CN100528186C - Process for preparing Chinese medicine compound injection for treating chronic renal failure and use - Google Patents
Process for preparing Chinese medicine compound injection for treating chronic renal failure and use Download PDFInfo
- Publication number
- CN100528186C CN100528186C CNB2006100902006A CN200610090200A CN100528186C CN 100528186 C CN100528186 C CN 100528186C CN B2006100902006 A CNB2006100902006 A CN B2006100902006A CN 200610090200 A CN200610090200 A CN 200610090200A CN 100528186 C CN100528186 C CN 100528186C
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- Prior art keywords
- radix
- rhizoma rhei
- water
- ethanol
- filtrate
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Landscapes
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Abstract
The present invention relates to compound Chinese medicine injection, and is especially one kind of compound Chinese medicine injection compounded with rhubarb and astragalus root and its preparation process and application.
Description
Technical field:
The present invention relates to a kind of Chinese medicine, particularly the Chinese medicine for preparing with Chinese herb rhubarb and Radix Astragali compatibility.
Background technology:
(Chronic Renal Failure CRF) is the syndrome in late period that Different types of etiopathogenises causes renal damage in chronic renal failure.Bibliographical information CRF incidence rate is occupied the patient 2%-5% of institute, accounts for 13.3% of kidney inpatient, and heart bypass operation back patient's CRF incidence rate then is 4%-15%.In CRF patient, need dialysis treatment more than 1/3.In the past ten years, along with the raising of diagnostic level, dialysis technology and monitoring quality, at the pathogenesis of CRF and the corresponding prophylactico-therapeutic measures that proposes in view of the above very big progress has been arranged, the mortality rate of CRF is still up to 30-80%.
CRF treats difficulty, the prognosis extreme difference, and dialysis therapy and renal transplantation can improve curative effect, and the part patient is survived, but it costs an arm and a leg, for kidney derived difficult.The non-dialysis therapy mainly contains essential amino acids (EAA) therapy, oral dialysis solution, oral Oxytarch etc., but often big because of the Western medicine side effect, costs an arm and a leg, and curative effect is unsatisfied with and stops.Therefore, how the infull progress of postponing chronic kidney function has become the important topic of attracting attention both at home and abroad.The Chinese medicine chronic disease has long history, can have breakthrough in the primary disease treatment so Chinese medicine and pharmacy is all expected by each side.In recent years, traditional Chinese medical science combined treatment CRF obtains certain effect, can effectively reduce blood urea nitrogen, creatinine content, improves kidney blood supply, lipid metabolism and calcium phosphorus ratio, human body immunity improving power, thus play the CRF process effect that delays.
The research of rhubarb treatment CRF: at the beginning of the sixties, Nanjing Traditional Chinese Medical College is first to obtain curative effect, sequential use in all parts of the country afterwards with he medicine treatment CRF of Radix Et Rhizoma Rhei compatibility.Wang Tong etc. [1] treat chronic renal failure with charred Radix Et Rhizoma Rhei capsule (with Radix Et Rhizoma Rhei roasting 3h in the high-temperature blast drying baker, be milled into powder after the cooling, incapsulate, every capsules contains charred Radix Et Rhizoma Rhei 0.37g), and 44 examples are organized in treatment, 5 of oral charred Radix Et Rhizoma Rhei capsules, every day 3 times; Matched group 38 examples, 4 of oral love Seats (Changtian Pharmaceutical Co., Ltd., Hebei produces, and lot number: the accurate word 1995 of medicine is defended No. 060471 in the Ji), every day 3 times.The result: treatment group total effective rate 86.4%, 76.3%, 2 group of clinical efficacy of matched group total effective rate has significant difference (P＜0.05).Song Haixiang etc. [2] treatment CRF48 example, treatment are organized oral captopril and Chinese herb rhubarb (each 3g, every day 2～3 times), matched group list clothes captopril.Treat after 6 months, treatment group patient's greasy urine cytokine 