CN106377622A - Traditional Chinese medicine for treating early diabetic nephropathy and preparation method thereof - Google Patents
Traditional Chinese medicine for treating early diabetic nephropathy and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/62—Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- 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)
- A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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)
- A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
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- 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)
- A61K36/57—Magnoliaceae (Magnolia family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/68—Plantaginaceae (Plantain Family)
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- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/738—Rosa (rose)
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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
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/79—Schisandraceae (Schisandra family)
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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
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention discloses a traditional Chinese medicine for treating early diabetic nephropathy and a preparation method thereof. The traditional Chinese medicine is prepared from the following active pharmaceutical ingredients in parts by weight: 15-25 parts of dodder, 15-25 parts of wolfberry fruit, 5-15 parts of schisandra fruit, 5-15 parts of Plantain seed, 25-35 parts of cherokee rose, 1-5 parts of hirudo and 4-8 parts of pseudo-ginseng. The preparation method comprises the following steps: performing ethanol reflux on the dodder, wolfberry fruit, schisandra fruit, Plantain seed, cherokee rose and pseudo-ginseng; and decocting the hirudo and alcohol extraction dregs in water to obtain the preparation. The traditional Chinese medicine has an effect for treating early diabetic nephropathy, wherein symptoms of the early diabetic nephropathy include soreness and weakness of the waist and knees or pain in heel, tinnitus, deafness, alopecia, gomphiasis, urine dribbling, foam in urine or turbid urine accompanied by limb numbness, dark purple tongue or tongue with ecchymosis or petechiae, purple sublingual vein and uneven pulse; since the natural plants are used, no obvious toxic or side effect is found in the research, and the traditional Chinese medicine has high safety; and the product can be made into pharmaceutical granules, tablets and capsules, and can be widely used.
Description
Technical field
The present invention relates to technical field of Chinese medicines, more particularly, to a kind of Chinese medicine treating early diabetic nephropathy and its preparation side
Method and application.
Background technology
Diabetic nephropathy (diabetic nephropathy, DN) is the microvascular complication of the most common most serious of diabetes
One of.There is research that Chinese inpatient retrospective analysis is shown, the prevalence of type 2 diabetes mellitus Nephropathy is 34.7%.DN master
It is characterized as that lasting albuminuria, renal function progressive go down and higher cardiovascular disease incidence rate and mortality rate.Research table
Bright, DN is the first cause of type 1 diabetes death；In type 2 diabetes mellitus (T2DM) patient, its harm is only second to heart and brain blood
Pipe disease.At present, in European some developed countries and the U.S., Japan etc., DN is first reason leading to end stagerenaldisease,
And in China, DN has also become the second disease being to lead to end stagerenaldisease.These patients finally need dialysis or renal transplantation
To sustain life, to account for the 40% of whole latter stage acceptance dialysis.Because the symptom of DN early stage is few, it is difficult to be noticeable, having substantially
Albuminuria or occur just being found during edema.Regrettably, once there is clinical DN, lacking effective ways and stoping its development, greatly
Proceed to chronic renal failure after most patient's several years, therefore, improve to the understanding of DN early lesion and take as early as possible and effectively arrange
Apply, be the key controlling DN.
Say from doctor trained in Western medicine angle, the pathogeny of diabetic nephropathy is completely clear and definite not yet, it is now recognized that sending out with diabetic nephropathy
Pathogenesis is formed with pass factor and not only includes previously studying for example lasting hyperglycemia of more factor, Advanced glycation endproducts, egg
Outside the activation of white kinase c, oxidative stress, also include inflammation, the insulin significantly increasing itself and chain with insulin gene
Amylin level increase, these factors can influence each other again, collective effect.And its diagnosis basis of early diabetic nephropathy are
The detection of microdose urine protein.
