CN1357344A - Nephrosis treating medicine and its prepn - Google Patents
Nephrosis treating medicine and its prepn Download PDFInfo
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- CN1357344A CN1357344A CN 00134008 CN00134008A CN1357344A CN 1357344 A CN1357344 A CN 1357344A CN 00134008 CN00134008 CN 00134008 CN 00134008 A CN00134008 A CN 00134008A CN 1357344 A CN1357344 A CN 1357344A
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Abstract
The nephrosis treating medicine is prepared by using Japanese, milkwort herb, motherwort, leech, etc. as raw material in certain proportion and after separate treatment according to their different characteristics. It is prepared to various forms, such as capsule and has obvious curative effect.
Description
The present invention relates to a kind of medicine for the treatment of nephropathy, specifically a kind of is the pure Chinese medicinal preparation of the treatment nephropathy made of raw material with the Chinese herbal medicine.
For nephropathy, many clinically employing Western medicine preparations treatment at present, they all present more toxic and side effects mostly, have also increased the burden of kidney in the treatment nephropathy; And traditional Chinese medicine also has very big unstability; Non-medicine operative therapys such as hemodialysis, artificial kidney transplanting can not fundamentally be captured the nephropathy difficulty.
The object of the present invention is to provide a kind of having no side effect for polytype nephropathy determined curative effect and the Chinese medicine preparation of the treatment nephropathy of stable curative effect.The invention still further relates to the manufacture method of this treatment of kidney disease agent.
Solution of the present invention is based on the pathogenetic understanding of Chinese medicine to nephropathy, according to dialectical characteristics, utilize rules such as warming YANG to promote diuresis, blood circulation promoting and blood stasis dispelling, with the pure Chinese medicinal preparation that card uses, preferred required natural drug forms, each medicine synergism of distinguishing the flavor of is to reach curative effect.
If drug main of the present invention is made by following component: Herba Polygalae Japonicae Herba Leonuri Hirudo
Wherein the Miao name of Herba Polygalae Japonicae is called " Vob nil lios bad (slightly stopping in the nest) "; The Miao name of Herba Leonuri is called " Jab laod ghel dliob (adding labor gives really) "; The Miao name of Hirudo is called " Gangb ninl (hilllock neck) ".
Medicine of the present invention can be made various dosage forms according to a conventional method, wherein preferred capsule.
The main medicinal component of Herba Polygalae Japonicae is the Herba Polygalae Japonicae Saponin, and its Saponin belongs to steroid saponin, and first, second, third, four kinds of glycoside units of fourth basic structure are arranged, and is a kind of pentacyclic triterpene derivant, and structural formula is as follows:
The Herba Polygalae Japonicae saponin A is little yellow solid, and fusing point is 185 ℃ (decomposition), and is (a)+120, water-soluble.Herba Polygalae Japonicae Saponin second, third, fourth are the white powder crystallization, and fusing point is respectively second 199-202 ℃, third 218-221 ℃, fourth 229-232 ℃, the equal water soluble of three, and in methanol and the ethanol, its glycoside is stable under neutrality or slightly acidic condition.So extract with decocting in water when extracting.
The Main Ingredients and Appearance of Herba Leonuri is leonurine (Leonurine), stachydrine (Stachydrine), leonurine first and leonurine the second grade alkaloid, the content of preceding two kinds of alkali is higher, the both has stronger alkalescence, can be water-soluble, so the method for employing water extract-alcohol precipitation when extracting.
Hirudo is a kind of traditional Chinese medicine, wherein contains anticoagulant composition hirudin, polypeptide class, heparin, antithrombotic element and various trace elements.Wherein hirudin and polypeptide class, heparin are water-soluble, and be stable in aqueous solution, but to thermally labile, so adopt the part fecula in the production technology, remainder adopts water-pure mixed solvent extraction, the method that low temperature concentrates.
The edema that whole body that medicine of the present invention causes for multiple reason or local edema, chronic nephritis, nephrotic syndrome etc. cause, lumbago, albuminuria, renal function chronic lesion and the Senile disease that causes, renal anemia etc. have the good curing effect, can improve the immunity of body.Evident in efficacy, treating both the principal and secondary aspects of a disease can promptly be eliminated the symptom of these gastropathy.Also can play the effect of nourishing stomach-YIN, regulating the stomach and sending down the abnormal ascending QI, this drug administration is convenient, has no side effect.