6 (IL6) and serum creatinine (Cr) significantly descend (P＜0.05), and significant difference (P＜0.05) are arranged relatively after the treatment of control group.Liu Jihong etc. [3] are on the general treatment basis, add Radix Et Rhizoma Rhei capsulae (containing rhubarb powder 6g/d), observe 42 examples, continued to follow up a case by regular visits to 28 months, the rhubarb treatment group has 22.7% patient to enter renal failure in latter stage at end, be starkly lower than 55.0% of matched group, difference has highly significant meaning (P＜0.01).Feng Wenxues etc. [4] are on the basis of low protein diet and symptomatic treatment, and the treatment group adds with Radix Et Rhizoma Rhei 8～12g, 1 decoction every day, suitably adjust the Radix Et Rhizoma Rhei consumption according to patient's situation of defecating in the treatment, must make every day defecation 2 times be degree, treatment was in hospital equal 1 month, and matched group does not then use rhubarb preparation.The result self contrasts all obviously decline of blood urea nitrogen (BUN), Cr before and after showing 2 groups of patient's medications, and treatment group and matched group contrast after the medication, meaning that there was a significant difference (P＜0.05), the spirit of treatment group in addition, diet improvement rate be apparently higher than matched group, its there was a significant difference meaning (P＜0.05).The clinical use of Radix Et Rhizoma Rhei compound recipe is more to be fixed just or intends Fang Weizhu certainly and carry out dialectical plus-minus with one, be equipped with the treatment of doctor trained in Western medicine conventional therapy and high-quality low protein diet, warding off boundary etc. [5] as Zhu adopts the kidney invigorating primordial QI reinforcing, blood circulation promoting and blood stasis dispelling, eliminating evilly rushes down turbid Chinese medicine and make Baoyuan kidney-strengthening I capsule and (contain Radix Et Rhizoma Rhei 5g in 30 of its compositions, Radix Ginseng Rubra, each 6g of Radix Aconiti Lateralis Preparata, Herba Epimedii, Radix Salviae Miltiorrhizae, each 12g of Radix Rehmanniae, Cortex Cinnamomi 3g), the treatment group adds usefulness Baoyuan kidney-strengthening I number on the basis of low protein diet and general Comprehensive Treatment, matched group adds uses the essential amino acids injection, logotype 60 days.The blood of treatment group as a result BUN, Cr significantly reduce, and endogenous creatinine clearance rate (Cr) significantly rises, and hemoglobin and RBC number obviously increase, and subjective symptoms is obviously improved, and treatment group total effective rate reaches 90%.Diao Hong etc. [6] use Radix Et Rhizoma Rhei 10g, every day 2 times is for tea-drinking, 3 of zhiling capsuleses (main component Cordyceps), and every day 3 times is oral, oral baoquan yanghua dianfen of matched group and intravenous drip kidney must be pacified injection, 2 groups of total effective rates are all greater than 78% as a result, but the matched group side effect is many, after some cases is taken medicine, because of significantly gastrointestinal symptom occurring, feel sick, stomachache and loss of appetite, cause acidosis symptom to increase the weight of, the treatment group does not then have similar performance; Zhi Nan [7] is with the clear spirit of kidney (Radix Et Rhizoma Rhei 10g, Radix Pseudostellariae 30g, Radix Astragali 20g, Herba Taraxaci 20g, Fructus Forsythiae 20g, Semen Plantaginis 15g, Cortex Eucommiae (parched) 15g, medicine prescriptions such as Herba Ecliptae 20g decoct extracting juice) oral medication 100 routine CRF patients, produce effects 39%, effective 48 examples, total effective rate 87%.Sun Yanbing etc. [8] cooperate low dose of gastrointestinal dialysis treatment uremia 57 examples that continue with new clear peaceful (main component Radix Et Rhizoma Rhei), treated 1 month, total effective rate reaches more than 70%, and the most patient's clinical symptoms in treatment back take a turn for the better, and symptom of digestive tract alleviates or disappears, and appetite is obviously improved, it is still remarkable to observe 1 year effect, outside the dehematize BUN, Cr, blood uric acid (UA), serium inorganic phosphorus (P) all have obvious decline, and CO2 combining power, CO2 CP (CO2CP), CCr raise.