Say from traditional Chinese medical science angle, the normalized names of disease of tcm of diabetic nephropathy is to quench one's thirst nephropathy, because of diabetes with the passing of time, prolonged illness and
Kidney, kidney qi virtual loss, lose and hide in envelope, essence is closed admittedly, and astringency inducing is had no right, cause bladder folding unfavorable, gasification is not normal, and sees turbid urine.Nephrons
Injured, not all right, damp and hot interior life of gasifying, damp and hot unit of being more impairment of the kidney, kidney mistake is astringent or styptic treatment for spontaneous sweating, lets out and see albuminuria under essence of water and grain.Disappear simultaneously
It is thirsty that with the passing of time lung spleen kidney three is dirty impaired, and three dirty among crucial in kidney.Kidney yang deficiency, difficulty in urination due to hypofunction of the kidney, then very, gas damages blood to pathogenic water benefit
Row is powerless, must cause raw in blood stasis, blood stasis due to renal deficiency is the main pathological basis of diabetic nephropathy.Symptoms include soreness of the waist and knees, tinnitus, urine have
In urine, foam is many or turbid urine etc..
Diabetic nephropathy there is no specific short, and clinical treatment management includes glycemic control, dietary management and other life sides
Formula management, controlling of blood pressure and RAAS intervene, and do not have more new means, and the medicine of current field of Chinese medicines treatment albumen urine does not have
Targetedly, and curative effect is not obvious, take effect more slow, this Chinese medicine can be directed to pathogenesis, determined curative effect.
Content of the invention
The present invention provides a kind of evident in efficacy, Chinese medicine and its preparation side for the treatment of early diabetic nephropathy of Small side effects
Method, solve existing Western medicine large side effects the problems such as.
The present invention employs the following technical solutions：A kind of Chinese medicine treating early diabetic nephropathy, by following parts by weight
Crude drug is made：Semen Cuscutae 15-25 part, Fructus Lycii 15-25 part, Fructus Schisandrae Chinensis 5-15 part, Semen Plantaginiss 5-15 part, Fructus Rosae Laevigatae 25-35
Part, Hirudo 1-5 part, Radix Notoginseng 4-8 part.
The Chinese medicine of described treatment early diabetic nephropathy, is made up of the crude drug of following parts by weight：20 parts of Semen Cuscutae, Chinese holly
20 parts of Fructus Lycii, 10 parts of Fructus Schisandrae Chinensis, 10 parts of Semen Plantaginiss, 30 parts of Fructus Rosae Laevigatae, 3 parts of Hirudo, 6 parts of Radix Notoginseng.
The Chinese medicine of described treatment early diabetic nephropathy, described Semen Cuscutae is Fructus Arctii (parched), and Fructus Schisandrae Chinensis are processed with vinegar Fructus Schisandrae Chinensis,
Semen Plantaginiss are Semen Plantaginis (parched), and Hirudo is stir-baked HIRUDO.
The Chinese medicine of described treatment early diabetic nephropathy, preparation method comprises the following steps：
a：Weigh Semen Cuscutae, Fructus Lycii, Fructus Schisandrae Chinensis, Semen Plantaginiss, Fructus Rosae Laevigatae, Radix Notoginseng by described portion rate, through alcohol reflux
Extract, filter, reclaim ethanol, be concentrated to give alcohol extracting concentrate；
b：Weigh Hirudo by described portion rate, merge with the medicinal residues after alcohol reflux in step a, boil through decocting, mistake
Filter, concentrates, and cooling, plus ethanol, precipitate with ethanol obtain water extract-alcohol precipitation concentrated solution, by the alcohol extracting concentrate of water extract-alcohol precipitation concentrated solution and step a
Merge, after concentrating under reduced pressure, drying, make extract dry powder；
c：Extract dry powder in step b is carried out wet granulation, is dried, plus adjuvant is prepared into granule or tablet or capsule
Agent.
