CN100536899C - Chinese medicine for treating and preventing early diabetes and nephropathy - Google Patents
Chinese medicine for treating and preventing early diabetes and nephropathy Download PDFInfo
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- CN100536899C CN100536899C CNB2005101223648A CN200510122364A CN100536899C CN 100536899 C CN100536899 C CN 100536899C CN B2005101223648 A CNB2005101223648 A CN B2005101223648A CN 200510122364 A CN200510122364 A CN 200510122364A CN 100536899 C CN100536899 C CN 100536899C
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Abstract
A Chinese medicine in the form of tablet, capsule, or particle for preventing and treating early-phase diabetic nephrosis is prepared from 13 Chinese-medicinal materials including American ginseng, red sage root, rehmannia root, yam, etc through respective pulverizing, extracting in water and shaping.
Description
Technical field
The present invention relates to the Chinese medicine of a kind of prevention and treatment diabetic nephropathy, particularly relating to a kind of is the endo-medicine with supplementing QI and nourishing YIN, kidney and spleen invigorating, blood circulation promoting and blood stasis dispelling, inducing diuresis to remove edema, expelling remnant toxicity effect that raw material is made with the Chinese herbal medicine, and spiritlessness and weakness, waist soreness, puffiness of the face and limbs, dizziness and albuminuria etc. is had the Chinese medicine preparation of fabulous curative effect.
Background technology
Diabetic nephropathy claims diabetic glomerulosclerosis again, is the distinctive serious microvascular complications of diabetes, also is diabetes patient's main causes of death.
Chinese medicine thinks, diabetic nephropathy is development on diabetes deficiency of both QI and YIN basis, and prolonged illness must the stasis of blood, and prolonged illness must be empty, the kidney usually involved in chronic disease, and asthenia of both the spleen and kidney, it is not normal that water liquid is failed cloth, disturbance in functioning of QI.The basic pathogenesis characteristics of primary disease are " deficiency in origin and excess in superficiality ", and deficiency in origin to be suffering from a deficiency of the kidney, and mark is real be that blood stasis, water wet, turbid poison etc.; Be familiar with its pathogenesis from diabetic nephropathy by stages, think that the early stage deficiency of YIN accumulation of heat of this disease is main pathogenesis, yin-damaging and Qi consuming with the passing of time then, and cause deficiency of both QI and YIN, instability of kidney QI, deficiency of both vital energy and Yin, passages through which vital energy circulates loses supports, and causes the stasis of blood by void, becomes that blood vessels are obstructed, the resistance of the channels stasis of blood.
At present, the disclosed Chinese medicine about the treatment diabetic nephropathy is in the majority to contain Radix Astragali QI invigorating person, for example, by Rhizoma Polygoni Cuspidati, the Radix Astragali, " the treatment diabetes and the medicine of vascular complication thereof and the preparation method (application number; 200410027181.3) of this medicine " that Cortex Cinnamomi is formed, by the Radix Astragali, Radix Pseudostellariae, Fructus Ligustri Lucidi, Fructus Lycii, Hirudo, " Chinese medicine composition of treatment diabetic nephropathy and preparation method thereof (application number; 01108448.0) " that Radix Et Rhizoma Rhei is formed, by the Radix Astragali, Fructus Corni, Radix Rehmanniae, Radix et Rhizoma Rhei (stir-fried with wine), Radix Puerariae, Rhizoma Alismatis, Radix Salviae Miltiorrhizae, Herba Leonuri, Semen Persicae, Radix Pseudostellariae, Fructus Lycii molecular " a kind of treatment diabetic nephropathy drugs and preparation method thereof (application number, 03113559.5) " etc.; Also having in addition with the turbid poison of removing summer-heat is main person, for example, and " a kind of treatment and the medicine (application number, 02159195.4) of diabetes and nephropathy preventing " formed by Fructus Corni, Radix Rehmanniae, Rhizoma Polygoni Cuspidati, Herba Hedyotidis Diffusae, Rhizoma Coptidis, Ramulus Euonymi.Diabetic nephropathy belongs to the disease of " deficiency in origin and excess in superficiality ", etiology and pathogenesis is intricate, though as similar above disclosed pure Chinese medicine certain curative effect is arranged, also not comprehensive at this sick etiology and pathogenesis concerted application of drugs after all, specific aim is not strong, has influenced curative effect steady in a long-term; And for diabetic nephropathy this disease of prevention take place significant, so prior art exists limitation in the prevention of primary disease and clinical practice.
Summary of the invention
The present invention seeks to overcome the deficiencies in the prior art, disclose a kind of Chinese medicine that can effectively prevent and treat early diabetic nephropathy with the Chinese crude drug of selecting meticulously.
