CN102861192A

CN102861192A - Medicine composition for chronic renal failure and peritoneal fibrosis

Info

Publication number: CN102861192A
Application number: CN2012103938382A
Authority: CN
Inventors: 杨洪涛
Original assignee: Individual
Current assignee: Individual
Priority date: 2012-04-26
Filing date: 2012-10-17
Publication date: 2013-01-09
Anticipated expiration: 2032-10-17
Also published as: CN102861192B

Abstract

The invention relates to a medicine composition for chronic renal failure and peritoneal fibrosis. The medicine composition is prepared by the following traditional Chinese materials: Chinese angelica, dried tangerine or orange peel, prepared rhubarb, astragalus mongholicus, pinellia ternate, herba epimedii, salvia miltiorrhiza and ramulus euonymi. The invention further provides a preparation method and application of the medicine composition. The medicine composition can be effectively used for treating chronic renal failure and can prevent or treat peritoneal fibrosis. Particularly, the medicine composition is suitable for chronic renal failure, can slow down kidney function decrease according to clinical effects, and can correct water, electrolyte and acid-base disturbance. Additionally, the medicine composition is suitable for end-stage renal disease peritoneal dialysis patients, improves survival quality of the peritoneal dialysis patients according to clinical effects and delays occurrence and development of peritoneal fibrosis.

Description

The pharmaceutical composition that is used for chronic renal failure and peritoneal fibrosis

Technical field

The invention belongs to technical field of Chinese medicines, relate to the pharmaceutical composition for the treatment of nephropathy, particularly can be used for the pharmaceutical composition for chronic renal failure and peritoneal fibrosis.The invention still further relates to the preparation method of described pharmaceutical composition, and the purposes of this pharmaceutical composition.

Background technology

Chronic renal failure is clinical common refractory disease; Therapeutic Method is with control protopathy at present; protecting remaining nephron function is main target; extremely latter stage at end, western medical treatment adopted kidney dialysis and renal transplantation more; though the state of an illness of some patients were is temporarily alleviated with small number of patients to be alleviated fully; but because somewhat expensive; side effect is many; survival of transplanted kidney time and the reasons such as minority symptomatic drugs are only arranged for kidney derived limited and Western medicine; cause there is no so far the way of fundamentally improving and recovering renal function injury, therefore look primary disease and be " the irreversible pathological changes of chronic progressive external ".In recent years, use the Chinese medicine chronic renal failure and obtained sure curative effect, use tcm therapy, various symptoms, sign for the chronic renal failure existence, performance differentiation of tcm integrally-regulated advantage is in time corrected, and can make the renal function of some patients were obtain to a certain degree improvement and recovery.

Peritoneal dialysis (PD) obviously is better than conventional hemodialysis as a kind of effective kidney replacement therapy means with its protection to residual renal function, in the kidney replacement therapy consequence is arranged.Can peritoneal dialysis be carried out for a long time and effectively, depends on that to a great extent can peritoneum continue to keep normal physiology and biological function.Along with the patients undergoing peritoneal dialysis life-time dilatation, peritoneal membrane function depletion and/or peritoneal fibrosis have become and have caused the saturating technical failed most important reason of abdomen, and become " bottleneck " of restriction peritoneal dialysis development.

In recent years, existing a large amount of Chinese medicine preparation were used for the research of control peritoneal fibrosis, and wherein ligustrazine may be by the protection Peritoneal Mesothelial Cells, and antiinflammatory, anticoagulant, fibrosis and improve the peritoneum structure increase ultrafiltration, improve dialysisadequacy.The medication of Chinese medicine intraperitoneal is domestic a small amount of bibliographical information, mainly concentrates on QI invigorating and medicine for promoting blood circulation and dispelling blood stasis, such as the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong etc.Observing them in the peritoneal dialysis of animal and human's class can improve efficiency of peritoneal dialysis, promote peritoneum that small-molecule substance is removed, increased ultrafiltration volume and improve peritoneal membrane function, but its pharmacological Mechanism it be not immediately clear, and is less on the impact report of Peritoneal Mesothelial Cells.Prevented and treated the clinical experimental research of peritoneal fibrosis, sclerosis, be the composition that adds certain medicine or change peritoneal dialysis liquid in peritoneal dialysis liquid in the past mostly.But the medicine that adds may stimulate former and then causes the generation of new peritoneal fibrosis as a kind of new bio-incompatibility.Oral administration route, after its process absorption of human body metabolism, make medicine have certain biocompatibility, and the through sick therapeutical effect of bringing into play, not only avoid the direct stimulation of medicine to Peritoneal Mesothelial Cells, and can bring into play the advantage of the exclusive fibrosis of Chinese medicine, sclerosis.

Therefore, this area still needs to have new treatment nephropathy especially for the treatment chronic renal failure, and the method for prevention or treatment peritoneal fibrosis.

Summary of the invention

The object of the invention is to treat nephropathy especially for the treatment chronic renal failure for clinical providing, and the method for prevention or treatment peritoneal fibrosis.The inventor finds can effectively to be used for the treatment of chronic renal failure take the pharmaceutical composition that the Radix Astragali etc. is made as Chinese prescription, and prevention or treat peritoneal fibrosis.The present invention is based on this discovery and be accomplished.

For this reason, first aspect present invention provides a kind of pharmaceutical composition, and it is by comprising that following Chinese crude drug prepares: Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Radix Et Rhizoma Rhei, the Radix Astragali, the Rhizoma Pinelliae, Herba Epimedii, Radix Salviae Miltiorrhizae, Ramulus Euonymi.In the present invention, Herba Epimedii also claims Herba Epimedii.

According to the pharmaceutical composition of first aspect present invention, it is to be prepared by the Chinese crude drug that comprises following proportioning:

Radix Angelicae Sinensis	10 weight portions,
		Pericarpium Citri Reticulatae	The 1-100 weight portion,
Radix Et Rhizoma Rhei	The 1-100 weight portion,
		The Radix Astragali	The 1-200 weight portion,
The Rhizoma Pinelliae	The 1-200 weight portion,
		Herba Epimedii	The 1-200 weight portion,
Radix Salviae Miltiorrhizae	The 1-300 weight portion,
		Ramulus Euonymi	The 1-300 weight portion.

In an embodiment of the above-mentioned pharmaceutical composition for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Pericarpium Citri Reticulatae is 2-75 weight portion, 3-50 weight portion, 4-40 weight portion, 5-30 weight portion, 5-20 weight portion, 5-15 weight portion, 8-12 weight portion or about 10 weight portions.

In an embodiment of the above-mentioned pharmaceutical composition for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Radix Et Rhizoma Rhei is 2-75 weight portion, 3-50 weight portion, 4-40 weight portion, 5-30 weight portion, 5-20 weight portion, 5-15 weight portion, 8-12 weight portion or about 10 weight portions.

In an embodiment of the above-mentioned pharmaceutical composition for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of the Radix Astragali is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions.

In an embodiment of the above-mentioned pharmaceutical composition for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of the Rhizoma Pinelliae is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions.

In an embodiment of the above-mentioned pharmaceutical composition for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Herba Epimedii is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions.

In an embodiment of the above-mentioned pharmaceutical composition for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Radix Salviae Miltiorrhizae is 2-250 weight portion, 3-200 weight portion, 4-175 weight portion, 5-150 weight portion, 10-100 weight portion, 15-75 weight portion, 20-50 weight portion, 25-40 weight portion or about 30 weight portions.

In an embodiment of the above-mentioned pharmaceutical composition for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Ramulus Euonymi is 2-250 weight portion, 3-200 weight portion, 4-175 weight portion, 5-150 weight portion, 10-100 weight portion, 15-75 weight portion, 20-50 weight portion, 25-40 weight portion or about 30 weight portions.

Radix Angelicae Sinensis	10 weight portions,
		Pericarpium Citri Reticulatae	The 2-75 weight portion,
Radix Et Rhizoma Rhei	The 2-75 weight portion,
		The Radix Astragali	The 2-150 weight portion,
The Rhizoma Pinelliae	The 2-150 weight portion,
		Herba Epimedii	The 2-150 weight portion,
Radix Salviae Miltiorrhizae	The 2-250 weight portion,
		Ramulus Euonymi	The 2-250 weight portion.

Radix Angelicae Sinensis	10 weight portions,
		Pericarpium Citri Reticulatae	The 3-50 weight portion,
Radix Et Rhizoma Rhei	The 3-50 weight portion,
		The Radix Astragali	The 5-75 weight portion,
The Rhizoma Pinelliae	The 5-75 weight portion,
		Herba Epimedii	The 5-75 weight portion,
Radix Salviae Miltiorrhizae	The 5-150 weight portion,
		Ramulus Euonymi	The 5-150 weight portion.

Radix Angelicae Sinensis	10 weight portions,
		Pericarpium Citri Reticulatae	The 5-20 weight portion,
Radix Et Rhizoma Rhei	The 5-20 weight portion,
		The Radix Astragali	The 8-30 weight portion,
The Rhizoma Pinelliae	The 8-30 weight portion,
		Herba Epimedii	The 8-30 weight portion,
Radix Salviae Miltiorrhizae	The 6-50 weight portion,
		Ramulus Euonymi	The 6-50 weight portion.

Radix Angelicae Sinensis

10 weight portions,

Pericarpium Citri Reticulatae	The 5-15 weight portion,
		Radix Et Rhizoma Rhei	The 5-15 weight portion,
The Radix Astragali	The 10-20 weight portion,
		The Rhizoma Pinelliae	The 10-20 weight portion,
Herba Epimedii	The 10-20 weight portion,
		Radix Salviae Miltiorrhizae	The 25-40 weight portion,
Ramulus Euonymi	The 25-40 weight portion.

According to the pharmaceutical composition of first aspect present invention, it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 10 weight portions, Radix Et Rhizoma Rhei 10 weight portions, the Radix Astragali 15 weight portions, the Rhizoma Pinelliae 15 weight portions, Herba Epimedii 15 weight portions, Radix Salviae Miltiorrhizae 30 weight portions, Ramulus Euonymi 30 weight portions.

According to the pharmaceutical composition of first aspect present invention, it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 8 weight portions, Radix Et Rhizoma Rhei 12 weight portions, the Radix Astragali 18 weight portions, the Rhizoma Pinelliae 12 weight portions, Herba Epimedii 15 weight portions, Radix Salviae Miltiorrhizae 25 weight portions, Ramulus Euonymi 35 weight portions.

According to the pharmaceutical composition of first aspect present invention, it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 12 weight portions, Radix Et Rhizoma Rhei 8 weight portions, the Radix Astragali 15 weight portions, the Rhizoma Pinelliae 18 weight portions, Herba Epimedii 12 weight portions, Radix Salviae Miltiorrhizae 35 weight portions, Ramulus Euonymi 25 weight portions.

According to the pharmaceutical composition of first aspect present invention, wherein each medical material directly is used as medicine with medical material or joins in the described pharmaceutical composition after extracting.

According to the pharmaceutical composition of first aspect present invention, wherein each medical material joins in the described pharmaceutical composition after extracting.In one embodiment, described each medical material is through joining in the described pharmaceutical composition after extracting independently of one another or together.In one embodiment, described each medical material is to join in the described pharmaceutical composition after extracting together.In one embodiment, described each medical material is to join in the described pharmaceutical composition after the decocting mode is extracted together.

According to the pharmaceutical composition of first aspect present invention, wherein can also comprise pharmaceutically acceptable carrier.

According to the pharmaceutical composition of first aspect present invention, it prepares basically as follows: each medical material directly is ground into powder, and mix homogeneously randomly adds pharmaceutically acceptable carrier, and get final product.

According to the pharmaceutical composition of first aspect present invention, comprising the extract of each medical material, and optional pharmaceutically acceptable carrier.

According to the pharmaceutical composition of first aspect present invention, it prepares basically as follows: each medical material is used extracted solvent extraction, and extract obtained direct packing, and get final product.

According to the pharmaceutical composition of first aspect present invention, it prepares basically as follows:

(a) each medical material is used the extraction solvent extraction;

(b) extracting solution is concentrated, make thick paste, perhaps further be dried to solids;

(c) step (b) gained thick paste or solids are directly packed, and be get final product; Perhaps randomly add pharmaceutically acceptable carrier, and get final product.

