CN104815140A - Composition for preventing or/and treating diabetes and preparation method of composition - Google Patents

Abstract

The invention relates to a pharmaceutical composition for preventing or/and treating diabetes and a preparation method of the composition. The pharmaceutical composition for preventing or/and treating diabetes is prepared from the following components in a certain weight proportion: psidium guajave, raw Chinese yam, raw astragalus, rhizoma anemarrhenae, raw endothelium corneum gigeriae galli, kudzu vine root, schisandra chinensis and radices trichosanthis. The pharmaceutical composition for preventing or/and treating diabetes can be prepared into any one of frequently-used orally taken dosage forms and health products, has the effects of preventing and treating diabetes and also has the functions of supplementing qi and promoting the production of body fluid, nourishing yin to clear away heat and invigorating spleen and kidney, so that the pharmaceutical composition for preventing or/and treating diabetes can realize the effect of well preventing and treating diabetes during daily application. The pharmaceutical composition for preventing or/and treating diabetes is obvious in effect, easy to take and good in taste, and has no toxic or side effect.

Description

A kind of prevention is or/and the composition and method of making the same for the treatment of diabetes

Technical field

The present invention relates to a kind of prevention or/and the composition and method of making the same for the treatment of diabetes, particularly a kind of prevention being derived from plant is or/and the composition and method of making the same for the treatment of diabetes, belongs to food, health product and medicine field.

Background technology

Diabetes (diabetes mellitus, DM) are class metabolic diseases, and its feature is that blood glucose is for a long time higher than standard value.Hyperglycemia can cause the symptom of three-many-one-little: eat many, drink many, frequent micturition and weight loss.If untreated, diabetes may cause many complication.Acute complications comprises diabetes DKA and the non-keto acid of hyperosmosis hyperglycemia is gone into a coma; Serious long-range complication then comprises cardiovascular disease, apoplexy, chronic kidney disease, diabetic foot and retinopathy etc.

The origin cause of formation of diabetes has two: pancreas cannot produce enough insulins, or cell is to insulin insensitivity.Diabetes are then divided into three classes clinically: (1) first patients with type Ⅰ DM is because health cannot produce enough insulins, past is also called insulin dependent diabetes mellitus (IDDM) (insulin-dependent diabetes mellitus, IDDM) or juvenile diabetes, the cause of disease is failed to understand at present; (2) Second-Type diabetes start from insulin resistant (cell is abnormal for the reaction of insulin) ^[3], the secretion along with disease progression insulin also may become not enough gradually ^[6].This type is called as non-insulin-dependent diabetes mellitus (non insulin-dependent diabetes mellitus, NIDDM) or adult diabetes mellitus in the past, and the cause of disease is overweight or lacks motion.One of ciril disease of Ye Shi developed country, patient's number constantly rises; (3) gestational diabetes is also common diabetes kind, and it refers to the past does not have diabetic history, but phenolics blood glucose higher than normal value anemia of pregnant woman with it.

Diabetes itself not necessarily work the mischief, but long-term blood glucose increases, trunk, blood capillary are impaired and jeopardize the heart, brain, kidney, peripheral nerve, eyes, foot etc., add up according to World Health Organization (WHO), diabetic complication, up to kind more than 100, is a kind of disease that current known complication is maximum.Be caused by cardiovascular and cerebrovascular vessel because Diabetes Death person has over half, 10% is caused by nephropathy.Because diabetes amputation is ND 10 ~ 20 times.The complication for this reason prevented diabetes is vital social problem.

The traditional Chinese medical science thinks that eating and drinking without temperance, disorder of emotion card, impairment of the kidney due to indulgence in sexual activities, natural endowment are not enough or excessively take the pathogenetic key factor of warm-dryness syndrome medicine equation glycosuria, and YIN fluid deficiency, production of dryness-heat in the interior are the pathogenetic basic pathogenesis of glycosuria, delay with the passing of time, deficiency of both QI and YIN.Doctor trained in Western medicine thinks that diabetes are a kind of metabolism disturbance syndromes caused by many reasons, and with insulin, relative or absolute deficiency causes blood glucose, glucose in urine to raise being the disease of feature.The diabete of traditional Chinese medical science meaning, clinically there is polydipsia, polyphagia, polyuria, the symptom such as tired of becoming thin, especially middle age with fatigue and weakness, nocturia for main symptom, weak long-term Western medicine controls, just there will be Drug resistance, the heart, cerebrovascular, kidney, optical fundus, retina and nervous system lesion can be caused, time serious, the complication such as ketoacidosis hyperosmolar coma can occur.

The prevention of diabetes and therapeutic modality comprise and maintain balanced diet, regular movement, smoking cessation, maintenance ideal body weight.For in diabetics, controlling of blood pressure and foodcare are also quite important.First patients with type Ⅰ DM must control blood glucose by insulin injection; Second-Type diabetes then can use oral medicine to control, injection of insulin of also can arranging in pairs or groups if necessary.The part oral medicine of diabetes and insulin all may cause hypoglycemia.For the Second-Type diabetics suffering from obesity simultaneously, bariatric surgery is effective treatment.For the patient of gestational diabetes, blood glucose can recover normal usually after manufacture.Current antidiabetic drug is the most used, that consumption is maximum medicine, also has insulinize in addition, to reach the object controlling blood glucose, complication prevention.

To sell in the market or the orally-taken blood sugar reducing medicine of known treatment diabetes mainly contains several as follows at present: 1) biguanides: main pharmacological is output by reducing hepatic glucose and improves peripheral insulin resistance and reduce blood glucose; 2) sulfonylurea drugs: belong to Drugs Promoting Insulin Secretion, main pharmacological is by stimulating islet β cell insulin, increases the insulin level in body and reduces blood glucose; 3) Thiazolidinediones (TZDs): blood glucose is reduced to the sensitivity of insulin action mainly through increasing target cell; 4) glinides: be the Insulin secretagogues of non-sulphanylureas, reduces post-prandial glycemia mainly through stimulating the Early insulin secretion of insulin; 5) alpha-glucosidase inhibitor: reduce post-prandial glycemia in the absorption of upper part of small intestine by suppressing carbohydrate; 6) dipeptidyl peptidase-4 (DPP-4) inhibitor: reduce GLP-1 inactivation in vivo by suppressing DPP-4, increases GLP-1 level in vivo.

If drug main Western medicine (chemical drugs) preparation of existing known treatment diabetes and Chinese medicine preparation, be generally the kind of single composition class, Western medicine then side effect is large, diabetic condition is played to the effect of emergency and short term therapy, but majority can produce ill effect, use comparatively complicated, and serious liver, kidney, the heart, lung disease and Pregnant Patients can not be taken, shortcoming that sphere of action is less etc., and this type of medicine mostly is dependence enhancing islets of langerhans usually reducing blood glucose, the related complication of diabetes cannot be solved, be difficult to effect a radical cure diabetes.Though Chinese medicine has longer effect, also usually because individual variation is limited, part population expression effect is undesirable.And also there is part side effect.

Or/and treat health product and the Chinese medicine preparation of diabetes, there is the deficiencies such as production cost is too high and raw material supply instability, control of product quality difficulty, slow curative effect or curative effect are not obvious in various prevention in the market.The present invention then provide a kind of easy to use, cheap, to prevention or/and treatment diabetes have health product and the Chinese medicine preparation of obvious curative effects.

Summary of the invention

Main purpose of the present invention is for above-mentioned prevention or/and the treatment health product of diabetes and the prior art of Chinese medicine preparation and product Problems existing, provide a kind of for prevention or/and treatment diabetic composition and preparation method thereof.Present composition prescription is simple, and the medical material of use, has raising human body immunity, and prevention, or/and obvious effect for the treatment of diabetes, has the effect of supplementing QI for promoting the production of body fluid, replenishing YIN and removing heat, strengthening spleen, tonifying kidney simultaneously.The present invention's prevention is or/and easy, the stable processing technique of preparation method, cheap and easy to carry and use for the treatment of diabetic composition.

For realizing object of the present invention, one aspect of the present invention provides a kind of prevention or/and the compositions for the treatment of diabetes, comprises following crude drug: Fructus psidii guajavae immaturus, Rhizoma Dioscoreae, the Radix Astragali, the Rhizoma Anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis.

Wherein, the weight of described crude drug is: Fructus psidii guajavae immaturus 5-50, Rhizoma Dioscoreae 5-35, Radix Astragali 5-40, Rhizoma Anemarrhenae 2-20, Endothelium Corneum Gigeriae Galli 7-40, Radix Puerariae 6-35, Fructus Schisandrae Chinensis 2-20, Radix Trichosanthis 3-25; Be preferably: Fructus psidii guajavae immaturus 10-50, Rhizoma Dioscoreae 10-30, Radix Astragali 10-30, Rhizoma Anemarrhenae 6-15, Endothelium Corneum Gigeriae Galli 10-30, Radix Puerariae 10-30, Fructus Schisandrae Chinensis 6-15, Radix Trichosanthis 6-20; More preferably: Fructus psidii guajavae immaturus 20, Rhizoma Dioscoreae 20, the Radix Astragali 20, the Rhizoma Anemarrhenae 10, Endothelium Corneum Gigeriae Galli 15, Radix Puerariae 15, Fructus Schisandrae Chinensis 10, Radix Trichosanthis 12.