Medicine of the present invention can be made (consumption is a weight portion) medicament by following component:
Radix Rehmanniae 80-120 part Rhizoma Dioscoreae 80-160 part Rhizoma Alismatis 40-60 part
Rhizoma Smilacis Glabrae 50-150 part Radix Platycodonis 50-150 part Rhizoma Imperatae 100-200 part
Cortex Eucommiae 50-100 part Herba Leonuri 80-160 part Radix Panacis Quinquefolii 20-40 part
Radix Ginseng 6-20 part Radix Salviae Miltiorrhizae 40-120 part Semen sojae atricolor 80-160 part
Herba Hedyotidis Diffusae 40-80 part
The optimum weight proportioning of medicine of the present invention is:
100 parts of 50 parts of Rhizoma Smilacis Glabraes of 100 portions of Rhizoma Alismatis of 100 portions of Rhizoma Dioscoreaes of Radix Rehmanniae
100 parts of 60 parts of Herba Linderniae Crustaceaes of 150 parts of Cortexs Eucommiae of 100 parts of Rhizoma Imperataes of Radix Platycodonis
100 parts in 50 parts of Semen sojae atricolors of 10 parts of Radix Salviae Miltiorrhizaes of 30 parts of Radix Ginsengs of Radix Panacis Quinquefolii
50 parts of Herba Hedyotidis Diffusaes
Medicine of the present invention is characterized in that said medicament is a said dosage form on any pharmaceutics.
Medicine of the present invention is characterized in that said medicament is tablet, capsule, granule.
The Chinese medicine of a kind of prevention and treatment early diabetic nephropathy, its preparation method is: get Rhizoma Dioscoreae in the prescription, Rhizoma Smilacis Glabrae, balloonflower powder and be broken into fine powder, Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii pulverize separately in the prescription are become fine powder; Residue Radix Rehmanniae, the Cortex Eucommiae, Herba Hedyotidis Diffusae, Semen sojae atricolor, Herba Leonuri, Rhizoma Imperatae, Rhizoma Alismatis are used the water extraction secondary, 1.5 hours for the first time, add 8 times of amounts of water, 1 hour for the second time, add 7 times of amounts of water, extract water temperature 98-102 ℃ at every turn, extracting solution filters, merging filtrate is evaporated to the extractum of relative density 1.35-1.40 (60 ± 5 ℃ heat survey); Extractum adds Rhizoma Dioscoreae, Rhizoma Smilacis Glabrae, Radix Platycodonis fine powder, and mixing is made bulky grain, vacuum drying, and dry substance is ground into fine powder, and mixing adds Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii fine powder respectively, and mix homogeneously is made said dosage form on any pharmaceutics.
Chinese medicine of the present invention, Radix Panacis Quinquefolii boosting qi and nourishing yin heat clearing away in the side, but Radix Ginseng strongly invigorating primordial QI, the two is a monarch drug altogether, and the merit of element culturing fixed folder supplementing QI and nourishing YIN is arranged; Rhizoma Dioscoreae can reinforcing spleen and kidney arresting seminal emission, Cortex Eucommiae invigorating the liver and kidney, two medicines share kidney and spleen invigorating, the merit that the product compatibility of Radix Rehmanniae heat clearing away tonifying YIN and Herba Hedyotidis Diffusae, Rhizoma Smilacis Glabrae, the sweet light detoxifcation of Rhizoma Imperatae is played expelling remnant toxicity altogether, more than be ministerial drug altogether; Radix Salviae Miltiorrhizae, Herba Leonuri blood circulation promoting and blood stasis dispelling, Semen sojae atricolor, Rhizoma Alismatis inducing diuresis to remove edema are adjuvant drug altogether; Radix Platycodonis lung qi dispersing gas, the lung being the upper source of fluids, opening the lung qi diuretic wet is messenger drug; Full side's giving consideration to both the incidental and fundamental, through-supplementation, strengthening vital QI to eliminate pathogenic factors, the effect of playing supplementing QI and nourishing YIN, kidney and spleen invigorating, blood circulation promoting and blood stasis dispelling, inducing diuresis to remove edema, expelling remnant toxicity altogether.The present invention is applicable to the prevention and the treatment of early diabetic nephropathy, sees that to the ill spiritlessness and weakness, waist soreness, puffiness of the face and limbs, dizziness and albuminuria etc. have fabulous effect, and has no side effect; Now experimentation is described below.
