CN103182040B - Traditional Chinese medicine composition for treating polycystic kidney disease, and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating polycystic kidney disease, and preparation method thereof Download PDF

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CN103182040B
CN103182040B CN201310092513.5A CN201310092513A CN103182040B CN 103182040 B CN103182040 B CN 103182040B CN 201310092513 A CN201310092513 A CN 201310092513A CN 103182040 B CN103182040 B CN 103182040B
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radix
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高建东
郑平东
何立群
王琛
侯卫国
李瑞玲
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Shuguang Hospital Affiliated to Shanghai University of TCM
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Shuguang Hospital Affiliated to Shanghai University of TCM
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Abstract

The invention discloses a traditional Chinese medicine composition for treating a polycystic kidney disease, which is mainly prepared by the following raw material medicine in parts by weight: 15-30 parts of pilose asiabell root, 15-30 parts of astragalus root, 10-15 parts of Chinese angelica root, 10-15 parts of red peony root, 10-15 parts of white peony root, 10-15 parts of burreed rhizome, 10-30 parts of ternate buttercup root, 1-2 parts of pangolin scales powder, 10-15 parts of plantain seed, 10-15 parts of white mustard seed, 10-15 parts of semenvaccariae, 10-15 parts of rhizome of drynaria, 10-15 parts of duchesnea indica and 10-15 parts of hedyotidis herba. Besides, the invention also discloses a method for preparing the traditional Chinese medicine composition. The traditional Chinese medicine composition has the function of improving the kidney function, renal tubules and glomeruli of a polycystic kidney disease patient, can effectively improve the clinical symptoms of patients such as waist and knee weakness, lower back swelling pain or sharp pain, physical and mental fatigue, intolerance to cold and cold limbs and limb numbness, can better treat the polycystic kidney disease, is convenient to take, and small in dosage, has no toxic side effect and is praised by patients.

Description

A kind of Chinese medicine composition for the treatment of multicystic kidney disease and preparation method thereof
Technical field:
The invention belongs to the field of Chinese medicines, relate to compound Chinese medicinal preparation, be specifically related to a kind of Chinese medicine composition for the treatment of multicystic kidney disease and preparation method thereof.
Background technology:
Polycystic kidney (polycystic kidney disease, PKD), it is one of modal heritability nephropathy of the mankind, it is about 1/1000～1/400 at whole world sickness rate, main pathological characters is that two kidneys extensively form cyst, carrying out property of cyst is grown up, and finally destroys the 26S Proteasome Structure and Function of kidney, and can involve many organs such as liver, cardiovascular.Age of onset generally, in 30-40 year, in 60 years old patient, more than 50% enters end stage renal failure, accounts for 10% left and right of the end stage renal failure cause of disease.In hemodialysis patients, approximately 2.7% due to ADPKD(autosomal dominant polycystic kidney disease) cause, in the saturating patient of abdomen, approximately 3.8% because ADPKD causes.The hemodialysis patients document data base of American-European countries and China District of Shanghai all shows, PKD is the 4th cause of disease that causes end stagerenaldisease.U.S. PKD patient has nearly 17000 people to enter end-stage renal failure every year, and medical expense is up to 600,000,000 dollars.
Along with the progress of molecule and cytobiology technology, ADPKD is all making important progress aspect the researchs such as gene studies, pathogenesis and diagnosis, but modern medicine still lacks desirable treatment means to its treatment.The hereditary causing as gene mutation, the Perfected process for the treatment of ADPKD is to adopt normal gene Substitution gene, corrects protein function abnormal, but the method that there is no at present realizes.Clinical treatment focuses on complication at present, relief of symptoms, and renal function protecting, but be difficult to effectively delay progression of disease, western medical treatment lacks effective medicine at present.Therefore find the measure that effectively delays progression of disease and become research emphasis.
For the treatment of polycystic kidney, the traditional Chinese medical science is according to the subjective symptoms of patient performance, and the deficiency and excess concrete condition determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs of the different phase of disease, the state of an illness, has unique curative effect.But at present ununified Syndrome Differentiation of Traditional Chinese Medicine method and standard also of primary disease, clinician is many, and the experience according to oneself is carried out differentiation of symptoms and signs for classification of syndrome.Aspect the Chinese medicine of effectively treatment, although there is the curative effect of several single medicines to have the checking of experiment, the report aspect of the concrete curative effect of Chinese medicine compound is also little.
Therefore, work out effective Chinese medicine compound, propose the basic data for the medication of the clinical side of sending, one side contributes to science to set forth Chinese medical theory, strives for more academic approval, for later therapy of combining Chinese and Western medicine PKD provides certain foundation; Improve the quality of living for more PKD patient on the other hand, and effectively Economy type medicine is paid.
Summary of the invention:
One of the technical problem to be solved in the present invention is to provide the Chinese medicine composition of the treatment multicystic kidney disease of a kind of safe and effective, taking convenience, price appropriateness.
Two of the technical problem to be solved in the present invention is to provide the preparation method of the Chinese medicine composition of this treatment multicystic kidney disease.
This Chinese medicine composition can, for a long time for the patient of multicystic kidney disease, can improve polycystic kidney disease clinical symptoms, improves its quality of life; And can improve renal function of patients, delay the effect of renal function exacerbation, and also there is good therapeutic effect to improving polycystic kidney disease glomerule, renal tubular function index of correlation and hematuria.
Particularly, the present invention adopts Chinese crude drug Radix Codonopsis, the Radix Astragali, Radix Angelicae Sinensis, Radix Paeoniae Rubra, the Radix Paeoniae Alba, Rhizoma Sparganii, Radix Ranunculi Ternati, Squama Manis powder, Semen Plantaginis, Semen Sinapis Albae, SEMEN VACCARIAE, Rhizoma Drynariae, Herba Duchesneae Indicae, Herba Hedyotidis Diffusae to make, the present invention be treatment multicystic kidney disease Chinese medicine composition (hereinafter to be referred as: press down capsule side).
Chinese crude drug Radix Codonopsis involved in the present invention, the Radix Astragali, Radix Angelicae Sinensis, Radix Paeoniae Rubra, the Radix Paeoniae Alba, Rhizoma Sparganii, Radix Ranunculi Ternati, Squama Manis powder, Semen Plantaginis, Semen Sinapis Albae, SEMEN VACCARIAE, Rhizoma Drynariae, Herba Duchesneae Indicae, Herba Hedyotidis Diffusae are recorded Chinese medicine by Chinese Pharmacopoeia, and meet pharmacopeia prescription.
In one aspect of the invention, a kind of Chinese medicine composition (pressing down capsule side) for the treatment of multicystic kidney disease is provided, is mainly made by the crude drug of following weight parts: 15～30 parts of Radix Codonopsis, 15～30 parts of the Radixs Astragali, 10～15 parts of Radix Angelicae Sinensis, 10～15 parts of Radix Paeoniae Rubra, 10～15 parts of the Radix Paeoniae Albas, 10～15 parts of Rhizoma Sparganii, 10～30 parts of Radix Ranunculi Ternatis, 1～2 part, Squama Manis powder, 10～15 parts of Semen Plantaginiss, 10～15 parts of Semen Sinapis Albaes, 10～15 parts of SEMEN VACCARIAE, 10～15 parts of Rhizoma Drynariae, 10～15 parts of Herba Duchesneae Indicaes, 10～15 parts of Herba Hedyotidis Diffusae.