EXAMPLE Example 1: optimization formula (percentage by weight): Herba Polygalae Japonicae 35-45% Herba Leonuri 25-35% Hirudo 20-30% adjuvant 0-10% adjuvant wherein can be pharmaceutically acceptable any material, as starch etc.Embodiment 2: capsule preparation method thereof: take by weighing the medicine of respectively distinguishing the flavor of (unit is gram) by following prescription: 1. Herba Polygalae Japonicae 580 Herba Leonuris 440 Hirudos 350 preparation technologies are cut into Herba Polygalae Japonicae pipe nipple and clean, decoct with water three times, time was respectively 1.5 hours, 1 hour and half an hour, merge three times extracting solution, after adopting thin film evaporation method simmer down to thick paste, adopt vacuum drying method to obtain dried cream, pulverized 60 mesh sieves and get fine powder (1); 2. Herba Leonuri being cut into pipe nipple cleans, decoct with water three times, time was respectively 1.5 hours, 1 hour and half an hour, merged three times extracting solution, after adopting the thin film evaporation method to be concentrated into 1 milliliter of medicinal liquid to be equivalent to 1 milligram of medical material, after concentrated solution added ethanol to the alcohol amount of containing and be 75% (v/v) standing over night, filter, behind filtrate recycling ethanol, evaporation and concentration gets thick paste, adopt vacuum drying method to obtain dried cream again, pulverized 60 mesh sieves and get fine powder (2); 3. after Hirudo being washed, dry dry product, pulverized 60 mesh sieves and got fine powder (3) 4. with fine powder (1) (2) (3) mixing, add the moistening 2-4 of 75% ethanol hour wet-milling, dry for dividing the capsule of packing into to get final product behind the dry powder.
The drug rate is 20% (percentage by weight) of crude drug.Capsular specification is 0.4 gram/grain.
Embodiment 3: clinical trial 1. animal acute toxicity test data medicines: medicine of the present invention, and the capsule formulation animal: mice is supplied with the experiment carrier by the Guiyang Medical College Experimental Animal Center: Guiyang Medical College pharmacology teaching and research room method:
Get 60 of healthy Kunming mouses, body weight 20-22 gram, male and female half and half are divided 2 groups at random, and one group is medicine group 30 gram/kilogram gastric infusions, administration every day 1 time, successive administration 6 days.Fasting and water are 3 hours before the experiment, 2 hours feedings and water after the administration.
Observed for two weeks, i.e. each in the administration and after the drug withdrawal, situations such as record animal dead number, animal behavior, diet, defecation, body weight in 1 week.Experimental result:
1 week do not see animal dead in the experimentation and after the drug withdrawal, no General Symptoms occurs, and animal is active, and diet is normal, and defecation is no abnormal, and medicine group body weight and matched group be zero difference relatively.So medicine its mouse oral dosis tolerata of the present invention greater than 30 gram/kilograms, is the avirulence material.
Become the each 2-2.5 gram of human oral clinically, every day 3 times, calculate 0.15 gram/kilogram by 50 kg body weight.The above results shows its mouse oral dosis tolerata greater than 30 gram/kilograms, is 200 times of adult's consumption, so medicine of the present invention is safe in Clinical Application.2. long-term toxicity test for animals
Long term toxicity test result to medicine of the present invention shows: feed 12 weeks of rat continuously with feedstuff and medicine, it is normal that each organizes rat growthing development, and animal health is active.Hemogram liver, renal function and biochemical indicator all there is not obvious influence.Above index is measured in drug withdrawal after 14 days, and last time measured every index Non Apparent Abnormality.Twice pathological examination all similar, laboratory animal dosage are 33.33 times of clinical adult's dosage, and all avirulence performances illustrate that the use clinically of this medicine is safe.3. cure mainly relevant Pharmacodynamic test of active extract material with function:
Medicine is a medicament capsule dosage form of the present invention, and creatinine reagent, phenol reagent are supplied with by Guiyang Medical College check system; Blood urea nitrogen: chemical reagent factory in Chongqing produces, lot number 1910167; Diacetylmonoxime: Shanghai chemical reagent head factory is produced, lot number 890502.BSA: Guizhou epidemic prevention station animal section newspaper supplies.Instrument: multi-purpose computer viscosity is taken into account multi-functional cell electrophoresis blood viscometer: gulf, Wuxi County Shitang medical detecting Instrument factory produces; The cell pack pipe, the design of 721 beam split light, centrifuge.Animal: the wistar rat is supplied with by the Academy of Traditional Chinese Medicine, Kweiyang.Experimental unit: Guiyang Medical College pharmacology teaching and research room
(1) to the influence of serum sickness type Glomerulonephritis Rats
Method: the moulding of experimental serum sickness type nephritis: under sterilising conditions, inject calf serum to rat tail vein, collect twenty-four-hour urine liquid with the metabolic cage method after 7 days by the albuminous amount of 350mg/kg.Detect urine protein with the Folin-phenol reagent.Urine protein illustrates that serum sickness type nephritis forms before normal group and medicine, eliminate kidney to the seronegativity animal.Be divided into 5 groups at random by sex, body weight, grouping and the same experiment of administration.3 weeks of successive administration, check urine protein weekly 1 time, 24 hours broken ends are got blood after the last administration, use centrifugal 10 minutes of 3000rpm, and separation of serum is measured its total protein, creatinine and blood urea nitrogen, and experimental result sees Table 1 to table 2.
