CN108295239A - Treatment albumen urinates Chinese medicine composition and its preparation method and application - Google Patents
Treatment albumen urinates Chinese medicine composition and its preparation method and application Download PDFInfo
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Abstract
The present invention provides a kind of Chinese medicine composition and its preparation method and application for the treatment of albumen urine, and the Chinese medicine composition includes following components：Silkworm cocoon polypeptide and corn silk polysaccharide.Can effectively be treated using the Chinese medicine composition in the present invention leads to the disease of albuminuria, and has no toxic side effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine compositions and its preparation method and application for the treatment of albumen urine, belong to the field of Chinese medicines.
Background technology
One of the index that albuminuria is the common clinical manifestation of disease in the urological system and can detect earliest.Normal condition
Under, normal person's Urine proteins are less than 150mg/d, and when kidney illness, glomerular filtration membrane permeability increases, and a large amount of protein is made to filter
It crosses into glomerular filtrate, considerably beyond the reabsorption ability of renal tubule, protein causes albuminuria in being urinated eventually into people, common
In the diseases such as all kinds of primary or secondary glomerulopathy, kidney circulation obstacle, anoxic.Urine proteins can be on a small quantity to daily
Number 10g or more, majority>2g/24h, typically based on albumin.When in reabsorption dysfunction, glomerular filtrate
Protein reabsorption reduce, also result in albuminuria, the glomerulus interstitial disease being common in caused by a variety of causes, such as diabetes
Nephrosis, pyelonephritis, antalgesic nephrosis, nephropathy due to antibiotics, heavy metal poisoning, congenital polycystic kidney and various congenital
Renal tubular disease etc..Albuminuria is the common sympton of chronic renal disease, and clinic is visible to have the increase of urine foam, long-term lose to control
Renal function can be caused further to deteriorate.In traditional Chinese medicine, corresponding name of disease is there is no, but in diseases such as " consumptive disease " " oedema " " pains in the back "
In visible corresponding corresponding symptom.With going deep into albuminuria renal damage understanding, how to control, reduce albuminuria
As protection renal function, the important research direction for delaying renal damage to be in progress.
Silkworm cocoon is the cocoon shell of Bombycidae insect bombyx mori (Bombyx mori L.), alias：Silkworm cocoon, cocoon be yellow, continuous silkworm,
Silkworm cocoon.It is sweet in flavor, warm-natured.Have the function of stopping blooding, quench the thirst and detoxification sore treatment.Corn stigma is for grass maize
The style and column cap of (Zea mays L.).
Treatment to renal albuminuria, clinical still weary effective therapy.Modern medicine is commonly used primarily directed to the treatment of the cause of disease
Drug：Cortex hormone of aadrenaline, immunosuppressive drug, angiotensin converting enzyme inhibitor and angiotensin receptor antagonist
Deng, although having certain effect, there is certain side effect, be not easy patient long-term use.
Invention content
In view of the foregoing deficiencies of prior art, the purpose of the present invention is to provide a kind of Chinese medicine composition and its preparations
Method and purposes cause the disease therapeuticing effect of albuminuria undesirable, the big problem of side effect in the prior art for solving.
In order to achieve the above objects and other related objects, the present invention provides a kind of Chinese medicine composition for the treatment of albumen urine, institute
It includes following components to state Chinese medicine composition：Silkworm cocoon polypeptide and corn silk polysaccharide.
Preferably, in the Chinese medicine composition, with the solids basis in silkworm cocoon polypeptide and corn silk polysaccharide, silkworm cocoon is more
The weight ratio of peptide and corn silk polysaccharide is：1：(0.1-10).
Preferably, the silkworm cocoon polypeptide and corn silk polysaccharide weight ratio are 1:(1~8)；Preferably 1:(1~6)；It is more excellent
It is selected as 1:(1~3)；Most preferably 1:1.
It is highly preferred that the silkworm cocoon polypeptide molecular weight is less than 15KD, the molecular weight of the corn silk polysaccharide be more than
3KD；More preferably 3~500KD.
Another aspect of the present invention provides the preparation method of silkworm cocoon polypeptide in above-mentioned Chinese medicine composition, such as adopts
It is that raw material is prepared by water extraction with silkworm cocoon.