In the present invention, the weight portion of preferred feedstock medicine is: 15 parts of Radix Codonopsis, 15 parts of the Radixs Astragali, 10 parts of Radix Angelicae Sinensis, 10 parts of Radix Paeoniae Rubra, 10 parts of the Radix Paeoniae Albas, 10 parts of Rhizoma Sparganii, 10 parts of Radix Ranunculi Ternatis, 1 part, Squama Manis powder, 15 parts of Semen Plantaginiss, 10 parts of Semen Sinapis Albaes, 10 parts of SEMEN VACCARIAE, 10 parts of Rhizoma Drynariae, 10 parts of Herba Duchesneae Indicaes, 10 parts of Herba Hedyotidis Diffusae.
In the present invention, the weight portion of another preferred feedstock medicine is: 30 parts of Radix Codonopsis, 30 parts of the Radixs Astragali, 15 parts of Radix Angelicae Sinensis, 15 parts of Radix Paeoniae Rubra, 15 parts of the Radix Paeoniae Albas, 15 parts of Rhizoma Sparganii, 30 parts of Radix Ranunculi Ternatis, 2 parts, Squama Manis powder, 15 parts of Semen Plantaginiss, 15 parts of Semen Sinapis Albaes, 15 parts of SEMEN VACCARIAE, 15 parts of Rhizoma Drynariae, 15 parts of Herba Duchesneae Indicaes, 15 parts of Herba Hedyotidis Diffusae.
Preferably, this Chinese medicine composition also comprises the crude drug of following weight portion: Rhizoma Polygoni Cuspidati 10-15 part, Herba Centellae 10-30 part, Radix et Rhizoma Rhei (processed) 10-15 part.This Chinese medicine composition is made up of the crude drug of following weight portion: 15～30 parts of Radix Codonopsis, 15～30 parts of the Radixs Astragali, 10～15 parts of Radix Angelicae Sinensis, 10～15 parts of Radix Paeoniae Rubra, 10～15 parts of the Radix Paeoniae Albas, 10～15 parts of Rhizoma Sparganii, 10～30 parts of Radix Ranunculi Ternatis, 1～2 part, Squama Manis powder, 10～15 parts of Semen Plantaginiss, 10～15 parts of Semen Sinapis Albaes, 10～15 parts of SEMEN VACCARIAE, 10～15 parts of Rhizoma Drynariae, 10～15 parts of Herba Duchesneae Indicaes, 10～15 parts of Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati 10-15 part, Herba Centellae 10-30 part, Radix et Rhizoma Rhei (processed) 10-15 part.This Chinese medicine composition can be used for the treatment of CKD(chronic kidney disease) III-IV phase patient.
Preferably, this Chinese medicine composition also comprises the crude drug of following weight portion: Herba Ecliptae 10-30 part, charred Nodus Nelumbinis Rhizomatis 10-30 part.This Chinese medicine composition is made up of the crude drug of following weight portion: 15～30 parts of Radix Codonopsis, 15～30 parts of the Radixs Astragali, 10～15 parts of Radix Angelicae Sinensis, 10～15 parts of Radix Paeoniae Rubra, 10～15 parts of the Radix Paeoniae Albas, 10～15 parts of Rhizoma Sparganii, 10～30 parts of Radix Ranunculi Ternatis, 1～2 part, Squama Manis powder, 10～15 parts of Semen Plantaginiss, 10～15 parts of Semen Sinapis Albaes, 10～15 parts of SEMEN VACCARIAE, 10～15 parts of Rhizoma Drynariae, 10～15 parts of Herba Duchesneae Indicaes, 10～15 parts of Herba Hedyotidis Diffusae, Herba Ecliptae 10-30 part, charred Nodus Nelumbinis Rhizomatis 10-30 part.This Chinese medicine composition can be used for the treatment of hematuria patient.
Pharmaceutical composition of the present invention is equipped with adjuvant, further makes compound preparation (oral medicinal herb preparation).The present invention treats the preparation process of the various routines in compound Chinese medicinal preparation employing this area of multicystic kidney disease, adds molding adjuvant or taste masking adjuvant, the oral medicinal herb preparations such as granulation agent, tablet, capsule, oral liquid.Described pharmaceutic adjuvant is selected from lactose, cane sugar powder, magnesium stearate, aspartame, Mentholum and/or oleum Citri sinensis essence etc.
In another aspect of this invention, provide a kind of preparation method of above-mentioned Chinese medicine composition, comprise the steps: to get above-mentioned formula ratio medicine (except Squama Manis powder) half amount, the 3-8 that adds water doubly measures, soak after half an hour, decoct 30-45min, then the 3-8 that adds water doubly measures, decoct 30-45min, filter, merge decoction liquor, include the half amount of Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug is pulverized (crossing 80 orders), with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, includes the half amount of Squama Manis powder in, add mannitol, lactose, cane sugar powder, aspartame, Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation.
In another aspect of this invention, provide the preparation method of another kind of above-mentioned Chinese medicine composition, comprise the steps: above-mentioned crude drug except Squama Manis powder to add 50% ethanol, decoct 1-1.5h, start timing with boiling, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1-1.5h, incline and extracting solution, merge the extracting solution of twice, filter, include Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, and soft material processed is crossed screen cloth, granulates, and dry, granulate, adds carboxymethyl starch sodium, and magnesium stearate is pressed into tablet, or encapsulated.
The consumption of Chinese medicine composition of the present invention and the course for the treatment of can appropriately adjust according to the light and heavy degree of dosage form, patient's age, disease, but be generally oral 2 times of every day, each 3～4 (grains), every (grain) 0.5 gram, or each 1 bag (6g/ bag), taking 3 months as one course for the treatment of, can use continuously 2 courses for the treatment of or longer time.
Chinese medicine composition of the present invention is through clinical research, and result shows, the renal function of Chinese medicine composition of the present invention to multicystic kidney disease patient and renal tubules, glomerule have protection and improvement effect.Tcm syndrome curative effect index is observed, and result shows, can obviously reduce soreness of the waist and knees, back distending pain or twinge, spiritlessness and weakness, aversion to cold and cold limbs, the clinical symptoms of numb limbs and tense tendons.Chinese medicine composition of the present invention can better be treated multicystic kidney disease, taking convenience, and dose is few, and long-term taking has no side effect, and patient assessment is good.
Chinese medicine composition of the present invention and compound preparation have following advantage and feature:
1, show to have effect through clinical research and improve polycystic kidney disease clinical symptoms, and can improve renal function of patients, delay renal function exacerbation.
2, can effectively improve polycystic kidney disease glomerule, renal tubular function index of correlation.
