CN101269180A - Traditional Chinese medicine compound preparation for treating nephritis and preparation method - Google Patents
Traditional Chinese medicine compound preparation for treating nephritis and preparation method Download PDFInfo
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- CN101269180A CN101269180A CNA2007100136957A CN200710013695A CN101269180A CN 101269180 A CN101269180 A CN 101269180A CN A2007100136957 A CNA2007100136957 A CN A2007100136957A CN 200710013695 A CN200710013695 A CN 200710013695A CN 101269180 A CN101269180 A CN 101269180A
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Abstract
The invention discloses a traditional Chinese medicine compound formulation for curing nephritis and a preparation method thereof. The formulation includes tablets, capsules, granules, soft capsules, pills and mixtures, etc., and comprises twelve traditional Chinese medicines of common cephalanoplos herb, milk veteh, radix rehmanniae recen, fiveleaf akebia, motherwort, corn stigma, lophatherum gracile, fried cattail pollen, nodus nelumbinis rhizomatis, angelica, gardenia and broiled liquorice. Traditional Chinese medicines are mixed according to the weight ratio of 60 to 100 shares of common cephalanoplos herb, 60 to 100 shares of milk veteh, 30 to 50 shares of radix rehmanniae recen, 15 to 25 shares of fiveleaf akebia, 30 to 50 shares of motherwort, 8 to 12 shares of corn stigma, 15 to 25 shares of lophatherum gracile portions, 8 to 12 shares of fried cattail pollen, 15 to 25 shares of nodus nelumbinis rhizomatis, 30 to 50 shares of angelica, 15 to 25 shares of gardenia and 15 to 25 shares of broiled liquorice. The traditional Chinese medicine compound formulation has the functions for removing pathogenic heat from blood, inducing diuresis to reduce edema and nourishing kidney. The formulation can be used for curing the symptoms such as acute nephritis hydrops and chronic nephritis hydrops, hematuria and proteinuria, etc. caused by accumulation of damp heat. The traditional Chinese medicine compound formulation takes optimized common traditional Chinese medicines as raw materials, has simple and easily controllable preparation technology, high content of effective components, short curative period of treatment and rapid effect, is based on the principle of curing the root and addressing both the symptoms and the root causes, ensures that the diseases are not easy to recur and has evident effect.
Description
1. technical field
The invention belongs to the pharmaceutical technology field, relate to a kind of compound Chinese medicinal preparation and preparation method for the treatment of nephritis.
2. background technology
At present, nephritis is a kind of commonly encountered diseases, frequently-occurring disease, according to North America, West Europe and Australia's statistics, in every million people's mouth, has every year 100-150 people that chronic renal failure takes place approximately.In China, infer that according to the statistical inquiry of 2,000,000 urban populations its incidence rate is about 668 people/1,000,000, is one of important disease of serious threat human life health.
The reason of nephritis morbidity and mechanism are extremely complicated, the most rejuvenations of patient now, the trend of especially oriented male aspect development.Hematuria, albuminuria, hypourocrinia, edema usually appear in nephrotic's initial stage, even cause symptoms such as hypertension or heart failure.The chronic nephritis obstinate is difficult to dig up the roots, and the treatment that enters late stage uremia is difficult more.The medication of western medicine nephritis also is difficult to find specific drug at present, and the disadvantage that western medical treatment exists is that side effect is big.And traditional Chinese medical science Chinese herbal medicine by universally acknowledged be the precious treasure-house of indispensable human medicine.Modern medicine is thought, the pathological change of nephritis mainly shows glomerule base film, makes vascular endothelial proliferation, basement membrane thickened, part glomerule generation degeneration, and then fibrosis.The renal tubules that links to each other with glomerule presents malnutrition and sexually revises, or makes the renal tubules atrophy, thereby albuminuria occurs.According to traditional Chinese medicine theory, think insufficiency of kidney-YANG, decline of the fire from the gate of life, water failing to be transformed into QI, humidity hysteresis blood addiction is the basic pathogenesis of nephritis patient.The traditional Chinese medical science is thought, " nephritis patient is unbalance relevant with vital QI being weakened and pathogen being violent, and the kidney being the origin of congenital constitution, and kidney is subjected to the essence of five ZANG-organs and six FU-organs and hides it ".It is not solid that deficiency of the kidney is then sealed the Tibetan, and vital essence leaks, and can not collect the essence of five ZANG-organs and six FU-organs gas, produces albuminuria.
The common Chinese medicine preparation that is used for the treatment of nephritis at present has LIUWEI DIHUANG WAN, ERXIAN TANG, shenyankangfu tablet etc., though acute and chronic nephritis is had certain curative effect, the course of treatment is long, and recovery from illness is slow, and easily recurrence.
3. summary of the invention
Purpose of the present invention just provides a kind of short treating period, rapid-action, and effecting a permanent cure, treating both the principal and secondary aspects of a disease and be difficult for recurrence particularly more has the compound Chinese medicinal preparation of the treatment nephritis of outstanding effect to the acute attack symptom.
