10 ℃ launched after 30 minutes, take out, dry, spray is with 10% ethanol solution of sulfuric acid, it is clear to be heated to speckle colour developing at 100 ℃, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan wavelength X according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B thin layer chromatography scanning)
S=510nm, λ
R=650nm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly.
This product contains the Radix Astragali by astragaloside (C for every bag
41H
68O
14) meter, must not be less than 1.20mg.
Five, usage and dosage: oral, every packed 10g, one time 1 bag, three times on the one.
The specific embodiment
The embodiment of the invention 1: the preparation of granule
500 parts of the Radixs Astragali, 333 parts of Radix Ophiopogonis, 250 parts of Radix Rehmanniae, 250 parts of Flos Loniceraes, 200 parts of Rhizoma Coptidis, 150 parts of Radix Saposhnikoviaes, 150 parts of Fructus Schisandrae Chinensis, 250 parts of Radix Salviae Miltiorrhizaes, 250 parts of Semen Ziziphi Spinosae (parched)s, 150 parts of Radix Glycyrrhizae Preparatas;
Get Radix Salviae Miltiorrhizae, add 70% alcohol reflux secondary, each 1h, merge extractive liquid, filters, and filtrate recycling ethanol also is evaporated to the clear paste that relative density is 1.28～1.30 (60 ℃); The medicinal residues and the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata decoct with water secondary, and the 1st time 2 hours, the 2nd time 1 hour, collecting decoction filtered, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.14～1.16 (60 ℃); Other gets Radix Rehmanniae, Flos Lonicerae, Semen Ziziphi Spinosae and decocts with water secondary, and each 1 hour, collecting decoction filtered, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.14～1.16 (60 ℃); Merge above-mentioned concentrated solution, add ethanol, make to contain the alcohol amount and reach 70%, cold preservation (2～2 ℃) 24 hours filters, filtrate recycling ethanol, and being evaporated to relative density is the clear paste of 1.25～1.30 (60 ℃); All the other Rhizoma Coptidis, Fructus Schisandrae Chinensis add 70% alcohol reflux secondary, and each 2 hours, merge extractive liquid, filtered, filtrate recycling ethanol, and being evaporated to relative density is the clear paste of 1.25～1.30 (60 ℃); Merge above-mentioned three kinds of clear paste, the low-temperature reduced-pressure drying is pulverized, and sieves; Add dextrin and cane sugar powder is an amount of, make granule, drying, promptly.
The embodiment of the invention 2; The preparation of granule
250 parts of the Radixs Astragali, 500 parts of Radix Ophiopogonis, 120 parts of Radix Rehmanniae, 370 parts of Flos Loniceraes, 100 parts of Rhizoma Coptidis, 230 parts of Radix Saposhnikoviaes, 80 parts of Fructus Schisandrae Chinensis, 370 parts of Radix Salviae Miltiorrhizaes, 120 parts of Semen Ziziphi Spinosae (parched)s, 230 parts of Radix Glycyrrhizae Preparatas;
After Radix Salviae Miltiorrhizae adopts alcohol extraction; Medicinal residues are again with the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata water extract-alcohol precipitation; Radix Rehmanniae, Flos Lonicerae and Semen Ziziphi Spinosae adopt water extract-alcohol precipitation; Rhizoma Coptidis, Fructus Schisandrae Chinensis are with alcohol extraction; Add suitable adjuvant at last, drying, promptly.
The embodiment of the invention 3: the preparation of capsule
750 parts of the Radixs Astragali, 150 parts of Radix Ophiopogonis, 370 parts of Radix Rehmanniae, 120 parts of Flos Loniceraes, 300 parts of Rhizoma Coptidis, 80 parts of Radix Saposhnikoviaes, 230 parts of Fructus Schisandrae Chinensis, 120 parts of Radix Salviae Miltiorrhizaes, 370 parts of Semen Ziziphi Spinosae (parched)s, 80 parts of Radix Glycyrrhizae Preparatas;
With tanshinone liposoluble constituent, filtration in a kind of extraction Radix Salviae Miltiorrhizae in supercritical extraction, ethanol refluxing process or the alcohol percolation method, filtrate recycling ethanol and concentrating under reduced pressure become clear paste; The medicinal residues and the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata decoct with water, and filter, and filtrate decompression concentrates; Radix Rehmanniae, Flos Lonicerae, Semen Ziziphi Spinosae decoct with water, and filter, and filtrate decompression concentrates; Merge above-mentioned two kinds of concentrated solutions, add ethanol, filter, filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste; Rhizoma Coptidis, Fructus Schisandrae Chinensis, alcohol reflux filters, filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste; Merge above-mentioned three kinds of clear paste, add adjuvant, granulate, drying, encapsulated, promptly.
