CN104840690A - Combination with auxiliary blood sugar and blood fat reduction effect - Google Patents

Abstract

The invention provides a combination with the auxiliary blood sugar and blood fat reduction effect. The combination is characterized by being formed by the following components of, by mass, 40 to 70% of whole leaf aloe dry powder, 10 to 30% of bitter gourd extract, 5 to 15% of pueraria extract, 5 to 15% of propolis and 2 to 6% of panax notoginseng saponins extract, wherein the sum of the components is 100%. According to the combination with the auxiliary blood sugar and blood fat reduction effect, the combination is performed on the aloe, the bitter gourd, the pueraria, the propolis and the panax notoginseng, the effects on islet cell repair, insulin secretion promotion, insulin resistance improvement, glucosidase activity inhibition, anti-oxidation, blood microcirculation improvement and the like are achieved, and the synergistic interaction is performed between the components so as to enable the auxiliary blood sugar and blood fat reduction effect of the combination to be maximized.

Description

A kind of compositions with auxiliary hyperglycemic and effect for reducing blood fat

Technical field

The present invention relates to a kind of compositions with auxiliary hyperglycemic and effect for reducing blood fat, belong to medicines and health protection field.

Background technology

Diabetes are one group of common incretion metabolism diseases, it is characterized by hyperglycemia, glycosuria, glucose tolerance, abnormal serum insulin concentration and insulin resistant etc.Diabetes are divided into 4 large classes, i.e. the diabetes of type 1 diabetes, type 2 diabetes mellitus, gestational diabetes and specific type.In China patient groups, based on type 2 diabetes mellitus or title noninsulindependent diabetes, accounting for more than 90.0%, is the main object of current oral drug therapy.

The type 2 diabetes mellitus cause of disease and pathogenesis are also indefinite at present, the insulin secretion that its significant pathophysiological features causes for islet beta cell function defect reduces (or relatively reducing) or insulin resistant or both jointly exist, insulin regulates and controls glucose metabolism ability and declines in body.Patient often merges one or more clinical manifestation of metabolism syndrome, as hypertension, dyslipidemia, obesity, hyperuricemia etc., in these risk factors, the risk factor of generally acknowledging is for causing atherosis dyslipidemia and blood glucose rising, and modal clinical manifestation is that hyperglycemia merges hyperlipemia.There is investigation display, there is dyslipidemia in the type 2 diabetes mellitus patient of 50% ~ 60%, especially when diabetic metabolic control is undesirable, its typical feature is that plasma tg raises, HDL-C (HDL-C) level reduces, low-density lipoprotein cholesterol (LDL-C) increases, and namely causes atherosis dyslipidemia.When serum TC is on close level, the danger of diabetics trouble cardiovascular disease is 2 ~ 4 times of ND.

When diabetes hyperlipemia merges other risk factors for atherosclerosis, the superposition of risk factor can make the danger of generation coronary heart disease greatly increase.Therefore, patients with dyslipidemia should be merged for diabetes, around the various risk factor of reduction, adopt science, rationally, based on the comprehensive therapy strategy of evidence-based medicine EBM.Clinical trial is verified, and Lipid modulating and glycemic control significantly can reduce the risk of diabetics generation cardiovascular event, then want preventing cardiovascular events to send out to existing cardiovascular disease person again.

Clinical treatment diabetes being merged to dyslipidemia, Western medicine achieves impressive progress, and conventional orally-taken blood sugar reducing medicine comprises thiazolidinediones (TZDs) and biguanides, and conventional fat-reducing medicament comprises statins and fibrate.

Oral antidiabetic drug and blood lipid regulation medicine use in conjunction show better effects to treatment of metabolic and prevention cardiocerebrovasculaevents events; And oral antidiabetic drug independent application controls type 2 diabetes mellitus blood glucose, shows certain effect to correction dyslipidemia, also has certain control action while blood lipid regulation Drug therapy hyperlipemia to type 2 diabetes mellitus disease progression.But, no matter be thiazolidinediones, biguanides orally-taken blood sugar reducing medicine, or Statins, shellfish special class dyslipidemia regulating drug, all there is more side effect, prolonged application adverse reaction rate is higher.In addition, these medicines, especially dyslipidemia regulating drug, medication in a short time can obtain good therapeutic effect, but great majority exist drug withdrawal rebound phenomena.

