CN101491629B - Medicine composition for treating diabetes and preparation method thereof - Google Patents

Medicine composition for treating diabetes and preparation method thereof Download PDF

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CN101491629B
CN101491629B CN2008100005442A CN200810000544A CN101491629B CN 101491629 B CN101491629 B CN 101491629B CN 2008100005442 A CN2008100005442 A CN 2008100005442A CN 200810000544 A CN200810000544 A CN 200810000544A CN 101491629 B CN101491629 B CN 101491629B
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weight portions
radix
corn
preparation
pharmaceutical composition
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CN101491629A (en
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曹永翔
陈立
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Bio Pharmaceutical Technology (Tianjin) Co., Ltd.
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BEIJING CHENZHONG RONGFU TECHNOLOGY Co Ltd
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Abstract

The invention discloses a pharmaceutical composition for treating diabetes, which consists of medicinal components or consists of medicinal components and pharmaceutically acceptable carries, wherein the medicinal components is prepared from wild yam, Radix Astragali, rhizoma anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, shizandra berry, trichosanthes root, corn, pea and peppermint. The composition has the efficacies in nourishing the kidney and yin, supplementing qi and promoting the production of body fluid. The composition can be used for treating the diabetes with the symptoms of polydipsia, diuresis, polyphagia and emaciation from the deficiency of stomach and kidney. The invention also discloses a method for preparing the pharmaceutical composition.

