CN1689608A - Compound medicine for treating diabetes and its preparation process - Google Patents
Compound medicine for treating diabetes and its preparation process Download PDFInfo
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- CN1689608A CN1689608A CN 200410024040 CN200410024040A CN1689608A CN 1689608 A CN1689608 A CN 1689608A CN 200410024040 CN200410024040 CN 200410024040 CN 200410024040 A CN200410024040 A CN 200410024040A CN 1689608 A CN1689608 A CN 1689608A
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Abstract
The present invention relates to one kind of compound diabetes treating medicine and its preparation process, and belongs to the field of Chinese medicine technology. The compound diabetes treating medicine is prepared with astragalus root, atractylodes rhizome and chicory in certain proportion. It has obvious curative effect, less toxic side effect and taking convenience, and the preparation process has high extracting rate and high medicine purity.
Description
(1) technical field under
The present invention relates to a kind of compound medicine for the treatment of diabetes and preparation method thereof, belong to technical field of Chinese medicines.
(2) background technology
Diabetes are that islet function is impaired, hypoinsulinism and a kind of endocrinopathy of the carbohydrate metabolism disturbance that causes.This disease is a chronic disease, and the various complication due to it have become that the patient is disabled, lethal main cause.Along with compatriots' growth in the living standard, the sickness rate of diabetes is more and more higher.Survey result was in 1994: China's diabetes prevalence exceeded 2.5 times before 15 years. and prediction will exceed 4 times in 15 years from now on.This disease does not still have the radical cure method at present at home and abroad.The Chinese medicine diabetes have its special advantages, and oral drug therapy does not have the wound no pain.But the general composition of raw materials of the medicine of existing treatment by Chinese herbs diabetes is more, complicated process of preparation, and the quality control difficulty, dose is more, and what have exists bigger side effect, as diabetes pill etc.
(3) summary of the invention
The present invention provides traditional Chinese compound medicine that a kind of hypoglycemic effect is good, toxicity is low and preparation method thereof in order to overcome above deficiency.
The medicine of treatment diabetes of the present invention comprises following materials of weight proportions: Radix Astragali 6-60g, Rhizoma Atractylodis 6-48g, Herba Cichorii 6-48g.
The medicine of treatment diabetes of the present invention in order to improve combined therapy effect, also is added with following materials of weight proportions: Semen Litchi 3-30g.
The compound medicine of treatment diabetes of the present invention, more preferably scheme is: comprise following materials of weight proportions, Radix Astragali 20-50g, Rhizoma Atractylodis 20-40g, Herba Cichorii 20-40g, Semen Litchi 15-25g.
The medicine of treatment diabetes of the present invention is obtained excellent curative for the ease of taking, and the above medicine is made capsule, tablet, concentrated pill or other pharmaceutically acceptable dosage form.
The preparation method of the medicine of treatment diabetes of the present invention may further comprise the steps,
(1) Rhizoma Atractylodis are ground into coarse powder, and extracting in water volatile oil 4 hours is collected volatile oil, medicinal liquid filter medicinal liquid A, medicinal residues keep.
(2) Radix Astragali, Herba Cichorii, Semen Litchi and Rhizoma Atractylodis medicinal residues merge, and decoct with water twice, and each two hours, filter, collecting decoction gets medical liquid B.
(3) above-mentioned medicinal liquid A, B are merged, be concentrated into about relative density 1.05 (55 ℃), be cooled to room temperature, add 95% ethanol and make and contain the alcohol amount and reach 60%, placed 24 hours, sucking filtration must medicinal liquid C.
(4) medicinal liquid C is reclaimed ethanol, concentrate, drying under reduced pressure gets dry extract, pulverizes, and adds appropriate amount of auxiliary materials and makes
Finished product
Be prescription analysis of the present invention below:
The Radix Astragali, nature and flavor are sweet, return lung, spleen channel, effect with invigorating QI to consolidate the body surface resistance, diuresis detoxifcation, evacuation of pus, expelling pus and promoting granulation, be used for that the deficiency of vital energy is weak, lack of appetite just the pool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficultly burst, burst for a long time do not hold back, blood deficiency and yellow complexion, chronic nephritis proteinuria, diabetes etc.
