CN106109599A - A kind of Chinese medicine composition treating nephrotic syndrome - Google Patents

A kind of Chinese medicine composition treating nephrotic syndrome Download PDF

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CN106109599A
CN106109599A CN201610714539.2A CN201610714539A CN106109599A CN 106109599 A CN106109599 A CN 106109599A CN 201610714539 A CN201610714539 A CN 201610714539A CN 106109599 A CN106109599 A CN 106109599A
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radix
chinese medicine
fructus
medicine composition
weight portion
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颜喜贤
颜丽敏
颜振辉
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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)
    • A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
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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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    • 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
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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    • A61K36/18—Magnoliophyta (angiosperms)
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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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    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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    • A61K2236/50—Methods involving additional extraction steps
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    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Abstract

The invention provides a kind of Chinese medicine composition treating nephrotic syndrome, it is made up of the crude drug of following weight portion: Radix Pseudostellariae 15 20, the Radix Astragali 20 30, the Rhizoma Atractylodis Macrocephalae 15 20, Poria 10 15, Semen Plantaginis 10 15, Bi 10 15, Radix Morindae Officinalis 10 15, Fructus Corni 15 20, Fructus Ligustri Lucidi 10 20, Radix Rehmanniae 10 20, Radix Rehmanniae Preparata 10 20, Fructus Rosae Laevigatae 15 20, Fructus Schisandrae Chinensis 10 15, Rhizoma Imperatae 15 20, Herba Cirsii 15 20, Herba Ecliptae 20 30, Hirudo 2.

Description

A kind of Chinese medicine composition treating nephrotic syndrome
One technical field
The present invention relates to the field of Chinese medicines, specifically, the present invention relates to treat the Chinese medicine composition of nephrotic syndrome.
Two background technologies
Nephrotic syndrome (NS) is one of important diseases of serious threat human health, and it is to be caused by renal glomerular disease , with High-grade Proteinuria, hypoproteinemia, hyperlipemia and edema (the most so-called " three high and one low ") etc. in various degree it is The clinical syndrome of feature.
Western medical treatment nephrotic syndrome mainly uses diuretic (such as hydrochlorothiazide tablet, Guangdong three just stone discrimination pharmacy etc.) and sugar 17-hydroxy-11-dehydrocorticosterone is (as prednisone acetate tablets Tianjin Tianyao Pharmaceutical Co., Ltd., Xin Yi pharmaceutical factory, prednisolone acetate sheet Shanghai have Limit company), glucocorticoid has obvious hepatic injury and diabetes side effect, apply limited substantially.
The common drug of Chinese traditional treatment nephrotic syndrome has kidney proheparin capsule (the Community in Baiyunshan, Guangzhou brilliance limited public affairs of pharmacy share Department, is mainly composed of incubation pupa powder, Radix Achyranthis Bidentatae powder), (Guangxi Wuzhou Pharmaceutical limited company, is mainly composed of nephritis peace capsule Five-leaved chasts tree), many papers and patent documentation also disclose that the prescription of some treatment nephrotic syndromes, but its drug effect is general relatively Difference, it is impossible to compared with Western medicine, is typically only used for auxiliary treatment during mild.
Three summary of the invention
Applicant on the basis of the conventional Chinese medicine such as Radix Astragali for the treatment of nephropathy of the traditional Chinese medical science, Semen Plantaginis, Fructus Corni, Poria etc., By reasonable compatibility, increasing and decreasing composition, be made for the Chinese medicine composition of a kind of new treatment nephrotic syndrome, it is to nephrotic syndrome Curative effect apparently higher than existing Chinese medicine, close to glucocorticoid therapy, can replace as the low toxic and side effects of glucocorticoid therapy In generation, selects.
On the one hand, the invention provides a kind of Chinese medicine composition for treating nephrotic syndrome, including following weight portion Raw material: Radix Pseudostellariae 15-20, Radix Astragali 20-30, Semen Plantaginis 10-15, Fructus Corni 15-20.