The single medicine of natural botanical source or compound preparation, there is multi-level, too many levels, Mutiple Targets action character, day by day to have manifested in the treatment of diabetes, hyperlipemia effect extensively, the advantage that not easily rebounds after the little and drug withdrawal of determined curative effect, side effect, especially most of Chinese medicine is while blood sugar lowering, blood fat reducing, produce the prevention of function of promoting blood circulation to disperse blood clots to cardiovascular and cerebrovascular disease and there is the incomparable advantage of Western medicine, be therefore more and more subject to attention and the acceptance of extensive patients.

Fat or long-term dyslipidemia often causes type 2 diabetes mellitus to occur, type 2 diabetes mellitus is also normal with dyslipidemia, there is indivisible relation between the two, together constitute the classical symptom of metabolic syndrome and the risk factor of cardiocerebrovasculaevents events, its inherent mechanism is the insulin resistant that organism metabolic disorder causes.At present, on market, the product of auxiliary hyperglycemic is more, and the product of auxiliary antilipemic is quite a few, but the product simultaneously with two kinds of functions is less.

Summary of the invention

For solution auxiliary hyperglycemic and effect for reducing blood fat are difficult to the problem of same medicine performance, the invention provides a kind of compositions with auxiliary hyperglycemic and effect for reducing blood fat.

Technical solution of the present invention realizes in the following manner: a kind of compositions with auxiliary hyperglycemic and effect for reducing blood fat, be made up of the component of following masses percentage composition: aloe full leaf xeraphium 40% ~ 70%, Fructus Momordicae charantiae extract 10% ~ 30%, Radix Puerariae extract 5% ~ 15%, propolis 5% ~ 15%, extract of panax notoginseng saponins 2% ~ 6%, the summation of above-mentioned each component is 100%.

Described aloe full leaf xeraphium to be polyoses content be 6 ~ 8% aloe full leaf xeraphium.

Described Fructus Momordicae charantiae extract to be total saponin content be 5 ~ 20% Fructus Momordicae charantiae extract.

Described Radix Puerariae extract to be general flavone content be 40 ~ 80% Radix Puerariae extract.

Described propolis is the propolis powder that chrysin content is not less than 2%.

Described extract of panax notoginseng saponins to be total saponin content be 75 ~ 85% extract of panax notoginseng saponins.

Compositions provided by the invention can be added suitable adjuvant routinely and is prepared into the preparations such as capsule, tablet, pill, powder, granule, oral liquid.

Wherein, Aloe, bitter, cold, nontoxic, let out, heart tonifying invigorated blood circulation, strengthen the effect of immunity and regeneration under there is sterilization, antiinflammatory, stomach invigorating.Fructus Momordicae charantiae, nature and flavor: cold are bitter; Function: clearing away summer-heat, improving eyesight is detoxified.Radix Puerariae: nature and flavor: cool, sweet in the mouth, pungent; Effect: induce sweat and bring down a fever, promotes the production of body fluid, rash, yang invigorating antidiarrheal.Propolis: nature and flavor: bitter, acrid, cold; Gui Jing: spleen, stomach warp; Effect: tonify deficiency for oral administration is weak, change turbid fat, only quench one's thirst; External removing toxic substances and promoting subsidence of swelling.Radix Notoginseng: nature and flavor: sweet, micro-hardship, warm in nature; Gui Jing: Liver Channel, stomach warp, heart channel, lung meridian, large intestine channel; Effect: loose blood; Analgesic therapy.

