CN100360156C - Chinese medicine composition new use - Google Patents
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- CN100360156C CN100360156C CNB2005101342774A CN200510134277A CN100360156C CN 100360156 C CN100360156 C CN 100360156C CN B2005101342774 A CNB2005101342774 A CN B2005101342774A CN 200510134277 A CN200510134277 A CN 200510134277A CN 100360156 C CN100360156 C CN 100360156C
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Abstract
The present invention relates to a novel pharmaceutical composition and new application thereof. The Chinese medicine composition comprises the following raw medicinals: 15 to 200 parts by weight of hemlock parsley, 40 to 450 parts by weight of membranous milkvetch root, 20 to 220 parts by weight of angelica, 15 to 185 parts by weight of epimedium herb, 15 to 205 parts by weight of rehmannia root, 15 to 185 parts by weight of oriental waterplantain rhizome and 15 to 185 parts by weight of tuckahoe. The Chinese medicine composition can treat acute renal failure, and has the functions of strengthening immunity and resisting fatigue.
Description
Technical field
The present invention relates to a class pharmaceutical composition, Its Preparation Method And Use, particularly relate to the purposes in pharmaceutical field.
Background technology
Acute renal failure is meant that a class causes renal function injury by multiple reason, the acute uremia syndrome of blood urea nitrogen, creatinine rising and Water-Electrolyte disorder occurs.Its cause of disease is: acute hypovolemia and peripheral circulatory failure that a variety of causes causes.Be mainly the immunoreation of (1) noxious substance, health, and such as infection such as acute glomerulonephritis or the disease grievous injury to kidney, it is depleted that it is taken place to medicine; Blood pressure when (2) serious calcination is hindered reduces suddenly, severe haemorrhage (for example being subjected to squeezing property wound) or heart disease grand mal etc. cause blood supply not normal, the grievous injury kidney; (3) the urinary tract somewhere is blocked, and urine stream is obstructed suddenly fully.Clinical manifestation is: oliguria takes place suddenly, and every day, the urine amount was less than 400 milliliters, and with nausea and vomiting, drowsiness, edema, hypertension and hematuria, albuminuria etc., often with severe complications such as heart failure, shocks.
Because acute nonfunction mostly is reversible, treatment should be primarily aimed in removing former factor, correct Water-Electrolyte and acid base imbalance, severe complications, the persons of having ready conditions such as active treatment heart failure, cardiac arrhythmia, encephalopathy, stress ulcer with bleeding should take dialysis therapy as far as possible.The treatment emphasis is for keeping water, electrolyte and acid-base balance in the body, and the control azotemia is treated protopathy and prevented various complication.Implement the patient of dialysis treatment, just can stop dialysis after the feelings of causing a disease are stable.Generally need not special handling during convalescent period, make regular check on renal function, avoid using the prejudicial medicine of kidney.
Though the medicine of treatment acute renal failure is a lot of on the market now, the toxicity of these medicines is generally all bigger, causes the part patient to use; And use unstable; Therapeutic effect is also not ideal.
The inventor discloses a class in Chinese patent application 200310110934.2 can treat pharmaceutical composition of chronic kidney hypofunction and preparation method thereof, and wherein the weight proportion of each crude drug is in this pharmaceutical composition:
Rhizoma Chuanxiong 15-25 weight portion, Radix Astragali 40-50 weight portion, Radix Et Rhizoma Rhei 12-18 weight portion, Radix Angelicae Sinensis 20-25 weight portion, Herba Epimedii 15-20 weight portion, Radix Rehmanniae 15-25 weight portion, Radix Paeoniae Alba 10-15 weight portion, Rhizoma Alismatis 15-20 weight portion, Poria 15-20 weight portion, Radix Notoginseng 6-8 weight portion.
Preferably:
Rhizoma Chuanxiong 15-20 weight portion, Radix Astragali 40-45 weight portion, Radix Et Rhizoma Rhei 12-15 weight portion, Radix Angelicae Sinensis 20-22 weight portion, Herba Epimedii 15-185 weight portion, Radix Rehmanniae 15-205 weight portion, Radix Paeoniae Alba 12-155 weight portion, Rhizoma Alismatis 15-185 weight portion, Poria 15-185 weight portion, Radix Notoginseng 6-75 weight portion.
Most preferably be:
Rhizoma Chuanxiong 20 weight portions, the Radix Astragali 40 weight portions, Radix Et Rhizoma Rhei 15 weight portions, Radix Angelicae Sinensis 20 weight portions, Herba Epimedii 15 weight portions, the Radix Rehmanniae 20 weight portions, the Radix Paeoniae Alba 15 weight portions, Rhizoma Alismatis 15 weight portions, Poria 15 weight portions, Radix Notoginseng 6 weight portions.
The disclosed above-mentioned prescription of this patent documentation can significantly improve the chronic kidney hypofunction patient oxidation resistance, promote outgrowth mesangial cell apoptosis, suppress residual renal fibrosis, reduce plasma creatinine and urea nitrogen concentration, haematochrome increasing, reduction mortality rate, prolong patient's life-span.
But acute renal failure is no matter on pathogenesis, and is still all completely different with chronic renal failure on symptom, is another disease.
Chronic renal failure is to occur in the renal function that slowly occurs on the various chronic renal diseases basis to go down, a kind of clinical syndrome until depletion, main performance is exactly that renal function goes down, and the metabolite retention causes kidney can not keep the stable of human internal environment.Cause the cause of disease more complicated of chronic renal failure, in the constitutional nephropathy, modal is that chronic glomerulonephritis accounts for the more than half of chronic renal failure total incidence.Clinical manifestation is: unable, tired, physically-draining, stomachache, diarrhoea, vomiting.Therapeutic scheme is primarily aimed at chronic glomerulonephritis.This shows that acute renal failure is different fully at aspects such as pathogenesis, clinical symptoms, Therapeutic Method with chronic renal failure, is two kinds of different diseases.
Those of ordinary skill in the art knows, the medicine of conventional therapy acute renal failure can not be treated chronic renal failure as arsenic trioxide injection etc.; And the medicine ginseng-astragalus-glutinous rehmannia soup of treatment chronic renal failure etc. can not be treated acute renal failure.
Multinomial experiment through the applicant shows, finds the new pharmaceutical composition of class treatment acute renal failure, and the part prescription is the further improvement of open proportioning in the Chinese patent application 200310110934.2 in this class pharmaceutical composition.Simultaneously, the inventor finds in the Chinese patent application 200310110934.2 disclosed proportioning except treating acute renal failure by a large amount of experiment, also treatment acute renal failure and/or enhancing immunity, resisting fatigue aspect is had significant effect.
