CN100360164C - Medicine for treating diabetes and its preparing process - Google Patents
Medicine for treating diabetes and its preparing process Download PDFInfo
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- CN100360164C CN100360164C CNB200510041051XA CN200510041051A CN100360164C CN 100360164 C CN100360164 C CN 100360164C CN B200510041051X A CNB200510041051X A CN B200510041051XA CN 200510041051 A CN200510041051 A CN 200510041051A CN 100360164 C CN100360164 C CN 100360164C
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Abstract
The present invention discloses a medicine for treating diabetes, and a preparation method thereof. The medicine is prepared from ginseng, astragalus root, wolfberry bark, kudzuvine root, common anemarrhena rhizome, Chinese yam, snakegourd root, schisandra fruit, chicken's gizzard-membrane and glyburide. The preparation method comprises the following steps: saponin components are firstly extracted from the ginseng, the astragalus root, the common anemarrhena rhizome and the Chinese yam by ethanol of high concentration, and polysaccharide components are then extracted by water decoction; the polysaccharide components are precipitated and separated out by the ethanol precipitation of ethanol of high concentration after concentration, and polysaccharide of high purity is obtained by filtration and precipitation; the kudzuvine root and the schisandra fruit are extracted by an ethanol refluxing method; the wolfberry bark, the snakegourd root and the chicken's gizzard-membrane are extracted by a method of water extraction and ethanol precipitation; all extracts are combined, ethanol is recovered, and the extract is concentrated into paste; the polysaccharide is added, and the mixture is decompressed, dried and pulverized into fine powder; the fine powder is jointly ground with glyburide fine powder and auxiliary material, the mixture is uniformly mixed, made into granules, tabletted and coated, and the medicine is obtained. The medicine of the present invention has the functions of benefiting qi, nourishing yin and quenching thirst. The medicine has significant clinical therapeutic effect on people with the symptom of qi and yin deficiency of noninsulin-dependent diabetes mellitus.
Description
Technology territory neck
The present invention relates to Chinese medicine patent medicine and preparation method thereof, particularly relate to a kind of Chinese medicine patent medicine and method for making thereof for the treatment of diabetes.
Background technology
Diabetes (Diabetes mellites, be called for short DM) be a kind of common incretion metabolism disease, " quenching one's thirst " category that belongs to the traditional Chinese medical science, because insulin secretion is relative or absolute not enough, the cellular metabolism effect shortage of insulin causes carbohydrate metabolism disturbance, the persistence hyperglycemia state appears, the glucose in urine positive, and glucose tolerance attenuating and insulin release test are unusual; On the basis of carbohydrate metabolism disturbance, again protein and fat metabolic disturbance even acid base imbalance can appear.In early days clinically can be asymptomatic, symptom typical case person has polydipsia, polyphagia, polyuria to reach with losing weight, symptom time groups such as companion's fatigue and weak (promptly " three-many-one-little), ketoacidosis, hyperosmolar coma, lactic acidosis can take place in severe patient, and easily merge multiple infection.Patients on long-term often occur together eye, kidney, the heart, cerebrovascular and nervous system chronic complicating diseases.Because primary disease sickness rate height, complication is many, has a strong impact on the healthy of people, has caused global medical circle extensive concern.
Diabetes are divided two kinds on I type and II type, and the I type is that the β cell granulations reduces because beta Cell of islet destroys, dysinsulinism, causing diabetes is insulin-dependent, and type ii diabetes is that insulin resistant and insulin action are not enough and cause morbidity, is non-insulin-dependent diabetes mellitus.
Chinese medicine prevention diabetes (being diabetes) have long history, and the practice through several thousand has accumulated a large amount of valuable experience, and formed the unique academic system gradually.Though Western medicine has curative effect preferably to treating diabetes, its inevitable side effect is arranged, cooperate Chinese medicine, can reduce its dose, Chinese medicine is improving symptom, is preventing and treating aspect such as complication curative effect is preferably all arranged.The Chinese medicine diabetes are paid attention to whole the adjustment, obviously be better than western modern medicine at aspects such as improving symptom, and toxic and side effects are little, and are safe.But the course of treatment of Chinese medicine diabetes is longer.