Further, the polypeptide production methods at least include the following steps：Silk cocoon is added water to cook, is filtered to get filtrate,
Filtrate ultrafiltration obtains permeate.
Preferably, the preparation method further includes that silk cocoon is crushed before decoction.
Preferably, the number of the decoction is 1~3 time, and every time plus the water of 4~12 times of weight, the time decocted every time are 1
~3 hours.
Preferably, the polypeptide production methods, filtering times are at least twice.
Preferably, the polypeptide production methods further include that will transmit through liquid concentrated and dry.
Preferably, the pressure of ultrafiltration is 0.15~0.3Mpa, the filter membrane that the ultrafiltration uses in the polypeptide production methods
Use molecular cut off for the filter membrane of 15~25KD.
More specifically, in the polypeptide production methods, the number of filtering is twice, specially：Filtrate is obtained after primary filtering,
Dilution, then carries out secondary filter, obtains filtrate, then ultrafiltration；The dilution refers to that filtrate is diluted to every 100ml to contain medicinal material 3
~9g, secondary filter use micro-filtrate membrane filtration, and the aperture of microfiltration membranes is 0.3 micron.
It is highly preferred that the dilution refers to that filtrate is diluted to every 100ml to contain medicinal material 5g.
It is highly preferred that the number of the decoction is 3 times, every time 1.5 hours.
It is further preferred that the secondary filter uses micro-filtrate membrane filtration, the aperture of microfiltration membranes is 0.3 micron.Microfiltration membranes refer generally to
Filter membrane of the pore size filter between 0.1-1 microns.
Preferably, the pressure of the ultrafiltration is 0.15~0.3Mpa, and the filter membrane that the ultrafiltration uses uses molecular cut off
For the filter membrane of 15~25KD molecules.
It is highly preferred that the concentration is by the way of being concentrated under reduced pressure.
Another aspect of the present invention provides the preparation method of corn silk polysaccharide in above-mentioned Chinese medicine composition, such as adopts
It is prepared by water extraction with corn stigma.
Further, polyoses producing method at least includes the following steps：Corn stigma is mixed with water, is heated to reflux and is carried
Liquid is taken, is filtered to get filtrate, trapped fluid is collected in ultrafiltration.
Preferably, the filtering uses microfiltration membranes.
It is highly preferred that the aperture of the microfiltration membranes is 0.45 micron.
Preferably, the filter membrane that the ultrafiltration uses is the filter membrane for using molecular cut off as 3~500KD.
Another aspect of the present invention provides purposes of the above-mentioned Chinese medicine composition in preparing treatment albumen urine drug.
It is known in current medical domain that the disease of albuminuria can be caused to have very much, include mainly：A, all kinds of originals
Hair property or secondary glomerulopathy, kidney circulation obstacle, anoxic, b, glomerulus interstitial disease, such as diabetic nephropathy, renal plevis kidney
Inflammation, antalgesic nephrosis, nephropathy due to antibiotics, heavy metal poisoning, congenital polycystic kidney and various congenital renal tubular diseases
Deng.
In traditional Chinese medical science field albuminuria is also shown in the diseases such as " consumptive disease " " oedema " " pain in the back ".
Another aspect of the present invention provides a kind of pharmaceutical composition for the treatment of albumen urine, and described pharmaceutical composition has
Effect ingredient contains Chinese medicine composition as described above.
Chinese medicine composition and pharmaceutical composition in the present invention can be prepared into any pharmaceutical by addition auxiliary material
Dosage form, including but not limited to：Tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule
Agent, oral solution, mouth containing agent, granule, electuary, pill, powder, paste, sublimed preparation, suspension, pulvis, solution, injection,
Suppository, ointment, emplastrum, creme, spray, drops, patch；It is preferable to use peroral dosage forms, including but not limited to：Capsule
Agent, tablet, oral solution, granule, pill, powder, sublimed preparation, paste etc..The oral preparation can contain common figuration
Agent, such as adhesive, filler, diluent, tablet agent, lubricant, disintegrant, colorant, flavoring agent and wetting agent, when necessary
Tablet can be coated.Wherein, suitable filler includes cellulose, mannitol, lactose and other similar fillings
Agent；Suitable disintegrant includes starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycollate；Suitable
Lubricant includes, such as magnesium stearate.Suitable wetting agent includes lauryl sodium sulfate etc..