Animal acute toxicity test of the present invention
Acute toxicity test research, get body weight 18-20g Kunming kind healthy mice male and female half and half, by the body weight random packet, dosage is respectively 48 gram crude drug/kg/ days, 24 gram crude drug/kg/ days, 12 gram crude drugs/kg/ day three a dosage groups and matched group, amount to four groups, every day, 2ml/ was every, give at twice, the blank group is given and is waited water gaging, observes a week continuously after the administration, observation index comprises, the activity of mice, diet, body weight and death condition.The result shows after the administration in 7 days animal activity freely, and ordinary circumstance is better, hair color, growth promoter, ingests all normally, and each group is not seen animal dead.Mice body weight and dissection back perusal be internal organs such as the heart, lung, kidney, spleen, stomach relatively, no abnormality seen variation between each group.Chinese medicine 48 grams of the present invention are equivalent to 170 times of clinical treatment dosage crude drug/kg/ day, and visible Chinese medicine clinical dosage of the present invention is safe.
Long-term toxicity test for animals of the present invention
One, method
Long term toxicity test research selects for use 80 body weight to be 100-115g, 7-8 age in week healthy Wistar kind rat, be divided into four groups at random, 20 every group, male and female half and half.Matched group is irritated stomach and is given consubstantiality hydrops, small dose group 12g crude drug of the present invention/kg body weight, middle dosage group 24g crude drug/kg body weight, heavy dose of group 48g crude drug/kg body weight.
Laboratory animal room adopts 20 ± 5 ℃ of air-conditioning attemperation, set time every day gastric infusion, and administration is 6 days weekly, drug withdrawal 1 day is weighed weekly once, adjusts dosage, at any time write down the behavior of dietary amount and animal in the administration process, experiment is got the every index of hematometry and is seen Table after finishing.
Two, result
Table 1 Chinese medicine of the present invention is to the influence of rat hemogram
| Group | Number of animals | Erythrocyte/mm 3 | Leukocyte/mm 3 | Platelet/mm 3 |
| Matched group | 20 | 606.4±85.04 | 13725±2560 | 43.18±7.1 |
| High dose | 20 | 627.3±68.3 | 12194.2±3907 | 44.96±7.8 |
| Middle dosage | 20 | 604.5±73.0 | 12686.6±2016 | 45.9±6.5 |
| Low dosage | 20 | 667.0±76.4 | 15410±3382.9 | 41.2±6.3 |
Table 2 Chinese medicine of the present invention is to the X ± SD that influences of rats'liver, renal function
| Group | Number of animals | Liver function (SGPT) % of unit | Renal function (NPN) mg% |
| Matched group | 20 | 20.29±5.45 | 18±2.84 |
| High dose | 20 | 25.1±4.2 | 20.4±2.36 |
| Middle dosage | 20 | 18.0±5.5 | 18.7±4.99 |
| Low dosage | 20 | 19.3±4.6 | 20.2±2.49 |
Table 3 Chinese medicine of the present invention is to the influence of rat body weight
| Group | Matched group | High dose | Middle dosage | Low dosage |
| Number of animals | 20 | 20 | 20 | 20 |
| Dosage | 48g crude drug/kg | 24g crude drug/kg | 12g crude drug/kg | |
| 1 week | 100.8±14.5 | 109.9±13.5 | 103.0±9.7 | 98±12.7 |
| 2 weeks | 129±19.6 | 135.2±16.7 | 116.5±10.5 | 125±20.7 |
| 3 weeks | 153±27.7 | 140.9±18.1 | 128.0±15.2 | 135±20.7 |
| 4 weeks | 165±26.1 | 165.1±23.7 | 141.6±22.9 | 164±21.6 |
| 5 weeks | 199±32 | 180±22 | 167.2±20.3 | 183±19 |
| 6 weeks | 213±34.7 | 199±27 | 184.1±18.1 | 217±23 |
| 7 weeks | 165±26.1 | 165.1±23.7 | 141.6±22.9 | 164±21.6 |
| 8 weeks | 232.2±34.8 | 210.8±22.5 | 207.5±21.4 | 235±25.2 |
| 9 weeks | 243.8±27.8 | 217±23.7 | 211.3±25.7 | 243±27.5 |
| 10 weeks | 243.4±40.9 | 222±23.7 | 216.1±26 | 254±35.7 |
| 11 weeks | 245.7±36 | 221±35 | 220.6±44.1 | 261±35.2 |
| 12 weeks | 250.6±34.2 | 232±31 | 221±35 | 264±34 |
By table 1, table 2, table 3 finding Chinese medicine of the present invention rat hemogram, hepatic and renal function, body weight all there is not obvious influence.In the administration process, any toxic reaction does not all appear in each dosage treated animal, hair gloss, diet, drinking-water, eyes, breathing, circulation and extremity activity are all normal, do not occur any animal dead yet, viscera tissues such as the heart, liver,spleen,kidney, lung, gastrointestinal are carried out pathological observation all find no specific lesions.