Rhizoma Atractylodis, nature and flavor suffering, hardship, temperature are returned spleen, stomach two warps.Main effect is drying damp and strengthening spleen, and it is turbid to ward off dirtyization, and wind-damp dispelling induces sweat, and makes eye bright.
Herba Cichorii is China's medical materials traditionally used in certain regions, has clearing away heat-damp and promoting diuresis, spleen invigorating detoxifcation function, mainly contains constituents such as triterpene, sesquiterpene, organic acid and has the blood fat reducing curative effect.The Herba Cichorii n-hexane extract is to rat blood sugar, insulin, and there is certain influence aspects such as hyperlipemia rat blood fat, hemorheology.
Semen Litchi sweet in the mouth, little hardship, warm in nature are gone into effects such as stomach is regulated the flow of vital energy through having, cold relieving, pain relieving, are used for diseases such as gastric abscess, vim and vigour pain, the twinge of women's Qi stagnation blood stasis abdominal part.Animal experiment and clinical practice show to have the obvious functions of blood sugar effect.Active site is the sterol and the glycoside composition of ethyl acetate extraction, and the polyalcohols of n-butanol extraction; α in the Semen Litchi-methylene cyclopropyl glycine is the effective ingredient of blood sugar lowering.
The Radix Astragali in the side, nature and flavor are sweet, return lung, spleen channel relatively to mend; Rhizoma Atractylodis nature and flavor suffering, hardship, temperature return spleen, stomach two through relatively dry, and the two is all the key medicine of spleen, stomach two warps, all can be drying damp and strengthening spleen, and the right Radix Astragali is relatively mended, and keeps and does not walk kind spleen reinforcing; Rhizoma Atractylodis are relatively dry, walk and do not keep kind activating the spleen.Spleen reinforcing then has the merit of QI invigorating, and activating the spleen then has the power of dampness.Be equipped with Herba Cichorii, Semen Litchi is gone into liver stomach warp, in the accent of regulating the flow of vital energy, strengthens the merit of transporting and transforming function of the spleen and stomach.All medicines are harmonious, and inspire, excite temper, make its " initiatively fortuneization " function be able to normal performance, and then organism metabolism is orderly, and clear person can rise, and turbid person can fall, and the blood glucose self energy of rising returns to normal.
Be clinical experiment result of the present invention below:
1. tcm diagnosis standard
(1) diabetes diagnostic criteria
The guideline of new Chinese medicine treatment diabetes (diabetes) clinical research of working out according in 1993 Ministry of Public Health, all have a thirsty polydipsia, and rapid digestion of food is easily hungry, and frequent micturition and sweet, body see that gradually patient such as become thin can make a definite diagnosis.
(2) Chinese medical discrimination standard
With reference to the related content of health ministry " the clinical research guideline of new Chinese medicine treatment diabetes (diabetes) " and " practical Chinese Internal Medicine ", as follows in conjunction with clinical tentative Chinese medical discrimination standard:
1. weakness of the spleen and stomach, the fortuneization disorder type
Fatigue and weakness, spontaneous perspiration or night sweat, thirst and liking drink, or polyphagia becomes thin, palpitation and insomnia, enlarged tongue or indentation is arranged, thin fur or thick in vain, it is uncomfortable to defecate, or just shapeless, thready pulse or unable.
2. weakness of the spleen and stomach, the deficiency of both YIN and YANG type
Coldness of the body and aversion to cold, tinnitus and soreness of loins, or hectic fever night sweat, or limbs owe temperature, loose stool, and clear urine in large amounts, light red tongue matter is tender, white and thin fur, deep-thready pulse or count accurately unable.