Through inventor's clinical practice and pharmacological testing for many years, filtering out the compound Chinese medicinal preparation of being made up of Herba Cirsii, the Radix Astragali, Radix Rehmanniae, Caulis Akebiae, Herba Leonuri, Stigma Maydis, Herba Lophatheri, Pollen Tyjphae (parched), Nodus Nelumbinis Rhizomatis, Radix Angelicae Sinensis, Fructus Gardeniae, Radix Glycyrrhizae Preparata all has curative effect preferably to treating various acute and chronic nephritis.
Herba Cirsii sweet in the mouth, bitterness cold, GUIXIN, Liver Channel, cooling blood for hemostasis, the detumescence of becoming silted up of dispelling; Radix Astragali sweet in the mouth, warm in nature, return lung, spleen channel, invigorating QI to consolidate the body surface resistance, diuresis poison holding, expelling pus and promoting granulation; The Radix Rehmanniae sweet in the mouth, cold in nature, GUIXIN, liver, kidney channel, clearing away heat and cooling blood, YIN nourishing and the production of body fluid promoting; Three flavors amount to clearing away heat and cooling blood for monarch drug, inducing diuresis to remove edema, and the nourishing YIN for benefiting the kidney is to control primary symptom.Herba Leonuri bitter in the mouth, hot cold nature are returned liver, pericardium channel, promoting blood flow to regulate menstruation, inducing diuresis to remove edema; The lightly seasoned property of Stigma Maydis is flat, returns the liver and gall warp, diuresis, purge heat, suppressing the hyperactive liver, function of gallbladder promoting; Herba Lophatheri sweet in the mouth, light, cold in nature, GUIXIN, lung, stomach warp, clearing heat and relieving fidgetness, diuresis; Three flavor medicines are assisted the monarch drug heat clearing away jointly, are invigorated blood circulation, ministerial drug is thought in diuresis.Caulis Akebiae bitter in the mouth cold nature, GUIXIN, small intestinal, urinary bladder channel, clearing away heart-fire, sharp stool, the stimulating milk secretion of stimulating the menstrual flow; The Pollen Tyjphae (parched) sweet in the mouth is flat, returns liver, pericardium channel, hemostasis, blood stasis dispelling, treating stranguria; Nodus Nelumbinis Rhizomatis sweet in the mouth, puckery, property is flat, returns liver, lung, stomach warp, hemostasis, repercussive; Radix Angelicae Sinensis sweet in the mouth, suffering, warm in nature, return liver, the heart, spleen channel, enrich blood invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation; The Fructus Gardeniae bitter in the mouth is cold in nature, GUIXIN, lung, tri-jiao channel, pathogenic fire purging relieving restlessness, clearing away heat and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body; The five tastes are helped jointly with ministerial drug.The Radix Glycyrrhizae Preparata sweet in the mouth is flat, GUIXIN, lung, spleen, stomach warp, and spleen reinforcing stomach function regulating, Yiqi and vein recovery more can make all medicines focus of going directly, for making it medicine.All medicines have share clearing away heat and cooling blood, inducing diuresis to remove edema, and the effect of kidney tonifying, the present invention can be used for diseases such as acute and chronic oedema due to nephritis due to the damp-heat accumulation, hematuria, albuminuria.
Through inventor's clinical practice for many years, each flavour of a drug weight proportion of the present invention all has clinical efficacy preferably in following scope:
60～100 parts of Herba Cirsiis, 60～100 parts of the Radixs Astragali, 30～50 parts of Radix Rehmanniae, 15～25 parts of Caulis Akebiaes, 30～50 parts of Herba Leonuris, 8～12 parts of Stigma Maydis, 15～25 parts of Herba Lophatheris, 8～12 parts of Pollen Tyjphae (parched), 15～25 parts of Nodus Nelumbinis Rhizomatis, 30～50 parts of Radix Angelicae Sinensis, 15～25 parts of Fructus Gardeniaes, 15～25 parts of Radix Glycyrrhizae Preparatas.
Each flavour of a drug of the present invention can obtain best clinical efficacy when following weight proportion is arranged:
80 parts of Herba Cirsiis, 80 parts of the Radixs Astragali, 40 parts of Radix Rehmanniae, 20 parts of Caulis Akebiaes, 40 parts of Herba Leonuris, 10 parts of Stigma Maydis, 20 parts of Herba Lophatheris, 10 parts of Pollen Tyjphae (parched), 20 parts of Nodus Nelumbinis Rhizomatis, 40 parts of Radix Angelicae Sinensis, 20 parts of Fructus Gardeniaes, 20 parts of Radix Glycyrrhizae Preparatas.
The present invention can be obtained by following method, but can not be interpreted as that the present invention only limits to following preparation technology.