Three, conclusion
Chinese medicine long term toxicity test of the present invention shows, high (be equivalent to clinical usual amounts 170 times), in, low (be equivalent to clinical usual amounts 42.5 times) three dosage group biochemistry, pathology have no significant change, so can think take for a long time under the usual amounts safety, reliably, non-toxic reaction.
The drug efficacy study data that the present invention is relevant with therapeutical effect
One, to the protective effect of diabetes rat kidney
1 experiment material
1.1 laboratory animal:
The Department Of Medicine, Peking University department of the Chinese Academy of Sciences of the laboratory animal section quality certification number: SCXK-(capital) 2002-005
1.2 medicine and reagent:
Streptozotocin: Streptozocin, STZ, U.S. sigma company.
Lotensin: the commercially available lot number of Novartis Pharma AG: 040504
Chinese medicine of the present invention: Tianjin Tongrentang Co., Ltd. provides lot number: 040716
1.3 dosage and grouping situation:
Blank group: wait water gaging.
Diabetic model group: wait water gaging.
Lotensin group: 0.015g/kg.
Chinese medicine I:4.2g crude drug/kg. of the present invention
Chinese medicine II:2.1g crude drug/kg. of the present invention
Chinese medicine III:1.0g crude drug/kg. of the present invention
1.4 experimental apparatus
TBA-40FR automatic biochemistry analyzer (Japanese Toshiba)
Johnson ﹠ Johnson's blood glucose meter (U.S.)
JEM-1010 transmission electron microscope (Japan)
2 experimental techniques
2.1 the preparation of diabetes model
With 80 male rats, surveyed blood glucose three days through tail blood earlier before the grouping, select the glucostasis animal and be divided into 10 of blank groups at random.Except that the blank group, the equal lumbar injection streptozotocin of experimental rat STZ (55mg/kg body weight).Be dissolved in the 0.1mmol/L citrate buffer solution before the STZ injection.The blank group is only injected the equivalent citrate buffer solution.Injected STZ3 days after tail blood is surveyed blood glucose, all fasting glucose 〉=16.7mmol/L person is the diabetes model animal, is ready for use on this experiment.Be divided into diabetic groups (model group), lotensin treatment group (positive drug group), treatment by Chinese herbs group (4.2g crude drug/kg of the present invention at random; 2.1g crude drug/kg; 1.0g crude drug/kg), 10 every group.
2.2 medication:
The present invention (4.2g crude drug/kg; 2.1g crude drug/kg; 1.0g crude drug/kg) high, medium and low three dosage groups and lotensin (15mg/kg) positive drug group.The gastric infusion amount is all by the 1ml/100g body weight.Blank group and diabetic model group are irritated stomach and are waited water gaging, more than respectively organize equal every day and irritate stomach once, continuous 8 weeks of gastric infusion.All rats of experimental session freely drink water, diet.
2.3 MAIN OUTCOME MEASURES:
The 8th weekend, collect the 24h urine, measure urine amount and urinary protein excretion rate.Measure body weight, sodium pentobarbital anesthesia (40mg/kg) back abdominal aortic blood is measured blood glucose, creatinine, blood urea nitrogen.Win that the bilateral kidney is weighed, conventional preparation paraffin section HE colored light sem observation, take the photograph sheet.The kidney segment of each animal is selected 10 of tangent glomerule at random, measures the glomerule diameter with the micrometering chi.Get the conventional preparation of partial cortical kidney transmission electron microscope specimen,, take the photograph sheet with Japanese JEM-1010 type transmission electron microscope primary part observation glomerule pathological changes.
2.4 statistical method
All data are all organized a T test statistics with the Spss10.0 statistical software and are handled.
3 experimental results
3.1 influence to each group rat blood sugar:
Chinese medicine of the present invention (4 week of the treatment of 4.2g crude drug/kg) the back blood glucose with treatment before and model group have and more significantly reduce (P＜0.05).Its result can see Table 1.