Summary of the invention
Can produce bigger side effect in treatment during diabetes in order to overcome Western medicine, the Chinese medicine diabetes long problem course of treatment the object of the present invention is to provide a kind of treatment diabetes medicament that can combine supplementing QI and nourishing YIN and chemical medicine antidiabetic drug; This medicine is to treatment diabetes and various complication determined curative effect thereof, and blood sugar lowering is steady, and toxic and side effects is little, and is safe, and diabetes are fundamentally effectively treated, and the irreplaceable advantage of chemical synthetic drug is arranged.The present invention also provides the preparation method of this medicine.This preparation method is effective component extracting fully, can remove impurity most possibly again, and suitable industrial production requirement.
The technical scheme that the present invention is taked for its purpose of realization: a kind of medicine for the treatment of diabetes, comprise Radix Ginseng, the Radix Astragali, Cortex Lycii, Radix Puerariae, the Rhizoma Anemarrhenae, Rhizoma Dioscoreae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Endothelium Corneum Gigeriae Galli and glibenclamide, it is characterized in that the weight of each component is: Radix Ginseng 162～198g, the Radix Astragali 486～594g, Cortex Lycii 810～990g, Radix Puerariae 324～396g, the Rhizoma Anemarrhenae 324～396g, Rhizoma Dioscoreae 324～396g, Radix Trichosanthis 405～495g, Fructus Schisandrae Chinensis 243～297g, Endothelium Corneum Gigeriae Galli 162～198 g, glibenclamide 270～330mg.
The preferable weight of each component is: Radix Ginseng 176～190g, the Radix Astragali 500～580g, Cortex Lycii 850～950g, Radix Puerariae 340～380g, the Rhizoma Anemarrhenae 330～380g, Rhizoma Dioscoreae 340～380g, Radix Trichosanthis 420～480g, Fructus Schisandrae Chinensis 255～280g, Endothelium Corneum Gigeriae Galli 176～190g, glibenclamide 280～320mg.
The optimum weight of each component is: Radix Ginseng 180g, Radix Astragali 540g, Cortex Lycii 900g, Radix Puerariae 360g, Rhizoma Anemarrhenae 360g, Rhizoma Dioscoreae 360g, Radix Trichosanthis 450g, Fructus Schisandrae Chinensis 270g, Endothelium Corneum Gigeriae Galli 180g, glibenclamide 300mg.
The preparation of active constituents of medicine of the present invention is the ethanol extraction saponin component that Radix Ginseng, the Radix Astragali, the Rhizoma Anemarrhenae, Rhizoma Dioscoreae are used higher concentration earlier, the reuse decocting boils and proposes the polysaccharide composition, concentrate the back and make polysaccharide become fractional precipitation to separate out with the high concentration ethanol precipitate with ethanol, the leaching precipitation obtains highly purified polysaccharide.Radix Puerariae and Fructus Schisandrae Chinensis adopt ethanol refluxing process to extract effective site; Cortex Lycii, Radix Trichosanthis, Endothelium Corneum Gigeriae Galli extraction process adopt decoction and alcohol sedimentation technique to remove tannin, starch etc., have kept effective ingredient to greatest extent.Each extracting solution merges, and reclaims ethanol, is condensed into clear paste, adds above-mentioned polysaccharide, and drying under reduced pressure is ground into fine powder, and with glibenclamide fine powder, adjuvant facing-up, mixing is made granule, tabletting, and coating, promptly.Concrete preparation method is as follows:
1. glibenclamide is ground into fine powder, crosses 80～120 mesh sieves;
2. Radix Puerariae, Fructus Schisandrae Chinensis add 75% alcohol reflux three times, and each 2 hours, merge extractive liquid, filtered filtrate for later use;
3. Radix Ginseng, the Radix Astragali, the Rhizoma Anemarrhenae, Rhizoma Dioscoreae four Chinese medicine material are ground into coarse powder 20～40 orders, make solvent with 60～80% ethanol, flood after 24 hours, and slowly percolation is collected percolate, and the liquid of filtering is standby; Medicinal residues decoct with water secondary, and each 1 hour, collecting decoction, being concentrated into relative density is 1.06～1.15 at 50 ℃, puts coldly, adds ethanol and makes ethanol content reach 70～90%, leaves standstill 24 hours, filters, precipitate is standby;
4. Cortex Lycii, Radix Trichosanthis, Endothelium Corneum Gigeriae Galli three flavor medical materials decoct with water three times, add 6 times of water gagings at every turn, each 1 hour, collecting decoction filters, and it is 1.05～1.15 in the time of 50 ℃ that filtrate is concentrated into relative density, put cold, add ethanol and make ethanol content reach 60～80%, leave standstill, get supernatant, filter filtrate for later use;
5. with Radix Puerariae, schisandrol extract; The percolate of Radix Ginseng, the Radix Astragali, the Rhizoma Anemarrhenae and Rhizoma Dioscoreae; Cortex Lycii, Radix Trichosanthis and Endothelium Corneum Gigeriae Galli alcohol deposit fluid merge, reclaim ethanol, be concentrated into relative density and be 1.30～1.35 clear paste in the time of 50 ℃, add above-mentioned precipitate, drying under reduced pressure in the time of 70 ℃ is ground into fine powder, crosses 70～120 mesh sieves, and with above-mentioned glibenclamide fine powder mixing, promptly get the active ingredient of medicine of the present invention;
6. the active component that is prepared into adds starch, pregelatinized Starch, carboxymethyl starch sodium as excipient, granulates, and drying, compacting is wrapped film-coat in flakes.