Further aspect, the Chinese medicine composition for treating nephrotic syndrome that the present invention provides, by following weight portion Crude drug make: Radix Pseudostellariae 15-20, Radix Astragali 20-30, Rhizoma Atractylodis Macrocephalae 15-20, Poria 10-15, Semen Plantaginis 10-15, Bi 10-15, Radix Morindae Officinalis 10-15, Fructus Corni 15-20, Fructus Ligustri Lucidi 10-20, Radix Rehmanniae 10-20, Radix Rehmanniae Preparata 10-20, Fructus Rosae Laevigatae 15-20, the five tastes Sub-10-15, Rhizoma Imperatae 15-20, Herba Cirsii 15-20, Herba Ecliptae 20-30, Hirudo 2.
Further aspect, the Chinese medicine composition for treating nephrotic syndrome that the present invention provides, by following weight portion Crude drug make: Radix Pseudostellariae 15, the Radix Astragali 20, the Rhizoma Atractylodis Macrocephalae 15, Poria 10, Semen Plantaginis 10, Bi 10, Radix Morindae Officinalis 10, Fructus Corni 20, Fructus Ligustri Lucidi 10, Radix Rehmanniae 10, Radix Rehmanniae Preparata 15, Fructus Rosae Laevigatae 15, Fructus Schisandrae Chinensis 10, Rhizoma Imperatae 15, Herba Cirsii 15, Herba Ecliptae 20, Hirudo 2.
Further aspect, the present invention provide for the Chinese medicine composition treating nephrotic syndrome be water decoction, extractum, Pill or granule.
On the other hand, the invention provides described for treating the preparation method of the Chinese medicine composition of nephrotic syndrome, bag Include step: by required weight portion weighting raw materials；
Medical material is cleaned, and is mixed in proportion, and adds the soak by water 3 times of 7 times of medical material gross weight, each 1 hour, merges 3 times pan-fried Boil liquid；Filtering, concentrate, obtaining proportion when 60 DEG C is the fluid extract of 1.12.
Four detailed description of the invention
The preparation of embodiment 1 Chinese medicine composition of the present invention
By required weight portion weighting raw materials:
Radix Pseudostellariae 15, the Radix Astragali 20, the Rhizoma Atractylodis Macrocephalae 15, Poria 10, Semen Plantaginis 10, Bi 10, Radix Morindae Officinalis 10, Fructus Corni 20, Fructus Ligustri Lucidi Son 10, Radix Rehmanniae 10, Radix Rehmanniae Preparata 15, Fructus Rosae Laevigatae 15, Fructus Schisandrae Chinensis 10, Rhizoma Imperatae 15, Herba Cirsii 15, Herba Ecliptae 20, Hirudo 2.
Medical material is cleaned, and is mixed in proportion, and adds the soak by water 3 times of 7 times of medical material gross weight, each 1 hour, merges 3 times pan-fried Boil liquid；Filtering, concentrate, obtaining proportion when 60 DEG C is the fluid extract of 1.12.
Embodiment 2 Chinese medicine composition of the present invention causes the effect of Chronic Renal Failure Rats to kidney 5/6 excision
Take the healthy normal Wistar rats 50 of body weight 220-260g, use 5/6 nephrectomy method to prepare uremic rats Model: rat is ventricumbent position after the chloral hydrate 0.3mL/100g intramuscular injection anesthesia of 10%, 1cm under the left back rib of row, the other 0.5cm of ridge cut Mouthful, expose nephropathy and divest the pole up and down about 2/3 of the thin film left kidney of trapezoidal excision, after 1 week, rat is on the same descending right side of position Otch, ligatures the kidney base of a fruit at the right hilus renalis and excises right kidney.Taking arteria caudalis blood after postoperative 5 weeks and survey serum creatinine, serum creatinine value is normal 43 rats that rat is more than 2-3 times be considered modeling success, choose wherein 40 test.