In the present invention; each medical material obtains being directly used in any type of product of preparation preparation (namely no longer extracting operation) (such as being extracting solution, thick paste, dried particles or powder etc. through extraction process separately or together; they not yet add pharmaceutic adjuvant); can be referred to as extract, routine thick paste described above or solids all can be described as extract.

According to the pharmaceutical composition of first aspect present invention, wherein said extraction solvent is water, ethanol or ethanol water.

Pharmaceutical composition according to first aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, ethanol or ethanol water decoct and/or reflux, extract, 1 ~ 5 time (for example 2 ~ 3 times), each 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour), collecting decoction, filter, filtrate decompression is concentrated into the thick paste that relative density is 1.1 ~ 1.5 (25 ° of C) (for example 1.2 ~ 1.4), drying, and get final product.

Pharmaceutical composition according to first aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); Filter, filtrate decompression is concentrated, drying, and get final product.

Pharmaceutical composition according to first aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); Filter, filtrate decompression is condensed into paste; Doubly measure 50 ~ 90% alcohol reflux 2-3 time with 2-5, with ethanol extract in 70-90 ° of C except ethanol, vacuum drying, and get final product.

Pharmaceutical composition according to first aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); It is 1.1 ~ 1.5 (25 ° of C) (for example 1.2 ~ 1.4) that decocting liquid is concentrated into relative density, adds 95% ethanol to concentration of alcohol and reaches 70%, and placement is spent the night, filter, and concentrated filtrate, drying, and get final product.

Second aspect present invention also provides following medicinal materials to be combined in for the preparation of the purposes in the medicine of prevention, improvement or treatment kidney disease or disease: Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Radix Et Rhizoma Rhei, the Radix Astragali, the Rhizoma Pinelliae, Herba Epimedii, Radix Salviae Miltiorrhizae, Ramulus Euonymi.

Second aspect present invention also provides following medicinal materials to be combined in for the preparation of the purposes in the medicine of prevention, improvement or treatment nephropathy and complication or symptom: Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Radix Et Rhizoma Rhei, the Radix Astragali, the Rhizoma Pinelliae, Herba Epimedii, Radix Salviae Miltiorrhizae, Ramulus Euonymi.Described nephropathy and complication thereof or symptom are such as but not limited to chronic renal failure, peritoneal fibrosis, because of peritoneal fibrosis due to the extrinsic factor (for example peritoneal dialysis), renal hypofunction, because of water, electrolyte and acid base imbalance due to the nephropathy.

Second aspect present invention also provides following medicinal materials to be combined in for the preparation of the purposes in the medicine for the treatment of chronic renal failure and/or prevention or treatment peritoneal fibrosis: Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Radix Et Rhizoma Rhei, the Radix Astragali, the Rhizoma Pinelliae, Herba Epimedii, Radix Salviae Miltiorrhizae, Ramulus Euonymi.

Second aspect present invention also provides following medicinal materials to be combined in for the preparation of improving the patients undergoing peritoneal dialysis life quality and/or delaying purposes in the medicine of genesis of peritoneal fibrosis:

According to the purposes of second aspect present invention, wherein said medicine is to be prepared by the Chinese crude drug that comprises following proportioning:

In an embodiment of the above-mentioned medicine for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Pericarpium Citri Reticulatae is 2-75 weight portion, 3-50 weight portion, 4-40 weight portion, 5-30 weight portion, 5-20 weight portion, 5-15 weight portion, 8-12 weight portion or about 10 weight portions.

In an embodiment of the above-mentioned medicine for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Radix Et Rhizoma Rhei is 2-75 weight portion, 3-50 weight portion, 4-40 weight portion, 5-30 weight portion, 5-20 weight portion, 5-15 weight portion, 8-12 weight portion or about 10 weight portions.

In an embodiment of the above-mentioned medicine for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of the Radix Astragali is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions.

In an embodiment of the above-mentioned medicine for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of the Rhizoma Pinelliae is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions.

In an embodiment of the above-mentioned medicine for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Herba Epimedii is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions.

In an embodiment of the above-mentioned medicine for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Radix Salviae Miltiorrhizae is 2-250 weight portion, 3-200 weight portion, 4-175 weight portion, 5-150 weight portion, 10-100 weight portion, 15-75 weight portion, 20-50 weight portion, 25-40 weight portion or about 30 weight portions.

In an embodiment of the above-mentioned medicine for preparing in 10 weight portion Radix Angelicae Sinensis, wherein the amount of Ramulus Euonymi is 2-250 weight portion, 3-200 weight portion, 4-175 weight portion, 5-150 weight portion, 10-100 weight portion, 15-75 weight portion, 20-50 weight portion, 25-40 weight portion or about 30 weight portions.

Radix Angelicae Sinensis	10 weight portions,
		Pericarpium Citri Reticulatae	The 5-15 weight portion,
Radix Et Rhizoma Rhei	The 5-15 weight portion,

The Radix Astragali	The 10-20 weight portion,
		The Rhizoma Pinelliae	The 10-20 weight portion,
Herba Epimedii	The 10-20 weight portion,
		Radix Salviae Miltiorrhizae	The 25-40 weight portion,
Ramulus Euonymi	The 25-40 weight portion.

According to the purposes of second aspect present invention, wherein said medicine is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 10 weight portions, Radix Et Rhizoma Rhei 10 weight portions, the Radix Astragali 15 weight portions, the Rhizoma Pinelliae 15 weight portions, Herba Epimedii 15 weight portions, Radix Salviae Miltiorrhizae 30 weight portions, Ramulus Euonymi 30 weight portions.

According to the purposes of second aspect present invention, wherein said medicine is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 8 weight portions, Radix Et Rhizoma Rhei 12 weight portions, the Radix Astragali 18 weight portions, the Rhizoma Pinelliae 12 weight portions, Herba Epimedii 15 weight portions, Radix Salviae Miltiorrhizae 25 weight portions, Ramulus Euonymi 35 weight portions.

According to the purposes of second aspect present invention, wherein said medicine is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 12 weight portions, Radix Et Rhizoma Rhei 8 weight portions, the Radix Astragali 15 weight portions, the Rhizoma Pinelliae 18 weight portions, Herba Epimedii 12 weight portions, Radix Salviae Miltiorrhizae 35 weight portions, Ramulus Euonymi 25 weight portions.

According to the purposes of second aspect present invention, wherein each medical material directly is used as medicine with medical material or joins in the described medicine after extracting.

According to the purposes of second aspect present invention, wherein each medical material joins in the described medicine after extracting.In one embodiment, described each medical material is through joining in the described medicine after extracting independently of one another or together.In one embodiment, described each medical material is to join in the described medicine after extracting together.In one embodiment, described each medical material is to join in the described medicine after the decocting mode is extracted together.

According to the purposes of second aspect present invention, can also comprise pharmaceutically acceptable carrier in the wherein said medicine.

According to the purposes of second aspect present invention, wherein said medicine prepares basically as follows: each medical material directly is ground into powder, and mix homogeneously randomly adds pharmaceutically acceptable carrier, and get final product.

According to the purposes of second aspect present invention, wherein said medicine comprises the extract of each medical material, and optional pharmaceutically acceptable carrier.

According to the purposes of second aspect present invention, wherein said medicine prepares basically as follows: each medical material is used extracted solvent extraction, and extract obtained direct packing, and get final product.

According to the purposes of second aspect present invention, wherein said medicine prepares basically as follows:

(a) each medical material is used the extraction solvent extraction;

According to the purposes of second aspect present invention, wherein said extraction solvent is water, ethanol or ethanol water.

Purposes according to second aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, ethanol or ethanol water decoct and/or reflux, extract, 1 ~ 5 time (for example 2 ~ 3 times), each 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour), collecting decoction, filter, filtrate decompression is concentrated into the thick paste that relative density is 1.1 ~ 1.5 (25 ° of C) (for example 1.2 ~ 1.4), drying, and get final product.

Purposes according to second aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); Filter, filtrate decompression is concentrated, drying, and get final product.

Purposes according to second aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); Filter, filtrate decompression is condensed into paste; Doubly measure 50 ~ 90% alcohol reflux 2-3 time with 2-5, with ethanol extract in 70-90 ° of C except ethanol, vacuum drying, and get final product.

Purposes according to second aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); It is 1.1 ~ 1.5 (25 ° of C) (for example 1.2 ~ 1.4) that decocting liquid is concentrated into relative density, adds 95% ethanol to concentration of alcohol and reaches 70%, and placement is spent the night, filter, and concentrated filtrate, drying, and get final product.

Third aspect present invention provides the method for preparing the described pharmaceutical composition of first aspect present invention, it comprises the steps: that with each pulverizing medicinal materials the gained powder directly forms pharmaceutical composition as pharmaceutical composition or after randomly mixing with pharmaceutically acceptable carrier; Perhaps, with each pulverizing medicinal materials, the gained powder obtains extract through extraction, and this extract directly forms pharmaceutical composition as pharmaceutical composition or after randomly mixing with pharmaceutically acceptable carrier.

According to the method for third aspect present invention, wherein each medical material joins in the described pharmaceutical composition after extracting.In one embodiment, described each medical material is through joining in the described pharmaceutical composition after extracting independently of one another or together.In one embodiment, described each medical material is to join in the described pharmaceutical composition after extracting together.In one embodiment, described each medical material is to join in the described pharmaceutical composition after the decocting mode is extracted together.

According to the method for third aspect present invention, wherein said pharmaceutical composition prepares basically as follows: each medical material directly is ground into powder, and mix homogeneously randomly adds pharmaceutically acceptable carrier, and get final product.

According to the method for third aspect present invention, wherein said pharmaceutical composition comprises the extract of each medical material, and optional pharmaceutically acceptable carrier.

According to the method for third aspect present invention, wherein said pharmaceutical composition prepares basically as follows: each medical material is used extracted solvent extraction, and extract obtained direct packing, and get final product.

According to the method for third aspect present invention, wherein said pharmaceutical composition prepares basically as follows:

(a) each medical material is used the extraction solvent extraction;

According to the method for third aspect present invention, wherein said extraction solvent is water, ethanol or ethanol water.

Method according to third aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, ethanol or ethanol water decoct and/or reflux, extract, 1 ~ 5 time (for example 2 ~ 3 times), each 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour), collecting decoction, filter, filtrate decompression is concentrated into the thick paste that relative density is 1.1 ~ 1.5 (25 ° of C) (for example 1.2 ~ 1.4), drying, and get final product.

Method according to third aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); Filter, filtrate decompression is concentrated, drying, and get final product.

Method according to third aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); Filter, filtrate decompression is condensed into paste; Doubly measure 50 ~ 90% alcohol reflux 2-3 time with 2-5, with ethanol extract in 70-90 ° of C except ethanol, vacuum drying, and get final product.

Method according to third aspect present invention, wherein said extract is the extract according to the method preparation that comprises the steps: get each medical material, pulverize, add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) water, about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); It is 1.1 ~ 1.5 (25 ° of C) (for example 1.2 ~ 1.4) that decocting liquid is concentrated into relative density, adds 95% ethanol to concentration of alcohol and reaches 70%, and placement is spent the night, filter, and concentrated filtrate, drying, and get final product.

Fourth aspect present invention provides the treatment chronic renal failure, and/or the method for prevention or treatment peritoneal fibrosis, and the method comprises the pharmaceutical composition to the first aspect present invention of the administration effective dose that needs are arranged.

Arbitrary embodiment of applicable equally other the arbitrary embodiment of arbitrary technical characterictic that arbitrary embodiment of either side of the present invention or this either side has or other either side, as long as they can be not conflicting, certainly at where applicable each other, necessary words can be done suitably to modify to individual features.The below is further described with characteristics to various aspects of the present invention.

All documents that the present invention quotes from, their full content is incorporated this paper by reference into, and if the expressed implication of these documents and the present invention when inconsistent, be as the criterion with statement of the present invention.In addition, various terms and phrase that the present invention uses have the general sense of well known to a person skilled in the art, nonetheless, the present invention still wishes at this these terms and phrase to be described in more detail and to explain, the term of mentioning and phrase are as the criterion with the implication that the present invention was explained if any inconsistent with known implication.