The invention provides the pharmacological action of the compositions with auxiliary hyperglycemic and effect for reducing blood fat: Aloe has auxiliary hyperglycemic effect for reducing blood fat, main composition is Aloe polysaccharide, its mechanism of action, for promoting islet cells reparation, strengthens Insulin receptor INSR sensitivity, thus improves insulin resistant; Balsam pear hypoglycemic effect is comparatively obvious, and main component comprises saponin, polysaccharide and polypeptide etc., and its mechanism of action is comparatively various, and Momordica charantial has ILA, and bitter gourd polypeptide can affect insulin secretion; Radix Puerariae is applied more in cardiovascular and cerebrovascular disease, its pharmacological action comprises blood pressure lowering, blood fat reducing, blood sugar lowering etc., main composition is Radix Puerariae flavone, its mechanism may with suppression glucosidase activity, anti peroxidation of lipid, improve vascular endothelial function, to improve blood microcirculation relevant; Radix Puerariae total flavones, has stronger alpha-glucosaccharase enzyme inhibition activity, can the hypoglycemic activity of enhancing composition; Radix Notoginseng is Chinese medicine material, and main composition is Radix Notoginseng total arasaponins, at present main medicine, health product with being applied to various cardiovascular and cerebrovascular disease class, and the mechanism of its reducing blood sugar and blood fat is mainly antiplatelet aggregation and falls fine effect, thus improves hemorheology; Propolis has comparatively strong anti-oxidation ability, can reduce over the harm of lipid oxide to blood vessel, prevent sclerosis of blood vessels, effectively reduces triglyceride content.

The advantage that the present invention possesses and effect: Aloe, Fructus Momordicae charantiae, Radix Puerariae, propolis, Radix Notoginseng combine by the present invention, respectively from islet cells reparation, insulin secretion accelerating, improve insulin resistant, glucosidase activity suppression, antioxidation, improve the many-sides such as blood microcirculation and play a role, between each component, mutual Synergistic, makes the auxiliary hyperglycemic of compositions, effect for reducing blood fat maximize.Animal experiment confirms, the compositions with auxiliary hyperglycemic and effect for reducing blood fat provided by the invention, has no significant effect normal mouse blood sugar, can reduce alloxan and cause diabetic mice fasting glucose, improves alloxan and causes diabetic mice carbohydrate tolerance; Can assist and reduce hypercholesterolemia rat model serum TC, LDL-C.Animal test results shows, compositions of the present invention is auxiliary while assisting in reducing blood sugar reduces TC, pure type 2 diabetes mellitus, pure hyperlipemia, type 2 diabetes mellitus are merged to dyslipidemia and all have prevention and auxiliary treatment, control the effect of progression of disease, add suitable adjuvant, can be used for preparing the medicine and the health food that prevent to merge dyslipidemia with treatment diabetes, hyperlipemia, diabetes.

Detailed description of the invention

Below in conjunction with detailed description of the invention, the present invention will be further described, and obviously, described embodiment is only the present invention's part embodiment, instead of whole embodiments.Based on the embodiment in the present invention, those of ordinary skill in the art, not making the every other embodiment obtained under creative work prerequisite, belong to the scope of protection of the invention.

Embodiment 1

The compositions with auxiliary hyperglycemic and effect for reducing blood fat is made up of the component of following masses percentage composition: polyoses content is the full leaf xeraphium 70% of Aloe vulgaris, the total saponin content Fructus Momordicae charantiae extract 10% that is 20%, the general flavone content Radix Puerariae extract 5% that is 80%, the chrysin content propolis 13% that is 2%, the total saponin content extract of panax notoginseng saponins 2% that is 75% of 6%, and the summation of above-mentioned each component is 100%.Propolis is preserved at-20 DEG C, takes out before use and pulverizes immediately, mixs homogeneously rapidly with other component.

Embodiment 2

The compositions with auxiliary hyperglycemic and effect for reducing blood fat is made up of the component of following masses percentage composition: polyoses content is the full leaf xeraphium 48% of Aloe vulgaris, the total saponin content Fructus Momordicae charantiae extract 27% that is 5%, the general flavone content Radix Puerariae extract 14% that is 40%, the chrysin content propolis 5% that is 3%, the total saponin content extract of panax notoginseng saponins 6% that is 85% of 8%, and the summation of above-mentioned each component is 100%.Propolis is preserved at-20 DEG C, takes out before use and pulverizes immediately, mixs homogeneously rapidly with other component.

Embodiment 3

The compositions with auxiliary hyperglycemic and effect for reducing blood fat is made up of the component of following masses percentage composition: polyoses content is the full leaf xeraphium 40% of Aloe vulgaris, the total saponin content Fructus Momordicae charantiae extract 27% that is 10%, the general flavone content Radix Puerariae extract 15% that is 60%, the chrysin content propolis 15% that is 2%, the total saponin content extract of panax notoginseng saponins 3% that is 80% of 7%, and the summation of above-mentioned each component is 100%.Propolis is preserved at-20 DEG C, takes out before use and pulverizes immediately, mixs homogeneously rapidly with other component.