The embodiment of the invention 4: the preparation of tablet
375 parts of the Radixs Astragali, 415 parts of Radix Ophiopogonis, 185 parts of Radix Rehmanniae, 310 parts of Flos Loniceraes, 150 parts of Rhizoma Coptidis, 190 parts of Radix Saposhnikoviaes, 115 parts of Fructus Schisandrae Chinensis, 310 parts of Radix Salviae Miltiorrhizaes, 185 parts of Semen Ziziphi Spinosae (parched)s, 190 parts of Radix Glycyrrhizae Preparatas.
Get Radix Salviae Miltiorrhizae, add 70% alcohol reflux secondary, each 1h, merge extractive liquid, filters, and filtrate recycling ethanol also is evaporated to the clear paste that relative density is 1.28～1.30 (60 ℃); The medicinal residues and the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata decoct with water secondary, and the 1st time 2 hours, the 2nd time 1 hour, collecting decoction filtered, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.14～1.16 (60 ℃); Other gets Radix Rehmanniae, Flos Lonicerae, Semen Ziziphi Spinosae and decocts with water secondary, and each 1 hour, collecting decoction filtered, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.14～1.16 (60 ℃); Merge above-mentioned concentrated solution, add ethanol, make to contain the alcohol amount and reach 70%, cold preservation (2～2 ℃) 24 hours filters, filtrate recycling ethanol, and being evaporated to relative density is the clear paste of 1.25～1.30 (60 ℃); All the other Rhizoma Coptidis, Fructus Schisandrae Chinensis add 70% alcohol reflux secondary, and each 2 hours, merge extractive liquid, filtered, filtrate recycling ethanol, and being evaporated to relative density is the clear paste of 1.25～1.30 (60 ℃); Merge above-mentioned three kinds of clear paste, the low-temperature reduced-pressure drying is pulverized, and sieves; Alcohol granulation with 70%, drying, granulate adds magnesium stearate, micropowder silica gel, mixing, tabletting, the bag film-coat, promptly.
The embodiment of the invention 5: the preparation of mixture
625 parts of the Radixs Astragali, 240 parts of Radix Ophiopogonis, 310 parts of Radix Rehmanniae, 185 parts of Flos Loniceraes, 250 parts of Rhizoma Coptidis, 115 parts of Radix Saposhnikoviaes, 190 parts of Fructus Schisandrae Chinensis, 185 parts of Radix Salviae Miltiorrhizaes, 310 parts of Semen Ziziphi Spinosae (parched)s, 115 parts of Radix Glycyrrhizae Preparatas;
Get Radix Salviae Miltiorrhizae, add 70% alcohol reflux secondary, each 1h, merge extractive liquid, filters, and filtrate recycling ethanol also is evaporated to the clear paste that relative density is 1.28～1.30 (60 ℃); The medicinal residues and the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata decoct with water secondary, and the 1st time 2 hours, the 2nd time 1 hour, collecting decoction filtered, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.14～1.16 (60 ℃); Other gets Radix Rehmanniae, Flos Lonicerae, Semen Ziziphi Spinosae and decocts with water secondary, and each 1 hour, collecting decoction filtered, and filtrate decompression is concentrated into the concentrated solution that relative density is 1.14～1.16 (60 ℃); Merge above-mentioned concentrated solution, add ethanol, make to contain the alcohol amount and reach 70%, cold preservation (2～2 ℃) 24 hours filters, filtrate recycling ethanol, and being evaporated to relative density is the clear paste of 1.25～1.30 (60 ℃); All the other Rhizoma Coptidis, Fructus Schisandrae Chinensis add 70% alcohol reflux secondary, and each 2 hours, merge extractive liquid, filtered, filtrate recycling ethanol, and being evaporated to relative density is the clear paste of 1.25～1.30 (60 ℃); Merge above-mentioned three kinds of clear paste, add distilled water, add soil temperature 80, aspartame is an amount of, stirring and dissolving filters, filtrate fill, sterilization, promptly.
Claims (10)
1, a kind of Chinese medicine preparation for the treatment of viral myocarditis, it is characterized in that according to the components by weight percent meter, make this Chinese medicine preparation raw materials of effective components and be: Radix Astragali 250-750 part, Radix Ophiopogonis 150-500 part, Radix Rehmanniae 120-370 part, Flos Lonicerae 120-370 part, Rhizoma Coptidis 100-300 part, Radix Saposhnikoviae 80-230 part, Fructus Schisandrae Chinensis 80-230 part, Radix Salviae Miltiorrhizae 120-370 part, Semen Ziziphi Spinosae (parched) 120-370 part, Radix Glycyrrhizae Preparata 80-230 part.