Particularly, described Rhizoma Dioscoreae selects Rhizoma Dioscoreae; Radix Astragali selected by the described Radix Astragali; Live chickens Endothelium corneum selected by described Endothelium Corneum Gigeriae Galli.

Medicine Fructus psidii guajavae immaturus of the present invention, Rhizoma Dioscoreae, the Radix Astragali, the Rhizoma Anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis combinationally use, and make each efficacy of drugs produce synergism, thus can more effectively prevent or/and treat diabetes.

Fructus psidii guajavae immaturus is warm in nature, sweet in the mouth, puckery, sour, nontoxic; Fructus psidii guajavae immaturus has astringing to arrest diarrhea, hemostasis, effect of antipruritic, carious pain, infantile night sweat, otitis media etc.Cure mainly and have loose bowels, chronic dysentery, eczema, the diseases such as wound hemorrhage.

There is manual inseminating in area and loses as wild kind Fructus psidii guajavae immaturus in China Fujian, Guangdong, Guangxi, Sichuan, Guizhou, Taiwan etc., is a kind of rich in natural resources.There are some researches show, Fructus psidii guajavae immaturus is rich in abundant nutritional labeling, wherein the content of protein and vitamin C height especially, in addition also containing vitamin A, B and microelements of calcium, phosphorus, ferrum, potassium etc.Fructus psidii guajavae immaturus has also been rich in the nutritional labelings such as dietary fiber, carotene, fat.The nutritional labelings such as fructose, sucrose, aminoacid are contained in addition in Fructus psidii guajavae immaturus.Often eat the nutritional labeling can supplemented human body and lack, building body improves body constitution, the most important thing is that the fat heat contained by Fructus psidii guajavae immaturus is lower.

" national Chinese herbal medicine compilation " Fructus psidii guajavae immaturus medical value is high, can prevent and treat hypertension, diabetes, for obesity and the not good patient of the intestines and stomach, and ideal edible fruits.Fruit nonhazardous, disease are polluted, and plant, from fruitlet, be just set with bag film because of scientific, until pluck, completely cutting off with insect, is the pollution-free food of standard.The equal edible of population.Be particularly suitable for the child of growth and development stage, for hypertension, diabetes, obesity and gastrointestinal upset person, be best edible fruits.Child and have constipation or have the people of interior-heat to eat more.The anti-constipation of people Ying Shen of liver-heat, because Fructus psidii guajavae immaturus has astringing to arrest diarrhea effect.

Be rich in the flavone compounds such as Quercetin and polysaccharide composition in Fructus psidii guajavae immaturus, there is preferably hypoglycemic effect compared with other Chinese medicine extract.Be commonly used to treat diabetes.Experiment shows, diabetics is often edible has obvious auxiliary therapeutic action for alleviating of disease.Fructus psidii guajavae immaturus is adopted to reduce blood glucose in Taiwan, treasured island very general.Wu Jianzhongs etc. produce extraction and isolation polysaccharides from guava pearl guava fruit from Fanyu, Guangdong, with dosage 300mg/kg gavage treatment alloxan induced hyperglycemia mice, result shows that polysaccharides from guava significantly can reduce blood glucose in diabetic mice, improve its oxidation resistance, illustrate that polysaccharides from guava has certain preventive and therapeutic effect to diabetes and complication thereof, antioxidation may be one of polysaccharides from guava blood sugar lowering mechanism.

Rhizoma Dioscoreae, also known as Rhizoma Dioscoreae, is the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae.It is one of four-Huai medicine that Gu Huai celebrates the Rhizoma Dioscoreae produced at mansion (modern Henan Province Jiaozuo City is domestic).Property flat, sweet in the mouth, return lung, spleen, kidney channel.There is strengthening the spleen and tonifying the lung, stomach reinforcing the kidney invigorating, benefit of reinforcing the kidney essence, hearing-improing and eyesight improving, help the five internal organs, bone and muscle strengthening, long will are calmed the nerves, effect of life lengthening.Be mainly used in treating weakness of the spleen and stomach, diet reduces, and suffers from diarrhoea in loose stool; Women's lukorrhagia due to hypofunction of the spleen; Chronic cough of deficiency lung dry pharynx; Emission due to deficiency of the kidney.Rhizoma Dioscoreae tuber containing diosgenin, dopamine, hydrochloric acid Rhizoma Dioscoreae alkali, polyphenol oxidase, allantoin, only wooden fork element II, glycoprotein, by mannose, glucose (glucose) and galactose 6.45: 1: 1.26 Chinese yam polysaccharides formed, again baric, beryllium, cerium, cobalt, chromium, copper, gallium, lanthanum, lithium, manganese, niobium, nickel, phosphorus, strontium, thorium, titanium, vanadium, yttrium, ytterbium, zinc, zirconium and sodium oxide, potassium oxide, aluminium oxide, ferrum oxide, calcium oxide, magnesium oxide etc. in molar ratio.Rhizome is containing dopamine, catecholamine and cholesterol, ergosterol, campesterol, stigmasterol, cupreol etc.

Modern pharmacological research shows that Rhizoma Dioscoreae Aqueous extracts can significantly suppress Cu2+ to the Denaturation of gamma Globulin, shows to have antarthritic effect.Rhizoma Dioscoreae Aqueous extracts also can eliminate urine protein, mutant cell is had to the effect suppressing to produce.Rhizoma Dioscoreae plants trace element because being rich in 18 seed amino acids and more than 10, and other mineral, so have strengthening the spleen and stomach, tonifying the lung kidney, invigorating the spleen and replenishing QI, spleen invigorating tonify deficiency, the effects such as beneficial essence, beneficial heart and tranquilizing mind of reinforcing the kidney, Rhizoma Dioscoreae is rich in multivitamin, aminoacid and mineral, Human Lipid Metabolism can be prevented and treated abnormal, and arteriosclerosis, to safeguarding that insulin normal function also has certain effect, there is enhancing body immunity, benefit heart and tranquilizing mind, rather coughs Dingchuan, the health-care effects such as slow down aging.A large amount of protein, vitamin B group, vitamin C, vitamin E, glucose, crude protein aminoacid, bile alkaline, allantoin etc. are rich in Rhizoma Dioscoreae; Wherein important nutritional labeling Rhizoma Dioscoreae soap is the precursor materials of synthesis estrogen, nourishing YIN and invigorating YANG, strengthens metabolic effect; And the phlegmatic temperament, zymigen etc. of the GL-PP composition contained in fresh tuber, cadiovascular lipidosis can be prevented, contribute to the absorption and digestion of gastrointestinal.

The Radix Astragali is the dry root of leguminous plant Radix Astagali or Radix Astragali, and warm in nature, sweet in the mouth returns lung, spleen channel, there is invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, the function of expelling pus and promoting granulation, it is weak to be mainly used in the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, burst for a long time and do not hold back, blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes etc.

The chemical composition of the Radix Astragali is flavonoid and flavonoid glycoside: as calycosin, 2 ', 4 ' dihydroxy-5,6-dimethoxy isoflavone, 3-hydroxy-9,10-dimethoxy pterocarpane, astragaloside I, V, III; Also contain the folic acid etc. of a large amount of astragalus polysaccharidess and cupreol, linoleic acid, linolenic acid, choline, betanin, aminoacid, sucrose, glucuronic acid and trace.

The function of the Radix Astragali is a lot of, and the such as Radix Astragali can make tubular blood vessel and renal blood vessels expansion, and makes whole body peripheral vasodilation, and skin circulation is freely contained, blood pressure drops; Can heart contraction be strengthened, have cardiotonic to the heart of exhaustion; The Radix Astragali has reduction blood glucose and antibacterial effect; Normal heart can be strengthened shrink, have cardiotonic to the heart of exhaustion; Can make tubular blood vessel and renal blood vessels expansion, and make whole body peripheral vasodilation, skin circulation is freely contained, and makes hyperpietic's blood pressure drops; Can significantly be lowered into fibrocyte collagen synthesis rate, improve connective tissue proliferation and sclerosis of blood vessels, increase blood vessel elasticity, improve amount of blood supply, thus the arteriosclerosis symptom of senile organism is improved.Effective ingredient in the Radix Astragali can improve left room configuration and the Ejection function of congestive heart failure, increase the cardiac function of ischemic myocardium rat, the primary cellular defect of ischemic myocardium can not be increased the weight of, remarkable increase myocardial cell membrane Calcium and magnesium, increase the transhipment of intracellular calcium, thus reduce too much gathering of cytosolic free calcium concentration in cardiomyocyte ion.Find in the research of the myocardial cell to viral infection, Radix Astragali injection can suppress the increase of the L-type Calcium Current of virus infected cell, alleviates virus to I_ NCX, and makes that the reversal potential of I_ NCX is negative to be moved.And Radix Astragali total glycosides can increase the expression of the mRNA of viral infection myocardial cell sarcoplasmic reticulum calcium pump, and the vigor of sarcoplasmic reticulum calcium pump can be improved.Astragalus polysaccharides obviously can resist the not normal mice atrial fibrillation brought out with chloroform of rat heart rate that barium chloride brings out, decreasing heart rate.