Technology one: get 12 flavor Chinese medicines such as Herba Cirsii, the Radix Astragali, Radix Rehmanniae, Caulis Akebiae, Herba Leonuri, Herba Lophatheri, Nodus Nelumbinis Rhizomatis, Radix Angelicae Sinensis, Radix Glycyrrhizae Preparata, Pollen Tyjphae (parched), Stigma Maydis, Fructus Gardeniae through cleaning processing, decoct with water three times, first and second time adds 10 times in water, decocts 2 hours, add 8 times in water for the third time, decocted 1 hour, collecting decoction filters, is concentrated into an amount of, add ethanol, regulate amount of alcohol 50%～80%, standing over night makes precipitation, get supernatant, filter, decompression filtrate recycling ethanol concentrates, dry, pulverize, get extract powder, standby.
Technology two: get 12 flavor Chinese medicines such as Herba Cirsii, the Radix Astragali, Radix Rehmanniae, Caulis Akebiae, Herba Leonuri, Herba Lophatheri, Nodus Nelumbinis Rhizomatis, Radix Angelicae Sinensis, Radix Glycyrrhizae Preparata, Pollen Tyjphae (parched), Stigma Maydis, Fructus Gardeniae through cleaning processing, decoct with water secondary, first adds 12 times in water, decocted 2 hours, for the second time add 10 times in water, decocted collecting decoction 2 hours, filter, be concentrated in right amount, add ethanol, regulate ethanol to 50%～80%, standing over night, make precipitation, get supernatant, filter, decompression filtrate recycling ethanol, concentrate, drying is pulverized, get extract powder, standby.
Technology three: get nine flavor Chinese medicines such as Herba Cirsii, the Radix Astragali, Radix Rehmanniae, Caulis Akebiae, Herba Leonuri, Herba Lophatheri, Nodus Nelumbinis Rhizomatis, Radix Angelicae Sinensis, Radix Glycyrrhizae Preparata through cleaning processing, decoct with water secondary, first adds 12 times in water, decocts 2 hours, for the second time add 10 times in water, decocted collecting decoction 2 hours, filter, be concentrated in right amount, add ethanol, regulate ethanol to 50%～80%, standing over night makes precipitation, get supernatant, filter decompression filtrate recycling ethanol, concentrate, get concentrated solution A, standby.Get Pollen Tyjphae (parched), Stigma Maydis, Fructus Gardeniae and add 60%～80% alcohol reflux secondary, add 10 times of amounts of alcohol at every turn, each 2 hours, filter, merging filtrate concentrates, and is dry after concentrated solution A merges, pulverize, extract powder, standby.
The preparation of tablet: get above-mentioned extract powder, add appropriate amount of auxiliary materials, mixing is granulated, tabletting, promptly.
The preparation of capsule: get above-mentioned extract powder, add appropriate amount of auxiliary materials, mixing is granulated, and is encapsulated, promptly.
The preparation of granule: get above-mentioned extract powder, add appropriate amount of auxiliary materials, mixing, packing, promptly.
The preparation of soft capsule: get medicinal plant oil or PEG400, add above-mentioned extract powder, grind well, get content with colloid mill, last soft capsule filling machine compacting, ball is washed in typing, drying, promptly.
The preparation of drop pill: get above-mentioned extract powder, add in molten matrix PEG6000 or PEG4000 or the mixture that both make by a certain percentage, stir evenly, under the keeping warm mode, medicinal liquid is splashed in the suitable cold substrate, take out, absorb condensed fluid, drying, promptly.
The present invention at preparation above-mentioned oral formulations and other pharmaceutically or during acceptable clinically arbitrary oral formulations, selectable filler has: starch, polyethylene glycol 6000, Macrogol 4000, PEG400, Icing Sugar, dextrin, calcium phosphate, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.; Selectable binding agent has: sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, PVP, pregelatinized Starch etc.; Selectable disintegrating agent has: dried starch, PVPP, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium etc.; Selectable lubricant has: magnesium stearate, Pulvis Talci, micropowder silica gel, sodium lauryl sulphate etc.
The present invention can be used for preparing the medicine for the treatment of acute and chronic nephritis, and particularly ball nephritis, pyelonephritis etc. do not have curative effect preferably to acute and chronic kidney.
For the ease of better understanding the present invention at the medical value aspect the treatment nephritis, part pharmacology of the present invention and clinical test data are disclosed.
The test example 1 part pharmacodynamics test relevant with the present invention
Experimental apparatus and material
Medicine and reagent
Tablet of the present invention (every gram contains crude drug 6.3g) is mixed with required dosage with 1% carboxymethylcellulose sodium solution during experiment; Tripterygium glycosides sheet (Zhejiang De'ende Pharmaceutical Co., Ltd.); Total protein Doumas method test kit (production of Sichuan Mai Ke Science and Technology Ltd.); Urea Nitrogen test kit (production of Sichuan Mai Ke Science and Technology Ltd.); Creatinine reagent box (production of Sichuan Mai Ke Science and Technology Ltd.); Albustix (production of Guilin culminant star biotech development company limited); Calf serum, (Hangzhou Ilex purpurea Hassk.[I.chinensis Sims biological engineering material institute)
Laboratory animal SD rat is some, and male and female have concurrently, body weight 180～200g.