3. weakness of the spleen and stomach, qi depression to blood stasis
Complexion is gloomy, and it is weak to become thin, numb limbs and tense tendons or twinge, and increase the weight of night, color of the lip obfuscation, dimly pale tongue, or purple dark angry the opening of Sublingual blue veins, white and thin fur, or few tongue, stringy pulse or heavy.
2. observe case and include standard in
Allly meet above-mentioned diagnostic criteria and Chinese medical discrimination typing standard person, all include in as first-selected case.
3. Therapeutic Method
(1) medicine
The capsule of making according to embodiment 4 described prescriptions and method for making: the Radix Astragali, Rhizoma Atractylodis, Herba Cichorii, Semen Litchi.
(2) administrated method and the course of treatment
Each 4, every day 3 times.One month is a course of treatment, treats a course of treatment.
4. observation index
(1) safety observation index
1. general physical examination: comprise height, body weight, growth, nutrition, blood pressure, body weight, electrocardiogram etc.
2. three big routines, liver function, kidney merit.
3. untoward reaction: observe with having or not behind this medicine and uncomfortablely feel, and, observe this medicine and have no side effect in conjunction with three big conventional regulating liver-QI kidney function test.
(2) health giving quality observation index
1. observe main clinic symptoms and sign situation of change, press tcm symptom scoring method reflection severity extent and change.
2. lab testing and other special examined
A. fasting glucose, 2 hours after the meal blood glucose, twenty-four-hour urine sugar quantitatively, each is surveyed once before the medication and after the medication.
B. blood fat (mainly comprising cholesterol, triglyceride) is respectively surveyed once before and after the treatment.
C. hemorheology is respectively surveyed once before and after the treatment.
D. glycosylated hemoglobin is before the treatment, treatment 4 weeks of back, 8 weeks, each was surveyed once.
5. efficacy assessment standard
(1) diabetes curative effect evaluation criteria
Change as criterion (is standard with Ministry of Public Health in 1993 " new Chinese medicine clinical research guideline ") according to clinical symptoms sign and laboratory examination.
1. produce effects: treatment back symptom and sign disappears substantially, fasting glucose<7.2mmoL/L (130mg/dl), 2 hours after the meal blood glucose<8.3mnml/L (150mg/dl), twenty-four-hour urine sugar quantitatively<10g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 30% before the treatment.
2. effective: treatment back symptom and sign has clear improvement, fasting glucose<8.3mmoL/L (150mg/dl), 2 hours after the meal blood glucose<10.0mmol/L (180mg/dl), twenty-four-hour urine sugar quantitatively<25.0g; Or the quantitative decline 10-29% before the treatment of blood glucose, twenty-four-hour urine sugar.
3. invalid: treatment back symptom and sign does not have obvious improvement, and blood sugar urinary sugar descends and do not reach above-mentioned standard.
(2) tcm syndrome efficacy assessment standard
1. produce effects: treatment back symptom integral value descends 〉=2/3.
2. effective: between the treatment back symptom integral value decline 2/3-1/3.
3. invalid: treatment back symptom integral value descends not as good as 1/3.
(3) the comprehensive total effects evaluation criteria of disease
With reference to " new Chinese medicine clinical research guideline " (Ministry of Public Health 1993) and in conjunction with clinical, tentative standard is as follows:
1. produce effects: clinical symptoms sign total mark value descends 〉=2/3, and the lab index inspection recovers normally substantially, or decline more than 30% before the treatment.
2. effective: clinical symptoms sign total mark value decline 〉=1/3,<2/3, the lab index inspection has certain improvement, or decline 10-29% before treating.
3. invalid: clinical symptoms sign total mark value descends<1/3, and the lab index inspection does not have improvement, or is declined by less than 10% before the treatment.