Table 1 pair is respectively organized influence (mmol/L) X ± SD N=10 of rat blood sugar
Annotate: all compared by the reagent group with model group
*P＜0.05
3.2 influence to the kidney of rats function:
Model group and blank group relatively rat urinary protein excretion rate, urine amount, serum creatinine and blood urea nitrogen all obviously raise.These 4 indexs of Chinese medicine 4.2g crude drug/kg of the present invention all obviously reduce, and Chinese medicine 2.1g crude drug/kg of the present invention also has a declining tendency, and the results are shown in Table (2～3)
Table 2 pair is respectively organized influence (umol/L) X ± SD of rat serum creatinine, blood urea nitrogen
Annotate: compared with model group by the reagent group
*P＜0.05
Table 3 pair is respectively organized the X ± SD that influences of rat urine protein, urine amount
Annotate: compared with model group by the reagent group
*P＜0.05
*P＜0.01
3.3 influence to renal index and glomerular volume:
Compare with blank group kidney of rats index (K/BW) and glomerular volume of model group enlarges markedly, and compare with model group renal index and glomerular volume of Chinese medicine 4.2g crude drug/kg of the present invention, 2.1g crude drug/kg obviously reduces.The results are shown in Table (4～5)
Table 4 pair is respectively organized the X ± SD that influences of rat body weight, renal index
Annotate: compared with model group by the reagent group
*P＜0.01
*P＜0.05
Table 5 pair is respectively organized the X ± SD that influences of rat glomerular volume
Annotate: compared with model group by the reagent group
*P＜0.01
*P＜0.05
3.4 the inspection of kidney form:
Light microscopic: model group kidney of rats bead mesangial region PAS stained positive material showed increased, mesentery basic unit increases, and mesangial region is obviously widened.The swelling of part renal cells comes off, the visible albumen sample of minority renal tubules intracavity cast.Chinese medicine I of the present invention, II group rat kidney pathological changes all has in various degree to be improved, and glomerular mesangium district PAS stained positive material reduces to some extent, and mesangial region does not have obvious broadening, and the renal cells pathological changes makes moderate progress.
Electronic Speculum: model group rat glomerular basement membrane is segmental and thickens, mesentery substrate showed increased, and epithelium is fusion in various degree, no normal alignment.Endotheliocyte and mesangial cell, its different dyeing knot is speckle shape skewness, and the organelle structure is unclear.Respectively be subjected to reagent group glomerule hemopoietic micro structure that certain improvement is all arranged, wherein lotensin, Chinese medicine 4.2g crude drug of the present invention/effect of kg group is the most obvious.
4 conclusions
This result of study shows: (4.2g crude drug/kg, 2.1g crude drug/kg) the blood glucose in diabetic rats index of correlation is had obvious reduction effect, this may be one of its mechanism of improving the diabetes nephropathy to Chinese drug-treated group of the present invention.Because hyperglycemia is the important risk factor that development takes place diabetic nephropathy, so the blood sugar lowering level can delay and alleviate the generation and the development of diabetic nephropathy effectively.This experiment confirm, Chinese medicine of the present invention has the blood sugar lowering effect, also can reduce serum creatinine and urea nitrogen levels simultaneously, reduces urine protein and urine amount.Alleviate the nephropathy degree.This and clinical to the diabetic nephropathy patient kidney play the protection and the improvement effect closely related.
5 lists of references
[1] Yu Demin, etc. the research of experimental streptozotocin diabetes animal model. Chinese diabetes magazine, 1995,2:105-109.
[2] Liu Zhihong, etc. diabetic nephropathy pathogeny disease [J]. Chinese Journal of Nephrology, 1999,15 (2): 120.
[3] Zhang Juntian. modern pharmacology experimental methodology [M]. Beijing: Beijing Medical University, combined publication society of China Concord Medical Science University, 1998.981.
Two, to the effect of rat experiment chronic nephritis
1 experiment material
1.1 laboratory animal: the department of the Chinese Academy of Sciences of the Department Of Medicine, Peking University's laboratory animal section quality certification number: SCXK (capital) 2002-005
1.2 medicine and reagent:
Doxorubicin hydrochloride: Haizheng Medicine Stock Co., Ltd., Zhejiang Prov's lot number: 20030902
Prednisone acetate tablets: Tianjin Lisheng Pharmaceutical Co., Ltd.'s lot number: 20040303
Chinese medicine of the present invention: Tianjin Tongrentang Co., Ltd. provides lot number: 20040716
Urine protein, blood urea nitrogen, serum creatinine, blood total protein test kit are produced by Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd.
1.3 dosage and grouping situation:
Blank group: wait water gaging.
Nephritis model group: wait water gaging.
Prednisolone acetate group: 13.3mg/kg.
Chinese medicine I:4.2g crude drug/kg. of the present invention
Chinese medicine II:2.1g crude drug/kg. of the present invention
Chinese medicine III:1.0g crude drug/kg. of the present invention
1.4 experimental apparatus
TBA-40FR automatic biochemistry analyzer Japan Toshiba
JEM-1010 NEC company transmission electron microscope
2 experimental techniques
2.1 the preparation of amycin renal injury model
Get 60 rats, ♀ ♂ half and half, body weight 220～± 20g, be divided into 6 groups at random, 10 every group, that is: blank group, nephritis model group, positive prednisolone acetate (13mg/kg) group, Chinese drug-treated group of the present invention (4.2g crude drug/kg; 2.1g crude drug/kg; 1.0g three dosage groups of crude drug/kg).Except that the blank group, all disposable tail vein injection amycin of all the other each rats (7.5mg/kg) begin administration next day.