As described above, the Chinese medicine composition of the present invention, has the advantages that：
Chinese medicine composition can effectively treat the various diseases that can lead to albuminuria, especially diabetic nephropathy and film
Property nephrosis.Experiment confirms silkworm cocoon polypeptide extract and corn silk polysaccharide extract, organically whole as one after mixing
Body, and it is more preferable than silkworm cocoon polypeptide extract and the effect of corn silk polysaccharide extract is used alone, there is synergistic make
With.
Specific implementation mode
Illustrate that embodiments of the present invention, those skilled in the art can be by this specification below by way of specific specific example
Disclosed content understands other advantages and effect of the present invention easily.The present invention can also be by addition different specific
Embodiment is embodied or practiced, and the various details in this specification can also be based on different viewpoints and application, not carry on the back
Various modifications or alterations are carried out under spirit from the present invention.
The compatibility of the present invention meets " monarch " principle of Chinese medicine, following each Chinese medicine interaction compatibilities that the present invention uses,
It can be played and cooperate with the effect of curing the disease, between each ingredient of Chinese medicine material used there is drug effect to be interweaved, mutually promote and coordinate effect
Energy.
Bulk pharmaceutical chemicals (or medicinal material) of the present invention can be bought from common pharmacy or Chinese medicine sales company
It arrives, specification meets the legal medical standards of country or meets the pertinent regulations such as Chinese Pharmacopoeia.Used medicinal material is except as otherwise saying
It is bright, it is tcm and herbal slice, which can also be after obtaining through being process.
So-called " patient " of the invention refers to people, wild animal and domestic animal with disease.Wild animal is under natural conditions
Animal without domestication.Domestic animal is to provide for the animal of food source and artificial feeding, such as monkey, ape, dog, mouse, storehouse
Mouse, pig, rabbit, horse, milk cow, buffalo, bull, sheep and goat etc.." patient " for giving diagnosis preferably selects mammal, especially
It is people.
The curative effect standard reference of the present invention《Disease of tcm judges criterion of therapeutical effect》In related criterion of therapeutical effect.Recovery from illness：Clinical condition
Shape all disappears, and laboratory examination is normal.It improves：Clinical symptom relief, laboratory examination improvement or normal.In vain：Clinical condition
Shape no significant improvement or aggravation.
The conventional method that Chinese medicine preparation may be used in the composition of the present invention is prepared into any conventional oral preparations, Huo Zhejing
The dosage form that can be further prepared into through common process of final extracting solution obtained by extraction the composition, including capsule, tablet,
Granule, powder, oral solution, soft capsule, pill, mixture, syrup, gelling agent and sustained-release preparation etc..To make above-mentioned dosage form
It can realize, pharmaceutically acceptable auxiliary material need to be added when preparing these dosage forms, such as filler, disintegrant, lubricant, help
Suspension, adhesive, sweetener, corrigent, preservative etc..
The preparation process of the present invention uses in principle《The technology requirement of new Chinese medicine Study on Preparation》, made with the modern times
The principle active component of agent new technology extraction drug is used as medicine, and adds some pharmaceutically acceptable auxiliary materials or carrier
Embodiment 1：The preparation of silkworm cocoon polypeptide extract
1000 grams of silkworm cocoon is taken, fragment is cut into, is added water to cook 3 times, every time plus the water of 6 times of weight, each decoction 1.5 are small
When, filtration, merging filtrate obtains silkworm cocoon filtrate；Silkworm cocoon filtrate is diluted to steaming shop water and is equivalent to medicinal material containing silkworm cocoon 5
The concentration of g/l00mL, it is 0.3 μm of micro-filtrate membrane filtration then to use aperture, obtains micro-filtrate；Micro-filtrate is with molecular cut off
The ultrafiltration membrane of 15KD~25KD carries out ultrafiltration under 0.2Mpa pressure, discards trapped fluid, merges the permeate of gained, through decompression
Concentration, freeze-drying is to get 600 grams of silkworm cocoon active polypeptide extract.