40 successful rats of modeling are equally divided into 4 groups, difference gavage outside normal rats forage feed:
The Chinese medicine composition extractum of embodiment 1 preparation, dilute with water 10 times by volume, 0.5ml/ every every day；
Hydrochlorothiazide tablet powder suspension (Guangdong three just stone discrimination pharmacy) 0.2mg/ every every day, 0.5ml；
Kidney proheparin capsule (Guangzhou BaiYunshan GuangHua Pharmacy Co., Ltd) powder solution, 15mg/ every every day, 0.5ml；
Normal saline, 0.5ml/ every every day；
Successive administration 3 weeks, measures rat serum osmotic pressure and osmotic pressure of urine after 3 weeks, fasting subsequently is not intake 2 days, collects 24 Hour urinary assay urine protein, and measure the blood urea nitrogen in blood, creatinine.
Kidney 5/6 excision causes the twenty-four-hour urine protein level in chronic renal failure experiment
Twenty-four-hour urine albumen g
Chinese medicine composition of the present invention 84.28±13.50
Hydrochlorothiazide tablet 71.22±16.14
Kidney proheparin capsule 137.98±38.10
Normal saline 205.59±32.41
Kidney 5/6 excision causes osmotic pressure of urine and blood osmotic pressure in chronic renal failure experiment
Osmotic pressure of urine mOsm/Kg H2O Blood osmotic pressure mOsm/Kg H2O
Chinese medicine composition of the present invention 432.90±26.31 321.83±32.53
Hydrochlorothiazide tablet 482.04±13.52 290.21±38.30
Kidney proheparin capsule 398.21±25.21 362.84±44.56
Normal saline 340.48±35.03 410.38±38.91
Kidney 5/6 excision causes the blood urea nitrogen in chronic renal failure experiment, creatinine level
Blood urea nitrogen (BUN) mmol/L Creatinine (Cr) μm ol/L
Chinese medicine composition of the present invention 12.12±4.55 72.11±16.95
Hydrochlorothiazide tablet 8.95±3.24 71.66±10.10
Kidney proheparin capsule 19.26±7.31 94.91±12.30
Normal saline 32.34±6.69 138.21±12.36
Test result indicate that, the Chinese medicine composition of the present invention, kidney 5/6 excision is caused the symptom of Chronic Renal Failure Rats Having mitigation, can effectively reduce rat serum BUN, Cr and twenty-four-hour urine protein level, effect is significantly better than kidney proheparin glue Capsule, the poorest compared with the Western medicine hydrochlorothiazide tablet of clear curative effect.And be remarkably improved rat osmotic pressure of urine level and Reducing its blood osmotic pressure level, effect is far above kidney proheparin capsule, even part and is better than hydrochlorothiazide tablet, recovers renal function There is good effect.
The embodiment 3 Chinese medicine composition of the present invention effect to adriamycin-induced nephropathy in Wistar rats Syndrome Model
Take the healthy normal Wistar rats 40 of body weight 220-260g.It is equally divided into 4 groups, sub-cage rearing, control room temperature At 15-20 DEG C, it is allowed to freely ingest, drink water.
Prepare nephrotic syndrome model by Bertani method, i.e. under non-narcotic, press the disposable tail of 6.5mg/kg body weight quiet Arteries and veins injection doxorubicin hydrochloride.Injecting doxorubicin hydrochloride 2 weeks, 24h urine protein has significance to raise before relatively injecting doxorubicin hydrochloride After, beginning gastric infusion:
Group 1: the Chinese medicine composition extractum of embodiment 1 preparation, dilute with water 10 times by volume, 0.5ml/ every every day；
Group 2: kidney proheparin capsule (Guangzhou BaiYunshan GuangHua Pharmacy Co., Ltd) powder solution, 15mg/ every every day, 0.5ml
Group 3: take " stilbene meadow yellow stuff treatment in " 21 nephropathy branch of China Association of Traditional Chinese Medicine academic meeting paper compilations " Treating Intractable Nephrotic clinical research " open treatment nephrotic syndrome herbal mixture (Radix Astragali, Rhizoma Imperatae, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, each 30g of Radix Salviae Miltiorrhizae, Fructus Corni 20g, Herba Epimedii, the Cortex Eucommiae, Pheretima, Fructus Rosae Laevigatae, Fructus Rubi, Hirudo, the raw each 15g of Radix Rehmanniae Preparata), Decocting 400ml, 0.5ml/ every every day；
Organized for 4: normal saline 0.5ml/ every every day.