2.2 medication
The gastric infusion amount is all by the 1ml/100g body weight.Blank group and nephritis model group are irritated stomach and are waited water gaging, more than organized by examination to irritate equal every day in 4 weeks of stomach one-time continuous.All rats of experimental session freely drink water, diet.
2.3 MAIN OUTCOME MEASURES
The 4th weekend, collect the 24h urine, measure urine protein.The pentobarbital sodium 40mg/kg intraperitoneal anesthesia of weighing, abdominal aortic blood, separation of serum is measured serum creatinine, blood urea nitrogen, blood albumin content, the results are shown in Table 1-2.At last rat is put to death, get nephridial tissue 10% formaldehyde fixed, HE dyeing, om observation.It is fixing earlier that other gets live body renal cortex 2.5% (v/v) glutaraldehyde, fixing behind 1% (m/m) osmic acid, Epon618 embedding, ultrathin section, the dyeing of 1% (m/m) acetic acid uranium, transmission electron microscope observing.
2.4 statistical method
All data are all made the T inspection statistics with Spss10.0 statistics software and are handled.
3 experimental results
3.1 to each group rat urine protein, blood urea nitrogen Determination on content
Chinese medicine of the present invention (4.2g crude drug/kg; 2.1g crude drug/kg) administration more all has the effect that reduces rat urine protein, blood urea nitrogen significantly with the nephritis model group after 4 weeks.The results are shown in Table 1.
3.2 mensuration to each group rat serum creatinine, albumin content
After 4 weeks of treatment by Chinese herbs of the present invention, compared with the nephritis model and to have reduced Glomerulonephritis Rats serum creatinine, albuminous content significantly.The results are shown in Table 2.
Table 1 pair is respectively organized the mensuration X ± SD n=10 of rat urine protein, blood urea nitrogen
Annotate: compared with model group by the examination group
*P＜0.05)
*P＜0.01
Table 2 pair is respectively organized rat serum creatinine, albuminous mensuration X ± SD N=10
Annotate: compare with model group
*P＜0.05
*P＜0.01
3.3 the inspection of kidney form
Light microscopic: the enlargement of rat model glomerule, the broadening of sacculus gap, visible proliferation of mesangial cells under the mirror, inflammatory cell infiltration, protein cast in the visible renal tubules under the part visual field.Treatment is respectively organized the change of glomerule pathology and is alleviated than model group.The model group glomerular basement membrane obviously thickens, and can see the basement membrane that thickens in the part glomerule and be the double track shape, and the high, medium and low dosage group of Chinese medicine of the present invention, basement membrane thickened alleviate than model group, and Chinese medicine high dose group wherein of the present invention effect is more obvious.
Electronic Speculum: as seen model group goes up subcutaneous a large amount of electron-dense thing deposition, and glomerular basement membrane obviously thickens, and podocyte swelling, podocytic process merge, visible endotheliocytic swelling, destruction.Subcutaneous electron-dense thing obviously reduces on Chinese medicine height of the present invention, the middle dosage group, and part has absorbing phenomenon, and the basement membrane thickened degree alleviates, and podocyte swelling alleviates, podocytic process partly recovers, and does not see that endotheliocyte destroys.
Chinese medicine low dose group basement membrane thickened of the present invention is obvious, but alleviates than model group, and still visible a large amount of nails are prominent, and podocytic process partly recovers, and does not see that endotheliocyte destroys.
4 conclusions
This result of study shows: Chinese drug-treated group of the present invention (4.2g crude drug/kg, 2.1g crude drug/kg) the nephritis rat model is had obvious reduction urine protein, serum creatinine and urea nitrogen levels and the effect of increase blood albumin.Can significantly alleviate the basement membrane that the glomerular capillary due to the nephritis rat model thickens.This shows that Chinese medicine of the present invention has significant improvement effect to the rat experiment nephritis, can provide theoretical foundation to its clinical practice by this test.
5 lists of references
[1] Xu Shuyun. pharmacological experimental methodology [M]. Beijing: People's Health Publisher, 1982.1071.
[2] Qi Chen. herbal pharmacology research method [M]. Beijing: People's Health Publisher, 1993.712.
[3] Xie Qiangmin, etc. tablet for chronic nephritis is to the effect [J] of rat experiment nephritis.
