CN100409893C - Medicine for treating functional renal failure and preparation method thereof - Google Patents

Medicine for treating functional renal failure and preparation method thereof Download PDF

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Publication number
CN100409893C
CN100409893C CNB2006100109279A CN200610010927A CN100409893C CN 100409893 C CN100409893 C CN 100409893C CN B2006100109279 A CNB2006100109279 A CN B2006100109279A CN 200610010927 A CN200610010927 A CN 200610010927A CN 100409893 C CN100409893 C CN 100409893C
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herba
portions
medicine
renal failure
rhizoma
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CN1883695A (en
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李飞染
王瑜
王增亮
王亭
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KUNMING HERUN PHARMACEUTICAL DEVELOPMENT Co Ltd
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Abstract

The present invention discloses a medicine for treating renal failure and a preparation method thereof. The present invention is prepared from raw materials of the following proportion by weight: 6 to 20 portions of herba polygoni capitati, 6 to 20 portions of pyrrosia leaf, 6 to 20 portions of creeping rostellularia herb, 15 to 30 portions of lalang grass rhizome, 8 to 25 portions of kudzuvine root, 6 to 15 portions of aleppo avens, 10 to 30 portions of herba glechomae, 3 to 10 portions of honeysuckle flower, 3 to 10 portions of madder, 3 to 12 portions of shortleaf kyllinga herb, 2 to 10 portions of common herons bill herb, 4 to 15 portions of dried tangerine peel, 3 to 15 portions of honeysuckle stem, 1 to 8 portions of grassleaf sweetflag rhizome and 4 to 12 portions of ginger. The formula of the present invention is unique and the technology is reliable; the medicine receives high praise from many patients who take the medicine to treat renal failure; the medicine has the effects of quickly reducing serum creatinine and urea nitrogen and enhancing renal function, appetite and physical strength, etc. of patients. Proved by clinical experiment on 161 cases of patients with renal failure, the total effective rate is 90%; the present invention has the advantages of safety, effectiveness, controllable quality, convenient use and low price; the present invention can be conveniently popularized in extensive urban and rural areas where medical condition is poor, which has positive social significance and economic significance.

Description

Medicine of treatment renal failure and preparation method thereof
Technical field
The present invention relates to Chinese patent medicine, specifically is the medicine of treatment renal failure of feedstock production and its preparation method with the Chinese herbal medicine.
Background technology
Renal failure is a kind of common frdquently encountered disease, and it seriously threatens human body health.Being characterized in that excess of the kidney matter suffers damage causes the renal function grievous injury, cause the hurried decline of glomerular filtration rate, nephronloss is regulated excretory function, nitrogen matter and a large amount of retentions of other metabolite in the body, as serum creatinine, blood urea nitrogen etc., can not keep water in the body, electrolyte, acid-base balance and cause various clinical symptoms, be a critical syndrome.Belong to traditional Chinese medical science obstruction and rejection, the difficulty in urination, the kidney-wind syndrome, category such as deficient.
According to relevant bibliographical information, end stage renal failure dialysis patient first annual death rate is 50% in the fifties, reduced to 10% to the nineties, this has benefited from the improvement of the technology of dialysing, but the mortality rate of renal failure is on the rise: rise to 75% of the nineties from 55% of the fifties.Drug therapy renal failure listing patent medicine is few, especially oral preparation of Chinese traditional medicinal treatment acute renal failure is not seen the listing kind, yet Chinese medicine has a lot of distinctive features at treatment critical illness renal failure, so medicine of the present invention is the urgent need of present clinical application to the treatment renal failure.
Summary of the invention
The purpose of this invention is to provide a kind of to the treatment renal failure medicine of better curative effect and preparation method thereof is arranged.