The Chinese medicine of described treatment early diabetic nephropathy, alcohol reflux 3 times in preparation method step a, flow back every time
1.5 hours, add 5 times amount that amount of alcohol is crude drug weight every time, ethanol volumetric concentration is 70%, united extraction liquid filters, filter
Liquid concentrating under reduced pressure reclaims ethanol, obtains alcohol extracting concentrate.
The Chinese medicine of described treatment early diabetic nephropathy, adds water to cook 2 times in preparation method step b, 2 hours every time, often
The secondary amount that adds water is 10 times of crude drug weight, merges decocting liquid twice, filters, and concentrates filtrate to and surveys relatively when 60 DEG C
Density is 1g/ml, cooling, plus ethanol reaches 60% to alcohol content volume ratio, stirs, and is centrifuged, centrifuge after placing 48 hours
4800 revs/min of speed, discards precipitation, reclaims centrifugal liquid, merges with alcohol extracting concentrate in step a, makes after concentrating under reduced pressure, drying
Extract dry powder.
The alcohol extraction of water extract-alcohol precipitation concentrated solution and step a is concentrated in step b by the Chinese medicine of described treatment early diabetic nephropathy
Liquid merges, and is vacuum dried, obtains extract dry powder after concentrating under reduced pressure under the conditions of 70 DEG C.
Application in the medicine of preparation treatment early diabetic nephropathy for the Chinese medicine of described treatment early diabetic nephropathy.
Application in the medicine of preparation treatment early diabetic nephropathy for the Chinese medicine of described treatment early diabetic nephropathy, institute
Stating early diabetic nephropathy is kidney deficiency blood stasis type early diabetic nephropathy, symptoms include soreness of the waist and knees or talalgia, Hiccough and deaf, loss of hairs
Luxated tooth, urine have Yu drip, foam is many in urine or turbid urine, with seeing numb limbs and tense tendons, purplish tongue or have ecchymosis, petechia, the tongue bottom vein stasis of blood
Purple, hesitant pulse.
Of the present invention a kind of treat Chinese medicine of early diabetic nephropathy and preparation method thereof adopt above technical scheme with
Prior art is compared, and has following technique effect：1st, the Chinese medicine preparation of the present invention shows with kidney tonifying admittedly through clinical study results
Take the photograph, promoting blood circulation to remove obstruction in the collateral acts on.2nd, adopt natural plants, be not found obvious toxic and side effects, safe, this product under study for action
Make and can make tablet pharmaceutically, capsule or granule.3rd, the present invention cures mainly：Early diabetic nephropathy, symptoms include waist and knee
Aching and limp or talalgia, Hiccough and deaf, loss of hairs luxated tooth, urine have Yu drip, foam is many in urine or turbid urine, purple with seeing numb limbs and tense tendons, body of the tongue
Dark or have ecchymosis, petechia, the tongue bottom vein stasis of blood is purple, hesitant pulse.The rule for the treatment of：Kidney tonifying astringency inducing, promoting blood circulation to remove obstruction in the collateral.Fang Xie：Fructus Lycii, Herba cuscutae in side
Son is monarch drug the kidney invigorating and essence nourishing, and Semen Cuscutae is the product of tonifying both YIN and YANG simply, its kidney invigorating and essence nourishing, help the moon and and oiliness, warming YANG and not dry；
Fructus Lycii is good at replenishing essence and is enriched blood, two medicines equal enter liver kidney channel, can nourishing liver and kidney；Fructus Schisandrae Chinensis and Fructus Rosae Laevigatae subsystem party ministerial drug, Fructus Schisandrae Chinensis
It is that the five tastes are all standby, and tart flavour is the denseest, effect is invigorating middle warmer puckery, the kidney invigorating of astringing the lung of residence；And Fructus Rosae Laevigatae sour in the mouth, sweet, puckery, mild-natured, can controlling nocturnal emission with astringent drugs
Reducing urination；We are wonderful in assistant with Herba Plantaginis simply, rush down and lead to it, and it is turbid to rush down tangible heresy, puckery in and logical, benefit and not stagnant, heat clearing away can be played and ooze
The using corrigent effect of wet diuresis, Radix Notoginseng, Hirudo promoting blood circulation to remove obstruction in the collateral are to make medicine, pseudo-ginseng blood-circulation-invigovating blood stasis dispelling, Hirudo promoting blood circulation to remove obstruction in the collateral, and priming enters kidney
Network, square invigorating middle warmer entirely has and rushes down, puckery in favourable, have benefit in rushing down, long term usage and oiliness, kidney tonifying astringency inducing, promoting blood circulation to remove obstruction in the collateral.