2, the Chinese medicine preparation of treatment viral myocarditis as claimed in claim 1, it is characterized in that according to the components by weight percent meter, make this Chinese medicine preparation raw materials of effective components and be: 500 parts of the Radixs Astragali, 333 parts of Radix Ophiopogonis, 250 parts of Radix Rehmanniae, 250 parts of Flos Loniceraes, 200 parts of Rhizoma Coptidis, 150 parts of Radix Saposhnikoviaes, 150 parts of Fructus Schisandrae Chinensis, 250 parts of Radix Salviae Miltiorrhizaes, 250 parts of Semen Ziziphi Spinosae (parched)s, 150 parts of Radix Glycyrrhizae Preparatas.
3, the Chinese medicine preparation of treatment viral myocarditis as claimed in claim 1 or 2 is characterized in that described Chinese medicine preparation is granule, hard capsule, soft capsule, tablet, drop pill, oral liquid or injection.
4, the Chinese medicine preparation of treatment viral myocarditis as claimed in claim 3 is characterized in that described Chinese medicine preparation is a granule.
5, the preparation method of the Chinese medicine preparation of treatment viral myocarditis as claimed in claim 1 or 2 is characterized in that: Radix Salviae Miltiorrhizae adopts alcohol extraction; Its medicinal residues are again with the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata water extract-alcohol precipitation; Radix Rehmanniae, Flos Lonicerae and Semen Ziziphi Spinosae adopt water extract-alcohol precipitation; Rhizoma Coptidis, Fructus Schisandrae Chinensis are with alcohol extraction; Add suitable adjuvant at last, be prepared into different preparations respectively.
6, the preparation method of the Chinese medicine preparation of treatment viral myocarditis as claimed in claim 5, it is characterized in that: with tanshinone liposoluble constituent, filtration in a kind of extraction Radix Salviae Miltiorrhizae in supercritical extraction, ethanol refluxing process or the alcohol percolation method, filtrate recycling ethanol and concentrating under reduced pressure become clear paste; The medicinal residues and the Radix Astragali, Radix Ophiopogonis, Radix Saposhnikoviae, Radix Glycyrrhizae Preparata decoct with water, and filter, and filtrate decompression concentrates; Radix Rehmanniae, Flos Lonicerae, Semen Ziziphi Spinosae decoct with water, and filter, and filtrate decompression concentrates; Merge above-mentioned two kinds of concentrated solutions, add ethanol, filter, filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste; Rhizoma Coptidis, Fructus Schisandrae Chinensis, alcohol reflux filters, filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste; Merge above-mentioned three kinds of clear paste, press the medicament common process and add corresponding auxiliary material, get granule.
7, the preparation method of the Chinese medicine preparation of treatment viral myocarditis as claimed in claim 6, its feature exists: get 250 parts of Radix Salviae Miltiorrhizaes, add 70% alcohol reflux secondary, each 1h, merge extractive liquid,, filter filtrate recycling ethanol and to be evaporated to 60 ℃ of relative densities be 1.28～1.30 clear paste; 500 parts of the medicinal residues and the Radixs Astragali, 333 parts of Radix Ophiopogonis, 150 parts of Radix Saposhnikoviaes, Radix Glycyrrhizae Preparata decoct with water secondary for 150 parts, and the 1st time 2 hours, the 2nd time 1 hour, collecting decoction filtered, and it is 1.14～1.16 concentrated solution that filtrate decompression is concentrated into 60 ℃ of relative densities; Other gets 250 parts of Radix Rehmanniae, 250 parts of Flos Loniceraes, Semen Ziziphi Spinosae and decocts with water secondary for 250 parts, and each 1 hour, collecting decoction filtered, and it is 1.14～1.16 concentrated solution that filtrate decompression is concentrated into 60 ℃ of relative densities; Merge above-mentioned concentrated solution, add ethanol, make to contain the alcohol amount and reach 70% ,-2～2 ℃ of cold preservations 24 hours, filter, filtrate recycling ethanol is evaporated to 60 ℃ of relative densities and is 1.25～1.30 clear paste; 200 parts of all the other Rhizoma Coptidis, 150 parts of Fructus Schisandrae Chinensis add 70% alcohol reflux secondary, and each 2 hours, merge extractive liquid, filtered, and filtrate recycling ethanol is evaporated to 60 ℃ of relative densities and is 1.25～1.30 clear paste; Merge above-mentioned three kinds of clear paste, the low-temperature reduced-pressure drying is pulverized, and sieves; Add dextrin and cane sugar powder is an amount of, make granule, drying is made 1000 parts, promptly.