Embodiment 4

The compositions with auxiliary hyperglycemic and effect for reducing blood fat is made up of the component of following masses percentage composition: polyoses content is the full leaf xeraphium 50% of Aloe vulgaris, the total saponin content Fructus Momordicae charantiae extract 30% that is 5%, the general flavone content Radix Puerariae extract 10% that is 40%, the chrysin content propolis 6% that is 3%, the total saponin content extract of panax notoginseng saponins 4% that is 85% of 8%, and the summation of above-mentioned each component is 100%.Propolis is preserved at-20 DEG C, takes out before use and pulverizes immediately, mixs homogeneously rapidly with other component.

Demonstration test is carried out to effect with the compositions of auxiliary hyperglycemic and effect for reducing blood fat provided by the invention below:

One, research purpose of the present invention

The pathophysiological mechanism of diabetes is that insulin resistant and insulin secretion lack, and the two all can cause disorders of lipid metabolism to cause dyslipidemia.When fatty tissue increasing number, especially when abdomen fat cell hypertrophy is loose, TG in adipose cell is easily decomposed to form free fatty (FAA), often high free fatty acid hyperlipemia is there is in circulation, and to make in TG and liver the triglyceride-rich lipoprotein synthesis such as VLDL, apoB100 increase, and its removing is also weakened, therefore can there is serious hypertriglyceridemia.Under the effect of cetp, cholesteryl ester in LDL and the TG in lipoprotein can exchange, TG in lipoprotein is transitted to LDL, form the LDL being rich in TG, the latter decomposes TG wherein under the effect of hepatic lipase (HL), and final formation contains the relatively many sLDL of cholesterol.SLDL is easily oxidized and produce lipid peroxide, and not easily by the ldl receptor approach metabolism of classics, thus by the scavenger receptor identification of Monocyte-macrophages, engulf, form foam cell, promote atherosclerotic generation.Meanwhile, when high very low density lipoprotein (VLDL)/hypertriglyceridemia, HDL is easy disintegrating after cholesterol transporter and hepatic lipase effect.Therefore, it is many with low hdl mass formed by blood stasis when blood fat disorder person presents hypertriglyceridemia.In above process, the increase of hepatic lipase activity and lipoprotein lipase activity reduce and play an important role.In addition, body is in hyperglycemia state for a long time causes the conversion coefficient of apo B to increase, and the binding ability of LDL and receptor is declined, thus has delayed its removing in blood plasma, increases macrophage and absorbs it, promote the formation of foam cell further.

Type 2 diabetes mellitus patient Yi Fasheng atherogenic dyslipidemia, this and type 2 diabetes mellitus occur together more central obesity and insulin resistant relevant.Central obesity often accompanies visceral fat accumulation, is the key character of metabolism syndrome, is also the main cause causing insulin resistant.In central obesity individuality, can fatty liver be caused, and liver enzyme level can be caused to raise, the even change of liver structure; Fat can cause β cell dysfunction after pancreas is piled up; Fat is piled up at internal organs also can cause secretion leptin, adiponectin, phylaxin, tumor necrosis factor-alpha (TNF-α), IL-6, angiotensin, PAI-1 etc. extremely, promotes generation and the development of cardiovascular and cerebrovascular disease.Insulin resistant can cause a series of consequence, infringement is produced to vitals, in order to compensatory, insulin requirements is increased, insulin secretion is corresponding increase also, the apoptosis speed that there is the individual pancreatic beta cell of diabetes inheritance susceptible factor will be accelerated, easily there is hyperglycemia, develop into clinical diabetes; Insulin resistant can start a series of inflammatory reaction, insulin resistant its inflammatory factor label individual, as c reactive protein (CRP) and cytokine interleukin element 6 (IL-6) level can obviously raise; Insulin resistant is also by the infringement of Endothelial Function, accelerate atherosclerotic process, show as that blood vessel endothelium adhesion factor increases, smooth muscle cell proliferation and vasodilation function reduction, this series of change is the key factor promoting atherogenesis; Insulin resistant also causes the unbalance of blood coagulation and Fibrinolytic function, there is hypercoagulability, because Fibrinogen, Plasminogen activator inhibitor 1 (PAI-1) level obviously increase, once there is blood coagulation in body, patient can not normally start fibrinolytic process, very easily causes the formation of thrombosis.