The proportioning of starch, pregelatinized Starch, carboxymethyl starch sodium and active component is: active component 350-450 gram, starch 40-60 gram, pregelatinized Starch 20-30 gram, carboxymethyl starch sodium 10-15 gram.
The best proportioning of starch, pregelatinized Starch, carboxymethyl starch sodium and active component is: active component 400 grams, starch 52 grams, pregelatinized Starch 25 grams, carboxymethyl starch sodium 12.5 grams.
Required various conventional adjuvant when the active component of medicine of the present invention can add different dosage form is prepared into any peroral dosage form commonly used as excipient, filler etc. with the formulation method of routine, as tablet, capsule, granule etc.
Beneficial effect of the present invention: medicine of the present invention can carry out integral body to the diabetes patient to be adjusted, and has supplementing QI and nourishing YIN, and the function of promoting the production of body fluid to quench thirst is used for non-insulin-dependent diabetes mellitus syndrome of deficiency of both qi and yin person, and clinical have a tangible curative effect.Prevent and treat aspects such as complication and obviously be better than western modern medicine improving symptom, and toxic and side effects is little, safe, diabetes are fundamentally effectively treated, the irreplaceable advantage of chemical synthetic drug is arranged.
The specific embodiment
Embodiment 1:
Material component: Radix Ginseng 176g, Radix Astragali 500g, Cortex Lycii 850g, Radix Puerariae 340g, Rhizoma Anemarrhenae 330g, Rhizoma Dioscoreae 340g, Radix Trichosanthis 420g, Fructus Schisandrae Chinensis 255g, Endothelium Corneum Gigeriae Galli 176g, glibenclamide 280mg.
Embodiment 2:
Material component: Radix Ginseng 190g, Radix Astragali 580g, Cortex Lycii 950g, Radix Puerariae 380g, Rhizoma Anemarrhenae 380g, Rhizoma Dioscoreae 380g, Radix Trichosanthis 480g, Fructus Schisandrae Chinensis 280g, Endothelium Corneum Gigeriae Galli 190g, glibenclamide 320mg.
Embodiment 3:
Optimum feed stock component: Radix Ginseng 180g, Radix Astragali 540g, Cortex Lycii 900g, Radix Puerariae 360g, Rhizoma Anemarrhenae 360g, Rhizoma Dioscoreae 360g, Radix Trichosanthis 450g, Fructus Schisandrae Chinensis 270g, Endothelium Corneum Gigeriae Galli 180g, glibenclamide 300mg.
