CN103463207B - Prevent and treat the composition of diabetes - Google Patents

Abstract

The present invention provides the composition of prevention and treatment diabetes, and in parts by weight, it contains 1 100 parts of 1 100 parts of Chinese cassia tree, 1 100 parts of plantain seed, 1 100 parts of mulberry leaf and balsam pear.Said composition has good blood sugar reducing function, is especially suitable for prevention and treatment insufficiency of both the spleen and the kindey patients with type Ⅰ DM.

Description

Prevent and treat the composition of diabetes

Technical field

The present invention relates to the composition of prevention and treatment diabetes.More particularly to using Chinese cassia tree, plantain seed, mulberry leaf, balsam pear as The composition of prevention and treatment diabetes prepared by primary raw material.

Background technology

Current global diabetic is 3.66 hundred million, and China diabetic about 92,400,000, and pre-diabetic 1.48 Hundred million, diabetes turn into the fourth-largest disease for causing population in the world dead.In view of the significant damage that diabetes are brought to the mankind, generation Boundary's health organization is referred to as " disaster of 21 century ".The course of disease length of diabetes, medical expense is expensive, according to Chinese Medical Association's diabetes Credit can count, and the direct medical expenses of diabetes mellitus in China reach 173,400,000,000 yuan, account for the 13% of the medical total expenses in the whole nation.Not only shadow Life and the quality of life of patient have been rung, heavy financial burden is also brought to the country and people, therefore has developed to have and aids in The health food or food of function of blood sugar reduction have extensive economical, societal benefits.

The domestic and international prevention and treatment for diabetes at present mainly use such as biguanide drug, sulfonylurea medicine, pancreas islet The chemicalses such as element, but problems be present in these medicines：Biguanides curative effect is low, and side effect is big, high newborn with producing long Acidaemia；With infringement liver, kidney, with sulfa drugs cross allergy occurs for sulfonylureas long；Insulin is long with generation Antibody, bioactivity reduce, and dosage increase, produce hyperinsulinemia.

In recent years, as the research about natural plants hypoglycemic effect deepens continuously, carried with natural plants or its activity Take thing to prepare the research of side effect smaller, suitable for long-term prevention and treatment diabetes medicine and health products for raw material increasingly to increase It is more.Medicine and health products research using natural plants or its activity extract as raw material is increasingly becoming exploitation prevention and treatment glycosuria One new direction of medicine and health products.

Chinese patent application CN200710065461.7 discloses a kind of health product with function of reducing blood sugar, it be with rhizoma alismatis, Poria cocos, The bighead atractylodes rhizome, mulberry leaf, motherwort, Chinese cassia tree, the root of kudzu vine, Chinese yam, plantain seed are raw material, and taking decocting, concentrate and be aided with potassium sorbate etc. will It is configured to oral liquid formulation.The health products are rich in glucose, volatile oil, organic acid, vitamin, amino acid and lot of trace member Element, beneficial to absorption of human body.The health products have promoting diuresis to clear away damp pathogen, and invigorating the spleen is rushed down the effect of turbid, reduce blood glucose, have curative for effect, nothing Toxic side effect, it is convenient to take, it is cheap the characteristics of.

Chinese patent application CN200810102841.8 discloses a kind of health food and its system with function of blood sugar reduction Preparation Method.The active component of the health food mainly by ganoderma lucidum, American Ginseng, Sessileflower Acanthopanax Bark tea, bluish dogbane, chrysanthemum indicum, Semen Cuscutae, Cover plate, semen allii tuberosi, radix polygonati officinalis, mulberry leaf, plantain seed, Poria cocos composition, in raw material also containing balsam pear, pumpkin, celery, hawthorn, garlic, Chinese yam etc..Special extracting method is designed according to the characteristic of every taste Chinese medicine, extraction gained medicinal extract is crushed, is aided with certain proportion ovum Phosphatide is prepared into soft capsule dosage form, shows by animal and human experimentation, and the health food has obvious function of blood sugar reduction, to sugar Tolerance, it is light, poisoning diabete curative effect is preferable, to the various complication of diabetes（Such as diabetic nephropathy, diabetes hepatopathy, god Through lesion）There is unique curative effect, life in patients can be improved.

Above-mentioned patent application is not directed to the treatment and prevention of insufficiency of both the spleen and the kindey patients with type Ⅰ DM.

Diabetes belong to diabete scope in the traditional Chinese medical science, at present the traditional Chinese medical science by diabete be roughly divided into the scorching deficiency of Yin, deficiency of both qi and yin, It is yin-yang deficiency.CTD Probe treats diabete, initiates in Zhang Zhongjing.It is yin-yang deficiency that this method is often used for the diabete later stage by later age doctor Stage.But as what diabete was recognized deepens continuously, and the progress to its prevention and treatment of complication, discovery, which is quenched one's thirst also, has factor body positive Void, from the beginning of having the deficiency of vital energy and deficiency of yang person concurrently simultaneously, spleen kidney yang unsaturated vapor is the interpretation of the cause, onset and process of an illness essence of diabetes B insulin resistance.Spleen Kidney yang unsaturated vapor causes insufficiency of both the spleen and the kindey patients with type Ⅰ DM, and its classical symptom includes the cold cold limb of shape, spiritlessness and weakness, soreness and weakness of waist and knees, limbs Edema, numb pain, complexion white, clear abundant urine or deficient, enuresis nocturna increase, it is uncomfortable etc. to defecate.Therefore, for for treat and There is demand for the medicine and health products of prevention insufficiency of both the spleen and the kindey patients with type Ⅰ DM.

The content of the invention

It is an object of the invention to provide one kind to have hypoglycemic effect, it is intended to prevents and treats the composition of diabetes. Said composition can reduce the incidence of disease of diabetes, and effectively mitigate the various clinical symptoms of diabetes, to yang deficiency of spleen and stomache glycosuria The preventing and treating of disease is especially effective.