In the present invention, term " pharmaceutical composition (it also can be described as " compositions " in the present invention) " or " medicine ", it is the dosage form of oral or drug administration by injection.In one embodiment, described pharmaceutical composition is the form of tablet, capsule, granule, pill, oral solutions, injection (liquid drugs injection and/or powder pin) etc.

In the present invention, term " extraction " can be the dipping under the room temperature, or extraction at elevated temperatures (for example decoct and/or reflux), the perhaps combination of these modes of operation.Can further include extract is further processed, for example further carry out purification, such as desolventize, to remove impurity by means of precipitation matter, solvent extraction, resin absorption separation etc.

As described herein, term " extract " will comprise the extract of any purity that can be used in the present invention purpose, spirit is appreciated that the dna purity of extract of the present invention can change in the larger context to those skilled in the art according to the present invention.The extract that obtains of each medicinal material extract of the present invention for example, difference according to different process conditions, the total medical material of 1kg is through extracting the arbitrary amount between the 10g to 500g that can obtain (10g to 200g for example, 20g to 200g for example, 50g to 200g for example) that is the extract of different purity, those skilled in the art can according to different needs, allocate the compositions that is fit to needs with the extract of different purity.In some embodiments of the present invention, described extract can be called extract powder.

In the present invention, can use the present composition of effective dose to be applied to the tested individuality that needs are arranged.As described herein, term " effective dose " refers to realize preventing and/or treating the purpose dosage of situation of the present invention, obstacle, disease or disease in the experimenter.Those skilled in the art can easily determine the using dosage of the present composition according to the context of the invention.Especially, this is according to the present invention, term " effective dose " can be understood as the present composition with reasonable effect/risk of being applicable to any therapeutic treatment and/or prevention than the q.s that treats and/or prevents described situation, obstacle, disease or disease.But the total consumption per day that it should be understood that the present composition can maked decision in the medical judgment scope reliably by those skilled in the art.For any concrete experimenter, the concrete horizontal fibrous root of prevention effective dose is decided according to many factors, and described factor comprises experimenter's age, body weight, general health situation, sex and diet; The concrete compositions that adopts; Other therapeutic active substance that is used in combination or uses simultaneously with the present composition; And the known similar factor of medical field.

The invention provides and comprise the compositions formulated together with one or more nontoxic physiology's acceptable carriers.Described compositions can be mixed with especially specially with solid or the liquid form confession is Orally administered or the confession rectal administration, perhaps is mixed with for injection and uses.

Include but not limited to capsule, tablet, pill, powder and granule for Orally administered solid dosage forms.In this type of solid dosage forms, reactive compound can be accepted excipient or carrier such as sodium citrate or dicalcium phosphate and/or following material with the physiology of at least a inertia and mix: a) filler or extender such as starch, lactose, sucrose, glucose, mannitol and silicic acid; B) binding agent such as carboxymethyl cellulose, alginate, gelatin, polyvinylpyrrolidone, sucrose and Radix Acaciae senegalis; C) wetting agent such as glycerol; D) disintegrating agent such as agar, calcium carbonate, Rhizoma Solani tuber osi or tapioca, alginic acid, some silicate and sodium carbonate; E) solution blocker such as paraffin; F) absorb accelerator such as quaternary ammonium compound; G) wetting agent such as spermol and glyceryl monostearate; H) adsorbent such as Kaolin and bentonite and i) lubricant such as Pulvis Talci, calcium stearate, magnesium stearate, solid polyethylene glycol, sodium lauryl sulphate and their mixture.In the situation of capsule, tablet and pill, also can comprise buffer agent in the described dosage form.

Comprise the acceptable Emulsion of physiology, solution, suspensoid, syrup and elixir for Orally administered liquid dosage form.Liquid dosage form also can contain this area inert diluent commonly used except containing active component, for example water or other solvents, solubilizing agent and emulsifying agent be ethanol, isopropyl alcohol, ethyl carbonate, ethyl acetate, benzylalcohol, benzyl benzoate, propylene glycol, 1,3 butylene glycol, dimethyl formamide, oils (particularly Oleum Gossypii semen, Oleum Arachidis hypogaeae semen, Semen Maydis oil, germ oil, olive oil, Oleum Ricini and Oleum sesami), glycerol, oxolane alcohol, Polyethylene Glycol and the fatty acid ester of sorbitan and their mixture for example.

In one embodiment of the invention, the pharmaceutical composition of each single dose is that medical material by following deal prepares through decocting, concentrated process: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 10g, Radix Et Rhizoma Rhei 10g, Radix Astragali 15g, Rhizoma Pinelliae 15g, Herba Epimedii 15g, Radix Salviae Miltiorrhizae 30g, Ramulus Euonymi 30g.

The described pharmaceutical composition of first aspect present invention granule can be prepared into, wherein the acceptable adjuvant of pharmacy can be randomly added.In the present invention, this granule can be called and hold up the kidney granule.

The inventor finds by clinical research, takes the incidence rate that Chinese medicine holds up the patients undergoing peritoneal dialysis of kidney granule ultrafiltration decline, malnutrition and peritonitis to occur and is far smaller than the patient who does not take Chinese medicine.The generation basis of peritoneal dialysis dependency peritoneal fibrosis is uremia, and its pathogenic characteristic is deficiency in origin and excess in superficiality, namely has simultaneously the pathological factors such as wet, poison, the stasis of blood, heat on the basis of deficiency of spleen and stomach, insufficiency of vital energy and blood.In addition, because of the life-time service glucose dialysis, near diabetes, namely the deficiency of YIN is with wet, poison, the stasis of blood, heat and see for the impact of peritoneum.Therefore, study according to the two total pathological factor, select a kind of effective Chinese medicine preparation, must have special income for the generation of intervening the relevant peritoneal fibrosis of peritoneal dialysis.

Therefore, this causes the basic factor of the saturating patient's ultrafiltration of long-range abdomen depletion for peritoneal fibrosis for we, the performance TCM Features, using Chinese medicine furthers investigate, the mechanism of intervening the relevant cell factor effect of peritoneal fibrosis to explore Chinese medicine is developed the thoroughly compound Chinese medicinal preparation of relevant peritoneal fibrosis of non-intraperitoneal administration control abdomen.

Patients undergoing peritoneal dialysis is many by due to the chronic kidney hypofunction, its course of disease delay, and to many positive QI-insufficiency of peritoneal dialysis stage, the domination of pathogen is reluctant to leave, thus must be prudent during using drugs to form a prescription, belong to sweet temperature because the product of QI invigorating, help the suspicion of heat; The product of yin nourishing have more to be grown greasyly, has and gives birth to wet fraud of loving heresy, and sweet temperature, grow to be bored with and easily check again mechanism of qi.And that purging FU-organs is let out is turbid, and the product of blood circulation promoting and blood stasis dispelling have the hot logical property of bitter cold more, with it improper yin-damaging and Qi consuming that is easy to.Just do not hinder righting and do not stay the evil principles of formulating prescriptions so must follow eliminating evil during combination drug.

In the present invention, to hold up the kidney granule to separate as the ingredients of typical pharmaceutical composition, side and pharmacological action can be described as follows:

(1) hold up the kidney granule mainly to be comprised of Chinese medicines such as the Radix Astragali, Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, the Rhizoma Pinelliae, Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizaes, the side of sending is take invigorating spleen and kidney, benefiting QI and nourishing blood group medicine as monarch drug; Blood circulation promoting and blood stasis dispelling, eliminating evil detoxifcation group medicine are ministerial drug; To make as helping altogether with middle the turbid descending group medicine, mainly share the merit of playing altogether benefiting QI and nourishing blood, dissolving blood stasis and detoxication and middle sending down the abnormal ascending QI in addition.Have benefiting QI and nourishing blood and middle the turbid descending, promoting blood circulation and detoxication function.This prescription confirms to improve renal function and the caused clinical symptoms of many renal failures, sign through clinical and experimentation, simultaneously, for improving the patients undergoing peritoneal dialysis life quality, delay the patients undergoing peritoneal dialysis peritoneal fibrosis and occur that clear and definite curative effect is all arranged, and safety is good.

(2) Radix Astragali is classified as top grade take tonify deficiency as main in the side by Shennong's Herbal.Be usually used in asthenia with the passing of time, low, the thready pulse without strength person of speech." book on Chinese herbal medicine meets former " carries that " Radix Astragali can all void of tonifying five ZANG-organs, controls the stringy pulse spontaneous perspiration, rushes down YIN-fire, removes lung-heat, losslessly then sends out, and has antiperspirant then to end." Radix Astragali tool and mending and oiliness characteristics.Radix Angelicae Sinensis is warm in nature, sweet in the mouth, suffering.Having enriches blood invigorates blood circulation, menstruction regulating and pain relieving, the effect of loosening bowel to relieve constipation." book on Chinese herbal medicine is just ": " so specially can enrich blood, its gas is light and hot for Radix Angelicae Sinensis, its sweet in the mouth and weighing, thus again can promoting the circulation of blood, invigorating middle warmer has, in the row benefit is arranged, the sincere gas medicine in the blood, and also the panacea in the blood is also.About mending to mend then of assistant, thus can support nutrition blood, the QI invigorating spermatogenesis, settling five organs, body by force, beneficial mind, all tangible deficient diseases, nothing is unsuitable.Assistant logical to attack then, so the pain relieving constipation of dispelling, relieving rigidity of muscles and joints is controlled contracture, paralysis, the card such as dry, puckery." share altogether and to be monarch drug, with the deficiency of qi and blood of tonifying five ZANG-organs, to help kidney qi.

(3) how double simultaneously again chronic renal failure is take void as this, but see that middle burnt taste become estranged, and accumulates in the turbid pathogen, so send again Pericarpium Citri Reticulatae, the Rhizoma Pinelliae 2 product.Pericarpium Citri Reticulatae acrid in the mouth, hardship, warm in nature, enter spleen, lung meridian, have the effect of " regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm ".Compendium of Material Medica cloud: " then mend with tonic, then rush down with cathartic, then rise with Hydrargyri Oxydum Rubrum, then fall with falling medicine.Spleen is the mother of Primordial Qi, and lung is the label of taking the photograph gas, so Pericarpium Citri tangerinae is two medicines through edema caused by disorder of QI, but with join and the reinforcing and reducing lifting also." Rhizoma Pinelliae head is stated from Shennong's Herbal, is listed in low-grades.It is warm in nature, and acrid in the mouth is poisonous, returns spleen, stomach, lung meridian.Effect with drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.Share altogether and to be ministerial drug, with middle the turbid descending, auxiliary monarch drug is cured the disease and is become this.

(4) primary disease course of disease delay belongs to pathogen usually intruding into collateral in protracted disease, its essence is the pertinacious disease that refers to that some prolonged illness difficulties heal, and treatment needs to use collateral dredging method, the method for namely dredging the network road.Select the Radix Salviae Miltiorrhizae of eliminating blood stasis to promote regeneration of blood, this medicine is bitter, is slightly cold, and enters conscience kidney three warps, has stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, the merit of the relieving restlessness that clears away heart-fire.Radix Salviae Miltiorrhizae begins to be stated from Shennong's Herbal, classifies as top grade." herbal classic " cloud: Radix Salviae Miltiorrhizae " main trusted subordinate's pathogen, borborygmus are faint, and cold and heat gather as leaking water, and broken disease is ended stuffy sensation with restlessness, QI invigorating except abdominal mass." Radix Et Rhizoma Rhei, property is bitter, and is cold.Return spleen, stomach, large intestine, liver, pericardium channel.Has purging heat and dredging bowels, removing pathogenic heat from blood and toxic substance from the body, the effect of eliminating blood stasis and inducing menstruation." not Lu " " expectorant is real for flat stomach, the therapeutic method to keep the adverse QI flowing downwards, stagnation of pathogenic heat between intestinal, trusted subordinate's distension, the cold blood of woman closes swollen, lower abdominal pain, all old blood stays knot." " Japan hanako materia medica " " sharp joint is let out and is moulded stagnant, aqueous vapor for logical all gas of a surname, blood circulation regulating, the extremity unbalanced cold and heat, and warm miasma heat-phlegm, sharp defecation, and apply all furuncle carbuncle poison." Radix Et Rhizoma Rhei rushes down and exert oneself to delay, and lays particular stress on eliminating fire and detoxication.Two medicines and usefulness are played altogether assistant and are made it merit, stay and the pathogenesis that do not become for the dead blood of pathogen usually intruding into collateral in protracted disease pertinacious phlegm, and with promoting tissue regeneration by removing blood stasis, purging FU-organs is let out turbid.

