CN103948754B - Drug for treating renal-deficiency humid-heat type chronic nephritis - Google Patents
Drug for treating renal-deficiency humid-heat type chronic nephritis Download PDFInfo
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Abstract
The invention discloses a drug for treating renal-deficiency humid-heat type chronic nephritis. The drug is prepared from the following material medicines in parts by weight: 20-40 parts of astragalus membranaceus, 8-12 parts of white atractylodes rhizome, 8-12 parts of pulp of dogwood fruit, 10-30 parts of eucommia ulmoides, 10-20 parts of rhizoma alismatis, 10-30 parts of herba pyrrosiae, 10-30 parts of oldenlandia diffusa and 3-7 parts of pseudo-ginseng. After being proved by a pharmacological experiment, the drug disclosed by the invention has a better function in treating chronic nephritis, is safe to take, suitable for preventing and treating chronic nephritis. The invention further discloses a preparation method and an application of the drug.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine, in particular, it is related to a kind of Chinese medicine treating chronic nephritiss and joins
Square medicine and its preparation method and application.
Background technology
Chronic nephritiss are common nephropathy, and the situation that prevalence is high, case fatality rate is high is extremely serious, and its sickness rate is in rise year by year
Trend.Chronic nephritiss are to be caused by many reasons, and pathological change differs, and it is mainly shown as edema, albuminuria, hematuria, with
And hypertension and decreased renal function, in Chinese medical book, not " chronic glomerulonephritiss " this name of disease, but clinical according to it
Performance and characteristics of incidence, this disease belongs to " edema " in Chinese medicine, " lumbago ", " the kidney-wind syndrome ", " difficulty in urination ", " obstruction and rejection ", " impairment of the kidney caused by overstrain ", " void
The category such as labor ", " poison of drowning ", " hematuria ".Sick position is mainly in spleen, kidney.The traditional Chinese medical science thinks that The spleen has the function to transport and transform nutrients, separating clear and excreting turbid, completes water paddy essence
Micro- absorption and transporting, participate in body aqueous metabolism；Spleen governing blood, makes blood run in vascular, prevents outside blood oozing from the body openings or subcuta neous tissue arteries and veins.Kidney master
Envelope is hidden, and hides nephroyin and nephroyang；The main water of kidney, completes aqueous metabolism.If pathology damage occurs, deficiency of spleen and stomach, spleen weakness, precise and tiny nothing
Method normal absorption, transporting；Kidney loses envelope and hides, and precise and tiny outer leak into urine and albuminuria；Spleen loses and has under one's command, and escape of blood from meridians, outside blood oozing from the body openings or subcuta neous tissue arteries and veins
Enter urine and cause hematuria；Spleen weakness, retention of water-damp in the body, overflow skin；Nephrons is not enough, and bladder loses in gasification, and it is entire unfavorable to open, and water is wet interior
Stop, form the disease of edema.Clinical observation is visible, and primary disease pathogenic factor is mainly damp and hot, blood stasis, turbid poison, water are wet.Therefore primary disease pathogenesis is this
Empty mark is real, simulataneous insufficiency and excessive.Kidney disease is not only fairly common, and medical expense is very high, and uremic patient is for each person every year
Dialysis expense need ten thousand yuans of 5-6, high medical expense brings very heavy financial burden to patient and society, and
Chronic nephritiss are still the first cause of disease that China leads to Uremia Dialysis at present, so, active treatment chronic nephritiss have important
Meaning.
At present, western medicine and medical practitioners treatment nephritis mainly adopt hormone, immunosuppressant, acei/arb class medicine etc., its course for the treatment of
Very long, it is easy to after drug withdrawal bounce, side effect is also relatively more, and patient compliance is poor.Market in urgent need one kind is widely applicable, Small side effects
Treatment kidney deficiency damp-heat type chronic nephritis Chinese medicine preparation.
Content of the invention
It is an object of the invention to provide it is a kind of evident in efficacy, in the treatment kidney deficiency damp-heat type chronic nephritis of Small side effects
Medicine preparation and preparation method thereof.
The present invention is achieved through the following technical solutions:
A kind of medicine for treating kidney deficiency damp-heat type chronic nephritis, extracts preparation by the crude drug of following weight
Form: Radix Astragali 20-40 part；Rhizoma Atractylodis Macrocephalae 8-12 part；Fructus Corni 8-12 part；Cortex Eucommiae 10-30 part；Rhizoma Alismatis 10-20 part；Folium Pyrrosiae 10-30 part；
Herba Hedyotidis Diffusae 10-30 part；Radix Notoginseng 3-7 part.
Above-mentioned for treating kidney deficiency damp-heat type chronic ephritis medicine, by following weight crude drug extract preparation and
Become: 30 parts of the Radix Astragali；10 parts of the Rhizoma Atractylodis Macrocephalae；10 parts of Fructus Corni；20 parts of the Cortex Eucommiae；15 parts of Rhizoma Alismatis；20 parts of Folium Pyrrosiae；20 parts of Herba Hedyotidis Diffusae；Three
75 parts.
Above-mentioned for treating kidney deficiency damp-heat type chronic ephritis medicine, preparation method comprises the following steps:
A) take the Rhizoma Atractylodis Macrocephalae by above-mentioned parts by weight, Herba Hedyotidis Diffusae two taste through extraction by steam distillation volatile oil, with β-ring
Dextrin inclusion；
B) take the Radix Astragali, the Cortex Eucommiae, Rhizoma Alismatis, Folium Pyrrosiae, the Radix Notoginseng five tastes by above-mentioned parts by weight, through alcohol reflux, filter, return
Receive ethanol, be concentrated to give alcohol extracting concentrate；
C) medicinal residues after step a steam distillation, the medicinal residues after b alcohol extraction are merged with Fructus Corni, boil through decocting, filter
Cross, concentrate, cool down, plus ethanol precipitate with ethanol obtains water extract-alcohol precipitation concentrated solution；The alcohol extracting concentrate of water extract-alcohol precipitation concentrated solution and step b is closed
And, it is spray-dried, make dry extract；
D) take the volatile oil clathrate compound of step a and the dry extract of c to carry out wet granulation, be dried, obtain final product medicine.