Description

A kind of pharmaceutical composition for the treatment of diabetes and preparation method thereof
Technical field:
The present invention relates to a kind of pharmaceutical composition for the treatment of diabetes, the invention still further relates to this preparation of drug combination method.
Background technology:
Diabetes are a kind of commonly encountered diseases, frequently-occurring disease, because the body insulin is absolute or relative the shortage, cause sugar, fat, protein metabolism disorder, cause the viscosity of hyperglycemia, hyperlipidemia and blood to increase, cause cardio cerebrovascular affection, diabetic nephropathy, retinopathy and very easily bring out infection, therefore very big to human body harm.Show as polydipsia more, polyuria, polyphagia is become thin, fatigue and lack of strength, the difference of sleeping lumbago, symptoms such as glucose in urine and blood sugar increasing.
At present the medicine of treatment diabetes has three classes: a class is a pure Chinese medicinal preparation, a class be in, the Western medicine mixture; Also having a class is exactly pure Western medicine such as insulin substitution therapy.But some curative effect of these medicines is very not definite, and perhaps untoward reaction is more.
Good wine soup comes from " Records of Tradition Chinese and Western Medicine in Combination " book, the main prescription of the card of quenching one's thirst for treatment.Quench one's thirst, be equivalent to the diabetes of doctor trained in Western medicine.Diabetes is due to how not risen by vigour.In the side based on the Radix Astragali, Radix Puerariae can make first gas lift, assistant with Rhizoma Dioscoreae, the Rhizoma Anemarrhenae, pollen is Kidney-Yin with big taste, make it sun rise cloudy should.To help taste strong, the property sealing kidney of getting the trimethyl gallic acid receipts closes with Endothelium Corneum Gigeriae Galli, and drinking-water is become under not being eager.Li Hongming has delivered the article of " good wine soup treatment type ii diabetes 58 examples " in " practical tcm internal medicine magazine " 1999 the 13rd the 4th phases of volume, good wine soup treatment group total effective rate is 90%, and the total effective rate of simple glyburide or diamicron western medicine group is 81.5%.
Good wine soup is as a traditional treatment diabetes prescription, exist to be inconvenient to the shortcoming of making, preserve, carrying and using, and it is all very big in difficulty on the volume, on the material properties to make dosage forms such as common sheet, ball, capsule, oral liquid.
The present invention has carried out rational improvement to the weak point that former good wine soup prescription exists, and has worked in coordination with the hypoglycemic activity of former prescription by adding corn, Semen Pisi sativi and Herba Menthae.Corn, Semen Pisi sativi and Herba Menthae all have certain diabetes auxiliary therapy effect: stomach function regulating during corn is transferred, blood fat reducing, blood pressure lowering, blood sugar lowering; The Semen Pisi sativi invigorating the spleen and replenishing QI, diuresis, association's Radix Astragali efficacy of a drug performance; The hot cool heat radiation of Herba Menthae helps the Radix Puerariae performance efficacy of a drug; Corn, Semen Pisi sativi and Herba Menthae are the more weak good function food of the property of medicine, the three can protect the stomach nourishing the stomach jointly, the medicine that is beneficial to good wine soup is digested and assimilated, secondly corn, Semen Pisi sativi can effectively reduce the syrupy viscosity of good wine soup in the process of preparation, medicine disintegrate and dispersion after being beneficial to the system of moulding, toasting and eating absorb, the mouthfeel that the Herba Menthae that adds also can effectively be proofreaied and correct slice, thin piece, the sticky flavor of reduction food increases pleasant sense.The more convenient manufacturing of dosage form after change decoction than before, store, carry and use, meet modern society and use.
Consult patent database, not seeing has compositions and the preparation method similar with the present invention.
Summary of the invention:
One of purpose of the present invention provides a kind of pharmaceutical composition for the treatment of diabetes safely and effectively.
Another purpose of the present invention provides this preparation of drug combination method.
Pharmaceutical composition of the present invention is made up of active ingredient or active ingredient and pharmaceutically acceptable carrier, and the raw material that wherein prepares described active ingredient is:
Rhizoma Dioscoreae 100-500 weight portion, Radix Astragali 50-250 weight portion, Rhizoma Anemarrhenae 60-300 weight portion, live chickens Endothelium corneum 20-100 weight portion, Radix Puerariae 10-80 weight portion, Fructus Schisandrae Chinensis 30-150 weight portion, Radix Trichosanthis 30-150 weight portion, corn 50-1500 weight portion, Semen Pisi sativi 50-1500 weight portion, Herba Menthae 20-80 weight portion.
Preferably: Rhizoma Dioscoreae 150-450 weight portion, Radix Astragali 100-200 weight portion, Rhizoma Anemarrhenae 110-250 weight portion, live chickens Endothelium corneum 30-90 weight portion, Radix Puerariae 20-70 weight portion, Fructus Schisandrae Chinensis 50-130 weight portion, Radix Trichosanthis 50-130 weight portion, corn 70-1300 weight portion, Semen Pisi sativi 70-1300 weight portion, Herba Menthae 30-70 weight portion.