To achieve the above object, the present inventor is former for the understanding and treatment of diabete and its complication mechanism based on the traditional Chinese medical science Then, deeply screened for many years with reference to the pharmacological research, animal experiment and clinical test to medicinal plant, process, selection is containing specific The present composition of the Chinese cassia tree, plantain seed, mulberry leaf, balsam pear of content as required component.

As the primary raw material for preparing the present composition, Chinese cassia tree, plantain seed, mulberry leaf, balsam pear have the effect that：

1. Chinese cassia tree

Chinese cassia tree is the dry bark of canella Chinese cassia tree, records come from earliest《Sheng Nong's herbal classic》, for clinical conventional temperature In medicine.Chinese cassia tree has mends fire supporing yang, let the fire back to its origin, eliminating cold to stop pain, the function of invigorate blood circulation.Chinese cassia tree ingredient has volatile oil (cinnamic acid), tannin, sequiterpene, diterpene-kind compound etc..Many researchs are found in recent years, and Chinese cassia tree has hypoglycemic and drop blood Fat acts on.The hypoglycemic mechanism of action of Chinese cassia tree includes：1. increase containing for serum insulin by protecting, stimulating beta Cell of islet Amount；2. increasing the sensitiveness of insulin, improve insulin resistance；3. free radical is removed, anti peroxidation of lipid；4. promote insulin Secretion, increase the content of serum insulin.

2. plantain seed

Plantain seed is the seed of Plantaginaceae plant Chinese herbaceous peony or ordinary building.Root, leaf and the seed of Asiatic plantain can be used as medicine. 《Sheng Nong's herbal classic》The top grade it being classified as in medicine.Plantain seed is sweet in flavor and cold in property, Ke Lishui, heat-clearing, improving eyesight, eliminating the phlegm.The traditional Chinese medical science is commonly used It treats the diseases such as detumescence turgor, puckery pain of heat gonorrhea, summer heat damp diarrhea, red eye, swell pain, phlegm-heat cough.The chemical composition of plantain seed includes Flavone compound（Such as cyanidenon, Homoplantaginin）, polysaccharide compound（Xylose, arabinose, rhamnose, galactolipin Deng）, triterpene compound（Ursolic acid, oleanolic acid）, material, the modern pharmacological research such as volatile oil and alkaloid show：Car Preceding son has the effect such as antidiarrheal, protect liver, decompression, antibacterial, reduction serum cholesterol.Foreign study shows that plantago asiatica linne polyoses are a kind of Partial fermentation dietary fiber, not only has the function that whole intestines defaecation, also reduces blood fat, adjusts the effect of blood glucose, grinds recently Study carefully the diabetic mice oxidative stress for finding plantago asiatica linne polyoses and inducing alloxan, the liver to ferrous sulfate-vitamin C induction Mitochondrial lipid peroxidation has antagonism, and oxidative stress occupies in the occurrence and development of diabetes and its chronic complicating diseases Critical role.

3. mulberry leaf

Mulberry leaf have the effect of expelling wind and clearing away heat, cooling blood for improving eyesight.Modern study shows：Alkaloid 1- deoxidations open country buttocks is mould in mulberry leaf Element（DNJ）（Content is 0.1 ~ 0.3%）It is most important hypoglycemic active ingredient.DNJ is mammal alpha-glucosidase activity Effective inhibitor, alpha-glucosidase is main in human body to be responsible for from starch and the non-reducing end about polysaccharide cuts grape Sugar, therefore, after alpha-glucosidase activity is suppressed, so as to slow down the formation speed of enteron aisle glucose, reduce glucose Regular supply to intestinal absorption, delay and reduce blood glucose in postprandial quick elevated phenomenon, reach treatment and control diabetes Purpose.The main component of the medicine " Acarbose " of the treatment diabetes of Germany's production is exactly that alpha-glucosidase activity suppresses Agent.

4. balsam pear

China since ancient times, just utilizes balsam pear as medicinal plant.《Herbal for Relief of Famines》With《Compendium of Materia Medica》Deng Gu In document, balsam pear is all once mentioned.In terms of diabetes, all emphasize it " can quench the thirst ", " cure mainly polydipsia and draw drink " etc..The Ming Dynasty is big Medicine scholar's Li Shizhen (1518-1593 A.D.) is said：" balsam pear is bitter in taste, cold, nontoxic, has except heat symptoms caused by an exopathgen, solves the tired, improving eyesight that clears away heart-fire, the work(of QI invigorating establishing-Yang Effect." balsam pear is very effective in cure for the retinopathy of one of three big complication of diabetes.

The present invention provides following technical scheme：

1st, composition, in parts by weight, it contains Chinese cassia tree 1-100 parts, plantain seed 1-100 parts, mulberry leaf 1-100 parts and hardship Melon 1-100 parts.

2nd, according to the composition of technical scheme 1, in parts by weight, it contains Chinese cassia tree 20-80 parts, preferably comprises Chinese cassia tree 30- 70 parts, further preferably Chinese cassia tree 40-50 parts.

3rd, the composition according to any one of technical scheme 1-2, in parts by weight, it contains plantain seed 20-80 Part, preferably comprise plantain seed 30-70 parts, further preferably plantain seed 40-50 parts.

4th, the composition according to any one of technical scheme 1-3, in parts by weight, it contains mulberry leaf 5-50 parts, excellent Choosing contains mulberry leaf 10-40 parts, further preferably mulberry leaf 15-30 parts.

5th, the composition according to any one of technical scheme 1-4, in parts by weight, it contains balsam pear 1-50 parts, excellent Choosing contains balsam pear 1-40 parts, further preferably balsam pear 5-25 parts.

6th, in the composition according to any one of technical scheme 1-5, wherein Chinese cassia tree, plantain seed, mulberry leaf and balsam pear One or more can be replaced with respective extract or freeze-dried powder.