Above-mentioned three groups of embodiment all adopt following preparation method:
1, glibenclamide is ground into fine powder, crosses 80 mesh sieves;
2, Radix Puerariae, Fructus Schisandrae Chinensis add 75% alcohol reflux three times, add 8 times of amounts at every turn, and each 2 hours, merge extractive liquid, filtered filtrate for later use;
3, Radix Ginseng, the Radix Astragali, the Rhizoma Anemarrhenae, Rhizoma Dioscoreae four Chinese medicine material are ground into coarse powder (20～40 order), according to the percolation (appendix IO of Chinese Pharmacopoeia version in 2000) under fluid extract and the extractum, make solvent with 70% ethanol, flood after 24 hours, slowly percolation is collected percolate 7000ml, and the liquid of filtering is standby; Medicinal residues decoct with water secondary, add 10 times of water gagings at every turn, and each 1 hour, collecting decoction, being concentrated into relative density is 1.08 (50 ℃), puts coldly, adds ethanol and makes ethanol content reach 80%, leaves standstill 24 hours, filters, precipitate is standby;
4, Cortex Lycii, Radix Trichosanthis, Endothelium Corneum Gigeriae Galli three flavor medical materials decoct with water three times, add 6 times of water gagings at every turn, and each 1 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.10 (50 ℃), puts coldly, adds ethanol and makes ethanol content reach 70%, leave standstill, get supernatant, filter filtrate for later use;
5, with above-mentioned each extracting solution (Radix Puerariae, schisandrol extract; Percolates such as Radix Ginseng; Alcohol deposit fluid such as Cortex Lycii) merge, reclaim ethanol, being concentrated into relative density is the clear paste of 1.30～1.35 (50 ℃), adds above-mentioned precipitate, and drying under reduced pressure (70 ℃) is ground into fine powder, crosses 80 mesh sieves, standby;
6, with above-mentioned extract powder and glibenclamide, starch 52g, pregelatinized Starch 25g, carboxymethyl starch sodium 12.5g, be wetting agent with 85% ethanol, the system granule, drying, tabletting, the bag film-coat is made 1000, promptly gets medicine of the present invention.
Tablet pharmacological toxicology data of the present invention
1, Pharmacodynamic test of active extract
By to the treatment of hyperglycemia model animal and to the tests such as blood sugar reducing function, carbohydrate tolerance and hemorheological property index of normal rat, verify tablet in treatment diabetes of the present invention effect, for clinical application provides foundation.
Rat is by 4.5g crude drug/kg.d, 9g crude drug/kg.d and 18g crude drug/kg.d (calculating 5,10 and 20 times that are equivalent to clinical adult (in 70kg) consumption 54g/d by kg body weight), oral administration.The result shows:
1. can obviously reduce the blood glucose value of alloxan hyperglycemia model animal and normal rat;
2. can significantly improve hyperglycemia model animal and intact animal's carbohydrate tolerance.
3. the organ coefficient to important immune organs such as hyperglycemia model animal spleen, thymus has certain increase effect.
4. can significantly improve the hyperglycemia model animal to hemorheological property.
Presentation of results tablet of the present invention have Replenishing QI and nourishing YIN, promoting the production of body fluid to quench thirst function.
2, toxicology test data
1. acute toxicity test
By oral administration, observe the size of the acute toxicity of extractum of the present invention (containing glibenclamide), for clinical application provides foundation.
Extractum of the present invention (containing glibenclamide) oral administration does not record its LD
50, recording its maximum dosage-feeding is 124g crude drug/kg, (calculates by kg body weight, is equivalent to 161 times of clinical adult (70kg meter) consumption per day 54g; Press body surface area and calculate, be equivalent to 18 times).After the administration, mice activity, the mental status, defecation, upgrowth situation etc. are normal, and the mice weight increase is obvious.Illustrate that extractum of the present invention (containing glibenclamide) is low to the mice oral toxicity, use safer.
2. rat long term toxicity test
By the rat long-term prescription, investigate the ordinary circumstance after extractum of the present invention (the containing glibenclamide) prolonged application, the influence of routine blood test, liver, renal function, blood glucose, blood fat, body weight, clotting time etc., and the reaction after the drug withdrawal and histology's variation are for clinical application provides foundation.
Extractum of the present invention (containing glibenclamide) rat presses 23.1 every day, 46.2 and 92.4g crude drug/kg (calculates by kg body weight, be equivalent to 30 of clinical adult (70kg meter) consumption per day 54g, 60 and 120 times), give rat continuous use 6 months, respectively at medication 3 months, June and 3 weeks of drug withdrawal are got blood, carry out the related item inspection, the result shows: the action of rat, hair, body weight, appetite, routine blood test, blood fat, hepatic and renal function and organ coefficient etc. and matched group ratio, all there is not significant difference, and blood glucose descends to some extent, relatively there were significant differences with the normal control group, but after 3 weeks of drug withdrawal, recover normal again.The gross anatomy perusal respectively organizes internal organs not have significant change, and the histological examination result shows: the heart, liver, spleen, lung, kidney, brain etc. also do not have obviously change, illustrate that extractum of the present invention (containing glibenclamide) is lower to rat prolonged application toxicity, use safer.