Summary of the invention
On the one hand, the object of the present invention is to provide a kind of pharmaceutical composition for the treatment of acute renal failure, wherein the weight proportion of each crude drug is: Rhizoma Chuanxiong 15-200 weight portion, Radix Astragali 40-450 weight portion, Radix Angelicae Sinensis 20-220 weight portion, Herba Epimedii 15-185 weight portion, Radix Rehmanniae 15-205 weight portion, Rhizoma Alismatis 15-185 weight portion, Poria 15-185 weight portion.
On the other hand, the object of the present invention is to provide the application of pharmaceutical composition of the present invention in the medicine of preparation enhancing immunity.
On the other hand, the object of the present invention is to provide the application of pharmaceutical composition of the present invention in preparation antifatigue medicine.
On the other hand, the object of the present invention is to provide the application of pharmaceutical composition of the present invention in the medicine of preparation treatment acute renal failure and enhancing immunity.
On the other hand, the object of the present invention is to provide the application of pharmaceutical composition of the present invention in preparation treatment acute renal failure and antifatigue medicine.
On the other hand, the object of the present invention is to provide the application of pharmaceutical composition of the present invention in preparation treatment acute renal failure, enhancing immunity and antifatigue medicine.
Pharmaceutical composition of the present invention can further be processed into said dosage form on any pharmaceuticss such as oral liquid, tablet, capsule, granule and injection according to actual needs.Above-mentioned dosage form all can be according to the conventional method preparation of pharmaceutical field.Prepare as pill: prescription according to the present invention is got each crude drug and is ground into fine powder, crosses the 120-140 mesh sieve, adds the water mixing, pill, and drying, promptly.
The preparation technology of tablet is: prescription according to the present invention is got each crude drug and is decocted with water three times, and 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is condensed into thick paste; Recipe quantity Radix Codonopsis, Lignum Aquilariae Resinatum are ground into fine powder, and with above-mentioned thick paste uniform mixing, drying is made granule, is pressed into 1000, sugar coating, promptly.
Technical scheme of the present invention is that the medicine with open treatment chronic kidney hypofunction in the Chinese patent application 200310110934.2 is used for preparing the application in the treatment acute renal failure.
It is the present invention's application that to get technical scheme be following pharmaceutical composition in the medicine of preparation treatment acute renal failure: Rhizoma Chuanxiong 15-200 weight portion, Radix Astragali 40-450 weight portion, Radix Angelicae Sinensis 20-220 weight portion, Herba Epimedii 15-185 weight portion, Radix Rehmanniae 15-205 weight portion, Rhizoma Alismatis 15-185 weight portion, Poria 15-185 weight portion.
Another technical scheme of the present invention is the application of following pharmaceutical composition in the medicine of preparation treatment acute renal failure: Rhizoma Chuanxiong 15-200 weight portion, Radix Astragali 40-450 weight portion, Radix Et Rhizoma Rhei 12-150 weight portion, Radix Angelicae Sinensis 20-220 weight portion, Herba Epimedii 15-185 weight portion, Radix Rehmanniae 15-205 weight portion, Radix Paeoniae Alba 12-155 weight portion, Rhizoma Alismatis 15-185 weight portion, Poria 15-185 weight portion, Radix Notoginseng 6-75 weight portion.
Another technical scheme of the present invention is the application of following pharmaceutical composition in the medicine of preparation treatment acute renal failure: Rhizoma Chuanxiong 15-25 weight portion, Radix Astragali 40-50 weight portion, Radix Et Rhizoma Rhei 12-18 weight portion, Radix Angelicae Sinensis 20-25 weight portion, Herba Epimedii 15-20 weight portion, Radix Rehmanniae 15-25 weight portion, Radix Paeoniae Alba 10-15 weight portion, Rhizoma Alismatis 15-20 weight portion, Poria 15-20 weight portion, Radix Notoginseng 6-8 weight portion.
Another technical scheme of the present invention is the application of following pharmaceutical composition in the medicine of preparation treatment acute renal failure: Rhizoma Chuanxiong 20 weight portions, the Radix Astragali 40 weight portions, Radix Et Rhizoma Rhei 15 weight portions, Radix Angelicae Sinensis 20 weight portions, Herba Epimedii 15 weight portions, the Radix Rehmanniae 20 weight portions, the Radix Paeoniae Alba 15 weight portions, Rhizoma Alismatis 15 weight portions, Poria 15 weight portions, Radix Notoginseng 6 weight portions.
Wherein, pharmaceutical composition application of the present invention is the application in the medicine of preparation treatment acute renal failure and enhancing immunity; Or the application in preparation treatment acute renal failure and antifatigue medicine; It also can be the application in preparation treatment acute renal failure, enhancing immunity and antifatigue medicine.
The dosage form of the pharmaceutical composition that uses in the application of the present invention is a said dosage form on any pharmaceutics.For example that pharmaceutical composition of the present invention and one or more are conventional pharmaceutical carrier mixes, and is prepared into required dosage form then.Above-mentioned dosage form all can be according to the conventional method preparation of pharmaceutical field.Prepare as pill: prescription according to the present invention is got each crude drug and is ground into fine powder, crosses the 120-140 mesh sieve, adds the water mixing, pill, and drying, promptly.
The preparation technology of tablet is: prescription according to the present invention is got each crude drug and is decocted with water three times, and 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is condensed into thick paste; Drying is made granule, is pressed into 1000, sugar coating, promptly.
Pharmaceutical composition of the present invention can by oral, snuffing is gone into, the mode of rectum or parenteral is applied to the patient who needs.Be used for when oral, can be made into conventional solid preparation, as tablet, powder, granule, capsule etc.; Or make liquid preparation, as water or oil-suspending agent, or other liquid preparations, as syrup, elixir etc.; When being used for parenteral, can be made into solution, lyophilized injectable powder of injection etc.
The inventor at first by observing the influence of the acute renal failure oliguria model that pharmaceutical composition of the present invention causes glycerol, verifies the drug effect of pharmaceutical composition of the present invention.