More preferably: Rhizoma Dioscoreae 200-400 weight portion, Radix Astragali 120-180 weight portion, Rhizoma Anemarrhenae 160-200 weight portion, live chickens Endothelium corneum 50-70 weight portion, Radix Puerariae 30-60 weight portion, Fructus Schisandrae Chinensis 80-100 weight portion, Radix Trichosanthis 70-110 weight portion, corn 80-1200 weight portion, Semen Pisi sativi 80-1200 weight portion, Herba Menthae 40-60 weight portion.
The active ingredient of selecting following raw materials according to make, curative effect is better:
Rhizoma Dioscoreae 300 weight portions, Radix Astragali 150 weight portions, the Rhizoma Anemarrhenae 180 weight portions, live chickens Endothelium corneum 60 weight portions, Radix Puerariae 45 weight portions, Fructus Schisandrae Chinensis 90 weight portions, Radix Trichosanthis 90 weight portions, corn 100 weight portions, Semen Pisi sativi 100 weight portions, Herba Menthae 50 weight portions.
Can adopt direct abrasive method or adopt the conventional extracting method in this area, for example decocting boils preparation active ingredient such as method.Described active ingredient can be made various pharmaceutical formulations with pharmaceutically acceptable carrier or excipient, and as pill, tablet, oral liquid, granule, capsule, soft capsule etc., tablet comprises conventional tablet, moulds film-making, dispersible tablet, slow releasing tablet etc.Wherein said pharmaceutically acceptable carrier or excipient are selected according to different dosage forms.
Preparation of drug combination method of the present invention, it may further comprise the steps: get Rhizoma Dioscoreae, Radix Astragali, the Rhizoma Anemarrhenae, live chickens Endothelium corneum, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis seven flavor medicine altogether, add water boil, one next hour, secondary merges the decoction liquor after-filtration altogether, is concentrated into sticky shape liquid.Grind jointly adding Herba Menthae after corn, the Semen Pisi sativi drying, mix homogeneously, even with above-mentioned sticky shape liquid agitation then.Above-mentioned active ingredient can be made various oral formulations such as pill, tablet, oral liquid, granule, capsule, soft capsule etc. with pharmaceutically acceptable carrier.
The invention still further relates to the preparation method of moulding film-making, may further comprise the steps: get Rhizoma Dioscoreae, Radix Astragali, the Rhizoma Anemarrhenae, live chickens Endothelium corneum, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis seven flavor medicine altogether, add water boil, one next hour, secondary merges after-filtration altogether, is concentrated into sticky shape liquid.Grind jointly adding Herba Menthae after corn, the Semen Pisi sativi drying, mix homogeneously, even with above-mentioned sticky shape liquid agitation then, mould with oodle maker and to make rectangular dough sheet shape, with the cutter dice, toast in the aluminium-plastic panel of packing into after ripe, promptly.
Pharmaceutical composition of the present invention has nourishing kidney-YIN, supplementing QI for promoting the production of body fluid effect.Can be used for polydipsia, polyuria, polyphagia is become thin, fatigue and lack of strength, the difference of sleeping lumbago, the stomach deficiency of the kidney yin performance diabetes of glucose in urine and blood sugar increasing.
The specific embodiment:
Mould the preparation of film-making
Embodiment 1 gets Rhizoma Dioscoreae 300 grams, Radix Astragali 150 grams, the Rhizoma Anemarrhenae 180 grams, live chickens Endothelium corneum 60 grams, Radix Puerariae 45 grams, Fructus Schisandrae Chinensis 90 grams, Radix Trichosanthis 90 grams seven flavor medicine altogether, add 8 times of water gagings and boil, next hour, secondary altogether, merge after-filtration, filtrate is concentrated into sticky shape liquid.Will corn 100 grams, the dry back of Semen Pisi sativi 100 grams add common grinding of Herba Menthaes 50 grams, mix homogeneously, even with above-mentioned sticky shape liquid agitation then, mould with oodle maker and to make rectangular dough sheet shape, with the cutter dice, toast in the aluminium-plastic panel of packing into after ripe.
Embodiment 2 gets Rhizoma Dioscoreae 250 grams, Radix Astragali 120 grams, the Rhizoma Anemarrhenae 160 grams, live chickens Endothelium corneum 50 grams, Radix Puerariae 40 grams, Fructus Schisandrae Chinensis 80 grams, Radix Trichosanthis 100 grams seven flavor medicine altogether, add 8 times of water gagings and boil, next hour, secondary altogether, merge after-filtration, filtrate is concentrated into sticky shape liquid.Will corn 100 grams, the dry back of Semen Pisi sativi 100 grams add common grinding of Herba Menthaes 50 grams, mix homogeneously, even with above-mentioned sticky shape liquid agitation then, mould with oodle maker and to make rectangular dough sheet shape, with the cutter dice, toast in the aluminium-plastic panel of packing into after ripe.