When diabetes hyperlipemia merges other risk factors for atherosclerosis, the superposition of risk factor can make the danger of generation coronary heart disease greatly increase.This kind of risk factors for atherosclerosis is: after older, hypertension, smoking and diabetes, female menopausal, familial history of coronary artery disease etc., and risk factor is more, and the probability of morbidity is larger.Therefore; patients with dyslipidemia should be merged for diabetes; around the various risk factor of reduction; employing science, rationally, based on the comprehensive therapy strategy of evidence-based medicine EBM, comprise and effectively lose weight, alleviate insulin resistant, well control blood glucose, control blood pressure, improve disorders of lipid metabolism, improve the measures such as blood circulation.

The present invention carries out studying according to the pathogenesis of type 2 diabetes mellitus, hyperlipemia, and then Aloe, Fructus Momordicae charantiae, Radix Puerariae, propolis, Radix Notoginseng are combined, respectively from islet cells reparation, insulin secretion accelerating, improve insulin resistant, glucosidase activity suppression, antioxidation, improve the many-sides such as blood microcirculation and play a role, between each component, mutual Synergistic, makes the auxiliary hyperglycemic of compositions, effect for reducing blood fat maximize.

Two, the function test of compositions assisting in reducing blood sugar provided by the invention

1 materials and methods

1.1 tested material

Compositions 1: embodiment 1 gained has the compositions of auxiliary hyperglycemic and effect for reducing blood fat.

Compositions 2: embodiment 2 gained has the compositions of auxiliary hyperglycemic and effect for reducing blood fat.

1.2 experimental animal

SPF level healthy adult Male Kunming strain mice 100, body weight 28 ± 2g.

1.3 high thermal energy fodders

Adeps Sus domestica 10%, sucrose 15%, yolk powder 15%, casein 5%, cholesterol 1.2%, sodium cholate 0.2%, calcium bicarbonate 0.6%, stone powder 0.4%, normal feedstuff 52.6%.

1.4 dosage groupings and given the test agent give

Mice normally ingests, drink water, and after conforming 5 days, gets 30 and is divided into 3 groups at random by body weight, be i.e. Normal group, compositions 1 high dose matched group and compositions 2 high dose matched group, often organizes 10.Be divided into 7 groups at random by blood glucose after all the other 70 animal model successes, often organize 10.I.e. model control group, two kinds of basic, normal, high 3 dosage groups of compositions (pressing 5 times of human body recommended amounts, 10 times, 20 multiple dose designs), all with 2ml/100g.bw gavage every day once, Normal group and model control group fill with isopyknic distilled water, continuous 30 days.Weigh in weekly 1 time and adjust gavage amount by body weight.Duration of test 3 matched groups are ingested normal diet, and 7 model group are ingested high thermal energy fodder.

1.5 modeling methods and Testing index

Animal conforms after 5d, fasting 24h, and with freshly prepared alloxan with 150mg/kg.bw dosage lumbar injection, fasting 10h after 5 days, measures fasting glucose.Give each test group given the test agent after 30 days, survey fasting glucose (being also carbohydrate tolerance test 0h blood glucose) and rate of descent, computing formula is: blood glucose value × 100% before (before test the rear blood glucose value of blood glucose value-test)/test, give the given the test agent of each formula test group various dose again, blank group, model control group gives equal-volume solvent, each group oral administration of glucose 2.0g/kg.bw after 15 minutes, measure to group 0.5 each after glucose, the blood sugar concentration (all using the full-automatic blood glucose meter of the vigor type produced by German Roche Holding Ag to measure) of 2 hours and Area under the curve of blood glucose, computing formula is: Area under the curve of blood glucose=1/2 [(0 hours blood glucose+0.5 hours blood glucose) × 0.5+ (2 hours blood glucose+0.5 hours blood glucose) × 1.5].