Instrument 722 grating spectrophotometers (Shanghai the 3rd analytical tool factory).
Experimental technique and result
The moulding of experimental serum sickness type nephritis is some with the SD rat, under sterilising conditions, inject (56 ℃ of calf serums by the 350mg/kg albumin to rat tail vein, 30min water-bath deactivation), 10 injecting normal salines of normal group, the moulding animal urine protein occurs after one week, and hairs is loose, loses weight, the movable minimizing, appetite weakens, and collects urine with urine collecting device, gets albustix and detects urine protein and be 50 of the rats of " ++ ", be divided into five groups at random: positive controls gives tripterygium glycosides 0.01g/kg, tablet of the present invention presses 0.25,0.5, three various dose administrations of 1.0g/kg, normal group and model group wait the distilled water of capacity, continuous 4 weeks.Observe variations such as the feed, sign, outward appearance, behavior of animal and pudendum urine dye during the treatment every day.
Observation item respectively before moulding, after the moulding 7,21,35d collects each rat 24h urine, carries out urine creatine, urine protein quantitation (para-aminosalicylic acid method) experiment; 36d puts to death the content that rat extracting blood is surveyed total serum protein, creatinine and blood urea nitrogen after the moulding; Get kidney and organize of science inspection of curing the disease.
The statistical method data are represented with X ± S, with t check carrying out statistical analysis between group.
The result
To influencing of serum sickness type Glomerulonephritis Rats urine creatine two weeks of tablet 1.0g/kg successive administration of the present invention and 0.5,1.0g/kg 4 weeks of successive administration all can reduce the 24h total excretion of rat urine creatine, and model group is organized a t check has significant difference, result to show the effect that the present invention has influences serum sickness type Glomerulonephritis Rats urine creatine excretion.The results are shown in Table 1.
Table 1 the present invention is to the influence of serum sickness type Glomerulonephritis Rats urine creatine (X ± S)
Compare with matched group,
*P＜0.05; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001; N=10
Influence to serum sickness type Glomerulonephritis Rats urine protein index
Rat carried out after the moulding of serum sickness type nephritis for the from the 1st to the 5th all urine protein 24h output and continues to increase, tablet 0.25 of the present invention, 0.5,1.0g/kg successive administration, all can reduce rat urine protein 24h total excretion the 2nd and the 4th week, and model group is organized a t check and is had significant difference, and the result shows that the present invention has the effect of significant reduction serum sickness type Glomerulonephritis Rats urine protein excretion.The results are shown in Table 2.
Table 2 the present invention is to the influence of serum sickness type Glomerulonephritis Rats urine protein index (X ± S)
Compare with matched group,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △P＜0.01,
△ △ △P＜0.001; N=10
To the tablet 0.5 of the present invention that influences of serum sickness type Glomerulonephritis Rats serum biochemistry index, the The Total albumen content of the serum sickness type Glomerulonephritis Rats that can raise in 4 weeks of 1.0g/kg successive administration; Tablet 0.25,0.5 of the present invention, 1.0g/kg all can reduce the serum urea nitrogen content of serum sickness type Glomerulonephritis Rats and reduce the serum creatinine content of serum sickness type nephritis rat model; The above results shows that tablet of the present invention can raise because of rat blood serum total protein level that serum sickness type nephritis reduces, reduce the rat blood serum blood urea nitrogen and the creatinine level that raise because of serum sickness type nephritis, sees Table 3.
Table 3 the present invention is to the influence of serum sickness type Glomerulonephritis Rats serum biochemistry index (X ± S)
Compare with matched group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with model group,
△P＜0.05,
△ △ △P＜0.001; N=10
To 24h after the pathological effect last administration of serum sickness type Glomerulonephritis Rats glomerule tissue, the rat sacrificed by exsanguination, take out two kidneys, fix with saturated picric acid fixative, draw materials paraffin embedding, section, HE dyeing, observation by light microscope, the pathological change of matter between reaching with 4000 times of sem observation glomerule, renal tubules.The result: visible kidney changes obviously under the model arrangement of mirrors, the obvious swelling of most of glomerule, and glomerular capillary clump inner cell is counted showed increased, endotheli ocytosis swelling.Tablet 0.25,0.5 of the present invention, 1.0g/kg group pathological changes glomerule obviously improves, the glomerular volume silght enlargement, endotheli ocytosis is not obvious, and the renal cells cloudy swelling alleviates, and no renal tubules chamber is narrow, and the pathological changes numbers of glomeruli also obviously reduces.