(5) all medicines share, can replenish spleen kidney etc. dirty be not enough to righting, can remove again the pathogenic factor such as turbid damp in the body, blood stasis with eliminating evil, thereby reach strengthening vital QI to eliminate pathogenic factors, the purpose for the treatment of both the principal and secondary aspects of a disease.

In the present invention, to hold up the kidney granule can be described as follows as the modern pharmacology analysis of typical pharmaceutical composition:

(a) Astragalus strengthening the body resistance, invigorating the spleen and replenishing QI class Chinese medicine, the Radix Astragali is many-sided to the therapeutical effect of chronic kidney hypofunction, and is comprehensive.The Radix Astragali contains coumarin, flavone compound, Saponin and micro-folic acid and several vitamin.Modern medicine study shows that the Radix Astragali includes and multiple antibiotic effective ingredient, and the immunologic function of energy enhancing body, therefore can also be used for the generation of some infectious disease of prevention.The prevent and treat aspect of astragalus extraction composition for glomerular sclerosis explained in many researchs, and think that its damage possible mechanisms for renal tubular interstitium is: matter monocyte chemoattractant protein-1 (MCP-1) was expressed between (1) downward modulation renal tubules reached, thereby directly alleviate the inflammatory cells such as mononuclear phagocyte in renal tubules, the gathering of a matter, activation, alleviate RIF-3; (2) make renal tubular interstitium TGF-β 1 and β ig-h3 (downstream molecules of TGF-β 1 and activation index now are confirmed that it is a kind of ECM composition) albumen and obviously downward modulation 24 of mrna expression; (3) induce increase people kidney Stromal fibroblasts to express C-MET HGFr C-met, thus the effect of performance protection renal tubules, anti-RIF.

(b) Radix Angelicae Sinensis contains basic lactone, n-butene acyl lactone, ferulic acid, nicotinic acid, sucrose and several amino acids, and sesquiterpenoids etc.At the fibrosis therapeutical effect of the correlational study that two medicines are shared by animal experimental observation herbal mixture astragalus angelica mixture, think this medicine the Main Function link of the onset time in the lysis and different phase be from pathological changes in early days, can be by reducing inflammatory cell reaction and TGF-β 1 expression-secretion, reduce the intrinsic cell transformation of kidney, differentiation and extracellular matrix components deposition, alleviate kidney region fibrosis and improve renal function.

(c) Pericarpium Citri Reticulatae, the Rhizoma Pinelliae are clinical herbal pair.Pericarpium Citri Reticulatae is the dry mature skin of rutaceae orange and congener thereof, and acrid in the mouth warm in nature is bitter, has the effect of regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm, and main component has Nobiletin, Hesperidin, contains limonene etc. in the Pericarpium Citri Reticulatae volatile oil.The Rhizoma Pinelliae is the tuber of the aroid Rhizoma Pinelliae, acrid in the mouth warm in nature, poisonous, have the effects such as drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass, main component has choline, cupreol-D-Glucose glycoside, after the hydrolysis the compositions such as ephedrine, polysaccharide, pinellin, tannin, also separablely from the Rhizoma Pinelliae go out glucosan.Pericarpium Citri Reticulatae has some similar or close pharmacological action with the Rhizoma Pinelliae, and can mutually replenish again.The two all has the effects such as eliminating phlegm and relieving cough is relievingd asthma, antiinflammatory, antiulcer, enhancing immunologic function, function of gallbladder promoting, and cardiovascular function is had certain influence.But Pericarpium Citri Reticulatae extract also gastrointestinal peristalsis inhibition, eliminate oxygen-derived free radicals, prevent sperm deformity; The various preparations that the Rhizoma Pinelliae is concocted have certain town to tell effect, in addition in addition anticancer, short cell division, antileukemie effect of the Rhizoma Pinelliae, and Rhizoma Pinelliae Preparata total alkali extract has inhibitory action to the growth of chronic myelogenous leukemia cell.

(d) water-soluble components of Radix Salviae Miltiorrhizae has significant inhibitory action to the important substance-methylguanidine of uremic toxins.Pharmacological evaluation shows, this composition has Renal Glomeruli In Rats, the renal tubular function of good raising ARF, it is active to improve nephridial tissue SOO, CAT, suppress the generation of lipid peroxide, infer accordingly this composition the mechanism of action may with resistant activity oxygen, it is relevant to improve active oxygen elimination enzymatic activity, has also improved the probability for the treatment of this method of ARF with the method for Scavenger of ROS simultaneously.In addition, Radix Salviae Miltiorrhizae can improve hemodynamic by permeable pressure head inside and outside improving blood capillary, reduces blood pressure, and improves renal function thereby improve renin angiotensin aldosterone system etc.Radix Salviae Miltiorrhizae can improve the Renal Glomeruli In Rats filtration rate decline that ciclosporin A is induced, and increases the drainage of N-acetyl-β-D-glucosaminidase (NAG) in the urine, lowers the expression of TGF-β 1 in the kidney, thereby alleviates kidney region fibrosis and small artery pathological changes.

(e) Radix Rehmanniae Preparata contains catalpol, rehmanin, mannitol, retinoid material, saccharide and aminoacid etc.Research in nearly 2 years has further deeply confirmed that Radix Et Rhizoma Rhei can effectively prevent and treat chronic renal failure (CRF), and is closely related with its main active chrysophanic acid, emodin.Emodin can suppress kidney Stromal fibroblasts (RIFS) propagation, induces its apoptosis, and can suppress various kinds of cell somatomedin and ECM composition; Chrysophanic acid can reverse renal cells (RTEC) hypertrophy that TGF-β 1 induces, and the ECM that suppresses its stimulation is synthetic, and can be active by downward modulation NF-KB (can induce various inflammatory reactions to start factor expression), Caspase-3, alleviates the RTEC apoptosis; The RIFS propagation that also can stop simultaneously TGF-β 1 to induce, and can suppress TGF-β 1 and activate the expression of RIFS and its fibronectin that causes (FN) of antagonism with synthetic.

In the present invention, to hold up the kidney granule to have the relevant peritoneal fibrosis of peritoneal dialysis through clinical research confirmation as typical pharmaceutical composition, it may mechanism of action be: 1. moving glucose dialysis can induce peritoneal tissues TGF-β 1 obviously to raise, peritoneum TGF-β 1 high expressed and peritoneal dialysis peritoneal fibrosis are closely related, hold up the kidney granule by directly reducing Serum of Peritoneal Dialysis Patients TGF-β 1 level, delay the peritoneal fibrosis process.2. CTGF is an important downstream factor of mediation TGF-β 1 short fibrosis effect, and TGF-β 1 can make HPMC express CTGF to increase, and the effect of CTGF is confined to Fibrotic generation more.Hold up the kidney granule by suppressing TGF-β 1 level, indirectly suppress generation and the expression of CTGF, delay peritoneal fibrosis.3. by the improvement to inflammatory conditions, lower the serum levels of inflammatory factor IL-6, the inflammatory cells such as inhibition macrophage are assembled at peritoneum, suppress progression of fibrosis.4. raise the serum HGF level, thereby suppress the level of TGF-β 1, reduce simultaneously the activity of the synthetic of extracellular matrix and inhibition PAI-1, prevented gathering of extracellular matrix, the control peritoneal fibrosis.5. raise serum BMP-7 level, anti-TGF-beta 1 short of money is expressed, the control peritoneal fibrosis.

In the present invention, be applicable to chronic renal failure to hold up the kidney granule as the therapeutic domain of typical pharmaceutical composition, clinical efficacy shows as and slows down renal hypofunction, corrects water, electrolyte and acid base imbalance.Be applicable to the end stagerenaldisease patients undergoing peritoneal dialysis, clinical efficacy shows as and improves the patients undergoing peritoneal dialysis life quality, delays the genesis of peritoneal fibrosis.

Some English initialisms that the present invention uses gather as follows:

Dummy suffix notation	Chinese	Dummy suffix notation	Chinese
				AGEs	Advanced glycation end products	ESRD	End stagerenaldisease
ALB	Albumin	FN	Fibronectin
				AQP1	Aquaporin	GFR	Glomerular filtration rate
bFGF	BFGF	HGB	Hemoglobin
				BMP-7	Bone morphogenetic protein-7	HGF	Hepatocyte growth factor
BUN	Blood urea nitrogen	IL-6	Interleukin-6
				Ca	Calcium	P	Phosphorus
CAPD	Continue non-bed peritoneal dialysis	PD	Peritoneal dialysis
				Ccr	Endogenous creatinine clearance rate	PET	Peritoneal equilibrium test
CTGF	Connective Tissue Growth Factor	PF	Peritoneal fibrosis
				Scr	Serum creatinine	PMCs	Peritoneal Mesothelial Cells
TGF-β1	Transforming growth factor-beta 1	RRF	Residual renal function
				VEGF	VEGF	UFF	Ultrafiltration is depleted
LPDS	Without lipoprotein serum	KDTA	Nephropathy and dialysis related quality of life

Description of drawings

Fig. 1 has described rat peritoneum Pathomorphologic observation result.

The specific embodiment

Further specify the present invention below by specific embodiment/experimental example, still, should be understood to, these embodiment and experimental example are only used for the more detailed usefulness that specifically describes, and should not be construed as for limiting in any form the present invention.The present invention carries out generality and/or concrete description to the material and the test method that use in the test.Although for realizing that the employed many materials of the object of the invention and operational approach are well known in the art, the present invention still does to describe in detail as far as possible at this.It will be apparent to those skilled in the art that hereinafter, if do not specify that material therefor of the present invention and operational approach are well known in the art.

A, Preparation Example part

Embodiment 1: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 75g, Radix Et Rhizoma Rhei 2g, Radix Astragali 150g, Rhizoma Pinelliae 2g, Herba Epimedii 150g, Radix Salviae Miltiorrhizae 2g, Ramulus Euonymi 250g.

Method for making: get each medical material of above-mentioned prescription, be ground into powder, encapsulated, every heavy 0.3g, and get final product.

Embodiment 2: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 2g, Radix Et Rhizoma Rhei 75g, Radix Astragali 2g, Rhizoma Pinelliae 150g, Herba Epimedii 2g, Radix Salviae Miltiorrhizae 250g, Ramulus Euonymi 2g.

Method for making: get each medical material of above-mentioned prescription, be ground into the powder of 80 mesh sieves, add the Mel of 1/5 weight portion, make piller, the about 0.1g of every ball, and get final product.

Embodiment 3: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 3g, Radix Et Rhizoma Rhei 50g, Radix Astragali 5g, Rhizoma Pinelliae 75g, Herba Epimedii 5g, Radix Salviae Miltiorrhizae 150g, Ramulus Euonymi 5g.

Embodiment 4: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 50g, Radix Et Rhizoma Rhei 3g, Radix Astragali 75g, Rhizoma Pinelliae 5g, Herba Epimedii 75g, Radix Salviae Miltiorrhizae 5g, Ramulus Euonymi 150g.

Embodiment 5: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 5g, Radix Et Rhizoma Rhei 20g, Radix Astragali 8g, Rhizoma Pinelliae 30g, Herba Epimedii 8g, Radix Salviae Miltiorrhizae 50g, Ramulus Euonymi 6g.

Method for making: get each medical material of above-mentioned prescription, add the decocting 1 hour of 8 times of amounts, filter; Filtering residue adds the decocting 1 hour of 5 times of amounts again, filters; Collecting decoction, being concentrated into relative density is 1.15 ~ 1.25 (25 ° of C), adds saccharin sodium 0.1%, fill and get final product to vial.

Embodiment 6: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 20g, Radix Et Rhizoma Rhei 5g, Radix Astragali 30g, Rhizoma Pinelliae 8g, Herba Epimedii 30g, Radix Salviae Miltiorrhizae 6g, Ramulus Euonymi 50g.