(2) mechanism of action of rhubarb treatment CRF
1. improving the performance that CRF patient's azotemia CRF patient gives prominence to is that nitrogen metabolism is unusual.A large amount of experiments and clinical research confirm that all Radix Et Rhizoma Rhei has reduction BUN, improves effects such as azotemia, and its effective ingredient is a rhatannin etc.Liu Xia [9] thinks that Radix Et Rhizoma Rhei can quicken noxious water and the protein metabolism product is drained from intestinal, can make synthetic being suppressed of carbamide in the hepatic and renal tissue simultaneously and blood urea nitrogen is reduced, the monoamino-acid of the raw material of intestinal absorption urea synthesis is reduced, thereby also can make the body protein split be suppressed to make BUN and Cr value to reduce, and can reduce serium inorganic phosphorus, the rising blood calcium, improve low calcium hyperphosphatemia, and can improve the level of part essential amino acids in the blood, it has the effect that improves amino acid balance, makes blood urea nitrogen synthetic proteins in the body.Yu Yusheng etc. [10] think that Radix Et Rhizoma Rhei can reduce blood Cr, BUN level, but patient's organism metabolism level is not suppressed, and nutriture obviously improves on the contrary.
2. suppress kidney compensatory hypertrophy and hypermetabolism state and think that at present it is the factor that causes renal function further to worsen that the metabolism of remaining nephron compensatory hypertrophy and glomerule enlivens.Li Leishi etc. [30] prove that with stripped renal perfusion technology the remaining nephron of 5/6 nephrectomy model has tangible oxygen consumption to increase, abnormal carbohydrate metabolism, and the glucose clearance rate reduces, and sodium heavily absorbs and reduces contour metabolic performance.Yang Junwei etc. [11] experimentation show give rhubarb treatment after, the synthetic degree that reduces of nephridial tissue RNA is much larger than DNA, show that Radix Et Rhizoma Rhei surpasses its influence to propagation to the influence of kidney hypertrophy, Radix Et Rhizoma Rhei also can obviously suppress the compensatory hypertrophy of remaining kidney after 5/6 nephrectomy.Illustrate that thus Radix Et Rhizoma Rhei can obviously suppress the compensatory hypertrophy of kidney, reduce the hypermetabolism state.
3. the mesangial cell (MsC) that influences to mesangial cell is the intrinsic cell of kidney, and the hypertrophy of MsC and substrate thereof is that one of hardened principal element takes place glomerule.Therefore, suppress the MsC paraplasm, help to delay the progress of CRF pathology.Grandson's the moon [12] studies show that Radix Et Rhizoma Rhei can obviously suppress the propagation of MsC, and this inhibitory action has reversibility, remove the effect of Radix Et Rhizoma Rhei to MsC after, the propagation of repressed MsC is recovered, illustrate that thus Radix Et Rhizoma Rhei does not does not kill and wound MsC under certain drug level, and only be to suppress its propagation.
4. Radix Et Rhizoma Rhei is the common performance of CRF to the lipid metabolic disorder that influences of lipid metabolism, is the key factor of impelling glomerular sclerosis.Correct lipid metabolic disorder, delaying the renal function deterioration is one of important measures for the treatment of at present CRF.[14] clinical researches such as Zhang Jinghong [13], Ji Shuming show that oral guarantor's kidney ball (based on the pill of Radix Et Rhizoma Rhei ethanol extract) can be corrected CRF patient's disorders of lipid metabolism, and blood fat reducing and adjusting lipoprotein and apolipoprotein improve the serum albumin level.Radix Et Rhizoma Rhei also can suppress the serum cholesterol deposition, reduces the permeability of blood vessel, strengthens the compactness of endotheliocyte, and the restriction harmful substance enters endotheliocyte.Simultaneously Radix Et Rhizoma Rhei can promote bile to discharge, and increases gastrointestinal motility, alleviates cholesterol accumulating in vivo.