3, can delay to a certain extent the growth of multicystic kidney disease patient cyst.
4, kidney and spleen invigorating movable blood soft hard method is the effective method of Chinese traditional treatment polycystic kidney, is worth us further to further investigate.
Brief description of the drawings:
Fig. 1 is treatment group and relatively schematic diagram of two groups of tcm syndrome curative effects of matched group in test example 3.2.1 of the present invention;
Fig. 2 is treatment group and relatively schematic diagram of two groups for the treatment of front and back syndrome total marks of matched group in test example 3.2.2 of the present invention;
Fig. 3 is treatment group and two groups of main clinical syndrome improvement rate schematic diagrams of matched group in test example 3.2.3 of the present invention.
Detailed description of the invention:
The invention will be further elaborated by the following examples:
Embodiment 1
Weighting raw materials: 15 grams of Radix Codonopsis, 15 grams of the Radixs Astragali, 10 grams of Radix Angelicae Sinensis, 10 grams of Radix Paeoniae Rubra, 10 grams of the Radix Paeoniae Albas, 10 grams of Rhizoma Sparganii, 10 grams of Radix Ranunculi Ternatis, 1 gram, Squama Manis powder, 15 grams of Semen Plantaginiss, 10 grams of Semen Sinapis Albaes, 10 grams of SEMEN VACCARIAE, 10 grams of Rhizoma Drynariae, 10 grams of Herba Duchesneae Indicaes, 10 grams of Herba Hedyotidis Diffusae.
Get above-mentioned raw materials medicine (except Squama Manis powder) half amount, add water 3 times and measure, soak after half an hour, decoct 45min, add water again 3 times and measure, decoct 30min, filter, merge decoction liquor, include 0.5 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 0.5 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 2
Weighting raw materials: 30 grams of Radix Codonopsis, 30 grams of the Radixs Astragali, 15 grams of Radix Angelicae Sinensis, 15 grams of Radix Paeoniae Rubra, 15 grams of the Radix Paeoniae Albas, 15 grams of Rhizoma Sparganii, 30 grams of Radix Ranunculi Ternatis, 2 grams, Squama Manis powder, 15 grams of Semen Plantaginiss, 15 grams of Semen Sinapis Albaes, 15 grams of SEMEN VACCARIAE, 15 grams of Rhizoma Drynariae, 15 grams of Herba Duchesneae Indicaes, 15 grams of Herba Hedyotidis Diffusae.
The half amount of getting above-mentioned formula ratio crude drug (except Squama Manis powder), adds water 8 times and measures, and soaks after half an hour, decocts 30min, add water again 8 times and measure, decoct 45min, filter, merge decoction liquor, include 1 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 1 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 3
Weighting raw materials: 18 grams of Radix Codonopsis, 18 grams of the Radixs Astragali, 12 grams of Radix Angelicae Sinensis, 12 grams of Radix Paeoniae Rubra, 12 grams of the Radix Paeoniae Albas, 12 grams of Rhizoma Sparganii, 20 grams of Radix Ranunculi Ternatis, 1.6 grams, Squama Manis powder, 12 grams of Semen Plantaginiss, 12 grams of Semen Sinapis Albaes, 12 grams of SEMEN VACCARIAE, 12 grams of Rhizoma Drynariae, 12 grams of Herba Duchesneae Indicaes, 12 grams of Herba Hedyotidis Diffusae.
The half amount of getting above-mentioned formula ratio crude drug (except Squama Manis powder), adds water 5 times and measures, and soaks after half an hour, decocts 40min, add water again 5 times and measure, decoct 40min, filter, merge decoction liquor, include 0.8 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 0.8 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 4
Weighting raw materials: 5 grams of Radix Codonopsis, 5 grams of the Radixs Astragali, 3 grams of Radix Angelicae Sinensis, 3 grams of Radix Paeoniae Rubra, 3 grams of the Radix Paeoniae Albas, 3 grams of Rhizoma Sparganii, 5 grams of Radix Ranunculi Ternatis, 0.5 gram, Squama Manis powder, 5 grams of Semen Plantaginiss, 3 grams of Semen Sinapis Albaes, 3 grams of SEMEN VACCARIAE, 3 grams of Rhizoma Drynariae, 3 grams of Herba Duchesneae Indicaes, 3 grams of Herba Hedyotidis Diffusae.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1.5h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1.5h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.5 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
Embodiment 5
Weighting raw materials: 7 grams of Radix Codonopsis, 7 grams of the Radixs Astragali, 5 grams of Radix Angelicae Sinensis, 5 grams of Radix Paeoniae Rubra, 5 grams of the Radix Paeoniae Albas, 5 grams of Rhizoma Sparganii, 10 grams of Radix Ranunculi Ternatis, 0.8 gram, Squama Manis powder, 7 grams of Semen Plantaginiss, 5 grams of Semen Sinapis Albaes, 5 grams of SEMEN VACCARIAE, 5 grams of Rhizoma Drynariae, 5 grams of Herba Duchesneae Indicaes, 5 grams of Herba Hedyotidis Diffusae.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.8 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
Embodiment 6
Weighting raw materials: 6 grams of Radix Codonopsis, 6 grams of the Radixs Astragali, 6 grams of Radix Angelicae Sinensis, 6 grams of Radix Paeoniae Rubra, 6 grams of the Radix Paeoniae Albas, 6 grams of Rhizoma Sparganii, 8 grams of Radix Ranunculi Ternatis, 0.6 gram, Squama Manis powder, 4 grams of Semen Plantaginiss, 4 grams of Semen Sinapis Albaes, 4 grams of SEMEN VACCARIAE, 4 grams of Rhizoma Drynariae, 6 grams of Herba Duchesneae Indicaes, 6 grams of Herba Hedyotidis Diffusae.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1.2h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1.2h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.6 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
Embodiment 7
Weighting raw materials: 15 grams of Radix Codonopsis, 15 grams of the Radixs Astragali, 10 grams of Radix Angelicae Sinensis, 10 grams of Radix Paeoniae Rubra, 10 grams of the Radix Paeoniae Albas, 10 grams of Rhizoma Sparganii, 10 grams of Radix Ranunculi Ternatis, 1 gram, Squama Manis powder, 15 grams of Semen Plantaginiss, 10 grams of Semen Sinapis Albaes, 10 grams of SEMEN VACCARIAE, 10 grams of Rhizoma Drynariae, 10 grams of Herba Duchesneae Indicaes, 10 grams of Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati 10g, Herba Centellae 10g, Radix et Rhizoma Rhei (processed) 10g.
Get above-mentioned raw materials medicine (except Squama Manis powder) half amount, add water 3 times and measure, soak after half an hour, decoct 45min, add water again 3 times and measure, decoct 30min, filter, merge decoction liquor, include 0.5 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 0.5 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 8
Weighting raw materials: 30 grams of Radix Codonopsis, 30 grams of the Radixs Astragali, 15 grams of Radix Angelicae Sinensis, 15 grams of Radix Paeoniae Rubra, 15 grams of the Radix Paeoniae Albas, 15 grams of Rhizoma Sparganii, 30 grams of Radix Ranunculi Ternatis, 2 grams, Squama Manis powder, 15 grams of Semen Plantaginiss, 15 grams of Semen Sinapis Albaes, 15 grams of SEMEN VACCARIAE, 15 grams of Rhizoma Drynariae, 15 grams of Herba Duchesneae Indicaes, 15 grams of Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati 15g, Herba Centellae 30g, Radix et Rhizoma Rhei (processed) 15g.