7th, the composition according to technical scheme 6, when using cinnamomum cassia extract, in terms of every 100 part composition by weight, Its content is 1-95 parts by weight, preferably 20-70 parts by weight, more preferably 30-65 parts by weight, most preferably 35-45 parts by weight； When using Semen Plantaginis extract, in terms of every 100 part composition by weight, its content is 1-95 parts by weight, preferably 20-70 weight Part, more preferably 30-65 parts by weight, most preferably 35-45 parts by weight；When using mulberry-leaf extract, with every 100 parts by weight group Compound meter, its content are the parts by weight of 1- 95, preferably 5-45 parts by weight, more preferably 10-35 parts by weight, most preferably 15-25 Parts by weight；When using Bitter Melon P.E, in terms of every 100 part composition by weight, its content is 1-95 parts by weight, preferably 1- 40 parts by weight, more preferably 1-30 parts by weight, most preferably 5-20 parts by weight；When using balsam pear freeze-dried powder, with every 100 weight Part composition meter, its content is 1-95 parts by weight, preferably 1-40 parts by weight, more preferably 1-30 parts by weight, most preferably 5- 20 parts by weight.

8th, the composition according to any one of 1-7 in technical scheme, in parts by weight, it contains ground cinnamon 20-80 parts Or cinnamomum cassia extract 20-70 parts, Semen Plantaginis extract 20-70 parts, mulberry-leaf extract 5-45 parts and Bitter Melon P.E or balsam pear Freeze-dried powder 1-40 parts.

9th, product, it includes the composition any one of technical scheme 1-8, and the product is medicine or health products, It is preferred that the product is granule, tablet, capsule, oral liquid, solid beverage, tea bag or powder.

10th, the composition any one of technical scheme 1-8 is being prepared for treating or preventing diabetes, preferably spleen Purposes in the medicine or health products of kidney yang deficiency syndrome diabetes.

Embodiment

In the compositions of the present invention, primary raw material Chinese cassia tree, plantain seed, mulberry leaf and balsam pear complement each other, and have collaboration drop blood Sugar effect, it is especially suitable for prevention and treatment insufficiency of both the spleen and the kindey patients with type Ⅰ DM.

In parts by weight, the present composition contain Chinese cassia tree 1-100 parts, plantain seed 1-100 parts, mulberry leaf 1-100 parts and Balsam pear 1-100 parts.In the composition, the content of Chinese cassia tree is preferably 20-80 parts by weight, more preferably 30-70 parts by weight, more Preferably 40-50 parts by weight；The content of plantain seed is preferably 20-80 parts by weight, more preferably 30-70 parts by weight, more preferably 40-50 parts by weight；The content of mulberry leaf is preferably 5-50 parts by weight, more preferably 10-40 parts by weight, more preferably 15-30 weight Part；The content of balsam pear is preferably 1-50 parts by weight, more preferably 1-40 parts by weight, more preferably 5-25 parts by weight.

In a kind of preferred embodiment, in parts by weight, the present composition contains Chinese cassia tree 20-80 parts, plantain seed 20-80 Part, mulberry leaf 5-50 parts and balsam pear 1-50 parts.In another preferred embodiment, in parts by weight, the present composition contains meat Osmanthus 30-70 parts, plantain seed 30-70 parts, mulberry leaf 10-40 parts and balsam pear 1-40 parts.In another preferred embodiment, with parts by weight Meter, the present composition contain Chinese cassia tree 40-50 parts, plantain seed 40-50 parts, mulberry leaf 15-30 parts and balsam pear 5-25 parts.

In above-mentioned composition, raw material Chinese cassia tree, plantain seed, mulberry leaf, balsam pear can use former powder, and former powder can use commercially available production Product, or commercially available Chinese cassia tree, plantain seed, mulberry leaf, balsam pear are handled using conventional crushing, sieving technology and prepared.Wherein Chinese cassia tree, plantain seed and mulberry leaf should meet《Pharmacopoeia of People's Republic of China》（2010 editions）The corresponding requirements of one.It is total in balsam pear powder The content of saponin should be not less than about the 0.01% of balsam pear powder gross weight.In one embodiment, balsam pear powder is usually light green Uniform powder, there is the distinctive taste and aroma of balsam pear, preferably cross 80 mesh sieves.

In the compositions of the present invention, the one or more in Chinese cassia tree, plantain seed, mulberry leaf and balsam pear original powder can be with respective Extract or freeze-dried powder replace.Cinnamomum cassia extract is commercially available, or is carried by routine well known by persons skilled in the art Method is taken to prepare.The content of Chinese cassia tree polyphenol should be not less than about the 10% of cinnamomum cassia extract gross weight in cinnamomum cassia extract.In one kind In embodiment, cinnamomum cassia extract is usually brown uniform powder, has the distinctive taste and aroma of Chinese cassia tree, its preferred mesh of mistake 80 Sieve.In a kind of embodiment, when using cinnamomum cassia extract, in terms of every 100 part composition by weight, it is in the compositions of the present invention Content be 1-95 parts by weight, preferably 20-70 parts by weight, more preferably 30-65 parts by weight, most preferably 35-45 parts by weight.

Semen Plantaginis extract is commercially available, or is prepared by general extraction methods well known by persons skilled in the art. The content of polysaccharide should be not less than about the 10% of Semen Plantaginis extract gross weight in Semen Plantaginis extract.In one embodiment, Semen Plantaginis extract is usually gray homogenous powder, lightly seasoned, its preferred mesh sieve of mistake 80.In a kind of embodiment, when using Chinese herbaceous peony During seed extract, in terms of every 100 part composition by weight, its content in the compositions of the present invention is 1-95 parts by weight, is preferably 20-70 parts by weight, more preferably 30-65 parts by weight, most preferably 35-45 parts by weight.