Above-mentioned for treating kidney deficiency damp-heat type chronic ephritis medicine, steam distillation in preparation method step a, using medicine
Material weight 6 times amount water soaks 1 hour, and distillation extracts volatile oil in 8 hours, and volatile oil adds 6 times of weight beta-schardinger dextrin -s, using saturation water
40 DEG C of electric stirrings of solwution method, mixing speed is 120r/min, and stirring carried out inclusion after 1.5 hours, and 40 DEG C of vacuum of clathrate are done
Dry.
Above-mentioned treatment kidney deficiency damp-heat type chronic ephritis medicine, alcohol reflux in preparation method step b, institute's alcohol adding amount is
12 times of decoction pieces gross weight, ethanol volumetric concentration is 70%, reflux, extract, in three times, 2 hours every time, united extraction liquid, filtration,
Decompression filtrate recycling ethanol, is concentrated into no alcohol taste.
Above-mentioned, boil through decocting in preparation method step c for treating kidney deficiency damp-heat type chronic ephritis medicine, amount of water is
12 times of decoction pieces gross weight, decoct in two times, 2 hours every time, merge decocting liquid, filtration, filtrate is concentrated into relatively close when 50 DEG C
Spend for 1.05～1.08, cool down, plus ethanol is less than 50% to alcohol content, stirs evenly, and places 48 hours, filtration, filtrate reclaims second
Alcohol, merging relative density when being concentrated into 50 DEG C with above-mentioned alcohol extracting concentrate is 1.10～1.15, adds dextrin appropriate, is entering one's intention as revealed in what one says
Temperature is 165～175 DEG C, is spray dried to dry extract under the conditions of 85～90 DEG C of pathogenic wind-warm of outlet.
Above-mentioned for treating kidney deficiency damp-heat type chronic ephritis medicine, in preparation method step d, take step a inclusion essential oil
Dry extract is taken to add appropriate Icing Sugar in thing and step c, dextrin mixes and carries out wet granulation, is dried, obtains final product medicine, dosage form is piece
Agent or granule or hard capsule.
Above-mentioned for treat kidney deficiency damp-heat type chronic ephritis medicine preparation treatment kidney deficiency damp-heat type chronic ephritis medicine in
Application.
In the present invention, the Rhizoma Atractylodis Macrocephalae is the dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae atractylodes macrocephala koidz.,
The Radix Astragali is leguminous plant Radix Astagali astragalus membranaceus (fisch.) bge.var.mongholicus
(bge.) dry root of hsiao, Fructus Corni is Cornaceae plant Fructus Corni comus officinalis sieb.et zucc.
Drying and ripening sarcocarp, the Cortex Eucommiae is the dry bark of Eucommiaceae plant Cortex Eucommiae eucommia ulmoides oliv., and Rhizoma Alismatis are Rhizoma Alismatis
The dry tuber of section plant Rhizoma Alismatis alisma orientalis (sam.) juzep., Radix Notoginseng is panax araliaceae plant panax
The dry root of notoginseng (burk.) f.h.chen, Folium Pyrrosiae is Plants of Polypodiaceae Folium Pyrrosiae pyrrosia lingua
(thunb.) dried leaves of farwell, Herba Hedyotidis Diffusae is Maguireothamnus speciosus Herba Hedyotidis Diffusae hedyotis diffusa
Willd. herb is dried.
The present invention, compared with the Chinese medicine of existing treatment chronic nephritiss, has the advantage that
(1) in side, Radix Astragali, Fructus Corni are monarch drug.Radix Astragali sweet in the mouth, slightly warm in nature, there are benefiting qi and raising yang, invigorating spleen for diuresis, benefit is defended
The work(of consolidating superficial resistance.Modern pharmacological research confirms that it has stronger immunoregulation effect, can promote differentiation and the maturation of t lymphocyte,
Inducing cell produces interferon, can release vasospasm simultaneously, improves microcirculation, strengthens tissue hypoxia-bearing capability, reduces albumen
The effects such as the effect such as urine, diuresis.Fructus Corni sweet in the mouth, slight bitter, enter liver kidney channel, there is invigorating the liver and kidney, the work(of arresting seminal emission gas, have protection and
Increase the strong function of depositing nephron.The common chronic nephropathy such as chronic nephritiss, diabetic nephropathy, chronic pyelonephritiss is with spleen deficiency of kidney-QI
It is common pattern of syndrome with deficiency of both QI and YIN, therefore air making-up and spleen enlivening, replenishing YIN to strengthen the kidney is the conventional rule for the treatment of of chronic nephropathy.Radix Astragali, mountain cornel in side
Meat one air making-up and spleen enlivening, one enriching yin and nourishing kidney, amount to supplementing QI and nourishing YIN, the work(of spleen kidney giving young employees remedial-courses in general knowledge and vocational skills, be all monarch drug.The Rhizoma Atractylodis Macrocephalae, the Cortex Eucommiae in side
For ministerial drug.Rhizoma Atractylodis Macrocephalae sweet in the mouth, hardship, warm in nature, have an air making-up and spleen enlivening, the work(of eliminate dampness and have diuretic effect, due to the common sympton of edema still chronic nephritiss,
And the disease of edema, " the fundamental cause of water disease being in the kidney ", " its system in spleen ", the Rhizoma Atractylodis Macrocephalae both can help the Radix Astragali with QI invigorating, again can dissipating dampness and activating spleen in case the Radix Astragali is stopped up
Air resister.Cortex Eucommiae sweet in the mouth, micro-pungent, warm in nature, enter liver kidney two warp, there is liver and kidney tonifying, the work(of strong muscles and bones, be usually used in treating Liver and kidney
The soreness of waist and knee joint of deficiency, sufficient knee joint flaccidity is soft powerless, and in side, the Cortex Eucommiae helps Fructus Corni invigorating kidney qi, is ministerial drug.Rhizoma Alismatis in side, Folium Pyrrosiae, white
Serpentis SHECAO, Radix Notoginseng are adjuvant drug altogether.Rhizoma Alismatis slightly sweet flavor, cold in nature, energy promoting diuresis to eliminate damp pathogen, expel the heat-evil treating stranguria.Cure mainly functioning of bladder unfavorable, water
Wet stop gathering, dysuria, oedema turgor, pharmacological research prove Rhizoma Alismatis can with blood pressure lowering, blood sugar lowering, blood fat reducing, increase urine volume, urine
Element and the excretion of sodium chloride.Folium Pyrrosiae sweet-bitter flavor, cold nature, energy relieving stranguria by diuresis, clearing away heat to stop bleeding.It is usually used in the heat of damp-heat in lower-JIAO