The half amount of getting above-mentioned formula ratio crude drug (except Squama Manis powder), adds water 8 times and measures, and soaks after half an hour, decocts 30min, add water again 8 times and measure, decoct 45min, filter, merge decoction liquor, include 1 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 1 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 9
Weighting raw materials: 18 grams of Radix Codonopsis, 18 grams of the Radixs Astragali, 12 grams of Radix Angelicae Sinensis, 12 grams of Radix Paeoniae Rubra, 12 grams of the Radix Paeoniae Albas, 12 grams of Rhizoma Sparganii, 20 grams of Radix Ranunculi Ternatis, 1.6 grams, Squama Manis powder, 12 grams of Semen Plantaginiss, 12 grams of Semen Sinapis Albaes, 12 grams of SEMEN VACCARIAE, 12 grams of Rhizoma Drynariae, 12 grams of Herba Duchesneae Indicaes, 12 grams of Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati 12g, Herba Centellae 20g, Radix et Rhizoma Rhei (processed) 12g.
The half amount of getting above-mentioned formula ratio crude drug (except Squama Manis powder), adds water 5 times and measures, and soaks after half an hour, decocts 40min, add water again 5 times and measure, decoct 40min, filter, merge decoction liquor, include 0.8 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 0.8 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 10
Weighting raw materials: 5 grams of Radix Codonopsis, 5 grams of the Radixs Astragali, 3 grams of Radix Angelicae Sinensis, 3 grams of Radix Paeoniae Rubra, 3 grams of the Radix Paeoniae Albas, 3 grams of Rhizoma Sparganii, 5 grams of Radix Ranunculi Ternatis, 0.5 gram, Squama Manis powder, 5 grams of Semen Plantaginiss, 3 grams of Semen Sinapis Albaes, 3 grams of SEMEN VACCARIAE, 3 grams of Rhizoma Drynariae, 3 grams of Herba Duchesneae Indicaes, 3 grams of Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati 3g, Herba Centellae 5g, Radix et Rhizoma Rhei (processed) 3g.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1.5h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1.5h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.5 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
Embodiment 11
Weighting raw materials: 7 grams of Radix Codonopsis, 7 grams of the Radixs Astragali, 5 grams of Radix Angelicae Sinensis, 5 grams of Radix Paeoniae Rubra, 5 grams of the Radix Paeoniae Albas, 5 grams of Rhizoma Sparganii, 10 grams of Radix Ranunculi Ternatis, 0.8 gram, Squama Manis powder, 7 grams of Semen Plantaginiss, 5 grams of Semen Sinapis Albaes, 5 grams of SEMEN VACCARIAE, 5 grams of Rhizoma Drynariae, 5 grams of Herba Duchesneae Indicaes, 5 grams of Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati 5g, Herba Centellae 7g, Radix et Rhizoma Rhei (processed) 5g.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.8 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
Embodiment 12
Weighting raw materials: 6 grams of Radix Codonopsis, 6 grams of the Radixs Astragali, 6 grams of Radix Angelicae Sinensis, 6 grams of Radix Paeoniae Rubra, 6 grams of the Radix Paeoniae Albas, 6 grams of Rhizoma Sparganii, 8 grams of Radix Ranunculi Ternatis, 0.6 gram, Squama Manis powder, 4 grams of Semen Plantaginiss, 4 grams of Semen Sinapis Albaes, 4 grams of SEMEN VACCARIAE, 4 grams of Rhizoma Drynariae, 6 grams of Herba Duchesneae Indicaes, 6 grams of Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati 6g, Herba Centellae 6g, Radix et Rhizoma Rhei (processed) 6g.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1.2h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1.2h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.6 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
Embodiment 13
Weighting raw materials: 15 grams of Radix Codonopsis, 15 grams of the Radixs Astragali, 10 grams of Radix Angelicae Sinensis, 10 grams of Radix Paeoniae Rubra, 10 grams of the Radix Paeoniae Albas, 10 grams of Rhizoma Sparganii, 10 grams of Radix Ranunculi Ternatis, 1 gram, Squama Manis powder, 15 grams of Semen Plantaginiss, 10 grams of Semen Sinapis Albaes, 10 grams of SEMEN VACCARIAE, 10 grams of Rhizoma Drynariae, 10 grams of Herba Duchesneae Indicaes, 10 grams of Herba Hedyotidis Diffusae, Herba Ecliptae 10g, charred Nodus Nelumbinis Rhizomatis 10g.
Get above-mentioned raw materials medicine (except Squama Manis powder) half amount, add water 3 times and measure, soak after half an hour, decoct 45min, add water again 3 times and measure, decoct 30min, filter, merge decoction liquor, include 0.5 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 0.5 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 14
Weighting raw materials: 30 grams of Radix Codonopsis, 30 grams of the Radixs Astragali, 15 grams of Radix Angelicae Sinensis, 15 grams of Radix Paeoniae Rubra, 15 grams of the Radix Paeoniae Albas, 15 grams of Rhizoma Sparganii, 30 grams of Radix Ranunculi Ternatis, 2 grams, Squama Manis powder, 15 grams of Semen Plantaginiss, 15 grams of Semen Sinapis Albaes, 15 grams of SEMEN VACCARIAE, 15 grams of Rhizoma Drynariae, 15 grams of Herba Duchesneae Indicaes, 15 grams of Herba Hedyotidis Diffusae, Herba Ecliptae 30g, charred Nodus Nelumbinis Rhizomatis 30g.
The half amount of getting above-mentioned formula ratio crude drug (except Squama Manis powder), adds water 8 times and measures, and soaks after half an hour, decocts 30min, add water again 8 times and measure, decoct 45min, filter, merge decoction liquor, include 1 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 1 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 15
Weighting raw materials: 18 grams of Radix Codonopsis, 18 grams of the Radixs Astragali, 12 grams of Radix Angelicae Sinensis, 12 grams of Radix Paeoniae Rubra, 12 grams of the Radix Paeoniae Albas, 12 grams of Rhizoma Sparganii, 20 grams of Radix Ranunculi Ternatis, 1.6 grams, Squama Manis powder, 12 grams of Semen Plantaginiss, 12 grams of Semen Sinapis Albaes, 12 grams of SEMEN VACCARIAE, 12 grams of Rhizoma Drynariae, 12 grams of Herba Duchesneae Indicaes, 12 grams of Herba Hedyotidis Diffusae, Herba Ecliptae 20g, charred Nodus Nelumbinis Rhizomatis 20g.