Pharmaceutical composition-National Traditional Chinese Medicine Modernization Engineering Research Center wherein of the present invention provides, and compound method is: the weighting profit requires 4 pharmaceutical composition, is mixed with concentration 0.05,0.1,0.2 extract/ml with distilled water.Positive drug is that NIAODUQING KELI-Kangchen Pharmaceutical Co., Ltd., Guangzhou produces.Lot number: 20040320, compound method: be made into 0.52g granule/ml with distilled water; The modeling medication is: glycerol, import packing product, the packing of Beijing, Beijing pharmaceutical factory, lot number: 000825; Negative control is a distilled water.The reagent that uses in the test: blood urea nitrogen (BUN), creatinine (Cr), sodium (Na), potassium (Ka), chlorine (Cl), calcium (Ca), phosphorus (P) test kit are the product of the safe chemical reagent company limited in Beijing; Instrument is Humanlyzer 2000 type semi-automatic biochemical analyzers; The rat metabolic cage; 70 male SD rats are provided by-Military Medical Science Institute's Experimental Animal Center, the quality certification number: SCXK-(army) 2002-001.
Pharmaceutical composition of the present invention is established four dosage groups: 2.0,1.0,0.5,0.25g extract/kg (respectively be equivalent to 11.0,5.5,2.8,1.4g crude drug/kg), respectively be equivalent to by the clinical plan of body surface area conversion 4,2,1,1/2 times with dosage.Positive drug NIAODUQING KELI dosage is 5.2g/kg, is equivalent to 2 times by the clinical daily dosage of people of body surface area conversion.
Rat is divided into 7 groups at random, be respectively 1. normal control group, 2. model group, 3. positive drug NIAODUQING KELI: 5.2g/kg, 4. pharmaceutical composition low dose group of the present invention: 2.8g crude drug/kg, 5. dosage group in the pharmaceutical composition of the present invention: 5.5g crude drug/kg, pharmaceutical composition high dose group 6. of the present invention: 11.0g crude drug/kg.Each dosage group of pharmaceutical composition of the present invention and positive drug group rat are gastric infusion, every day 1 time, administration volume 10ml/kg, successive administration 5 days.Model group and normal control group are irritated stomach and are given with the volume distilled water.After administration in the 4th day, each group rat is prohibited water 16h, the next day of administration 1 time again, and after administration at once, each is organized rat bilateral leg muscle and injects 50% glycerol, every side 5ml/kg (except the normal control group).Then, the rat list is only put into metabolic cage, collect and write down every rat 24h urine amount, amount of drinking water, and measure glucose in urine, urine protein concentration.After urine collecting finishes, the sacrificed by exsanguination rat, separation of serum is measured serum creatinine, blood urea nitrogen and potassium, sodium, cl concn.Test data is all represented with mean ± standard deviation.Each dosage group of pharmaceutical composition of the present invention and positive drug group compare with model group respectively, with t-check carrying out statistical analysis.Experimental result sees Table 1:
The acute kidney merit that table 1 toxin clearing away and the kidney nourishing causes glycerol decline the urine amount of rat and the influence of amount of drinking water (n=10,
)
| Group | Dosage (the g crude drug/kg) | n | Swimming time (min) |
| Matched group SHENBAO HEJI toxin clearing away and the kidney nourishing (low) toxin clearing away and the kidney nourishing (in) toxin clearing away and the kidney nourishing (height) | 0 15.6ml/kg 4 8 16 | 10 9 10 10 10 | 20.14±9.90 24.72±6.93 32.76±9.20 * 29.37±12.82 39.17 23.93 * |
Annotate: compare with model group
*P＜0.05,
*P＜0.01
As can be seen from Table 1, the normal matched group of urine amount of model group rat and amount of drinking water obviously reduces (P＜0.01), the urine amount of pharmaceutical composition 11.0g crude drug of the present invention/kg dosage treated animal increases (comparing P＜0.05 with model group) than model group, amount of drinking water has the trend of increasing than model group, but does not have the significance,statistical meaning.These results show, pharmaceutical composition of the present invention can improve the oliguria symptom of the acute renal failure rat that glycerol causes to a certain extent.NIAODUQING KELI has increase trend to the urine amount of acute renal failure rat.
Secondly, the inventor has observed the influence of pharmaceutical composition of the present invention to acute renal failure rat serum BUN and Cr, verifies the drug effect of pharmaceutical composition of the present invention.
The acute kidney merit that table 2 toxin clearing away and the kidney nourishing causes glycerol decline rat renal function influence (n=10,
)
| Group | Dosage (the g crude drug/kg) | n | Swimming time (min) |
| Matched group SHENBAO HEJI toxin clearing away and the kidney nourishing (low) toxin clearing away and the kidney nourishing (in) toxin clearing away and the kidney nourishing (height) | 0 15.6ml/kg 4 8 16 | 10 9 10 10 10 | 20.14±9.90 24.72±6.93 32.76±9.20 * 29.37±12.82 39.17 23.93 * |
Annotate: compare with model group
*P＜0.05,
*P＜0.01,
* *P＜0.001
The result shows that the change of serum C r of model group rat, BUN level significantly increase (comparing P＜0.05 or P＜0.01 with the normal control group).The blood Cr level of pharmaceutical composition 11.0g crude drug of the present invention/kg dosage group reduces (P＜0.05) than model group, but its BUN level and model group relatively do not have significant difference.Pharmaceutical composition 5.5g crude drug/kg of the present invention and 2.8g crude drug/kg dosage do not have obvious influence to BUN, Cr content.The blood Cr of positive drug NIAODUQING group has reduction trend than model group, but not statistically significant.These results show that injection causes that the acute renal failure tool has some improvement to pharmaceutical composition of the present invention to glycerin muscle, and blood Cr concentration is reduced.
Once more, the inventor has observed the influence of pharmaceutical composition of the present invention to sodium, potassium, level of chlorine in the acute renal failure rat blood, verifies the drug effect of pharmaceutical composition of the present invention.The results are shown in Table 3:
The acute kidney merit that table 3 toxin clearing away and the kidney nourishing causes glycerol decline the electrolytical influence of rat blood (n=10,
)
| Group | Dosage (the g crude drug/kg) | n | Swimming time (min) |
| Matched group SHENBAO HEJI toxin clearing away and the kidney nourishing (low) toxin clearing away and the kidney nourishing (in) toxin clearing away and the kidney nourishing (height) | 0 15.6ml/kg 4 8 16 | 10 9 10 10 10 | 20.14±9.90 24.72±6.93 32.76±9.20* 29.37±12.82 39.17 23.93* |
Annotate: compare with model group
*P＜0.05,
*P＜0.01,
* *P＜0.001
The blood Na level of acute renal failure model group significantly reduces (P＜0.05) than matched group, and blood Ka and blood Cl level and matched group are not seen significant difference.The blood Na that pharmaceutical composition 5.5g crude drug/kg of the present invention and 2.8g crude drug/kg dosage group can significantly suppress the acute renal failure rat reduces, and blood sodium is had certain regulating action unusually.But (11.0g crude drug/kg) blood Na index is not had obvious improvement effect when dosage is higher.