Mulberry-leaf extract is commercially available, or is prepared by general extraction methods well known by persons skilled in the art.Mulberry The content of 1-DNJ should be not less than about the 1% of mulberry-leaf extract gross weight in leaf extract.In a kind of embodiment In, mulberry-leaf extract is usually green and brown color uniform powder, has the distinctive smell of mulberry leaf, its preferred mesh sieve of mistake 80.One kind is implemented In mode, when using mulberry-leaf extract, in terms of every 100 part composition by weight, its content in the compositions of the present invention is 1- 95 parts by weight, preferably 5-45 parts by weight, more preferably 10-35 parts by weight, most preferably 15-25 parts by weight.

Bitter Melon P.E is commercially available, or is prepared by general extraction methods well known by persons skilled in the art.It is bitter The content of Total saponin should be not less than about the 10% of Bitter Melon P.E gross weight in melon extract.In one embodiment, balsam pear Extract is usually yellowish-brown uniform powder, has the distinctive taste and aroma of balsam pear, its preferred mesh sieve of mistake 80.A kind of embodiment party In formula, when using Bitter Melon P.E, in terms of every 100 part composition by weight, its content in the compositions of the present invention is 1-95 Parts by weight, preferably 1-40 parts by weight, more preferably 1-30 parts by weight, most preferably 5-20 parts by weight.

Balsam pear freeze-dried powder is commercially available, or is squeezed the juice by routine well known by persons skilled in the art, be filtering and concentrating, cold It is prepared by lyophilized drying method.The content of Total saponin should be not less than about the 1% of freeze-dried powder gross weight in balsam pear freeze-dried powder.Implement in one kind In mode, balsam pear freeze-dried powder is usually yellowish-brown uniform powder, has the distinctive taste and aroma of balsam pear, preferably crosses 80 mesh sieves. When using balsam pear freeze-dried powder, in terms of every 100 part composition by weight, its content in the compositions of the present invention is 1-95 weight Part, preferably 1-40 parts by weight, more preferably 1-30 parts by weight, most preferably 5-20 parts by weight.

In a kind of preferred embodiment, in parts by weight, the present composition includes ground cinnamon 20-80 parts, plantain seed carries Take thing 20-70 parts, mulberry-leaf extract 5-45 parts and Bitter Melon P.E 1-40 parts.In another preferred embodiment, with weight Point meter, the present composition include ground cinnamon 20-80 parts, Semen Plantaginis extract 20-70 parts, mulberry-leaf extract 5-45 parts and Balsam pear freeze-dried powder 1-40 parts.In another preferred embodiment, in parts by weight, the present composition includes cinnamomum cassia extract 20-70 parts, Semen Plantaginis extract 20-70 parts, mulberry-leaf extract 5-45 parts and Bitter Melon P.E 1-40 parts.It is another preferred In embodiment, in parts by weight, the present composition include cinnamomum cassia extract 20-70 parts, Semen Plantaginis extract 20-70 parts, Mulberry-leaf extract 5-45 parts and balsam pear freeze-dried powder 1-40 parts.More preferably in embodiment, in parts by weight, present invention combination Thing includes ground cinnamon 30-70 parts, Semen Plantaginis extract 30-65 parts, mulberry-leaf extract 10-35 parts and Bitter Melon P.E 1-30 parts； More preferably in embodiment, in parts by weight, the present composition includes ground cinnamon 30-70 parts, Semen Plantaginis extract 30-65 Part, mulberry-leaf extract 10-35 parts and balsam pear freeze-dried powder 1-30 parts；More preferably in embodiment, in parts by weight, present invention combination Thing includes cinnamomum cassia extract 30-65 parts, Semen Plantaginis extract 30-65 parts, mulberry-leaf extract 10-35 parts and Bitter Melon P.E 1-30 Part；More preferably in embodiment, in parts by weight, the parts of 30-65 containing cinnamomum cassia extract, Semen Plantaginis extract in the present composition 30-65 parts, mulberry-leaf extract 10-35 parts and balsam pear freeze-dried powder 1-30 parts.

Can further it be added in the present composition acceptable auxiliary on pharmaceutically acceptable auxiliary additive or food Additive is helped, so as to which the product for preventing and treating diabetes be made, the product can be medicine or health products etc..According to need Will, the forms such as granule, tablet, capsule, oral liquid, solid beverage, tea bag, powder can be made in the product.

Acceptable auxiliary adds on pharmaceutically acceptable auxiliary additive or food suitable for the present composition Agent is added to include but is not limited to adhesive, lubricant, disintegrant, flavouring, antioxidant etc..

Above-mentioned adhesive include but is not limited to hydroxypropyl cellulose, cornstarch, pregelatinized starch, modified corn starch, Polyvinylpyrrolidone, hydroxypropyl methyl cellulose, lactose, Arabic gum, ethyl cellulose, cellulose acetate etc..

Above-mentioned lubricant includes but is not limited to magnesium stearate, zinc stearate, calcium stearate, talcum, stearic acid, colloid dioxy SiClx, palmitic acid etc..

Above-mentioned disintegrant includes but is not limited to Ac-Di-Sol, PVPP, starch, Ma Ling Sweet potato starch, pregelatinized starch, cornstarch, primojel, microcrystalline cellulose, hydroxypropyl cellulose etc..

Above-mentioned flavouring includes but is not limited to fruit essence, Aspartame, steviol glycoside etc..

Above-mentioned antioxidant includes but is not limited to anti-Butylated Hydroxyanisole（BHA）, Butylated Hydroxytoluene（BHT）, propylgallate （PG）, ascorbic acid, alpha-tocopherol etc..

Beneficial effect

The present composition can be prepared into medicine or health products, edible safety, build up health, can effectively prevent diabetes, The especially generation of insufficiency of both the spleen and the kindey patients with type Ⅰ DM.