The half amount of getting above-mentioned formula ratio crude drug (except Squama Manis powder), adds water 5 times and measures, and soaks after half an hour, decocts 40min, add water again 5 times and measure, decoct 40min, filter, merge decoction liquor, include 0.8 gram, Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder (crossing 80 orders).Second half crude drug was pulverized 80 orders, with CO60 sterilizing (irradiation dose 8k), mixed with extract powder, include 0.8 gram, Squama Manis powder in, add following appropriate pharmaceutic adjuvant: mannitol, lactose, cane sugar powder, aspartame and Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation, 6 grams every bag.
Embodiment 16
Weighting raw materials: 5 grams of Radix Codonopsis, 5 grams of the Radixs Astragali, 3 grams of Radix Angelicae Sinensis, 3 grams of Radix Paeoniae Rubra, 3 grams of the Radix Paeoniae Albas, 3 grams of Rhizoma Sparganii, 5 grams of Radix Ranunculi Ternatis, 0.5 gram, Squama Manis powder, 5 grams of Semen Plantaginiss, 3 grams of Semen Sinapis Albaes, 3 grams of SEMEN VACCARIAE, 3 grams of Rhizoma Drynariae, 3 grams of Herba Duchesneae Indicaes, 3 grams of Herba Hedyotidis Diffusae, Herba Ecliptae 5g, charred Nodus Nelumbinis Rhizomatis 5g.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1.5h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1.5h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.5 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
Embodiment 17
Weighting raw materials: 7 grams of Radix Codonopsis, 7 grams of the Radixs Astragali, 5 grams of Radix Angelicae Sinensis, 5 grams of Radix Paeoniae Rubra, 5 grams of the Radix Paeoniae Albas, 5 grams of Rhizoma Sparganii, 10 grams of Radix Ranunculi Ternatis, 0.8 gram, Squama Manis powder, 7 grams of Semen Plantaginiss, 5 grams of Semen Sinapis Albaes, 5 grams of SEMEN VACCARIAE, 5 grams of Rhizoma Drynariae, 5 grams of Herba Duchesneae Indicaes, 5 grams of Herba Hedyotidis Diffusae, Herba Ecliptae 7g, charred Nodus Nelumbinis Rhizomatis 7g.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.8 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
Embodiment 18
Weighting raw materials: 6 grams of Radix Codonopsis, 6 grams of the Radixs Astragali, 6 grams of Radix Angelicae Sinensis, 6 grams of Radix Paeoniae Rubra, 6 grams of the Radix Paeoniae Albas, 6 grams of Rhizoma Sparganii, 8 grams of Radix Ranunculi Ternatis, 0.6 gram, Squama Manis powder, 4 grams of Semen Plantaginiss, 4 grams of Semen Sinapis Albaes, 4 grams of SEMEN VACCARIAE, 4 grams of Rhizoma Drynariae, 6 grams of Herba Duchesneae Indicaes, 6 grams of Herba Hedyotidis Diffusae, Herba Ecliptae 6g, charred Nodus Nelumbinis Rhizomatis 6g.
Above-mentioned crude drug except Squama Manis powder is added to 50% ethanol, decoct 1.2h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1.2h, incline and extracting solution, merge the extracting solution of twice, filter, include 0.6 gram, Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, soft material processed, cross 18 eye mesh screens, granulate, dry, 14 mesh sieve granulate, add following appropriate pharmaceutic adjuvant: carboxymethyl starch sodium, magnesium stearate, is pressed into tablet, every heavy 500mg, or encapsulated, 0.5 gram of every capsules.
By test example, beneficial effect of the present invention is further elaborated below:
Test example 1 presses down the clinical research of capsule side
1 clinical data
1.1 case sources
All cases derives from the CKDI-IV phase PKD patient of year March in January, 2010 to 2012 in 75 examples that meet study condition in Shuguang Hospital and the Urology Department outpatient service of Long March hospital, ward, (glomerular filtration rate GFR calculates according to MDRD formula).Be divided into treatment group and the Primary Care matched group of Primary Care (seeing following 2.1)+medicine (Chinese medicine composition of the present invention) treatment (seeing following 2.2).
1.2 diagnostic criteria
1.2.1 Western medicine diagnose standard
With reference to Wang Haiyan chief editor " nephrology " (third edition), Li Leishi, the diagnostic criteria of Liu Zhihong chief editor " Chinese nephrology " (first edition) polycystic kidney is drafted.
Main standard: 1. renal cortex, medullary substance are covered with multiple fluidity cysts;
2. clear and definite ADPKD family history.
Minor criteria: 1. polycystic liver;
2. renal insufficiency;
3. celiocele;
4. heart valve disorders;
5. pancreatic cyst;
6. intracranial aneurysm;
7. cyst of seminal vesicle;
8. blepharoptosis.
As long as meet two main standard and any one minor criteria, clinical diagnosable ADPKD; As Section 1 main standard only, without Inheritance history, to there be 3 above minor criterias, just can make a definite diagnosis ADPKD.
1.2.2 tcm diagnosis standard
Publish Zheng Xiao cornel chief editor " new Chinese medicine guideline of clinical investigations (trying) " about standard and the Issued by China State Bureau of Technical Supervision " National Standard of the People's Republic of China's tcm clinical practice diagnosis and treatment term syndrome part " of deficiency of spleen-YANG and kidneyYANG and blood stasis pattern of syndrome with reference to Chinese Medicine science and technology publishing house in 2002, standard GB/T/T16751.2-1997, about the standard of deficiency of spleen-YANG and kidneyYANG and syndrome of blood stasis.
1. primary symptom: abdominal mass, soreness of the waist and knees, back distending pain or twinge, spiritlessness and weakness, aversion to cold and cold limbs, numb limbs and tense tendons;
2. time disease: lethargy, edema of lower limbs, ecchymosis, squamous and dry skin, uncomfortable in chest, nocturia;
3. tongue arteries and veins: purplish tongue is dark or dark red, and tongue is white, the unable or string of deep-slow pulse is puckery etc.
Possess 2 of primary symptoms, 2 of inferior diseases, the i.e. diagnosable deficiency of spleen-YANG and kidneyYANG blood stasis type of holding concurrently.
1.3 inclusive criteria
1. meet polycystic kidney diagnostic criteria;
2. age 25-75 year;
3. row kidney replacement therapy not;
4. without the serious primary disease such as cardiovascular, liver and hemopoietic system;
5. renal function GFR >=15ml/min.
1.4 exclusion standard
1. do not meet polycystic kidney diagnostic criteria;
2. the age is less than 25 years old or is greater than 75 years old;
3. row kidney alternative medicine before medical or admission examination;
4. gestation or women breast-feeding their children;
5. be associated with the serious primary disease such as cardiovascular, liver and hemopoietic system;
6. psychotic or can not clear expression malaise symptoms person;
7. participate in other clinical medicines experimenter simultaneously;
8. renal function GFR < 15ml/min.
1.5 rejecting standards
1. include the rear discovery person that do not meet inclusive criteria in;
2. those who are allergic to this drug;
3. data is not congruent affects diagnosis or statistics person;
4. enter the patient of CKDV phase, termination test;
5. the double patient of serum creatinine, termination test.