The part clinical trial relevant of test example 2 with the present invention
Diagnostic criteria:
The tcm diagnosis standard
(1) insufficiency of QI of the lung and kidney:
1. puffiness of the face and limbs, shallow complexion
2. weak breath is weak
3. easy catching a cold
4. ache of the spinal column
5. light red tongue, white and moist fur, indentation is arranged, thready and weak pulse
(2) deficiency of spleen-YANG and kidneyYANG:
1. edema is obvious, and Mian Se Koushi is white
2. aversion to cold and cold limbs
3. ache of the spinal column or soreness of the shank lower limb are soft.Talalgia
4. Mental fatigue, indigestion and loss of appetite or loose stool
5. sexual function not normal (seminal emission, sexual impotence, premature ejaculation) or menoxenia
6. tongue is tender light fat, and indentation is arranged, deep-thready pulse or heavy unable late
(3) hepatic and renal YIN deficiency:
1. dryness with foreign body sensation in the eyes or blurred vision
2. dizzy, tinnitus
3. dysphoria with feverish sensation in the chest palms and soles, dry mouth and throat
4. ache of the spinal column or nocturnal emission or menoxenia
5. the few tongue of red tongue, stringy and thready pulse or count accurately
(4) deficiency of both QI and YIN:
1. lusterless complexion
2. the weak or easy infection of weak breath
3. afternoon low grade fever or feverish sensation in the palms and soles
4. dry mouth and throat or long-term pharyngalgia are pharyngeal dark red
5. body of the tongue is red partially, few tongue, thready pulse or a little less than.
The Western medicine diagnose standard
(1) acute glomerulonephritis:
1. onset is slow, state of an illness delay, the time heavy when light, renal function progressively goes down, anemia can appear in the later stage, electrolyte disturbance, situations such as blood urea nitrogen, serum creatinine rising;
2. performances such as edema, albuminuria, hematuria and hypertension are in various degree arranged;
3. can bring out acute attack because of reasons such as respiratory tract infection in the course of disease, the performance of similar acute nephritis occur.Also there is some cases that the automatic catabasis can be arranged.
(2) chronic glomerulonephritis:
1. onset is slow, state of an illness delay, the time heavy when light, renal function progressively goes down, anemia can appear in the later stage, electrolyte disturbance, situations such as blood urea nitrogen, serum creatinine rising;
2. performances such as edema, albuminuria, hematuria and hypertension are in various degree arranged;
3. can bring out acute attack because of reasons such as respiratory tract infection in the course of disease, the performance of similar acute nephritis occur.Also there is some cases that the automatic catabasis can be arranged;
Each 2 of Therapeutic Method, every day 3 times.1 month was 1 course of treatment, 1～3 course of treatment.
Efficacy assessment standard
Recovery from illness: symptom, sign disappear, and routine urinalysis and blood biochemistry recover normal fully
Produce effects: symptom, sign disappear, and routine urinalysis is near normal
Take a turn for the better: symptom, sign and routine urianlysis take a turn for the better
Invalid: through the first quarter moon treatment, symptom, sign make moderate progress, but routine urianlysis does not have progress
Therapeutic outcome and conclusion
Table 4 clinical efficacy result of the test of the present invention
By clinical test results of the present invention as can be seen, this product onset comparatively slowly and lasting, be suitable for obeying for a long time in the patient of chronic nephritis, 60 days clinical total effective rate can reach 78.33%, 90 day clinical total effective rate and reach 90%, clinical efficacy is excellent.
4. the specific embodiment
Embodiment 1
Prescription: Herba Cirsii 4kg Radix Astragali 4kg Radix Rehmanniae 2kg Caulis Akebiae 1kg
Herba Leonuri 2kg Stigma Maydis 0.5kg Herba Lophatheri 1kg Pollen Tyjphae (parched) 0.5kg
Nodus Nelumbinis Rhizomatis 1kg Radix Angelicae Sinensis 2kg Fructus Gardeniae 1kg Radix Glycyrrhizae Preparata 1kg
Method for making:
1) gets above-mentioned 12 flavor Chinese medicines such as Herba Cirsii and carry out cutting, clean processing according to the requirement of each medicine concocted specification;
2) take by weighing each pharmaceutical decocting piece by recipe quantity, add 12 times of amounts of water, heating decocted 2 hours;
3) filter, medicinal residues add 10 times of amounts of water again, and heating decocted 2 hours;
4) filter, collecting decoction is put and is evaporated to relative density 1.10～1.20 in the concentration tank, puts coldly, adds ethanol and contains the alcohol amount to 60%, standing over night;
5) draw supernatant, decompression recycling ethanol continues to be concentrated into the thick paste of relative density 1.30～1.40 to there not being the alcohol flavor, vacuum drying (60 ℃ ,-0.1Mpa);
6) pulverize, cross sieve No. 5, get extract powder, standby.
Result: obtain the about 1kg of extract powder altogether
The preparation of tablet:
Prescription: extract powder 200g
Microcrystalline Cellulose 50g
Starch 230g
Carboxymethyl starch sodium 15g
Magnesium stearate 5g
Make 1000 altogether
Preparation technology:
1) gets above-mentioned extract powder, microcrystalline Cellulose, the starch of recipe quantity, mixing;
2) add an amount of 80%～90% ethanol system soft material, cross 20 purposes granulation sieve;
3) the about 30min of baking below 60 ℃;
4), continue under same temperature, to dry by the fire to dry with the sieve granulate of granulating.