Method for making: get each medical material of above-mentioned prescription, add the decocting 1 hour of 8 times of amounts, filter; Filtering residue adds the decocting 1 hour of 5 times of amounts again, filters; Collecting decoction, being concentrated into relative density is 1.15 ~ 1.25 (25 ° of C), spray drying gets extract powder, the starch of the weight such as adding and this extract powder, mix homogeneously, encapsulated, be pharmaceutical composition of the present invention.

Embodiment 7: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 5g, Radix Et Rhizoma Rhei 5g, Radix Astragali 10g, Rhizoma Pinelliae 10g, Herba Epimedii 10g, Radix Salviae Miltiorrhizae 25g, Ramulus Euonymi 25g.

Method for making: get each medical material of above-mentioned prescription, add the decocting 1 hour of 8 times of amounts, filter; Filtering residue adds the decocting 1 hour of 5 times of amounts again, filters; Collecting decoction, being concentrated into relative density is 1.15 ~ 1.25 (25 ° of C), adds 95% ethanol to determining alcohol and reaches 70%, hold over night, filter, the filtrate spray drying gets extract powder, adds the sucrose of 2 times of weight of this extract powder, mix homogeneously, granulate, obtain granule, be pharmaceutical composition of the present invention.

Embodiment 8: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 15g, Radix Et Rhizoma Rhei 15g, Radix Astragali 20g, Rhizoma Pinelliae 20g, Herba Epimedii 20g, Radix Salviae Miltiorrhizae 40g, Ramulus Euonymi 40g.

Method for making: get each medical material of above-mentioned prescription, add the decocting 1 hour of 6 times of amounts, filter; Filtering residue adds the decocting 1 hour of 6 times of amounts again, filters; Collecting decoction, being concentrated into relative density is 1.15 ~ 1.25 (25 ° of C), spray drying gets extract powder; Get 1 part of above extract powder, add 2 parts of starch, 2 parts of microcrystalline Cellulose, mix homogeneously, encapsulated, be pharmaceutical composition of the present invention.

Embodiment 9: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 10g, Radix Et Rhizoma Rhei 10g, Radix Astragali 15g, Rhizoma Pinelliae 15g, Herba Epimedii 15g, Radix Salviae Miltiorrhizae 30g, Ramulus Euonymi 30g.

Method for making: get each medical material of above-mentioned prescription, add the water soaking 8 hours of 8 times of amounts, fried in shallow oil again 2 hours, filter; Filtering residue adds the decocting 1 hour of 6 times of amounts again, filters; Collecting decoction, being concentrated into relative density is 1.15 ~ 1.25 (25 ° of C), spray drying gets extract powder, the sucrose of the weight such as adding and this extract powder, mix homogeneously is granulated, and gets granule, is pharmaceutical composition of the present invention.

Embodiment 10: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 8g, Radix Et Rhizoma Rhei 12g, Radix Astragali 18g, Rhizoma Pinelliae 12g, Herba Epimedii 15g, Radix Salviae Miltiorrhizae 25g, Ramulus Euonymi 35g.

Method for making: the method according to embodiment 9 prepares granule, is pharmaceutical composition of the present invention.

Embodiment 11: prepare pharmaceutical composition of the present invention

Prescription: Radix Angelicae Sinensis 10g, Pericarpium Citri Reticulatae 12g, Radix Et Rhizoma Rhei 8g, Radix Astragali 15g, Rhizoma Pinelliae 18g, Herba Epimedii 12g, Radix Salviae Miltiorrhizae 35g, Ramulus Euonymi 25g.

B, biological test example part

In some experiments, the inventor is used for the volunteer with corresponding disease or disease take pharmaceutical composition provided by the invention as reagent.The result shows that pharmaceutical composition of the present invention can be used for the treatment of chronic renal failure effectively, and prevention or treatment peritoneal fibrosis.The result shows that pharmaceutical composition of the present invention goes for chronic renal failure, and clinical efficacy shows as and slows down renal hypofunction, corrects water, electrolyte and acid base imbalance.The result shows that also pharmaceutical composition of the present invention goes for the end stagerenaldisease patients undergoing peritoneal dialysis, and clinical efficacy shows as and improves the patients undergoing peritoneal dialysis life quality, delays the genesis of peritoneal fibrosis.

Below in the test example, such as in addition explanation, the reagent of use is embodiment 9 gained extract powders (also can be described as in the present invention and hold up the kidney granule), face the time spent to form every 1ml medicinal liquid with water dissolution/suspendible and contain the reagent that the crude drug amount is 2g, for.

Test example 1: hold up the kidney granule on the experimentation of peritoneal dialysis rat dialysisadequacy and peritoneal fibrosis impact

One, materials and methods

1. material and instrument

1.1 laboratory animal: 75 of healthy male SD rats, body weight 180-200g; Rat feeding is in zoopery section cleaning level Animal House; Raising condition: 12h illumination, 24 ℃ of room temperatures, 45% relative humidity, the diet of whole experimentation rat and drink water unrestricted; The poultry raiser has laboratory animal practitioner post certificate.

1.2 experiment reagent: 1.5% peritoneal dialysis solution, 4.25% peritoneal dialysis solution (LPDS), the production of Baxter medical treatment company limited; TGF-β 1ELISA test kit, HGF ELISA test kit, CTGF ELISA test kit, BMP-7ELISA test kit, IL-6ELISA test kit, VEGF ELISA test kit: the bio tech ltd production of Tianjin Hao ocean.

2, experimental technique

2.1 experiment grouping: after adaptability raised for 1 week, according to the rat body weight grouping, be divided at random:

The A group: Normal group (n=15 is only),

The B group: renal failure 5/6 excision+1.5%PD group (n=15 is only),

The C group: renal failure 5/6 excision+1.5%PD+ holds up kidney groups of grains (n=15 is only),

The D group: renal failure 5/6 excision+4.25%PD group (n=15 is only),

The E group: renal failure 5/6 excision+4.25%PD+ holds up kidney groups of grains (n=15 only).

2.2 animal model preparation

A group: Normal group: without any processing.Intraperitoneal injection of saline, 100ml/kg/d, continuous 4 weeks;

B group: renal failure 5/6 excision+1.5%PD group: row rat 5/6 nephrectomy method.Experiment is divided into two steps, the first step altogether: left kidney 2/3 excision: 1. intraperitoneal anesthesia: the capable lumbar injection of chloral hydrate 0.3ml/l00g rat body weight by 10%.2. after anaesthetizing successfully, the ventricumbent position is fixed, by the other 0.5cm intersection point of 1cm and spinal column under the rib of rats with left back place, successively cut skin, muscle, free left kidney divests kidney peplos, behind upper and lower each the 1/3 place's suture ligature of level of left kidney, excise successively, the nephridial tissue of downcutting is weighed and record.Myometrial suture is confirmed without after obviously hemorrhage in gelfoam hemostasis.3 days prevention infection of postoperative continuous application Cefazolin sodium.Second step: right kidney is cut entirely: carry out in a week after left kidney 2/3 excision.Select right-hand cutout, with same anesthesia method, same position, in right hilus renalis place's ligation kidney base of a fruit, excise right kidney.3 days prevention infection of postoperative continuous application Cefazolin sodium.Adopt rat eye socket rear vein beard blood collection method blood sampling 1-2ml in six weeks of postoperative, the censorship renal function is confirmed the modelling success.Lumbar injection 1.5%LPDS, 100ml/kg/d, continuous 4 weeks;

The C group: renal failure 5/6 excision+1.5%PD+ holds up the kidney groups of grains: at first make renal failure 5/6 excision model (the same).Lumbar injection 1.5%LPDS, 100ml/kg/d gives simultaneously gavaging and holds up kidney granule (5ml/kg/d), continuous 4 weeks;

D group: renal failure 5/6 excision+4.25%PD group: at first make renal failure 5/6 excision model (the same).Lumbar injection 4.25%LPDS, 100ml/kg/d, continuous 4 weeks;

The E group: renal failure 5/6 excision+4.25%PD+ holds up the kidney groups of grains: at first make renal failure 5/6 excision model (the same).Lumbar injection 4.25%LPDS, 100ml/kg/d gives simultaneously gavaging and holds up the kidney granule (5ml/kg/d is equivalent to 10g crude drug/kg/d), continuous 4 weeks;

The lumbar injection method: take Right Lower Abdomen near the groin mid point as point of puncture, pin H/A plane is 30-45 ° of angle abdomen back inserting needle to the right, equal conventional povidone iodine skin degerming 2 times and wipe away driedly before the per injection prevents that disinfectant solution from entering the abdominal cavity with syringe needle.Low level, and slightly tilting to the right, make internal organs to the right upper abdomen concentrate the chance of wearing out internal organs with minimizing.Be careful in the injection process having or not and be expelled to stomach wall and have or not anus and the urethra leakage.Operating period, note changing the injection site, avoid long-time same position injection, cause the local subcutaneous scleroma.For the processing of each group institute injecting fluid, all take intraperitoneal to keep, do not extract out.

2.3 hold up preparation and the intervention of kidney granule

2.3.1 hold up kidney granulometric composition and preparation: see embodiment 9.

Hold up gavaging of kidney granule: certainly dialysis beginning, C group and E are organized, give gavaging and hold up the kidney granule, with every 200g body weight SD rat calculating, gavage dosage 1ml/d.All the other each groups are given and are gavaged the 1ml normal saline, gavage altogether for 4 weeks.

2.4 data acquisition and sample reception

2.4.1 the record modeling initially reaches modeling and respectively organizes rat body weight the 4th weekend and change.Each organizes rat in modeling the 4th all footline peritoneal membrane function tests, and 48h stops peritoneal dialysis before the test.10% chloral hydrate anesthesia rat, lumbar injection 4.25% dialysis solution 25ml, 4h is accurately measured the peritoneal fluid scale of construction.Leave and take respectively simultaneously blood and the about 0.5ml of peritoneal dialysis liquid specimen.With blood, peritoneal dialysis liquid specimen centrifuge (1500r/min, 5min), measure concentration of glucose with automatic clinical chemistry analyzer, calculate ultrafiltration volume (UF) and the glucose transport amount (MGT) of every rat.Specific formula for calculation is as follows:

Ultrafiltration volume=(quality of the quality-gauze after the gauze suction) * 1L/g+ drainage flow-lumbar injection amount

Glucose transport amount (Mass transfer of glucose, MTG)=(dialysis solution initial glucose concentration * injection dialysate volumes)-(the last dialysis solution output at last concentration of glucose * end of dialysing) mmol/kg.

2.4.2 the fibrosis correlation factor is measured

A) sample process: room temperature blood natural coagulation 10-20min, the centrifugal 20min of 2000-3000r/min collects the supernatant specimen.

B) dilution of standard substance and application of sample: establish gauge orifice 10 holes on the coated plate of enzyme mark, in the 1st, the 2nd hole, add respectively standard substance 100 μ l, then in the 1st, the 2nd hole, add standard substance diluent 50 μ l, mixing; Then from the 1st, the 2nd hole, respectively get 100 μ l and be added to respectively the 3rd, the 4th hole, add respectively again standard substance diluent 50 μ l, mixing in the 3rd, the 4th hole; Then respectively get first 50 μ l, mixing in the 3rd, the 4th hole; Respectively get 50 μ l from the 5th, the 6th hole behind the mixing, be added to respectively in the 7th, the 8th hole, add respectively again standard substance diluent 50 μ l, mixing from the 7th, the 8th hole; Get respectively 50 μ l from the 7th, the 8th hole again, be added to the 9th, the 10th hole, add respectively again standard substance diluent 50 μ l from the 9th, the 10th hole, from the 9th, the 10th hole, respectively get behind the mixing 50 μ l discard (dilution after each hole application of sample amount be 50 μ l, concentration is respectively 120ng/L, 80ng/L, 40ng/L, 20ng/L, 10ng/L).

C) application of sample: blank well (the blank hole does not add sample and enzyme marking reagent, and all the other each step operations are identical), testing sample hole are set respectively.On the coated plate of enzyme mark, add first sample diluent 40 μ l in the testing sample hole, and then add testing sample 10 μ l (the final dilution factor of sample is 5 times).Application of sample is added on ELISA Plate hole bottom with sample, does not touch hole wall as far as possible, gently shakes mixing.

D) incubation: with the rearmounted 37 ℃ of incubation 30min of shrouding film shrouding.

E) dosing: with 30 times of concentrated cleaning solutions, 30 times of diluted for use of distilled water.