The case of rejecting is answered to illustration, and its case report form should retain for future reference.Reject case and do not make curative effect statistical analysis, but at least accepting 1 treatment, and being easy to judge untoward reaction and having keeper, should analyze untoward reaction.
1.6 standards that come off
1. observe in naturally come off, lost to follow-up;
2. there is complication or special physiological variation etc. and should not continue reception test in experimenter, exits voluntarily.
The case coming off is answered itemized record reason, and the switching of its last curative effect testing result is carried out to statistical analysis for final result.
2 methods
2.1 Primary Care
1. generally process: take a good rest, avoid violent muscle power, movable and abdominal part is wounded.CKDIII, CKDIV phase patient give low-salt high-quality low protein diet.And opened with 4 tid oral.
2. the various complication of active treatment: control blood pressure: losartan, gives calcium ion antagonist if desired; Hematuria acute stage: etamsylate, reptilase etc.; Accompanying infection: anti-infective therapy etc.
2.2 medicines (Chinese medicine composition of the present invention)
Press down capsule side: formed by Radix Codonopsis, the Radix Astragali, Radix Angelicae Sinensis, Radix Paeoniae Rubra, the Radix Paeoniae Alba, Rhizoma Sparganii, Radix Ranunculi Ternati, Squama Manis powder (divide and gulp down), Semen Plantaginis, Semen Sinapis Albae, SEMEN VACCARIAE, Rhizoma Drynariae, Herba Duchesneae Indicae, Herba Hedyotidis Diffusae.
Plus-minus: CKDIII-IV phase patient adds Rhizoma Polygoni Cuspidati, Herba Centellae, Radix et Rhizoma Rhei (processed).
Hematuria adds Herba Ecliptae, charred Nodus Nelumbinis Rhizomatis.
2.3 the course for the treatment of
Two groups all taking 6 months as the clinical observation time limit.
2.4 observation index
2.4.1 clinical symptoms and sign
Set up clinical observation table, carry out syndrome integration.Clinical observation table is published Zheng Xiao cornel chief editor " new Chinese medicine guideline of clinical investigations (trying) " about the standard formulation of deficiency of spleen-YANG and kidneyYANG and blood stasis pattern of syndrome with reference to Chinese Medicine science and technology publishing house in 2002.
Primary symptom: abdominal mass, soreness of the waist and knees, back distending pain or twinge, spiritlessness and weakness, aversion to cold and cold limbs, numb limbs and tense tendons;
Inferior disease: lethargy, edema of lower limbs, ecchymosis, squamous and dry skin, uncomfortable in chest, nocturia.
Wherein normal 0 point of primary symptom, slight 2 points, 4 points of moderates, 6 points of severes; Normal 0 point of inferior disease, slight 1 point, 2 points of moderates, 3 points of severes.Tongue fur pulse condition record separately, does not participate in integral contrast.
2.4.2 lab index
2.4.2.1 general index: B-ultrasonic renal: the maximum cyst volume of two kidneys and Kidney Volume, renal function (BUN, Scr, UA), glomerular filtration rate (GFR), routine urinalysis, urine NAG, RBP, microdose urine protein/urine creatine.
2.4.2.2 safety indexes: routine blood test (WBC, RBC, HGB, PLT), liver function (ALT, AST, γ-GT).
2.4.2.3 indication test method: B-ultrasonic renal adopts U.S. GELOGIQS ultrasonic developing-out unit, and frequency probe is 3.5MHZ; Routine urinalysis adopts Urine Analyzer algoscopy; Liver, renal function, urine NAG, RBP, microdose urine protein, urine creatine adopt automatic biochemical analyzer algoscopy; Routine blood test adopts blood analyser to measure; Glomerular filtration rate calculates with the MDRD formula of simplifying:
GFR=186 × Scr -1.154× Age -0.203(× 0.742 in this way women) ml/min/1.73m 2.
2.4.3 the timing node that each group is observed:
0 week, 3 months, 6 months each records 1 time of two groups of patient's tcm syndrome integrations; 0 week, 6 months each records 1 time of renal function (BUN, Scr, UA); Safety indexes 0 week and 6 months each records 1 time.Treatment group kidneys of patients B ultrasonic, urine NAG, RBP, 0 week, 6 months each records 1 time of microdose urine protein/urine creatine; Separately treatment group choose 20 routine patients treatment after 3 months repetition measurement renal function (BUN, Scr, UA) once, and record.
2.4.4 drug combination
If use the medicine of non-treatment primary disease, must observe table in record.
2.5 curative effect determinate standard
With reference to the tcm syndrome curative effect determinate standard of defined in " new Chinese medicine guideline of clinical investigations "; " new Chinese medicine treatment chronic renal failure guideline of clinical investigations " chronic kidney hypofunction curative effect determinate standard and Cao Haigen chief editor " ultrasonic guide puncture Clinics and Practices " cyst of kidney efficacy assessment standard, the criterion of therapeutical effect of formulation is as follows:
2.5.1 tcm syndrome efficacy evaluation foundation
1. clinical recovery tcm clinical practice symptom, sign disappear or substantially disappear, and syndrome integration reduces >=95%;
2. effective tcm clinical practice symptom, sign are obviously improved, and syndrome integration reduces >=70%;
3. effectively tcm clinical practice symptom, sign all take a favorable turn, and syndrome integration reduces >=30%;
4. invalid tcm clinical practice symptom, sign are all not improved, even increase the weight of, syndrome integration reduces less than 30%.
Note: computing formula (nimodipine method) is: [integration before (the rear integration of integration-treatment before treatment) ÷ treatment] × 100%
2.5.2 the curative effect determinate standard foundation of cardinal symptom
1. transference cure after clinical recovery treatment.
2. after effective treatment, mild symptoms weight classification Ti declines 2 grades, by severe to slightly.
3. effectively mild symptoms weight classification Ti declines 1 grade after treatment, by severe to moderate, or by moderate to slightly.
4. unchanged before and after futile treatment.
2.5.3 cyst efficacy determination foundation
1. clinic control ultrasound diagnosis show cyst obviously dwindle be greater than 1/2 or disappear, through more than 6 months observe without recurrence;
2. effective ultrasound diagnosis shows that cyst no longer increases, or dwindles and reach 1/2, through more than 6 months observing without recurrence;
3. effectively ultrasound diagnosis shows that cyst no longer increases or slightly dwindles;
4. invalid ultrasound diagnosis shows that cyst increases.
2.5.4 comprehensive therapeutic effect judgment basis
1. clinic control clinical symptom disappearance; Controlling of blood pressure is normal; GFR increases >=20%; And (or) serum creatinine reduces >=20%;
2. effective clinical symptoms makes moderate progress; Controlling of blood pressure is normal; GFR increases >=10%; And (or) serum creatinine reduces >=10%;
3. effective clinical symptom makes moderate progress; Controlling of blood pressure is normal; GFR is without reduction, or increase <10%; And (or) serum creatinine is without increase, or reduce <10%;
4. invalid clinical symptoms is not improved or increases the weight of; GFR reduces; And (or) serum creatinine increases.