5) carboxymethyl starch sodium and the magnesium stearate of adding recipe quantity, mixing, tabletting, promptly.
The preparation of capsule:
Prescription: extract powder 200g
Microcrystalline Cellulose 50g
Starch 100g
Magnesium stearate 3g
Micropowder silica gel 7g
Make 1000 of capsules altogether
Preparation technology:
1) gets extract powder, microcrystalline Cellulose, the starch of above-mentioned recipe quantity, mixing;
2) add an amount of 80%～90% ethanol system soft material, cross 20 purposes granulation sieve;
3) the about 30min of baking below 60 ℃;
4), continue under same temperature, to dry by the fire to dry with the sieve granulate of granulating.
5) magnesium stearate, the micropowder silica gel of adding recipe quantity, mixing, encapsulated, promptly.
The preparation of granule:
Prescription: extract powder 200g
Icing Sugar 700g
Dextrin 100g
Make granule 1000g altogether
Preparation technology:
1) get Icing Sugar and pulverize, cross 100 mesh sieves, standby;
2) take by weighing extract powder, Icing Sugar, the dextrin of above-mentioned recipe quantity, mixing adds an amount of 90%～95% alcohol granulation, crosses 20 mesh sieves;
3) oven dry below 60 ℃, granulate continues to dry by the fire to moisture below 5%;
4) packing, promptly.
The drop pill preparation:
Prescription: extract powder 100g
PEG6000 200g
Polyoxyethylene sorbitan monoleate 20g
Make drop pill 10000 balls altogether
Preparation technology:
1) get the PEG6000 of recipe quantity, heating makes fusion;
2) polyoxyethylene sorbitan monoleate of adding recipe quantity, mixing;
3) add extract powder, mixing is taken advantage of a favourable situation to shift and is put in the drop pill hopper, and 80 ℃ of insulations are dripped and made ball;
4) collect drop pill, remove surface solvent, drying, packing, promptly.
The oral solutions preparation:
Prescription: extract powder 100g
Sucrose 100g
Sodium benzoate 3g
Edible essence is an amount of
Water is an amount of
Make 1000ml altogether
Preparation technology:
1) presses recipe quantity weighing extract powder, sucrose, add in the 800ml water;
2) warmly make dissolving, filter;
3) filtrate adds water adjustment total amount to 1000ml, adds sodium benzoate, edible essence, makes dissolving;
4) fine straining, fill, promptly.
Preparation of soft capsule:
Prescription: extract powder 150g
Soybean oil 220g
Fabaceous lecithin 25g
Cera Flava 15g
Make 1000 altogether
Preparation technology:
1) takes by weighing the extract powder of recipe quantity, pulverize, cross 100 mesh sieves;
2) soybean oil, fabaceous lecithin, the Cera Flava heating that takes by weighing recipe quantity makes dissolving, and mixing is as substrate;
3) substrate is put be chilled to room temperature, slowly add extract powder, the limit edged stirs;
4) mixture is added in the colloid mill, be ground into the pasty state content;
5) change in the encapsulating machine hopper, be pressed into soft capsule, ball is washed in typing, drying, and packing, promptly.
Embodiment 2
Prescription: Herba Cirsii 4kg Radix Astragali 4kg Radix Rehmanniae 2kg Caulis Akebiae 1kg
Herba Leonuri 2kg Stigma Maydis 0.5kg Herba Lophatheri 1kg Pollen Tyjphae (parched) 0.5kg
Nodus Nelumbinis Rhizomatis 1kg Radix Angelicae Sinensis 2kg Fructus Gardeniae 1kg Radix Glycyrrhizae Preparata 1kg
Method for making:
1) gets 12 flavor Chinese medicines such as Herba Cirsii, the Radix Astragali, Radix Rehmanniae, Caulis Akebiae, Herba Leonuri, Herba Lophatheri, Nodus Nelumbinis Rhizomatis, Radix Angelicae Sinensis, Radix Glycyrrhizae Preparata, Pollen Tyjphae (parched), Stigma Maydis, Fructus Gardeniae by above-mentioned prescription and clean process of preparing Chinese medicine processing according to a conventional method;
2) take by weighing above-mentioned Herba Cirsii, the Radix Astragali, Radix Rehmanniae, Caulis Akebiae, Herba Leonuri, Herba Lophatheri, Nodus Nelumbinis Rhizomatis, Radix Angelicae Sinensis, each medical material of Radix Glycyrrhizae Preparata by recipe quantity, add 12 times of amounts of water, heating decocted 2 hours;
3) filter, medicinal residues add 10 times of amounts of water again, and heating decocted 2 hours;
4) filter, collecting decoction is put and is evaporated to relative density 1.10～1.20 in the concentration tank, puts coldly, adds ethanol and contains the alcohol amount to 60%, standing over night;
5) absorption supernatant, decompression recycling ethanol gets concentrated solution to there not being the alcohol flavor, and is standby;
6) take by weighing three flavor medical materials such as remaining Pollen Tyjphae (parched), Stigma Maydis, Fructus Gardeniae by recipe quantity, add 10 times of amounts of 70% ethanol, reflux, extract, 2 hours;
7) filter, medicinal residues add 10 times of amounts of 70% ethanol, reflux, extract, 2 hours again;
8) filter, merge alcohol extract, reclaim ethanol to there not being the alcohol flavor;
9) merge with water extract-alcohol precipitation liquid, continue to be concentrated into relative density to 1.30～1.40 thick pastes, be transferred to vacuum drying oven carry out vacuum drying (60 ℃, 0.1Mpa).