At last, the inventor observes the influence of pharmaceutical composition of the present invention to acute renal failure rat glucose in urine and urine protein, verifies the drug effect of pharmaceutical composition of the present invention.The results are shown in Table 4:
The acute kidney merit that table 4 toxin clearing away and the kidney nourishing causes glycerol decline rat glucose in urine and urine protein influence (n=10,
)
| Group | Dosage (the g crude drug/kg) | n | Swimming time (min) |
| Matched group SHENBAO HEJI toxin clearing away and the kidney nourishing (low) toxin clearing away and the kidney nourishing (in) toxin clearing away and the kidney nourishing (height) | 0 15.6ml/kg 4 8 16 | 10 9 10 10 10 | 20.14±9.90 24.72±6.93 32.76±9.20* 29.37±12.82 39.17 23.93* |
Annotate: compare with model group
*P＜0.05,
*P＜0.01,
* *P＜0.001
In sum, pharmaceutical composition 11.0g crude drug/kg of the present invention can increase the urine amount of acute renal failure rat due to the glycerol, improves the oliguria symptom, can significantly reduce blood Cr level, improves renal function; 5.5,2.8g crude drug/kg dosage can correct down the electrolyte disturbance of acute renal failure rat, make blood sodium unusual be improved significantly; 11.0,5.5 and 2.8g crude drug/kg dosage under level of sugar is had certain reduction trend.Therefore, pharmaceutical composition of the present invention has some improvement to the acute renal failure oliguria model tool due to the glycerol.
The inventor is also by observing the influence of the mice delayed hypersensitivity that pharmaceutical composition of the present invention causes sheep red blood cell (SRBC) sensitization.
Wherein, pharmaceutical composition-National Traditional Chinese Medicine Modernization Engineering Research Center of the present invention provides, compound method: the weighting profit require 8 with distilled water be mixed with concentration 37.5,75,150mg extract/ml (be equivalent to 0.2,0.4 respectively, 0.8g crude drug/ml).Positive drug: NIAODUQING KELI-Kangchen Pharmaceutical Co., Ltd., Guangzhou provides.Lot number: 20040320.Compound method: be made into 0.52g granule/ml with distilled water.The Western medicine positive control drug: prednisolone acetate, lot number: 031101, Shanghai General Pharmaceutical Co., ltd..Negative control product: distilled water.Laboratory animal ICR mice is provided by Military Medical Science Institute's Experimental Animal Center, the animal quality certification number: SCXK-(army) 2002-001.
Pharmaceutical composition of the present invention is established 3 dosage groups, is respectively 16,8,4g crude drug/kg, respectively is equivalent to by with dosage 4,2,1 times of the clinical plan of body surface area conversion; Western medicine positive control drug prednisolone acetate dosage is 10mg/kg, and Chinese medicine positive control drug NIAODUQING KELI dosage is 7.8g granule/kg, is 2 times of clinical consumption.
Mice is divided into 7 groups at random by body weight, every group 10, be respectively: 1. normal control group, 2. model group, 3. NIAODUQING KELI 7.8g/kg, 4. prednisolone acetate 10mg/kg, pharmaceutical composition low dose group 5. of the present invention: 4g crude drug/kg, 6. dosage group in the pharmaceutical composition of the present invention: 8g crude drug/kg, pharmaceutical composition high dose group 7. of the present invention: 16g crude drug/kg.
Each dosage group of pharmaceutical composition of the present invention is gastric infusion, and consistent with approach with clinical plan, the positive control drug prednisolone acetate is an administered intramuscular.Wherein, each dosage group of pharmaceutical composition of the present invention and NIAODUQING KELI group gastric infusion every day 1 time, administration volume 20ml/kg body weight, successive administration 10 days.Model group and normal control group are irritated stomach and are given distilled water with volume, Western medicine positive control drug prednisolone acetate group 5mg/kg, the next day administered intramuscular 1 time, totally 5 times.At the 6th day of administration, except that the normal control group, each organized the equal back of mice subcutaneous injection 2 * 109/mlSRBC100ul sensitization.96h after the sensitization, left back sole Intradermal is injected 2 * 1010/mlSRBC20 ul once more and is attacked sensitized mice, in attacking back 24h, put to death mice, neat ankle joint is cut the bilateral rear foot (with the right side rear foot as own control) and is weighed, with toes swelling degree (toes swelling difference behind the bilateral) as tardy super quick response strength.Each is organized test data and all represents with mean ± standard deviation.Each test group and positive control drug group compare with model group respectively, with t-check carrying out statistical analysis.The results are shown in Table 5:
Table 5 toxin clearing away and the kidney nourishing to the influence of delayed hypersensitivity (n=10,
)
| Group | Dosage (the g crude drug/kg) | n | Swimming time (min) |
| Matched group SHENBAO HEJI toxin clearing away and the kidney nourishing (low) toxin clearing away and the kidney nourishing (in) toxin clearing away and the kidney nourishing (height) | 0 15.6ml/kg 4 8 16 | 10 9 10 10 10 | 20.14±9.90 24.72±6.93 32.76±9.20* 29.37±12.82 39.17 23.93* |
Annotate: compare with model group
*P＜0.05,
*P＜0.01
The result shows that the model group mice presents intensive delayed hypersensitivity, and antigen is attacked the remarkable swelling of parapodum toe, and toes swelling degree is significantly higher than normal control group (P＜0.01).The foot swelling degree of pharmaceutical composition 4,8 of the present invention, 16g crude drug/kg dosage group mice significantly reduces (P＜0.05 or P＜0.01) than model group.Chinese medicine positive drug NIAODUQING KELI and Western medicine positive drug are sprinkled the mud pine all has significant inhibitory effect to delayed hypersensitivity.The result shows that pharmaceutical composition of the present invention has significant inhibitory effect to the mice delayed hypersensitivity.So pharmaceutical composition of the present invention can significantly suppress the mice delayed hypersensitivity, and is inhibited to the abnormal cell immunity.