Table 1 medicine of the present invention is to the serum sickness type nephritis urine protein influence of output (X ± SD)
23 weeks of treatment week of treatment 1 week treatment after the modeling before the modeling of twenty-four-hour urine albumen (mg) group number of animals dosage
(only) be blank group 60 9.87 ± 1.08 10.17 ± 1.42 9.95 ± 1.39 10.10 ± 1.01 9.97 ± 0.89 pathological model groups 10 0 9.45 ± 1.81 52.67 ± 7.02 51.26 ± 7.79 50.18 ± 10.32 45.73 ± 9.13 (g/kg)
※ ※ ※ ※ ※ ※ BAOSHENKANG group 10 0.2 9.23 ± 1.77 54.83 ± 6.82 37.03 ± 6.83 30.36 ± 4.95 27.16 ± 2.87
※ ※ ※ ※ ※ medicine 1 group 10 8 9.29 ± 1.04 52.53 ± 7.35 42.98 ± 10.44 32.23 ± 5.11 24.91 ± 3.34
※ ※ ※ ※ medicine 2 group 10 4 9.41 ± 0.86 51.78 ± 8.78 47.82 ± 8.05 38.32 ± 6.62 30.70 ± 7.73
Annotate: ※ represents relatively P＜0.05 of medicine group and pathological model group; ※ ※ represents that P＜0.01 table 2 medicine of the present invention is to the influence of the serum creatinine of the capable nephritis of serum sickness, total protein, blood urea nitrogen (the group number of animals dosage creatinine total protein blood urea nitrogen of x ± SD)
(only) be (umol/L) (g/L) (mmol/L) blank group 60 61.28 ± 5.55 73.98 ± 2.44 7.76 ± 1.06 (g/kg)
※ pathological model group 10 0 74.65 ± 3.11 61.92 ± 3.14 9.73 ± 0.82
※ ※ ※ BAOSHENKANG group 10 0.2 62.10 ± 7.49 72.62 ± 2.68 8.51 ± 1.02
※ ※ ※ medicine 1 group 10 8 68.90 ± 3.81 72.53 ± 2.88 8.54 ± 1.49
※ ※ ※ medicine 2 group 10 4 63.65 ± 3.50 71.51 ± 3.37 8.67 ± 1.45
(2) diuresis
Get 50 of rats, body weight 180-240g, female, male half and half, be divided into 2 groups of 5 groups of blank groups, hydrochlorothiazide group, BAOSHENKANG group, 1 group of medicine and medicines at random.Collect urine with the metabolic cage method.After each Mus water load is pressed the normal saline lumbar injection of 2ml/100g body weight, gently press abdominal part to drain surplus urine, collect 24 hours preceding urine amounts of medicine subsequently.Fasting and water were pressed 2ml/100g body weight gastric infusion or distilled water after 3 hours, give simultaneously with medicine before the water load of same amount; Twenty-four-hour urine amount behind the collection medicine.Experimental result sees Table 3.The urine amount obviously increased after experimental result showed two experimental grouies (2 groups of 1 group of medicine and medicines) medication, with matched group and self notable difference more all arranged.