Embodiment 2：The preparation of corn silk polysaccharide extract
1000 grams of corn stigma is taken to soak 12 hours, heating and refluxing extraction 3 hours；Filtration, filtrate cross 0.45 μm of moisture film
Micro-filtration collects filtrate；By gained filtrate after the ultrafiltration membrane that molecular cut off is 3~500KDa；Collect the medicine for not penetrating filter membrane
Liquid concentrates, dry, obtains 200 grams of corn silk polysaccharide extract.
Embodiment 3：The egg to diabetic nephropathy is respectively applied alone with it in silkworm cocoon polypeptide extract and corn silk polysaccharide extract
The comparative studies of albiduria effect
The silkworm cocoon polypeptide extract and corn silk polysaccharide extract prepared using embodiment 1 and embodiment 2 is tested.
SD rats are bought, adaptable fed 7 days, have a blood test sugared normal, Urine proteins qualitative test feminine gender, animal health condition are good
It is good, start to test.It is randomly divided into two groups, i.e. blank control group (blank group) 10, early stage model group 50 by weight.Experiment
Start each group early stage rat and give high sugar, high fat diet (adding 20% sucrose, 10% lard, 2.5% cholesterol in conventional feed),
The normal diet and blank control group is then freely ingested, two groups of equal free waters.After 8 weeks after early diabetic nephropathy Rat Fast,
10% chloraldurate solution 3.5ml/kg is injected intraperitoneally, is anaesthetized, injection capacity is 0.3ml/100g weight.Confirm anesthesia
Afterwards, row left kidney resection：Rat prone position is fixed on operating table, is lost hair or feathers, exposed skin, conventional iodophor disinfection, from
Skin and muscle layer, exposure kidney and circumrenal adipose capsule are cut at left side backbone and the angle for helping bone, are ligatured at the hilus renalis,
Left kidney is completely extractd, checks without after bleeding profusely, sutures muscle layer and skin.2 weeks after operation, after each group Rat Fast 18h, press
50mg/kg gives streptozotocin (STZ)-secondary property intraperitoneal injection, i.e., specific dosage is weight (citric acid before use
Buffer solution, concentration blank control group inject the citrate buffer of equivalent.After injecting STZ 72h, tail vein blood surveys blood
Sugar, and stay and urinate for 24 hours.With blood glucose level>>16.7mmol/L, glucose in urine are positive and survey urine protein positive after stablizing 5 days and 2 weeks,
It is included in observation object as early animal model foundation standard.The successful rat of modeling is divided at random by Urine proteins and blood glucose value
For group：Model control group (abbreviation model group) and benazepril hydrochloride group (abbreviation positive drug group), silkworm cocoon polypeptide group (CJ) group
(abbreviation CJ groups), corn silk polysaccharide (YM) group (abbreviation YM groups) and silkworm cocoon polypeptide+corn silk polysaccharide (YC) group (abbreviation YC
Group), every group each 10, often single cage is raised after group #, blood glucose and the more not statistically significant (P of Urine proteins between each group rat>
0.05)。
After modelling, be utilized respectively silkworm cocoon polypeptide, corn silk polysaccharide and silkworm cocoon polypeptide+corn silk polysaccharide,
It is treated with benazepril hydrochloride (positive drug group).Silkworm cocoon polypeptide dosage is 50mg/kg/ days, corn silk polysaccharide 50mg/
Kg/ days, (the two pressed 1 to silkworm cocoon polypeptide+corn silk polysaccharide dosage:1 mixing) dosage be 50mg/kg/ days, positive drug group dosage
It is 0.9mg/kg/ days, gastric infusion.Normal group and model group give the distilled water of equivalent respectively, start after being administered to 4
Weekend experiment terminates.Experimental result such as table 1~3.