The Rhizoma Anemarrhenae is the dry rhizome of liliaceous plant Rhizoma Anemarrhenae Anemarrhena asphodeloides Bunge..Cold in nature, bitter in the mouth, sweet; Return lung, stomach, kidney channel.Have clearing away heat-fire, the effect of moisturizing of promoting the production of body fluid, is mainly used in fever caused by exogenous pathogenic factors, high hot excessive thirst, lung-heat type cough, osteopyrexia and fever, and interior-heat is quenched one's thirst, dryness of the intestine constipation.

It is yellow and thick that the Rhizoma Anemarrhenae is used for the disease of the lung sthenia gastropyrexias such as epidemic febrile disease, high heat are fidgety, thirsty, full and large pulse and dyspnea and cough due to lung-heat, expectorant.Rhizoma Anemarrhenae bitter cold, upper can clearing away lung-heat, middle can clearing stomach fire, therefore be applicable to the disease that lung stomach has excess-heat, the normal and same use of Gypsum Fibrosum of the Rhizoma Anemarrhenae, can strengthen the clearing away heat-fire effect of Gypsum Fibrosum; For fever due to yin deficiency, cough due to consumptive disease and the disease such as to quench one's thirst.Rhizoma Anemarrhenae energy purte the white and nourishing kidney, therefore can not only excess-heat clearly, and can clearind deficient heat.Many and the same use of Cortex Phellodendri clinically, allocate in drugs for nourishing yin, as ZHIBAI DIHUANG WAN, control the disease such as hyperactivity of fire caused by deficiency of YIN, hectic fever hectic fever due to YIN-deficiency, the Rhizoma Anemarrhenae joins nourishing YIN and moistening the lung medicine as product such as Radix Adenophorae (Radix Glehniae), Radix Ophiopogonis, Bulbus Fritillariae Cirrhosae, can be used for deficiency of the lung cough caused by dryness; Join clearing away heat and promoting production of body fluid medicine as product such as Radix Trichosanthis, Radix Ophiopogonis, RADIX PUERARIAE, available controlling is quenched one's thirst.

The chemical composition that the rhizome of the Rhizoma Anemarrhenae mainly contains is saponin, total saponin content is about 6%, mainly contain 6 kinds of Saponins, be respectively zhimusaponin A-I, A-II, A-III, A-IV, B-I and B-II, wherein zhimusaponin A-III is the disaccharidase glycoside that Sa Ersa ruscogenin and timobiose are combined into, and zhimusaponin A-I is Sa Ersa ruscogenin β-D-galactopyranosyl glucoside.Ruscogenin in Asphodeloides Bge Rhizome is Sa Ersa ruscogenin mainly, the content in dry root about 0.5%, also has markogenin, new gitogenin in addition.The Saponin separated from Asphodeloides Bge Rhizome in the past was once called Chinonin, inferred that is that right that examines the mixture of Saponin, zhimusaponin A-III, A-IV, B etc.Rhizome is still containing reducing sugar and phlegmatic temperament, tannic acid, fatty oil, nicotinic acid, niacin amide, the Mengiferin etc. of volume.

The rhizome of the Rhizoma Anemarrhenae is also containing multiple anemaran, anemaran A, B, C, D and cis-Cupressus funebris Syringaresinol, monomethyl-cis-Cupressus funebris Syringaresinol, oxidation-cis-Cupressus funebris Syringaresinol, 2,6,4 '-trihydroxy-4-methoxy benzophenone, p-hydroxyphenyl crotonic acid, hyenic acid ethylene fat, cupreol ， Fructus Mangifera Indicae glycoside etc.

Modern pharmacological research shows that the Rhizoma Anemarrhenae has following pharmacological action: 1. antibacterial action, Rhizoma Anemarrhenae decoct has stronger inhibitory action to staphylococcus, Bacillus typhi on agar plate, also inhibitory action is had to dysentery bacterium, Salmonella paratyphi, escherichia coli, bacillus subtilis, vibrio cholera, in husky Bai Shi culture medium, to some common pathogenic dermatophytosis also some bacteriostasis; 2. refrigeration function, Rhizoma Anemarrhenae extractum 2 milliliters/kilogram (1 milliliter suitable crude drug 2 grams), with escherichia coli (0.03%) 2.3 milliliter, be injected in rabbit subcutaneous simultaneously, or first Escherichia Coli Injection, reinjected extractum after 15 minutes, and body temperature does not all raise, and therefore has refrigeration function; 3. antitumor action, zhimusaponin transplants nude rat to people's hepatocarcinoma Tumor suppression growth, makes life span extension; Separately treatment Skin Squamous Cell Carcinoma, cervical cancer etc. there are is good therapeutic effect and had no side effect.4. anticoagulant effect; 5. choleretic effect.

Endothelium Corneum Gigeriae Galli, also known as ENDOTHELIUM CORNEUM GIGERIAE GALLI, is the dry inner wall of sandbag of Phasianidae animal man chicken Gallus gallus domesticus Brisson.Property is put down, sweet in the mouth; Return spleen, stomach, small intestinal, urinary bladder channel.There is invigorating the stomach and promoting digestion, the function of arresting seminal emission, be mainly used in food stagnation and do not disappear, vomiting dysentery, infantile malnutrition, the enuresis, seminal emission.

Endothelium Corneum Gigeriae Galli contains gastric hormone, keratin, micro-pepsin, amylase, multivitamin, and the keratin sample of histochemical method's display gizzard is sumptuous containing a kind of glycoprotein, its cysteine containing rate lower than general epithelium keratin.The chicken gizzard tunica intima of being born 4 ~ 8 weeks, containing bluish-green pigment and flavochrome, is respectively the yellow derivant of bilitrien and biliverdin; Gizzard is containing vitamin (total amount 100 grams): vitamin B1-100 microgram, B2-200 microgram, nicotinic acid 7.0 milligrams, 5 milligrams, ascorbic acid.Ascorbic acid content again, every gram of gizzard containing 0.11 milligram of reduced form, total ascorbic acid 0.12 milligram; In total ascorbic acid, reduced form accounts for 92%, and oxidized form accounts for 8%.

Pharmacological research shows that Endothelium Corneum Gigeriae Galli significantly can strengthen gastric motility, and show as stomach motion and extend and peristalsis enhancing, gastric emptying rate is accelerated; Make the secretory volume of gastric juice increase stomach function regulating motion to strengthen.Healthy People oral Grilled chicken Endothelium corneum powder 5g, through 45-60 minute, gastric secretion increases 30-37% than control value, recovers normal in 2 hours.Gastric acidity is also obviously increased.Free acid or total acidity generally start to rise after taking medicine 1 hour, reach peak, decline gradually later in 1-2 hour, recover normal after 3 hours.Endothelium Corneum Gigeriae Galli water decoction, acid extraction thing are got rid of radiostrontium to acceleration and are had certain effect, and research thinks that the ammonium chloride in Endothelium Corneum Gigeriae Galli is one of effective ingredient promoting that strontium is discharged.Endothelium Corneum Gigeriae Galli also has food digesting action in addition, and entering blood after the digestion of medicine Endothelium Corneum Gigeriae Galli stimulates gastric gland secretion increase and play indirect digestion-aid effect; Endothelium Corneum Gigeriae Galli also has the effect of inhibition tumor cell in addition.

Radix Puerariae another name Pueraria lobata, Pachyrhizua angulatus, Radix puerariae, Pueraria montana (Lour.) Merr. rattan; For the dry root of legume pueraria lobata Pueraria lobata (Willd.) Ohwi or Radix Puerariae rattan Pueraria thomsonii Benth..Cool in nature, sweet in the mouth, pungent; Return spleen, stomach warp.There is expelling pathogenic factors from muscles for reducing heat, promote the production of body fluid, rash, the effect of yang invigorating antidiarrheal, be mainly used in fever caused by exogenous pathogens headache, stiff nape and back, thirsty, quench one's thirst, measles without adequate eruption, hematodiarrhoea, has loose bowels; Hypertension neck pain.