The diseases such as pouring, stranguria with blood, hematuria.Pharmacological research shows, Folium Pyrrosiae has antiinflammatory and resisting pathogenic microbes and diuresis, can be clinically used for
Treatment acute and chronic nephritis, pyelonephritis, in addition to eliminating edema, also have minimizing albuminuria, improve renal function effect.Agkistrodon
SHECAO slightly sweet flavor, cool in nature, energy heat-clearing and toxic substances removing, promoting blood circulation and detumescence, cure mainly furuncle carbuncle, laryngopharynx swelling and pain, damp-heat in lower-JIAO.Modern pharmacology
Research finds that it has the effect of stronger resisting pathogenic microbes, and reticuloendothelial system hypertrophy, increase can be stimulated cytophagous
Phagocytic activity, the defence capability of enhancing body.And in patients with chronic glomerulonephritis, lung kidney two is its Relapse rate or increases through damp and hot
Common cause, though Herba Hedyotidis Diffusae has the work(of heat-clearing and toxic substances removing, its property slightly sweet flavor anxiety that no bitter cold injures one's stomach.Due to chronic kidney disease
Common retention of damp-heat in the interior in mark excess syndrome, and, the damp and hot key factor being multiple chronic kidney disease Relapse rates or increasing, Gu Qingli
The damp and hot then conventional rule for the treatment of for chronic nephropathy.In side, Rhizoma Alismatis, Folium Pyrrosiae, Herba Hedyotidis Diffusae three medicine share and reach heat-clearing and toxic substances removing, and dampness removing disappears
Swollen work(.Radix Notoginseng sweet and slightly bitter taste, warm in nature, health product function dissipate stasis of blood hemostasis, reducing swelling and alleviating pain, stops blooding and does not stay the stasis of blood.For multiple bleedings
Disease and treating swelling and pain by traumatic injury.Modern pharmacology research finds that it has the thrombin increasing in blood, and makes local vasoconstriction, from
And reach anastalsis.And Radix Notoginseng Total saponin can suppress platelet aggregation, experiment in vitro has anticoagulant active.It can be seen that Radix Notoginseng
Coagulant and anticoagulant dual regulation and the traditional Chinese medical science think that the effect of its promoting blood circulation and hemostasis is consistent.Chronic nephropathy clinically common hematuria,
And the modal performance of Renal pathology is then the intrinsic cell proliferation of multiple kidneys, and it is often accompanied by glomerular sclerosiss and renal interstitial
Fibrosiss, Radix Notoginseng had both had hemostasis, had promoting blood circulation not stay stasis of blood effect to be just applied to multiple chronic nephropathys again.The present invention is improving patient
Clinical symptoms, renal function protecting, safety aspect has preferable advantage.The traditional Chinese medical science thinks chronic nephritiss main clinical manifestation, inspection
Test index often damp and hot to kidney deficiency related, belong to Primary Asthenia-Secondary Sthenia Syndrome, spleen deficiency of kidney-QI is this, hot and humid ecchymosis are to mark, compatibility of the present invention its
Effect is tonifying speen and tonifying kidney, boosting qi and nourishing yin, and eliminating damp-heat cures mainly chronic glomerulonephritiss spleen kidney qi Yin bivacuity, damp-heat brewing internally.
(2) Chinese medicine is mostly decoction at present, and recipe quantity is big, flavour of a drug are many, and using inconvenience, and the present invention has relatively to chronic nephritiss
Good defencive function；
(3) preparation process is simple, extraction efficiency is high, cost-effective；
(4) medicine of the present invention can be made into the dosage forms such as granule, capsule, tablet or pill, taking convenience；
(5) present invention shows through clinical and pharmacological tests, and this Chinese medicine preparation can significantly improve clinical card marquis, reduce urine
Albumen, reduction serum creatinine, urea nitrogen levels, suppression inflammatory reaction and inflammatory mediator release, promote repairing of glomerule pathological lesion
Multiple, thus there is good therapeutical effect to chronic nephritiss, developing paired chronic nephritiss has assistant protection function health product or treatment
The new drug of chronic nephritiss, its market capacity is big, and economic benefit and social benefit are obvious.
Specific embodiment
Embodiment 1:
Take Radix Astragali 200g；Rhizoma Atractylodis Macrocephalae 120g；Fructus Corni 80g Cortex Eucommiae 300g；Rhizoma Alismatis 100g；Folium Pyrrosiae 300g；Herba Hedyotidis Diffusae
100g；Radix Notoginseng 70g,
A. take the Rhizoma Atractylodis Macrocephalae, Herba Hedyotidis Diffusae two taste through extraction by steam distillation volatile oil, using medical material weight 6 times amount water logging
Bubble 1 hour, distillation extracts volatile oil in 8 hours, and volatile oil adds 6 times of weight beta-schardinger dextrin -s, electronic using 40 DEG C of saturated water solution method
Stirring, mixing speed is 120r/min, and stirring carries out inclusion, 40 DEG C of vacuum drying of clathrate after 1.5 hours.
B. the Radix Astragali, the Cortex Eucommiae, Rhizoma Alismatis, Folium Pyrrosiae, the Radix Notoginseng five tastes are taken, through alcohol reflux, institute's alcohol adding amount is decoction pieces gross weight
12 times, ethanol volumetric concentration is 70%, reflux, extract, in three times, 2 hours every time, united extraction liquid, filtration, and filtrate decompression returns
Receive ethanol, be concentrated into no alcohol taste.Filtration, reclaims ethanol, is concentrated to give alcohol extracting concentrate；
C. the medicinal residues after step a steam distillation, the medicinal residues after the alcohol extraction of step b are merged with Fructus Corni, boil through decocting,
Amount of water is 12 times of decoction pieces gross weight, decocts in two times, 2 hours every time, merges decocting liquid, filtration, filtrate is concentrated into 50 DEG C
When relative density be 1.05, cooling, plus ethanol to alcohol content be 50%, stir evenly, place 48 hours, filtration, filtrate recycling ethanol,
Merging relative density when being concentrated into 50 DEG C with above-mentioned steps b alcohol extracting concentrate is 1.15, adds dextrin appropriate, in import pathogenic wind-warm is
165 DEG C, under the conditions of 90 DEG C of pathogenic wind-warm of outlet, it is spray dried to dry extract.
D. take in step a volatile oil clathrate compound and step c and take dry extract, plus appropriate dextrin mixes and carries out wet granulation,
It is dried, tabletting, prepare piece agent.
