CN105560694A - Medicine composition for treating diabetic nephropathy and preparation method thereof - Google Patents

Medicine composition for treating diabetic nephropathy and preparation method thereof Download PDF

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CN105560694A
CN105560694A CN201610047032.6A CN201610047032A CN105560694A CN 105560694 A CN105560694 A CN 105560694A CN 201610047032 A CN201610047032 A CN 201610047032A CN 105560694 A CN105560694 A CN 105560694A
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pharmaceutical composition
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diabetic nephropathy
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不公告发明人
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Jinan Xingyi Medical Technology Co Ltd
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Jinan Xingyi Medical Technology Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/02—Algae
    • A61K36/03—Phaeophycota or phaeophyta (brown algae), e.g. Fucus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
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    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815—Lycium (desert-thorn)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
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    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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    • A61K2236/00—Isolation 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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    • A61K2236/00—Isolation 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/55—Liquid-liquid separation; Phase separation

Abstract

The invention discloses a medicine composition for treating diabetic nephropathy and a preparation method thereof. The medicine composition is prepared by matching folium mori, peanut branches and leaves, cortex lycii radicis, litsea glutinosa roots, palm kernels, kelp, leaf mustard stem leaves, portulaca oleracea, potentilla discolor and macluraxanthone, the medicine composition can be prepared into various dosage forms according to a conventional preparation process, and the curative effect on diabetic nephropathy is remarkable.

Description

A kind of pharmaceutical composition for the treatment of diabetic nephropathy and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of pharmaceutical composition for the treatment of diabetic nephropathy and preparation method thereof.
Background technology
In recent years, due to factors such as the change of growth in the living standard, dietary structure, the rhythm of life be becoming tight day and few dynamic life style of sitting more, whole world onset diabetes rate rapid development, diabetes have become the chronic disease of the third-largest serious threat human health after tumor, cardiovascular pathological changes.Current global diabetics is more than 1.2 hundred million people, and China patients occupies the second in the world, within 1994, just reaches 2,000 ten thousand.Estimate according to World Health Organization (WHO), by 2025, global maturity-onset diabetes patient numbers will increase to 300,000,000, and diabetes mellitus in China patient numbers will reach 4,000 ten thousand, and in future 50 years, diabetes will be Chinese serious public health problems.
Diabetic nephropathy is one of topmost microvascular complication of diabetes, and end stagerenaldisease caused by it oneself become the main cause causing Delayed graft function gradually.At present, for the treatment of diabetic nephropathy, doctor trained in Western medicine limit, substantially with blood sugar lowering, tune fat or fit applications ACEI, ARB class medicine symptomatic treatment, but result is produced effects not good.And Chinese medicine is on treatment primary disease, play characteristic, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, with disease plus-minus, especially improve diabetic nephropathy early, mid-term clinical symptoms and pathological changes, curative effect is more remarkable, effectively can prevent, delay the generation of diabetic nephropathy, development.
Folium Mori: this product is the dried leaves of moraceae plants Mulberry MorusalbaL..Gather after first frost, removing impurity, dries.The many shrinkages of [character] this product, fragmentation.Complete person has handle, in avette or width egg shape after blade flattens, and long 8 ~ 15cm, wide 7 ~ 13cm; Tip is gradually sharp, and base portion cuts shape, circle or heart-shaped, and there are sawtooth or crenation in edge, the irregular division had.Upper surface yellow green or light yellowish brown, what have has little verruca; Lower surface color is slightly shallow, and vein is given prominence to, and scun is netted, by thin hair on arteries and veins, and arteries and veins base tool tuft.Matter is crisp.Feeble QI, lightly seasoned, micro-bitterness.[nature and flavor] are sweet, bitter, cold.[return through] returns lung, Liver Channel.[function cures mainly] dispelling wind and heat pathogens, clearing away lung-heat and moistening for dryness, liver heat removing and eyesight improving.For anemopyretic cold, lung-heat type cough, dizziness headache, conjunctival congestion is dim-sighted.[extracts] " Chinese Pharmacopoeia ".
Semen arachidis hypogaeae branch and leaf: be the stem and leaf of leguminous plant Semen arachidis hypogaeae.Gather in summer, autumn stem and leaf, clean, using fresh herb or chopping are dried.[character] Semen arachidis hypogaeae annual herb.Stem height 30-70cm, crawls or uprightly, has rib, being become mildewed by brown color.Even number winglike compound leaf, alternate; The long 2-5cm of petiole, is become mildewed by brown; Stipule is large, and base portion and petiole base adhesion, lanceolar, long 3-4cm, vein is obvious.Usual 4 pieces of lobule, oval is Long Circle to obovate sometimes, long 2-6cm, wide 1-2.5cm, tip circle or blunt.Brightly yellowish color, list is raw or cluster in axil, and florescence is several without bennet; Calyx pipe is elongated, 3 symphysis above calyx tooth, below one be separated into two lips; Corolla butterfly, vexil subcircular, roomy, ala is separated with fossil fragments; Stamen 9, symphysis, 1 degeneration, flower pesticide 5 Long Circles, 4 are bordering on circle; Style is elongated, and stigma top is raw, and dredge raw fine, soft fur, have 1 in ovary to several ovule, the different after fertilization of embryo, ovary handle is stretched to underground, grows for pod.Pod oblong, contracting of often hanging between seed, peel is thick, keratin, tool projection net arteries and veins, long 1-5cm.Seed 1-4.The florescence 6-7 month, the fruit phase 9-10 month.[nature and flavor] are sweet light; Flat.[return through] Liver Channel.[function cures mainly] heat-clearing and toxic substances removing, blood pressure lowering of allaying excitement.Main traumatic injury, carbuncle sore tumefacting virus, insomnia, hypertension.[extracts] " China's book on Chinese herbal medicine ".