5. can produce lipid peroxide with the hydroxyl free radical reaction to unsaturated fatty acids a large amount of on the membranous structure in the elimination effect nephridial tissue cell membrane of free radical and the cell, influence the founction metabolism and the structure of nephridial tissue cell, finally cause renal function to go down.[16] such as Wang Hongzhong [15], Liao Shengbao studies show that, CRF patient's blood plasma superoxide dismutase (SOD) content descends, BUN, Cr descend after using Radix Et Rhizoma Rhei or Radix Et Rhizoma Rhei compound preparation, SOD raises, owing to improved the activity of SOD, thereby the free radical that nephridial tissue is produced can access preferably and eliminate, and avoids and reduced the generation of free radical, and the oxidation and the antioxidation of body played equilibrated effect.Show that thus Radix Et Rhizoma Rhei has good elimination free radical effect.
6. other Radix Et Rhizoma Rhei also have and promote bone marrow to make hematoblastic effect, to improve the fragility of blood capillary.Qiu Yang etc. [17] find that emodin produces inhibitory action to chronic renal failure patient tumors necrosin.Xiao Wei etc. [18] report Radix Et Rhizoma Rhei still have rush down down, multiple efficacies such as antiinflammatory, antibiotic, antiviral, analgesia, microcirculation improvement, anticoagulant, hemostasis, function of gallbladder promoting and diuresis, this all may be the mechanism of action that delays the CRF disease progression.The research of Radix Astragali treatment CRF: Miao Hua etc. [19] adopt Chinese medicine (Radix Et Rhizoma Rhei 20g, Radix Aconiti Lateralis Preparata 9g, Herba Violae 12g, Folium Sennae 2g add water 200mL) deep retention enema 1～2h, 1 time/d; Take low protein diet, supply with heat, giving kidney must aminoacid, 2-ketoacid and essential vitamins, replenishes the ferrum agent; Reduce the absorption of intestinal phosphorus, correct hyperkalemia and metabolic acidosis; The strict liquid intake and output volume that calculates, restriction sodium, water are taken in; Correct hypovolemia treatment CRF patient 20 examples and organize in contrast, treatment is organized 20 examples and is added on above-mentioned treatment basis with quiet of Radix Astragali 60mL+5% Glucose Liquid 250mL, 1 time/d.Two groups was 1 course of treatment with 1 month all.Doing well,improving situations such as the observation of treatment front and back is felt sick, vomiting, edema, hypertension, and look into renal function.38 examples symptom after treating has in various degree improvement among the 40 routine patients as a result, serum creatinine (SCr) decline 30 examples, blood urea nitrogen (BUN) decline 32 examples, CO2-CP rises, blood potassium returns to normally, and blood calcium raises in various degree, and serium inorganic phosphorus reduces in various degree, blood pressure is controlled to some extent, breathes, gastrointestinal symptom is controlled or take a turn for the better.Blood BUN and SCr all be significantly improved (P all＜0.05) before and after two groups of treatments; Two groups of blood BUN and SCr difference all have significant difference (P all＜0.05), illustrate that treatment group curative effect is better than matched group.
List of references:
1 Wang Tong, Ma Wei, golden Potiria pectinifera (Mukller et Tro Sehel). charred Radix Et Rhizoma Rhei capsule for treating chronic renal failure clinical observation. Hubei College Of Traditional Chinese Medicine's journal, 2003,5 (2): 38 39
2 Song sea Xiang, prince's sweet smell, Zhang Fengfang, etc. the detection and the Radix Et Rhizoma Rhei of chronic renal failure patient greasy urine cytokine 6 influence it. Chinese combination of Chinese and Western medicine magazine, 2000,20 (2): 107 109
3 Liu Ji are red, Lang Xujun. the clinical observation of Radix Et Rhizoma Rhei postponing chronic kidney function failure progress. and the new traditional Chinese medical science, 2001,33 (5): 51 52
4 Feng Wenxues, Li Xike, Zhan Meilan, etc. the efficacy analysis of rhubarb treatment chronic renal insufficiency 25 examples. Henan pharmaceutical information, 2000,8 (2): 57