Specific embodiment
Below in conjunction with example, the invention will be further described, and embodiment is only used for that the present invention will be described, not
Constitute restriction to right, it may occur to persons skilled in the art that other alternative means, all in right of the present invention
In claimed range.
In the present invention, Radix Notoginseng is the drying of panax araliaceae plant Parmx notoginseng (Burk.) F.H.Chen
Root and rhizome.Hirudo is Hirudinidae animal whitmania W/i＆mcznia pigra Whitman, Hirudo Hirudo for this product
Being dried of nipponica Whitman or Folium Salicis Babylonicae Hirudo W/iifmamaacranulata W hitman is all.Fructus Schisandrae Chinensis for
The dry mature fruit of magnoliaceae schisandra Schisandra chinensis (Turcz.) Baill..Semen Plantaginiss are Herba Plantaginis
The dry mature seed of section plant Herba Plantaginis Plantago asiatica L or Plantago depressa Willd Plantago depressa Willd..
Gold is the dry mature fruit of rosaceous plant gold laevigata Michx..Fructus Lycii is swallow section plant Ningxia
The dry mature fruit of Fructus Lycii Lycium barbarum L..Semen Cuscutae is convolvulaceous plant Cuscuta australis Cwscwia
Australis R.Br. or the dry mature seed of Semen Cuscutae Cuscuta chinensis Lam..Concentration of alcohol described herein
For volumetric concentration.Semen Cuscutae of the present invention is Fructus Arctii (parched), and Fructus Schisandrae Chinensis are processed with vinegar Fructus Schisandrae Chinensis, and Semen Plantaginiss are Semen Plantaginis (parched), water
Trematodiasiss are stir-baked HIRUDO.
Embodiment 1：
Weigh Semen Cuscutae 20g, Fructus Lycii 20g, Fructus Schisandrae Chinensis 10g, Semen Plantaginiss 10g, Fructus Rosae Laevigatae 30g, Hirudo 3g, Radix Notoginseng 6g.
A. take Semen Cuscutae, Fructus Lycii, Fructus Schisandrae Chinensis, Semen Plantaginiss, Fructus Rosae Laevigatae, Radix Notoginseng, alcohol reflux 3 times, flow back every time
1.5 hours, add 5 times amount that amount of alcohol is crude drug weight every time, ethanol volumetric concentration is 70%, united extraction liquid filters, filter
Liquid concentrating under reduced pressure reclaims ethanol, obtains alcohol extracting concentrate；
B. weigh Hirudo by described portion rate, with step a in through volumetric concentration be 70% alcohol reflux after medicine
Slag merges, and adds water to cook 2 times, 2 hours every time, the amount adding water every time was 10 times of crude drug weight, merges decocting liquid twice, mistake
Filter, concentrating filtrate to and surveying relative density when 60 DEG C is 1g/ml, cooling, plus ethanol reaches 60% to alcohol content volume ratio, stirs
Mix uniformly, be centrifuged after placing 48 hours, 4800 revs/min of centrifuge speed, discard precipitation, reclaim alcohol extraction in centrifugal liquid, with step a
Concentrated solution merges, and is vacuum dried, obtains extract dry powder after concentrating under reduced pressure under the conditions of 70 DEG C；
c：Extract dry powder in step b is carried out wet granulation, is dried, plus starch is prepared into granule.