Radix Puerariae is containing daidzein, daidzin, puerarin, 4 '-methoxy puerarin, daidzein-4 ', 7-diglucoside, daidzein-7-(6-O-malonyl)-glycoside, genistein, formoononetin, daidzein-8-C-celery glycosyl (1 → 6)-glycoside, genistein-8-C-celery glycosyl (1 → 6)-glycoside, puerarin xyloside, 3'-hydroxypuerarin, 3 '-methoxy puerarin, 4 '-O-glucosyl group puerarin, Radix Puerariae phenol, Radix Puerariae glycoside A, B, formoononetin-7-glycoside, lupenone, cupreol, behenic acid, lignoceric acid, 1-lignocerane acid glyceride, allantoin, cupreol-β-D-Glucose glycoside, 6, 7-dimethoxy coumarin, 5-methyl hydantoin and with sophoradiol, cantoniensis triol, soyasapogenol A, B, Radix Puerariae soap alcohol C, A and Radix Puerariae soap alcohol B methyl ester are the triterpenoid saponin of glycoside unit.Pueraria lobata is also containing daidzein, daidzin, puerarin and cupreol.Radix Puerariae rattan root is containing daidzin, puerarin, 4 '-methoxy puerarin, daidzein and trace daidzein-4,7 '-diglucoside.

The pharmacological action of Radix Puerariae is as follows: 1. to the effect of blood circulation, and the flavone proposed in Radix Puerariae can increase brain and crown vascular flow amount.After anesthesia Canis familiaris L. Internal carotid artery injection Radix Puerariae flavone, cerebral blood flow increases, the corresponding reduction of vascular resistance; Intravenous injection can improve the cerebral circulation of hypertensive arteriosclerosis patient, and its action temperature and.Radix Puerariae flavone and kudzuvine root wine extractum are injected in coronary artery and the vein of Canis familiaris L., and coronary vasodilator blood flow all can be made to increase, and vascular resistance reduces.2. spasmolysis; 3. hypoglycemic activity, the oral Pueraria lobata of rabbit, starts 2 hours blood glucoses and rises, decline immediately, within the 3rd, 4 hour, declines minimum, to Rabbit Kidney upper parathyrine hyperglycemia not only without antagonism, makes it on the contrary to increase, but can promote that blood glucose recovers normal ahead of time.Radix Puerariae water extract declines after Rabbits ' Blood Sugar also can be made just to increase, and more remarkable to the effect of hungry osmium rabbit blood glucose increasing, ether extract then has no significant effect carbohydrate metabolism; 4. antipyretic and estrogen-like effects.

Fructus Schisandrae Chinensis is the dry mature fruit of magnoliaceae schisandra Schisandra chinensis (Turcz.) Baill. or schisandra chinensis Schisandra sphenanthera Rehd.et Wils..Warm in nature, sour in the mouth, sweet; Return lung, the heart, kidney channel, have convergence astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, the effect of kidney calming, energy Qi-benefiting and heart-nourishing, is used for the treatment of chronic cough dyspnea due to deficiency, emission, enuresis frequent micturition, incessant chronic diarrhea, spontaneous perspiration, night sweat, and Tianjin wound is thirsty, deficient pulse of losing heart, the diseases such as interior-heat is quenched one's thirst, palpitation and insomnia.

Fructus Schisandrae Chinensis contains schizandrin, deoxidation schizandrin, the new element of son simply, schisandrol, Schisantherin A, B, C, D, E, F, G, H, J, K1, K2, K3, L1, L2, M1, M2, N2, O, R etc.Fruit is containing multiple lignanoid: gomisin A, gomisin B and schisandra chinensis ester B, gomisin C and schisandra chinensis ester A, Gomisin F., G, schizandrin and wuweizi alcohol A, Gomisin D., Gomisin H., Radix Angelicae Sinensis acyl Gomisin H., crotonocyl Gomisin H., benzoic acid Gomisin H., GJ, front Ge meter Xin etc.; Also containing volatile oil, its composition has α-thujene, α-and nopinene, lauro lene, α-phellandrene, β-terpinene, 4-terpinenol, α-terpinenol, α-(king is ancient) (king's bar) alkene, beta-elemene, acoradiene, α-and β-cedrene, nerolidol, furfural, methyln nonyl ketone and p-isopropyl acid etc.

Modern pharmacological research shows that fruit of Fructus Schisandrae Chinensis volatile oil causes mouse sleep time all obviously to shorten (P < 0.001) to pentobarbital sodium.It shortens pentobarbital sodium and causes the mechanism of the length of one's sleep, may be to caused by liver drug enzyme inducing action.Schisantherin B and schizandrin have sedation to mice; Fructus Schisandrae Chinensis can make mice autonomic activities obviously reduce, and increased dosage amount obviously can strengthen maincenter tranquilizer chlorpromazine and reserpine to from a movable inhibitory action, and resists the excitation of central stimulants amfetamine to autonomic activities.Have protective effect to liver, can promote the generation of hepatic glycogen significantly, schisandrin B can mix hepatic protein speed and show and increase, and shows to increase protein synthesis.The lignans that Fructus Schisandrae Chinensis contains has mitigation for the contraction caused by PGF2a, inhibited for the contraction caused by CaCl2.Fructus Schisandrae Chinensis has to be strengthened and regulates myocardial cell and heart, the arteriolar energy metabolism of kidney, improves the effects such as the nutrition of cardiac muscle and function.Research also finds that Fructus Schisandrae Chinensis has adjustment cardiovascular system, improves sanguimotor function.

Radix Trichosanthis is the dry root of cucurbitaceous plant Fructus Trichosanthis Trichosanthes kirilowii Maxim. or trichosanthes rosthornii Harms Trichosan-thes rosthornii Herms.Cold nature, sweet in the mouth, micro-hardship; Attach to the lung and stomach meridians.There is clearing away heat and promoting production of body fluid, the function of detumescence and apocenosis; Be mainly used in calentura excessive thirst, lung-heat type cough, interior-heat is quenched one's thirst, sore swollen toxin.Clinically for lung-heat type cough, can with the compatibility such as Radix Adenophorae (Radix Glehniae), Radix Ophiopogonis; For consumption of body fluid caused by febrile disease and the disease such as to quench one's thirst, can with the compatibility such as Radix Ophiopogonis, the Rhizoma Anemarrhenae.

The chemical composition of Radix Trichosanthis is mainly trichosanthin and several amino acids: alpha-hydroxymethyl serine, aspartic acid, citrulline, serine, glutamic acid, threonine, glycine, valine, tyrosine, phenylalanine, histidine, lysine, arginine, ornithine and peptide class, ribose, xylose, arabinose, glucose, galactose etc.; Also containing radices trichosanthis Polysaccharide A, B, C, D, E; Rhizome is containing having anticancer and immunocompetent polysaccharide, and by glucose, galactose, fructose, mannose, xylose and epsilon protein form.Fresh also contains 7-stigmastene-3 β-ol glucopyanoside, bryonia alcohol acid, Cueurbitacin B and D, 23,24-dihydro Cueurbitacins etc.

Radix Trichosanthis causes miscarriage and antiearly pregnancy effect, to early pregnancy rabbit when gestation the 11st day, and intramuscular injection radix trichosanthis pro injectione (Shanghai biochemical-pharmaceutical factory product is the sterile cryo drying agent of the crude extract of trichosanthin, per ampoule contain 2mg), 2mg/kg; Experimental result shows, the uterus of early pregnancy rabbit is in quiescent condition completely, lacks reaction to the stimulation of material of hastening parturition.Radix Trichosanthis, when doses, can make blastocyst necrosis, liquefaction, cause eventually and absorb completely.Radix Trichosanthis is to the activation of rabbit uterus flesh, and suppress prevented though can be added exogenous progestogen or apply prostaglandin synthesis, the antiearly pregnancy effect of Radix Trichosanthis is not resisted.The effect of this result prompting Radix Trichosanthis termination of pregnancy, is not secondary to the suppression of hormone secretion, or the synthesis of prostaglandin and release, thus supports that Radix Trichosanthis directly acts on the result of placental trophoblasts termination of pregnancy.Radix Trichosanthis also has antitumaous effect; Only, after 24 hours, subcutaneous injection Radix Trichosanthis 0.2ml/ only (5mg/kg), and interval 4-6 day presses former injected sc Radix Trichosanthis 1 time again for 18-22g healthy mice subcutaneous injection tumor cell suspension (former times or 1: 1) 0.2ml/.Result shows Treated With Trichosanthin ascitic type liver cancer, ascites volume can be made to reduce, life span extension.Radix Trichosanthis also has the inhibitory action of tumor cell, and the propagation of trichosanthin to Jar people's choriocarcinoma cell has obvious inhibitory action, the inhibitory action stronger to the hCG secretion display of Jar cell; Radix Trichosanthis warm macerating lyophilized preparation and the suppression ratio of water logging agent to uterus carcinoma U-14 high.Effect that Radix Trichosanthis has Promote immunity function to improve, effect of antibacterial and antivirus action and AIDS virus resisting, suppress HIV (human immunodeficiency virus) (HIV) copying in the immunocyte infected, reduce the viable count be infected by the virus in immunocyte, its effective inhibition concentration is 0.05-10ug/ml.