10) dry extract is taken out in liquidation, pulverizes, and crosses sieve No. 5, extract powder, standby.
Result: obtain the about 1.1kg of extract powder altogether
The preparation of tablet:
Prescription: extract powder 200g
Microcrystalline Cellulose 50g
Starch 230g
PVPP 15g
Magnesium stearate 5g
Make 1000 altogether
Preparation technology:
1) gets above-mentioned extract powder, microcrystalline Cellulose, the starch of recipe quantity, mixing;
2) add an amount of 80%～90% ethanol system soft material, cross 20 purposes granulation sieve;
3) the about 30min of baking below 60 ℃;
4), continue under same temperature, to dry by the fire to dry with the sieve granulate of granulating.
5) PVPP and the magnesium stearate of adding recipe quantity, mixing, tabletting, promptly.
The preparation of capsule:
Prescription: extract powder 200g
Starch 150g
Magnesium stearate 3g
Micropowder silica gel 7g
Make 1000 of capsules altogether
Preparation technology:
1) gets extract powder, the starch of above-mentioned recipe quantity, mixing;
2) add an amount of 80%～90% ethanol system soft material, cross 20 purposes granulation sieve;
3) the about 30min of baking below 60 ℃;
4), continue under same temperature, to dry by the fire to dry with the sieve granulate of granulating.
5) magnesium stearate, the micropowder silica gel of adding recipe quantity, mixing, encapsulated, promptly.
The preparation of granule:
Prescription: extract powder 200g
Lactose 500g
Stevioside 1g
Make granule 1000g altogether
Preparation technology:
1) get Icing Sugar and pulverize, cross 100 mesh sieves, standby;
2) take by weighing extract powder, lactose, the stevioside of above-mentioned recipe quantity, mixing adds an amount of 70%～80% alcohol granulation, crosses 20 mesh sieves;
3) oven dry below 60 ℃, granulate continues to dry by the fire to moisture below 5%;
4) packing, promptly.
The drop pill preparation:
Prescription: extract powder 100g
PEG6000 200g
Polyoxyethylene sorbitan monoleate 20g
Make drop pill 10000 balls altogether
Preparation technology:
1) get the PEG6000 of recipe quantity, heating makes fusion;
2) polyoxyethylene sorbitan monoleate of adding recipe quantity, mixing;
3) add extract powder, mixing is taken advantage of a favourable situation to shift and is put in the drop pill hopper, and 80 ℃ of insulations are dripped and made ball;
4) collect drop pill, remove surface solvent, drying, packing, promptly.
The oral solutions preparation:
Prescription: extract powder 100g
Xylitol 50g
Sodium benzoate 3g
Edible essence is an amount of
Water is an amount of
Make 1000ml altogether
Preparation technology:
1) presses recipe quantity weighing extract powder, xylitol, add in the 800ml water;
2) warmly make dissolving, filter;
3) filtrate adds water adjustment total amount to 1000ml, adds sodium benzoate, edible essence, makes dissolving;
4) fine straining, fill, promptly.
Preparation of soft capsule:
Prescription: extract powder 150g
PEG400 300g
Polyoxyethylene sorbitan monoleate 50ml
Make 1000 altogether
Preparation technology:
1) takes by weighing the extract powder of recipe quantity, pulverize, cross 100 mesh sieves;
2) take by weighing PEG400, the polyoxyethylene sorbitan monoleate of recipe quantity, mixing is as substrate;
3) get the extract powder that has crushed, slowly add in the substrate, the limit edged stirs;
4) mixture is added in the colloid mill, be ground into the pasty state content;
5) change in the encapsulating machine hopper, be pressed into soft capsule, ball is washed in typing, drying, and packing, promptly.
Claims (9)
1. a compound Chinese medicinal preparation and a preparation method for the treatment of nephritis is characterized in that mainly being made up of following raw material of Chinese medicine: Herba Cirsii, the Radix Astragali, Radix Rehmanniae, Caulis Akebiae, Herba Leonuri, Stigma Maydis, Herba Lophatheri, Pollen Tyjphae (parched), Nodus Nelumbinis Rhizomatis, Radix Angelicae Sinensis, Fructus Gardeniae, Radix Glycyrrhizae Preparata.