Embodiment 2：
Weigh Semen Cuscutae 15g, Fructus Lycii 25g, Fructus Schisandrae Chinensis 5g, Semen Plantaginiss 15g, Fructus Rosae Laevigatae 25g, Hirudo 5g, Radix Notoginseng 4g.
A. take Semen Cuscutae, Fructus Lycii, Fructus Schisandrae Chinensis, Semen Plantaginiss, Fructus Rosae Laevigatae, Radix Notoginseng, alcohol reflux 3 times, flow back every time
1.5 hours, add 5 times amount that amount of alcohol is crude drug weight every time, ethanol volumetric concentration is 70%, united extraction liquid filters, filter
Liquid concentrating under reduced pressure reclaims ethanol, obtains alcohol extracting concentrate；
B. weigh Hirudo by described portion rate, with step a in through volumetric concentration be 70% alcohol reflux after medicine
Slag merges, and adds water to cook 2 times, 2 hours every time, the amount adding water every time was 10 times of crude drug weight, merges decocting liquid twice, mistake
Filter, concentrating filtrate to and surveying relative density when 60 DEG C is 1g/ml, cooling, plus ethanol reaches 60% to alcohol content volume ratio, stirs
Mix uniformly, be centrifuged after placing 48 hours, 4800 revs/min of centrifuge speed, discard precipitation, reclaim alcohol extraction in centrifugal liquid, with step a
Concentrated solution merges, and is vacuum dried, obtains extract dry powder after concentrating under reduced pressure under the conditions of 70 DEG C；
c：Extract dry powder in step b is carried out wet granulation, is dried, plus starch, tabletting, prepare piece agent.
Embodiment 3：
Weigh Semen Cuscutae 25g, Fructus Lycii 15g, Fructus Schisandrae Chinensis 15g, Semen Plantaginiss 5g, Fructus Rosae Laevigatae 35g, Hirudo 1g, Radix Notoginseng 8g.
A. take Semen Cuscutae, Fructus Lycii, Fructus Schisandrae Chinensis, Semen Plantaginiss, Fructus Rosae Laevigatae, Radix Notoginseng, alcohol reflux 3 times, flow back every time
1.5 hours, add 5 times amount that amount of alcohol is crude drug weight every time, ethanol volumetric concentration is 70%, united extraction liquid filters, filter
Liquid concentrating under reduced pressure reclaims ethanol, obtains alcohol extracting concentrate；
B. weigh Hirudo by described portion rate, with step a in through volumetric concentration be 70% alcohol reflux after medicine
Slag merges, and adds water to cook 2 times, 2 hours every time, the amount adding water every time was 10 times of crude drug weight, merges decocting liquid twice, mistake
Filter, concentrating filtrate to and surveying relative density when 60 DEG C is 1g/ml, cooling, plus ethanol reaches 60% to alcohol content volume ratio, stirs
Mix uniformly, be centrifuged after placing 48 hours, 4800 revs/min of centrifuge speed, discard precipitation, reclaim alcohol extraction in centrifugal liquid, with step a
Concentrated solution merges, and is vacuum dried, obtains extract dry powder after concentrating under reduced pressure under the conditions of 70 DEG C；
c：Extract dry powder in step b is carried out wet granulation, is dried, plus starch, encapsulating capsule, it is prepared into capsule.
Embodiment 4：The present invention treats the clinical observation experiment of early diabetic nephropathy
Early diabetic nephropathy diagnostic criteria：Will according to the course of disease and Pathophysiology evolution process according to Mogensen in 1987
The change of diabetes kidney was divided into for 5 phases, and weight is proportionate with glomerular sclerosiss degree.III phase：The early diabetic nephropathy phase.GFR
Substantially normal；UAE continues 20～200 μ g/min (or 30～300mg/24h).