Technical scheme of the present invention is according to motherland's traditional medicine dialectical the executing of treatment of kidney disease to be administered opinion, in conjunction with Chinese medicine modern pharmacology and clinic study, by long-term clinical application and animal effect experiment, find that the present invention is a kind of to reducing serum creatinine, plasma creatinine, serum urea nitrogen and improving endogenous creatinine clearance rate, improves the medicine that the kidney merit has the treatment renal failure of significant curative effect effect.It is the medicine by following materials of weight proportions preparation:
Herba Polygoni Capitati 6~20 Folium Pyrrosiaes 6~20 Herba Rostellulariaes 6~20 Rhizoma Imperataes 15~30
Radix Puerariae 8~25 Radix seu Herba Gei aleppici 6~15 Herba Glechomaes 10~30 Flos Lonicerae 3~10
Radix Rubiae 3~10 Herba Kyllingaes 3~12 Herba Erodiis 2~10 Pericarpium Citri Reticulataes 4~15
Caulis Lonicerae 3~15 Rhizoma Acori Graminei 1~8 Rhizoma Zingiberis Recens 4~12
The raw material preferred weight proportioning of the medicine of treatment renal failure of the present invention is:
Herba Polygoni Capitati 10~15 Folium Pyrrosiaes 10~15 Herba Rostellulariaes 10~15 Rhizoma Imperataes 10~20
Radix Puerariae 10~20 Radix seu Herba Gei aleppici 10~15 Herba Glechomaes 11~20 Flos Lonicerae 4~8
Radix Rubiae 4~8 Herba Kyllingaes 4~10 Herba Erodiis 3~8 Pericarpium Citri Reticulataes 8~12
Caulis Lonicerae 4~10 Rhizoma Acori Graminei 2~6 Rhizoma Zingiberis Recenss 5~9
The optimum weight proportioning of the raw material of the medicine of treatment renal failure of the present invention is:
Herba Polygoni Capitati 13 Folium Pyrrosiaes 14 Herba Rostellulariaes 12 Rhizoma Imperataes 12
Radix Puerariae 12 Radix seu Herba Gei aleppici 13 Herba Glechomaes 13 Flos Lonicerae 4
Radix Rubiae 5 Herba Kyllingaes 5 Herba Erodiis 3 Pericarpium Citri Reticulataes 10
Caulis Lonicerae 5 Rhizoma Acori Graminei 2 Rhizoma Zingiberis Recenss 6
The preparation method of the medicine of treatment renal failure of the present invention:
Above ten five tastes medical materials are carried out the size that pre-treatment is machined to regulation, add the common decoction of water three times, add 13 times of amounts of water for the first time, soaked 4 hours, boiled then 10 minutes, filter; Add for the second time 9 times of amounts of water, after boiled 50 minutes, filter; Add 7 times of amounts of water for the third time, boiled 30 minutes, filter; Merge three times filtrate, be evaporated to about 2/3 volume, the relative density in the time of 60 ℃ is 1.01~1.02, left standstill 4~6 hours, and the leaching supernatant, relative density is 1.15~1.18 when being evaporated to 60 ℃ again, spray drying gets dry extract; Get 1 part of dry extract, add 1 part in dextrin, mixing adds 15~25% ethanol (concentration is 75~85%) and makes wet granular by the mixed material amount, drying (temperature≤80 ℃), and granulate is made finished granule.
With the Herba Polygoni Capitati inducing diuresis for treating stranguria syndrome, detoxify in the prescription of the present invention, dissipating blood stasis is controlled the difficulty in urination, nephritis, cystitis etc. have good effect, according to modern study, Herba Polygoni Capitati can recover kidney of rats tubule absorption function, improves the glomerular filtration function, promotes the restitution of renal tubules and glomerule pathological changes; Stagnate with the Herba Rostellulariae dampness removingization, heat-clearing and toxic substances removing, promoting blood circulation and stopping pain also can be moved back cold and heat; With the Folium Pyrrosiae inducing diuresis for treating stranguria syndrome, clearing away heat and cooling blood is gone into the lung meridian urinary bladder channel again; With the Rhizoma Imperatae clearing away heat and promoting diuresis, spleen is returned in cooling blood for hemostasis, stomach warp and urinary bladder channel; Treating stranguria with the Herba Glechomae dampness removing, heat-clearing and toxic substances removing is gone into the kidney channel urinary bladder channel; Above-mentioned five tastes diuresis, treating stranguria, detoxifcation, heat clearing away, removing heat from blood is gone out with drawing turbid pathogen, and the malicious heresy of dispelling is then rectified and is set upright gas.Promote the production of body fluid with Radix Puerariae again in the side and bring down a fever, yang invigorating antidiarrheal, with going into spleen, stomach two warps, " Bencao Congxin " said: " Radix Puerariae lightly floats to rise and sends out, and goes into Yangming Channel.Can inspire gastric qi up, promoting the production of body fluid to quench thirst is doublely gone into spleen channel ... for controlling the panacea that clearing heat in QI system sink and has loose bowels." modern pharmacology is a lot of to