CN104983759A - Traditional Chinese medicine composition treating diabetic nephropathy and preparing method thereof - Google Patents

Traditional Chinese medicine composition treating diabetic nephropathy and preparing method thereof Download PDF

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CN104983759A
CN104983759A CN201510481693.5A CN201510481693A CN104983759A CN 104983759 A CN104983759 A CN 104983759A CN 201510481693 A CN201510481693 A CN 201510481693A CN 104983759 A CN104983759 A CN 104983759A
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ginsenoside
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chinese medicine
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diabetic nephropathy
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刘春同
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Qingdao Lanshengyang Medical Biological Technology Co Ltd
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Abstract

The invention belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition treating diabetic nephropathy and a preparing method thereof. The traditional Chinese medicine composition comprises total flavones of moringa oleifera leaf, stibene glucoside, ginsenoside Rb 1, ginsenoside Rg1, ginsenoside Rd, ginsenoside Re, bilobalide, kaempferol and quercetin. The medicine components are reasonable, the synergism effect is high, the traditional Chinese medicine composition serves as the medicine compatibility for treating the diabetic nephropathy, and the clinic verifies that very obvious effects are achieved.

Description

A kind of Chinese medicine composition for the treatment of diabetic nephropathy and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of Chinese medicine composition for the treatment of diabetic nephropathy and preparation method thereof.
Background technology
Diabetic nephropathy is one of common complication of diabetes, the metabolic disease of diabetes to be a kind of with hyperglycemia be feature.Hyperglycemia be then due to defect of insulin secretion or its biological agent impaired, or both have concurrently and cause.The hyperglycemia that diabetes long-term existence is concurrent, easily causes various tissue, particularly eye, kidney, heart, blood vessel, neural chronic lesion and dysfunction.The traditional Chinese medical science is thought: deficiency of both qi and yin with blood stasis is the Major Clinical pattern of syndrome of diabetic nephropathy.
At present, the medicine for the treatment of diabetes is divided three classes: 1, pure Western medicine, and such medicine is with insulin, sulphanylureas, meglitinide, biguanides, Thiazolidine ketone and α glycosidase inhibitor for representative, and advantage is that blood sugar lowering is rapid, Be very effective, but side effect
Obviously, not only have hypoglycemic risk, and oral drugs are unsuitable for hepatic and kidney function obstacle patient use mostly, and can cause suffering from
Person's medicine secondary failure; 2, Chinese and Western is in conjunction with medicine class, and such medicine is because there is western medicine composition, and have side effect to Liver and kidney function, long-term taking is large to body harm; 3, pure Chinese medicine, smaller to human body toxic and side effects with pure Chinese medicine, overall can improve the symptom of patient, but decoction uses trouble, the interdependence of patient is poor.Diabetic nephropathy is the one of diabetes chronic microvascular complication, there is no desirable protective agents at present, the measure of present control diabetic nephropathy mainly contains: low protein diet, smoking cessation, hypoglycemic medicine and insulin control blood glucose, lipid-lowering statins, angiotensin-convertion enzyme inhibitor (ACEI), angiotensin II receptor blockers (ARB) class controls blood pressure.Although existing Western medicine has certain Renoprotective Effect, its liver toxicity, nephrotoxicity also can not be ignored, and these measures can not etiological treatment, and therapeutical effect is single, lacks blood pressure, blood fat, the therapeutic alliance of blood glucose, and late result is not good.So far, desirable medicine is not still had can be applied to the treatment of diabetic nephropathy clinically.
Leaf of Moringa refers to the leaves of the perennial tropical deciduous tree Moringa tree (being also called drumstick tree) originating in India, and be a kind of high calcium plant product, calcium content is more than 4 times of milk, in addition, also containing the very high trace element such as potassium, ferrum, zinc.The tender leaf of Moringa of the selected children of leaf of Moringa powder, forms through micronizing, has comprehensive extra-nutrition, improves immunity, eliminating toxin and beautifying the skin, and logical intestinal is convenient, the effects such as fat-reducing.Leaf of Moringa powder is nutritious and comprehensive, and vitamin E is 70 times and 40 times of spirulina and analysis for soybean powder respectively.Moringa has " miracle tree ", the title of " mother's ace buddy " and " medical treasure case ".In Africa, it is called as the cattle milk of the poor; In India, Moringa has had the edible history of more than one thousand years, has become one of indispensable food of daily life; Be referred to as in China Taiwan " 21 century human body bodyguard ".