5 Zhu ward off boundary, field the army and the people, and Qiu Jianjun, etc. Baoyuan kidney-strengthening I capsule for treating chronic renal failure clinical research. the practical clinical emergency treatment of the combination of Chinese and Western medicine, 1999,6 (4): 165 167
6 Diao Hong, Zhou Xijing. Radix Et Rhizoma Rhei zhiling capsules treatment chronic kidney hypofunction curative effect is inquired into. practical country doctor's magazine, 1999,6 (6): 32 33
7 south. the clear spirit treatment of kidney chronic renal insufficiency 100 routine observation of curative effect. Beijing traditional Chinese medical science, 2000, (4): 15 16
8 Sun Yan soldiers, Chen Bingliang, Jia Qiang, etc. the new clear peaceful low dose of gastrointestinal dialysis treatment uremia clinical observation on the therapeutic effect that continues that cooperates. Chinese combination of Chinese and Western medicine magazine, 2000,20 (9): 660 663
9 Liu Xia. the application of opinion Radix Et Rhizoma Rhei in chronic renal failure. Hebei combination of Chinese and Western medicine magazine, 1998,7 (11): 1,781 1,782 29 Yu Yu give birth to, Li Leishi, the chapter rising sun. the late result observation of Chinese herb rhubarb treatment chronic kidney hypofunction. and nephropathy and dialysis renal transplantation magazine, 1995,4 (1): 3,235 10 Li Lei stones, Liu Jihong, Zhang Jinghong. the clinical and experimentation of Radix Et Rhizoma Rhei delaying chronic kidney hypofunction. combination of Chinese and Western medicine magazine, 1991,11 (7): 392 396
11 Yang Jun are big, Li Leishi. and Radix Et Rhizoma Rhei is to the influence of unilateral nephrectomy metanephros compensatory hypertrophy. Jiangsu medical science, 1992,18 (6): 319
12 grandson's the moon. the biochemical research of Chinese herb rhubarb---physcione distributes and drainage in the intravital absorption of rat. China Medicine University's journal, 1988,19 (3): 179
13 scapes are red, Yao Xiaodan, and Song Yan, etc. the late result of Radix Et Rhizoma Rhei and captopril delaying chronic kidney hypofunction progress. Chinese Journal of Nephrology, 1993,9 (4): 197 201
14 season daybreak bright, Li Leishi, Ji Daxi, etc. protect kidney pill for curing chronic hemodialysis patient's clinical research. Chinese combination of Chinese and Western medicine magazine, 1993,13 (20:71 73
15 Wang Hong loyalties, Zhang Jinjun, an old handle of the Big Dipper etc. dehumidifying expelling phlegm method treatment chronic renal insufficiency clinical experimental research. Journal of Traditional Chinese Medicine, 1996,37 (12): 732 734
16 Liao are holy precious, Zhang Jinghu, and Wang Yuanjin, etc. herbal enema is to the influence of chronic kidney hypofunction rat MMS, SOD. Anhui Chinese Medicine College journal, 1996,15 (3): 54
17 Qiu Yang, Yang Yuxiu is appointed clearly, etc. the inhibitory action that emodin produces chronic renal failure patient tumors necrosin. Chinese Journal of Nephrology, 1998,14 (3): 188 189
18 Xiao Wei, Deng Hongzhu, horse cloud. the clinical experimental research general introduction of rhubarb treatment chronic renal failure. CHINA JOURNAL OF CHINESE MATERIA MEDICA, 2002,27 (4): 241 244
19 Seedling China, Li Wenbin. the Radix Astragali adds composite treatment treatment chronic renal insufficiency 20 examples [J]. modern combination of Chinese and Western medicine magazine, 2002,11 (19): 1893-1894
The Chinese medicine for the treatment of CRF in the market is few, and existing medicine has the renal failure capsule, and other has some bibliographical informations, but some belongs to and cure the symptoms, not the disease, and some uses expensive composition, and some is cut and interrupt using owing to uncertain therapeutic efficacy in application process.
The invention provides a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect.
Summary of the invention:
The present invention has succeeded in developing a kind of injectable drug for the treatment of chronic kidney hypofunction with Radix Et Rhizoma Rhei and Radix Astragali compatibility on the prior art basis, two medicine additions have synergism, has solved the injection problem of unstable simultaneously in preparation process, has improved stability.