Embodiment 2:
Take Radix Astragali 400g；Rhizoma Atractylodis Macrocephalae 80g；Fructus Corni 120g Cortex Eucommiae 100g；Rhizoma Alismatis 200g；Folium Pyrrosiae 100g；Herba Hedyotidis Diffusae
300g；Radix Notoginseng 30g,
A. take the Rhizoma Atractylodis Macrocephalae, Herba Hedyotidis Diffusae two taste through extraction by steam distillation volatile oil, using medical material weight 6 times amount water logging
Bubble 1 hour, distillation extracts volatile oil in 8 hours, and volatile oil adds 6 times of weight beta-schardinger dextrin -s, electronic using 40 DEG C of saturated water solution method
Stirring, mixing speed is 120r/min, and stirring carries out inclusion, 40 DEG C of vacuum drying of clathrate after 1.5 hours.
B. the Radix Astragali, the Cortex Eucommiae, Rhizoma Alismatis, Folium Pyrrosiae, the Radix Notoginseng five tastes are taken, through alcohol reflux, institute's alcohol adding amount is decoction pieces gross weight
12 times, ethanol volumetric concentration is 70%, reflux, extract, in three times, 2 hours every time, united extraction liquid, filtration, and filtrate decompression returns
Receive ethanol, be concentrated into no alcohol taste.Filtration, reclaims ethanol, is concentrated to give alcohol extracting concentrate；
C. the medicinal residues after step a steam distillation, the medicinal residues after the alcohol extraction of step b are merged with Fructus Corni, boil through decocting,
Amount of water is 12 times of decoction pieces gross weight, decocts in two times, 2 hours every time, merges decocting liquid, filtration, filtrate is concentrated into 50 DEG C
When relative density be 1.08, cooling, plus ethanol to alcohol content be 50%, stir evenly, place 48 hours, filtration, filtrate recycling ethanol,
Merging relative density when being concentrated into 50 DEG C with above-mentioned steps b alcohol extracting concentrate is 1.10, adds dextrin appropriate, in import pathogenic wind-warm is
175 DEG C, under the conditions of 85 DEG C of pathogenic wind-warm of outlet, it is spray dried to dry extract.
D. take in step a volatile oil clathrate compound and step c and take dry extract, plus appropriate dextrin mixes and carries out wet granulation,
It is dried, be prepared into granule.
Embodiment 3:
Take Radix Astragali 300g；Rhizoma Atractylodis Macrocephalae 100g；Fructus Corni 100g Cortex Eucommiae 200g；Rhizoma Alismatis 150g；Folium Pyrrosiae 200g；Herba Hedyotidis Diffusae
200g；Radix Notoginseng 50g,
A. take the Rhizoma Atractylodis Macrocephalae, Herba Hedyotidis Diffusae two taste through extraction by steam distillation volatile oil, using medical material weight 6 times amount water logging
Bubble 1 hour, distillation extracts volatile oil in 8 hours, and volatile oil adds 6 times of weight beta-schardinger dextrin -s, electronic using 40 DEG C of saturated water solution method
Stirring, mixing speed is 120r/min, and stirring carries out inclusion, 40 DEG C of vacuum drying of clathrate after 1.5 hours.
B. the Radix Astragali, the Cortex Eucommiae, Rhizoma Alismatis, Folium Pyrrosiae, the Radix Notoginseng five tastes are taken, through alcohol reflux, institute's alcohol adding amount is decoction pieces gross weight
12 times, ethanol volumetric concentration is 70%, reflux, extract, in three times, 2 hours every time, united extraction liquid, filtration, and filtrate decompression returns
Receive ethanol, be concentrated into no alcohol taste.Filtration, reclaims ethanol, is concentrated to give alcohol extracting concentrate；
C. the medicinal residues after step a steam distillation, the medicinal residues after the alcohol extraction of step b are merged with Fructus Corni, boil through decocting,
Amount of water is 12 times of decoction pieces gross weight, decocts in two times, 2 hours every time, merges decocting liquid, filtration, filtrate is concentrated into 50 DEG C
When relative density be 1.06, cooling, plus ethanol to alcohol content be 50%, stir evenly, place 48 hours, filtration, filtrate recycling ethanol,
Merging relative density when being concentrated into 50 DEG C with above-mentioned steps b alcohol extracting concentrate is 1.13, adds dextrin appropriate, in import pathogenic wind-warm is
170 DEG C, under the conditions of 87 DEG C of pathogenic wind-warm of outlet, it is spray dried to dry extract.
D. take in step a volatile oil clathrate compound and step c and take dry extract, plus appropriate dextrin mixes and carries out wet granulation,
It is dried, encapsulating capsule, be prepared into hard capsule.
Embodiment 4: the present invention (the clear Zhixieli granules of kidney tonifying) pharmacological experiment:
1 materials and methods
1.1. sample: prepare the present invention according to above-described embodiment 2, obtain dry extract.
1.2. laboratory animal: wistar rat, body weight (150-200) g, male and female half and half, tested by Nanjing University of Traditional Chinese Medicine
Animal center provides, laboratory animal production licence number: scxk (Soviet Union) 2008-0010, and animal is randomly divided into 5 groups by body weight, often
Group 10.
1.3. key instrument and reagent: automatic clinical chemistry analyzer；Biochemical reagents box builds up biological engineering purchased from Nanjing and grinds
Study carefully institute；It is configured to the ethanol of 30% concentration with distilled water；Hepatic tissue pathology section is made by Pathology Deparment of Jiangsu TCM Hospital.
2. the clear Zhixieli granules brightic effect for rat heymann of kidney tonifying of the present invention
The preparation of 2.1 renal cortex Freund's complete adjuvant suspensions
Take 150-200gwistar rat, de- vertebra is put to death, speed wins kidney insertion conduit, with normal saline repeatedly rinse to
Turn white, cut kidney, take renal cortex 3g to make homogenate and be mixed into 40ml with Freund's complete adjuvant, plus normal saline 40ml, thoroughly
Emulsifying, standby.