Containing flavone compound in leaf of Moringa, the physiologically active of flavone compound is comparatively extensive, has scavenging free radicals, antioxidation, anticancer, anti-cancer, effect such as treatment cardiovascular diseases, blood sugar lowering etc.
Chinese patent application 201410436459.6 discloses a kind of Chinese medicine composition for the treatment of diabetic nephropathy, and this Chinese medicine composition is obtained by following raw material: Radix Astragali 10-50 part, Caulis Spatholobi 10-50 part, Radix Rehmanniae Preparata 10-50 part, Rhizoma Dioscoreae 5-20 part, Fructus Corni 5-20 part, Semen Euryales 5-30 part, Fructus Rosae Laevigatae 5-20 part, Hirudo (processed) 1-5 part, Radix Et Rhizoma Rhei 2-15 part, Herba Potentillae Discoloris 5-30 part, Poria 10-50 part, Semen Plantaginis 10-50 part.This Chinese medicine composition has the albuminuretic excretion of minimizing, and extend effect of the tempo of diabetic nephropathy, but this Chinese medicine composition is at blood sugar lowering, kidney and spleen invigorating aspect effect is not very remarkable.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of Chinese medicine composition for the treatment of diabetic nephropathy; this pharmaceutical composition has effect of blood sugar lowering, kidney and spleen invigorating and benefiting QI for activating blood circulation, also has and effectively improves and renal function protecting, good effect; the advantages such as cure rate is high, taking convenience.In addition, the present invention also provides corresponding manufacturing process to be made and facilitate easy-to-use preparation under the prerequisite ensureing curative effect by this pharmaceutical composition.
In order to solve this technical problem, inventor has invented a brand-new Chinese medicine composition and its preparation technology, perfectly solves above-mentioned technical problem.
Chinese medicine composition of the present invention comprises the raw materials of following parts by weight: 5-30 part total flavones of Moringa oleifera leaf, 1-18 part stilbene glucoside, 1-10 part ginsenoside Rb1,1-10 part ginsenoside Rg1,1-2 part ginsenoside Rd, 1-4 part ginsenoside Re, 1-4 part bilobalide, 1-2 part kaempferol and 1-2 part Quercetin.
Further, described Chinese medicine composition comprises the raw materials of following parts by weight: 5 parts of total flavones of Moringa oleifera leafs, 1 part of stilbene glucoside, 1 part of ginsenoside Rb1,1 part of ginsenoside Rg1,1 part of ginsenoside Rd, 1 part of ginsenoside Re, 1 part of bilobalide, 1 part of kaempferol and 1 part of Quercetin.
Further, described Chinese medicine composition comprises the raw materials of following parts by weight: 30 parts of total flavones of Moringa oleifera leafs, 18 parts of stilbene glucosides, 10 parts of ginsenoside Rb1s, 10 parts of ginsenoside Rg1s, 2 parts of ginsenoside Rds, 4 parts of ginsenoside Res, 4 parts of bilobalides, 2 parts of kaempferols and 2 parts of Quercetins.
Further, described Chinese medicine composition comprises the raw materials of following parts by weight: 20 parts of total flavones of Moringa oleifera leafs, 10 parts of stilbene glucosides, 5 parts of ginsenoside Rb1s, 5 parts of ginsenoside Rg1s, 1.5 parts of ginsenoside Rds, 2 parts of ginsenoside Res, 2 parts of bilobalides, 1.5 parts of kaempferols and 1.5 parts of Quercetins.
Further, described Chinese medicine composition is made into capsule, tablet, powder, granule, oral liquid or pill.