Embodiment 3 gets Rhizoma Dioscoreae 200 grams, Radix Astragali 170 grams, the Rhizoma Anemarrhenae 150 grams, live chickens Endothelium corneum 40 grams, Radix Puerariae 50 grams, Fructus Schisandrae Chinensis 100 grams, Radix Trichosanthis 80 grams seven flavor medicine altogether, add 8 times of water gagings and boil, next hour, secondary altogether, merge after-filtration, filtrate is concentrated into sticky shape liquid.Will corn 100 grams, the dry back of Semen Pisi sativi 100 grams add common grinding of Herba Menthaes 50 grams, mix homogeneously, even with above-mentioned sticky shape liquid agitation then, mould with oodle maker and to make rectangular dough sheet shape, with the cutter dice, toast in the aluminium-plastic panel of packing into after ripe.
Pharmacodynamic experiment
Be definite evaluation curative effect of the present invention, now the animal experiment situation be summarized as follows.
1. the foundation of animal model
This experiment adopts STZ to produce the medicine of experimental hyperglycemia as inducing mouse, and selects for use glyburide as positive control.
2. material and reagent
STZ (Sigma company), glyburide (0.25g/ sheet, Double-Crane Pharmaceutical Co., Ltd), glucose kit (middle liter north control biotech inc), medical materials such as Rhizoma Dioscoreae, Radix Astragali, the Rhizoma Anemarrhenae, live chickens Endothelium corneum, Radix Puerariae, Fructus Schisandrae Chinensis, big pollen, Herba Menthae are available from Beijing Pharma Inc. of Tongrentang.Sodium carboxymethyl cellulose, corn, Semen Pisi sativi are food grade.
Laboratory animal is a Kunming kind white mice, and Experimental Animal Center breeding in the car thing Academy of Medical Sciences is male, and body weight is 25~28 grams.
3. experimental technique
3.1 the preparation of sample
The preparation of STZ injection: STZ is dissolved in 0.05mmolL -1, PH4.5 citrate buffer solution in, being made into concentration is 4gL -1STZ solution, preparation before using.
The preparation of glyburide: glibenclamide tablet is ground to form fine powder, and the sodium carboxymethyl cellulose with 1% is made into 5gL -1Suspension.
The preparation of experiment medicine group: good wine is moulded film-making grind to form fine powder, the sodium carboxymethyl cellulose with 1% is made into 5gL -1Suspension.
The preparation of adjuvant group: with corn: Semen Pisi sativi: Herba Menthae is ground with 2: 2: 1 ratio, and the sodium carboxymethyl cellulose with 1% is made into 5gL -1Suspension.
The preparation of former prescription group: the medical material of recipe quantity in the good wine soup prescription, to boil with 8 times of water gagings, next hour, secondary merges the back evaporate to dryness altogether, and the sodium carboxymethyl cellulose with 1% is made into 5gL -1Suspension.
3.2 the foundation of laboratory animal diabetes model
Use the STZ solution for preparing in advance, press 80mgKg -1Give mice by intraperitoneal injection, measured the 12h fasting blood sugar on the 11st day before injection and after the injection, set up blood sugar increasing diabetic mice model.Healthy male Kunming kind white mice is divided into blank group, STZ model group, positive controls, corn Semen Pisi sativi Herba Menthae adjuvant group, former prescription group, experiment medicine group, 5 every group at random by body weight.Except that the normal control group, other the every group STZ injection (80mgKg that equal lumbar injection prepares -1), after the 11st day, measure mice 12h fasting glucose.Use glyburide (100mgKg respectively -1), experiment medicine (100mgKg -1) adjuvant (100mgKg -1), former prescription (100mgKg -1) irritate stomach, normal control and STZ group are irritated stomach with the sodium carboxymethyl cellulose of equivalent, once a day.After 12 days, measure mice 12h fasting glucose, and after getting blood 1 hour with 50% glucose by 20m1Kg -1Irritate stomach, measure the 2h blood glucose value.
3.3 experimental result
Mice is used 80mgKg -1The STZ injection is after 11 days, and blood sugar concentration is raised to 5.8mmolL -1, relatively there is significance to raise (P<0.01) with the blank group with before injecting STZ, meet experimental animal model.Behind 12 days of administration, experiment medicine group mice and STZ model group compare, and blood sugar concentration has significance to descend (P<0.01), and hypoglycemic effect is better than positive control drug glyburide.The 2h blood sugar concentration is compared after the meal, and experiment medicine group also is lower than STZ model group (P<0.01).Corn Semen Pisi sativi Herba Menthae adjuvant group and STZ model group comparison blood sugar concentration have slight decline, and experiment medicine group hypoglycemic effect obviously is better than former prescription group, illustrate that corn Semen Pisi sativi Herba Menthae adjuvant group can produce synergism with former prescription group, better produces blood sugar reducing function.
The medicine administered to bring out the cold thing is to the regulating action of STZ rising mouse blood sugar with to the influence of 2h blood glucose after the meal
Figure S2008100005442D00071
Grouping Fasting glucose (mmolL -1) 2h blood glucose (mmolL after the meal -1)
1d 11d After the 12d administration
The former prescription group experiment of blank group STZ model group positive controls corn Semen Pisi sativi Herba Menthae adjuvant group medicine group 3.45±0.70 3.46±0.54 3.37±0.63 3.38±0.42 3.56±0.56 3.29±0.59 3.43±0.57 5.89±0.66* 5.88±0.89* 5.78±0.88* 5.66±0.63* 5.62±0.67* 3.59±0.54 6.12±0.65 4.49±0.46 # 5.69±0.62 4.22±0.51 # 3.91±0.42 # 5.70±1.02 10.52±2.11 7.68±1.28 # 9.18±0.78 7.21±1.12 # 7.01±1.16 #
Annotate: compare P<0.01 before * and normal control group and the injection STZ; # and STZ model group be P<0.01 relatively