1 each group rat of table, 0,2,4 weekend blood glucose compares (mean ± SD)
| Group | n | 0 week (mmol/L) | 2 weeks (mmol/L) | 4 weeks (mmol/L) |
| Normal group | 10 | 5.28±0.32 | 5.47±0.28 | 5.62±0.31 |
| Model group | 10 | 17.76±1.28 | 21.14±3.38 | 23.22±4.76 |
| Positive drug group | 10 | 17.74±2.24 | 22.01±2.38 | 23.59±3.68 |
| CJ groups | 10 | 17.68±1.88 | 19.28±1.25# | 20.36±4.87# |
| YM groups | 10 | 18.02±2.34 | 18.47±1.58# | 16.24±2.34# |
| YC groups | 10 | 17.88±1.87 | 17.24±2.47# | 15.38±3.64# |
Note:* the P compared with model group<0.05,
2 each group of table treatment different time microdose urine protein (UAE) compares (mean ± SD)
Note:* the P compared with model group<0.01,#The P compared with YC groups<0.01
Each group serum creatinine (Scr) and urea nitrogen (BUN) compare (mean ± SD) at the end of table 3 is tested
| Group | n | BUN(mmol/L) | Scr(mmol/L) |
| Normal group | 10 | 4.26±0.77 | 32.24±3.58 |
| Model group | 10 | 5.86±0.91 | 40.31±3.62 |
| Positive drug group | 10 | 5.61±0.38* | 37.24±2.68* |
| CJ groups | 10 | 5.27±0.62* | 35.54±2.67* |
| YM groups | 10 | 5.54±0.48* | 36.17±3.10* |
| YC groups | 10 | 4.89±0.68* | 34.21±3.69* |
Note:* the P compared with model group<0.01
Experimental result is shown in Table 1, table 2 and table 3, the experimental results showed that, compared with blank group, model group and each treatment group's blood glucose
It is significantly increased with microdose urine protein (UAE), shows modeling success.After treatment, positive drug group makees blood glucose without notable
With, and CJ groups, YM groups and YC groups can significantly reduce blood glucose to a certain degree, and it is most notable with YC group reduction degree, show silk cocoon
Shell polypeptide+corn stigma plays the role of collaboration more reduces blood glucose.
In addition, positive drug group has certain reduction to act on microdose urine protein (UAE), but it is not so good as CJ groups, YM groups
With YC groups, and YC groups effect highly significant when treating 2 weeks and 4 weeks is more notable than independent CJ groups and YM group effects,
Show that silkworm cocoon polypeptide adds corn silk polysaccharide to play the role of collaboration and reduces Urine proteins.
In addition, and CJ groups, YM groups and YC groups can also serum creatinine (Scr) and urea nitrogen (BUN) levels.
In terms of comprehensive, silkworm cocoon polypeptide and corn silk polysaccharide conjunctive use can cooperate with the symptom for improving diabetic nephropathy to make
With.
Embodiment 4：Proteinuria efficacy and blood glucose comparative studies of the Chinese medicine composition object of different ratio to diabetic nephropathy
Silkworm cocoon polypeptide (CJ) and corn silk polysaccharide (YM) prepared by Example 1 and 2 methods, respectively with composition A
(CJ:YM ratios are 1:10), composition B (CJ:YM ratios are 5:5), composition C (CJ:YM ratios are 10:1) it is experiment pair
As according to the method for embodiment 3, replicating Diabetic Nephropathy model.After modelling, be respectively adopted composition A,
Composition B, composition C and benazepril hydrochloride (positive drug group) are treated.Composition A, composition B and composition C agent
Amount is 50mg/kg/ days, and positive drug group dosage is 0.9mg/kg/ days, gastric infusion.Normal group and model group are given respectively
The distilled water for giving equivalent starts to terminate to the experiment of 4 weekends after being administered.Experimental result such as table 4.
The mixture of the different compounds of table 4. is to diabetic nephropathy rats blood glucose and Microalbuminuria
(note：*P<0.01, relatively there are significant differences with model group；#P<0.01 has very compared with composition B groups
Significant difference)
Experimental result is shown in Table 4, the results showed that, compared with blank group, model group and each treatment group's blood glucose and urine Microalbunin
(UAE) is significantly increased in vain, shows modeling success.After treatment, positive drug group to blood glucose without remarkable effect, and composition
A, composition B and composition C can significantly reduce blood glucose, UAE, BUN and Scr effect to a certain degree, and be dropped with composition B groups
Low degree is most notable, more notable than composition A and composition C effects, should be the result shows that silkworm cocoon polypeptide and corn silk polysaccharide etc.