2.6 statistical method
Mean ± standard deviation for data description and median (M) expression, gained data uses SPSS18.0 statistical analysis software to process.T inspection and non parametric tests analytical method for measurement data, enumeration data x 2inspection.P<0.05 is that there were significant differences; P<0.01 is for there being highly significant difference; P>0.05 is without significant difference.
3 results
Have 75 routine patients and include this clinical observation in, wherein treatment group has 5 examples not complete clinical observation, comprises 3 examples that come off, termination test 2 examples, have the effective case of 70 example and can carry out analysis of cases, wherein treatment group 35 examples, matched group 35 examples, male is totally 43 examples, and women is totally 27 examples.In two groups of patients, 82.9% has family history, 74.3% complicated hypertension medical history, and 71.4% with hepatic cyst, 64.3% with pain, and 67.1% with calculus, and 31.4% with albuminuria, 38.6% with hematuria, and 47.1% with urinary tract infection, and 44.3% occurs that uric acid increases.
The comparison of 3.1 physical data
The each group of table 1 sex, the comparison at age
The comparison of the table 2 liang group patient course of disease
Table 3 liang group patient CKD comparison by stages
Each group of no significant difference (P>0.05) in age, sex, the course of disease and the state of an illness.In table 1,2,3.
Treatment group: 35 examples, Scr50～353 μ mol/L before treatment, average 147.11 ± 85.83 μ mol/L;
Matched group: 35 examples, Scr60～283 μ mol/L before treatment, average 127.34 ± 76.12 μ mol/L.
The variation of tcm syndrome before and after 3.2 liang of group treatments
3.2.1 two groups of tcm syndrome curative effects comparison
Table 4 liang group tcm syndrome curative effect comparison
(note: * and matched group be P<0.01 relatively)
As shown in table 4, Fig. 1, its explanation: before and after two groups of treatments, tcm syndrome curative effect relatively has significant difference (P<0.01), and treatment group is better than matched group.
3.2.2 two groups of tcm syndrome total marks comparison
Syndrome total mark comparison before and after table 5 liang group treatment
(note: * and matched group be P<0.01 relatively, compares P<0.01 in # treatment group group).
As shown in table 5, Fig. 2, its explanation: treatment group syndrome total mark all had significance to decline for 3rd month, the 6th month compared with 0 week, all have significant difference (P<0.01) compared with matched group; Treatment group 0 week all has significant difference (P<0.01) compared with between 3 months, 0 week and 6 months integrations.
3.2.3 two groups of main tcm syndromes improve situation comparison
Before and after table 6 liang group treatment, main syndromes improves situation comparison
(note: represent P>0.05 with matched group comparison * *, * represents P<0.05, #represent P<0.01)
As shown in table 6, Fig. 3, its explanation: after 6 months, the treatment group soreness of waist is weak, the improvement degree of back distending pain or twinge, spiritlessness and weakness, aversion to cold and cold limbs, numb limbs and tense tendons is obviously better than matched group (P<0.05, P<0.01); Though it is variant that the improvement degree of two groups of abdominal mass symptoms is compared, do not there is statistical significance (P>0.05).
Before and after 3.3 liang of group treatments, renal function improves situation
3.3.1 the variation of Scr, BUN, UA before and after two groups of treatments
Before and after table 7 liang group treatment, Scr, BUN improve situation comparison (M)
(note: * represents P<0.05 with matched group comparison, ◆ represent P>0.05)
Before and after table 8 liang group treatment, UA improves situation comparison (μ mol/L)
(note: with matched group comparison ◆ represent P>0.05)
Table 7, table 8 illustrate: after 6 months, treatment group Scr declines during compared with 0 week to some extent, and improvement degree is better than matched group (P<0.05); BUN, UA aspect, although treatment group declines to some extent compared with matched group, do not have statistical significance (P>0.05).
3.3.2 the variation of GFR before and after two groups of treatments
Before and after table 9 liang group treatment, GFR improves situation comparison (ml/min/1.73m 2) (M)
(note: #representative and relatively P<0.01 of matched group)
Table 9 illustrates: after 6 months, treatment group GFR obviously improved compared with 0 week, had significant difference (P<0.01) compared with matched group.
3.3.3 CKD variation by stages before and after two groups of treatments
CKD variation by stages before and after table 10 liang group treatment
Table 10 illustrates: after 6 months, treatment group CKD was clearly better compared with 0 week, and the patient of CKD1-3 phase obviously increases, and the patient of CKD4 phase obviously reduces, and matched group has 2 examples to make progress as the CKD3 phase from the CKD2 phase after 6 months.Treatment group has obvious statistical significance (P<0.01) compared with matched group.
The comparison of comprehensive therapeutic effect before and after 3.4 liang of group patient treatments
The comparison of comprehensive therapeutic effect before and after table 11 liang group treatment
(note: #with relatively P<0.01 of matched group)
Table 11 illustrates: after 6 months, the comprehensive therapeutic effect for the treatment of group is 71.43%, and the effective percentage of matched group is 37.14%, two group to be compared and have significant difference (P<0.01), and treatment group is better than matched group.
The improvement situation of index of correlation before and after 3.5 treatment group treatments
3.5.1 before and after treatment group treatment, urine NAG, RBP, urine trace albumin/urine creatine are improved situation
Before and after the treatment of table 12 treatment group, urine NAG, RBP improve situation comparison (M)
(note: * and 0 week comparison P<0.05)
Before and after the treatment of table 13 treatment group, microdose urine protein/urine creatine is improved situation comparison (mg/L/g/L) (M)
(note: #with 0 week comparison P<0.01)
Table 12, table 13 illustrate: aspect the improving of renal tubules, glomerular function, treatment group has clear improvement before treatment after 6 months in treatment, and both compare has notable difference (P<0.05, P<0.01).
3.5.2 before and after treatment group treatment, the maximum cyst volume of two kidneys improves situation
Before and after the treatment of table 14 treatment group, the maximum cyst volume of two kidneys improves situation comparison (mm 3) (M)
(note: ◆representative and 0 week comparison P>0.05)
Table 14 illustrates: treatment group after treatment 6 months, although the maximum cyst volume of right side kidney reduce to some extent, no difference of science of statistics (P>0.05).
3.5.3 before and after treatment group treatment, two kidney Kidney Volumes improve situation
Before and after the treatment of table 15 treatment group, two kidney volumes improve situation comparison (mm 3) (M)
(note: ◆with 0 week comparison P>0.05)
Table 15 illustrates: treatment group is after treatment 6 months, although the reducing to some extent of left kidney volume, no difference of science of statistics (P>0.05).
3.5.4 0 week, 3 months, 6 months renal functioies of the routine patient treatment for the treatment of group 20: serum creatinine improves situation
Before and after the routine patient treatment of table 16 treatment group 20, Scr improves situation comparison (μ mol/L) (M)
(note: ◆represent 0 week and compare P>0.05)
Table 16 illustrates: although the routine patient for the treatment of group 20 treatment 3 months after with treatment 6 months after creatinine compared with 0 week to some extent decline, no difference of science of statistics (P>0.05).