The influence of table 3 pair rat urine amount (twenty-four-hour urine amount behind the twenty-four-hour urine amount medicine before the group number of animals dosage medicine of X ± SD)
(only) be (ml) (ml) blank group 10 0 7.11 ± 1.89 6.98 ± 2.05 (g/kg)
The two hydrogen of △ ※ restrain former plug and organize 10 0.04 7.01 ± 1.13 11.90 ± 3.28
△ ※ BAOSHENKANG group 10 0.2 7.01 ± 2.50 9.70 ± 2.08
△ ※ medicine 1 group 10 8 7.18 ± 2.55 12.80 ± 3.43
△ ※ medicine 2 group 10 4 7.12 ± 1.82 9.80 ± 0.83
Annotate: △ represents to compare before the medication and after the medication P＜0.01; ※ represents medicine group and blank group relatively, learns by statistics and handles P＜0.01.
(3) to the influence of stasis syndrome rat model hemorheology
Get 50 of rats, body weight 270-330g, female, male half and half, divide 5 groups at random, 2 groups of blank group, blood stasis model group, BAOSHENKANG group, 1 group of medicine and medicines; Dosage is the same, and be administered five times every day, continuous use 8 days.Last administration or water (removed the blank group) after 1 hour, the equal subcutaneous injection adrenalin hydrochloride of each treated animal 0.08ml (10ug/ml)/100ml body weight, inject altogether 2 times, two minor ticks 4 hours are injected epinephrine for the first time and after 2 hours rat were put into water 5 minutes.Fasting behind the modeling type is got blood inferior morning and is surveyed blood mobility change index, and experimental result sees Table 4.
Table 4 medicine of the present invention to the influence of stasis syndrome rat model hemorheology (the group number of animals dosage whole blood of x ± s) than blood plasma than the electric packed cell volume erythrocyte sedimentation rate of erythrocyte fibrin
(only) be (%) mm/ hour former (mmg) blank group 10 0 3.76 ± 0.25 1.47 ± 0.27 20.53 ± 1.80 40.80 ± 2.77 4.60 ± 2.60 48.0 ± 16.10 of viscosity viscosity swimming time (second) (g/kg)
△ △ △ △ △ △ △ △ △ △ blood stasis model group 10 0 4.17 ± 0.17 2.02 ± 0.32 24.07 ± 1.32 46.0 ± 3.37 21.0 ± 9.10 70.0 ± 24.49
※ ※ ※ ※ ※ ※ BAOSHENKANG group 10 0.2 4.04 ± 0.24 1.56 ± 0.11 21.95 ± 3.29 41.08 ± 3.50 14.33 ± 3.21 63.33 ± 15.28
※ ※ ※ ※ ※ ※ ※ ※ ※ ※ medicine 1 group 10 8 3.73 ± 0.35 1.61 ± 0.09 21.55 ± 2.12 42.20 ± 2.84 7.60 ± 3.21 50.10 ± 10.64
※ ※ ※ medicine 2 group 10 4 3.97 ± 0.32 1.72 ± 0.14 22.55 ± 2.66 43.75 ± 3.50 7.85 ± 2.99 58.50 ± 18.92
Annotate: △ △ represents relatively P＜0.01 of blood stasis model group and blank group, and ※ represents relatively P＜0.05 of medicine group and blood stasis model group, ※ ※ P＜0.01.
Experimental result shows that blood stasis model treated animal hemorheology is sticking, dense, coagulates change, and promptly whole blood contrast viscosity and plasma viscosity increase, and packed cell volume increases, and erythrocyte electrophoresis speed speeds, expression blood " dense "; Fibrinogen increases the increase of expression blood coagulation.Blood stasis model group and blank group are relatively learned by statistics and are handled, and P＜0.01 illustrate significant differences, medicine of the present invention each organize can make the blood stasis model hemorheology sticking, dense, obviously alleviate the effect of invigorating blood circulation with fixed attention.