Ratio Use Limitation fruit is best.
Embodiment 5：Traditional Chinese medicine composition for treating diabetic nephropathy high protein urinates the clinical research of disease
Inclusion criteria：Diabetic Nephropathy patients 80 are screened, according to nephrosis branch of Traditional Chinese Medicine association in 2007《Diabetogenous nephrosis
Disease diagnosis, differentiation of symptoms and signs for classification of syndrome and efficacy assessment standard (tentative program)》：1. there is exact diabetes medical history, the course of disease is often 6~10
Year or more；2. meeting Mogensen diabetic nephropathy staging diagnosis standards belongs to the diabetic nephropathy III phases, i.e. lasting albumin
Urine, urinary albumin-creatinine ratio ratio>300ug/mg or urinary albumin excretion ratio>200ug/min or urinary albumin are quantitative>300mg/
For 24 hours or quantity of proteinuria>0.5g/24h.It is abnormal to exclude serious hepatic and renal function, pregnant woman, women breast-feeding their children.
Research process：Experimental subjects is divided into treatment group and Primary Care group, every group 40.Separately by SAS statistical packages
Simulation generates the table of random numbers, and being included in exclusion criteria according to research approach enters a group case, subject according to the priority for being included in research,
Treatment group and control group are sequentially entered by random number serial number.Treatment group：The traditional Chinese medicine composition for treating prepared using Examples 1 and 2
(silkworm cocoon polypeptide (CJ) and corn silk polysaccharide (YM) 1:1 mixture), dosage per person 500mg takes after mixing it with water for one day 2, secondary
It takes, once in the morning and once at night.Primary Care group：Melbine+depressor treatment, specification 10mg/ pieces are a piece of daily, night
Clothes.Two groups of the course for the treatment of is 2 weeks.Efficacy determination refers to nephrosis branch of China Association of Traditional Chinese Medicine in 2007《Diabetic nephropathy diagnoses
And efficacy assessment standard (tentative)》The efficacy on diabetic nephropathy evaluation criteria of publication is formulated.(being shown in Table 5)
5 Comprehensive Assessment scalar quantization table of table
(1) albuminuria interpretation of result
After treatment, urine albumen amount for 24 hours (Pro for 24 hours) and microdose urine protein (mALB) number of Primary Care group group patient
Value is substantially reduced before relatively treating, and YC has and has very to urine albumen amount for 24 hours (Pro for 24 hours) and microdose urine protein (mALB)
It is significant to reduce (P<0.01), (6 are shown in Table).
The different treatment histonurias of table 6 compare
| Group | It treats front/rear | 24hPro(g/24h) | Urinate mALB (mg/L) |
| Primary Care group | Before treatment | 2.92±1.28 | 1130.30±492.11 |
| After treatment | 2.61±1.14* | 1109.48±539.76 | |
| YC groups | Before treatment | 2.89±1.45 | 1268.05±318.31 |
| After treatment | 1.25±0.39** | 543.74±694.02** |
* compared with before treatment, P<0.05 significant difference；* is compared with before treatment, P<0.01 has highly significant difference
(2) renal function interpretation of result
After treatment, Primary Care group is significantly improved effect, serum urea nitrogen to glomerular filtration rate (eGFR)
(BUN) kept stable and serum creatinine (Scr) also have the phenomenon that increasing；And YC groups creatinine, urea nitrogen, glomerular filtration
Rate significantly improves, and prompts to improving renal function significant effect.(being shown in Table 7)
The different treatment group's renal functions of table 7 compare
* compared with before treatment, the statistically significant P of difference<0.05.