In a word, clinically, Chinese medicine composition of the present invention can improve polycystic kidney disease clinical symptoms, and can improve renal function of patients, delays the effect of renal function exacerbation, and to improving polycystic kidney disease glomerule, renal tubular function index of correlation also has good therapeutic effect.Traditional Chinese medical science kidney and spleen invigorating movable blood soft hard method suits the pathogenesis of multicystic kidney disease, is worthy of popularization.At present, its mechanism still needs animal experiment study constantly to explore and demonstration.

Claims (9)

1. treat the Chinese medicine composition of multicystic kidney disease for one kind, it is characterized in that, made by the crude drug of following weight parts: 15～30 parts of Radix Codonopsis, 15～30 parts of the Radixs Astragali, 10～15 parts of Radix Angelicae Sinensis, 10～15 parts of Radix Paeoniae Rubra, 10～15 parts of the Radix Paeoniae Albas, 10～15 parts of Rhizoma Sparganii, 10～30 parts of Radix Ranunculi Ternatis, 1～2 part, Squama Manis powder, 10～15 parts of Semen Plantaginiss, 10～15 parts of Semen Sinapis Albaes, 10～15 parts of SEMEN VACCARIAE, 10～15 parts of Rhizoma Drynariae, 10～15 parts of Herba Duchesneae Indicaes, 10～15 parts of Herba Hedyotidis Diffusae.
2. the Chinese medicine composition for the treatment of multicystic kidney disease as claimed in claim 1, it is characterized in that, the weight portion of described crude drug is: 15 parts of Radix Codonopsis, 15 parts of the Radixs Astragali, 10 parts of Radix Angelicae Sinensis, 10 parts of Radix Paeoniae Rubra, 10 parts of the Radix Paeoniae Albas, 10 parts of Rhizoma Sparganii, 10 parts of Radix Ranunculi Ternatis, 1 part, Squama Manis powder, 15 parts of Semen Plantaginiss, 10 parts of Semen Sinapis Albaes, 10 parts of SEMEN VACCARIAE, 10 parts of Rhizoma Drynariae, 10 parts of Herba Duchesneae Indicaes, 10 parts of Herba Hedyotidis Diffusae.
3. the Chinese medicine composition for the treatment of multicystic kidney disease as claimed in claim 1, it is characterized in that, the weight portion of described crude drug is: 30 parts of Radix Codonopsis, 30 parts of the Radixs Astragali, 15 parts of Radix Angelicae Sinensis, 15 parts of Radix Paeoniae Rubra, 15 parts of the Radix Paeoniae Albas, 15 parts of Rhizoma Sparganii, 30 parts of Radix Ranunculi Ternatis, 2 parts, Squama Manis powder, 15 parts of Semen Plantaginiss, 15 parts of Semen Sinapis Albaes, 15 parts of SEMEN VACCARIAE, 15 parts of Rhizoma Drynariae, 15 parts of Herba Duchesneae Indicaes, 15 parts of Herba Hedyotidis Diffusae.
4. treat the Chinese medicine composition of multicystic kidney disease for one kind, it is characterized in that, made by the crude drug of following weight parts: 15～30 parts of Radix Codonopsis, 15～30 parts of the Radixs Astragali, 10～15 parts of Radix Angelicae Sinensis, 10～15 parts of Radix Paeoniae Rubra, 10～15 parts of the Radix Paeoniae Albas, 10～15 parts of Rhizoma Sparganii, 10～30 parts of Radix Ranunculi Ternatis, 1～2 part, Squama Manis powder, 10～15 parts of Semen Plantaginiss, 10～15 parts of Semen Sinapis Albaes, 10～15 parts of SEMEN VACCARIAE, 10～15 parts of Rhizoma Drynariae, 10～15 parts of Herba Duchesneae Indicaes, 10～15 parts of Herba Hedyotidis Diffusae, Rhizoma Polygoni Cuspidati 10-15 part, Herba Centellae 10-30 part, Radix et Rhizoma Rhei (processed) 10-15 part.
5. treat the Chinese medicine composition of multicystic kidney disease for one kind, it is characterized in that, made by the crude drug of following weight parts: 15～30 parts of Radix Codonopsis, 15～30 parts of the Radixs Astragali, 10～15 parts of Radix Angelicae Sinensis, 10～15 parts of Radix Paeoniae Rubra, 10～15 parts of the Radix Paeoniae Albas, 10～15 parts of Rhizoma Sparganii, 10～30 parts of Radix Ranunculi Ternatis, 1～2 part, Squama Manis powder, 10～15 parts of Semen Plantaginiss, 10～15 parts of Semen Sinapis Albaes, 10～15 parts of SEMEN VACCARIAE, 10～15 parts of Rhizoma Drynariae, 10～15 parts of Herba Duchesneae Indicaes, 10～15 parts of Herba Hedyotidis Diffusae, Herba Ecliptae 10-30 part, charred Nodus Nelumbinis Rhizomatis 10-30 part.
6. the Chinese medicine composition as described in claim 1-5 any one, is characterized in that, described Chinese medicine composition is made oral medicinal herb preparation.
7. Chinese medicine composition as claimed in claim 6, is characterized in that, described oral medicinal herb preparation is granule, capsule or tablet.
8. a preparation method for the Chinese medicine composition of the treatment multicystic kidney disease as described in claim 1-7 any one, is characterized in that, it comprises the steps:
Weighting raw materials, the half amount of getting the crude drug except Squama Manis powder, the 3-8 that adds water doubly measures, and soaks after half an hour, decoct 30-45min, the 3-8 that adds water again doubly measures, and decocts 30-45min, filters, merges decoction liquor, include the half amount of Squama Manis powder in, concentrating under reduced pressure, drying under reduced pressure obtains dry extract, is ground into fine powder; Second half crude drug is pulverized, and use CO60 sterilizing, mixes with extract powder, includes the half amount of Squama Manis powder in, adds mannitol, lactose, cane sugar powder, aspartame, Mentholum, after mix homogeneously with 60～70% ethanol as binding agent granulation.
9. a preparation method for the Chinese medicine composition of the treatment multicystic kidney disease as described in claim 1-7 any one, is characterized in that, it comprises the steps:
Weighting raw materials, adds 50% ethanol by the crude drug except Squama Manis powder, decocts 1-1.5h, with the beginning timing of seething with excitement, incline and extracting solution, medicinal residues add 50% ethanol, decoct 1-1.5h, incline and extracting solution, merge the extracting solution of twice, filter, include Squama Manis powder in, concentrating under reduced pressure obtains extractum; Add starch, micropowder silica gel, carboxymethyl starch sodium, mix homogeneously, adds water, and soft material processed is crossed screen cloth, granulates, and dry, granulate, adds carboxymethyl starch sodium, and magnesium stearate is pressed into tablet, or encapsulated.
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