The inventor has also observed the influence of pharmaceutical composition of the present invention to immunocompromised mouse lymphocyte propagation, to estimate the regulating action of its pair cell immunity.
Wherein, pharmaceutical composition-National Traditional Chinese Medicine Modernization Engineering Research Center of the present invention provides, lot number 040615.Compound method: the weighting profit require 8 with distilled water be mixed with concentration 37.5,75,150mg extract/ml (be equivalent to 0.2,0.4 respectively, 0.8g crude drug/ml).Positive control drug is that SHENBAO HEJI-Jiangxi Huiren Pharmaceutical Co., Ltd produces lot number: 0501012.The negative control product are distilled water.The medication of modeling type is that prednisolone acetate-Shanghai General Pharmaceutical Co., ltd. produces lot number: 031101.The ICR mice is provided by Military Medical Science Institute's Experimental Animal Center, the animal quality certification number: SCXK-(army) 2002-001.
With pharmaceutical composition of the present invention establish 16,8,4g crude drug/kg dosage group.Respectively be equivalent to by the clinical plan of body surface area conversion 4,2,1 times with dosage; Positive control drug SHENBAO HEJI 15.6ml/kg is equivalent to 2 times of clinical dosages.Mice is divided into 6 groups at random by body weight, every group 10, be respectively: 1. normal control group, 2. model group, 3. positive control drug SHENBAO HEJI: 15.6ml/kg, 4. pharmaceutical composition low dose group of the present invention: 4g crude drug/kg, dosage group in the pharmaceutical composition 5. of the present invention: 8g crude drug/kg, pharmaceutical composition high dose group 6. of the present invention: 16g crude drug/kg.
Pharmaceutical composition of the present invention and positive control drug SHENBAO HEJI are gastric infusion, and be consistent with approach with clinical plan.Be administered once every day, and volume is the 20ml/kg body weight, and continuous 10 days, normal control group and model group were irritated stomach and given with the volume distilled water.In the 4th, 6,8,10 day of administration, except that the normal control group, all the other were respectively organized the equal intramuscular injection acetic acid of mice and sprinkle mud pine 5mg/kg, and each is organized rat bilateral leg muscle and injects 30% glycerol, every side 3ml/kg (except the normal control group).The 11st day, put to death mice, takes out the spleen of every mice, only prepare the spleen lymphocyte suspension by the literature method list, RPMI 1640 liquid that usefulness contains 5% hyclone are modulated into 5 * 106/ml with the splenocyte of every Mus.The splenocyte for preparing is joined in 96 well culture plates by the 0.1ml/ hole, the splenocyte of every mice adds 3 multiple holes, add the culture fluid 100 μ l (final concentration is 5 μ g/ml) that contain ConA, after culture plate is positioned over and cultivates 72h in 37 ℃ of 5%CO2 incubators, centrifugal, abandon supernatant, the MTT 50 μ l that every hole adds 1mg/ml put 4h in 37 ℃ of 5%CO2 incubators.Then, every hole adds DMSO 150 μ l, and concussion makes lysis, in wavelength 570nm (reference wavelength 630nm) colorimetric, measures the OD value with microplate reader respectively.
Calculate earlier the OD meansigma methodss in three multiple holes of every mice respectively, and then the meansigma methods of every group of the mean value calculation that draws with every mice.Every group data represent with mean ± standard deviation that all each dosage group of pharmaceutical composition of the present invention and SHENBAO HEJI group compare with model group respectively, with t-check carrying out statistical analysis.The results are shown in Table 6:
Table 6 toxin clearing away and the kidney nourishing to lymphopoietic influence (n=10,
)
| Group | Dosage (the g crude drug/kg) | n | Swimming time (min) |
| Matched group SHENBAO HEJI toxin clearing away and the kidney nourishing (low) toxin clearing away and the kidney nourishing (in) toxin clearing away and the kidney nourishing (height) | 0 15.6ml/kg 4 8 16 | 10 9 10 10 10 | 20.14±9.90 24.72±6.93 32.76±9.20* 29.37±12.82 39.17 23.93* |
Annotate: compare with model group
*P＜0.05
Table 6 shows, sprinkles splenocyte that mud pine 5mgkg-1d-1 * 4 times can make mice to mouse muscle injection acetic acid the dissociative reaction of mitogen ConA is reduced, and shows that the T lymphopoiesis function to mice suppresses.Can obviously resist acetic acid for mouse gavaging pharmaceutical composition 16 of the present invention, 4g/kg and sprinkle the inductive mouse cell immunologic function inhibition of mud pine, obviously strengthen the inductive splenocyte dissociative reaction of ConA (sprinkling mud pine model group relatively P＜0.05 and P＜0.01 with acetic acid respectively).The positive control drug SHENBAO HEJI has enhancing trend to the inductive splenocyte dissociative reaction of ConA, but not statistically significant (P＞0.05).The result shows that pharmaceutical composition of the present invention can obviously strengthen the inductive splenocyte dissociative reaction of ConA, and the pair cell immunity has potentiation.Simultaneously, trial drug can be corrected the electrolyte disturbance of acute renal failure rat, make blood sodium unusual be improved significantly, acute renal failure is had certain therapeutical effect.
The inventor has further observed pharmaceutical composition of the present invention to the excretory influence of the inductive immunocompromised mouse spleen lymphocyte of cyclophosphamide hemolytic antibody, to understand the regulating action of pharmaceutical composition of the present invention to humoral immune function.
Wherein, pharmaceutical composition of the present invention is provided by National Traditional Chinese Medicine Modernization Engineering Research Center, compound method: the weighting profit require 8 with distilled water be mixed with concentration 37.5,75,150mg extract/ml (be equivalent to 0.2,0.4 respectively, 0.8g crude drug/ml).The Chinese medicine positive control drug: SHENBAO HEJI-Jiangxi Huiren Pharmaceutical Co., Ltd produces, lot number: 0501012.Negative control product: distilled water.The medication of modeling type: cyclophosphamide-Hualian Pharmaceutical Co., Ltd., Shanghai produces, lot number: 010907
Balb/c mice-Military Medical Science Institute's Experimental Animal Center, the animal quality certification number: SCXK-(army) 2002-001.
Pharmaceutical composition of the present invention establishes 4,8,16g crude drug/kg dosage group, respectively is equivalent to by with dosage 4,2,1 times of the clinical plan of body surface area conversion.Positive control drug SHENBAO HEJI 15.6ml/kg is equivalent to 2 times of clinical dosage.