Successive administration 8 weeks.
24h urine protein quantitation measures each group before modeling, after modeling 2,6,10 weeks, and each group of rat is all put into metabolic cage In, normal water, collect 24h urine, do urine protein and measure.
After being administered 8 weeks, at the end of experiment, each group rat broken end takes blood, separates serum, and automatic clinical chemistry analyzer measures ALB.
Adriamycin-induced nephropathy in Wistar rats Syndrome Model 24h urine protein (mg)
Before modeling After modeling 2 weeks After modeling 6 weeks After modeling 8 weeks
Group 1 7.65±0.32 90.65±3.98 190.84±30.50 120.74±15.88
Group 2 7.85±0.61 90.38±4.90 200.86±26.30 210.45±21.21
Group 3 7.40±0.39 88.59±6.54 195.32±19.85 240.86±30.90
Group 4 8.22±0.58 92.33±7.56 240.85±20.50 320.98±55.20
Adriamycin-induced nephropathy in Wistar rats Syndrome Model ALB (g/L)
ALB
Group 1 28.54±3.09
Group 2 26.71±4.12
Group 3 26.09±3.71
Group 4 22.41±2.30
Data show that the Chinese medicine composition of the present invention has obvious curative effect to adriamycin-induced nephropathy in Wistar rats Syndrome Model, and two most important Index 24h urine protein and ALB all have clear improvement (particularly, reversed the trend that 24h urine protein persistently raises), and improve width Spend and (particularly, organize 2 to fail to stop 24h urine protein persistently to raise with the Chinese medicine organizing 3 significantly more than existing Chinese patent medicine and prescriptions of Chinese medicine Trend).
The actual effect of embodiment 4 traditional Chinese medicine composition for treating of the present invention nephrotic syndrome
Patient chooses:
Being in secrecy privacy purposes, patient specifically originates and data does not do disclosure.
Inclusive criteria: (1) High-grade Proteinuria, urine protein quantitation >=3.5g/d；(2) hypoproteinemia, plasma albumin≤ 30g/L；(3) edema；(4) hyperlipemia.Wherein (1) (2) two is diagnosis necessary requirement.Get rid of whole body system and congenital something lost Nephrotic syndrome caused by Hereditary diseases, the front blood urea nitrogen (BUN) for the treatment of, creatinine (sCr) raise or endogenous creatinine clearance rate (cCr) reduction person.
Totally 80 example patient, wherein male 35 example, women 45 example, age 18-55 year, average 39.3 years old；The course of disease 1 year to 7 years, Average 4.5 years.80 example patients are randomly divided into 4 groups.
Dosage regimen
Group 1: oral prednisone (Tianjin Tianyao Pharmaceutical Co., Ltd.), dosage is 50mg every day.As liver occurs in patient Hypofunction situation, is taken equivalent prednisolone (Xin Yi pharmaceutical factory, Shanghai company limited).Use hormone according to " the first beginning measures foot, subtracts Amount is slow, maintaining treatment length " principle.After hormone therapy 8 weeks, successively decrease (i.e. often 1-2 week subtracting commercial weight 10%) as usual, works as decrement Take the next day of two feed rations being changed into during to half 25mg every day.
Group 2: the Chinese medicine composition extractum of embodiment 1 preparation, dilute with water 10 times by volume, each 100ml, 1 day 3 Secondary；
Group 3: kidney proheparin capsule (Guangzhou BaiYunshan GuangHua Pharmacy Co., Ltd), 1 time 5,3 times on the 1st；
Group 4: take " stilbene meadow yellow stuff treatment in " 21 nephropathy branch of China Association of Traditional Chinese Medicine academic meeting paper compilations " Treating Intractable Nephrotic clinical research " open treatment nephrotic syndrome herbal mixture (Radix Astragali, Rhizoma Imperatae, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, each 30g of Radix Salviae Miltiorrhizae, Fructus Corni 20g, Herba Epimedii, the Cortex Eucommiae, Pheretima, Fructus Rosae Laevigatae, Fructus Rubi, Hirudo, the raw each 15g of Radix Rehmanniae Preparata), Decocting 400ml, is administered orally at twice；
Curative effect is judged after taking medicine continuously 3 months.