(3) blood sugar effects are analyzed
After treatment, it is significantly improved in terms of Primary Care group fasting blood-glucose (FBG) and 2h postprandial blood sugars (PBG), YC
It is significantly improved in terms of group fasting blood-glucose (FBG) and 2h postprandial blood sugars (PBG), relative extent is not so good as Primary Care group, there is system
Meter learns meaning (P<0.05) (8 are shown in Table)
Patient's FBG and PBG situation of change table after the different therapeutic modalities of table 8
| Group | It treats front/rear | FBG(mmol/L) | PBG(mmol/L) |
| Primary Care group | Before treatment | 7.81±2.44 | 11.51±2.10 |
| After treatment | 5.90±1.76* | 8.29±2.328 | |
| YC groups | Before treatment | 7.78±2.38 | 11.01±2.03 |
| After treatment | 6.98±1.49* | 9.39±2.41* |
* compared with before treatment, the statistically significant P of difference<0.05.
Clinical test results show that Chinese medicine composition of the present invention can significantly reduce the Urine proteins for 24 hours of Diabetic Nephropathy patients
Amount (Pro for 24 hours), microdose urine protein (mALB) have the improvement result of highly significant, are significantly improved to renal function, to blood glucose
Level has a degree of improvement result.Therefore, (silkworm cocoon polypeptide (CJ) and corn silk polysaccharide (YM) 1:1 mixture is to sugar
The sick kidney condition of urine is significantly improved.
Embodiment 5：Traditional Chinese medicine composition for treating membranous nephropathy high protein urinates the clinical research of disease
Rat adaptable fed is collected after 1 week to urine for 24 hours in metabolic cage, measure for 24 hours quantity of proteinuria (for 24 hours-
Upro)<5mg is randomly divided into normal group (15) and modeling group (30).It is lured with positive ionization bovine serum albumin(BSA) (C-BSA)
Membranous nephropathy is led, takes C-BSA30mg to be dissolved in physiological saline 15mL and is mixed with equivalent incomplete Freund's adjuvant, it is fully emulsified.
Take emulsion 1mL in the nape part of modeling group rat, the multiple points in groin, oxter be subcutaneously injected carry out it is pre- immune, the next day 1 time,
Totally 3 times.Then it is formally immunized by each 16mg/kg/d tail vein injections C-BSA, 3 times a week, continuous 4 weeks.In metabolism
Urine for 24 hours is collected in cage, is measured-UPro ＞ 20mg for 24 hours and is prompted modeling success.The bodies such as each tail vein injection of normal rats
Long-pending physiological saline.Surviving after modeling and being detected through-UPro for 24 hours confirms the successful rat of modeling totally 24.
24 rats are randomly divided into model group, silkworm cocoon polypeptide and corn silk polysaccharide 1:1 mixture (YC) group (is implemented
It is prepared by example 1 and 2), every group 10.YC group dosage is 50mg/kg, and Normal group and model group give the distillation of equivalent respectively
Water starts to terminate to the experiment of 4 weekends after being administered.
The mixture of the different compounds of table 9. is to Membranous Nephritis Rats blood glucose microdose urine protein (UAE)
(note：The * P compared with model group<0.05, there are significant differences, * * P<0.01 significant differences)
Experimental result is shown in Table 9, the results showed that, compared with being given with blank, model group and each treatment group's blood glucose and urine Microalbunin
(UAE) is significantly increased in vain, shows modeling success.After treatment, YC groups can significantly reduce to a certain degree blood glucose, UAE,
BUN and Scr effects, should be the result shows that silkworm cocoon polypeptide and corn silk polysaccharide equal proportion have good drop egg using to membranous nephropathy
Albiduria acts on.
Above embodiment is can not to be interpreted as the limit to the present invention in order to illustrate embodiment disclosed by the invention
System.In addition, in various modifications and invention listed herein method, composition variation, do not departing from the scope of the present invention
Be obvious for those skilled in the art under the premise of spirit.Although having combined a variety of tools of the present invention
Body preferred embodiment has carried out specific description to the present invention, it is to be understood that, the present invention should not be limited only to these specific implementations
Example.In fact, various, obviously modification is all answered to obtain invention for those skilled in the art as described above
It is included within the scope of the invention.
Claims (11)
1. a kind of Chinese medicine composition for the treatment of albumen urine, which is characterized in that the Chinese medicine composition includes at least：Silkworm cocoon polypeptide
And corn silk polysaccharide.