Experimental result shows that medicine of the present invention has the effect of obvious minimizing serum sickness type Glomerulonephritis Rats urine protein, serum creatinine and blood urea nitrogen; Be significantly increased the effect of total serum protein.Brief summary:
Medicine of the present invention has the effect of obvious minimizing serum sickness type nephritis (C-BSA) rat urine protein, serum creatinine and blood urea nitrogen; Be significantly increased the effect of total serum protein amount.Can make sticking, thick, the obviously reduction with fixed attention of the hemorheology of blood stasis model animal model, the stronger effect of invigorating blood circulation is arranged, have stronger diuresis.4. brief summary one experimental unit is observed in the clinical verification of clinical verification brief summary one, Drug therapy chronic nephritis of the present invention: Hospital Attached to Guiyang Medical College's Urology Department
According to No. 189 file of Qianweiyaozhi (95) and " kidney Yuan capsule (medicine of the present invention) treatment chronic nephritis clinical verification scheme " 13 routine chronic nephritis patients being carried out the clinical observed result of answering is reported as follows:
1, general clinical data
This clinical observation treatment inpatient 12 people, outpatient 1 people, case choice criteria and typing, classification is undertaken by " proof scheme ".Be divided into 2 groups at random, 8 examples are organized in treatment, matched group 5 examples, course of disease half a year to 20 year, wherein treatment group male 6 examples, women's 2 examples, age 17-39 year, 27.9 ± 7.64 years old mean age, matched group male 3 examples, women's 2 examples, age 27-66 year, 49.4 ± 14.2 years old mean age.
2. observe and method: observation index, curative effect judging standard is all undertaken by " proof scheme ", 3 of oral medicines of the present invention a time are organized in treatment, 3 times/day, 3 of the oral BAOSHENKANG sheets of matched group one time, 3 times/day, the various Chinese medicine and western medicine of stop using during the treatment hormone and other treatment chronic nephritis do not use the prejudicial medicine of kidney.
3, observed result: treatment group and matched group be respectively with the treatment of medicine of the present invention and BAOSHENKANG sheet, 4-5 after week therapeutic outcome see Table 5,6.
Symptom and inspection urine protein situation of change are relatively before and after two groups of treatments of table 5
| The group symptom | Treatment group n=8 | Matched group n=5 | ||
| Before the treatment | After the treatment | Before the treatment | After the treatment | |
| Light in heavy | Fully recover from an illness to show to delay not have more to imitate and separate effect | Light in heavy | Fully recover from an illness to show to delay not have more to imitate and separate effect | |
| Edema | ????7 | 7 | ??1????1????3 | 3??????2 |
| Ache of the spinal column | ????4 | 4 | ???????2????2 | 2??????2 |
| Nausea and vomiting | ????4 | 4 | ????????????2 | 1??????1 |
| Oliguria | ????4????2 | 5 | ????????????1 | 1 |
| Dizziness and blurred vision | ?????????3 | 1 | ????1 | ???????1 |
| Breast, ascites | ?????????3 | 3 | ||
| Inappetence | ????6 | 4 | ????????????2 | 1??????1 |
| Urine protein g/24h (average) | ????5.03 | ????2.54 | ????6.18 | ????5.61 |
| Urine protein slip % | ???????????49.5 | ?????????????9.2 | ||
Two groups of therapeutic outcomes of table 6 relatively
Group is alleviated basic alleviation enabledisable fully
((((example/P%) treatment group (8 example) 2 25 2 25 3 37.5 1 12.5 matched groups (5 example) 004 80 1 20 of example/P%) of example/P%) of example/P%)
Brief summary: show through clinical observation result, medicine of the present invention has inducing diuresis to remove edema preferably, eliminate the effect of urine protein, the various clinical symptoms that chronic nephritis is caused have fast and significantly alleviate and the elimination effect especially, the sx effect of comparing with matched group is outstanding, after medication 4-5 week, the slip of urine protein reaches 49.5%, therapeutic outcome treatment group and matched group difference are obvious, do not see in the clinical observation of treatment group that untoward reaction (is particularly suitable for medicines such as hormone Tripterygium glycosides are had the case of gastrointestinal reaction, no model case), curative effect is definitely preferably arranged, good practical values is arranged clinically so medicine of the present invention is used for the treatment of chronic nephritis.Two, clinical observation brief summary two experimental units of Drug therapy chronic nephritis of the present invention: Guiyang College of Traditional Chinese Medicine's one attached institute internal medicine
According to No. 189 literary composition written instructions of Guizhou Province Department of Public Health Qianweiyaozhi (95) and " kidney Yuan capsule (medicine of the present invention) treatment chronic nephritis clinical verification scheme " 20 routine chronic nephritis patients being carried out the clinical observed result of answering is reported as follows:
1, clinical data
1.1. case is selected and grouping
Select the chronic nephritis patient of all serum creatinines less than 442 μ mol/L (5mg).Person due to the factors such as eliminating diabetes, systemic lupus erythematosus (sle), or be diagnosed as the nephrotic syndrome or the phase patient of renal insufficiency uremia.This organizes 20 examples, inpatient's 17 examples, outpatient service 3 examples.February to 10 course of treatment is year surplus.Be divided into two groups at random, medication therapy groups 15 examples of the present invention, male's 7 examples wherein, women 8 example age 16-53 year, average 30.3 ± 9.12 years old; BAOSHENKANG matched group 5 examples, male's 3 examples wherein, women's 2 examples, age 23-48 year, average 29.14 ± 10.13 years old.Two groups of situations are similar substantially.