the research of Radix Puerariae, confirms that the Radix Puerariae isoflavone composition has the effect of regulating cardiac function, has blood vessel dilating; improve blood effect, particularly microcirculation improvement, the effect of anticoagulant; and Detoxication is arranged, hypotensive activity reduces the effect of blood viscosity etc.; With Pericarpium Citri Reticulatae regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm; With the Rhizoma Zingiberis Recens warming spleen and stomach for dispelling cold, the regulating the stomach and sending down the abnormal ascending QI removing dampness, control damp and hot in resistance companion's nausea and vomiting, the merit of tool improving appetite is also had a diaphoresis effect, has certain effect to draining the internal metabolism material; Loose wind except that cold with Herba Kyllingae, and inducing diuresis to remove edema cures mainly chyluria, hematuria, turbid urine; With Radix seu Herba Gei aleppici detoxifcation dehumidifying, promoting blood circulation and detumescence, the tonify deficiency kidney tonifying has blood pressure lowering, controls dizziness, the merit that fills blood; The Herba Erodii expelling wind and removing dampness, the meridian dredging, convergence life; With the Radix Rubiae removing heat from blood, hemostasis, the meridian dredging; Used Flos Lonicerae and Caulis Lonicerae in the side, this mainly is to get its heat-clearing and toxic substances removing, the effect of dispelling wind collateral dredging; Fang Zhongzuo then is to get its refreshment of having one's ideas straightened out, the merit of removing dampness appetizing with a little Rhizoma Acori Graminei.All medicines share in the side has curative effect effect preferably to the treatment kidney disease.This medicine can reduce serum creatinine (Scr), and blood urea nitrogen (BUN) improves endogenous creatinine clearance rate (Ccr), recovers the kidney filtering function, promotes the recovery of renal function.
Below be the effect experiment data of medicine of the present invention:
Experiment one, this medicine cause the influence of renal failure rat to gentamycin:
Male SD rat, conform after 1 week, be the normal control group at random, model control group, medicine high dose group (6 times of clinical equivalent dosage), middle dosage group (3.4 times of clinical equivalent dosage), low dose group (2 times of clinical equivalent dosage) and NIAODUQING KELI group (daily dose 13.3g/kg), grouping and dosage see Table 1, except that the normal control group, each organizes equal every day of subcutaneous injection gentamycin sulfate 100mg/kg, each administration group is gastric infusion simultaneously, 2 times/day, successive administration 12 days, behind the last administration 1h, collect urinary assay Cr content, femoral artery is got blood and is surveyed serum creatinine, serum urea nitrogen content and plasma creatinine content, calculate endogenous creatinine clearance rate, the results are shown in Table 1.
This medicine of table 1 causes the influence of renal failure rat biochemical indicator to gentamycin
Figure C20061001092700061
Annotate: compare with model group, *P<0.05, *P<0.01.
The large, medium and small dosage successive administration of this medicine 12 days is compared with model control group, and the reduction gentamycin is caused serum creatinine, the serum urea nitrogen of renal failure rat and improves endogenous creatinine clearance rate the highly significant meaning, and can significantly reduce plasma creatinine; Compare with model group, can significantly increase rat body weight.
Experiment two, this medicine cause the influence of renal failure rat to glycerol
Male SD rat, conform after 1 week, tell 10 at random and be the normal control group, after remaining animal is prohibited water 20h, select for use weight loss and dehydration animal to experimentize, each Mus is all pressed the dosage of 10ml/kg with 50% glycerol normal saline solution, inject at rat both sides hindlimb muscle respectively, the 24h posterior orbit is got hematometry serum creatinine (Cr), blood urea nitrogen (BUN) content, matched group is also got hematometry simultaneously, choose BUN, the modeling rat that Cr content surpasses normal group average 80% experimentizes, according to BUN, Cr content is divided into 5 groups at random: model control group, medicine high dose group (6 times of clinical equivalent dosage), middle dosage group (3.4 times of clinical equivalent dosage), low dose group (2 times of clinical equivalent dosage) and NIAODUQING KELI group (daily dose 13.3g/kg), grouping and dosage see Table 1, the every 12h of each administration group is administered once, and successive administration 7 times is behind the last administration 1h, femoral artery is got blood and is surveyed serum creatinine, urea nitrogen content the results are shown in Table 2.T check comparable group differences.