1.6 statistical analysis

Adopt SPSS 17.0 software kit to carry out statistical analysis, the comparison of the group difference of each Testing index mean adopts variance analysis, and test group significance level gets P=0.05.If F value >=F0.05, P≤0.05, carry out adding up (adopting LSD method) comparative test group and model control group diversity with the comparative approach between two of mean between multiple test group and a matched group, test group significant level gets P=0.05.Rank test is used instead to the data of nonnormal distribution or heterogeneity of variance and carries out statistical analysis.

2 result of the tests

2.1 impacts on Mouse Weight

Each test group the weight of animals difference (P > 0.05) that compares with Normal group that there are no significant before modeling, after modeling, test mid-term and test latter stage two kinds of compositions the weight of animals difference (P > 0.05) that compares with Normal group that there are no significant, show that two kinds of compositionss have no adverse effects to normal the weight of animals.Test model in mid-term each treated animal body weight is all remarkable in Normal group (P<0.05), after test, each model group body weight is also lower than Normal group, but model+two kinds of compositions low dose group compare there was no significant difference (P > 0.05) with Normal group, illustrate that the symptom that loses weight because of diabetes appears in model group animal, and two kinds of compositions low dose group body weight reductions to mice may there is certain reverse effect.In table 1.

Table 1 is on the impact of Mouse Weight

Note: * 3 non-modelings of matched group, body weight is and model group contemporaneity numerical value (before namely testing after modeling, dividing into groups afterwards); △ represents and compares P<0.05 with Normal group.

2.2 impacts on normal mouse fasting glucose

As shown in Table 2, after test, compositions matched group fasting glucose is compared with Normal group, and the equal not statistically significant of difference (P > 0.05), illustrates two kinds of compositionss to normal mouse blood sugar without impact.

Table 2 is on the impact of normal mouse fasting glucose

2.3 impacts on diabetic mice fasting glucose

Test is compared except there was no significant difference (P > 0.05) with model control group except model+compositions 1 low dose group latter stage, tested material each treated animal fasting glucose is all remarkable in model control group (P<0.05), illustrates that two kinds of compositionss all have the effect reducing diabetic mice fasting glucose in various degree.In table 3.

Table 3 is on the impact of diabetic mice fasting glucose

Note: △ represents and compares P<0.05 with Normal group, and * represents and compares P<0.05 with model control group

2.4 impacts on diabetic mice carbohydrate tolerance

The Area under the curve of blood glucose of model control group significantly increases (P<0.05) with Normal group, model+compositions 1 high dose group Area under the curve of blood glucose is significantly lower than model control group (P<0.05), and model+compositions 2 each dosage group Area under the curve of blood glucose is all remarkable in model control group (P<0.05).Model+compositions 2 is low, high dose group 0.5h blood sugar concentration is significantly lower than model control group (P<0.05), each test group animal 2h blood sugar concentration is all remarkable in model control group, illustrates that two kinds of compositionss all have the effect reducing diabetic mice carbohydrate tolerance test blood sugar concentration in various degree.In table 4.

Table 4 is on the impact of diabetic mice carbohydrate tolerance

Note: △ represents and compares P<0.05 with Normal group, ^*represent and compare P<0.05 with model control group.

3 conclusions

According to relevant evaluation standard, an index positive in fasting glucose and carbohydrate tolerance binomial index, and on intact animal's fasting glucose without impact, can judge that this given the test agent auxiliary hyperglycemic function animal test results is positive.In this test, two kinds of compositionss all have auxiliary hyperglycemic effect in various degree.The auxiliary hyperglycemic effect of compositions 2 is slightly better than compositions 1.

Three, the function test of compositions blood-fat-decreasing provided by the invention

1 materials and methods

1.1 tested material

Compositions 1: embodiment 1 gained has the compositions of auxiliary hyperglycemic and effect for reducing blood fat.

Compositions 2: embodiment 2 gained has the compositions of auxiliary hyperglycemic and effect for reducing blood fat.

1.2 laboratory animal

SPF level healthy adult male SD rat 80, body weight 200 ± 20g, often organizes 10.

1.3 hyperlipidemia model feedstuffs

78.8% normal feedstuff, 1% cholesterol, 10% yolk powder and 10% Adeps Sus domestica, 0.2% cholate.