6. statistical method
Measurement data adopts the t check, and enumeration data adopts the X2 check, and clinical ranked data relatively adopt Rid-it to analyze.All measurement datas are all used X ± S (means standard deviation) expression.P<0.05 is a significant difference, and P<0.01 is a significant differences.
7. clinical research result
The symptom and sign curative effect changes shown in table 1-table 3 before and after the treatment:
Clinical symptoms sign efficacy analysis before and after table 1 treatment
Group example digital display is imitated the enabledisable total effective rate
Treatment organizes 10 451 90%
Metabolism of blood glucose relatively before and after table 2 treatment
Average is treated 4 all averages before the treatment of group project
Fasting glucose (mmol/) 12.5 ± 3.1 8.9 ± 2.9
Treatment group 2 hours after the meal blood glucose (mmol/) 15.3 ± 3.5 11.9 ± 3.3
Twenty-four-hour urine sugar is (g) 13.9 ± 5.8 10.8 ± 4.1 quantitatively
With comparing P<0.01 before the treatment
The analysis of diabetes curative effect before and after table 3 treatment
Group example digital display is imitated the enabledisable total effective rate
Treatment organizes 10 451 90%
Model case:
The king so-and-so, woman, 49 years old, people from Rushan City.
Dizzy murky, weak, xerostomia is thirsty, and amount of drinking water is many, coldness of the body and aversion to cold, and palpitation and insomnia, it is shapeless to defecate, and matter is loose, and day, once the urine amount was many, and body of the tongue is dark partially, white and thin fur, stringy and thready pulse.Laboratory indexes: blood glucose 18.5mmol/L.
After taking medicine one month, it is normal to defecate, the thirsty disappearance of xerostomia, and urine is obviously reduced, and all the other all diseases are significantly improved.Laboratory indexes: blood glucose: 11.2mmol/L.
According to above clinical experiment result, medicine of the present invention has evident in efficacy, and toxic and side effects is little, taking convenience.Preparation method of the present invention has the extraction ratio height, the advantage that pharmaceutical purity is high.
(4) specific embodiment
Embodiment 1
Rhizoma Atractylodis 3000g extracting in water volatile oil 4 hours is collected volatile oil, filters, and gets medicinal liquid A.
Medicinal residues after Rhizoma Atractylodis extract decoct with water 2 times with Radix Astragali 4000g, Herba Cichorii 1000g merging, each 2 hours, merge extractive liquid,, filter medical liquid B.
Above-mentioned medicinal liquid A, B merged be concentrated into relative density 1.05-1.10 (55 ℃), add ethanol and make and contain the alcohol amount and reach 60%.Left standstill 24 hours, and filtered, the filtrate recycling ethanol drying under reduced pressure gets dry extract, pulverizes, and it is encapsulated to cross 80 mesh sieves.
Usage and consumption: oral, three times on the one, one time 3.
Embodiment 2
Rhizoma Atractylodis decoction pieces 4000g extracting in water volatile oil 4 hours is collected volatile oil, medicinal liquid filter medicinal liquid A, medicinal residues keep.
Medicinal residues and Radix Astragali 2000g, Herba Cichorii 1500g merge and to decoct with water 2 times, each 2 hours, merge extractive liquid,, filter medical liquid B.
Above-mentioned medicinal liquid A, B, merging are concentrated into relative density 1.05-1.10 (55 ℃), add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, sucking filtration, filtrate recycling ethanol, drying under reduced pressure gets dry extract, pulverizes, with appropriate amount of auxiliary materials mixing, tabletting.
Usage and consumption: oral, three times on the one, one time 3.
Embodiment 3
Rhizoma Atractylodis decoction pieces 2000g extracting in water volatile oil 4 hours is collected volatile oil, medicinal liquid filter medicinal liquid A, medicinal residues keep.
Medicinal residues and Radix Astragali 3000g, Herba Cichorii 2000g, Semen Litchi 2000g merge and to decoct with water 2 times, each 2 hours, merge extractive liquid,, filter medical liquid B.