2.2heymann glomerulonephritis
Choose 150-200gwistar rat, after breeding observing 1w, put into metabolic cage and collect 24h urine, urine analyzer is examined
Survey urine protein.The rat taking urine protein detection negative is used for modeling.Wherein 8 rats, as Normal group.Remaining rat warp
Lumbar injection renal cortex Freund's complete adjuvant suspension 2ml/ is only.Same method, with dosage injection, inject 1 time at interval of 2w, altogether
Injection 5 times, lw after final injection, rat is respectively put in rat metabolism cage, collects 24h urine, biuret method surveys urine protein
Content.The notable rising of urine albumen amount is set to model success indicator.Hank mould rat 50, be divided into 5 groups by randomly assigne, i.e. model
Group, positive drug group, test medicine (high, medium and low) group, every group 10.Each group rat starts gastric infusion on the 9th week in experiment,
Gastric infusion 1 time, successive administration 28d daily, blank group, model group give normal saline, and positive drug group gives nephritis
Piece, test medicine gives kidney tonifying clear Zhixieli granules extractum, and administered volume is 1ml/100g.
2.3 observation index
2.3.124h urine volume and urine protein detection: after Cheng Mo (before administration), rat is put into by administration for the 14th, 28 days
24h urine volume is collected, biuret method measures urine protein content, the results are shown in Table 1 in rat metabolism cage.
2.3.2bun, gre, total serum protein, serum albumin detection: (before administration), administration the 14th after Cheng Mo
At the end of it and administration, (28d after administration) takes blood through eye socket, carries out blood biochemical detection, the results are shown in Table 2, table 3.
2.4 experimental result
2.4.1 ordinary circumstance is formally after immunity, and it is loose mixed and disorderly that different degrees of lethargy, hair in immunized animal
Matt, the powerless, phenomenon such as loose stool, ascites of crawl.After administration, model group animal lethargy, the loose tarnish of hair
Gradually increase, shenyankangfu tablet group and kidney tonifying clear Zhixieli granules each group are than improvement, but still see that spiritual beach wormwood wastes, and hair is loose unglazed
Pool.
2.4.2 urine protein dynamic change rat metabolism cage accesses urine, measures twenty-four-hour urine protein content.
124 hours urine protein quantitation of table (mg/24 hour,N=10)
| Packet | Before administration | Administration 14 days | Administration 28 days |
| Blank group | 1.6076±0.8448 | 2.993±1.46 | 3.1±0.55 |
| Model group | 4.244±1.283** | 7.219±2.65* | 6.94±2.40** |
| Shenyankangfu tablet group | 4.061±1.357** | 4.66±0.45* | 3.78±1.22△ |
| High dose group | 4.909±1.952** | 5.32±0.99* | 3.50±1.46△ |
| Middle dose group | 4.721±1.597** | 5.04±1.11* | 4.78±1.29* |
| Low dose group | 5.059±1.985** | 5.42±1.11* | 4.38±0.909* |
Note: compare with blank group,*P < 0.05,**p<0.01；Compare with model group△p<0.05,△△p<0.01.
Result shows, after modeling Rat 24 h urine albumen amount dramatically increase (**P < 0.01), no notable between modeling group each group
Difference.After treatment 14 days, each administration group effect notable (compare with blank group,*p<0.05).After treatment 28 days, nephritis
Piece group, kidney tonifying clear Zhixieli granules high dose group effect is significant (is compared with model group△P < 0.05), in the clear Zhixieli granules of kidney tonifying, low dosage
Group effect notable (compare with blank group,*p<0.05).
2.4.3 serum albumin dynamic change rat eye socket takes blood, measures serum albumin.
Table 2 serum albumin (g/l,N=10)
| Packet | Before administration | Administration 14 days | Administration 28 days |
| Blank group | 33.3±2.23 | 32.68±1.41 | 32.08±2.29 |
| Model group | 28.98±2.065** | 26.98±2.55** | 26.08±2.05** |
| Shenyankangfu tablet group | 28.13±2.89** | 24.94±2.94** | 27.78±0.85** |
| High dose group | 28.38±3.20** | 26.58±2.14** | 29.98±1.19△ |
| Middle dose group | 28.61±2.67** | 25.92±3.12** | 31.38±0.97△△ |
| Low dose group | 28.48±1.86** | 24.82±3.59** | 27.72±2.61* |
Note: compare with blank group,*P < 0.05,**p<0.01；Compare with model group△p<0.05,△△p<0.01.
Result shows, after modeling rat serum albumin dramatically increase (compare with blank group,**P < 0.01), modeling group is each
No significant difference between group.After treatment 14 days, each administration group effect notable (compare with blank group,**p<0.01).Treatment 28 days
Afterwards, kidney tonifying clear Zhixieli granules height, middle dose group effect is significant (are compared with model group△P < 0.05,△△p<0.01).Shenyankangfu tablet
Group, kidney tonifying clear Zhixieli granules low dose group effect notable (compare with blank group,*P < 0.05,**p<0.01).
2.4.4 serum creatinine dynamic change rat eye socket takes blood, measures serum creatinine.
Table 3 serum creatinine (umol/l,N=10)
| Packet | Before administration | Administration 14 days | Administration 28 days |
| Blank group | 20.33±1.86 | 22.8311.47 | 23.40±1.81 |
| Model group | 30.40±4.92** | 30.14±3.97** | 27.66±1.36* |
| Shenyankangfu tablet group | 31.80±5.71** | 32.42±4.72** | 27.611.67* |
| High dose group | 29.40±5.54** | 28.25±2.06** | 23.67±2.32△△ |
| Middle dose group | 32.2±1.92** | 28.7515.67* | 24.71±2.42△ |
| Low dose group | 31.2±8.34* | 31.25±4.36** | 28.2±1.48 |
Note: compare with blank group,*P < 0.05,**p<0.01；Compare with model group△p<0.05,△△p<0.01.
Result shows, after modeling rat blood serum creatinine significantly increase (compare with blank group,*P < 0.05,**P < 0.01), make
No significant difference between module each group.After treatment 14 days, each administration group effect notable (compare with blank group,**p<0.01).Treatment
After 28 days, the clear Zhixieli granules of kidney tonifying are high, middle dose group effect is significant (is compared with model group△P < 0.05,△△p<0.01).Nephritis
Piece group, kidney tonifying clear Zhixieli granules low dose group effect notable (compare with blank group,*p<0.05).