2. Chinese medicine composition according to claim 1, it is characterised in that：In the Chinese medicine composition, with silkworm cocoon polypeptide
And the solids basis in corn silk polysaccharide, the weight ratio of silkworm cocoon polypeptide and corn silk polysaccharide are：1：(0.1-10).
3. Chinese medicine composition according to claim 2, it is characterised in that：The silkworm cocoon polypeptide and corn silk polysaccharide weight
Than being 1:(1~8)；Preferably 1:(1~6)；More preferably 1:(1~3)；Most preferably 1:1.
4. Chinese medicine composition according to claim 1, it is characterised in that：The silkworm cocoon polypeptide molecular weight be less than
The molecular weight of 15KD, the corn silk polysaccharide are more than 3KD；More preferably 3~500KD.
5. Chinese medicine composition according to claim 1, it is characterised in that：The silkworm cocoon polypeptide is using silkworm cocoon as raw material
It is prepared by water extraction, the corn silk polysaccharide is prepared by water extraction using corn stigma as raw material.
6. Chinese medicine composition according to claim 1, it is characterised in that：The silkworm cocoon polypeptide, which uses, to be included the following steps
Preparation method be made：Silk cocoon is added water to cook, is filtered to get filtrate, filtrate ultrafiltration obtains permeate；
The corn silk polysaccharide is prepared using the preparation method included the following steps：Corn stigma is mixed with water, is heated to reflux and obtains
Extracting solution is obtained, is filtered to get filtrate, trapped fluid is collected in ultrafiltration.
7. Chinese medicine composition according to claim 6, it is characterised in that：
The preparation method of the silkworm cocoon polypeptide further include in following technical characteristic any one or it is several：
A. silk cocoon is crushed before decoction；
B. the number of the decoction is 1~3 time, and every time plus the water of 4~12 times of weight, the time decocted every time are 1~3 hour；
C. filtering times are at least twice；
D. further include that will transmit through liquid concentrated and dry；
E. the pressure of ultrafiltration is 0.15~0.3Mpa, and the filter membrane that the ultrafiltration uses uses molecular cut off for the filter of 15~25KD
Film；The preparation method of the corn silk polysaccharide further include in following technical characteristic any one or it is several：
F. filtering uses micro-filtrate membrane filtration；
G. the filter membrane that the ultrafiltration uses is the filter membrane for using molecular cut off as 3~500KD；
H. further include by trapped fluid concentration and drying.
8. Chinese medicine composition according to claim 6, it is characterised in that：In the silkworm cocoon polypeptide production methods, filtering
Number be twice, specially：Filtrate is obtained after primary filtering, then dilution carries out secondary filter, obtains filtrate, then ultrafiltration obtains
Cross liquid；The dilution refers to that filtrate is diluted to every 100ml to contain 3~9g of medicinal material, and secondary filter uses micro-filtrate membrane filtration, micro-filtration
The aperture of film is 0.3 micron.
9. Chinese medicine composition according to claim 8, it is characterised in that：The number of the decoction is 3 times, and 1.5 is small every time
When, the dilution refers to that filtrate is diluted to every 100ml to contain medicinal material 5g.
10. such as purposes of claim 1~9 any one of them Chinese medicine composition in preparing treatment albumen urine drug.
11. a kind of pharmaceutical composition for the treatment of albumen urine, the active ingredient of described pharmaceutical composition contain such as any one of 1~9 institute
The Chinese medicine composition stated.
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| CN109223992A (en) * | 2018-09-30 | 2019-01-18 | 杨茗橘 | It is a kind of prevent and treat albuminuria Chinese medicine composition and its application |
| CN115282238A (en) * | 2022-08-29 | 2022-11-04 | 上海复活石医药科技有限公司 | Preparation method of traditional Chinese medicine composition for preventing and treating proteinuria, preparation and application thereof |
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| CN109223992B (en) * | 2018-09-30 | 2021-07-06 | 上海复活石医药科技有限公司 | Traditional Chinese medicine composition for preventing and treating proteinuria and application thereof |
| CN115282238A (en) * | 2022-08-29 | 2022-11-04 | 上海复活石医药科技有限公司 | Preparation method of traditional Chinese medicine composition for preventing and treating proteinuria, preparation and application thereof |
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