Cortex Lycii: this product is the dry root bark of matrimony vine of solanaceae plant LyciumchinenseMill. or lycium barbarum LyciumbarbarumL..Excavate root at the beginning of spring or after autumn, clean, strip root bark, dry.[character] this product is tubular or channel-shaped, long 3 ~ 10cm, wide 0.5 ~ 1.5cm, thick 0.1 ~ 0.3cm.Outer surface lark is to brown color, coarse, has irregular longitudinal crack, easily becomes flakey to peel off.Inner surface yellow-white is to lark, more smooth, has thin longitudinal grin.Body is light, and matter is crisp, frangibility, and section is uneven, outer yellowish-brown, internal layer canescence.Feeble QI, taste is micro-sweet then bitter.[nature and flavor] are sweet, cold.[return through] returns lung, liver, kidney channel.[function cures mainly] removing heat from blood removes and steams, lung heat clearing pathogenic fire reducing.For deficiency of YIN hectic fever, hectic fever due to YIN-deficiency night sweat, cough due to lung-heat, spitting of blood, epistaxis, interior-heat is quenched one's thirst.[extracts] " Chinese Pharmacopoeia ".
Purling withered tree root: the purling withered tree Litseaglutinosa(Lour. of Lauraceae Litsea plant) C.B.Rob., is used as medicine with root.Xia Qiu gathers, and root is cleaned section and dried.[nature and flavor] are sweet, bitter, puckery, cool.[function cures mainly] clearing away damp-heat, detumescence poison, hemostasis, pain relieving.Root: take orally and control diarrhoea, traumatic injury, parotitis, diabetes.[extracts] " national Chinese herbal medicine compilation ".
Fructus trachycarpi: be the mature fruit of babassu Petiolus Trachycarpi.Gather when peel existing lividity around the Frost's Descent, dry.[character] dry fruit is kidney shape, long 7 ~ 9 millimeters, minor axis 5 ~ 7 millimeters.The dark-grey brown or lark in surface, has netted wrinkle, sometimes peels off, and inside is comparatively level and smooth, at the fruit stem that the recess of kidney shape is short and small as seen, or the residual trace of the fruit stem of circle.Matter is hard.After peelling off peel and seed coat, the brown endosperm of visible two panels plumpness.Gas without, lightly seasoned.[nature and flavor] are bitter, flat.[function cures mainly] supplement to the Herbal: " astringing intestine to stop diarrhea, antidiarrheal dysentery, hemorrhoidal hamorrhage, metrorrhagia, leukorrhagia, nourish blood." [extracts] " * dictionary ".
Thallus Laminariae (Thallus Eckloniae): be the herb of Zosteraceae plant Zostera marina.Spring, summer, Qiu Jieke gather, and removing impurity, cleans with fresh water, dry in the shade.[character] dry herb, in elongated, belt-shaped, Quan Yuan, normal shrinkage or curling, how cataclasm, diameter about 2 ~ 8 millimeters, thin as a piece of paper, surperficial brown-green, to brown, above has off-white color salt efflorescence.Matter is crisp as paper, and fracture has fine, soft fur sample fiber.Smelly faint; Salty in the mouth.[function cures mainly] softening and eliminating sputum, diuretic expels the heat-evil.Control goiter tuberculosis, hernia abdominal mass, edema, beriberi.[extracts] " * dictionary ".
Caulis et Folium Brassicae junceae stem and leaf: be the young stem and leaf of crucifer mustard Lay.[nature and flavor] are pungent, temperature.[return through] 1. " must join book on Chinese herbal medicine ": " enter meridian of Hand-TAI YIN." 2. " book on Chinese herbal medicine is looked for the truth ": " enters lung, stomach, double enter kidney." [function cures mainly] lung qi dispersing eliminating phlegm, warming middle-JIAO promoting the circulation of QI.Control in cold fluid-retention and contain, cough expectorant is stagnant, and chest and diaphragm is full vexed.[extracts] " * dictionary ".