From result above, the clear Zhixieli granules of kidney tonifying significantly lower twenty-four-hour urine albumen and creatinine, increasing serum albumin,
Shenyankangfu tablet significantly reduces twenty-four-hour urine albumen, reduces serum creatinine and raises trend, but effect is not notable, for albuminous fall
Low nothing significantly improves.Than kidney tonifying, clear Zhixieli granules reduce serum flesh, raise the effect of blood albumin better than SHENYANKANG two medicine phases
Multiple piece.
Therefore, the clear Zhixieli granules of kidney tonifying have preferable therapeutical effect to heymann nephritis, can improve heymann Glomerulonephritis Rats
Symptom, reduces twenty-four-hour urine protein quantification and serum creatinine level increasing serum albumin.
3. the clear Zhixieli granules of kidney tonifying brightic effect for rat c-bsa
3.1 experimental technique
3.1.1 the preparation of Cationic bovine serum albumin (c-bsa)
(1) take 67ml anhydrous ethylenediamine (eda) liquid, plus 500ml distilled water, then plus 6mol/l hydrochloric acid 350ml adjustment ph value
To 4.75, it is cooled to 25 DEG C, is stirred, add natural bovine serum albumin (n-bsa) 5g to be dissolved in the molten of 25ml double distilled water
Liquid, adds 1.8g carbonization diimmonium salt hydrochlorate (edchcl) again and maintains 25 DEG C after stirring, continuously stirred 2h keeps ph value 4.75,
Afterwards plus 4mol/l (ph value 4.75) acetate buffer solution 30ml, terminating reaction, obtain final product the c-bsa solution (pi=of isoelectric point, IP raising
9.2).
(2) c-bsa solution is placed in semi-transparent bag, with 4 DEG C of distilled waters dialysis 72h (3～5h changes water once), lyophilization
Afterwards, obtain bsa dry powder.Be stored in -30 DEG C standby.
(3) take above-mentioned powder, i.e. Cationic bovine serum albumin, dissolved with 0.01mol/lph7.4pbs before use, mistake
Filter bacterium.
3.1.2 incomplete Freund's adjuvant preparation
Lanoline 10g, liquid paraffin 40ml, 108 DEG C of sterilization 15min；Mortar ultra violet lamp 2h, on superclean bench
Add lanoline in mortar, add liquid paraffin by lanoline mass volume ratio 1:3 in grinding, be ground to and all hook, obtain final product not
Complete Freund's adjuvant.It is stored in refrigerator (4 DEG C) standby.
3.1.3c-bsa Nephritis Model
Take rat 72, after adaptability raises 3d, collect 24h urine, biuret colorimetry surveys 24h urine protein, by 24h urine
Protein content and body weight, are randomly divided into normal group, positive drug control group, model group, the clear Zhixieli granules of kidney tonifying are high, in, bottom dosage group
Totally six groups.Pre- immunity, c-bsa1mg is dissolved in pbs0.5ml, fully emulsified with ifa equivalent after, to the subcutaneous note of rat multiple spot
Penetrate；Formally immunity, 8d starts, the next day tail vein injection c-bsa16mg/kg time, common 29d.Collect twenty-four-hour urine liquid,
Detect its twenty-four-hour urine albumen.Each group urine protein significantly raises rat and starts gastric infusion within the 12nd week in experiment, and daily gavage is given
Medicine 1 time, successive administration 28d, blank group, model group give normal saline, and positive drug group gives shenyankangfu tablet suspension, is subject to
Reagent group gives kidney tonifying clear Zhixieli granules extractum.Administered volume is 1ml/100g.
3.1.4il-6 the foundation of assay method and standard curve
3.1.4.1il-6 assay method
1) take out test kit from refrigerator, to balance room temperature within 20 minutes in advance.Lath needed for test is taken out, not in hermetic bag
Lath and desiccant are put back in pot model bag and are sealed in 4 DEG C, respectively by specimen and (the 0pg/ml hole additional examination of variable concentrations standard substance
Dilution agent liquid) add in respective aperture.Seal reacting hole with shrouding gummed paper, 37 DEG C of incubators are incubated 40min.
Note: il-6 standard substance are diluted to 2000,1000,500,250,125,62.5,31.25 (pg/ml) successively.
2) wash plate 6 times, add distilled water and each 50ul of first antibody working solution (except blank).Sealed instead with shrouding gummed paper
Ying Kong, 37 DEG C of incubators are incubated 20min.
3) wash plate 6 times, add enzyme labelled antibody working solution (100ul/ hole).Seal reacting hole with shrouding gummed paper, 37 DEG C of incubators
Incubation 10min.
4) wash plate 6 times (concentrated cleaning solution distilled water dilutes 1:20), add substrate working solution 100ul/ hole, 37 DEG C of incubators
Dark place lucifuge incubation 15min.
5) add terminate liquid 100ul/ hole, after mixing, at once measure a value.
3.1.4.2il-6 the foundation of standard curve
Make abscissa to mark Huaihe River product concentration, a value makees vertical coordinate, draws il-6 standard curve, calculated according to mark Huaihe River curve each
Il-6 level in group upper liquid.
3.2 observation index
3.2.124h urine volume and urine protein detection: after Cheng Mo (before administration), rat is put into by administration for the 14th, 28 days
24h urine volume is collected, biuret method measures urine protein content in rat metabolism cage.
3.2.2bun, gre, total serum protein, serum albumin detection: after Cheng Mo (before administration), be administered the 14th
At the end of it and administration, (28d after administration) takes blood through eye socket, carries out blood biochemical detection.
3.2.3 serum il-6 detection: after film forming (before administration) and administration at the end of (28d after administration) take through eye socket
Blood, application bio-rad680 type microplate reader completes il-6 detection with double antibodies sandwich elisa method.
3.3 experimental result
3.3.1 ordinary circumstance formally immunity after, occurred smart dispirited in various degree by immune rat, the loose mixed and disorderly nothing of hair
Gloss, crawl is powerless, and big loose stool is thin, the phenomenon such as ascites.After administration, model group rats lethargy, the loose tarnish of hair, grab
Take powerless, the thin grade in big loose stool gradually increases, shenyankangfu tablet group and the sharp clearly agent each group of kidney tonifying are than improvement, but still see that spirit is withered
Waste, the loose tarnish of hair, crawl is powerless, and big loose stool is thin.