Had through research by the present composition that ground cinnamon, plantago powder, mulberry leaf powder and balsam pear powder form to OLETF rats There is significant collaboration blood sugar decreasing effect.Especially by cinnamomum cassia extract, Semen Plantaginis extract, mulberry-leaf extract and Bitter Melon P.E group Into the present composition to OLETF rats have very significantly collaboration blood sugar decreasing effect；Compared with model group, of the present invention group Compound can significantly reduce blood glucose (p<0.05), some is even better than positive control Rosiglitazone（See embodiment 6）.

By 30 clinical observations, diabetic takes the present composition, 3 times a day, 2 tablets each time, the course for the treatment of 30 My god.As a result：Effective 23, effective 6, invalid 1, total effective rate 96.7%（See embodiment 7）.

It is present composition Small side effects, safe to use.ICR acute toxicity test in mice shows：With clinical dosage（5 grams/ Bag, 1 times/day）80 times of gastric infusions, Continuous Observation 7 days, none is dead.Long term toxicity test shows 40 times with clinical dosage SD rat continuous gavages are given, observation does not occur obvious toxic side effect in 6 months.

Embodiment

The present invention is illustrated by the following examples, following examples are not carried out to the present invention in any way Limitation.

In the examples below, all raw materials and reagent use commercially available prod, and wherein Chinese cassia tree, plantain seed, mulberry leaf are purchased from wide Western hundred original herbal Co., Ltds of Yulin；Cinnamomum cassia extract is purchased from Acetar Bio-tech Inc.（Batch number TY2011108）；Semen Plantaginis extract is purchased from Ningbo Liwah Plant Extract Technology Co., Ltd.（Lot number 20111201）；Mulberry leaf carry Thing is taken to be purchased from Shaanxi Jin Tai bioengineering Co., Ltd（Batch number JT20111225）；Balsam pear freeze-dried powder is purchased from Beihai, Guangxi All kinds of fruits source fruit juice food Co., Ltd（Batch number 201117）；Bitter Melon P.E is purchased from Shaanxi Jin Tai bioengineering Co., Ltd （Batch number JT20111214）；Balsam pear is purchased from Ou Shang Suzhou golden pheasant Hu Dian.

Present composition product of the embodiment 1 containing ground cinnamon, plantago powder, mulberry leaf powder and balsam pear powder

Capsule preparation method thereof：

Chinese cassia tree, plantain seed, mulberry leaf, balsam pear are crushed respectively, 80 mesh sieves is crossed, then each dispensing is weighed according to formula, by meat Cassia lignea flour, plantago powder, mulberry leaf powder, balsam pear powder and microcrystalline cellulose are well mixed, and are loaded capsule, are produced.

Method for preparing tablet thereof：Chinese cassia tree, plantain seed, mulberry leaf, balsam pear are crushed respectively, cross 100 mesh sieves, is then claimed according to formula Each dispensing is taken, by ground cinnamon, plantago powder, mulberry leaf powder, balsam pear powder, microcrystalline cellulose, hydroxypropyl methyl cellulose, polyethylene pyrrole Pyrrolidone K30, CMS are received, are well mixed, with 50% appropriate amount of ethanol softwood, the granulation of 20 mesh sieves, 60 DEG C of dryings, 20 mesh Whole grain is sieved, additional magnesium stearate is well mixed, and tabletting produces.

Method for preparing solid beverage thereof：Chinese cassia tree, plantain seed, mulberry leaf, balsam pear are crushed respectively, cross 60 mesh sieves, then according to Side weighs each dispensing, ground cinnamon, plantago powder, mulberry leaf powder, balsam pear powder, maltodextrin, steviol glycoside is well mixed, packing is .

Embodiment 2：The present composition containing ground cinnamon, Semen Plantaginis extract, mulberry-leaf extract and Bitter Melon P.E Product

Capsule preparation method thereof：

Chinese cassia tree is crushed, 80 mesh sieves is crossed, then each dispensing is weighed according to formula, by ground cinnamon, Semen Plantaginis extract, mulberry leaf Extract, Bitter Melon P.E and microcrystalline cellulose are well mixed, and are loaded capsule, are produced.

Method for preparing tablet thereof：Chinese cassia tree is crushed, 100 mesh sieves is crossed, then each dispensing is weighed according to formula, by ground cinnamon, car Preceding seed extract, mulberry-leaf extract, Bitter Melon P.E, microcrystalline cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone K30, CMS are received, are well mixed, and with 50% appropriate amount of ethanol softwood, 20 mesh sieves are pelletized, 60 DEG C of dryings, 20 mesh sieve whole grains, Additional magnesium stearate is well mixed, and tabletting produces.

Method for preparing solid beverage thereof：Chinese cassia tree is crushed, cross 60 mesh sieves, then weigh each dispensing according to formula, by ground cinnamon, Semen Plantaginis extract, mulberry-leaf extract, Bitter Melon P.E, maltodextrin, steviol glycoside are well mixed, and are dispensed and are produced.

Embodiment 3：The present composition containing ground cinnamon, Semen Plantaginis extract, mulberry-leaf extract and balsam pear freeze-dried powder Product

Capsule preparation method thereof：Chinese cassia tree is crushed, 80 mesh sieves is crossed, then each dispensing is weighed according to formula, by ground cinnamon, Chinese herbaceous peony Seed extract, mulberry-leaf extract, balsam pear freeze-dried powder, microcrystalline cellulose are well mixed, and are loaded capsule, are produced.

Method for preparing tablet thereof：Chinese cassia tree is crushed, 100 mesh sieves is crossed, then each dispensing is weighed according to formula, by ground cinnamon, car Preceding seed extract, mulberry-leaf extract, balsam pear freeze-dried powder, microcrystalline cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone K30, CMS are received, are well mixed, and with 50% appropriate amount of ethanol softwood, 20 mesh sieves are pelletized, 60 DEG C of dryings, 20 mesh sieve whole grains, Additional magnesium stearate is well mixed, and tabletting produces.