Prevention of the present invention or/and treatment diabetes Chinese medicine composition in Rhizoma Dioscoreae, Radix Astragali spleen reinforcing reinforce the kidney, supplementing QI for promoting the production of body fluid, makes temper liter first, and loose essence reaches lung, and transporation of body fluid is to quench the thirst, and second make kidney qi solid, envelope store essential substances is micro-with reducing urination, is monarch drug; The Rhizoma Anemarrhenae, Radix Trichosanthis nourishing YIN and clearing away heat, nutrient solution of promoting the production of body fluid, moisturizes and quenches the thirst, and is ministerial drug; The monarch and his subjects match, supplementing QI and nourishing YIN, cloth Tianjin of promoting the production of body fluid (gas is prosperous to promote the production of body fluid); Moisturize and quench the thirst, tonifying the kidney to reduce urination.Radix Puerariae has clearing away heat and promoting production of body fluid and quenches the thirst.Radix Puerariae and the Radix Astragali match, and rise that to send out taste positive clearly, and transporation of body fluid and quenching the thirst is adjuvant drug; Endothelium Corneum Gigeriae Galli helps spleen health movement, and transporting and transforming nutrients from foodstuff is precise and tiny, and holding concurrently can reducing urination." dissipating fluid-retention food in saccharic be body fluid also " " Records of Tradition Chinese and Western Medicine in Combination "; Fructus Schisandrae Chinensis reinforces the kidney and promotes the production of body fluid, and does not make body fluid dirty.Match with Rhizoma Dioscoreae, the power that tonifying the kidney to consolidate the essence promotes the production of body fluid strengthens, for making medicine.

This Chinese medicine composition has hypoglycemic activity, and Fructus psidii guajavae immaturus and the party's compatibility strengthen the effect of blood sugar lowering.And to after cancer radiation, diabetes, hyperthyroidism, coronary heart disease, hypertension, obesity, Infantile Summer Fever, diabetes insipidus etc. belong to QIYINLIANGXU, the hot person of middle restless with anxiety has prevention, therapeutical effect.

The present invention improves a kind of prevention on the other hand or/and treat the preparation method of the combination of diabetes, comprises the step that following order is carried out:

1) crude drug is prepared according to following weight:

Fructus psidii guajavae immaturus 5-50, Rhizoma Dioscoreae 5-35, Radix Astragali 5-40, Rhizoma Anemarrhenae 2-20, Endothelium Corneum Gigeriae Galli 7-40, Radix Puerariae 6-35, Fructus Schisandrae Chinensis 2-20, Radix Trichosanthis 3-25

2) by after raw material mix homogeneously, heating extraction is carried out to mixture, collect extracting solution;

3) concentration is carried out to extracting solution, obtained active component.

Wherein, step 1) described in the weight of raw material be: Fructus psidii guajavae immaturus 10-50, Rhizoma Dioscoreae 10-30, Radix Astragali 10-30, Rhizoma Anemarrhenae 6-15, Endothelium Corneum Gigeriae Galli 10-30, Radix Puerariae 10-30, Fructus Schisandrae Chinensis 6-15, Radix Trichosanthis 6-20; Be preferably: Fructus psidii guajavae immaturus 20, Rhizoma Dioscoreae 20, the Radix Astragali 20, the Rhizoma Anemarrhenae 10, Endothelium Corneum Gigeriae Galli 15, Radix Puerariae 15, Fructus Schisandrae Chinensis 10, Radix Trichosanthis 12.

Wherein, step 2) described in heating extraction carry out in accordance with the following steps:

A) mixed material is added water soaking, the weight of the water added is 6-12: 1 with the ratio of the weight of mixed material, soaks to carry out first time after 20-90min and decoct process, and decoction temperature is 80-100 DEG C, and decocting time is 2-5 hour;

B) first time extracting solution is filtered, collect filtrate;

C) in filtering residue, at least add water 1 time, proceed at least 1 time and decoct process, wherein, the weight of the water at every turn added is 1-5: 1 with the ratio of the weight of mixed material raw material, and decoction temperature is 80-100 DEG C, and decocting time is 1-3 hour;

D) filter, filtrate is merged, the extracting solution described in acquisition.

Particularly, steps A) described in soak time be preferably 30-60min, the weight of the water added is preferably 6-9: 1 with the ratio of the weight of mixed material; Step C) in the weight of water that adds be 1-3: 1 with the ratio of the weight of mixed material.

Wherein, step 3) described in active component be concentrated extract.

Particularly, described concentrated extract relative density be 1.05-1.5.

Wherein, step 3) described in concentration extracting solution is carried out under vacuum conditions reduction vaporization and concentrates, thickening temperature is 80-100 DEG C, be preferably 80 DEG C, relative pressure time concentrated is-0.05 ~-0.1MPa, is preferably-0.05 ~-0.09MPa, more preferably-0.07MPa.

Of the present inventionly to be used for the treatment of or/and the Chinese medicine composition that prevents diabetes can make clinical acceptable peroral dosage form with acceptable adjuvant on pharmaceutics by tradition or modern production process.As capsule, tablet, granule, pill, oral liquid etc.Excipient substance used can be selected from " handbook of pharmaceutical excipients " (Handbook ofPharmaceutical excipients, is edited by A.Wade and P.J.Weller by the 2nd edition; AmericanPharmaceutical Association publishes, Washington and The Pharmaceutical Press, London, 1994) acceptable carrier, such as starch, dextrin, lactose, microcrystalline cellulose, gelatin, sucrose, the magnesium stearate etc. on reference book Chinese materia medica such as.Need long-term prescription clinically, it is convenient to make solid preparation storage, and patient takes facility, also more meeting the market requirement.Preferred dosage form is capsule, granule, tablet, pill, powder, oral liquid etc.

Further aspect of the present invention provides a kind of above-mentioned arbitrary described compositions in preparation treatment or/and the application prevented diabetes in medicine and/or health product.

The present invention prepare for preventing or/and treat diabetes Chinese medicine composition use time, oral 1-2 time of every day, each 3-6 gram (crude drug), anemia of pregnant woman forbids taking, forbid edible maror during medication and drink, continuous use is after 1 month, and fasting glucose, after the meal 2 hours blood glucoses, glycohemoglobin are selected to reduce; Diabetic symptom obviously improves; In order, after drug withdrawal, blood glucose is steady for blood sugar recovery.

Of the present invention for preventing or/and the Chinese medicine composition tool for the treatment of diabetes has the following advantages:

1, Chinese medicine composition of the present invention is for thirsty frequent micturition, sleepyly to breathe hard, the pathogenic factor symptomatic treatment of the diabetes that deficient and thready pulse is unable, Chinese medicine composition of the present invention is composited by plurality of Chinese composition, the active component of medicine wherein, mutual synergism, the direct pin cause of disease, the Crack cause for diabetes takes too many levels Comprehensive Treatment, cures from the source of onset diabetes, therapeutic effect is fast, and effect rapidly.

2, the present invention's prevention is or/and treatment diabetic composition prescription compatibility science, determined curative effect, and safety is high, quality controllable; Remarkable to the clinical efficacy of the diabetes of YIN fluid deficiency, production of dryness-heat in the interior, blood sugar reducing function is remarkable, reduces the generation of diabetics clinical complication.

3, the prevention prepared of the present invention is or/and the Chinese medicine composition for the treatment of diabetes has no side effect, and preparation technology is simple, constant product quality successful, and easy to use, has filled up the deficiency in the Chinese patent medicine market on existing market.

4, the present invention is simple for the preparation method of the Chinese medicine composition preventing or treat diabetes, and process conditions are gentle, with low cost, expense is low, reduces the treatment cost of diabetes, saves clinical hygiene medical treatment cost, suitable marketing application, makes more patients therefrom benefit.

Detailed description of the invention

Further describe the beneficial effect of medicine of the present invention below by detailed description of the invention, these test examples include the pharmacodynamics test of medicine hypoglycemic granule of the present invention (embodiment 1).These embodiments are only exemplary, do not form any restriction to scope of the present invention.It will be understood by those skilled in the art that and do not departing under formula thinking of the present invention, purposes scope and can modify to the details of technical solution of the present invention and form or replace, but these amendments and replacement all fall within the scope of protection of the present invention.

Test example 1

1, test material

1-1, medicine and reagent

Prepared by 1-1-1, compound for reducing blood suger trial drug of the present invention

To test through super-dry, pulverizing the obtained compound for reducing blood suger dry extract dry powder that sieves in embodiment 1.

1-1-2, positive control medicine

JIANGTANGSHU JIAONANG (Tian Tai Pharmaceutical limited company of Jilin Province; Specification: 0.3g*60 grain).

1-2, reagent

Streptozotocin (STZ): Sigma Co., USA.

Before experiment, streptozotocin is dissolved in (pH=4.2-4.3) in 0.05M citric acid ice bath buffer salt solution and is configured to 13mg/ml solution, for subsequent use.