Mice is divided into 6 groups at random by body weight, every group 10, be respectively: 1. normal control group, 2. model group, 3. SHENBAO HEJI: 15.6ml/kg, 4. pharmaceutical composition low dose group of the present invention: 4g crude drug/kg, dosage group in the pharmaceutical composition 5. of the present invention: 8g crude drug/kg, pharmaceutical composition high dose group 6. of the present invention: 16g crude drug/kg.Pharmaceutical composition of the present invention and SHENBAO HEJI are gastric infusion, and be consistent with approach with clinical plan.Every day gastric infusion once, volume is the 20ml/kg body weight, continuous 10 days.Normal control group and model group are irritated stomach and are given with the volume distilled water.After the administration the 7th, 8,9 day, except that the normal control group, all the other respectively organize the equal intraperitoneal injection of cyclophosphamide 15mg/kg of mice, every day each once, for three days on end.After giving cyclophosphamide the 1st time, the equal intravenous injection sheep red blood cell of all mices is with sensitization, after the sensitization 96 hours, the sacrificed by exsanguination mice is taken out spleen, the preparation spleen lymphocyte, in the spleen lymphocyte suspension, add sheep red blood cell and guinea pig serum, 37 ℃ hatch 1h after, centrifugal, get supernatant and measure the OD value in wavelength 405nm with semi-automatic biochemical analyzer.
Calculate every group meansigma methods, data are all represented with mean ± standard deviation.The data of each dosage group of pharmaceutical composition of the present invention and SHENBAO HEJI group compare with the cyclophosphamide model group respectively, with t-check carrying out statistical analysis.The results are shown in Table 7:
The influence that table 7 pharmaceutical composition of the present invention produces mouse spleen lymphocyte antibody (n=10,
)
| Group | Dosage (the g crude drug/kg) | n | Swimming time (min) |
| Matched group SHENBAO HEJI toxin clearing away and the kidney nourishing (low) toxin clearing away and the kidney nourishing (in) toxin clearing away and the kidney nourishing (height) | 0 15.6ml/kg 4 8 16 | 10 9 10 10 10 | 20.14±9.90 24.72±6.93 32.76±9.20* 29.37±12.82 39.17 23.93* |
Annotate: compare with normal control
*P＜0.01,
* *P＜0.001
The result shows, cyclophosphamide 15mg/kgip after 1 time/d * 3d modeling, can make mouse spleen lymphocyte hemolytic antibody secretion level obviously reduce (comparing P＜0.01 with the normal control group).Pharmaceutical composition 8 of the present invention, 16g crude drug/kg give mice successive administration 10 days, the spleen lymphocyte hemolytic antibody of the inductive immunocompromised mice of cyclophosphamide are secreted have obvious facilitation (comparing P＜0.01 with model group)).Secretion also has facilitation to the positive control drug SHENBAO HEJI to the mouse spleen lymphocyte hemolytic antibody.Pharmaceutical composition of the present invention can be corrected the electrolyte disturbance of acute renal failure rat, make blood sodium unusual be improved significantly, acute renal failure there is certain therapeutical effect. the spleen lymphocyte hemolytic antibody secretion to the inductive immunocompromised mice of cyclophosphamide simultaneously has obvious facilitation, shows that the humoral immune function to the immunocompromised mice has potentiation.
The inventor knows clearly pharmaceutical composition of the present invention to the prolongation effect of mice low temperature swimming time at further experiment, whether has antifatigue effect to estimate pharmaceutical composition of the present invention.
Wherein, pharmaceutical composition of the present invention, National Traditional Chinese Medicine Modernization Engineering Research Center, compound method: the weighting profit require 8 with distilled water be mixed with concentration 37.5,75,150mg extract/ml (be equivalent to 0.2,0.4 respectively, 0.8g crude drug/ml).2.2 Chinese medicine positive control drug: SHENBAO HEJI-Jiangxi Huiren Pharmaceutical Co., Ltd, lot number: 0501012.Negative control product: distilled water.Laboratory animal and raising: the ICR mice, male, 50, provide the animal quality certification number by Institute of Experimental Animals, Chinese Academy of Medical Sciences: SCXK-(army) 2002-001.Pharmaceutical composition of the present invention establishes 4,8,16g crude drug/kg dosage group, respectively is equivalent to by with dosage 4,2,1 times of the clinical plan of body surface area conversion.The positive control drug SHENBAO HEJI is 15.6ml/kg, is equivalent to 2 times of clinical dosage.
Mice is divided into 5 groups at random by body weight, every group 10, be respectively: 1. matched group, 2. SHENBAO HEJI: 15.6ml/kg, 3. pharmaceutical composition low dose group of the present invention: 4g crude drug/kg, 4. dosage group in the pharmaceutical composition of the present invention: 8g crude drug/kg, pharmaceutical composition high dose group 5. of the present invention: 16g crude drug/kg.Pharmaceutical composition of the present invention and SHENBAO HEJI are gastric infusion, and be consistent with approach with clinical plan.Be administered once every day, and volume is the 0.2ml/10g body weight, continuous 10 days.Matched group is irritated stomach and is given with the volume distilled water.1h after the last administration swims the single bucket (diameter 30cm, depth of water 20cm, 15 ℃ of water temperatures) that mixes up water temperature and water depth in advance of only putting into of mice, and observe mice and surpass 7 seconds time to sinking under the water from entry, will be this time sheet swimming time.
Calculate every group swimming time meansigma methods, data are all represented with mean ± standard deviation.The data of each dosage group of pharmaceutical composition of the present invention and SHENBAO HEJI group compare with matched group respectively, with t-check carrying out statistical analysis.The results are shown in Table 8:
Table 8 pharmaceutical composition of the present invention is to the influence of mice swimming time
| Group | Dosage (the g crude drug/kg) | n | Swimming time (min) |
| Matched group SHENBAO HEJI toxin clearing away and the kidney nourishing (low) toxin clearing away and the kidney nourishing (in) toxin clearing away and the kidney nourishing (height) | 0 15.6ml/kg 4 8 16 | 10 9 10 10 10 | 20.14±9.90 24.72±6.93 32.76±9.20* 29.37±12.82 39.17 23.93* |
Annotate: compare with matched group
*P＜0.01,
* *P＜0.001
The result shows, control group mice continues swimming time 20.14 ± 9.90min in low temperature environment, pharmaceutical composition 4g crude drug/kg of the present invention and 16g crude drug/kg give the continuous gastric infusion of mice 10 days, but the low temperature swimming time of significant prolongation mice (comparing P＜0.05) with matched group, pharmaceutical composition 8g crude drug/kg of the present invention has certain prolongation trend to swimming time, but, there is not the significance meaning on the statistics because standard deviation is bigger.The result shows that pharmaceutical composition of the present invention can obviously prolong mice low temperature swimming time, has the obvious anti-fatigue effect.