This medicine of table 2 causes the influence (x ± s) of renal failure rat to glycerol
Figure C20061001092700071
Annotate: compare with model group, *P<0.05, *P<0.01; Compare before and after the administration on the same group, ▲ P<0.05, ▲ ▲ P<0.01.
The large, medium and small dosed administration of this medicine seven times is compared with model control group, can significantly reduce serum creatinine, urea nitrogen content that glycerol causes the renal failure rat; Before serum creatinine after the administration, urea nitrogen content also significantly are lower than administration on the same group.
This research adopts gentamycin, glycerol to bring out the pharmacological testing of kidney of rats nonfunction, observes main pharmacological, and the result shows:
1) gentamycin brings out the pharmacological testing of kidney of rats nonfunction
The large, medium and small dosage successive administration of this medicine 12 days, compare with model control group, the serum creatinine, serum urea nitrogen and the raising endogenous creatinine clearance rate that the reduction gentamycin are caused the renal failure rat have the highly significant meaning, and can significantly reduce plasma creatinine, weight increase.
2) glycerol brings out the pharmacological testing of rat acute renal failure
The large, medium and small dosed administration of this medicine seven times is compared with model control group, can significantly reduce serum creatinine, urea nitrogen content that glycerol causes the renal failure rat; Before serum creatinine after the administration, urea nitrogen content also significantly are lower than administration on the same group.
The safety experiment data of medicine of the present invention:
This drug prescription is medical material that standard is recorded by 15 flavor medical materials, does not contain the toxicity medical material in the side, does not also have the taboo of eighteen incompatible medicaments, nineteen medicaments of mutual restraint.Acute toxicity test and long term toxicity test result that this medicine is carried out show: acute toxicity test can not surveyed the LD of this product 50, the maximum dosage-feeding of surveying its gastric infusion is 66g/kg, is equivalent to 118 times of clinical plan consumption, does not see toxic reaction.Trimestral long term toxicity test, gastric infusion has certain influence to rats eating amount, body weight gain and the heart, liver, kidney, stomach, brain, testis, epididymis, adrenal organ coefficient continuously; Biochemical some index demonstration administration group of hematology and serum and matched group are variant, should pay close attention to patient's digestive system function and hematological examination during the prompting clinical trial.The histopathologic examination of heavy dose of group does not find the overt toxicity reaction.The result shows that medicine of the present invention is oral administration in used dosage and administration time, and rat is not had the overt toxicity effect.
Below be the clinical experimental data of medicine of the present invention:
161 routine renal failure patients have been carried out clinical experiment, and 37 examples of wherein fully recovering account for 23%; Produce effects 80 examples account for 50%; Effective 16 examples account for 10%; Stablize 12 examples, account for 7%; Invalid 16 examples account for 10%.Total effective rate reaches 90%.And to the treatment before and after serum creatinine, blood urea nitrogen, endogenous creatinine clearance rate carried out the clinical medicine statistical procedures, the highly significant meaning is arranged.The result shows that this product has curative effect effect preferably to the treatment renal failure.The clinical medicine statistical procedures sees following form for details.
Table 1 treatment renal failure observation of curative effect statistical table
Figure C20061001092700081
The influence of table 2 pair kidney anovulatory dysfunctional uterine hemorrhage biochemical indicator (X ± S)
Figure C20061001092700091
Annotate: table 1, curative effect determinate standard are with reference to 167 pages of Zheng Xiao cornel chief editor " new Chinese medicine clinical research guideline " versions in 2002.
Table 2, treatment front and back comparison on the same group, " *" P<0.05 differs significance; " *" P<0.01 differed the highly significant meaning.
The preparation method of granule of the present invention, technology is simple, easy row, simultaneously reliably controlled again, guaranteed should heavy dose prescription medical material effective ingredient collect basically in the middle of final preparation, make that product is easy to store and use.Unique from characteristic because of the prescription of medicine of the present invention just, technology is reliable, and is very good with patient's reflection of many renal failures of this medicine, the very fast decline of serum creatinine and blood urea nitrogen, and the kidney merit improves, and patient's appetite muscle power etc. obviously strengthen.