3.3.2 urine protein dynamic change rat metabolism cage accesses urine, measures twenty-four-hour urine protein content.The results are shown in Table 4.
424 hours urine protein quantitation of table (mg/kg 24 hours,N=12)
| Packet | Before administration | Administration 14 days | Administration 28 days |
| Blank group | 32.4±5.24 | 16.58±6.54 | 12.2±3.35 |
| Model group | 66.8±29.95* | 33.61±9.45** | 32.45±10.67** |
| Shenyankangfu tablet group | 101.7±32.9** | 21.62±7.93△ | 15.22±6.20△ |
| High dose group | 57.2±19.73* | 18.13±8.95△ | 16.76±3.65△△ |
| Middle dose group | 74.9±25.77** | 22.18±5.10△ | 14.78±5.31△ |
| Low dose group | 51.56±12.08* | 24.81±4.88* | 15.97±3.66△△ |
Note: compare with blank group,*P < 0.05,**p<0.01；Compare with model group△p<0.05,△△p<0.01.
Result shows, after modeling Rat 24 h urine albumen amount be significantly more than normal group (*P < 0.05,**P < 0.01), modeling
No significant difference between group each group.Treatment 14 days after, kidney tonifying clear Zhixieli granules height, middle dose group, shenyankangfu tablet group effect is significant (with
Model group compares△P < 0.05), low dose group effect notable (compare with blank group,*p<0.05).When 28 days, administration each group effect
Fruit significantly (is compared with model group△p<0.05,△△P < 0.01), low, high dose group effect extremely notable (compare with model group,△△p<
0.01).This medicine can significantly reduce urine protein.
3.3.3 creatinine dynamic change rat eye socket takes blood, measure serum creatinine.The results are shown in Table 5.
Table 5 serum creatinine (umol/l,N=12)
| Packet | Before administration | Administration 14 days | Administration 28 days |
| Blank group | 16.57±1.84 | 24±1 | 23.8±0.75 |
| Model group | 22.88±2.26* | 27±1.94** | 26.2±1.17** |
| Shenyankangfu tablet group | 24.33±3.77* | 24.33±1.37△ | 23.17±2.19△ |
| High dose group | 24.77±5.55* | 24.33±1.22△△ | 23.8±0.98△ |
| Middle dose group | 25.67±4.67** | 23.89±2.81△ | 24.2±0.75△ |
| Low dose group | 27.2±5.56* | 24.29±1.98△ | 24±1.41△ |
Note: compare with blank group,*P < 0.05,**p<0.01；Compare with model group△p<0.05,△△p<0.01.
Result shows, after modeling rat blood serum creatinine significantly increase (compare with blank group,*P < 0.05,**P < 0.01), make
No significant difference between module each group.After treatment 14 days, each administration group effect all significantly (is compared with model group△p<0.05,△△p<
0.01), high dose group effect more notable (compare with model group,△△p<0.01).After treatment 28 days, each group effect all notable (△p<
0.05).This medicine can significantly reduce serum creatinine.
3.3.4 serum albumin dynamic change rat eye socket takes blood, measures serum albumin.The results are shown in Table 6.
Table 6 serum albumin (g/l,N=12)
| Packet | Before administration | Administration 14 days | Administration 28 days |
| Blank group | 35.93±0.81 | 37.3±1.08 | 35.83±0.75 |
| Model group | 34.29±1.30* | 35.57±0.57** | 34.62±0.16** |
| Shenyankangfu tablet group | 33.4±1.15** | 35.6±1.26** | 35.24±0.38△ |
| High dose group | 32.7±3.57* | 36.96±1.37△ | 35.8±0.94△ |
| Middle dose group | 34.23±1.53* | 37.26±0.90△△ | 35.76±0.96△ |
| Low dose group | 33.56±1.82* | 35.99±0.78* | 32.13±3.07* |
Note: compare with blank group,*P < 0.05,**p<0.01；Compare with model group△p<0.05,△△p<0.01.
Result shows, after modeling rat serum albumin dramatically increase (compare with blank group,*p<0.05**, p < 0.01),
No significant difference between modeling group each group.After treatment 14 days, the clear Zhixieli granules of kidney tonifying are high, middle dose group effect is significant is (with model group ratio
Relatively△P < 0.05,△△p<0.01).After treatment 28 days, the clear Zhixieli granules of shenyankangfu tablet group, kidney tonifying are high, middle dose group effect is all notable
(compare with model group△p<0.05).This medicine can notable increasing serum albumin, effect is early than shenyankangfu tablet.
3.3.5 cholesterol dynamic change rat eye socket takes blood, measures serum cholesterol.The results are shown in Table 7.
Table 7 serum cholesterol (mmol/l,N=12)
| Packet | Before administration | Administration 14 days | Administration 28 days |
| Blank group | 1.78±0.13 | 1.47±0.11 | 1.35±0.07 |
| Model group | 2.36±0.42* | 1.78±0.19** | 1.61±0.19* |
| Shenyankangfu tablet group | 2.7±0.42* | 1.82±0.29* | 1.53±0.12* |
| High dose group | 2.16±0.41* | 1.84±0.32* | 1.36±0.13△ |
| Middle dose group | 2.13±0.31* | 1.55±0.09△ | 1.40±0.11△ |
| Low dose group | 2.26±0.38* | 1.72±0.20* | 1.30±0.18△ |
Note: compare with blank group,*P < 0.05,**p<0.01；Compare with model group△p<0.05,△△p<0.01.
After modeling, each group cholesterolemia all significantly raise (compare with normal group,*P < 0.05), no aobvious between modeling group each group
Write difference.When treating 14 days, kidney tonifying clear Zhixieli granules middle dose group effect is significant (compare with model group,△p<0.05).When 28 days,
The clear Zhixieli granules of kidney tonifying each dosage group effect all notable (compare with model group,△p<0.05).Point out this medicine can improve cholesterol to raise
Trend, effect early than, be better than shenyankangfu tablet.
3.3.6 before and after treating, rat blood serum il-6 level compares rat eye socket and takes blood, measures serum il-6.The results are shown in Table 8.