Injection of the present invention is formed through processing and preparing by the Chinese herb rhubarb and the Radix Astragali, and Radix Et Rhizoma Rhei and Radix Astragali raw material consist of:
The Radix Astragali: Radix Et Rhizoma Rhei=1: 10-10: 1
Preferred Radix Et Rhizoma Rhei and Radix Astragali raw material consist of:
The Radix Astragali: Radix Et Rhizoma Rhei=1: 5-5: 1
Particularly preferred Radix Et Rhizoma Rhei and Radix Astragali raw material consist of:
The Radix Astragali: Radix Et Rhizoma Rhei=1: 2-2: 1
Most preferred Radix Et Rhizoma Rhei and Radix Astragali raw material consist of:
The Radix Astragali: Radix Et Rhizoma Rhei=1: 1
In more than forming, weight is calculated with crude drug, as the most preferred Radix Astragali: Radix Et Rhizoma Rhei=4500 part: 4500 parts, wherein part is represented weight portion, every part if be unit with the gram, more than forms to can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000 grams, oral liquid 1000ml, 1000 of injections etc.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Single medicinal material in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine injection preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutically active substance in the Chinese medicine preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form is meant the unit of preparation, as every of injection etc.
Injection of the present invention, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this active substance can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Injection of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material etc.
Preparation of the present invention is determined usage and dosage according to patient's situation in use,
Chinese medicine preparation of the present invention can prepare by the following method.
1) gets the Radix Astragali, be ground into coarse granule, add 2-20 times of water gaging and fry in shallow oil extraction three times, each 1.5 hours, merge extractive liquid, filtered, add the 1-10% gelatin in the filtrate, stir, left standstill 8 hours, filter, filtrate is concentrated into relative density 1.15-1.25 (60 ℃ of surveys), adds ethanol and makes and contain the alcohol amount and reach 60-95%, cold preservation 8 hours is filtered, and filtrate is passed through polyamide, decompression recycling ethanol adds suitable quantity of water to there not being the alcohol flavor, passes through macroporous resin, earlier with the suitable quantity of water eluting, discard water lotion, reuse 20-60% ethanol elution is closely colourless to eluent, continues and uses the 40-70% ethanol elution, collect ethanol elution, decompression recycling ethanol adds suitable quantity of water and makes medicine liquid volume be equivalent to contain the about 2-5g/ml of raw medicinal herbs to there not being the alcohol flavor, presses 1-10% and adds active carbon, 50-80 ℃ is incubated 10-60 minute, filter, filtrate decompression is concentrated into dried, promptly.
2) get the Radix Et Rhizoma Rhei coarse powder, add 2-20 and doubly measure the ethanol that contains and carry out reflux, extract, 2-5 time, merge extractive liquid,, leave standstill, the leaching supernatant, being evaporated to does not have the alcohol flavor, cryopreservation 1-4 hour, filter the macroporous resin column of filtrate by handling well, be washed to nearly neutrality, reuse ethanol-5% sodium hydroxide (4: 1) is eluted to closely colourless, collects ethanol-5% sodium hydroxide (4: 1) eluent, decompression recycling ethanol left standstill 1-12 hour, filtered, filtering residue is washed till neutrality with water for injection, drying, promptly.
3) get mannitol, the Radix Astragali, Radix Et Rhizoma Rhei extract, mix, add 4000ml water, the back that stirs is 7-10 with the 1-20%NaOH adjust pH, add the injection water to 5000ml, add 0.1% active carbon, boiled 20 minutes, filter, filtrate adds the injection water and is adjusted to 5000ml, the microporous filter membrane fine straining, in the infusion bottle of packing into filtrate branch, 100-130 ℃, 30-60 minute pressure sterilizing.Microporous filter membrane fine straining under the aseptic condition divides (5ml/ props up), lyophilization in the 10ml cillin bottle of packing into, Zha Gai, and quality inspection promptly gets the lyophilizing finished product.
Following data declaration beneficial effect of the present invention by experiment:
(1) clinical research of treatment CRF
Influence (the treatment group adopts injection of the present invention, and matched group adopts ligustrazine 0.12g to add among the 5% glucose 250ml, and quiet, every day 1 time, 2 weeks were 1 course of treatment) to renal function.