Herba portulacae: this product is portulacaceous plant Herba Portulacae PortulacaoleraceaL., with all herbal medicine.[character] annual herb, length can reach 35 centimetres.The lower portion of the stem is crawled, four loose branches, top slightly can uprightly or tiltedly on, plump succulence, green or lavender, all Glabrous.Single leaf alternate or near to life; Blade meat is plump, rectangle or cochlear, or obovate, long 0.6 ~ 2.7 centimetre, wide 0.4 ~ 1.1 centimetre, tip circle, slightly recessed or truncate, the wide wedge shape of base portion, likeness in form Dens Equi, therefore named " Herba Portulacae "; Quan Yuan, above dark, below light green or dim red, outside a good appetite suddenly appearing in a serious disease arteries and veins, remaining arteries and veins is all not obvious.Open yellow little Hua summer, 3 ~ 5 cluster in the involucre that branch top 4 ~ 5 is lobate.Sepal 2; Petal 5, yellow, recessed head, opens time dry and contains most; Stamen 10 ~ 12; Ovary is the next, and style top 4 ~ 5 is cleaved into linear, stretches out on stamen.Capsule is conical, is cap shape from waist transverse fissure, inside has the oblate tiny seed of most black.[nature and flavor] acid, cold.[function cures mainly] clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body.For bacillary dysentery, acute gastroenteritis, acute appendicitis, mastitis, bleeding hemorrhoids, leucorrhea; Furuncle swelling toxin is controlled in external, eczema, herpes zoster.[extracts] " national Chinese herbal medicine compilation ".
Herba Potentillae Discoloris: Rosaceae potentilla plants Herba Potentillae Discoloris PotentilladiscolorBunge, is used as medicine with herb or root.Xia Qiu gathers, and cleans and dries.[nature and flavor] sweet, micro-hardship, flat.[function cures mainly] heat-clearing and toxic substances removing, cooling blood for hemostasis.For enteritis, bacillary dysentery, amebic dysentery, spit blood, epistaxis, has blood in stool, leucorrhea; Wound is controlled in external, carbuncle furuncle and phyma poison.[extracts] " national Chinese herbal medicine compilation ".
Maclura aurantiaca ketone (Macluraxanthone): CAS 5848-14-6, molecular formula C 23h 22o 6, molecular weight 394.42.[pharmacological action] expelling worm.[ingredient origin] Garcinia maingayii bakupari, Moraceae Maclura aurantiaca peel of stem.
Maclura aurantiaca ketone (Macluraxanthone).
Summary of the invention
The object of the invention is the deficiency overcoming background technology, pharmaceutical composition of a kind of effective treatment diabetic nephropathy and preparation method thereof is provided.
The present invention adopts following technical scheme to realize:
Composition and the weight portion of making the crude drug of the pharmaceutical composition of this treatment diabetic nephropathy are:
Folium Mori 90-110 weight portion, Semen arachidis hypogaeae branch and leaf 80-100 weight portion, Cortex Lycii 20-40 weight portion, purling withered tree root 50-70 weight portion, Fructus trachycarpi 40-60 weight portion, Thallus Laminariae (Thallus Eckloniae) 10-30 weight portion, Caulis et Folium Brassicae junceae stem and leaf 10-30 weight portion, Herba portulacae 10-30 weight portion, Herba Potentillae Discoloris 5-10 weight portion, Maclura aurantiaca ketone 3-5 weight portion.
Preferably be used for the treatment of the pharmaceutical composition of diabetes, be made up of the crude drug of following weight portion:
Folium Mori 100 weight portion, Semen arachidis hypogaeae branch and leaf 90 weight portion, Cortex Lycii 30 weight portion, purling withered tree root 60 weight portion, Fructus trachycarpi 50 weight portion, Thallus Laminariae (Thallus Eckloniae) 20 weight portion, Caulis et Folium Brassicae junceae stem and leaf 20 weight portion, Herba portulacae 20 weight portion, Herba Potentillae Discoloris 6 weight portion, Maclura aurantiaca ketone 4 weight portion.
Treat a pharmaceutical composition for diabetic nephropathy, it is characterized in that pharmaceutical composition can adopt the conventional method of galenic pharmacy to be prepared into tablet, capsule, drop pill.
Treat a pharmaceutical composition for diabetic nephropathy, it is characterized in that the treatment diabetes medicament that pharmaceutical composition and chemical drugs or Chinese medicine form.
Treat a preparation method for the pharmaceutical composition of diabetic nephropathy, it is characterized in that preparing as follows:
The composition of crude drug and weight portion are: Folium Mori 90-110 weight portion, Semen arachidis hypogaeae branch and leaf 80-100 weight portion, Cortex Lycii 20-40 weight portion, purling withered tree root 50-70 weight portion, Fructus trachycarpi 40-60 weight portion, Thallus Laminariae (Thallus Eckloniae) 10-30 weight portion, Caulis et Folium Brassicae junceae stem and leaf 10-30 weight portion, Herba portulacae 10-30 weight portion, Herba Potentillae Discoloris 5-10 weight portion, Maclura aurantiaca ketone 3-5 weight portion;
Preparation method:
(1) Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, purling withered tree root is got by crude drug proportioning, mixing, micronizing to 80 micron, with weight percent concentration 80% ethanol as solvent, 55 DEG C of warm macerating extract, and extraction time is 4 times, each extraction time is 1.5 hours, each solvent load be Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, 12 times of purling withered tree root medical material gross weight, filter, obtain medicinal residues A and extracting solution, extracting solution reclaims ethanol, concentrated, dry, obtain extract A;
(2) Fructus trachycarpi is got by crude drug proportioning, Thallus Laminariae (Thallus Eckloniae), Caulis et Folium Brassicae junceae stem and leaf, Herba portulacae, Herba Potentillae Discoloris, mixing, micronizing to 100 micron, and obtain medicinal residues A with step (1) and mix, be solvent with weight percent concentration 20% ethanol, heating and refluxing extraction, extraction time is 3 times, each extraction time is 2 hours, each solvent load is 14 times of above-mentioned medical material gross weight, filter, extracting solution reclaims ethanol, be concentrated into relative density 1.13, filter, medicinal liquid is by XDA-10 macroporous adsorptive resins, first wash with water, use the alcoholic solution eluting XDA-10 macroporous adsorptive resins of weight percent concentration 40% again, collect weight percent concentration 40% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) get Maclura aurantiaca ketone by crude drug proportioning, add extract A, extract B successively, mixing, obtains pharmaceutical composition.