Above-mentioned medicinal liquid A, B, merging are concentrated into relative density 1.05-1.10 (55 ℃), add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, sucking filtration, filtrate recycling ethanol, concentrate thick paste.Semen Litchi is ground into fine powder and thick paste mixing pill, polishing, drying.
Usage and dosage: oral, three times on the one, a 2g.
Embodiment 4
Rhizoma Atractylodis decoction pieces 3000g extracting in water volatile oil 4 hours is collected volatile oil, medicinal liquid filter medicinal liquid A, medicinal residues keep.
Medicinal residues and Radix Astragali 4000g, Herba Cichorii 3000g, Semen Litchi 1000g merge and to decoct with water 2 times, each 2 hours, merge extractive liquid,, filter medical liquid B.
Above-mentioned medicinal liquid A, B, merging are concentrated into relative density 1.05-1.10 (55 ℃), add ethanol and make and contain alcohol amount and reach 60%, left standstill 24 hours, sucking filtration, the filtrate recycling ethanol drying under reduced pressure gets dry extract, pulverizes, and it is encapsulated to cross 80 mesh sieves.
Usage and dosage: oral, three times on the one, one time 4.
Claims (6)
1. a compound medicine for the treatment of diabetes is characterized in that: comprise following materials of weight proportions, Radix Astragali 6-60g, Rhizoma Atractylodis 6-48g, Herba Cichorii 6-48g.
2. the compound medicine of treatment diabetes according to claim 1 is characterized in that: also comprise following materials of weight proportions, Semen Litchi 3-30g.
3. the compound medicine of treatment diabetes according to claim 2 is characterized in that: comprise following materials of weight proportions, Radix Astragali 20-50g, Rhizoma Atractylodis 20-40g, Herba Cichorii 20-40g, Semen Litchi 15-25g.
4. according to the compound medicine of claim 1,2 described treatment diabetes, it is characterized in that: described medicine is made capsule, tablet, pill or other pharmaceutically acceptable dosage form.
5. the preparation method of the compound medicine of the described treatment diabetes of claim 1 is characterized in that: may further comprise the steps,
A. Rhizoma Atractylodis are ground into coarse powder, and extracting in water volatile oil 4 hours is collected volatile oil, medicinal liquid filter medicinal liquid A, medicinal residues keep;
B. the Radix Astragali, Herba Cichorii and Rhizoma Atractylodis medicinal residues merge, and decoct with water twice, each two hours, filter, collecting decoction, medical liquid B;
C. above-mentioned medicinal liquid A, B are merged, be concentrated into about relative density 1.05 (55 ℃), be cooled to room temperature, add 95% ethanol and make and contain the alcohol amount and reach 60%, placed 24 hours, sucking filtration must medicinal liquid C;
D. medicinal liquid C is reclaimed ethanol, concentrate, drying under reduced pressure gets dry extract, pulverizes, and adds appropriate amount of auxiliary materials and makes finished product.
6. the preparation method of the compound medicine of the described treatment diabetes of claim 2 is characterized in that: may further comprise the steps,
A. Rhizoma Atractylodis are ground into coarse powder, and extracting in water volatile oil 4 hours is collected volatile oil, medicinal liquid filter medicinal liquid A, medicinal residues keep;
B. the Radix Astragali, Herba Cichorii, Semen Litchi and Rhizoma Atractylodis medicinal residues merge, and decoct with water twice, each two hours, filter, collecting decoction, medical liquid B;
C. above-mentioned medicinal liquid A, B are merged, be concentrated into about relative density 1.05 (55 ℃), be cooled to room temperature, add 95% ethanol and make and contain the alcohol amount and reach 60%, placed 24 hours, sucking filtration must medicinal liquid C;
D. medicinal liquid C is reclaimed ethanol, concentrate, drying under reduced pressure gets dry extract, pulverizes, and adds appropriate amount of auxiliary materials and makes finished product.
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