Renal function comparison before and after table 1. treatment (x ± SD)
Injection sees Table 1 to the influence of renal function.Bun descends to some extent after the treatment of control group; It is not obvious that Cr descends, and CCr rises not remarkable, and compares difference before the treatment and do not have significance (P＞0.05); Treatment group Bun, Cr obviously descends, and CCr obviously improves, and compares difference significance (P＜0.05 or P＜0.01) is arranged before the treatment.The difference of comparing between two groups all has significance (P＜0.05).
The analysis of curative effect:
Table 2. liang group treatment back effective percentage relatively
The treatment group is better than matched group, and difference has significance (P＜0.05).
The function of injection of the present invention cure mainly for: QI invigorating consolidates, the blood stasis dispelling the turbid descending.Be used for chronic renal failure, the fatigue and weakness due to the spleen deficiency of kidney-QI turbid damp of holding concurrently, blood stasis, nausea and vomiting, poor appetite abdominal distention, heavy sensation of the body is sleepy, soreness of waist lumbago, loose stool, nocturia are long clearly, very then cold extremities with aversion to cold.Dim complexion, light red tongue or purple dark, tongue has indentation or sees the ecchymosis petechia, Tai Bai or thick greasy, diseases such as deep and weak pulse.And have: 2. the azotemia that 1. improves CRF patient suppresses kidney compensatory hypertrophy and hypermetabolism state; 3. suppress the MsC paraplasm, help to delay the progress of CRF pathology; 4. correct lipid metabolic disorder, delay renal function and worsen; 5. to the elimination effect of free radical.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1:
Get Radix Astragali 4500g, be ground into coarse granule, add 6 times of water gagings and fry in shallow oil extraction three times, each 1 hour, merge extractive liquid, filtered, add 2% gelatin in the filtrate, stir, filter, filtrate is concentrated into relative density 1.15-1.25 (60 ℃ of surveys), adds ethanol and makes and contain the alcohol amount and reach 80%, cold preservation 8 hours, filter, filtrate is by polyamide, and decompression recycling ethanol is to there not being the alcohol flavor, add suitable quantity of water, make medicine liquid volume be equivalent to contain the about 4g/ml of raw medicinal herbs, pass through D
101Macroporous resin, with the suitable quantity of water eluting, discard water lotion earlier, reuse 30% ethanol elution is closely colourless to eluent, continue and use 50% ethanol elution, collect ethanol elution, decompression recycling ethanol adds suitable quantity of water and makes medicine liquid volume be equivalent to contain the about 4g/ml of raw medicinal herbs to there not being the alcohol flavor, add active carbon by 2%, filter, filtrate decompression is concentrated into dried, promptly gets Radix Astragali extract.
Rhubarb medicinal material coarse powder 4500g, adding 8 times of amounts contains 12% vitriolic ethanol and carries out reflux, extract, twice, each 2 hours, merge extractive liquid, left standstill, the leaching supernatant, being evaporated to does not have the alcohol flavor, adds NaOH and transfers pH to 8, filters, the macroporous resin column of filtrate by handling well, be washed to nearly neutrality, reuse ethanol-3% sodium hydroxide (3: 1) is eluted to closely colourless, decompression recycling ethanol, concentrated hydrochloric acid is transferred pH2-4, left standstill 12 hours, and filtered, filtering residue is washed till neutral back with water for injection and checks that not having the matter of mixing gets final product, drying promptly gets Radix Et Rhizoma Rhei extract.
Get mannitol 70g, Radix Et Rhizoma Rhei extract and Radix Astragali extract, mix, add 4000ml water, the back that stirs is 8 with the 15%NaOH adjust pH, add the injection water to 5000ml, add 0.2% active carbon, boiled 20 minutes, filter, filtrate adds the injection water and is adjusted to 5000ml, the microporous filter membrane fine straining, in the infusion bottle of packing into filtrate branch, 115 ℃, 30 minutes pressure sterilizings.Microporous filter membrane fine straining under the aseptic condition divides in the cillin bottle of packing into (5ml/ props up).