Method for preparing solid beverage thereof：Chinese cassia tree is crushed, cross 60 mesh sieves, then weigh each dispensing according to formula, by ground cinnamon, Semen Plantaginis extract, mulberry-leaf extract, balsam pear freeze-dried powder, maltodextrin, steviol glycoside are well mixed, and are dispensed and are produced.

Embodiment 4：Of the present invention group containing cinnamomum cassia extract, Semen Plantaginis extract, mulberry-leaf extract and Bitter Melon P.E Composition powder

Capsule preparation method thereof：Weigh each dispensing according to formula, by cinnamomum cassia extract, Semen Plantaginis extract, mulberry-leaf extract, Bitter Melon P.E, microcrystalline cellulose are well mixed, and are loaded capsule, are produced.

Method for preparing tablet thereof：Each dispensing is weighed according to formula, by Chinese cassia tree extract, mulberry-leaf extract, Bitter Melon P.E, crystallite Cellulose, hydroxypropyl methyl cellulose, PVP K30, CMS are received, are well mixed, with 50% appropriate amount of ethanol Softwood processed, the granulation of 20 mesh sieves, 60 DEG C of dryings, 20 mesh sieve whole grains, additional magnesium stearate are well mixed, and tabletting produces.

Method for preparing solid beverage thereof：Each dispensing is weighed according to formula, cinnamomum cassia extract, Semen Plantaginis extract, mulberry leaf are carried Take thing, Bitter Melon P.E, maltodextrin, steviol glycoside to be well mixed, dispense and produce.

Embodiment 5：Present composition production containing cinnamomum cassia extract, plantain seed, mulberry-leaf extract and balsam pear freeze-dried powder Product

Capsule preparation method thereof：Weigh each dispensing according to formula, by cinnamomum cassia extract, Semen Plantaginis extract, mulberry-leaf extract, Balsam pear freeze-dried powder, microcrystalline cellulose are well mixed, and are loaded capsule, are produced.

Method for preparing tablet thereof：Weigh each dispensing according to formula, by cinnamomum cassia extract, Semen Plantaginis extract, mulberry-leaf extract, Balsam pear freeze-dried powder, microcrystalline cellulose, hydroxypropyl methyl cellulose, PVP K30, CMS are received, mixed It is even, it is well mixed, is pressed with 50% appropriate amount of ethanol softwood, the granulation of 20 mesh sieves, 60 DEG C of dryings, 20 mesh sieve whole grains, additional magnesium stearate Piece produces.

Method for preparing solid beverage thereof：Each dispensing is weighed according to formula, cinnamomum cassia extract, Semen Plantaginis extract, mulberry leaf are carried Take thing, balsam pear freeze-dried powder, maltodextrin, steviol glycoside to be well mixed, dispense and produce.

Hypoglycemic effect of the embodiment 6 to OLETF rats

Prepare following test specimen：（1）160g cinnamomum cassia extracts and 340g microcrystalline celluloses are weighed, 1000 glue are made Capsule；（2）160g Semen Plantaginis extracts and 340g microcrystalline celluloses are weighed, 1000 capsules are made；（3）Weigh the extraction of 60g mulberry leaf Thing and 440g microcrystalline celluloses, 1000 capsules are made；（4）20g Bitter Melon P.Es and 480g microcrystalline celluloses are weighed, is made 1000 capsules；（5）160g cinnamomum cassia extracts, 160g Semen Plantaginis extracts and 180g microcrystalline celluloses are weighed, is made 1000 Capsule；（6）160g cinnamomum cassia extracts, 60g mulberry-leaf extracts and 280g microcrystalline celluloses are weighed, 1000 capsules are made；（7）Claim 160g cinnamomum cassia extracts, 20g Bitter Melon P.Es and 320g microcrystalline celluloses are taken, 1000 capsules are made；（8）Weigh 160g Chinese herbaceous peonies Seed extract, 60g mulberry-leaf extracts and 280g microcrystalline celluloses, 1000 capsules are made；（9）Weigh the extraction of 160g plantain seeds Thing, 20g Bitter Melon P.Es and 320g microcrystalline celluloses, 1000 capsules are made；（10）Weigh 60g mulberry-leaf extracts, 20g balsam pears Extract and 420g microcrystalline celluloses, 1000 capsules are made；（11）Weigh 160g cinnamomum cassia extracts, the extraction of 160g plantain seeds Thing, 60g mulberry-leaf extracts and 120g microcrystalline celluloses, 1000 capsules are made；（12）Weigh 160g cinnamomum cassia extracts, 160g cars Preceding seed extract, 20g Bitter Melon P.Es and 160g microcrystalline celluloses, 1000 capsules are made；（13）Weigh the extraction of 160g Chinese cassia trees Thing, 60g mulberry-leaf extracts, 20g Bitter Melon P.Es and 260g microcrystalline celluloses, 1000 capsules are made；（14）Weigh 160g cars Preceding seed extract, 60g mulberry-leaf extracts, 20g Bitter Melon P.Es and 260g microcrystalline celluloses, 1000 capsules are made；（15）Claim 160g ground cinnamons, 160g plantago powders, 60g mulberry leaf powders, 20g balsam pear powders and 100g microcrystalline celluloses are taken, 1000 capsules are made. （16）Weigh 160g cinnamomum cassia extracts, 160g Semen Plantaginis extracts, 60g mulberry-leaf extracts, 20g Bitter Melon P.Es and 100g crystallites Cellulose, 1000 capsules are made.