Claims (3)
1, a kind of preparation method for the treatment of the medicine of diabetes comprises Radix Ginseng, the Radix Astragali, Cortex Lycii, Radix Puerariae, the Rhizoma Anemarrhenae, Rhizoma Dioscoreae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Endothelium Corneum Gigeriae Galli and glibenclamide in the medicine material, it is characterized in that:
(1), the weight of each material component is: Radix Ginseng 162～198g, the Radix Astragali 486～594g, Cortex Lycii 810～990g, Radix Puerariae 324～396g, the Rhizoma Anemarrhenae 324～396g, Rhizoma Dioscoreae 324～396g, Radix Trichosanthis 405～495g, Fructus Schisandrae Chinensis 243～297g, Endothelium Corneum Gigeriae Galli 162～198g, glibenclamide 270～330mg;
(2), preparation process:
1., glibenclamide is ground into fine powder, mistake 80～120 mesh sieves;
2., Radix Puerariae, Fructus Schisandrae Chinensis add 75% alcohol reflux three times, each 2 hours, merge extractive liquid, filtered, filtrate for later use;
3., Radix Ginseng, the Radix Astragali, the Rhizoma Anemarrhenae, Rhizoma Dioscoreae four Chinese medicine material be ground into coarse powder 20～40 orders, makes solvent with 60～80% ethanol, floods after 24 hours, slowly percolation is collected percolate, percolation is standby; Medicinal residues decoct with water secondary, and each 1 hour, collecting decoction, being concentrated into relative density is 1.06～1.15 at 50 ℃, puts coldly, adds ethanol and makes ethanol content reach 70～90%, leaves standstill 24 hours, filters, precipitate is standby;
4., Cortex Lycii, Radix Trichosanthis, Endothelium Corneum Gigeriae Galli three flavor medical materials, decoct with water three times, add 6 times of water gagings at every turn, each 1 hour, collecting decoction filters, and it is 1.05～1.15 in the time of 50 ℃ that filtrate is concentrated into relative density, put cold, add ethanol and make ethanol content reach 60～80%, leave standstill, get supernatant, filter filtrate for later use;
5., with Radix Puerariae, schisandrol extract; The percolate of Radix Ginseng, the Radix Astragali, the Rhizoma Anemarrhenae and Rhizoma Dioscoreae; Cortex Lycii, Radix Trichosanthis and Endothelium Corneum Gigeriae Galli alcohol deposit fluid merge, reclaim ethanol, be concentrated into relative density and be 1.30～1.35 clear paste in the time of 50 ℃, add above-mentioned precipitate, drying under reduced pressure in the time of 70 ℃ is ground into fine powder, crosses 70～120 mesh sieves, and with above-mentioned glibenclamide fine powder mixing, promptly get the active ingredient of medicine;
6., the active ingredient that is prepared into, add starch, pregelatinized Starch, carboxymethyl starch sodium as excipient, granulate, drying, compacting in flakes, the bag film-coat.
2, preparation method according to claim 1 is characterized in that the proportioning of starch, pregelatinized Starch, carboxymethyl starch sodium and active ingredient is: active ingredient 350-450 gram, starch 40-60 gram, pregelatinized Starch 20-30 gram, carboxymethyl starch sodium 10-15 gram.
3, preparation method according to claim 1 is characterized in that the proportioning of starch, pregelatinized Starch, carboxymethyl starch sodium and active ingredient is: active ingredient 400 grams, starch 52 grams, pregelatinized Starch 25 grams, carboxymethyl starch sodium 12.5 grams.
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| CNB200510041051XA CN100360164C (en) | 2005-07-13 | 2005-07-13 | Medicine for treating diabetes and its preparing process |
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| CN101664504B (en) * | 2008-09-03 | 2011-09-07 | 刘爱莲 | Medicament for treating diabetes and preparation method thereof |
| CN107998262A (en) * | 2016-11-02 | 2018-05-08 | 王晓丽 | A kind of Chinese medicine composition for adjusting diabetes B |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1159051C (en) * | 2002-03-28 | 2004-07-28 | 葛强 | Hypoglycemic granule of ten ingredients and its prepn |
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| CN1159051C (en) * | 2002-03-28 | 2004-07-28 | 葛强 | Hypoglycemic granule of ten ingredients and its prepn |
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