Embodiment 2:
Prescription is formed: Radix Astragali 450g, and rhubarb medicinal material coarse powder 4500g,
Preparation method: with embodiment 1
Embodiment 3:
Prescription is formed: Radix Astragali 4500g, and rhubarb medicinal material coarse powder 450g,
Preparation method: with embodiment 1
Embodiment 4:
Prescription is formed: Radix Astragali 900g, and rhubarb medicinal material coarse powder 4500g,
Preparation method: with embodiment 1
Embodiment 5:
Prescription is formed: Radix Astragali 4500g, and rhubarb medicinal material coarse powder 900g,
Preparation method: with embodiment 1
Embodiment 6:
Prescription is formed: Radix Astragali 2250g, and rhubarb medicinal material coarse powder 4500g,
Preparation method: with embodiment 1
Embodiment 7:
Prescription is formed: Radix Astragali 4500g, and rhubarb medicinal material coarse powder 2250g,
Preparation method: with embodiment 1
Embodiment 8:
Prescription is formed: Radix Astragali 4500g, and rhubarb medicinal material coarse powder 4500g,
Preparation method: with embodiment 1, but after branch is packed cillin bottle into, carry out lyophilization, Zha Gai, quality inspection promptly gets 1000 of lyophilizing finished products.
Claims (1)
1, a kind of treatment chronic renal failure Chinese medicine compound injection is characterized in that, described injection be by in
The medicine Radix Et Rhizoma Rhei and the Radix Astragali are feedstock production, and wherein the weight proportion of the Radix Et Rhizoma Rhei and the Radix Astragali is: the Radix Astragali: Radix Et Rhizoma Rhei=1: 1, and its preparation method process following steps:
1) gets Radix Astragali 4500g, be ground into coarse granule, add 6 times of water gagings and fry in shallow oil extraction three times, each 1 hour, merge extractive liquid, filtered, add 2% gelatin in the filtrate, stir, filter, survey filtrates for 60 ℃ and be concentrated into relative density 1.15-1.25, add ethanol and make and contain the alcohol amount and reach 80%, cold preservation 8 hours, filter, filtrate is by polyamide, and decompression recycling ethanol is to there not being the alcohol flavor, add suitable quantity of water, make medicine liquid volume be equivalent to contain the about 4g/ml of raw medicinal herbs, pass through D
101Macroporous resin, with the suitable quantity of water eluting, discard water lotion earlier, reuse 30% ethanol elution is closely colourless to eluent, continue and use 50% ethanol elution, collect ethanol elution, decompression recycling ethanol adds suitable quantity of water and makes medicine liquid volume be equivalent to contain the about 4g/ml of raw medicinal herbs to there not being the alcohol flavor, add active carbon by 2%, filter, filtrate decompression is concentrated into dried, promptly;
2) get rhubarb medicinal material coarse powder 4500g, adding 8 times of amounts contains 12% vitriolic ethanol and carries out reflux, extract, twice, each 2 hours, merge extractive liquid, left standstill, the leaching supernatant, being evaporated to does not have the alcohol flavor, adds NaOH and transfers pH to 8, filters, the macroporous resin column of filtrate by handling well, be washed to nearly neutrality, the reuse ratio is that 3: 1 ethanol-3% sodium hydroxide eluting is extremely closely colourless, decompression recycling ethanol, concentrated hydrochloric acid is transferred pH2-4, left standstill 12 hours, and filtered, filtering residue is washed till neutral back with water for injection and checks that not having the matter of mixing gets final product, drying, promptly;
3) get mannitol 70g, Radix Et Rhizoma Rhei extract and Radix Astragali extract, mix, add 4000ml water, stirring back is 8 with the 15%NaOH adjust pH, adds the injection water to 5000ml, adds 0.2% active carbon, boiled 20 minutes, filter, filtrate adds the injection water and is adjusted to 5000ml, the microporous filter membrane fine straining, pack into filtrate branch in the infusion bottle, 115 ℃, 30 minutes pressure sterilizings, microporous filter membrane fine straining under the aseptic condition divides in the 5ml cillin bottle of packing into.
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Assignee: Beijing Huamu Great Exploit Sci&tech Co., Ltd. Assignor: Yang Dong|Liu Kecheng|Yang Mingjun Contract record no.: 2010110000159 Denomination of invention: Process for preparing Chinese medicine compound injection for treating chronic renal failure and use Granted publication date: 20090819 License type: Exclusive License Open date: 20070124 Record date: 20100920 |
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