TCM syndrome diagnostic criteria：With reference to (national combination of Chinese and Western medicine deficiency syndrome and senile disease research Professional Committee《The traditional Chinese medical science is empty
Demonstrate,prove dialectical reference standard》And Chinese medicine (new drug) guideline of clinical investigations (trying)《Syndrome of blood stasis》Formulate early diabetic nephropathy kidney
The diagnostic criteria of empty syndrome of blood stasis.
Nephrasthenia syndrome
1. ache of the spinal column；2. soreness of the shank knee joint is soft or talalgia；3. Hiccough and deaf；4. loss of hairs luxated tooth；5. urine has Yu drip or incontinence；
6. sexual hypofunction, sterile, infertile.Possess three and can be diagnosed as kidney deficiency.
Syndrome of blood stasis
Primary symptom：Twinge, localized pain, tenderness, (such as lip, tooth eye, onyx are purple dark, the red thread of skin table, or abdomen for venation blood stasis
Portion's blue veins exposes), subcutaneous paralysis speckle, amass, blood circulating out of vessels, purplish tongue or have ecchymosis, petechia, tongue arteries and veins is slightly opened, hesitant pulse, pulsus deletuss or
Heavy string, stringy and slow pulse.
Secondary disease：Squamous and dry skin, numb limbs and tense tendons or hemiplegia, insane, manic, forgetful, topoparesthesia of being crazy about, trauma history, operation
History and history of artificial abortion.
Syndrome of blood stasis primary symptom 2, or primary symptom I item, secondary disease 2, you can diagnosis.
Therapeutic Method：According to early diabetic nephropathy diagnostic criteria and TCM syndrome diagnostic criteria, choose 32 early stage sugar
The sick nephrotic of urine, takes the granule of above-described embodiment 1 method preparation, 3 times a day, every time 1 bag, often wraps 10 grams, take 2
Month, observation index：On-test and detection of end microdose urine protein/creatinine, microdose urine protein, urinal beta2 microglobulin, urine α
Each 1 time of 1 microglobulin.Use kidney tonifying astringency inducing in advance, HuoXueTongLuo oral Liquor has treated 32 early diabetic nephropathy patients, by treatment
Own control in front and back, is counted using SPSS 16.0, is tested from two groups of paired samples, selects non parametric testss.Urine is micro
P value before and after albumin/creatinine, microdose urine protein, Urinary α1-microglobulin are treated is respectively：0.000th, 0.001,0.000, p<
0.01, there is significant difference, before and after urinal beta2 microglobulin treatment, p value is respectively 0.02, p<0.05, there is statistical significance.
Before and after treatment, microdose urine protein/creatinine, microdose urine protein, urinal beta2 microglobulin, Urinary α1-microglobulin compare：
(P<0.01, comparing presence before and after treatment statistically has significant difference.P<Presence system is compared before and after 0.05 treatment
Variant on meter)
Result explanation：By the clinical observation of 32 early diabetic nephropathies, find that the present invention can be obviously improved patient's waist
The symptom such as knees soreness or talalgia, Hiccough and deaf, loss of hairs luxated tooth, urine have Yu drip, foam is many in urine, and it is micro substantially to reduce urine
Albumin/creatinine, microdose urine protein, urinal beta2 microglobulin, Urinary α1-microglobulin, to minimizing early diabetic nephropathy Urinary
Microalbumin has significant curative effect, thus delaying the progress of diabetic nephropathy, illustrates that present invention treatment early diabetic nephropathy is treated
Effect is notable.
Claims (9)
1. a kind of Chinese medicine treating early diabetic nephropathy it is characterised in that：It is made up of the crude drug of following parts by weight：Herba cuscutae
Sub- 15-25 part, Fructus Lycii 15-25 part, Fructus Schisandrae Chinensis 5-15 part, Semen Plantaginiss 5-15 part, Fructus Rosae Laevigatae 25-35 part, Hirudo 1-5 part, three
Seven 4-8 parts.