By system test research, safety of medicine of the present invention, effective, quality controllable, take easyly, inexpensive, apply in the vast town and country of the medical condition of being more convenient for difference, the lower extensive patients of interests income has positive social meaning and economic implications.
The specific embodiment
Embodiment 1:
Choose following raw materials according (unit of weight kilogram):
Herba Polygoni Capitati 13 Folium Pyrrosiaes 14 Herba Rostellulariaes 12 Rhizoma Imperataes 12
Radix Puerariae 12 Radix seu Herba Gei aleppici 13 Herba Glechomaes 13 Flos Lonicerae 4
Radix Rubiae 5 Herba Kyllingaes 5 Herba Erodiis 3 Pericarpium Citri Reticulataes 10
Caulis Lonicerae 5 Rhizoma Acori Graminei 2 Rhizoma Zingiberis Recenss 6
Preparation method:
Above ten five tastes medical materials are carried out the size that pre-treatment is machined to regulation, add the common decoction of water three times, add 13 times of amounts of water for the first time, soaked 4 hours, boiled then 10 minutes, filter; Add for the second time 9 times of amounts of water, after boiled 50 minutes, filter; Add 7 times of amounts of water for the third time, boiled 30 minutes, filter; Merge three times filtrate, be evaporated to about 2/3 volume, the relative density in the time of 60 ℃ is 1.01~1.02, left standstill 4~6 hours, and the leaching supernatant, relative density is 1.15~1.18 when being evaporated to 60 ℃ again, spray drying gets dry extract; Get 1 part of dry extract, add 1 part in dextrin, mixing adds 15~25% ethanol (concentration is 75~85%) and makes wet granular by the mixed material amount, drying (temperature≤80 ℃), and granulate is made finished granule.
Embodiment 2:
Choose following raw materials according (unit of weight kilogram):
Herba Polygoni Capitati 15 Folium Pyrrosiaes 14 Herba Rostellulariaes 13 Rhizoma Imperataes 13
Radix Puerariae 14 Radix seu Herba Gei aleppici 15 Herba Glechomaes 20 Flos Lonicerae 8
Radix Rubiae 9 Herba Kyllingaes 10 Herba Erodiis 7 Pericarpium Citri Reticulataes 13
Caulis Lonicerae 10 Rhizoma Acori Graminei 5 Rhizoma Zingiberis Recenss 8
Method with embodiment 1 is prepared into granule, or is prepared into tablet with existing known technology.
Embodiment 3:
Choose following raw materials according (unit of weight kilogram):
Herba Polygoni Capitati 10 Folium Pyrrosiaes 9 Herba Rostellulariaes 8 Rhizoma Imperataes 8
Radix Puerariae 10 Radix seu Herba Gei aleppici 10 Herba Glechomaes 11 Flos Lonicerae 6
Radix Rubiae 7 Herba Kyllingaes 3 Herba Erodiis 6 Pericarpium Citri Reticulataes 8
Caulis Lonicerae 4 Rhizoma Acori Graminei 4 Rhizoma Zingiberis Recenss 5
Method with embodiment 1 is prepared into granule, or is prepared into capsule with existing known technology.
Embodiment 4:
Choose following raw materials according (unit of weight kilogram):
Herba Polygoni Capitati 20 Folium Pyrrosiaes 20 Herba Rostellulariaes 20 Rhizoma Imperataes 30
Radix Puerariae 25 Radix seu Herba Gei aleppici 14 Herba Glechomaes 30 Flos Lonicerae 10
Radix Rubiae 10 Herba Kyllingaes 12 Herba Erodiis 10 Pericarpium Citri Reticulataes 15
Caulis Lonicerae 15 Rhizoma Acori Graminei 8 Rhizoma Zingiberis Recenss 12
Method with embodiment 1 is prepared into granule, or is prepared into pill with existing known technology.