Again further, the preparation method of described total flavones of Moringa oleifera leaf comprises following step:
A: take leaf of Moringa, dry, pulverize, and crosses 45 mesh sieves, obtains leaf of Moringa powder;
B: get the leaf of Moringa powder that steps A obtains, add petroleum ether, reflux defat 3 times at 68 DEG C, each 6 h, filters, go filtrate, by filter residue and drying, obtain dry filtering residue;
C: add 70% ethanol in the dry filtering residue that step B obtains, process 7min under microwave power 600W, supersound extraction 2 times, extracts 25min at every turn, filters and obtains extracting solution, merge extractive liquid, obtain total flavones of Moringa oleifera leaf crude extract;
D: the crude extract obtained by step C joins in AB-8 type macroporous adsorptive resins, carries out gradient elution, with NaNO with the ethanol that distilled water and volume fraction are respectively 30%, 50%, 70% successively 2-Al (NO 3) 3-NaOH system color developing detection, under wavelength is 510nm, measure absorbance inspection know, collect the ethanol elution of 50% and 70%, merge eluent, eluent decompression recycling ethanol is concentrated into 1/5 of original volume, and obtain concentrated solution, concentrated solution being placed in 60 DEG C of water-bath evaporates to dryness to relative density is the extractum of 1.25, drying, obtains total flavones of Moringa oleifera leaf powder.
Accordingly, the preparation method of described Chinese medicine composition comprises following step:
Take stilbene glucoside, ginsenoside Rb1, ginsenoside Rg1, ginsenoside Rd, ginsenoside Re, bilobalide, kaempferol and Quercetin, add the water of initial feed 8-12 times of weight, soak 12-24 hour, backflow decocts 1-3 hour, filter, add the water of initial feed 3-6 times of weight again, backflow decocts 1-3 hour, filters, obtain filtrate, merging filtrate, being concentrated into 50 DEG C of-60 DEG C of relative densities is the Chinese medical concrete of 1.25-1.35, dry, be ground into fine powder, mix with total flavones of Moringa oleifera leaf, stir, obtain Chinese medicine composition of the present invention.
Found the clinical observation on the therapeutic effect of diabetic nephropathy clinical volunteers patient by Chinese medicine composition of the present invention, Chinese medicine composition of the present invention has good effect, obvious effective rate advantages of higher.The patient of this clinical trial is the patient in 45-79 year, because diabetic nephropathy patient is generally middle-aged and elderly people, so select the patient of this scope as subjects.This test adopts metformin hydrochloride tablet as a control group, metformin hydrochloride tablet not only has hypoglycemic activity, also may there is the effect lost weight with hyperinsulinemia, by comparing with traditional Chinese medicine composition for treating effect of the present invention, embody the curative effect of Chinese medicine composition of the present invention in the sick nephropathy for the treatment of urine, make inventor surprisingly, treatment A group, the obvious effective rate for the treatment of B group and treatment C group is all greater than 80%, total effective rate is all greater than 90%, much larger than obvious effective rate and the total effective rate of matched group, wherein, obvious effective rate and the total effective rate for the treatment of C group are the highest, visible, pharmaceutical composition good effect of the present invention, obvious effective rate is high, can as the drug use for the treatment of diabetic nephropathy.
Found by the experimental study that affects of Chinese medicine composition of the present invention on diabetic nephropathy rats, Chinese medicine composition of the present invention has the effect of blood glucose value, glycolated hemoglobin, urine volume and the urine protein obviously reducing diabetic nephropathy rats.This experiment is by setting up Diabetic nephropathy animal model, and the disease condition of simulation diabetic nephropathy patient, by gastric infusion, draws the therapeutic effect of Chinese medicine composition of the present invention.Learnt by table 2, after the rat administration of senior middle school's low dose group, blood glucose value obviously reduces, and compared with model group, have the difference of significance, and model group compares with sham operated rats, and the blood glucose value before administration and after administration all has extremely significant difference; Learnt by table 3, after administration, the rat glycolated hemoglobin of senior middle school's low dose group and the difference having significance of model group; Learnt by table 4, after the rat administration of senior middle school's low dose group, urine volume obviously reduces, and compared with model group, have the difference of significance, and model group compares with sham operated rats, and the urine volume before administration and after administration all has extremely significant difference; Learnt by table 5, after the rat administration of senior middle school's low dose group, urine protein obviously reduces, and compared with model group, have the difference of significance, and model group compares with sham operated rats, and the urine protein before administration and after administration all has extremely significant difference.Visible, Chinese medicine composition of the present invention obviously can reduce the blood glucose value of diabetic nephropathy rats, glycolated hemoglobin, urine volume and urine protein, has significant curative effect, can be used as the drug use for the treatment of diabetic nephropathy in treatment diabetic nephropathy.