By 180 OLETF rats（Purchased from Japanese big tomb pharmacy Tokushima research institute, 20 week old, male and female half and half）Without specific Pathogen level（SPF levels）Under the conditions of raise, raise with standard feed（Purchased from the western limited public affairs of pul-Bi Kai experimental animals in Shanghai Department）.Raising was randomly divided into 18 groups to 32 weeks.Gastric infusion 3 weeks, once a day.Wherein each group dosage is respectively：Model Group：The mL/kg body weight of physiological saline 10；Rosiglitazone group：2.5mg/kg body weight；Cinnamomum cassia extract group：160 mg/kg body weight；Car Preceding seed extract group：160mg/kg body weight；Mulberry-leaf extract group：60 mg/kg body weight；Bitter Melon P.E group：20mg/kg body weight； Cinnamomum cassia extract+Semen Plantaginis extract group：160mg cinnamomum cassia extracts/kg body weight+160mg Semen Plantaginis extracts/kg body weight；Meat Osmanthus extract+mulberry-leaf extract group：160mg cinnamomum cassia extracts/kg body weight+60mg mulberry-leaf extracts/kg body weight；Cinnamomum cassia extract + Bitter Melon P.E group：160mg cinnamomum cassia extracts/kg body weight+20mg Bitter Melon P.Es/kg body weight；Semen Plantaginis extract+mulberry leaf Extract group：160mg Semen Plantaginis extracts/kg body weight+60mg mulberry-leaf extracts/kg body weight；Semen Plantaginis extract+balsam pear extraction Thing group：160mg Semen Plantaginis extracts/kg body weight+20mg Bitter Melon P.Es/kg body weight；Mulberry-leaf extract+Bitter Melon P.E group： 60mg mulberry-leaf extracts/kg body weight+20mg Bitter Melon P.Es/kg body weight；Cinnamomum cassia extract+Semen Plantaginis extract+mulberry leaf extraction Thing group：160mg cinnamomum cassia extracts/kg body weight+160mg Semen Plantaginis extracts/kg body weight+60mg mulberry-leaf extracts/kg body weight；Meat Osmanthus extract+Semen Plantaginis extract+Bitter Melon P.E group：160mg cinnamomum cassia extracts/kg body weight+160mg Semen Plantaginis extracts/ Kg body weight+20mg Bitter Melon P.Es/kg body weight；Cinnamomum cassia extract+mulberry-leaf extract+Bitter Melon P.E group：160mg Chinese cassia trees are extracted Thing/kg body weight+60mg mulberry-leaf extracts/kg body weight+20mg Bitter Melon P.Es/kg body weight.Semen Plantaginis extract+mulberry-leaf extract + Bitter Melon P.E group：160mg Semen Plantaginis extracts/kg body weight+60mg mulberry-leaf extracts/kg body weight+20mg Bitter Melon P.Es/ Kg body weight；Ground cinnamon+plantago powder+mulberry leaf powder+balsam pear powder group：160mg ground cinnamons/kg body weight+160mg plantago powders/kg bodies Weight+60mg mulberry leaf powder kg body weight+20mg balsam pear powders/kg body weight.Cinnamomum cassia extract+Semen Plantaginis extract+mulberry-leaf extract+balsam pear Extract group：160mg cinnamomum cassia extracts/kg body weight+160mg Semen Plantaginis extracts/kg body weight+60mg mulberry-leaf extracts/kg bodies Weight+20mg Bitter Melon P.Es/kg body weight.Administration detects the fasting blood-glucose of each group after terminating.

The as shown by data of table 1, compared with model group, ground cinnamon+plantago powder+mulberry leaf powder+balsam pear powder group has significant Blood sugar decreasing effect.In addition, cinnamomum cassia extract+Semen Plantaginis extract+mulberry-leaf extract+Bitter Melon P.E group is with very significant Blood sugar decreasing effect, its effect are even better than Rosiglitazone positive controls.Compared to be only given only cinnamomum cassia extract, plantain seed carries Take in thing, mulberry-leaf extract and Bitter Melon P.E any one, two or three of group, cinnamomum cassia extract+plantain seed carries Take thing+mulberry-leaf extract+Bitter Melon P.E group that there is significant collaboration blood sugar decreasing effect.It can be seen that compared with model group, the present invention Composition can significantly reduce blood glucose (p<0.05), extractive composition of the present invention is even better than positive control Rosiglitazone.

The effect of lowering blood sugar of embodiment 7 is tested

The capsule that sample is selected in embodiment 4.

(1) 60 insufficiency of both the spleen and the kindey diabetes mellitus types of clinical data are randomly divided into two groups, treatment group 30, wherein man 15 Example, female 15,65 years old ± 7.2 years old age, the course of disease ± 5.12 7.52；Control group 30, wherein man 15, female 15, year 66 years old ± 7.7 years old age, the course of disease ± 4.91 7.45.It is statistically analyzed, indices difference is anticipated without statistics between two groups Justice, there is comparativity.

(2) the oral capsule of the present invention for the treatment of method treatment group, 3 times a day, 2 tablets each time, the course for the treatment of is 30 days.Control group mouth 3 grams of SHENQI JIANGTANG KELI is taken, 3 times a day, the course for the treatment of is 30 days.

(3) observation index

1. curative effect index

Fasting blood-glucose, postprandial 2 hours blood glucose, glycosylated hemoglobins are each when preceding and treatment end is treated to be surveyed 1 time.

2. tcm symptom

Observe following symptom change：Shape tremble with fear limb is cold, spiritlessness and weakness, soreness and weakness of waist and knees, limbs edema, numb pain, complexion In vain, clear abundant urine or deficient, enuresis nocturna increase, defecate it is uncomfortable.By above-mentioned symptom according to《The clinic of new Chinese medicine treatment diabetes is ground Study carefully guideline》（2002 editions）" tcm symptom scalar quantization standard ", be divided into without, it is light, in, weigh four grades, using sxemiquantitative Grade score evaluation method, is calculated as 0,2,4,6 point, and before treatment, score registration is carried out after treatment, observes product before and after treatment Divide change.

(4) criterion of therapeutical effect refers to facing for the new Chinese medicine treatment diabetes in new Chinese medicine guideline of clinical investigations Bed research guideline is worked out.