Preferably treat a preparation method for the pharmaceutical composition of diabetic nephropathy, it is characterized in that preparing as follows:
The composition of crude drug and weight portion are: Folium Mori 100 weight portion, Semen arachidis hypogaeae branch and leaf 90 weight portion, Cortex Lycii 30 weight portion, purling withered tree root 60 weight portion, Fructus trachycarpi 50 weight portion, Thallus Laminariae (Thallus Eckloniae) 20 weight portion, Caulis et Folium Brassicae junceae stem and leaf 20 weight portion, Herba portulacae 20 weight portion, Herba Potentillae Discoloris 6 weight portion, Maclura aurantiaca ketone 4 weight portion;
Preparation method:
(1) Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, purling withered tree root is got by crude drug proportioning, mixing, micronizing to 80 micron, with weight percent concentration 80% ethanol as solvent, 55 DEG C of warm macerating extract, and extraction time is 4 times, each extraction time is 1.5 hours, each solvent load be Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, 12 times of purling withered tree root medical material gross weight, filter, obtain medicinal residues A and extracting solution, extracting solution reclaims ethanol, concentrated, dry, obtain extract A;
(2) Fructus trachycarpi is got by crude drug proportioning, Thallus Laminariae (Thallus Eckloniae), Caulis et Folium Brassicae junceae stem and leaf, Herba portulacae, Herba Potentillae Discoloris, mixing, micronizing to 100 micron, and obtain medicinal residues A with step (1) and mix, be solvent with weight percent concentration 20% ethanol, heating and refluxing extraction, extraction time is 3 times, each extraction time is 2 hours, each solvent load is 14 times of above-mentioned medical material gross weight, filter, extracting solution reclaims ethanol, be concentrated into relative density 1.13, filter, medicinal liquid is by XDA-10 macroporous adsorptive resins, first wash with water, use the alcoholic solution eluting XDA-10 macroporous adsorptive resins of weight percent concentration 40% again, collect weight percent concentration 40% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) get Maclura aurantiaca ketone by crude drug proportioning, add extract A, extract B successively, mixing, obtains pharmaceutical composition.
Treat a preparation method for the pharmaceutical composition of diabetic nephropathy, it is characterized in that pharmaceutical composition can adopt the conventional method of galenic pharmacy to be prepared into tablet, capsule, drop pill.
Treat a preparation method for the pharmaceutical composition of diabetic nephropathy, it is characterized in that the treatment diabetes medicament that pharmaceutical composition and chemical drugs or Chinese medicine form.
Pharmaceutical composition is evident in efficacy in treatment diabetic nephropathy.
Detailed description of the invention
Embodiment 1: pharmaceutical composition for the treatment of diabetic nephropathy and preparation method thereof
Composition and the weight portion of the crude drug of the pharmaceutical composition for the treatment of diabetic nephropathy are:
Folium Mori 100 weight portion, Semen arachidis hypogaeae branch and leaf 90 weight portion, Cortex Lycii 30 weight portion, purling withered tree root 60 weight portion, Fructus trachycarpi 50 weight portion, Thallus Laminariae (Thallus Eckloniae) 20 weight portion, Caulis et Folium Brassicae junceae stem and leaf 20 weight portion, Herba portulacae 20 weight portion, Herba Potentillae Discoloris 6 weight portion, Maclura aurantiaca ketone 4 weight portion;
Preparation method:
(1) Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, purling withered tree root is got by crude drug proportioning, mixing, micronizing to 80 micron, with weight percent concentration 80% ethanol as solvent, 55 DEG C of warm macerating extract, and extraction time is 4 times, each extraction time is 1.5 hours, each solvent load be Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, 12 times of purling withered tree root medical material gross weight, filter, obtain medicinal residues A and extracting solution, extracting solution reclaims ethanol, concentrated, dry, obtain extract A;
(2) Fructus trachycarpi is got by crude drug proportioning, Thallus Laminariae (Thallus Eckloniae), Caulis et Folium Brassicae junceae stem and leaf, Herba portulacae, Herba Potentillae Discoloris, mixing, micronizing to 100 micron, and obtain medicinal residues A with step (1) and mix, be solvent with weight percent concentration 20% ethanol, heating and refluxing extraction, extraction time is 3 times, each extraction time is 2 hours, each solvent load is 14 times of above-mentioned medical material gross weight, filter, extracting solution reclaims ethanol, be concentrated into relative density 1.13, filter, medicinal liquid is by XDA-10 macroporous adsorptive resins, first wash with water, use the alcoholic solution eluting XDA-10 macroporous adsorptive resins of weight percent concentration 40% again, collect weight percent concentration 40% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) get Maclura aurantiaca ketone by crude drug proportioning, add extract A, extract B successively, mixing, obtains pharmaceutical composition.