Compared with prior art, the present invention has following technical advantage:
1, Chinese medicine composition of the present invention is in treatment diabetic nephropathy, has the effect reducing blood glucose, glycolated hemoglobin, urine volume and urine protein, and the patient being applicable to person in middle and old age's section in age uses;
2, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, and toxic and side effects is little;
3, Chinese medicine composition of the present invention has the effect that effectively improvement and renal function protecting, spleen invigorating are invigorated blood circulation, and also has good effect, the advantages such as cost is low, and obvious effective rate is high, taking convenience.
Detailed description of the invention
It will be understood by those skilled in the art that technology disclosed in following examples represents the technology playing good action in the practice of the invention of the present inventor's discovery.But, many changes can be made in disclosed specific embodiments, and still obtain same or analogous result, and not depart from the spirit and scope of the present invention.
embodiment 1:
The embodiment of the present invention 1 pharmaceutical composition comprises the raw materials of following parts by weight: 5 parts of total flavones of Moringa oleifera leafs, 1 part of stilbene glucoside, 1 part of ginsenoside Rb1,1 part of ginsenoside Rg1,1 part of ginsenoside Rd, 1 part of ginsenoside Re, 1 part of bilobalide, 1 part of kaempferol and 1 part of Quercetin.
Preparation method is as follows:
(1) total flavones of Moringa oleifera leaf is prepared:
A: take leaf of Moringa, dry, pulverize, and crosses 45 mesh sieves, obtains leaf of Moringa powder;
B: get the leaf of Moringa powder that steps A obtains, add petroleum ether, reflux defat 3 times at 68 DEG C, each 6 h, filters, go filtrate, by filter residue and drying, obtain dry filtering residue;
C: add 70% ethanol in the dry filtering residue that step B obtains, process 7min under microwave power 600W, supersound extraction 2 times, extracts 25min at every turn, filters and obtains extracting solution, merge extractive liquid, obtain total flavones of Moringa oleifera leaf crude extract;
D: the crude extract obtained by step C joins in AB-8 type macroporous adsorptive resins, carries out gradient elution, with NaNO with the ethanol that distilled water and volume fraction are respectively 30%, 50%, 70% successively 2-Al (NO 3) 3-NaOH system color developing detection, under wavelength is 510nm, measure absorbance inspection know, collect the ethanol elution of 50% and 70%, merge eluent, eluent decompression recycling ethanol is concentrated into 1/5 of original volume, and obtain concentrated solution, concentrated solution being placed in 60 DEG C of water-bath evaporates to dryness to relative density is the extractum of 1.25, drying, obtains total flavones of Moringa oleifera leaf powder.
(2) stilbene glucoside is taken, ginsenoside Rb1, ginsenoside Rg1, ginsenoside Rd, ginsenoside Re, bilobalide, kaempferol and Quercetin, add the water of initial feed 8 times of weight, soak 12 hours, backflow decoction 2 hours, filter, add the water of initial feed 5 times of weight again, backflow decoction 2 hours, filter, obtain filtrate, merging filtrate, being concentrated into 50 DEG C of relative densities is the Chinese medical concrete of 1.25, dry, be ground into fine powder, mix with total flavones of Moringa oleifera leaf, stir, add suitable adjuvant, incapsulate in shell, obtain Chinese medicinal composition capsules agent of the present invention.
embodiment 2:
The embodiment of the present invention 2 pharmaceutical composition comprises the raw materials of following parts by weight: 30 parts of total flavones of Moringa oleifera leafs, 18 parts of stilbene glucosides, 10 parts of ginsenoside Rb1s, 10 parts of ginsenoside Rg1s, 2 parts of ginsenoside Rds, 4 parts of ginsenoside Res, 4 parts of bilobalides, 2 parts of kaempferols and 2 parts of Quercetins.
Preparation method is with embodiment 1.
embodiment 3:
The embodiment of the present invention 3 pharmaceutical composition comprises the raw materials of following parts by weight: 20 parts of total flavones of Moringa oleifera leafs, 10 parts of stilbene glucosides, 5 parts of ginsenoside Rb1s, 5 parts of ginsenoside Rg1s, 1.5 parts of ginsenoside Rds, 2 parts of ginsenoside Res, 2 parts of bilobalides, 1.5 parts of kaempferols and 1.5 parts of Quercetins.