Table 8 each group rat il-6 expression comparison (pg/ml,)
| Packet | n | Before administration | Administration 28 days |
| Blank group | 9 | 14.09±3.65 | 19.43±4.05 |
| Model group | 8 | 105.97±44.17** | 257.00±81.49** |
| Shenyankangfu tablet group | 8 | 305.52±195.99** | 140.28±102.34△# |
| High dose group | 9 | 262.26±112.10** | 54.56±34.18△## |
| Low dose group | 8 | 199.03±56.04** | 59.95±40.63△# |
Note: compare with blank group,*P < 0.05,**p<0.01；Compare with model group,△p<0.05,△△p<0.01；With treatment
Before compare,#P < 0.05,##p<0.01.
After modeling, each group rat blood serum il-6 level significantly raises (comparing, p < 0.01) with normal group, between modeling group each group
No significant difference.When 28 days, shenyankangfu tablet group, kidney tonifying clear Zhixieli granules high and low dose group rat blood serum il-6 level is below
Model group, both compare significant difference (p < 0.05).
Therefore, the clear Zhixieli granules of kidney tonifying are low, high dose group can pole significantly reduce 24h urine protein (△△p<0.01).High dose group
Effect can pole significantly reduce creatinine (△△P < 0.01), Serum Interleukin-6.Shenyankangfu tablet group and height, middle dose group all significantly drop
Low serum albumin (△P < 0.05), and early than shenyankangfu tablet.Each dosage group all significantly improve cholesterol raise trend (△p<
0.05), its effect early than, be better than shenyankangfu tablet.
This study demonstrates that, the clear Zhixieli granules of kidney tonifying have preferable therapeutical effect to c-bsa nephritis, can improve its symptom, reduce
24h urine protein quantitation and serum creatinine level, increasing serum albumin and improve cholesterol raise trend, wherein with high dose group imitate
Really particularly evident.
Claims (7)
1. a kind of medicine for treating kidney deficiency damp-heat type chronic nephritis is it is characterised in that raw material by following weight
Medicine extracts and is prepared from: Radix Astragali 20-40 part；Rhizoma Atractylodis Macrocephalae 8-12 part；Fructus Corni 8-12 part；Cortex Eucommiae 10-30 part；Rhizoma Alismatis 10-20 part；Stone
Reed 10-30 part；Herba Hedyotidis Diffusae 10-30 part；Radix Notoginseng 3-7 part, preparation method comprises the following steps:
A) take the Rhizoma Atractylodis Macrocephalae by above-mentioned parts by weight, Herba Hedyotidis Diffusae two taste, through extraction by steam distillation volatile oil, uses beta-schardinger dextrin-
Inclusion；
B) take the Radix Astragali, the Cortex Eucommiae, Rhizoma Alismatis, Folium Pyrrosiae, the Radix Notoginseng five tastes by above-mentioned parts by weight, through alcohol reflux, filter, reclaim second
Alcohol, is concentrated to give alcohol extracting concentrate；
C) medicinal residues after step a steam distillation, the medicinal residues after b alcohol extraction are merged with Fructus Corni, boil through decocting, filtration, 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 b, spray
Mist is dried, and makes dry extract；
D) take the volatile oil clathrate compound of step a and the dry extract of c to carry out wet granulation, be dried, obtain final product medicine.
2. it is used for as claimed in claim 1 treating kidney deficiency damp-heat type chronic ephritis medicine it is characterised in that joining by following weight portion
The crude drug of ratio extracts and is prepared from: 30 parts of the Radix Astragali；10 parts of the Rhizoma Atractylodis Macrocephalae；10 parts of Fructus Corni；20 parts of the Cortex Eucommiae；15 parts of Rhizoma Alismatis；Folium Pyrrosiae 20
Part；20 parts of Herba Hedyotidis Diffusae；5 parts of Radix Notoginseng.
3. it is used for treating kidney deficiency damp-heat type chronic ephritis medicine it is characterised in that preparation method step a as claimed in claim 1
Middle steam distillation, is soaked 1 hour using medical material weight 6 times amount water, and distillation extracts volatile oil in 8 hours, and volatile oil adds 6 times of weights
Amount beta-schardinger dextrin-, using 40 DEG C of electric stirrings of saturated water solution method, mixing speed is 120r/min, and stirring was carried out after 1.5 hours
Inclusion, 40 DEG C of vacuum drying of clathrate.
4. it is used for treating kidney deficiency damp-heat type chronic ephritis medicine it is characterised in that preparation method step b as claimed in claim 1
Middle alcohol reflux, institute's alcohol adding amount is 12 times of decoction pieces gross weight, and ethanol volumetric concentration is 70%, reflux, extract, in three times,
2 hours every time, united extraction liquid, filtration, decompression filtrate recycling ethanol, it is concentrated into no alcohol taste.
5. it is used for treating kidney deficiency damp-heat type chronic ephritis medicine it is characterised in that preparation method step c as claimed in claim 1
In, boil through decocting, amount of water is 12 times of decoction pieces gross weight, decocts in two times, 2 hours every time, merge decocting liquid, filtration, filter
When liquid is concentrated into 50 DEG C, relative density is 1.05～1.08, cooling, plus ethanol is less than 50% to alcohol content, stirs evenly, and places 48
Hour, filtration, filtrate recycling ethanol, merging relative density when being concentrated into 50 DEG C with above-mentioned alcohol extracting concentrate is 1.10～1.15,
Add dextrin appropriate, be 165～175 DEG C in import pathogenic wind-warm, under the conditions of 85～90 DEG C of pathogenic wind-warm of outlet, be spray dried to dry extract.
6. it is used for treating kidney deficiency damp-heat type chronic ephritis medicine it is characterised in that preparation method step d as claimed in claim 1
In, take take dry extract to add appropriate Icing Sugar in step a volatile oil clathrate compound and step c, dextrin mixes and carries out wet granulation, do
Dry, obtain final product medicine, dosage form is tablet or granule or hard capsule.
7. it is used for as claimed in claim 1 treating kidney deficiency damp-heat type chronic ephritis medicine in preparation treatment kidney deficiency damp-heat type chronic kidney
Application in scorching medicine.
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| "益肾清利颗粒干预慢性肾小球肾炎肾虚湿热证的临床观察与动物实验";吴金珠;《中国优秀硕士学位论文全文数据库 医药卫生科技辑》;20121015;第24页最后2行-第25页第1-4行，第26页表格，第27页第3段 * |
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