1.2 observational technique (1) before observation, is corrected complication such as infection, hypertension.(2) registration on time item by item.
Be a course of treatment February.
2. Therapeutic Method
Medication therapy groups of the present invention, medicament capsule of the present invention a time 4 (every 0.5g), three times on the one, oral.The BAOSHENKANG matched group, BAOSHENKANG sheet one time 3 (every 50mg), three times on the one, oral.All kinds of Chinese and western drugses of hormone and other treatment chronic nephritis of stopping using during the treatment are in order to avoid interference medicine-feeding observation of curative effect also uses the medicine that the kidney toxic and side effects is arranged.
3. therapeutic outcome
3.1 criterion of therapeutical effect and observation: undertaken by " treatment proof scheme ".The curative effect situation is seen
Table 7, table 8.
Upro before and after two groups of treatments of table 7, Scr changes relatively
| Treatment group matched group | ||
| ??Upro(g/24h) | Before the treatment | 1.87±1.32????????1.94±1.27 |
| After the treatment | 0.64±0.57????????1.47±1.32 | |
| ??Scr ??(μmol/L) | Before the treatment | 296.8±133.6??????314.5±112.6 |
| After the treatment | 161.2±103.4??????238.5±103.7 | |
Two groups of curative effects of table 8 relatively
Alleviate the basic enabledisable of alleviating fully
Example number (%) kidney Yuan capsule treatment group 3 (20.00) 2 (13.30) 8 (53.40) 2 (13.30) (15 example) BAOSHENKANG matched group 01 (20.00) 2 (40.00) 2 (40.00) (5 examples)
Medication therapy groups total effective rate of the present invention is 86.7%, and the BAOSHENKANG matched group is 60%, and learn by statistics and handle susceptible of proof: medication therapy groups of the present invention is better than BAOSHENKANG matched group (P＜0.05).
4, brief summary
Medicine of the present invention has blood circulation promoting and blood stasis dispelling, the dispelling dampness and promoting diuresis effect.Observe 20 examples through clinical verification, the result shows, all serum creatinines there is curative effect preferably less than the chronic nephritis of 442 μ mol/L, total effective rate is 86.7%, renal function obviously improves, and serum creatinine reduces, and can make symptom obviously alleviate or disappear within a short period of time (7-10 days), all case untoward reaction and toxic and side effects do not occur in the clinical observation process.
4, the model case example 1: make pottery * *, man, 16 years old, admission number 55931.Because of repeated intermittent edema 2 years, increase the weight of companion's cough 20 days, be admitted to hospital April 29 nineteen ninety-five.Card meeting edema, shallow complexion, weak breath is weak, and ache of the spinal column is indigestion and loss of appetite.Light red tongue is fat indentation, and yellow and thin fur is greasy slightly, thready and rolling pulse.Upro2.89/24h, Scr201.5 μ mol/L, BUN9.6mmol/L, URT: urine protein ++ ++ a pipe 3-5/Lp, leukocyte 5-6/HP, erythrocyte 1-2HP, BRT:Hb84g/L WBC9.70 * 10
9/ LN77%L33%, liver function is normal, total serum protein 34.2g/L, albumin 13.0g/L, globulin 21.2g/L.Electrocardiogram, Type B are ultrasonic, and inspection shows no obvious abnormalities.Diagnosing chronic nephritis plain edition, chronic renal insufficiency azotemia phase.Syndrome in TCM belongs to the asthenia of both the spleen and kidney retention of damp-heat in the interior.Give each 4 of medicine of the present invention, three times on the one, oral.The all backs edema of taking medicine is gradually moved back.Finish for the 8 thorough courses of treatment recurrence of disease at the same time next year have urine examined albumen ±, leukocyte 0-2, erythrocyte 0-1, routine blood test Hb120.0g/L, leukocyte 6.0 * 10
9/ L, N72%L28%, twenty-four-hour urine albumen 0.15g, BUN6.1mmol/L, Scr108.5 μ mol/L, liver function is normal, total serum protein 70.0g/L, albumin 36.5g/L, globulin 33.5g/L, state of an illness direct release.