Preparation method is with embodiment 1.
embodiment 4:
The embodiment of the present invention 4 pharmaceutical composition comprises the raw materials of following parts by weight: 18 parts of total flavones of Moringa oleifera leafs, 13 parts of stilbene glucosides, 6 parts of ginsenoside Rb1s, 8 parts of ginsenoside Rg1s, 2 parts of ginsenoside Rds, 3 parts of ginsenoside Res, 1 part of bilobalide, 2 parts of kaempferols and 1 part of Quercetin.
Preparation method is with embodiment 1.
embodiment 5:
The embodiment of the present invention 5 pharmaceutical composition comprises the raw materials of following parts by weight: 19 parts of total flavones of Moringa oleifera leafs, 14 parts of stilbene glucosides, 8 parts of ginsenoside Rb1s, 6 parts of ginsenoside Rg1s, 1 part of ginsenoside Rd, 2 parts of ginsenoside Res, 3 parts of bilobalides, 1 part of kaempferol and 2 parts of Quercetins.
Preparation method is with embodiment 1.
chinese medicine composition clinical trial data of the present invention
One, diagnostic criteria
Tcm diagnosis standard: have foam in urine, weak, nausea and vomiting, shallow complexion or dark and gloomy, heavy sensation of the body edema, soreness of the waist and knees and abdominal distention, nocturia, forgetful, insomnia, dizziness and tinnitus, feverish sensation in the palms and soles, purplish tongue or light red tongue or ecchymosis, thick fur is greasy, deep-thready pulse or puckery; Dialectically logical to adjust for weakness of the spleen and kidney, lung lose, the water stasis of blood tied mutually, water turbid regardless of.
Two, clinical trial
1, physical data
All selected diabetic nephropathy clinical volunteers patients are divided into four groups at random, treatment A group 90 example, wherein male patient 55 example, female patient 35 example; Treatment B group 90 example, wherein male patient 48 example, female patient 42 example; Treatment C group 90 example, wherein male patient 50 example, female patient 40 example; Matched group 90 example, wherein male patient 49 example, female patient 41 example.Age is 45 years old-79 years old, 62 years old mean age.Four groups of influence factors such as age, symptom, through statistical procedures, there was no significant difference, meets a point set condition.
2, Therapeutic Method
Treatment A group: take the capsule (0.2g*100 grain/bottle) that embodiment 1 prepares, every day 3 times, each 4, serve on 1 month;
Treatment B group: take the capsule (0.2g*100 grain/bottle) that embodiment 2 prepares, every day 3 times, each 4, serve on 1 month;
Treatment C group: take the capsule (0.2g*100 grain/bottle) that embodiment 3 prepares, every day 3 times, each 4, serve on 1 month;
Matched group: take metformin hydrochloride tablet (smart Heihe pharmaceutcal corporation, Ltd of Harbin Pharmaceutical Group three, accurate word H20064095, the 0.25g*50 grain/bottle of traditional Chinese medicines), one time 2,3 times on the one, serve on 1 month.
3, evaluation of clinical curative effect standard
Efficacy on diabetic nephropathy judges:
Effective: clinical symptoms is improved obviously, soreness of the waist and knees, fatigue and weak, dry mouth and throat, nocturia etc. disappear or substantially disappear, blood sugar level fluctuation is within normal range, blood pressure≤128/80mmHg, 24h urine protein < 30mg, blood urea nitrogen and creatinine are all down to normal level;
Effective: clinical symptom relief, soreness of the waist and knees, fatigue and weak, dry mouth and throat, nocturia etc. be improved significantly, fasting glucose controls desirable, and fluctuation of blood pressure is at about 140/90mmHg, 24h urine protein and blood urea nitrogen creatinine all have decline, but do not take a turn for the better completely;
Invalid: clinical symptoms is improved not obvious, blood pressure and blood glucose decline without decline or have but undesirable, and 24h urine protein quantitation and blood urea nitrogen creatinine all do not decline, or decline and do not reach effective standard.