8, the discrimination method of the Chinese medicine granules of treatment viral myocarditis as claimed in claim 4 is characterized in that:
(1) thin layer of Radix Ophiopogonis is differentiated: get this granule 6g, add water 30ml, heating makes dissolving, adds 1.5ml hydrochloric acid, heated and boiled 10 minutes is put coldly, adds water and complements to 30ml, adds chloroform and extracts 3 times, each 30ml, merge extractive liquid, is concentrated into about 2ml, as need testing solution; Other gets control medicinal material 2g Radix Ophiopogonis, adds water 30ml, decocts 20 minutes, filters, and filtrate adds hydrochloric acid 0.5ml, shines medical material solution in pairs with legal system; Test according to the Chinese Pharmacopoeia thin layer chromatography, draw need testing solution 4 μ l, control medicinal material solution 8 μ l, put respectively on same silica gel g thin-layer plate, be 7: 1 chloroform with proportioning: acetone is developing solvent, launches, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color;
(2) thin layer of Flos Lonicerae is differentiated: get this granule 4g, add water 30ml, heating makes dissolving, puts cold, adding the hydrochloric acid adjust pH is 1～2, uses ethyl acetate extraction 3 times, and each 15ml merges ethyl acetate extraction liquid, evaporate to dryness, residue add methanol 5ml makes dissolving, as need testing solution; Extracting honeysuckle control medicinal material 0.5g adds methanol 15ml in addition, and supersound process 20 minutes filters, and filtrate evaporate to dryness, residue add methanol 5ml makes dissolving, in contrast medical material solution; Get the chlorogenic acid reference substance again, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution; According to the test of Chinese Pharmacopoeia thin layer chromatography, draw need testing solution 5 μ l, control medicinal material solution 3 μ l, reference substance solution 2 μ l, putting respectively on same polyamide film, is that developing solvent launches with 25% glacial acetic acid solution, and exhibition is apart from 6cm, take out, dry, put under the ultra-violet lamp of 365nm and inspect; In the test sample chromatograph, respectively with reference substance chromatograph and the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) thin layer of Rhizoma Coptidis is differentiated: get this granule 1g, add ethanol 20ml, supersound process 20 minutes filters, and filtrate evaporate to dryness, residue add methanol 5ml makes dissolving, as need testing solution; Other gets Rhizoma Coptidis control medicinal material 0.5g, shines medical material solution in pairs with legal system; Get the berberine hydrochloride reference substance again, add methanol and make the solution that every 1ml contains 0.5mg, in contrast product solution; According to Chinese Pharmacopoeia thin layer chromatography test, draw each 5 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be that n-butyl alcohol-glacial acetic acid-water of 7: 1: 2 is developing solvent with proportioning, launch, take out, dry; Put under the ultra-violet lamp of 365nm and inspect, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
(4) thin layer of Fructus Schisandrae Chinensis is differentiated: get this granule 10g, add water 40ml, heating makes dissolving, put cold, with water saturated ether extraction 2 times, 20ml at every turn, merge extractive liquid, is flung to ether, residue adds ethyl acetate 2ml makes dissolving, as need testing solution; Other gets the schisandrin B reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution; According to the test of Chinese Pharmacopoeia thin layer chromatography, draw need testing solution 10 μ l, reference substance solution 4 μ l put in same silica gel G F respectively
254On the lamellae, be that 9: 1 toluene-ethyl acetate is developing solvent, launch, take out, dry, put under the ultra-violet lamp of 254nm and inspect with proportioning; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
(5) thin layer of Radix Salviae Miltiorrhizae is differentiated: get 5ml hydrochloric acid and add water to 100ml, get hydrochloric acid solution; Get this granule 8g, add hydrochloric acid solution 40ml, heating in water bath 1 hour, with water saturated ether extraction 2 times, each 40ml merges ether solution, reclaim ether to about 15ml, with 2% aqueous sodium carbonate washing 2 times, each 10ml, merge alkali liquor, add hydrochloric acid and transfer pH value to 2, with water saturated ether extraction 3 times, each 15ml, merge extractive liquid, volatilizes, residue adds methanol 2ml makes dissolving, as need testing solution; Other gets the protocatechualdehyde reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; Test according to the Chinese Pharmacopoeia thin layer chromatography, draw need testing solution 10 μ l, reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with proportioning is that toluene-ethyl acetate-formic acid of 15: 10: 1 is developing solvent, launches, and takes out, dry, spray is the mixed solution of 1: 1 phloroglucinol ethanol-concentrated sulphuric acid with freshly prepared 1% proportioning; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