1-3, experimental animal

Healthy Kunming mouse (male and female half and half, body weight 16-18g), the laboratory animal quality certification number: 0097976.Credit number: scxK (Guangdong) 2008-0002, is provided by Guangdong Medical Lab Animal Center.

2, test method

Get healthy mice 80, before experiment, fasting 18 hours, freely drinks water, and streptozotocin (STZ) the solution 0.2ml of preparation before lumbar injection experiment, dosage is 130mg/kg.Hematometry mouse blood sugar value is got after lumbar injection STZ solution 72h, select blood glucose value >=13.8mmol/L mice as diabetic mice, choose wherein 60 random point 3 groups, often organize 20, be respectively model control group, positive drug control group, compound for reducing blood suger group of the present invention.

Separately get healthy mice 20, as blank group.Blank group mouse peritoneal injection same volume normal saline.

To blank group, model control group, matched group, compound for reducing blood suger group mouse stomach of the present invention administration: wherein blank group and model control group give normal saline 2.0ml/100g, positive controls gives JIANGTANGSHU JIAONANG 10mg/100g, and give the dosage of the dosage 10mg/100g of of the present invention group of pharmaceutical composition, once a day, continuous 3 weeks, and fasting 3 hours before last administration, within after administration 2 hours, get blood and survey blood glucose value, carry out statistical procedures, experimental result is in table 1.

3, result of the test

Statistical procedures: experimental result with represent, adopt t inspection, measure the significance of group difference.

Table 1 is on the impact of STZ model mice blood glucose

Result of the test shows: model group is compared with blank group, and the blood glucose value of the two has significant diversity and reaches, and shows this test modeling success; Compare with model control group, JIANGTANGSHU JIAONANG, compound for reducing blood suger group of the present invention are all to diabetic mice hypoglycemic activity effect highly significant (P < 0.01) caused by streptozotocin; The reduction blood glucose action effect of compound for reducing blood suger of the present invention and JIANGTANGSHU JIAONANG is remarkable, shows that compound for reducing blood suger of the present invention has obvious inhibitory action to being caused the blood glucose rising caused by Mice Islet Cells β damage by STZ, can play hypoglycemic activity.

Test example 2

1, test material

1-1, medicine and reagent

Prepared by 1-1-1, compound for reducing blood suger trial drug of the present invention

To test through super-dry, pulverizing the obtained compound for reducing blood suger dry extract dry powder that sieves in embodiment 1.

1-1-2, positive control medicine

JIANGTANGSHU JIAONANG (Tian Tai Pharmaceutical limited company of Jilin Province; Specification: 0.3g*60 grain).

1-2, reagent

Alloxan: Sigma Co., USA.

Alloxan is dissolved in normal saline, is mixed with 60mg/ml solution for standby.

1-3, experimental animal

Healthy Kunming mouse (male and female half and half, body weight 16-18g), the laboratory animal quality certification number: 0097976.Credit number: scxK (Guangdong) 2008-0002, is provided by Guangdong Medical Lab Animal Center.

2, test method

Get healthy mice 80, fasting 18 hours before experiment, freely drinks water, the alloxan solution that lumbar injection is prepared, and dosage is 130mg/kg, every day lumbar injection once, inject 2d continuously.Mouse blood sugar value is measured after last lumbar injection alloxan solution 72h, select blood glucose value >=13.8mmol/L mice as diabetic mice, random selecting wherein 60, random point 3 groups, often organize 20, be respectively model control group, positive drug control group, compound for reducing blood suger group of the present invention.

Separately get healthy mice 20, as blank group.Blank group mouse peritoneal injection same volume normal saline, every day lumbar injection once, inject 2d continuously.

To blank group, model control group, positive drug control group, compound for reducing blood suger group mouse stomach of the present invention administration: wherein blank group and model control group give normal saline 10mg/100g, positive controls gives JIANGTANGSHU JIAONANG 10mg/100g, the dosage of the dosage 10mg/100g of of the present invention group of pharmaceutical composition, once a day, continuous 3 weeks, and fasting 3 hours before last administration, after administration 2 test result with represent, adopt t inspection, measure the significance of group difference.

Table 2 is on the impact of alloxan model mice blood glucose

Result of the test shows: model group is compared with blank group, and the blood glucose value of the two has significant diversity and reaches, and shows this test modeling success; Compare with model control group, compound for reducing blood suger group of the present invention is to diabetic mice hypoglycemic activity effect highly significant (P < 0.001) caused by alloxan, the reduction blood glucose action effect of compound for reducing blood suger of the present invention and JIANGTANGSHU JIAONANG is remarkable, show that compound for reducing blood suger of the present invention has obvious inhibitory action to being caused the blood glucose rising caused by Mice Islet Cells β damage by alloxan, play significant hypoglycemic activity.

Test example 3 the present invention reduces blood glucose compositions toxicological test

(1) acute toxicity test

By of the present invention have reduce blood glucose efficacy pill 1000g (crude drug)/kg gavaged to kunming mice.There is not any toxic reaction, without animal dead in one week.

(2) long term toxicity test

By of the present invention have reduce blood glucose efficacy pill long term toxicity test carried out to rat, continuous heavy dose (100 times of adult human dose) gastric infusion, administration time long (90 days), with the general performance before and after animals administer, body weight, food ration, hematology and Biochemical Indices In Serum, routine urinalysis, bone marrow classification, organ weights, organ coefficient for Testing index, and be aided with the pathological examination that animal respectively organizes internal organs, the toxicity profile of overall merit medicine.The indices of result display rat is all normal.Histopathologic examination's result display, rat respectively organizes internal organs no abnormality seen.

In sum: of the present invention have that to reduce blood glucose efficacy toxicity low, and safety range is wide, the present invention has that to reduce blood glucose efficacy edible safety reliable.

Test example 4 treats the clinical observation on the therapeutic effect of diabetes

1, object of study

Choose in May, 2013 to 2014 year December Beijing University of Traditional Chinese Medicine Subsidiary Dongfang Hospital tested case 250 example, adopt parallel control, random method for designing, be divided into 3 groups at random, wherein test male 52 example in 1 group, women 48 example, year mean age (54.1 ± 1.5), the course of disease 12 ~ 32 months; To test in 2 groups male 58 example, women 42 example, the mean age (52.4 ± 1.8) year, the course of disease 12 ~ 33 months; To test in 3 groups male 27 example, women 23 example, the mean age (53.7 ± 1.2) year, the course of disease 14 ~ 35 months.

Each group of case there are no significant in sex, the course of disease, age distribution etc. difference, has comparability.

2, case selection

Draft according to Ministry of Public Health " new Chinese medicine guideline of clinical investigations " diagnostic criteria in 1993.

1. traditional Chinese medical science diabetes diagnostic criteria: all to have thirsty polydipsia, rapid digestion of food easily hungry, frequent micturition and sweet, body are gradually shown in that the disease such as to become thin can be made a definite diagnosis; 2. Western medicine diagnose standard: have diabetic symptom, any time blood glucose >=11.1mmol/L or fasting glucose >=7.8m mol/L.

3, Therapeutic Method

All cases, at treatments period, all require diet control, and participate in suitable physical training.Compound for reducing blood suger prepared by all oral embodiment of the present invention 1,2 for the treatment of group, every day 3 times, each 5g, ante cibum takes on an empty stomach half an hour, takes 1-6 month continuously.Matched group takes JIANGTANGSHU JIAONANG, every day 3 times, oral 5 at every turn, and ante cibum takes on an empty stomach half an hour, takes 1-6 month continuously.Treatment group, matched group withdraw other class hypoglycemic medicine at experimental session all simultaneously.

Patient is regular weekly to be followed up a case by regular visits at special outpatient clinic, carries out clinical observation.Detect fasting glucose, 2h-plasma glucose respectively, glycolated hemoglobin and blood fat (TC, TG) before and after treatment, after treatment terminates, check 1 time.

4, criterion of therapeutical effect

Efficacy assessment standard: 1. effective: after treatment, symptom disappears substantially, fasting glucose < 7.0mmol/L, 2 hours blood glucose < 8.3mmol/L after the meal, glycolated hemoglobin and the full recovery of blood fat (TC, TG) laboratory indexes normal; 2. effective: after treatment, symptom is obviously improved, fasting glucose < 8.0mmol/L, after the meal 2 hours blood glucose < 10mmol/L, glycolated hemoglobin and blood fat (TC, TG) laboratory indexes makes moderate progress before comparatively treating, but does not recover normal; 3. invalid: after treatment, symptom is not improved, blood glucose, glycolated hemoglobin and blood fat (TC, TG) decline and do not reach above-mentioned standard.

5, experimental result and analysis

Before the treatment of table 3 each experimental group, treatment after 1 month blood glucose, glycohemoglobin compare

Note: self compare with before and after treatment, * P < 0.05, * * P < 0.01, * * * P < 0.001.