Pharmacology and Clinics of Chinese Materia Medica, 1998,14 (4): 33
The specific embodiment
Embodiment 1 preparation tablet
Take by weighing raw material by following weight proportion:
Radix Rehmanniae 100g Rhizoma Dioscoreae 100g Rhizoma Alismatis 50g Rhizoma Smilacis Glabrae 100g Radix Platycodonis 100g
Rhizoma Imperatae 150g Cortex Eucommiae 60g Herba Leonuri 100g Radix Panacis Quinquefolii 30g Radix Ginseng 10g
Radix Salviae Miltiorrhizae 50g Semen sojae atricolor 100g Herba Hedyotidis Diffusae 50g
Preparation method:
Get Rhizoma Dioscoreae in the prescription, Rhizoma Smilacis Glabrae, balloonflower powder and be broken into fine powder, Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii pulverize separately in the prescription are become fine powder; Residue Radix Rehmanniae, the Cortex Eucommiae, Herba Hedyotidis Diffusae, Semen sojae atricolor, Herba Leonuri, Rhizoma Imperatae, Rhizoma Alismatis are used the water extraction secondary, 1.5 hours for the first time, add 8 times of amounts of water, 1 hour for the second time, add 7 times of amounts of water, extract water temperature 98-102 ℃ at every turn, extracting solution filters, merging filtrate is evaporated to the extractum of relative density 1.35-1.40 (60 ± 5 ℃ heat survey); Extractum adds Rhizoma Dioscoreae, Rhizoma Smilacis Glabrae, Radix Platycodonis fine powder, and mixing is made bulky grain, vacuum drying, and dry substance is ground into fine powder, mixing adds Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii fine powder respectively, and mix homogeneously is granulated, tabletting, the bag film-coat is made about 1076 (every 0.48g contains crude drug 0.92g), promptly.Usage and dosage, oral, one time 5,3 times on the one.
Embodiment 2 preparation capsules
Take by weighing raw material by following weight proportion:
Radix Rehmanniae 120g Rhizoma Dioscoreae 160g Rhizoma Alismatis 60g Rhizoma Smilacis Glabrae 150g Radix Platycodonis 150g
Rhizoma Imperatae 200g Cortex Eucommiae 100g Herba Leonuri 160g Radix Panacis Quinquefolii 40g Radix Ginseng 20g
Radix Salviae Miltiorrhizae 120g Semen sojae atricolor 160g Herba Hedyotidis Diffusae 80g
Preparation method:
Get Rhizoma Dioscoreae in the prescription, Rhizoma Smilacis Glabrae, balloonflower powder and be broken into fine powder, Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii pulverize separately in the prescription are become fine powder; Residue Radix Rehmanniae, the Cortex Eucommiae, Herba Hedyotidis Diffusae, Semen sojae atricolor, Herba Leonuri, Rhizoma Imperatae, Rhizoma Alismatis are used the water extraction secondary, 1.5 hours for the first time, add 8 times of amounts of water, 1 hour for the second time, add 7 times of amounts of water, extract water temperature 98-102 ℃ at every turn, extracting solution filters, merging filtrate is evaporated to the extractum of relative density 1.35-1.40 (60 ± 5 ℃ heat survey); Extractum adds Rhizoma Dioscoreae, Rhizoma Smilacis Glabrae, Radix Platycodonis fine powder, and mixing is made bulky grain, vacuum drying, and dry substance is ground into fine powder, mixing adds Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii fine powder respectively, and mix homogeneously is granulated, encapsulated, make 1310 (every 0.6g contains crude drug 1.16g), promptly.Usage and dosage, oral, one time 4,3 times on the one.
Embodiment 3 preparation tablets
Take by weighing raw material by following weight proportion:
Radix Rehmanniae 80g Rhizoma Dioscoreae 80g Rhizoma Alismatis 40g Rhizoma Smilacis Glabrae 50g Radix Platycodonis 50g
Rhizoma Imperatae 100g Cortex Eucommiae 50g Herba Leonuri 80g Radix Panacis Quinquefolii 20g Radix Ginseng 6g
Radix Salviae Miltiorrhizae 40g Semen sojae atricolor 80g Herba Hedyotidis Diffusae 40g
Preparation method:
Get that Rhizoma Dioscoreae powder is broken into fine powder in the prescription, Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii pulverize separately in the prescription are become fine powder; Residue Radix Rehmanniae, the Cortex Eucommiae, Herba Hedyotidis Diffusae, Semen sojae atricolor, Herba Leonuri, Rhizoma Imperatae, Rhizoma Alismatis, Radix Platycodonis water extraction secondary, 1.5 hours for the first time, add 8 times of amounts of water, 1 hour for the second time, add 7 times of amounts of water, extract water temperature 98-102 ℃ at every turn, extracting solution filters, merging filtrate is evaporated to the extractum of relative density 1.35-1.40 (60 ± 5 ℃ heat survey); Smilax glabra ethanol extracts twice, extracts 1.5 hours at every turn, extracts 78-82 ℃ of temperature, and extracting solution filters, and merging filtrate is evaporated to the extractum of relative density 1.30-1.35 (60 ± 5 ℃ of heat are surveyed); Two kinds of extractum add Rhizoma Dioscoreae fine powder and appropriate amount of starch or dextrin, and mixing is made bulky grain, vacuum drying, dry substance is ground into fine powder, and mixing adds Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii fine powder and an amount of Icing Sugar respectively, mixing is made granule 770g (every g contains crude drug 0.92g), promptly.Usage and dosage, oral, a 5g, 3 times on the one.