F) washing: throw off the shrouding film, discard liquid, dry, cleaning mixture is filled it up with in every hole, discards after leaving standstill 30s, so repeats 5 times, pats dry.

G) incubation: biconditional operation 4.

H) washing: biconditional operation 5.

I) colour developing: every hole adds first developer A50 μ l, except the blank well.

J) stop: every hole adds stop buffer 50 μ l, cessation reaction (this moment, blueness transferred yellow to).

K) measure: with the blank well zeroing, the 450nm wavelength is sequentially measured the absorbance (OD value) in each hole.Mensuration should be carried out in the 15min behind stop buffer.

2.5 observation index: observe cardinal principle state, body weight change, Morphology of Peritoneum Following change, the change of peritoneum filtering function and the Serum Fibrosis regulatory factor of respectively organizing laboratory animal and express variation.

3, statistical analysis: use SPSS11.5 statistics software, (x ± s) expression carries out statistical analysis to data to measurement data with mean ± standard deviation.The relatively employing t check of two sample means.Relatively adopt one factor analysis of variance between group.P＜0.05 difference has significance.

Two, result

1. it is good, flexibly movable respectively to organize rat ordinary circumstance: the A group rat mental status after the treatment, and sight becomes clear god, and the fur light is moist, and the diet growth is as usual, and defecation is normal.All the other are respectively organized rat and in various degree growth retardation, lethargy, asthenia drowsiness all occur, sight is dark and gloomy dull, bradykinesia, fur withered without the pool in addition come off, the minimizing of ingesting, oliguria, rare performance that waits of defecating, but through behind the dialysis treatment about 2 weeks each group all go out present condition and go up gradually, movable increasing, hydrouria, the phenomenons such as diet increase, B, C, D, E group rat state have no notable difference.

2. the body weight change of rat see the following form (means standard deviation, gram) before and after the treatment:

Group	n	Body weight before the treatment	Body weight after the treatment
				The A group	15	250.25±10.09	390.67±16.56
The B group	12	213.10±23.14	320.33±17.80 ^＊＊
				The C group	13	220.13±22.12	359.60±22.21 ^＊Δ
The D group	13	212.31±14.06	366.43±14.66 ^＊Δ
				The E group	11	192.35±18.11	396.20±26.66 ^ΔΔ◇

Annotate: A organizes relatively with the same period: ^*P＜0.05, ^*P＜0.01; B organizes relatively with the same period: ^ΔP＜0.05, ^{The Δ Δ}P＜0.01; C organizes relatively with the same period: ^◇P＜0.05.

3. change in renal function comparative result.

Respectively organize the Renal Function in Rats testing result before the treatment See the following form

Group	n	BUN(mmol/L)	Scr(umol/L)
				The A group	15	7.56±1.00	30.23±4.36
The B group	12	17.12±6.36 ^＊＊	82.16±2.30 ^＊＊
				The C group	13	15.62±6.24 ^＊＊	85.20±6.21 ^＊＊
The D group	13	15.56±4.21 ^＊＊	78.43±8.64 ^＊＊
				The E group	11	16.84±5.14 ^＊＊	91.20±6.66 ^＊＊

Annotate: compare with the A group: ^*P＜0.01.Prompting modeling success.

Respectively organize the Renal Function in Rats testing result after the treatment

See the following form

Group	n	BUN(mmol/L)	Scr(umol/L)
				The A group	15	6.99±1.13	30.67±5.50
The B group	12	13.18±2.10 ^＊＊	60.34±7.80 ^＊＊
				The C group	13	12.23±2.72 ^＊＊	49.60±6.21 ^＊＊◇Δ
The D group	13	14.54±4.09 ^＊＊	66.58±6.38 ^＊＊
				The E group	11	11.95±4.11 ^＊＊◇	47.20±5.58 ^＊＊◇Δ

Annotate: compare with the A group: ^*P＜0.01; Compare with the B group: ^ΔP＜0.05; D organizes relatively with the same period: ^◇P＜0.05.

4. ultrafiltration volume and glucose transport amount are relatively: peritoneal effluent is situation substantially: each group model rat is unrealized positive ultrafiltration all, but drainage flow is in various degree all arranged.It is faint yellow that draining fluids roughly is, and minority has pale red even is courageous and upright.Relatively each treated animal filtering function index, ultrafiltration volume and glucose transport amount comparable situation See the following form.

Group	n	Ultrafiltration volume (ml)	Glucose transport amount (mmol/kg)
				The A group	15	4.95±1.04	17.74±0.40
The B group	12	-16.25±5.02 ^＊＊●Δ	16.58±0.98 ^＊ΔΔ

The C group	13	-3.31±13.83	17.16±0.79 ^ΔΔ
				The D group	13	-14.04±11.73 ^＊＊●Δ	16.26±1.17 ^＊＊ΔΔ
The E group	11	-1.83±11.50	14.54±1.59 ^＊＊

Annotate: compare with the A group: ^*P＜0.05, ^*P＜0.01; Compare with the C group: ^●P ﹤ 0.05; Compare with the E group: ^ΔP＜0.05, ^{The Δ Δ}P＜0.01.

5. peritoneum pathology morphological change

5.1 rat peritoneum Pathomorphologic observation: see Fig. 1.As shown in the figure, through HE dyeing, the row PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM shows that the densification of A group parietal peritoneum is smooth, and peritoneum thickness is without remarkable change; Each concentration model group and intervention group peritoneum thickness thicken in various degree, and peritoneum thickened degree C group and E group are light, but B group and D group are serious, and there is in various degree cell infiltration in each group.

5.2 rat peritoneum thickness measure: specimen slice row Masson dyeing is respectively organized in experiment, choose at random upper and lower, left and right, in each 2 high power field, measure its peritoneum thickness, get its meansigma methods as parietal peritoneum thickness.Experiments of measuring is respectively organized rat peritoneum thickness, and the result shows that B group, D group and C group, E group peritoneum average thickness all increase than the A group.Wherein, each model group and E group peritoneum thickness and A group have significant difference (P ﹤ 0.01).Comparison there was no significant difference except between B group and E group (P〉0.05), compare tool significant difference (P ﹤ 0.01) between variable concentrations model and intervention group.Each organizes the rat peritoneum varied in thickness relatively

The results are shown in following table.

Annotate: ^●Compare P ﹤ 0.05 with the A group, ^{● ●}Compare P ﹤ 0.01 with the A group; ^ZeroCompare P ﹤ 0.05 with the B group, ⁰⁰Compare P ﹤ 0.01 with the B group; ^◆Compare P ﹤ 0.05 with the D group, ^{◆ ◆}Compare P ﹤ 0.01 with the D group; ^★Compare P ﹤ 0.05 with the C group, ^{★ ★}Compare P ﹤ 0.01 with the C group;

Compare P ﹤ 0.05 with the E group,

Compare P ﹤ 0.01 with the E group.

6. the change of the short peritoneal fibrosis relevant cell factor of each group

The results are shown in following table.

Group	n	TGF-β1	CTGF	IL-6	VEGF
						The A group	15	69.84±16.36	226.10±32.01	31.93±6.20	0.18±0.01
The B group	12	115.94±14.23 ^＊＊☆☆	1091.98±102.93 ^＊＊	105.47±12.31 ^＊＊	0.49±0.08 ^＊＊
						The C group	13	104.01±20.67 ^＊☆☆	601.13±117.22 ^{＊＊ΔΔ☆☆}	70.98±15.64 ^＊＊Δ☆	0.50±0.07 ^＊＊
The D group	13	231.45±19.66 ^＊＊	1224.92±172.40 ^＊＊	94.59±15.22 ^＊＊	0.61±0.10 ^＊＊
						The E group	11	108.24±17.48 ^＊＊☆☆	685.20±110.63 ^＊＊Δ☆☆	76.31±14.10 ^＊＊☆	0.47±0.10 ^＊＊☆

Annotate: compare with the A group: ^*P＜0.05, ^*P＜0.01; Compare with the B group: Δ P＜0.05, Δ Δ P＜0.01; Compare with the D group: ☆ P＜0.05, ☆ ☆ P＜0.01.

Each group suppresses the change of peritoneal fibrosis relevant cell factor

The results are shown in following table.

Group	n	HGF	BMP-7
				The A group	15	105.01±20.02	106.98±18.21
The B group	12	159.85±19.96 ^＊	261.93±27.32 ^＊＊
				The C group	13	212.74±22.74 ^＊＊ΔΔ	279.36±25.90 ^＊＊
The D group	13	197.27±20.91 ^＊＊Δ	257.02±30.29 ^＊＊
				The E group	11	233.69±23.29 ^＊＊ΔΔ	342.16±29.99 ^＊＊☆Δ

Annotate: A organizes relatively: ^*P＜0.05, ^*P＜0.01; Compare with the B group: ^ΔP＜0.05, ^{The Δ Δ}P＜0.01; Compare with the D group: ^☆P＜0.05, ^{☆ ☆}P＜0.01.

Three, brief summary

1. ordinary circumstance and body weight change: in the experimentation, when being expert at left kidney 2/3 excision, because 1 of overdose of anesthesia rat cadavers is the B group, because the hemostasis of excision position is not thorough, 1 of hemorrhagic shock rat cadavers is the E group.Sting dead 3 of trunk because of the lumbar injection mistake, wherein the B group is 1,1 of C group, 1 of E group; Gavage is strayed into respiratory tract, dead 1, is the E group.6 of unknown causes dead (cause of the death may be relevant with the whole body organ failure that serious renal failure causes, and through obduction, sign do not occur significantly infecting), wherein the B group is 1,1 of C group, 2 of D groups, 2 of E groups.In dialysis treatment and the Chinese medicine intervention, rat integrality aspect has no notable difference between each group.Body weight change aspect, each is organized rat body weight and all occurs increasing, but that A group and D group, E group rat body weight increase is obviously faster than other groups, consider D group, E group rat body weight increase obvious comparatively fast may be relevant with the application of high concentration peritoneal dialysis.

2. change in renal function: this topic experiment is the result show: the Scr aspect, after the treatment, each model group Scr level is also apparently higher than Normal group (A group) P＜0.01.In concentration dialysis treatment group, use and hold up its Scr level of kidney granule intervention group to reduce obvious P＜0.05, namely C group, E group Scr level are obviously organized low than B group, D.When also explanation is dialysed, use and hold up the kidney granule can reduce dialysis rat Scr level, strengthen dialysisadequacy, the protection residual renal function.The BUN aspect, after the treatment, each model group BUN level is still apparently higher than Normal group (A group) P＜0.01, but E group BUN level is apparently higher than D group P＜0.05.When dialysis is described, uses and hold up the kidney granule can reduce dialysis rat BUN level, strengthen dialysisadequacy, the protection residual renal function.

3. hold up the kidney granule to the change of efficiency of peritoneal dialysis: ultrafiltration volume and glucose transport amount are to estimate the important indicator of patients undergoing peritoneal dialysis efficiency of peritoneal dialysis, and itself and peritoneal fibrosis degree have direct relation.This result of study shows, after 4 weeks for the treatment of, except Normal group (A group), all the other each groups all are presented as negative ultrafiltration, but in concentration dialysis treatment group, application is held up its ultrafiltration conditions of kidney granule intervention group obviously to be better than not using and is held up kidney groups of grains P＜0.05, its effect significantly, simultaneously, glucose transport amount aspect also is presented as analog result, and prompting holds up the kidney granule for improving efficiency of peritoneal dialysis, improve the dialysis ultrafiltration, delay peritoneal fibrosis and have clearly effect.

4. hold up the kidney granule on the impact of peritoneal fibrosis

Show that 4.1 respectively organize PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM after the treatment densification of A group parietal peritoneum is smooth, peritoneum thickness is without remarkable change; All the other peritoneum thickness thicken in various degree, and the peritoneum thickened degree heavily is respectively C group, E group, B group and D group by gently causing, and there is in various degree cell infiltration in each group.Measure and respectively organize the rat peritoneum average thickness, each model and intervention group all obviously increase than A group peritoneum average thickness as a result.Wherein, each model group and E group peritoneum thickness and A group have significant difference.Except between B group and E group, compare the there was no significant difference, compare the tool significant difference between variable concentrations model and intervention group.Pathomorphism and the prompting of peritoneum thickness results, the application of variable concentrations peritoneal dialysis liquid can cause that all peritoneal fibrosis in various degree occurs, and peritoneal fibrosis degree and the proportional relation of peritoneal dialysis liquid concentration.Notable difference occurs through holding up the kidney granule to intervene the posterior peritoneum progression of fibrosis, hold up the kidney granule can delay to a certain extent the generation process of peritoneal fibrosis.