Experimental result shows:

The JIANGTANGSHU JIAONANG of the Chinese medicine composition and matched group of 1, taking the treatment diabetes of the embodiment of the present invention 1,2 is continuously after 1 month, patient's fasting glucose (FPG), after the meal 2 hours blood glucoses (2h PG), glycolated hemoglobin value, compare with before medication, have and significantly reduce and have statistical significance, show that the JIANGTANGSHU JIAONANG of compound for reducing blood suger of the present invention and matched group has therapeutical effect in various degree to diabetes;

2, the present invention prepare compound for reducing blood suger patient fasting glucose (FPG), after the meal 2 hours blood glucoses (2h PG), glycolated hemoglobin value, compared with the JIANGTANGSHU JIAONANG for the treatment of of control group diabetes, Be very effective, there is statistical significance, show that compound for reducing blood suger of the present invention has good therapeutic effect to diabetics;

3, take the patient of in compound for reducing blood suger patient of the present invention 50% after taking medicine 1 week, its fasting glucose, after the meal 2 hours blood glucose levels are similar to the effect that stomodaeum takes chemical classes antidiabetic drug; After taking medicine 2 weeks, the patients of 75% is that fasting glucose, after the meal 2 hours blood glucose horizontal stables decline, and close to normal level, and health takes a favorable turn; Glucostasis after impaired glucose tolerance patient takes medicine 3 months, recovers normal level substantially.

The each experimental group of table 4 treats comparitive study after 6 months

	Treat 1 group	Treat 2 groups	Matched group
				Experimenter's quantity (example)	100	100	50
Effective (example)	82	80	18
				Effectively (example)	10	10	15
Invalid (example)	8	10	17
				Aggregate efficiency (%)	92.0	90.0	66.0

Experimental result from table 4: 1) after 6 months clinical treatments, the xerostomia of most of diabetics, thirsty, polyphagia, easily tired, gluttony, crapulence, frequent micturition, weak, the clinical symptoms such as visual deterioration improve significantly, the present invention treats 1 group, treat 2 groups, the total effective rate of the treatment diabetes of matched group is respectively 92.0%, 90.0%, 66.0%, matched group (JIANGTANGSHU JIAONANG) is 66.0%, above clinical efficacy result illustrates: Chinese medicine composition prepared by technical solution of the present invention is in treatment diabetes, there is curing protrusion effect, curative effect is all better than matched group, 2) according to the test statistics of 6 months, take the compound for reducing blood suger of the present invention diabetes patient in mid-term of 6 months continuously, blood sugar recovery is completely normal and account for 89% without person repeatedly after drug withdrawal, after drug withdrawal, slight person repeatedly accounts for 7%, after drug withdrawal, the still unstable person of blood glucose accounts for 4%, but the performance of the clinical symptoms of non-diabetic, continue to take compound for reducing blood suger of the present invention and still substantially recover normal.

Above clinical efficacy result shows: Chinese medicine composition prepared by technical solution of the present invention is in treatment diabetes, and especially have obvious therapeutic effect to diabetes, each embodiment group medicine all has curing protrusion effect.Result shows, Chinese medicine composition of the present invention has the advantages such as preparation technology is scientific and reasonable, drug effect is clear and definite, stable curative effect is reliable, no matter its beneficial effect is from the treatment process of medicine, or on the forming technique of finished product preparation, all effectively ensure that the excellent results of Chinese medicine composition of the present invention, this proves further, Chinese medicine composition of the present invention is a kind of determined curative effect, prevent and treat diabetes medicament safely and effectively, there is huge market potential, be worth further genralrlization.

Further illustrate the preparation method of the present composition by the following examples.

Embodiment 1 hypoglycemic granule preparation of the present invention

1) raw material (unit: × 10g) is taken according to following proportioning

Fructus psidii guajavae immaturus 20, Rhizoma Dioscoreae 20, the Radix Astragali 20, the Rhizoma Anemarrhenae 10, Endothelium Corneum Gigeriae Galli 15, Radix Puerariae 15, Fructus Schisandrae Chinensis 10, Radix Trichosanthis 12

2) by medical material Fructus psidii guajavae immaturus, after Rhizoma Dioscoreae, the Radix Astragali, the Rhizoma Anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis rinsing, be placed in Multifunctional Chinese medicine and extract still and mix homogeneously, add tap water and soak 30min, wherein, the ratio of the weight of the tap water added and the weight (dry weight) of medicinal material mixture is 9: 1;

3) open multi-functional extraction still power supply to heat, be heated to 100 DEG C, keep at this temperature constant temperature extract 3h, then filter, obtain first time extracting solution for subsequent use;

Heating-up temperature is not limited to 100 DEG C, and other temperature are all applicable to the present invention.

4) in filtering residue, add tap water, the ratio of the weight of the tap water added and the weight (dry weight) of medicinal material mixture is 5: 1, heating extraction, keeps heating-up temperature to be extract 3h at 100 DEG C, filters and obtains second time extracting solution;

5) 2 extracting solution are merged be placed on and carry out reduction vaporization in vacuum high energy evaporation concentrator and concentrate, obtained concentrated extract, wherein, the relative pressure of concentrating under reduced pressure be-0.07MPa (namely with an atmospheric pressure for 0, pressure when controlling concentrating under reduced pressure is-0.07MPa relative to an atmospheric pressure), thickening temperature is 80 DEG C, and 2 extracting solution are condensed into the extractum that relative density is 1.2;

6) concentrated extract carries out dry, pulverize rear mistake 180 mesh sieve at 45-50 DEG C, obtains dry extract powder;

7) mixed with adjuvant dextrin by dry extract powder, adhesive made by ethanol, granulates, dry, and namely obtained the present invention is used for the treatment of the Chinese medicine composition (hypoglycemic granule) of diabetes.

Embodiment 2 Jiangtang capsule preparation of the present invention

1) raw material (unit: × 10g) is taken according to following proportioning

Fructus psidii guajavae immaturus 10, Rhizoma Dioscoreae 30, the Radix Astragali 10, the Rhizoma Anemarrhenae 6, Endothelium Corneum Gigeriae Galli 30 Radix Puerariae 30, Fructus Schisandrae Chinensis 15, Radix Trichosanthis 6

2) by medical material Fructus psidii guajavae immaturus, after Rhizoma Dioscoreae, the Radix Astragali, the Rhizoma Anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis rinsing, be placed in Multifunctional Chinese medicine and extract still and mix homogeneously, add tap water and soak 90min, wherein, the ratio of the weight of the tap water added and the weight (dry weight) of medicinal material mixture is 6: 1;

3) open multi-functional extraction still power supply to heat, be heated to 80 DEG C, keep constant temperature at this temperature to extract 4 hours, then filter, obtain first time extracting solution for subsequent use;

4) in filtering residue, tap water is added, heating extraction 1 time, the ratio of the weight of the tap water added in heating extraction process and the weight (dry weight) of medicinal material mixture is 5: 1, heating extraction, keep heating-up temperature to be extract 3h at 80 DEG C, filter and obtain 1 extracting solution;

5) 2 extracting solution are merged be placed on and carry out reduction vaporization in vacuum high energy evaporation concentrator and concentrate, obtained concentrated extract, wherein, the relative pressure of concentrating under reduced pressure be-0.07MPa (namely with an atmospheric pressure for 0, pressure when controlling concentrating under reduced pressure is-0.07MPa relative to an atmospheric pressure), thickening temperature is 80 DEG C, and 3 extracting solution are condensed into the extractum that relative density is 1.1;

6) mixed concentrated liquid is carried out lyophilization, and pulverize, the obtained Chinese medicine composition dry powder for reducing blood glucose;

7), after dry extract powder being mixed with adjuvant microcrystalline cellulose, load snap fit capsule, make Jiangtang capsule agent.

Embodiment 3 metformin preparation of the present invention

1) raw material (unit: × 10g) is taken according to following proportioning

Fructus psidii guajavae immaturus 50, Rhizoma Dioscoreae 10, the Radix Astragali 30, the Rhizoma Anemarrhenae 15, Endothelium Corneum Gigeriae Galli 10, Radix Puerariae 10, Fructus Schisandrae Chinensis 6, Radix Trichosanthis 20

2) by medical material Fructus psidii guajavae immaturus, after Rhizoma Dioscoreae, the Radix Astragali, the Rhizoma Anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis rinsing, be placed in Multifunctional Chinese medicine and extract still and mix homogeneously, add tap water and soak 20min, wherein, the ratio of the weight of the tap water added and the weight (dry weight) of medicinal material mixture is 12: 1;

3) open multi-functional extraction still power supply to heat, be heated to 100 DEG C, keep constant temperature at this temperature to extract 2 hours, then filter, obtain first time extracting solution for subsequent use;

4) in filtering residue, point tap water is added 3 times, heating extraction 3 times, the ratio of the weight of the tap water added in each heating extraction process and the weight (dry weight) of medicinal material mixture is 1: 1, and heating extraction temperature is 90 DEG C, extraction time is 1 hour, filters and obtains 3 extracting solution;

5) 4 extracting solution are merged be placed on and carry out reduction vaporization in vacuum high energy evaporation concentrator and concentrate, obtained concentrated extract, wherein, the relative pressure of concentrating under reduced pressure be-0.095MPa (namely with an atmospheric pressure for 0, pressure when controlling concentrating under reduced pressure is-0.095MPa relative to an atmospheric pressure), thickening temperature is 80 DEG C, and 3 extracting solution are condensed into the extractum that relative density is 1.5;

6) concentrated extract carries out dry, pulverize rear mistake 100 mesh sieve at 45-50 DEG C, obtains dry extract powder;

7) mixed with adjuvant dextrin by dry extract powder, alcohol granulation, dry, tabletting machine, namely obtained the present invention is for reducing the Chinese medicine composition (metformin) of blood glucose.