Example 2: Teng * *, woman, 43 years old, cadre, admission number 55915.Because of increasing the weight of April 22 January in nineteen ninety-five in 6 years, lumbago is admitted to hospital.BP190/120mmHg, albumen has urine examined ++, leukocyte 1-3, erythrocyte 3-5, cast 1-2, routine blood test Hb60.0g/L, WBC4.0 * 10
9/ L, N70%L30%, Upro1.2g, Scr4140.9 μ mol/L, BUN115.79mmol/L.Be diagnosed as hypertension type of chronic glomerulonephritis, the chronic renal insufficiency azotemia phase.Give captopril 25mg earlier three times on the one, nifedipine 10mg three times on the one, quiet of 10%G.S.300ml+ dopamine 10mg+ phentolamine 20mg.Once a day, quiet of Radix Salviae Miltiorrhizae Injection 16ml+10%G.S.200ml, once a day, a week back fluctuation of blood pressure is at 150-130/90-100mmHg, the ordinary circumstance back drug withdrawal that takes a turn for the better.Give each 4 of medicine of the present invention then, three times on the one.Symptom disappears substantially after February, the check urine protein ± and, leukocyte 0-2, erythrocyte 0-1, routine blood test HB94g/L, WBC4.5 * 10
9/ L, N74% L26%, Upro are 0, BUN8.42mmol/L, Scr148.38 μ mol/L.Three, observation of curative effect brief summary three experimental units of Drug therapy chronic nephritis of the present invention: PLA's the 44 central hospital's Urology Department
By No. 189 file of Qianweiyaozhi (95) and " kidney Yuan capsule (medicine of the present invention) treatment chronic nephritis clinical verification scheme " 13 routine chronic nephritis patients being carried out the clinical observed result of answering in May, 95-July is reported as follows: 1, the object of observation: in my institute's Urology Department inpatient, use Drug therapy chronic nephritis 8 examples of the present invention, male's 5 examples wherein, women's 3 examples, 18～64 years old age, meansigma methods 36.6 ± 19.1 years old, by " clinical verification scheme " Western medicine diagnose standard diagnostics and typing, general type of chronic glomerulonephritis 6 examples, hypertension type 1 example, acute attack type 1 example all has the different renal insufficiency of degree in the above-mentioned case.Matched group 5 examples, male's 3 examples wherein, women's 2 examples, in age 26-62 year, 49.8 ± 17.6 years old mean age, case situation and treatment group are basic identical.2, method: measure 4 hours urine protein quantitation respectively before and after all object of observation treatments, qualitative, serum creatinine, blood urea nitrogen, endogenous creatinine clearance rate, and other routine requires inspection item, stops other medicines without exception, give each 3～4 of medicine of the present invention, 3 times/day, 4 weeks were a course of treatment.Other is all undertaken by " clinical verification scheme ".
Experimental result sees Table 9,10.