4, therapeutic outcome
Table 1 therapeutic effect
5, conclusion
The patient of this clinical trial is the patient in 45-79 year, because diabetic nephropathy patient is generally middle-aged and elderly people, so select the patient of this scope as subjects.This test adopts metformin hydrochloride tablet as a control group, metformin hydrochloride tablet not only has hypoglycemic activity, also may there is the effect lost weight with hyperinsulinemia, by comparing with traditional Chinese medicine composition for treating effect of the present invention, embody the curative effect of Chinese medicine composition of the present invention in the sick nephropathy for the treatment of urine, make inventor surprisingly, treatment A group, the obvious effective rate for the treatment of B group and treatment C group is all greater than 80%, total effective rate is all greater than 90%, much larger than obvious effective rate and the total effective rate of matched group, wherein, obvious effective rate and the total effective rate for the treatment of C group are the highest, visible, pharmaceutical composition good effect of the present invention, obvious effective rate is high, can as the drug use for the treatment of diabetic nephropathy.
chinese medicine composition of the present invention affects experimental study to diabetic nephropathy rats
1, Modling model
Select healthy male adult SD rats 60, body weight 0.35kg-0.4kg, 60 rats are divided into 5 groups at random, often organize 12, be respectively sham operated rats, model group, low dose group, middle dosage group and high dose group.Feed with high lipid food, do not limit and take the photograph water.Sham operated rats carries out sham-operation, all the other 4 groups carry out one-sided kidney ligation operation after inject abdominal cavity with streptozotocin.Operation consent Rat Fast 12h, injection Nembutal sodium solution is anaesthetized, and after confirming anesthesia, rats in sham-operated group is gone after cutting skin and muscle layer again and sewed up, and all the other groups are along kidney base of a fruit ligation kidney arteriovenous and ureter.When postoperative 2 weeks, each group of Rat Fast 18h, the citrate buffer solution of the disposable injection Isodose of rats in sham-operated group, all the other group disposable celiacs inject 1% streptozotocin solution 0.55g/kg, concrete administration volume is 5.5ml/kg, and after injection, rat freely ingests water.After modeling completes 72h, survey blood glucose through tail vein blood.Modeling Success criteria: 1. fasting glucose >=16.65mmol/L; 2. glucose in urine strong positive; 3. urine volume is greater than 50% of matched group, and namely model is set up.
2, test method
After modeling terminates, the nursing of each group detected each group of rat fasting blood-glucose after 1 week, left and took each group of rat urine volume, measured 24h urine albumen amount.Then, each group of rat gives corresponding tested material by following dosage gavage: the high, medium and low dosage of the Chinese medicine composition that the other gavage embodiment of the present invention 3 of high, medium and low dosage component prepares, is respectively 0.21g/kgd, 0.63 g/kgd and 1.26 g/kgd; Sham operated rats and model group are with isopyknic distilled water gavage.Adopt glucose oxidase method to detect rat fasting blood-glucose, immune gel diffusion method survey glycolated hemoglobin, metabolic cage collection rat 24h urine after 6 weeks in administration, calculate 24h urine volume and 24h urine albumen amount.
3, result of the test
Table 2 respectively group diabetic nephropathy rats change of blood sugar compares
Note: compare with sham operated rats, ★ ★p < 0.01, compares with model group, p < 0.05, ▲ ▲p < 0.01.
Table 3 respectively group diabetic nephropathy rats glycolated hemoglobin compares
Note: compare with sham operated rats, ★ ★p < 0.01, compares with model group, p < 0.05.
The comparison of diabetic nephropathy rats urine volume change respectively organized by table 4
Note: compare with sham operated rats, ★ ★p < 0.01, compares with model group, p < 0.05, ▲ ▲p < 0.01.
The comparison of diabetic nephropathy rats urine protein change respectively organized by table 5
Note: compare with sham operated rats, ★ ★p < 0.01, compares with model group, p < 0.05, ▲ ▲p < 0.01.