Embodiment 2: pharmaceutical composition for the treatment of diabetic nephropathy and preparation method thereof
Composition and the weight portion of the crude drug of the pharmaceutical composition for the treatment of diabetic nephropathy are:
Folium Mori 90 weight portion, Semen arachidis hypogaeae branch and leaf 100 weight portion, Cortex Lycii 20 weight portion, purling withered tree root 70 weight portion, Fructus trachycarpi 40 weight portion, Thallus Laminariae (Thallus Eckloniae) 30 weight portion, Caulis et Folium Brassicae junceae stem and leaf 10 weight portion, Herba portulacae 30 weight portion, Herba Potentillae Discoloris 5 weight portion, Maclura aurantiaca ketone 5 weight portion;
Preparation method:
(1) Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, purling withered tree root is got by crude drug proportioning, mixing, micronizing to 80 micron, with weight percent concentration 80% ethanol as solvent, 55 DEG C of warm macerating extract, and extraction time is 4 times, each extraction time is 1.5 hours, each solvent load be Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, 12 times of purling withered tree root medical material gross weight, filter, obtain medicinal residues A and extracting solution, extracting solution reclaims ethanol, concentrated, dry, obtain extract A;
(2) Fructus trachycarpi is got by crude drug proportioning, Thallus Laminariae (Thallus Eckloniae), Caulis et Folium Brassicae junceae stem and leaf, Herba portulacae, Herba Potentillae Discoloris, mixing, micronizing to 100 micron, and obtain medicinal residues A with step (1) and mix, be solvent with weight percent concentration 20% ethanol, heating and refluxing extraction, extraction time is 3 times, each extraction time is 2 hours, each solvent load is 14 times of above-mentioned medical material gross weight, filter, extracting solution reclaims ethanol, be concentrated into relative density 1.13, filter, medicinal liquid is by XDA-10 macroporous adsorptive resins, first wash with water, use the alcoholic solution eluting XDA-10 macroporous adsorptive resins of weight percent concentration 40% again, collect weight percent concentration 40% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) get Maclura aurantiaca ketone by crude drug proportioning, add extract A, extract B successively, mixing, obtains pharmaceutical composition.
Embodiment 3: pharmaceutical composition for the treatment of diabetic nephropathy and preparation method thereof
Composition and the weight portion of the crude drug of the pharmaceutical composition for the treatment of diabetes are:
Folium Mori 110 weight portion, Semen arachidis hypogaeae branch and leaf 80 weight portion, Cortex Lycii 40 weight portion, purling withered tree root 50 weight portion, Fructus trachycarpi 60 weight portion, Thallus Laminariae (Thallus Eckloniae) 10 weight portion, Caulis et Folium Brassicae junceae stem and leaf 30 weight portion, Herba portulacae 10 weight portion, Herba Potentillae Discoloris 10 weight portion, Maclura aurantiaca ketone 3 weight portion;
Preparation method:
(1) Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, purling withered tree root is got by crude drug proportioning, mixing, micronizing to 80 micron, with weight percent concentration 80% ethanol as solvent, 55 DEG C of warm macerating extract, and extraction time is 4 times, each extraction time is 1.5 hours, each solvent load be Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, 12 times of purling withered tree root medical material gross weight, filter, obtain medicinal residues A and extracting solution, extracting solution reclaims ethanol, concentrated, dry, obtain extract A;
(2) Fructus trachycarpi is got by crude drug proportioning, Thallus Laminariae (Thallus Eckloniae), Caulis et Folium Brassicae junceae stem and leaf, Herba portulacae, Herba Potentillae Discoloris, mixing, micronizing to 100 micron, and obtain medicinal residues A with step (1) and mix, be solvent with weight percent concentration 20% ethanol, heating and refluxing extraction, extraction time is 3 times, each extraction time is 2 hours, each solvent load is 14 times of above-mentioned medical material gross weight, filter, extracting solution reclaims ethanol, be concentrated into relative density 1.13, filter, medicinal liquid is by XDA-10 macroporous adsorptive resins, first wash with water, use the alcoholic solution eluting XDA-10 macroporous adsorptive resins of weight percent concentration 40% again, collect weight percent concentration 40% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) get Maclura aurantiaca ketone by crude drug proportioning, add extract A, extract B successively, mixing, obtains pharmaceutical composition.
Embodiment 4: the preparation of tablet
Example 1 compositions 155g, adds starch 45g and mixes, and granulates, dry, adds microcrystalline Cellulose 3g, magnesium stearate 2g, and mixing, is pressed into 1000, obtains present composition tablet.