Claims (5)

1. pharmaceutical composition for the treatment of diabetes, it is characterized in that: it is made up of active ingredient or active ingredient and pharmaceutically acceptable carrier, and the raw material that wherein prepares described active ingredient is: Rhizoma Dioscoreae 300 weight portions, Radix Astragali 150 weight portions, the Rhizoma Anemarrhenae 180 weight portions, live chickens Endothelium corneum 60 weight portions, Radix Puerariae 45 weight portions, Fructus Schisandrae Chinensis 90 weight portions, Radix Trichosanthis 90 weight portions, corn 100 weight portions, Semen Pisi sativi 100 weight portions, Herba Menthae 50 weight portions.
2. pharmaceutical composition as claimed in claim 1 is characterized in that: it is a peroral dosage form.
3. pharmaceutical composition as claimed in claim 1 is characterized in that: it is to mould film-making.
4. preparation of drug combination method as claimed in claim 1 may further comprise the steps: get Rhizoma Dioscoreae, Radix Astragali, the Rhizoma Anemarrhenae, live chickens Endothelium corneum, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis, add 8 times of water gagings and boil, one next hour, secondary merges the decoction liquor after-filtration altogether, is concentrated into sticky shape liquid; With after corn, the Semen Pisi sativi drying and Herba Menthae grind, mix homogeneously, even with above-mentioned sticky shape liquid agitation then.
5. preparation of drug combination method as claimed in claim 4, it comprises gets Rhizoma Dioscoreae, Radix Astragali, the Rhizoma Anemarrhenae, live chickens Endothelium corneum, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis seven flavor medicine altogether, adds 8 times of water gagings and boils, one next hour, secondary merges the decoction liquor after-filtration, the sticky shape liquid of simmer down to altogether; With after corn, the Semen Pisi sativi drying and Herba Menthae grind, mix homogeneously, then with above-mentioned sticky shape liquid agitation evenly after, mould with oodle maker and to make rectangular dough sheet shape, with the cutter dice, toast in the aluminium-plastic panel of packing into after ripe.
CN2008100005442A 2008-01-21 2008-01-21 Medicine composition for treating diabetes and preparation method thereof Expired - Fee Related CN101491629B (en)

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Publication number Priority date Publication date Assignee Title
CN102488827B (en) * 2011-12-14 2013-08-07 哈药集团中药二厂 Preparation method for Yuye decoction lyophilized orally administrated preparation
CN102430040A (en) * 2011-12-30 2012-05-02 山西振东开元制药有限公司 Medicament for treating diabetes
CN104491342A (en) * 2014-11-29 2015-04-08 高春娟 Medicament for treating diabetes and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1314160A (en) * 2000-03-17 2001-09-26 王申 Oral pill for curing diabetes and its complication
CN1785387A (en) * 2005-11-11 2006-06-14 李永红 Capsnle for treating type II diabetes
CN1799602A (en) * 2004-12-31 2006-07-12 李文军 Qi-invigorating, yin-nourishing medicinal pills and preparation method thereof
CN1857618A (en) * 2006-04-04 2006-11-08 宁波诚年药业有限公司 Chinese medicine preparation for reducing sugar

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1314160A (en) * 2000-03-17 2001-09-26 王申 Oral pill for curing diabetes and its complication
CN1799602A (en) * 2004-12-31 2006-07-12 李文军 Qi-invigorating, yin-nourishing medicinal pills and preparation method thereof
CN1785387A (en) * 2005-11-11 2006-06-14 李永红 Capsnle for treating type II diabetes
CN1857618A (en) * 2006-04-04 2006-11-08 宁波诚年药业有限公司 Chinese medicine preparation for reducing sugar

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