4, conclusion
This experiment is by setting up Diabetic nephropathy animal model, and the disease condition of simulation diabetic nephropathy patient, by gastric infusion, draws the therapeutic effect of Chinese medicine composition of the present invention.Learnt by table 2, after the rat administration of senior middle school's low dose group, blood glucose value obviously reduces, and compared with model group, have the difference of significance, and model group compares with sham operated rats, and the blood glucose value before administration and after administration all has extremely significant difference; Learnt by table 3, after administration, the rat glycolated hemoglobin of senior middle school's low dose group and the difference having significance of model group; Learnt by table 4, after the rat administration of senior middle school's low dose group, urine volume obviously reduces, and compared with model group, have the difference of significance, and model group compares with sham operated rats, and the urine volume before administration and after administration all has extremely significant difference; Learnt by table 5, after the rat administration of senior middle school's low dose group, urine protein obviously reduces, and compared with model group, have the difference of significance, and model group compares with sham operated rats, and the urine protein before administration and after administration all has extremely significant difference.Visible, Chinese medicine composition of the present invention obviously can reduce the blood glucose value of diabetic nephropathy rats, glycolated hemoglobin, urine volume and urine protein, has significant curative effect, can be used as the drug use for the treatment of diabetic nephropathy in treatment diabetic nephropathy.
Owing to describing the present invention by above preferred embodiment, in spirit of the present invention and/or scope, any for replacement/of the present invention or combination implement the present invention, be all apparent for a person skilled in the art, and be included among the present invention.

Claims (7)

1. treat the Chinese medicine composition of diabetic nephropathy for one kind, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight: 5-30 part total flavones of Moringa oleifera leaf, 1-18 part stilbene glucoside, 1-10 part ginsenoside Rb1,1-10 part ginsenoside Rg1,1-2 part ginsenoside Rd, 1-4 part ginsenoside Re, 1-4 part bilobalide, 1-2 part kaempferol and 1-2 part Quercetin.
2. the Chinese medicine composition for the treatment of diabetic nephropathy as claimed in claim 1, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight: 5 parts of total flavones of Moringa oleifera leafs, 1 part of stilbene glucoside, 1 part of ginsenoside Rb1,1 part of ginsenoside Rg1,1 part of ginsenoside Rd, 1 part of ginsenoside Re, 1 part of bilobalide, 1 part of kaempferol and 1 part of Quercetin.
3. the Chinese medicine composition for the treatment of diabetic nephropathy as claimed in claim 1, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight: 30 parts of total flavones of Moringa oleifera leafs, 18 parts of stilbene glucosides, 10 parts of ginsenoside Rb1s, 10 parts of ginsenoside Rg1s, 2 parts of ginsenoside Rds, 4 parts of ginsenoside Res, 4 parts of bilobalides, 2 parts of kaempferols and 2 parts of Quercetins.
4. the Chinese medicine composition for the treatment of diabetic nephropathy as claimed in claim 1, it is characterized in that, described Chinese medicine composition comprises the raw materials of following parts by weight: 20 parts of total flavones of Moringa oleifera leafs, 10 parts of stilbene glucosides, 5 parts of ginsenoside Rb1s, 5 parts of ginsenoside Rg1s, 1.5 parts of ginsenoside Rds, 2 parts of ginsenoside Res, 2 parts of bilobalides, 1.5 parts of kaempferols and 1.5 parts of Quercetins.
5. the Chinese medicine composition of the treatment diabetic nephropathy as described in as arbitrary in claim 1-4, is characterized in that: described Chinese medicine composition is made into capsule, tablet, powder, granule, oral liquid or pill.
6. the Chinese medicine composition of the treatment diabetic nephropathy as described in as arbitrary in claim 1-4, it is characterized in that, the preparation method of described total flavones of Moringa oleifera leaf comprises the steps:
A: take leaf of Moringa, dry, pulverize, and crosses 45 mesh sieves, obtains leaf of Moringa powder;
B: get the leaf of Moringa powder that steps A obtains, add petroleum ether, reflux defat 3 times at 68 DEG C, each 6 h, filters, go filtrate, by filter residue and drying, obtain dry filtering residue;
C: add 70% ethanol in the dry filtering residue that step B obtains, process 7min under microwave power 600W, supersound extraction 2 times, extracts 25min at every turn, filters and obtains extracting solution, merge extractive liquid, obtain total flavones of Moringa oleifera leaf crude extract;
D: the crude extract obtained by step C joins in AB-8 type macroporous adsorptive resins, carries out gradient elution, with NaNO with the ethanol that distilled water and volume fraction are respectively 30%, 50%, 70% successively 2-Al (NO 3) 3-NaOH system color developing detection, under wavelength is 510nm, measure absorbance inspection know, collect the ethanol elution of 50% and 70%, merge eluent, eluent decompression recycling ethanol is concentrated into 1/5 of original volume, and obtain concentrated solution, concentrated solution being placed in 60 DEG C of water-bath evaporates to dryness to relative density is the extractum of 1.25, drying, obtains total flavones of Moringa oleifera leaf powder.