Embodiment 5: the preparation of capsule
Example 2 compositions 180g, adds starch 45g, mixing, granulates, and dry, granulate, adds appropriate magnesium stearate, and mixing, obtains present composition capsule by encapsulated 1000.
Embodiment 6: the preparation of drop pill
Taking polyethylene glycol 6000 250g water-bath (80 DEG C) heating boils molten, add embodiment 3 compositions 20g, stirring, is coolant with liquid paraffin, puts in glass tubing (4*80cm), chilling temperature is 2 DEG C, drip internal-and external diameter is 7.0/2.0 (mm/mm), and drip is 2cm apart from liquid level, drips speed with per minute 60 for optimum condition, blot the condensing agent on drop pill surface with cotton, obtain present composition drop pill.
Embodiment 7: the pharmaceutical composition for the treatment of diabetic nephropathy
Composition and the weight portion of the crude drug of the pharmaceutical composition for the treatment of diabetic nephropathy are: Folium Mori weight portion 100, Cortex Lycii weight portion 20, purling withered tree root weight portion 50, Maclura aurantiaca ketone 1 weight portion.
Embodiment 8: the pharmaceutical composition for the treatment of diabetes
Composition and the weight portion of the crude drug of the pharmaceutical composition for the treatment of diabetic nephropathy are: Folium Mori weight portion 40, Cortex Lycii weight portion 80, purling withered tree root weight portion 30, Maclura aurantiaca ketone 3 weight portion.
Embodiment 9: the pharmaceutical composition for the treatment of diabetic nephropathy
Composition and the weight portion of the crude drug of the pharmaceutical composition for the treatment of diabetic nephropathy are: Folium Mori weight portion 50, Cortex Lycii weight portion 50, purling withered tree root weight portion 50, Maclura aurantiaca ketone 2 weight portion.
Experimental example 1: the experimental study for the treatment of diabetic nephropathy
1 clinical data
DN patient's (caused by liver and kidney deficiency, blood stasis turbid damp type) that 80 examples are collected during being in January, 2011-2013 year February.TCM syndrome diagnostic criteria is with reference to " new Chinese medicine guideline of clinical investigations ", and differentiation of symptoms and signs for classification of syndrome standard is with reference to " diabetic nephropathy diagnosis, differentiation of symptoms and signs for classification of syndrome and efficacy assessment standard (tentative program) ".DM diagnostic criteria is formulated with reference to the diabetes diagnostic criterion of WHO diabetes study group proposition in 1999.80 routine patients are divided into treatment group and matched group at random, treatment group 40 example, matched group 40 example.Treat front 2 groups of Genders, age, diabetic duration, diabetic nephropathy course of disease formation etc. to compare, no significant difference (P > 0.05), illustrates that 2 groups of patients have comparability.
2 methods
2.1 Therapeutic Method
2 groups of patients all adopt Primary Care.Treatment group adds pharmaceutical composition (embodiment 1 pharmaceutical composition lot number 20091212) while Primary Care, each 1g, and 3 times/day oral; Matched group adds with Benazepril hydrochloride contents in tablets (lotensin, Novartis Pharma AG produces, the accurate word H20030514 of traditional Chinese medicines) 10mg while above-mentioned Primary Care, 1 times/day, oral.Within 2 months, be 1 course for the treatment of, observe 1 course for the treatment of altogether.
2.2 observation index
Fasting glucose (FBG), 2h-plasma glucose (2hPG), glycolated hemoglobin (HbA1c) is detected, 24hUpro, UAER respectively at before and after treatment.
2.3 efficacy determination
The standard of curative effect evaluation is evaluated with reference to " new Chinese medicine guideline of clinical investigations ".
2.4 statistical method
Adopt the process of SPSS17.0 statistical software.Routine carries out homogeneity test of variance and Normal distribution test, and measurement data represents with (x ± s), and measurement data compares employing t inspection, and 2 groups of effective percentage compare employing X 2 test, and test statistics meaning is set to P < 0.05.
3 therapeutic outcomes
After 3.1 treatments, two groups of comprehensive therapeutic effects compare
Two groups of comprehensive therapeutic effects compare, and treatment group is significantly better than matched group, in table 1.
Table 1 is treated rear two groups of comprehensive therapeutic effects and is compared
Group Number of cases Effective Effectively Invalid Total effective rate/%
Treatment group 40 16 22 2 95.00 ##
Matched group 40 10 22 8 80.00
Note: compare between group, ##p < 0.05.
Two groups of FBG, 2hPG, HbA before and after 3.2 treatments 1c comparitive study
Two groups of FBG, 2hPG, HbA after treatment 1before c all comparatively treats, obviously, treatment group is better than matched group, in table 2 in change.
Table 2 treats front and back two groups of FBG, 2hPG, HbA 1c comparitive study (x ± s)
Note: compare with before treatment, ##p < 0.05.
Two groups of 24hUpro, UAER comparitive study before and after 3.3 treatments
Before and after treatment, 24hUpro, UAER all change, and treatment group is better than matched group, in table 3.