1.4 dosage groupings and given the test agent give

Rat feed in barrier system maintains feedstuff and observes 5 days, 8 groups are divided at random by body weight, i.e. basic, normal, high 3 dosage groups (pressing 2.5 times of human body recommended amounts, 5 times, 10 multiple dose designs) of Normal group, model control group, two kinds of compositionss, all with 1ml/100g.bw gavage every day once, Normal group and model control group fill with isopyknic distilled water, continuous 30 days.Weigh in weekly 1 time and adjust gavage amount by body weight.

Duration of test, Normal group is ingested normal diet, and model control group and 6 test group are ingested hyperlipidemia model feedstuff.After within 30 days, experiment periods terminates, rat, to fasting 16h after tested material, is collected femoral artery blood, measures serum TC, TG, HDL-C, LDL-C level respectively with automatic clinical chemistry analyzer.

1.5 date processing

Adopt SPSS17.0 software kit, variance analysis is adopted to the comparison of rat body weight, blood fat TC, TG, HDL-C, LDL-C; If heterogeneity of variance, then variable is suitably changed, after variance is neat, the data after conversion are added up; If variable variance after conversion is still uneven, then uses rank test instead and add up.Significance level gets P=0.05.

2 experimental results

2.1 impacts on rat body weight

At the end of experiment, model control group compares body weight with Normal group slightly to be increased, but not statistically significant (P > 0.05); Each tested treated animal body weight and high fat matched group be there was no significant difference (P > 0.05) more also.Each treated animal is movable normal in experimentation, and performance without exception, shows that each formula all has no adverse effects to rat growthing development and general health situation.In table 5.

Table 5 is on the impact (X ± SD) of rat body weight

2.2 impacts on rat fat

Compared with Normal group, model control group TC raises, and difference has statistical significance (p<0.01); Model control group TG also has increase with LDL-C compared with Normal group, but difference does not have statistical significance (p > 0.05).Compared with model control group, low, the middle dosage group of compositions 1, the middle dosage group TC of compositions 2 reduce, and difference has statistical significance (p<0.05).6 experimental group TG with LDL-C are compared with model group, and difference does not have statistical significance (p > 0.05), but in compositions 1, TG, LDL-C of dosage group have obvious reduction trend compared with model group.Each group is compared all without significant difference (p > 0.05) with the HDL-C of matched group.In table 6.

Table 6 is on the impact (X ± SD) of SD rat fat

Note: * * represents and compares P<0.01 with normal group matched group, ^△represent and compare P<0.05 with model control group.

3 conclusions

According to relevant evaluation standard, under this experiment condition, compositions 1,2 has auxiliary reduction cholesterol function to a certain degree.Each test group is showed no significantly auxiliary reduction triglyceride function.

Four, the invention provides the test that compositions per os gavage gives SD rat acute toxicity

1 test objective

SD rat oral gavage gives the compositions of 2 kinds of different formulations, and observation group's compound may cause the character of toxic reaction, degree and reversibility; Infer toxicity target organ or target tissue; For the design of repeat administration toxicity test provides reference.

2 test materials

2.1 laboratory animal

2.1.1 essential information

SPF level SD rat, female 174.0 ~ 202.2g, male 191.3 ~ 226.2g, source: Beijing Vital River Experimental Animals Technology Co., Ltd. (production licence number: SCXK (capital) 2011-0001, quality certification serial number: 0273286), the environmental adaptation phase after entering the room: first conform before rat test of entering the room 6 days and do corresponding inspection, the environmental adaptation scope of examination: whether, animal general state, the weight of animals consistent with the quality index required when ordering.

2.1.2 rearing conditions

The large mouse cage tool of plastics (470mm × 345mm × 200mm) is raised, stocking density: 5/cage; Cage tool space displacement frequency: do not require displacement; Feeding environment condition standard: GB14925-2001; Feeding environment control system: Honeywell company EBI400 controls all-fresh air central air conditioner system automatically; Temperature: room temperature 19.27 ~ 24.24 DEG C; Humidity: relative humidity 43.57 ~ 55.4%; Illumination: artificial lighting, 12 hours light and shades are alternately (within 07: 30, turn on light, within 19: 30, turn off the light); Rate of ventilation: 10 ~ 20 times/hour, 100% all-fresh air.