The specific embodiment
Further specify the present invention below in conjunction with the specific embodiment, but do not limit the present invention in any way.
Each embodiment takes by weighing raw material according to the listed proportioning of table 9, and each raw material is in the weight kilogram: above-mentioned other raw material pulverizing except that Radix Notoginseng, and with 50% alcohol reflux 3 times, each 1.5 hours; The ethanol consumption satisfies following proportioning, and weight is in kilogram, and volume is in liter:
For the first time: crude drug weight: ethanol volume=1: 2.5-3
Second and third time: crude drug weight: ethanol volume=1: 1.5-2
Merge extractive liquid, is concentrated into the thick paste shape, and adds the starch mixing of 1-1.5% weight ratio, and oven dry is collected dry extract and beaten powder; Add raw sangqi ginseng powder and appropriate amount of starch mixing more in proportion, the weight that makes starch add back patent medicine is the 4-4.5% of crude drug in whole weight; As binding agent, 16 mesh sieves are granulated with 80% ethanol; Oven drying at low temperature below 60 ℃; 14 mesh sieve granulate are distributed into capsule by every 0.45 gram.Whole process is all carried out satisfying under the national drug production standard condition.
Each Example formulations of table 9. is formed (weight proportion)
| Material name | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | Embodiment 7 |
| Rhizoma Chuanxiong | 20 | 15 | 17 | 20 | 21 | 22 | 25 |
| The Radix Astragali | 40 | 40 | 42 | 44 | 46 | 48 | 50 |
| Radix Et Rhizoma Rhei | 15 | 12 | 0 | 14 | 15 | 16 | 18 |
| Radix Angelicae Sinensis | 20 | 20 | 21 | 22 | 23 | 24 | 25 |
| Herba Epimedii | 15 | 15 | 16 | 17 | 18 | 19 | 20 |
| The Radix Rehmanniae | 20 | 15 | 17 | 19 | 20 | 22 | 25 |
| The Radix Paeoniae Alba | 15 | 10 | 0 | 12 | 13 | 14 | 15 |
| Rhizoma Alismatis | 15 | 15 | 16 | 17 | 18 | 19 | 20 |
| Poria | 15 | 15 | 16 | 17 | 18 | 19 | 20 |
| Radix Notoginseng | 6 | 6 | 0 | 6.5 | 7 | 7.5 | 8 |
Embodiment 8: extract with separating and be prepared into high-capacity injection
Rhizoma Chuanxiong 150g, Herba Epimedii 150g, Radix Angelicae Sinensis 200g, Rhizoma Alismatis 150g are added 70wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 1.5 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (80 ℃, d=1.10), label, indicate the name of an article, lot number, date etc.
Radix Astragali 400g, Radix Rehmanniae 200g, Poria 150g are added water for injection 3200ml soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop when being concentrated into proportion 1.12 concentrating, put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B, and device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
The concentrated solution B that the concentrated solution A and the water of above-mentioned alcohol extraction are carried fully mixes, get above-mentioned concentrated solution and add water for injection 440ml, heated and boiled 20 minutes, stir and add active carbon 0.8g down, continued to boil 10 minutes, take out cooling, filter carbon removal, add water for injection to nearly 400ml, NaOH solution adjust pH with 10wt.% is 6.5, coarse filtration, the elementary 3um of fine straining (adopting three grades of microfiltration technology), secondary 0.45um, three grades of 0.22um, embedding in the ampoule of 20ml 100 ℃, sterilization in 30 minutes promptly gets injection after the passed examination.
Embodiment 9:
Rhizoma Chuanxiong 200g, Herba Epimedii 150g, Radix Angelicae Sinensis 220g, Radix Et Rhizoma Rhei 150g are added 70wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (80 ℃, d=1.10), label, indicate the name of an article, lot number, date etc.
Radix Astragali 450g, Radix Rehmanniae 205g, Poria 185g, Radix Paeoniae Alba 155g, Rhizoma Alismatis 185, Radix Notoginseng 5g are added water for injection 3200ml soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop when being concentrated into proportion 1.12 concentrating, put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B (d=1.12), and device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
The concentrated solution B that the concentrated solution A and the water of above-mentioned alcohol extraction are carried fully mixes, get above-mentioned concentrated solution and add water for injection 440ml, heated and boiled 20 minutes, stir and add active carbon 0.8g down, continued to boil 10 minutes, take out cooling, filter carbon removal, add water for injection to nearly 400ml, NaOH solution adjust pH with 10wt.% is 6.5, coarse filtration, the elementary 3um of fine straining (adopting three grades of microfiltration technology), secondary 0.45um, three grades of 0.22um, embedding in the ampoule of 20ml 100 ℃, sterilization in 30 minutes promptly gets injection after the passed examination.
The preparation of the lyophilized injectable powder of embodiment 10:20ml
(1) get Rhizoma Chuanxiong 200g, Herba Epimedii 185g, Radix Angelicae Sinensis 200g, Radix Et Rhizoma Rhei 150g, more than 7 times of 60wt.% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I.
(2) Radix Astragali 450g, Radix Rehmanniae 15g, Poria 100g, Radix Paeoniae Alba 155g, Rhizoma Alismatis 15, Radix Notoginseng 75g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter, merging filtrate obtains extracting compositions.Get and extract compositions 10g, add the injection water and make dissolving in right amount, add sodium chloride 2.25, adjust volume to 250ml with water for injection, add an amount of injection charcoal, boiled 20 minutes, and put coldly, filter, sterilization, irritate in low boron glass ampoule bottle by 1ml volume branch, cool drying promptly gets the lyophilized injectable powder sample.
The preparation of the lyophilized injectable powder of embodiment 11:20ml
(1) get Rhizoma Chuanxiong 100g, Herba Epimedii 100g, Radix Angelicae Sinensis 200g, Radix Et Rhizoma Rhei 50g, more than 5 times of 60wt.% ethanol of each component gross weight, heating and refluxing extraction 2 times, each 2.5 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I.