Two groups of 24hUpro, UAER comparitive study (x ± s) in front and back treated by table 3
Note: compare with before treatment, ##p < 0.05; Compare with after treatment of control group, △p < 0.05.
Result of study shows, pharmaceutical composition obviously can improve the clinical symptoms of DN patient, reduces 24hUpro, UAER, and effect is obviously better than contrast medicine lotensin.
Experimental example 2 model case:
Lee XX, man, 62 years old, previously hypertension more than 10 year, blood pressure is up to 230/100mmHg, diabetic history 10 years, discontinuity edema 5 years, malaise 1 month, abdominal distention, nausea and vomiting, hypourocrinia (every day is 500 ~ 800ml about), urine foam increased, in local township hospital 10 days, therapeutic effect is poor, goes to a doctor subsequently not obvious in provincial hospital treatment curative effect, checks: urine PRO++, twenty-four-hour urine protein quantification 15.18g/24 hour, blood urea nitrogen 11.9mmoL/L, creatinine 342umoL/L.Within 2013, JIUYUE starts combination of oral medication (embodiment 1 pharmaceutical composition lot number 20091212), each 1g, 3 times/day on 21st, after 60 days, result of laboratory test is shown: urine PRO+, and pressure value is tending towards normal, hydrosarca and malaise transference cure, spirit, appetite, sleep, serum creatinine 135.5 μm of ol/L, blood urea nitrogen 7.2mmol/L, fasting glucose 5.6mmol/L, 2 hours blood glucose 7.8mmol/L after the meal, stable disease is left hospital.
Liu XX, female, 51 years old, once suffer from diabetes 11 years, in November, 2000 started insulin injection, every day 56 unit, now urine protein has occurred 3 years, general ++ ~ +++, renal function moderate is impaired, and before treatment, blood urea nitrogen reaches 12.68mmol/L, creatinine 312 μm of ol/L.In addition diabetes mellitus's classical symptom is serious, and " three-many-one-little " is obvious, and lethargy is depressed.Start combination of oral medication (embodiment 1 pharmaceutical composition lot number 20091212) in July, 2013, each 1g, 3 times/day, after 60 days, blood urea nitrogen 8.9mmol/L, creatinine 230 μm of ol/L, treat after 6 months and chemically examine, blood urea nitrogen 5.07mmol/L, creatinine 130 μm of ol/L.Diabetic symptom disappears substantially, and spirit takes a turn for the better.

Claims (8)

1. treat a pharmaceutical composition for diabetic nephropathy, it is characterized in that the composition of the crude drug making this pharmaceutical composition and weight portion are:
Folium Mori 90-110 weight portion, Semen arachidis hypogaeae branch and leaf 80-100 weight portion, Cortex Lycii 20-40 weight portion, purling withered tree root 50-70 weight portion, Fructus trachycarpi 40-60 weight portion, Thallus Laminariae (Thallus Eckloniae) 10-30 weight portion, Caulis et Folium Brassicae junceae stem and leaf 10-30 weight portion, Herba portulacae 10-30 weight portion, Herba Potentillae Discoloris 5-10 weight portion, Maclura aurantiaca ketone 3-5 weight portion.
2. a kind of pharmaceutical composition for the treatment of diabetic nephropathy according to claim 1, is characterized in that the composition of the crude drug making this pharmaceutical composition and weight portion are:
Folium Mori 100 weight portion, Semen arachidis hypogaeae branch and leaf 90 weight portion, Cortex Lycii 30 weight portion, purling withered tree root 60 weight portion, Fructus trachycarpi 50 weight portion, Thallus Laminariae (Thallus Eckloniae) 20 weight portion, Caulis et Folium Brassicae junceae stem and leaf 20 weight portion, Herba portulacae 20 weight portion, Herba Potentillae Discoloris 6 weight portion, Maclura aurantiaca ketone 4 weight portion.
3. a kind of pharmaceutical composition for the treatment of diabetic nephropathy according to claim 1, is characterized in that pharmaceutical composition can adopt the conventional method of galenic pharmacy to be prepared into tablet or capsule or drop pill.
4. a kind of pharmaceutical composition for the treatment of diabetic nephropathy according to claim 1, is characterized in that the treatment medicine for treating diabetic nephropathy that pharmaceutical composition and chemical drugs or Chinese medicine form.