Embodiment 4 oral liquid for decreasing blood sugar preparation of the present invention

1) raw material (unit: × 10g) is taken according to following proportioning

Fructus psidii guajavae immaturus 5, Rhizoma Dioscoreae 5, the Radix Astragali 40, the Rhizoma Anemarrhenae 20, Endothelium Corneum Gigeriae Galli 40, Radix Puerariae 6, Fructus Schisandrae Chinensis 2, Radix Trichosanthis 25

2) by medical material Fructus psidii guajavae immaturus, after Rhizoma Dioscoreae, the Radix Astragali, the Rhizoma Anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis rinsing, be placed in Multifunctional Chinese medicine and extract still and mix homogeneously, add tap water and soak 60min, wherein, the ratio of the weight of the tap water added and the weight (dry weight) of medicinal material mixture is 9: 1;

3) open multi-functional extraction still power supply to heat, be heated to 100 DEG C, keep constant temperature at this temperature to extract 3 hours, then filter, obtain first time extracting solution for subsequent use;

4) in filtering residue, point tap water is added 2 times, heating extraction 2 times, the ratio of the weight of the tap water added in each heating extraction process and the weight (dry weight) of medicinal material mixture is 5: 1, heating extraction, keep heating-up temperature to be extract 3 hours at 100 DEG C, filter and obtain 2 extracting solution;

5) 3 extracting solution are merged be placed on and carry out reduction vaporization in vacuum high energy evaporation concentrator and concentrate, obtained concentrated extract, wherein, the relative pressure of concentrating under reduced pressure be-0.07Pa (namely with an atmospheric pressure for 0, pressure when controlling concentrating under reduced pressure is-0.07MPa relative to an atmospheric pressure), thickening temperature is 100 DEG C, and 3 extracting solution are condensed into the extractum that relative density is 1.1;

6) concentrated solution is sub-packed in composite plastic film packaging, makes oral liquid for decreasing blood sugar.

Embodiment 5 Jiangtangwan pill preparation of the present invention

1) raw material (unit: × 10g) is taken according to following proportioning

Fructus psidii guajavae immaturus 50, Rhizoma Dioscoreae 35, the Radix Astragali 5, the Rhizoma Anemarrhenae 2, Endothelium Corneum Gigeriae Galli 7, Radix Puerariae 35, Fructus Schisandrae Chinensis 20, Radix Trichosanthis 3

2) by medical material Fructus psidii guajavae immaturus, after Rhizoma Dioscoreae, the Radix Astragali, the Rhizoma Anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis rinsing, be placed in Multifunctional Chinese medicine and extract still and mix homogeneously, add tap water and soak 60min, wherein, the ratio of the weight of the tap water added and the weight (dry weight) of medicinal material mixture is 6: 1;

3) open multi-functional extraction still power supply to heat, be heated to 80 DEG C, keep constant temperature at this temperature to extract 5 hours, then filter, obtain first time extracting solution for subsequent use;

4) in filtering residue, point tap water is added 2 times, heating extraction 2 times, the ratio of the weight of the tap water added in each heating extraction process and the weight (dry weight) of medicinal material mixture is 4: 1, and heating extraction temperature is 80 DEG C, 2 hours extraction times, filter and obtain 2 extracting solution;

5) 3 extracting solution are merged be placed on and carry out reduction vaporization in vacuum high energy evaporation concentrator and concentrate, obtained concentrated extract, wherein, the relative pressure of concentrating under reduced pressure be-0.05MPa (namely with an atmospheric pressure for 0, pressure when controlling concentrating under reduced pressure is-0.05MPa relative to an atmospheric pressure), thickening temperature is 100 DEG C, and 3 extracting solution are condensed into the extractum that relative density is 1.3;

6) mixed concentrated liquid is carried out spraying dry, obtain for compound for reducing blood suger dry extract dry powder;

7) dry extract powder is mixed with adjuvant refined honey, stir to be placed in pill mechanism and carry out pill, then dry, obtain compound for reducing blood suger concentrated pill.

Claims (10)

1. prevent, or/and control a compositions for diabetes, to it is characterized in that comprising following crude drug: Fructus psidii guajavae immaturus, Rhizoma Dioscoreae, the Radix Astragali, the Rhizoma Anemarrhenae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, Fructus Schisandrae Chinensis, Radix Trichosanthis.

2. prevent or/and control the compositions of diabetes as claimed in claim 1, it is characterized in that the weight of described crude drug is: Fructus psidii guajavae immaturus 5-50, Rhizoma Dioscoreae 5-35, Radix Astragali 5-40, Rhizoma Anemarrhenae 2-20, Endothelium Corneum Gigeriae Galli 7-40, Radix Puerariae 6-35, Fructus Schisandrae Chinensis 2-20, Radix Trichosanthis 3-25.

3. prevent or/and control the compositions of diabetes as claimed in claim 2, it is characterized in that the weight of described crude drug is preferably: Fructus psidii guajavae immaturus 10-50, Rhizoma Dioscoreae 10-30, Radix Astragali 10-30, Rhizoma Anemarrhenae 6-15, Endothelium Corneum Gigeriae Galli 10-30, Radix Puerariae 10-30, Fructus Schisandrae Chinensis 6-15, Radix Trichosanthis 6-20.

4. compositions as claimed in claim 3, is characterized in that the weight of described crude drug is: Fructus psidii guajavae immaturus 20, Rhizoma Dioscoreae 20, the Radix Astragali 20, the Rhizoma Anemarrhenae 10, Endothelium Corneum Gigeriae Galli 15, Radix Puerariae 15, Fructus Schisandrae Chinensis 10, Radix Trichosanthis 12.

5. prevent, or/and control a preparation method for diabetic composition, to comprise the step of carrying out as follows:

1) crude drug is prepared according to following weight:

Fructus psidii guajavae immaturus 5-50, Rhizoma Dioscoreae 5-35, Radix Astragali 5-40, Rhizoma Anemarrhenae 2-20, Endothelium Corneum Gigeriae Galli 7-40, Radix Puerariae 6-35, Fructus Schisandrae Chinensis 2-20, Radix Trichosanthis 3-25;

2) by after raw material mix homogeneously, heating extraction is carried out to mixture, collect extracting solution;

3) concentration is carried out to extracting solution, obtained active component.

6. preparation method as claimed in claim 5, is characterized in that step 1) described in the weight of crude drug be: Fructus psidii guajavae immaturus 10-50, Rhizoma Dioscoreae 10-30, Radix Astragali 10-30, Rhizoma Anemarrhenae 6-15, Endothelium Corneum Gigeriae Galli 10-30, Radix Puerariae 10-30, Fructus Schisandrae Chinensis 6-15, Radix Trichosanthis 6-20.

7. the preparation method as described in claim 5 or 6, is characterized in that step 2) described in heating extraction carry out in accordance with the following steps:

A) mixed material is added water soaking, the weight of the water added is 6-12:1 with the ratio of the weight of mixed material, soaks to carry out first time after 20-90min and decoct process, and decoction temperature is 80-100 DEG C, and decocting time is 2-5 hour;

B) first time extracting solution is filtered, collect filtrate;

C) in filtering residue, at least add water 1 time, proceed at least 1 time and decoct process, wherein, the weight of the water at every turn added is 1-5: 1 with the ratio of the weight of mixed material raw material, and decoction temperature is 80-100 DEG C, and decocting time is 1-3 hour;

D) filter, filtrate is merged, the extracting solution described in acquisition.

8. compositions as claimed in claim 7, is characterized in that steps A) described in soak time be preferably 30-60min, the weight of the water added is preferably 6-9: 1 with the ratio of the weight of mixed material.

9. the preparation method as described in claim 5 or 6, is characterized in that described step 3) in, described extracting solution being concentrated into relative density is 1.05 ~ 1.5.

10. the Chinese medicine composition that as described in claim 5-9 prepared by method for the preparation for the treatment of or/and application in the medicine prevented diabetes and/or health product.