(2) Radix Astragali 200g, Radix Rehmanniae 100g, Poria 185g, Radix Paeoniae Alba 50g, Rhizoma Alismatis 100, Radix Notoginseng 75g are added water for injection 3200ml and soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter, merging filtrate obtains extracting compositions.Get and extract compositions 10g, add the injection water and make dissolving in right amount, add sodium chloride 2.25g, adjust volume to 250ml with water for injection, add an amount of injection charcoal, boiled 20 minutes, and put coldly, filter, sterilization, irritate in low boron glass ampoule bottle by 1ml volume branch, cool drying promptly gets the lyophilized injectable powder sample.
Embodiment 12: the preparation method of granule
Medical materials such as Rhizoma Chuanxiong 100g, Herba Epimedii 100g, Radix Angelicae Sinensis 20g, Radix Et Rhizoma Rhei 50g are added 70wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 1.5 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A, label, indicate the name of an article, lot number, date etc.
Medical materials such as Radix Astragali 200g, Radix Rehmanniae 150g, Poria 15g, Radix Paeoniae Alba 50g, Rhizoma Alismatis 100, Radix Notoginseng 30g are added water for injection 3200ml to be soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1.5 hours, filter, merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop to concentrate when being concentrated into proportion 1.0 (70 ℃), put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B, and device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
With the starch oven dry, sieve, mannitol sieves, and is standby.Take by weighing the extractum of recipe quantity and mannitol 500g, starch 150g mix homogeneously, on granulation machine, granulate with 12 order stainless steel meshs, boiled bed drying, 12 mesh sieve granulate are measured particulate content and moisture, packing, every packed 7g, sealing is preserved in shady and cool dry place
Embodiment 13: the preparation of tablet
1. Rhizoma Chuanxiong 200g, Herba Epimedii 150g, Radix Angelicae Sinensis 200g, Radix Et Rhizoma Rhei 150g are added 60wt.% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 1.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (d=1.06), label, indicate the name of an article, lot number, date etc.
Radix Astragali 400g, Radix Rehmanniae 200g, Poria 150g, Radix Paeoniae Alba 12g, Rhizoma Alismatis 150, Radix Notoginseng 60g are added water for injection 3200ml to be soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1 hour, filter, merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop to concentrate when being concentrated into proportion 1.08 (70 ℃), put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B, and (70 ℃, d=1.08), device is placed in addition, labels, and indicates the name of an article, lot number, date etc.
Get A, B uniform mixing, add filler 200g, mix homogeneously; Mixture is put in the granulator, added 30wt.% ethanol 60ml, granulate, drying gets final product.
2. get vitamin 50 grams, add filler 120g, mix homogeneously; Mixture is put in the granulator, added 6wt.% binding agent 35ml, granulate, drying gets final product.
3. even by the prescription mixed with two groups, survey content, 33 towards the rotary tablet machine tabletting, and packing gets final product.
Embodiment 14: the preparation of suppository
(1) Rhizoma Chuanxiong 200g, Herba Epimedii 185g, Radix Angelicae Sinensis 220g, Radix Et Rhizoma Rhei 150g are added 60% ethanol in multi-function extractor, soaked overnight.The reflux, extract, secondary, each 1.0 hours, filter medicinal residues I and medicinal liquid I, keep medicinal residues I, medicinal liquid I places the concentrating under reduced pressure pot, concentrate concentrated solution A (d=1.06), label, indicate the name of an article, lot number, date etc.
(2) Radix Astragali 40g, Radix Rehmanniae 200g, Poria 150g, Radix Paeoniae Alba 150g, Rhizoma Alismatis 150g, Radix Notoginseng 6g being added water for injection 3200ml soaked 1 hour, add above-mentioned reservation medicinal residues I, add 3200ml water for injection and decoct secondary, each 1 hour, filter, merging filtrate, the reject medicinal residues are put amalgamation liquid in the triple effect concentrator, stop to concentrate when being concentrated into proportion 1.08 (70 ℃), put and be chilled to room temperature, slowly add 95% ethanol of amount of calculation, make concentration of alcohol reach 50%, placement is spent the night, extract supernatant, discard precipitate.Concentrated supernatant gets concentrated solution B, and (70 ℃, d=1.08), merge extractive liquid, is concentrated into the thick paste shape, dries, and collects dry extract and beats powder, labels, and indicates the name of an article, lot number, date etc.
Take by weighing suppository base in beaker, heating in water bath to 60 ℃ fusing adds extract powder in the molten matrix, and the limit edged stirs, and is to be cooled to about 40 ℃ to mix homogeneously, irritates mould, and cooling gets final product.
Claims (3)
1. the application of pharmaceutical composition in preparation antifatigue medicine, the weight proportion of each crude drug is in the described pharmaceutical composition: Rhizoma Chuanxiong 15-200 weight portion, Radix Astragali 40-450 weight portion, Radix Et Rhizoma Rhei 12-150 weight portion, Radix Angelicae Sinensis 20-220 weight portion, Herba Epimedii 15-185 weight portion, Radix Rehmanniae 15-205 weight portion, Radix Paeoniae Alba 12-155 weight portion, Rhizoma Alismatis 15-185 weight portion, Poria 15-185 weight portion, Radix Notoginseng 6-75 weight portion.
2. application according to claim 1, the weight proportion of each crude drug is in the described pharmaceutical composition: Rhizoma Chuanxiong 15-25 weight portion, Radix Astragali 40-50 weight portion, Radix Et Rhizoma Rhei 12-18 weight portion, Radix Angelicae Sinensis 20-25 weight portion, Herba Epimedii 15-20 weight portion, Radix Rehmanniae 15-25 weight portion, Radix Paeoniae Alba 10-15 weight portion, Rhizoma Alismatis 15-20 weight portion, Poria 15-20 weight portion, Radix Notoginseng 6-8 weight portion.
3. application according to claim 2, the weight proportion of each crude drug is in the described pharmaceutical composition: Rhizoma Chuanxiong 20 weight portions, the Radix Astragali 40 weight portions, Radix Et Rhizoma Rhei 15 weight portions, Radix Angelicae Sinensis 20 weight portions, Herba Epimedii 15 weight portions, the Radix Rehmanniae 20 weight portions, the Radix Paeoniae Alba 15 weight portions, Rhizoma Alismatis 15 weight portions, Poria 15 weight portions, Radix Notoginseng 6 weight portions.
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