2. according to claim 1 treatment early diabetic nephropathy Chinese medicine it is characterised in that：By following parts by weight
Crude drug is made：20 parts of Semen Cuscutae, 20 parts of Fructus Lycii, 10 parts of Fructus Schisandrae Chinensis, 10 parts of Semen Plantaginiss, 30 parts of Fructus Rosae Laevigatae, 3 parts of Hirudo, three
76 parts.
3. according to claim 1 treatment early diabetic nephropathy Chinese medicine it is characterised in that：Described Semen Cuscutae is to fry cattle
Burdock, Fructus Schisandrae Chinensis are processed with vinegar Fructus Schisandrae Chinensis, and Semen Plantaginiss are Semen Plantaginis (parched), and Hirudo is stir-baked HIRUDO.
4. the Chinese medicine for the treatment of early diabetic nephropathy as claimed in claim 1 is it is characterised in that preparation method includes following step
Suddenly：
a：Weigh Semen Cuscutae, Fructus Lycii, Fructus Schisandrae Chinensis, Semen Plantaginiss, Fructus Rosae Laevigatae, Radix Notoginseng by described portion rate, through alcohol reflux,
Filter, reclaim ethanol, be concentrated to give alcohol extracting concentrate；
b：Weigh Hirudo by described portion rate, merge with the medicinal residues after alcohol reflux in step a, boil through decocting, filter, dense
Contracting, cooling, plus ethanol, precipitate with ethanol, obtain water extract-alcohol precipitation concentrated solution, water extract-alcohol precipitation concentrated solution is merged with the alcohol extracting concentrate of step a,
Extract dry powder is made after concentrating under reduced pressure, drying；
c：Extract dry powder in step b is carried out wet granulation, is dried, plus adjuvant is prepared into granule or tablet or capsule.
5. as claimed in claim 4 treatment early diabetic nephropathy Chinese medicine it is characterised in that：Second in preparation method step a
Alcohol reflux extracts 3 times, every time backflow 1.5 hours, adds 5 times amount that amount of alcohol is crude drug weight every time, and ethanol volumetric concentration is
70%, united extraction liquid, filters, filtrate reduced in volume reclaims ethanol, obtains alcohol extracting concentrate.
6. as claimed in claim 4 treatment early diabetic nephropathy Chinese medicine it is characterised in that：Add in preparation method step b
Decocting boils 2 times, and 2 hours every time, the amount adding water every time was 10 times of crude drug weight, merges decocting liquid twice, filters, by filtrate
Being evaporated to when 60 DEG C and surveying relative density is 1g/ml, cooling, plus ethanol reaches 60% to alcohol content volume ratio, stirs, puts
It is centrifuged after putting 48 hours, 4800 revs/min of centrifuge speed, discards precipitation, reclaim alcohol extracting concentrate in centrifugal liquid, with step a and close
And, make extract dry powder after concentrating under reduced pressure, drying.
7. as claimed in claim 4 treatment early diabetic nephropathy Chinese medicine it is characterised in that：By water extract-alcohol precipitation in step b
Concentrated solution is merged with the alcohol extracting concentrate of step a, is vacuum dried, obtains extract dry powder after concentrating under reduced pressure under the conditions of 70 DEG C.
8. described in claim 1 or 2, treat the medicine in preparation treatment early diabetic nephropathy for the Chinese medicine of early diabetic nephropathy
In application.
9. the Chinese medicine for the treatment of early diabetic nephropathy as claimed in claim 8 is in the medicine of preparation treatment early diabetic nephropathy
Application it is characterised in that：Described early diabetic nephropathy be kidney deficiency blood stasis type early diabetic nephropathy, symptoms include soreness of the waist and knees or
Talalgia, Hiccough and deaf, loss of hairs luxated tooth, urine have Yu drip, foam is many in urine or turbid urine, with seeing numb limbs and tense tendons, purplish tongue or have
Ecchymosis, petechia, the tongue bottom vein stasis of blood is purple, hesitant pulse.
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