It is 1. effective：Fasting blood-glucose and postprandial 2 hours blood glucose drop to normal range (NR)；Or fasting blood-glucose and postprandial 2 hours blood Sugared value decrease beyond 40% before treatment, and glycosylated hemoglobin value drops to normally, or decrease beyond before treating 30%.

It is 2. effective：Fasting blood-glucose and postprandial 2 hours blood glucose decrease beyond 20% before treatment, but not up to effective standard, Glycosylated hemoglobin value decrease beyond 10% before treatment, but not up to effective standard.

3. tcm symptom is not improved, even aggravating, disease integration is reduced less than 30%；Fasting blood-glucose and postprandial 2 Hour blood glucose is without decline, or declines effective standard that is not up to, and glycosylated hemoglobin value not up to has criterion without decline, or decline It is accurate.

(5) in efficacy result treatment group 30, effective 23, effective 6, invalid 1, total effective rate 96.7%, control Group 30, effective 17, effective 6, invalid 6, total effective rate 76.7%.

(6) after two groups of therapeutic evaluation Case treatment 30 days, there were significant differences in terms of curative effect (P<0.05), from patient Analyzed in terms of the improvement of the leading indicator such as blood glucose, tcm symptom, there is preferable effect in treatment group, the results are shown in Table 2 and table 3.

Complex clinical observes result, it can be deduced that to draw a conclusion：

1. the composition of the involved prevention and treatment diabetes especially insufficiency of both the spleen and the kindey patients with type Ⅰ DM of invention has good Blood sugar reducing function, either fasting blood-glucose or postprandial 2 hours blood glucose have clear improvement.

2. the composition of the involved prevention and treatment diabetes of invention is for the cold limb of shape of insufficiency of both the spleen and the kindey patients with type Ⅰ DM Cold, spiritlessness and weakness, soreness and weakness of waist and knees, limbs edema, numb pain, complexion white, clear abundant urine or deficient, enuresis nocturna increase, defecated The clinical symptoms such as uncomfortable are significantly improved effect.

The above-described embodiment and examples of the present invention describe the purpose with explanation merely to illustrate, not in any way The limitation present invention.It is obvious that those skilled in the art can be variously changed and change according to the teaching of the context of the invention.This A little changes and change are all fallen within the spirit and scope of the invention that claim is limited.

Claims (16)

1. the composition for preventing or treating diabetes, in parts by weight, it is made up of following raw material：Chinese cassia tree 20-80 parts, car Preceding sub- 20-80 parts, mulberry leaf 10-40 parts and balsam pear 1-40 parts.

2. composition according to claim 1, in parts by weight, it contains Chinese cassia tree 30-70 parts.

3. composition according to claim 1, in parts by weight, it contains Chinese cassia tree 40-50 parts.

4. composition according to claim 1, in parts by weight, its plantain seed 30-70 part.

5. composition according to claim 1, in parts by weight, its plantain seed 40-50 part.

6. composition according to claim 1, in parts by weight, it contains mulberry leaf 15-30 parts.

7. composition according to claim 1, in parts by weight, it contains balsam pear 5-25 parts.

8. one or more of use in composition according to claim 1, wherein Chinese cassia tree, plantain seed, mulberry leaf and balsam pear Respective extract or freeze-dried powder replace.

9. composition according to claim 8, when using cinnamomum cassia extract, in terms of every 100 part composition by weight, it contains Measure as 20-70 parts by weight；When using Semen Plantaginis extract, in terms of every 100 part composition by weight, its content is 20-70 weight Part；When using mulberry-leaf extract, in terms of every 100 part composition by weight, its content is 5-45 parts by weight；Extracted when using balsam pear During thing, in terms of every 100 part composition by weight, its content is 1-40 parts by weight；When using balsam pear freeze-dried powder, with every 100 weight Part composition meter, its content is 1-40 parts by weight.

10. composition according to claim 8, when using cinnamomum cassia extract, in terms of every 100 part composition by weight, its Content is 30-65 parts by weight；When using Semen Plantaginis extract, in terms of every 100 part composition by weight, its content is 30-65 weights Measure part；When using mulberry-leaf extract, in terms of every 100 part composition by weight, its content is 10-35 parts by weight；When using balsam pear During extract, in terms of every 100 part composition by weight, its content is 1-30 parts by weight；When using balsam pear freeze-dried powder, with every 100 Part composition by weight meter, its content are 1-30 parts by weight.

11. composition according to claim 8, when using cinnamomum cassia extract, in terms of every 100 part composition by weight, its Content is 35-45 parts by weight；When using Semen Plantaginis extract, in terms of every 100 part composition by weight, its content is 35-45 weights Measure part；When using mulberry-leaf extract, in terms of every 100 part composition by weight, its content is 15-25 parts by weight；When using balsam pear During extract, in terms of every 100 part composition by weight, its content is 5-20 parts by weight；When using balsam pear freeze-dried powder, with every 100 Part composition by weight meter, its content are 5-20 parts by weight.

12. according to the composition any one of claim 1 and 8-9, in parts by weight, it is made up of following raw material：Meat Cassia lignea flour 20-80 parts or cinnamomum cassia extract 20-70 parts, Semen Plantaginis extract 20-70 parts, mulberry-leaf extract 5-45 parts and balsam pear Extract or balsam pear freeze-dried powder 1-40 parts.

13. the product for preventing or treating diabetes, it includes the composition any one of claim 1-12, institute It is medicine or health products to state product.

14. the product described in claim 13, it is granule, tablet, capsule, oral liquid, solid beverage, tea bag or is dissipated Agent.

15. the composition any one of claim 1-12 is preparing medicine or guarantor for treating or preventing diabetes Purposes in strong product.

16. the purposes described in claim 15, wherein the diabetes are insufficiency of both the spleen and the kindey patients with type Ⅰ DM.