5. treat a preparation method for the pharmaceutical composition of diabetic nephropathy, it is characterized in that preparing as follows:
The composition of crude drug and weight portion are: Folium Mori 90-110 weight portion, Semen arachidis hypogaeae branch and leaf 80-100 weight portion, Cortex Lycii 20-40 weight portion, purling withered tree root 50-70 weight portion, Fructus trachycarpi 40-60 weight portion, Thallus Laminariae (Thallus Eckloniae) 10-30 weight portion, Caulis et Folium Brassicae junceae stem and leaf 10-30 weight portion, Herba portulacae 10-30 weight portion, Herba Potentillae Discoloris 5-10 weight portion, Maclura aurantiaca ketone 3-5 weight portion;
Preparation method:
(1) Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, purling withered tree root is got by crude drug proportioning, mixing, micronizing to 80 micron, with weight percent concentration 80% ethanol as solvent, 55 DEG C of warm macerating extract, and extraction time is 4 times, each extraction time is 1.5 hours, each solvent load be Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, 12 times of purling withered tree root medical material gross weight, filter, obtain medicinal residues A and extracting solution, extracting solution reclaims ethanol, concentrated, dry, obtain extract A;
(2) Fructus trachycarpi is got by crude drug proportioning, Thallus Laminariae (Thallus Eckloniae), Caulis et Folium Brassicae junceae stem and leaf, Herba portulacae, Herba Potentillae Discoloris, mixing, micronizing to 100 micron, and obtain medicinal residues A with step (1) and mix, be solvent with weight percent concentration 20% ethanol, heating and refluxing extraction, extraction time is 3 times, each extraction time is 2 hours, each solvent load is 14 times of above-mentioned medical material gross weight, filter, extracting solution reclaims ethanol, be concentrated into relative density 1.13, filter, medicinal liquid is by XDA-10 macroporous adsorptive resins, first wash with water, use the alcoholic solution eluting XDA-10 macroporous adsorptive resins of weight percent concentration 40% again, collect weight percent concentration 40% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) get Maclura aurantiaca ketone by crude drug proportioning, add extract A, extract B successively, mixing, obtains pharmaceutical composition.
6. a kind of preparation method for the treatment of the pharmaceutical composition of diabetic nephropathy according to claim 5, is characterized in that preparing as follows:
The composition of crude drug and weight portion are: Folium Mori 100 weight portion, Semen arachidis hypogaeae branch and leaf 90 weight portion, Cortex Lycii 30 weight portion, purling withered tree root 60 weight portion, Fructus trachycarpi 50 weight portion, Thallus Laminariae (Thallus Eckloniae) 20 weight portion, Caulis et Folium Brassicae junceae stem and leaf 20 weight portion, Herba portulacae 20 weight portion, Herba Potentillae Discoloris 6 weight portion, Maclura aurantiaca ketone 4 weight portion;
Preparation method:
(1) Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, purling withered tree root is got by crude drug proportioning, mixing, micronizing to 80 micron, with weight percent concentration 80% ethanol as solvent, 55 DEG C of warm macerating extract, and extraction time is 4 times, each extraction time is 1.5 hours, each solvent load be Folium Mori, Semen arachidis hypogaeae branch and leaf, Cortex Lycii, 12 times of purling withered tree root medical material gross weight, filter, obtain medicinal residues A and extracting solution, extracting solution reclaims ethanol, concentrated, dry, obtain extract A;
(2) Fructus trachycarpi is got by crude drug proportioning, Thallus Laminariae (Thallus Eckloniae), Caulis et Folium Brassicae junceae stem and leaf, Herba portulacae, Herba Potentillae Discoloris, mixing, micronizing to 100 micron, and obtain medicinal residues A with step (1) and mix, be solvent with weight percent concentration 20% ethanol, heating and refluxing extraction, extraction time is 3 times, each extraction time is 2 hours, each solvent load is 14 times of above-mentioned medical material gross weight, filter, extracting solution reclaims ethanol, be concentrated into relative density 1.13, filter, medicinal liquid is by XDA-10 macroporous adsorptive resins, first wash with water, use the alcoholic solution eluting XDA-10 macroporous adsorptive resins of weight percent concentration 40% again, collect weight percent concentration 40% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) get Maclura aurantiaca ketone by crude drug proportioning, add extract A, extract B successively, mixing, obtains pharmaceutical composition.
7. a kind of preparation method for the treatment of the pharmaceutical composition of diabetic nephropathy according to claim 5, is characterized in that pharmaceutical composition can adopt the conventional method of galenic pharmacy to be prepared into tablet or capsule or drop pill.
8. a kind of preparation method for the treatment of the pharmaceutical composition of diabetic nephropathy according to claim 5, is characterized in that pharmaceutical composition and chemical drugs or Chinese medicine form and treats medicine for treating diabetic nephropathy.
CN201610047032.6A 2016-01-25 2016-01-25 Medicine composition for treating diabetic nephropathy and preparation method thereof Withdrawn CN105560694A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116832082A (en) * 2023-07-13 2023-10-03 海南医学院 A radix seu cortex Litseae Rubrae extract, its preparation method and application in preparing medicine for treating and/or preventing cardiovascular diseases
CN116832082B (en) * 2023-07-13 2024-05-17 海南医学院 A radix seu cortex Litseae Rubrae extract, its preparation method and application in preparing medicine for treating and/or preventing cardiovascular diseases

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116832082A (en) * 2023-07-13 2023-10-03 海南医学院 A radix seu cortex Litseae Rubrae extract, its preparation method and application in preparing medicine for treating and/or preventing cardiovascular diseases
CN116832082B (en) * 2023-07-13 2024-05-17 海南医学院 A radix seu cortex Litseae Rubrae extract, its preparation method and application in preparing medicine for treating and/or preventing cardiovascular diseases

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Application publication date: 20160511