Claims (5)
1, the Chinese medicine of a kind of prevention and treatment early diabetic nephropathy is characterized in that making that raw materials of effective components is formed and weight proportion is:
Radix Rehmanniae 80-120 part Rhizoma Dioscoreae 80-160 part Rhizoma Alismatis 40-60 part
Rhizoma Smilacis Glabrae 50-150 part Radix Platycodonis 50-150 part Rhizoma Imperatae 100-200 part
Cortex Eucommiae 50-100 part Herba Leonuri 80-160 part Radix Panacis Quinquefolii 20-40 part
Radix Ginseng 6-20 part Radix Salviae Miltiorrhizae 4 0-120 part Semen sojae atricolor 80-160 parts
Herba Hedyotidis Diffusae 40-80 part.
2, according to the Chinese medicine of described a kind of prevention of claim 1 and treatment early diabetic nephropathy, wherein each raw material weight proportioning is:
100 parts of 50 parts of Rhizoma Smilacis Glabraes of 100 portions of Rhizoma Alismatis of 100 portions of Rhizoma Dioscoreaes of Radix Rehmanniae
100 parts of 60 parts of Herba Leonuris of 150 parts of Cortexs Eucommiae of 100 parts of Rhizoma Imperataes of Radix Platycodonis
100 parts in 50 parts of Semen sojae atricolors of 10 parts of Radix Salviae Miltiorrhizaes of 30 parts of Radix Ginsengs of Radix Panacis Quinquefolii
50 parts of Herba Hedyotidis Diffusaes.
3, according to the Chinese medicine of described a kind of prevention of claim 1 and treatment early diabetic nephropathy, it is characterized in that it being to make said dosage form on any pharmaceutics.
4, according to the Chinese medicine of described a kind of prevention of claim 3 and treatment early diabetic nephropathy, it is characterized in that said dosage form is tablet, capsule or granule.
5, according to the Chinese medicine of described a kind of prevention of claim 1 and treatment early diabetic nephropathy, its preparation method is: get Rhizoma Dioscoreae in the prescription, Rhizoma Smilacis Glabrae, balloonflower powder and be broken into fine powder, Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii pulverize separately in the prescription are become fine powder; Residue Radix Rehmanniae, the Cortex Eucommiae, Herba Hedyotidis Diffusae, Semen sojae atricolor, Herba Leonuri, Rhizoma Imperatae, Rhizoma Alismatis are used the water extraction secondary, 1.5 hours for the first time, add 8 times of amounts of water, 1 hour for the second time, add 7 times of amounts of water, extract water temperature 98-102 ℃ at every turn, extracting solution filters, merging filtrate, concentrating under reduced pressure and between 55 ℃-65 ℃ heat survey the extractum that relative density becomes 1.35-1.40; Extractum adds Rhizoma Dioscoreae, Rhizoma Smilacis Glabrae, Radix Platycodonis fine powder, and mixing is made bulky grain, vacuum drying, and dry substance is ground into fine powder, and mixing adds Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Panacis Quinquefolii fine powder respectively, and mix homogeneously is made said dosage form on any pharmaceutics.
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| CNB2005101223648A CN100536899C (en) | 2005-12-15 | 2005-12-15 | Chinese medicine for treating and preventing early diabetes and nephropathy |
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| CN102526559A (en) * | 2010-12-28 | 2012-07-04 | 天津同仁堂集团股份有限公司 | Traditional Chinese medicine for treating early-phase nephrotic syndrome |
| CN102727790A (en) * | 2011-04-08 | 2012-10-17 | 天津同仁堂集团股份有限公司 | Quality control method of nephritis recovery tablets |
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Non-Patent Citations (2)
| Title |
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| 中药复方治疗糖尿病肾病研究进展. 陈秋，邱宗荫，夏永鹏.第七次全国中医糖尿病学术大会论文汇编. 2003 |
| 中药复方治疗糖尿病肾病研究进展. 陈秋，邱宗荫，夏永鹏.第七次全国中医糖尿病学术大会论文汇编. 2003 * |
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