2. according to claim 1, it is characterized in that mainly making: 1～160 part of Herba Cirsii, 1～160 part of the Radix Astragali, 1～80 part of Radix Rehmanniae, 1～40 part of Caulis Akebiae, 1～60 part of Herba Leonuri, 1～20 part of Stigma Maydis, 1～40 part of Herba Lophatheri, 1～20 part of Pollen Tyjphae (parched), 1～40 part of Nodus Nelumbinis Rhizomatis, 1～80 part of Radix Angelicae Sinensis, 1～40 part of Fructus Gardeniae, 1～40 part of Radix Glycyrrhizae Preparata by following parts by weight of traditional Chinese medicines raw material.
3. according to claim 1, it is characterized in that mainly making: 60～100 parts of Herba Cirsiis, 60～100 parts of the Radixs Astragali, 30～50 parts of Radix Rehmanniae, 15～25 parts of Caulis Akebiaes, 30～50 parts of Herba Leonuris, 8～12 parts of Stigma Maydis, 15～25 parts of Herba Lophatheris, 8～12 parts of Pollen Tyjphae (parched), 15～25 parts of Nodus Nelumbinis Rhizomatis, 30～50 parts of Radix Angelicae Sinensis, 15～25 parts of Fructus Gardeniaes, 15～25 parts of Radix Glycyrrhizae Preparatas by following parts by weight of traditional Chinese medicines raw material.
4. according to claim 1, it is characterized in that mainly making: 80 parts of Herba Cirsiis, 80 parts of the Radixs Astragali, 40 parts of Radix Rehmanniae, 20 parts of Caulis Akebiaes, 40 parts of Herba Leonuris, 10 parts of Stigma Maydis, 20 parts of Herba Lophatheris, 10 parts of Pollen Tyjphae (parched), 20 parts of Nodus Nelumbinis Rhizomatis, 40 parts of Radix Angelicae Sinensis, 20 parts of Fructus Gardeniaes, 20 parts of Radix Glycyrrhizae Preparatas by the raw material of Chinese medicine of following optimum weight portion rate.
5. as the described compound Chinese medicinal preparation of claim 1～4, it is characterized in that it can be clinically or pharmaceutically acceptable arbitrary oral formulations.
6. oral formulations as claimed in claim 4 is characterized in that it can be tablet, capsule, granule, soft capsule, drop pill, mixture etc.
7. the preparation method of the described compound Chinese medicinal preparation of claim 1～3 is characterized in that having following processing step:
(1) Chinese medicine is purified, is concentrated:
The weighting profit requires 1 described Chinese medicinal raw materials in proportion by weight through cleaning processing, adds suitable solvent and extracts, makes with extra care, and concentrates, and drying is pulverized, and gets extract powder, and is standby.
(2) preparation of tablet: get extract powder and add proper auxiliary materials, granulate, tabletting, promptly.
(3) preparation of capsule: get extract powder and add proper auxiliary materials, granulate, encapsulated, promptly.
(4) preparation of granule: get extract powder and add proper auxiliary materials, granulate, packing, promptly.
(5) preparation of soft capsule: get extract powder and add in the suitable substrate prepared to grind well through colloid mill and make content, be pressed into soft capsule, ball is washed in typing, drying, promptly.
(6) preparation of drop pill: get extract powder and add in the fused suitable substrate, mixing drips and makes ball, drying, promptly.
8. as the described compound Chinese medicinal preparation of claim 1～4, it is characterized in that the application in treatment nephritis.
9. compound Chinese medicinal preparation as claimed in claim 8 is in the application of treatment in the nephritis, it is characterized in that acute and chronic nephritis that this compound preparation can be used for treating a variety of causes and cause, glomerulonephritis, pyelonephritis etc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100136957A CN101269180A (en) | 2007-03-20 | 2007-03-20 | Traditional Chinese medicine compound preparation for treating nephritis and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100136957A CN101269180A (en) | 2007-03-20 | 2007-03-20 | Traditional Chinese medicine compound preparation for treating nephritis and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656260A (en) * | 2012-09-17 | 2014-03-26 | 李承平 | Common cephalanoplos herb heat-clearing and strangury-freeing tablets |
| CN106389705A (en) * | 2016-11-23 | 2017-02-15 | 张晓燕 | Traditional Chinese medicine composition for treating hematuria |
-
2007
- 2007-03-20 CN CNA2007100136957A patent/CN101269180A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656260A (en) * | 2012-09-17 | 2014-03-26 | 李承平 | Common cephalanoplos herb heat-clearing and strangury-freeing tablets |
| CN106389705A (en) * | 2016-11-23 | 2017-02-15 | 张晓燕 | Traditional Chinese medicine composition for treating hematuria |
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Open date: 20080924 |