4.2 hold up the kidney granule on the impact of peritoneal fibrosis relevant cell factor: peritoneum is natural semipermeable membrane, removes moisture and toxin by principles such as disperse, infiltration, ultrafiltration.Ultrafiltration, i.e. the process that moisture is shifted by blood side direction dialysis fluid side during peritoneal dialysis is the main mechanism of moisture in the peritoneal dialysis removing body.This afunction namely is called ultrafiltration depletion.The standardized test of international peritoneal dialysis association's committee's suggestion employing in 2000 defines this concept, namely uses 4.25% glucose dialysis and stays abdomen after 4 hours, if the net ultrafiltration amount less than 400ml, is namely thought ultrafiltration depletion has occured.Ultrafiltration depletion is thoroughly common one of serious complication that reaches of long-term abdomen, also is the main cause that the saturating patient of abdomen is forced to withdraw from peritoneal dialysis.Along with the prolongation of peritoneal dialysis treatment time, abdomen saturating patient's peritoneum ultrafiltration ability is faded, and about 36% above patient can occur this problem in dialysis after 6 years.The peritoneal dialysis ultrafiltration depletion that peritoneal fibrosis causes becomes study hotspot in recent years.Complete the reaching of the long-term maintenance of peritoneum structure function normally is precondition and the essential condition that peritoneal dialysis is long-term, efficient, high-quality carries out.

4.1 short peritoneal fibrosis correlation factor

This result of study shows: compare with the A group, the relevant short fibrosis factor expression level of all the other each model group P＜0.01 that all obviously raises, thereby the carrying out along with dialysis treatment is described, low concentration and high concentration dialysis solution all can raise the expression of the short fibrosis factor, accelerate the generation of peritoneal fibrosis.TGF-β 1 aspect, the expression of D group is obviously respectively organized rising P＜0.05 than other, the impact that the high sugar of prompting is expressed TGF-β 1, simultaneously, the change of E group TGF-β 1 level confirms to hold up the kidney granule obvious to the inhibitory action that TGF-β 1 expresses.CTGF and IL-6 aspect, the result is similar to TGF-β 1, and wherein the C group further confirms to hold up the kidney granule clear and definite to the inhibitory action of CTGF and IL-6 expression than the variation of B group.The VEGF aspect, E group obviously reduces P＜0.05 than the D group, illustrates that to hold up the kidney granule obvious to the inhibitory action of vegf expression.

4.2 anti-peritoneal fibrosis correlation factor

This result of study shows: along with carrying out and the Fibrotic generation of dialysis treatment, rise all appears in HGF and BMP-7 expression, the equal compared with normal matched group of the two level of each model group P＜0.01 that obviously raises.Wherein, the HGF aspect, the C group is organized obvious rising P＜0.01 than B, and prompting holds up the kidney granule can obviously raise the expression of HGF, thereby suppresses the generation of peritoneal fibrosis.The BMP-7 aspect, the E group is organized obvious rising P＜0.05 than D, and prompting holds up the kidney granule can obviously raise the expression of BMP-7, thereby suppresses the generation of peritoneal fibrosis.As seen, hold up the kidney granule can suppress the expression such as short fibrosis factor TGF-β 1, CTGF, IL-6, CTGF, simultaneously, can raise again the expression of fibrosis factor HGF, BMP-7, and then play the generation that suppresses the relevant peritoneal fibrosis of peritoneal dialysis.

The inventor is in other test, repeat the method for above test example 1, but use respectively embodiment 1 to 8 and 10 kinds of samples of embodiment 10-11 gained to test, the result shows that these 10 kinds of samples of use acquired results in above test example 1 described method is identical with use embodiment 9 sample acquired results.

Test example 2: hold up the kidney granule on the clinical research of efficiency of peritoneal dialysis and peritoneal fibrosis impact

The purpose of this test is to use holds up the kidney granule that patients undergoing peritoneal dialysis is carried out dialectical intervention, observation holds up the kidney granule on the impact of patients undergoing peritoneal dialysis dialysisadequacy, life quality, Efficacy of Traditional Chinese Medicine and peritoneal fibrosis, simultaneously, observe the change of peritoneal fibrosis relevant cell factor by clinical experimental research, the possible mechanism of action of kidney granule control peritoneal fibrosis is held up in discussion, for Chinese medicine prevention peritoneal dialysis peritoneal fibrosis provides theoretical foundation and method.Specifically by to December in 2009 1 day to this research of voluntary participation between 31 days Mays in 2010, and patients undergoing peritoneal dialysis 240 examples of signature Informed Consent Form are carried out differentiation of symptoms and signs for classification of syndrome, and give and hold up the kidney granule therapy, observe the saturating life in patients of abdomen, serum creatinine (Scr), blood urea nitrogen (BUN), hemoglobin (HGB), albumin (ALB), electrolyte, serum calcium (Ca), serum paraoxonase (P), the variation of the index such as peritoneum balance test (PET) and peritoneal fibrosis relevant cell factor is estimated and is held up the kidney granule on the impact of efficiency of peritoneal dialysis and peritoneal fibrosis.

1, case is selected

Selected object: December in 2009 1 day is to this research of voluntary participation between 31 days Mays in 2010, and patients undergoing peritoneal dialysis 240 examples of signature Informed Consent Form.

Diagnostic criteria: the diagnostic criteria of the chronic kidney disease that 2002 " detection of chronic renal disease progress and guideline of prevention and treatment/Patients With Kidney Diseases life quality guidance (K/DOQI) " formulates according to AKF.

Case is selected, case is got rid of, reject the case standard: formulate according to chronic kidney disease patients undergoing peritoneal dialysis general standard.

2, Therapeutic Method:

All cases is at first through one month primary election phase, and this phase gives Primary Care when continuing to carry out former peritoneal dialysis scheme, comprise the treatment of diet, complication etc., and the person that meets the inclusive criteria after month enters winding and treated.

(1) treatment group: give Primary Care+treatment by Chinese herbs, scheme is as follows:

Primary Care: a. take peritoneal dialysis as the basis, for the patient who has the complication such as anemia, hypertension according to K/DOQI guide recommend method and dosage medication.Mainly comprise the processing of the complication such as control blood pressure, anemia; B. dietetic nutrition: carry out with reference to China's " chronic kidney disease proteinaceous nutrient treatment Consensus of experts ".Treatment by Chinese herbs: use embodiment 9 gained granules (also can be described as in the present invention and hold up the kidney granule) to be reagent (dosage is taken as the every 60kg body weight of patient and hold up the kidney granule to be equivalent to 30 gram crude drugs every day).

(2) matched group: give Primary Care+placebo, Primary Care is the same, and placebo is and the consistent placebo of Chinese medicine granules outward appearance.

Take 3 months as a course for the treatment of, treat continuously 2 courses for the treatment of.

3, observation index and detection method

(1) Evaluation on quality of life: adopt nineteen ninety-five to be developed by Rand Corporation (RAND), and by Aingen, common " kidney disease dialysis patient investigation of life quality table " (seeing Appendix 2) the Kidney Disease and Quality of Life that completes that subsidizes of Baxter Healthcare CorPoration and Arizona State University (University of Arizona) ^TMShort Form (KDQOL-SF ^TM) 1.3 scales, the KDQOL-SFTM1.3 scale is with reference to classification and the methods of marking of the formulations such as Hays RD in this research, be converted to the conversion score by actual score, compare, each field scoring is the meansigma methods of each project scoring of this field, scoring higher this field life quality of reflection surveyee in field is higher, and best result is 100 minutes, minimumly is divided into 0 minute.Some term abbreviations that occur in the context of the invention can be referring to above-mentioned " application form ".

(2) efficiency of peritoneal dialysis index of correlation: serum creatinine (Scr), blood urea nitrogen (BUN), hemoglobin (HGB), albumin (ALB), electrolyte, serum calcium (Ca), serum paraoxonase (P).The peritoneal dialysis index of correlation: peritoneum balance test (PET) reaches when finishing each course for the treatment of before treatment and respectively detects once.Before treatment, reach each record patient twenty-four-hour urine amount and ultrafiltration volume when finishing each course for the treatment of.

(3) tcm syndrome integration and therapeutic evaluation: before treatment and each course for the treatment of when finishing three time points use tcm syndrome integration application forms and carry out the investigation of tcm syndrome integration, judge curative effect.The tcm syndrome curative effect determinate standard:

A. clinical remission: tcm clinical practice symptom, sign disappear or substantially disappear 95% of syndrome integration minimizing.

B. produce effects: tcm clinical practice symptom, sign are obviously improved, and the syndrome integration reduces 〉=70%.

C. effective: tcm clinical practice symptom, sign all take a favorable turn, and the syndrome integration reduces 〉=30%.

D. invalid: all without obviously improving, even increase the weight of, the syndrome integration reduces less than 30% for tcm clinical practice symptom, sign.

(4) peritoneal fibrosis cytokines measurement: before treatment, reach treatment during June, about extracting vein blood 3ml, inject blood taking tube, under the normal temperature condition, 3000 turn under the condition centrifugal 10 minutes, get the about 1-1.5ml of supernatant (serum) with the BT syringe, inject 2ml cold storage pipe, the sealed membrane sealing is inserted in the preservation environment of-70 ℃ of following conditions.Please the special messenger be collected by serum by the problem responsible department, adopt ELISA method detection fibers relevant cell factor transforming growth factor-beta 1 (TGF-β 1), Connective Tissue Growth Factor (CTGF), interleukin-6 (IL-6), hepatocyte growth factor (HGF), bone morphogenesis protein-7 (BMP-7) level.

(5) statistical method: data are carried out statistical analysis with SPSS11.5 statistics software, measurement data with mean scholar standard deviation ( ) expression, behind normality, homogeneity test of variance (with 0.05 as inspection level), ask that sample relatively adopts the t check for two groups when variance is neat, many groups are asked and are relatively used variance analysis; Two samples relatively adopt rank test during heterogeneity of variance; Enumeration data adopts X 2 test, during nonnormal distribution, adopts rank test.Take P＜0.05 as difference statistical significance is arranged.

4, result:

(1) hold up the kidney granule on the impact of life quality

Relatively show in the group: in the treatment group, all obviously raise before the treatment and after treatment March after KDTA overall score treatment June (P＜0.01); In the branch field, treatment group integration after SPL (symptom with uncomfortable, Symptom/problem list) aspect treatment June obviously is better than treating front integration (P＜0.01), and other field has no notable difference (P〉0.05).Aspect SF-36 (general health related quality of life) overall score, treatment obviously is better than treatment front (P＜0.01) after June, in the branch field, find obviously to be better than after treatment June aspect PF (P＜0.01) before the treatment, remaining field has no notable difference (P〉0.05).In the matched group, KDTA overall score and SF-36 overall score two aspects obviously reduce (P＜0.01) before the treatment after all seeing treatment March, and treatment treat March after June after overall score see obvious rising (P＜0.01).In each branch field, be showed no notable difference (P〉0.05) before and after the treatment.Relatively, after treatment March and after treatment June, be showed no notable difference (P〉0.05) aspect KDTA overall score and the SF-36 overall score between two groups between two groups.In the branch field, each field also has no notable difference (P〉0.05).

(2) hold up the kidney granule on the impact of efficiency of peritoneal dialysis index of correlation.The renal function aspect relatively shows in the group: the BUN level is treated front remarkable decline (P＜0.05) after treatment June, relatively treat June between group after BUN horizontal stretcher group significantly reduce (P＜0.01) than matched group; Relatively be showed no significant difference (P〉0.05) in the Scr group and between group.Aspect Peritoneal Transport, relatively be showed no significant difference (P〉0.05) before and after two groups of internal therapies and between group.Aspect 24h ultrafiltration volume and 24h urine amount, have no significant change before and after the treatment group treatment, treatment of control group after June two all see obvious reduction (P＜0.05), and significantly reduce (P＜0.05) with treatment group with time point.