Embodiment 5:
Choose following raw materials according (unit of weight kilogram):
Herba Polygoni Capitati 6 Folium Pyrrosiaes 6 Herba Rostellulariaes 6 Rhizoma Imperataes 6
Radix Puerariae 10 Radix seu Herba Gei aleppici 6 Herba Glechomaes 10 Flos Lonicerae 3
Radix Rubiae 3 Herba Kyllingaes 6 Herba Erodiis 2 Pericarpium Citri Reticulataes 4
Caulis Lonicerae 3 Rhizoma Acori Graminei 1 Rhizoma Zingiberis Recens 4
Method with embodiment 1 is prepared into granule, or is prepared into oral liquid with existing known technology.

Claims (4)

1. medicine for the treatment of renal failure, the raw material that it is characterized in that this medicine forms and weight proportion is:
Herba Polygoni Capitati 6~20 Folium Pyrrosiaes 6~20 Herba Rostellulariaes 6~20 Rhizoma Imperataes 15~30
Radix Puerariae 8~25 Radix seu Herba Gei aleppici 6~15 Herba Glechomaes 10~30 Flos Lonicerae 3~10
Radix Rubiae 3~10 Herba Kyllingaes 3~12 Herba Erodiis 2~10 Pericarpium Citri Reticulataes 4~15
Caulis Lonicerae 3~15 Rhizoma Acori Graminei 1~8 Rhizoma Zingiberis Recens 4~12
2. the medicine of treatment renal failure according to claim 1 is characterized in that the raw material composition and the weight proportion of medicine is:
Herba Polygoni Capitati 10~15 Folium Pyrrosiaes 10~15 Herba Rostellulariaes 10~15 Rhizoma Imperataes 10~20
Radix Puerariae 10~20 Radix seu Herba Gei aleppici 10~15 Herba Glechomaes 11~20 Flos Lonicerae 4~8
Radix Rubiae 4~8 Herba Kyllingaes 4~10 Herba Erodiis 3~8 Pericarpium Citri Reticulataes 8~12
Caulis Lonicerae 4~10 Rhizoma Acori Graminei 2~6 Rhizoma Zingiberis Recenss 5~9
3. the medicine of treatment renal failure according to claim 1 is characterized in that the weight proportion of its raw material is:
Herba Polygoni Capitati 13 Folium Pyrrosiaes 14 Herba Rostellulariaes 12 Rhizoma Imperataes 12
Radix Puerariae 12 Radix seu Herba Gei aleppici 13 Herba Glechomaes 13 Flos Lonicerae 4
Radix Rubiae 5 Herba Kyllingaes 5 Herba Erodiis 3 Pericarpium Citri Reticulataes 10
Caulis Lonicerae 5 Rhizoma Acori Graminei 2 Rhizoma Zingiberis Recenss 6
4. the preparation method of the medicine of any described treatment renal failure of claim 1~3, it is characterized in that: any described ten five tastes medical materials of claim 1~3 are carried out the size that pre-treatment is machined to regulation, add the common decoction of water three times, add for the first time 13 times of amounts of water, soaked 4 hours, boiled then 10 minutes, and filtered; Add for the second time 9 times of amounts of water, after boiled 50 minutes, filter; Add 7 times of amounts of water for the third time, boiled 30 minutes, filter; Merge three times filtrate, be evaporated to about 2/3 volume, the relative density in the time of 60 ℃ is 1.01~1.02, left standstill 4~6 hours, and the leaching supernatant, relative density is 1.15~1.18 when being evaporated to 60 ℃ again, spray drying gets dry extract; Get 1 part of dry extract, add 1 part in dextrin, mixing is pressed the ethanol of mixed material amount adding 15~25%, and concentration of alcohol is 75~85%, makes wet granular, drying, and granulate is made finished granule.
CNB2006100109279A 2006-05-30 2006-05-30 Medicine for treating functional renal failure and preparation method thereof Expired - Fee Related CN100409893C (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1268355A (en) * 2000-01-08 2000-10-04 陈柏林 Yichanmanshenkang medicine for curing nephroses

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1268355A (en) * 2000-01-08 2000-10-04 陈柏林 Yichanmanshenkang medicine for curing nephroses

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* Cited by examiner, † Cited by third party
Title
国家药品监督管理局国家中成药标准汇编(中成药地方标准上升国家标准部分)内科肾系分册. 国家药品监督管理局. 2002
国家药品监督管理局国家中成药标准汇编(中成药地方标准上升国家标准部分)内科肾系分册. 国家药品监督管理局. 2002 *

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