The result relatively before and after the treatment of table 9 treatment group
(average) 0.62 6.55 167.63 50.30 t value 4.7686 6.2092 3.3099 3.6383 P value＜0.01＜0.01＜0.01＜0.01, (average) 1.48 11.08 300.88 86.33 treatment back before the treatment of urine protein quantitation serum creatinine blood urea nitrogen endogenous creatinine clearance rate
Two groups of therapeutic outcomes of table 10 relatively
Brief summary: above result shows that relatively the P value is all less than 0.01 before and after four observation index treatments, and Drug therapy chronic nephritis of the present invention has obvious diuresis, detumescence, reduces urine protein, reduces serum creatinine, and blood urea nitrogen improves the endogenous creatinine clearance rate effect.More obvious to chronic nephritis especially with the case effect of light moderate renal function injury.
| Group | Alleviate main level fully and separate enabledisable |
| (routine %) | |
| Treatment group (n-8) matched group (n-5) | ?2??28.6??2??28.6?????2??28.6????1??14.3 ??????????3??60.0?????1??20.0????1??20.0 |
In addition, this group observation period after an example is taken medicine, have slight feel sick, do not see any side effect.Model case: 1, Wang Xiangguo, the male, 20 years old, Nayong County Wood-scoop village teacher, patient's identification number 165087 because of lumbago, edema repeatedly 1 year, increased the weight of for 1 week, changed institute on June 4th, 95 over to by Nayong County hospital, and it is special that history of past illness, family history do not have.Have a medical check-up, body temperature 36.9 degree, blood pressure 150/100mmHg, puffiness of face, body weight 60.1kg, two severe lower extremity edema (thigh and waist etc. are thick), the cardiopulmonary feminine gender, aching and limp, sign of ascites is positive, two kidneys district kowtows pain, chemically examine: routine blood test Hb60g, WBC8.0 * 10
9/ L, NO.75, routine urinalysis, albumen +++, WBC 0-7, RBC 0-1, twenty-four-hour urine protein quantification 3.25g, endogenous creatinine clearance rate 46.7ml/ branch, biochemical investigation renal function, blood glucose are normal, liver function, normal, the two kidney B ultrasonic of blood fat: two kidneys are fat big, and essence echo strengthens with the aggregation system boundary unclear.Electrocardiogram is normal, and diagnosis: general type of chronic glomerulonephritis, tcm diagnosis: insufficiency of QI of the lung and kidney disease gives each 4 of medicine of the present invention, 3 times/day.The urine amount increases gradually after three days, can reach 2000ml the most for a long time, weak, nauseating, the soreness of waist and knee joint of back patient, edema disappearance around the treatment, routine urinalysis is normal more than three times, twenty-four-hour urine protein quantification 0.2g, interior granulation promoting acid anhydride elimination factor 48.8ml/ branch, the 5th week, body weight 37.5kg, anasarca complete obiteration, various symptoms disappear substantially, recovery from illness.
Claims (6)
1. medicine for the treatment of nephropathy is characterized in that it mainly is the medicament of being made according to conventional method by following raw material components:
Herba Polygalae Japonicae
Herba Leonuri
Hirudo
2. the medicine of treatment nephropathy according to claim 1 is characterized in that the percentage by weight of each raw material components is:
Herba Polygalae Japonicae 35-45%
Herba Leonuri 25-35%
Hirudo 20-30%
Adjuvant 0-10%
3. the medicine of treatment nephropathy according to claim 1 and 2 is characterized in that the optimum ratio of each raw material components is: Herba Polygalae Japonicae 580 grams, Herba Leonuri 440 grams, Hirudo 350 grams.
4. the medicine of treatment nephropathy according to claim 1 is characterized in that said medicament is a said dosage form on any pharmaceutics.
5. the medicine of treatment nephropathy according to claim 4 is characterized in that said medicament is a capsule.
6. the preparation method according to the capsule formulation of the medicine of the said treatment nephropathy of claim 5 is: Herba Polygalae Japonicae is extracted with decocting in water; Herba Leonuri is extracted with decoction and alcohol sedimentation technique; Hirudo is adopted the part fecula, and remainder adopts water-pure mixed solvent to extract, the method that low temperature concentrates, and the drug rate of patent medicine is 20% of a primary dose.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00134008 CN1189191C (en) | 2000-12-08 | 2000-12-08 | Nephrosis treating medicine and its prepn |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00134008 CN1189191C (en) | 2000-12-08 | 2000-12-08 | Nephrosis treating medicine and its prepn |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1357344A true CN1357344A (en) | 2002-07-10 |
| CN1189191C CN1189191C (en) | 2005-02-16 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 00134008 Expired - Fee Related CN1189191C (en) | 2000-12-08 | 2000-12-08 | Nephrosis treating medicine and its prepn |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1189191C (en) |
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2000
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| Publication number | Publication date |
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| CN1189191C (en) | 2005-02-16 |
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