(3) hold up the kidney granule on the impact of peritoneal fibrosis relevant cell factor: two groups of horizontal statistical analysis of peritoneal fibrosis relevant cell factor before and after the treatment, compare in the group: in the treatment group, the IL-6 level is treated front obvious reduction (P＜0.05) after the treatment, HGF, BMP-7 level significantly raise (P＜0.01), and other indexs have no significant change (P〉0.05).In the matched group, TGF-β 1 level is treated front remarkable rising (P＜0.05) after the treatment, obviously reduces (P＜0.05) before the treatment behind the IL-6 horizontal stretcher, and other indexs have no significant change (P〉0.05).Compare between two groups after the treatment, treatment group obviously is better than matched group (P＜0.05) at control TGF-β 1, CTGF aspect horizontal, simultaneously, treatment group is in the effect that is increased significantly than matched group aspect HGF, the BMP-7 (P＜0.01), and improve IL-6 horizontal aspect, curative effect has no significant difference (P〉0.05) between two groups.

(4) hold up kidney granule TCM Therapeutic: treatment group holds up the kidney granule can obviously reduce syndrome integration behind the patient treatment, and along with the prolongation for the treatment of time, the syndrome integration obviously reduces, and total effective rate obviously raises.By between two groups as seen, after treatment March and after treatment June, treatment group patient's integration changes and total effective rate all obviously is better than matched group.

By above result as seen, the present invention holds up the kidney granule can improve clinical symptoms and the sign of patients undergoing peritoneal dialysis, improves life in patients, improves patient's dialysisadequacy; Remove to increase patients undergoing peritoneal dialysis urotoxin and water, delay losing of patient's residual renal function, improve patient's dialysisadequacy; Suppress to a certain extent the rise of short fibrosis cytokine serum TG F-β 1, CTGF, IL-6 and VEGF level, can raise to a certain extent again antagonism fibrosis cytokine HGF, BMP-7 level, finally suppress or delay the generation of the relevant peritoneal fibrosis of peritoneal dialysis; Film dialysis rat model peritoneal fibrosis degree and the proportional relation of peritoneal dialysis solution concentration; hold up the kidney granule can obviously delay the fibrosis progression of peritoneal dialysis rat model peritoneal tissues form; protect the normal of peritoneal tissues morphosis, thus the generation of antagonism peritoneal fibrosis.

Claims

1. pharmaceutical composition, it is by comprising that following Chinese crude drug prepares: Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Radix Et Rhizoma Rhei, the Radix Astragali, the Rhizoma Pinelliae, Herba Epimedii, Radix Salviae Miltiorrhizae, Ramulus Euonymi.

2. according to claim 1 pharmaceutical composition, it is characterized in that following (a) to (h) each or multinomial:

(a) it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 1-100 weight portion, Radix Et Rhizoma Rhei 1-100 weight portion, Radix Astragali 1-200 weight portion, Rhizoma Pinelliae 1-200 weight portion, Herba Epimedii 1-200 weight portion, Radix Salviae Miltiorrhizae 1-300 weight portion, Ramulus Euonymi 1-300 weight portion;

(b) it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 2-75 weight portion, Radix Et Rhizoma Rhei 2-75 weight portion, Radix Astragali 2-150 weight portion, Rhizoma Pinelliae 2-150 weight portion, Herba Epimedii 2-150 weight portion, Radix Salviae Miltiorrhizae 2-250 weight portion, Ramulus Euonymi 2-250 weight portion;

(c) it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 3-50 weight portion, Radix Et Rhizoma Rhei 3-50 weight portion, Radix Astragali 5-75 weight portion, Rhizoma Pinelliae 5-75 weight portion, Herba Epimedii 5-75 weight portion, Radix Salviae Miltiorrhizae 5-150 weight portion, Ramulus Euonymi 5-150 weight portion;

(d) it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 5-20 weight portion, Radix Et Rhizoma Rhei 5-20 weight portion, Radix Astragali 8-30 weight portion, Rhizoma Pinelliae 8-30 weight portion, Herba Epimedii 8-30 weight portion, Radix Salviae Miltiorrhizae 6-50 weight portion, Ramulus Euonymi 6-50 weight portion;

(e) it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 5-15 weight portion, Radix Et Rhizoma Rhei 5-15 weight portion, Radix Astragali 10-20 weight portion, Rhizoma Pinelliae 10-20 weight portion, Herba Epimedii 10-20 weight portion, Radix Salviae Miltiorrhizae 25-40 weight portion, Ramulus Euonymi 25-40 weight portion;

(f) it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 10 weight portions, Radix Et Rhizoma Rhei 10 weight portions, the Radix Astragali 15 weight portions, the Rhizoma Pinelliae 15 weight portions, Herba Epimedii 15 weight portions, Radix Salviae Miltiorrhizae 30 weight portions, Ramulus Euonymi 30 weight portions;

(g) it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 8 weight portions, Radix Et Rhizoma Rhei 12 weight portions, the Radix Astragali 18 weight portions, the Rhizoma Pinelliae 12 weight portions, Herba Epimedii 15 weight portions, Radix Salviae Miltiorrhizae 25 weight portions, Ramulus Euonymi 35 weight portions; And/or

(h) it is to be prepared by the Chinese crude drug that comprises following proportioning: Radix Angelicae Sinensis 10 weight portions, Pericarpium Citri Reticulatae 12 weight portions, Radix Et Rhizoma Rhei 8 weight portions, the Radix Astragali 15 weight portions, the Rhizoma Pinelliae 18 weight portions, Herba Epimedii 12 weight portions, Radix Salviae Miltiorrhizae 35 weight portions, Ramulus Euonymi 25 weight portions.

3. according to claim 1 to 2 pharmaceutical composition, it is characterized in that following (a) to (g) each or multinomial:

(a) in the pharmaceutical composition for preparing in per 10 weight portion Radix Angelicae Sinensis, wherein the amount of Pericarpium Citri Reticulatae is 2-75 weight portion, 3-50 weight portion, 4-40 weight portion, 5-30 weight portion, 5-20 weight portion, 5-15 weight portion, 8-12 weight portion or about 10 weight portions;

(b) in the pharmaceutical composition for preparing in per 10 weight portion Radix Angelicae Sinensis, wherein the amount of Radix Et Rhizoma Rhei is 2-75 weight portion, 3-50 weight portion, 4-40 weight portion, 5-30 weight portion, 5-20 weight portion, 5-15 weight portion, 8-12 weight portion or about 10 weight portions;

(c) in the pharmaceutical composition for preparing in per 10 weight portion Radix Angelicae Sinensis, wherein the amount of the Radix Astragali is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions;

(d) in the pharmaceutical composition for preparing in per 10 weight portion Radix Angelicae Sinensis, wherein the amount of the Rhizoma Pinelliae is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions;

(e) in the pharmaceutical composition for preparing in per 10 weight portion Radix Angelicae Sinensis, wherein the amount of Herba Epimedii is 2-150 weight portion, 3-125 weight portion, 4-100 weight portion, 5-75 weight portion, 6-50 weight portion, 7-40 weight portion, 8-30 weight portion, 10-20 weight portion, 12-18 weight portion or about 15 weight portions;

(f) in the pharmaceutical composition for preparing in per 10 weight portion Radix Angelicae Sinensis, wherein the amount of Radix Salviae Miltiorrhizae is 2-250 weight portion, 3-200 weight portion, 4-175 weight portion, 5-150 weight portion, 10-100 weight portion, 15-75 weight portion, 20-50 weight portion, 25-40 weight portion or about 30 weight portions; And/or

(g) in the pharmaceutical composition for preparing in per 10 weight portion Radix Angelicae Sinensis, wherein the amount of Ramulus Euonymi is 2-250 weight portion, 3-200 weight portion, 4-175 weight portion, 5-150 weight portion, 10-100 weight portion, 15-75 weight portion, 20-50 weight portion, 25-40 weight portion or about 30 weight portions.

4. according to claim 1 to 3 pharmaceutical composition, it is characterized in that following (a) to (g) each or multinomial:

Each medical material directly is used as medicine with medical material or joins in the described pharmaceutical composition after extracting;

Each medical material joins in the described pharmaceutical composition after extracting;

Each medical material is through joining in the described pharmaceutical composition after extracting independently of one another or together;

Each medical material is to join in the described pharmaceutical composition after extracting together;

Each medical material is to join in the described pharmaceutical composition after the decocting mode is extracted together;

It prepares basically as follows: each medical material directly is ground into powder, and mix homogeneously randomly adds pharmaceutically acceptable carrier, and get final product;

Comprising the extract of each medical material, and optional pharmaceutically acceptable carrier; And/or

It prepares basically as follows: each medical material is used is extracted solvent extraction, and extract obtained direct packing, and get final product.

5. according to claim 1 to 4 pharmaceutical composition, it prepares basically as follows:

(a) each medical material is used the extraction solvent extraction;

6. according to claim 5 pharmaceutical composition, wherein said extraction solvent is water, ethanol or ethanol water.

7. according to claim 1 to 6 pharmaceutical composition, wherein join extract in this pharmaceutical composition, that obtain through extraction with each medical material,

The extract according to the method preparation that comprises the steps: get each medical material, pulverize, the water, ethanol or the ethanol water that add 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times) decoct and/or reflux, extract, 1 ~ 5 time (for example 2 ~ 3 times) each 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour), collecting decoction filters, and filtrate decompression is concentrated into the thick paste that relative density is 1.1 ~ 1.5 (25 ° of C) (for example 1.2 ~ 1.4), drying, and get final product;

The extract according to the method preparation that comprises the steps: get each medical material, pulverize, add the water of 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times), about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); Filter, filtrate decompression is concentrated, drying, and get final product;

The extract according to the method preparation that comprises the steps: get each medical material, pulverize, add the water of 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times), about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); Filter, filtrate decompression is condensed into paste; Doubly measure 50 ~ 90% alcohol reflux 2-3 time with 2-5, with ethanol extract in 70-90 ° of C except ethanol, vacuum drying, and get final product; And/or

The extract according to the method preparation that comprises the steps: get each medical material, pulverize, add the water of 5 ~ 20 times (for example 5 ~ 15 times, for example 8 ~ 12 times), about 80 ~ 100 ° of C, decoct and extract 0.5 ~ 5 hour (for example 0.5 ~ 3 hour, for example 1 ~ 3 hour); It is 1.1 ~ 1.5 (25 ° of C) (for example 1.2 ~ 1.4) that decocting liquid is concentrated into relative density, adds 95% ethanol to concentration of alcohol and reaches 70%, and placement is spent the night, filter, and concentrated filtrate, drying, and get final product.

8. following medicinal materials is combined in for the preparation of the purposes in the medicine of prevention, improvement or treatment kidney disease or disease: Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Radix Et Rhizoma Rhei, the Radix Astragali, the Rhizoma Pinelliae, Herba Epimedii, Radix Salviae Miltiorrhizae, Ramulus Euonymi.

9. following medicinal materials is combined in the purposes in the preparation medicine: Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Radix Et Rhizoma Rhei, the Radix Astragali, the Rhizoma Pinelliae, Herba Epimedii, Radix Salviae Miltiorrhizae, Ramulus Euonymi, and described medicine is used for:

Prevention, improvement or treatment nephropathy and complication or symptom;

Prevention, improve or treatment chronic renal failure, peritoneal fibrosis, because of peritoneal fibrosis due to the extrinsic factor (for example peritoneal dialysis), renal hypofunction, because of water, electrolyte and acid base imbalance due to the nephropathy

Treatment chronic renal failure and/or prevention or treatment peritoneal fibrosis;

Improve the patients undergoing peritoneal dialysis life quality and/or delay the genesis of peritoneal fibrosis.

10. the method for preparing each described pharmaceutical composition of claim 1-7, it comprises the steps: that with each pulverizing medicinal materials the gained powder directly forms pharmaceutical composition as pharmaceutical composition or after randomly mixing with pharmaceutically acceptable carrier; Perhaps, with each pulverizing medicinal materials, the gained powder obtains extract through extraction, and this extract directly forms pharmaceutical composition as pharmaceutical composition or after randomly mixing with pharmaceutically acceptable carrier.Perhaps, the method is as described in the description third aspect.