7. one kind prepare as arbitrary in claim 1-4 as described in the method for Chinese medicine composition for the treatment of diabetic nephropathy, it is characterized in that comprising the steps: to take stilbene glucoside, ginsenoside Rb1, ginsenoside Rg1, ginsenoside Rd, ginsenoside Re, bilobalide, kaempferol and Quercetin, add the water of initial feed 8-12 times of weight, soak 12-24 hour, backflow decocts 1-3 hour, filter, add the water of initial feed 3-6 times of weight again, backflow decocts 1-3 hour, filter, obtain filtrate, merging filtrate, being concentrated into 50 DEG C of-60 DEG C of relative densities is the Chinese medical concrete of 1.25-1.35, dry, be ground into fine powder, mix with total flavones of Moringa oleifera leaf, stir, obtain Chinese medicine composition of the present invention.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105769944A (en) * 2016-03-11 2016-07-20 田洋 Moringa oleifera extract with weight reducing effect, as well as preparation method and use of moringa oleifera extract
KR101802089B1 (en) 2016-09-26 2017-11-27 경희대학교 산학협력단 Pharmaceutical composition for prevention or treatment of diabetic neuropathic pain comprising GS-E3D as an active ingredient

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101700265A (en) * 2009-11-20 2010-05-05 许淑清 Application of pseudo-ginseng and extract thereof in preparing medicament for curing and/or preventing diabetic microangiopathies
CN101845467A (en) * 2010-05-10 2010-09-29 苏州瑞蓝博中药技术开发有限公司 Method for extracting kaempferol
CN102883733A (en) * 2010-02-10 2013-01-16 奥力榨油化株式会社 AGE production inhibitor
CN103209971B (en) * 2010-11-12 2014-08-20 天津医科大学 Flavone derivatives and their preparative method and medical use
CN104098584A (en) * 2013-04-03 2014-10-15 广东东阳光药业有限公司 Ginkgolide B derivative and application thereof in medicines
CN104147316A (en) * 2014-05-21 2014-11-19 北京中医药大学东直门医院 Traditional Chinese medicinal composition for treating diabetic nephrophthy
CN104758325A (en) * 2015-04-03 2015-07-08 萧丽雅 Extraction method and application of moringa oleifera leaf total flavones

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101700265A (en) * 2009-11-20 2010-05-05 许淑清 Application of pseudo-ginseng and extract thereof in preparing medicament for curing and/or preventing diabetic microangiopathies
CN102883733A (en) * 2010-02-10 2013-01-16 奥力榨油化株式会社 AGE production inhibitor
CN101845467A (en) * 2010-05-10 2010-09-29 苏州瑞蓝博中药技术开发有限公司 Method for extracting kaempferol
CN103209971B (en) * 2010-11-12 2014-08-20 天津医科大学 Flavone derivatives and their preparative method and medical use
CN104098584A (en) * 2013-04-03 2014-10-15 广东东阳光药业有限公司 Ginkgolide B derivative and application thereof in medicines
CN104147316A (en) * 2014-05-21 2014-11-19 北京中医药大学东直门医院 Traditional Chinese medicinal composition for treating diabetic nephrophthy
CN104758325A (en) * 2015-04-03 2015-07-08 萧丽雅 Extraction method and application of moringa oleifera leaf total flavones

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105769944A (en) * 2016-03-11 2016-07-20 田洋 Moringa oleifera extract with weight reducing effect, as well as preparation method and use of moringa oleifera extract
KR101802089B1 (en) 2016-09-26 2017-11-27 경희대학교 산학협력단 Pharmaceutical composition for prevention or treatment of diabetic neuropathic pain comprising GS-E3D as an active ingredient

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Application publication date: 20151021