Criterion of therapeutical effect:
Complete incidence graph: symptom, sign disappear, routine urinalysis inspection continues for 3 times normal, urine protein quantitation, blood fat, blood plasma egg In vain, serum immune globulin, hemorheology index all recover normal；
Part alleviate: symptom, sign disappear, urine protein qualitative (±)-(++), 24h urine protein quantitation relatively treats front minimizing More than 1/2, blood fat is obviously improved, and serum immune globulin, hemorheology index are close or recover normal；
Do not alleviate: symptom is all not improved with sign and laboratory inspection, or increases the weight of.
Each group curative effect is summed up
Complete incidence graph Part is alleviated Do not alleviate
Group 1 7 10 1
Group 2 6 11 3
Group 3 3 10 7
Group 4 3 12 5
Note: have two patients seriously to exit experiment in 1st month in treatment due to liver function injury in group 1.
Data show: the Chinese medicine composition actual clinical effect of the present invention significantly more than existing Chinese patent medicine and prescriptions of Chinese medicine, Close to glucocorticoid therapy, and the Chinese medicine composition of the present invention contrasts glucocorticoid therapy in toxic and side effects and also has Clear superiority, it can be as the excellent option for the treatment of nephrotic syndrome.

Claims (5)

1. for treating a Chinese medicine composition for nephrotic syndrome, including the raw material of following weight portion: Radix Pseudostellariae 15-20, Huang Stilbene 20-30, Semen Plantaginis 10-15, Fructus Corni 15-20.
2. the Chinese medicine composition described in claim 1, is made up of the crude drug of following weight portion: Radix Pseudostellariae 15-20, Radix Astragali 20- 30, Rhizoma Atractylodis Macrocephalae 15-20, Poria 10-15, Semen Plantaginis 10-15, Bi 10-15, Radix Morindae Officinalis 10-15, Fructus Corni 15-20, Fructus Ligustri Lucidi 10-20, Radix Rehmanniae 10-20, Radix Rehmanniae Preparata 10-20, Fructus Rosae Laevigatae 15-20, Fructus Schisandrae Chinensis 10-15, Rhizoma Imperatae 15-20, Herba Cirsii 15-20, Herba Ecliptae 20-30, Hirudo 2.
3. the Chinese medicine composition described in claim 2, is made up of the crude drug of following weight portion: Radix Pseudostellariae 15, the Radix Astragali 20, the Rhizoma Atractylodis Macrocephalae 15, Poria 10, Semen Plantaginis 10, Bi 10, Radix Morindae Officinalis 10, Fructus Corni 20, Fructus Ligustri Lucidi 10, Radix Rehmanniae 10, Radix Rehmanniae Preparata 15, Fructus Rosae Laevigatae 15, Fructus Schisandrae Chinensis 10, Rhizoma Imperatae 15, Herba Cirsii 15, Herba Ecliptae 20, Hirudo 2.
4. the Chinese medicine composition of any one of claim 1-3, it is water decoction, extractum, pill or granule.
5. the preparation method of the extractum of claim 4 Chinese medicine composition, including step:
By required weight portion weighting raw materials；
Medical material is cleaned, and is mixed in proportion, and adds the soak by water 3 times of 7 times of medical material gross weight, each 1 hour, merges 3 decoction liquor； Filtering, concentrate, obtaining proportion when 60 DEG C is the fluid extract of 1.12.
CN201610714539.2A 2016-08-25 2016-08-25 A kind of Chinese medicine composition treating nephrotic syndrome Pending CN106109599A (en)

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