9, the content assaying method of the Chinese medicine granules of treatment viral myocarditis as claimed in claim 4 is characterized in that:
Get this granule 2.5g, the accurate title, decide, add hot water 20ml and make dissolving, add chloroform and extract 3 times, each 20ml discards chloroform solution, water liquid is with water saturated n-butanol extraction 4 times, each 20ml merges n-butyl alcohol liquid, reuse 1% sodium hydroxide solution washing 3 times, each 25ml, each washing all needs shake well, and repetitive operation again discards alkali liquor behind the standing demix, with the saturated washing of n-butyl alcohol 2 times to neutral, each 25ml, n-butyl alcohol liquid evaporate to dryness, the residue proportioning is that ethyl acetate-about 10ml of methanol mixed solution of 10: 3 makes dissolving; 105 ℃ in 200-300 order silica gel baking 0.5h gets 1.5g, the wet method upper prop, and internal diameter 9mm is ethyl acetate-methanol mixed solution 10ml prewashing of 10: 3 with proportioning; Above-mentioned residue solution is added on the silicagel column, is ethyl acetate-methanol mixed solution 80ml eluting of 10: 3 with proportioning, collects eluent, water bath method, and the residue dissolve with methanol, and be settled in the 2ml measuring bottle, shake up, as need testing solution; Other gets the astragaloside reference substance, and accurate the title decides, and adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; Test according to the Chinese Pharmacopoeia thin layer chromatography, draw need testing solution 8 μ l～12 μ l, reference substance solution 1 μ l and 3 μ l, put respectively on same silica gel G precoated plate, chloroform-methanol-the water that with proportioning is 2: 2: 1 is developing solvent at lower floor's solution of placing 3h below 10 ℃, presaturation below 10 ℃ launched after 30 minutes, take out, dry, spray is with 10% ethanol solution of sulfuric acid, it is clear to be heated to speckle colour developing at 100 ℃, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan wavelength X according to the Chinese Pharmacopoeia thin layer chromatography scanning
S=510nm, λ
R=650nm measures test sample trap integrated value and reference substance trap integrated value, calculates, and it is C by molecular formula that the every 10g of this granule contains the Radix Astragali
41H
68O
14The astragaloside meter, must not be less than 1.20mg.
10, claim 1 or the 2 described Chinese medicine preparation application in the medicine of preparation treatment viral myocarditis.
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| CN101947301B (en) * | 2010-09-03 | 2012-01-25 | 南方医科大学 | Medicine composition for preventing and treating vital myocarditis and preparation method thereof |
| CN102824594B (en) * | 2012-09-20 | 2013-09-11 | 河南中医学院 | Traditional Chinese medicine for treating vital myocarditis |
| CN103169862A (en) * | 2012-12-12 | 2013-06-26 | 延安市职业技术学院 | Traditional Chinese medicine formula for treating vital myocarditis |
| CN103142849B (en) * | 2013-02-17 | 2014-07-23 | 郭荣杰 | Chinese medicine preparation for treating acute vital myocarditis |
| CN103202996B (en) * | 2013-04-17 | 2015-06-10 | 刘俊菊 | Traditional Chinese medicine for treating myocarditis |
| CN103446410B (en) * | 2013-09-16 | 2015-02-18 | 于惠 | Traditional Chinese medicine preparation for treating viral myocarditis |
| CN103690832B (en) * | 2013-12-30 | 2015-09-09 | 王雪雁 | A kind of Chinese medicine composition for the treatment of viral myocarditis |
| CN105031217A (en) * | 2015-08-26 | 2015-11-11 | 南京正宽医药科技有限公司 | Pharmaceutical preparation for treating viral myocarditis |
| CN105079438B (en) * | 2015-09-11 | 2018-08-10 | 山东大学 | A kind of pharmaceutical preparation for treating vital myocarditis |
| CN105288132A (en) * | 2015-10-30 | 2016-02-03 | 程素芹 | Traditional Chinese medicine preparation for treating viral myocarditis |
| CN106237066A (en) * | 2016-08-25 | 2016-12-21 | 西安必康制药集团有限公司 | A kind of medicine of supporing yang QI invigorating and yin nourishing and preparation method thereof |
| CN110988248B (en) * | 2019-12-23 | 2021-06-18 | 河北中医学院 | Rapid thin-layer identification method for radix puerariae intestine clearing granules |
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