2.1.3 feedstuff

60Coradiation sterilizing Mus full-valence pellet feed, feeding method: freely absorb, manufacturer: Shanghai Slac Experimental Animal Co., Ltd. provides, the Feedstuff Enterprises examination quality certification: Shanghai raises careful (2008) 04002.

Nutritional labeling detects: with reference to GB14924.3-2001, the confirmation of food pollution thing content: with reference to GB14924.2-2001, by supply of forage, business provides.

2.1.4 drinking-water

Laboratory animal drinking water (reverse osmosis water); Method of supplying water: drinking bottle splendid attire, freely absorbs; Total plate count detects: with reference to GB5749-2006, self-inspection after sampling (1 time/week); The confirmation of water pollutant content: with reference to GB5749-2006, send the unit with relevant qualification to detect after sampling, at least 2 times every year.

2.1.5 animal grouping

Group designs: solvent control group, compositions 1 group, compositions 2 groups; Size of animal: often organize 10; Sex ratio: male and female half and half; Group technology: according to rat body weight random district group; Concrete grouping information is in table 7.

Table 7 divides into groups information slip

Remarks: the first digitized representation group (1,4,5 represent solvent control group, compositions 1 group, compositions 2 groups respectively) of number of animals.Second letter represents sex (M is male, and F is female), and third and fourth bit value represents cage for animal number, and the 5th, 6 represents animal sequence number.

2.2 test sample

Compositions 1: embodiment 1 gained has the compositions of auxiliary hyperglycemic and effect for reducing blood fat.

Compositions 2: embodiment 2 gained has the compositions of auxiliary hyperglycemic and effect for reducing blood fat.

2.2.3 compound method

Before use, take a certain amount of composition powder, add after appropriate sterilized water for injection stirs, supply sterilized water for injection to volume required, be uniformly dispersed with homogeneous dispersion machine, be namely mixed with required solution.Room temperature, airtight, shading preservation after preparation, the same day uses.

2.3 reference substance

Sterilized water for injection, colourless clear liquid, 500mL/ bottle, Kelun Pharm Ind Co., Ltd., Sichuan produces, lot number: M11063023; The airtight preservation of room temperature, effect duration: 2013 05 month.Directly take before use, room temperature, airtight, shading preservation after preparation, the same day uses.

3 test methods and observation index

3.1 dose design and administration

5 kinds of natural plant extracts raw materials of the urgency done before this test malicious result of the test display prescription are the natural drug/food having no toxicity.

Issue " Chinese medicine, natural drug acute toxicity test technological guidance principle " with reference to 2005 03 month SFDA, the maximum of each prescription of this experiment investigation can dosage, route of administration: per os gavage; Administration volume: 20mL/kg/ time; Administration frequency: administration 2 times in a day, about 4 hours interval times, concrete dose design is in table 8.

Table 8 dose design table

3.2 observation index

3.3.1 general state is observed

After administration 7 days (administration the same day be test the 1st day), at least once a day.Observation index or content: include but not limited to situation and other toxic manifestations such as rat outward appearance sign, general behavior activity, the mental status, breathing state, feces character, genitals outward appearance, death; Veterinary confirms above-mentioned observed content and observed result weekly at least one times.

3.3.2 body weight

Test the 1st (before administration), within 3,5,7 days, measure each group of all survival rats body weight.

3.3.3 food ration

Test and within the 2nd, 6 day, measure each group of all survival rats food ration.Assay method: measure each rearging cage to forage volume on the 1st day, 2nd day in roughly the same timing residual feed amount, the difference of the two is each rearging cage animal total food-intake of 24 hours, with this divided by every cage number of animals, calculates the average food ration of every animal.

3.3 statistical analysis

The quantitative target such as body weight, food ration adopts mean ± standard deviation (X ± SD) to describe, one factor analysis of variance (ANOVA) is adopted to analyze, when group differences has a statistical significance (P≤0.05), Dunnett ' st inspection (Dunnett method) is adopted to compare each administration group and solvent control group group difference.When sample number is less than 3, directly list initial data, these group data are not carried out statistics and are compared.

4 result of the tests

4.1 general state

After administration in 7 day observation period, each group rat has no moribund/death results.Only within the 2nd day, there is transient loose stool and soft stool in test in compositions 2 groups of rats.Respectively group rat outward appearance sign, general status, inner directed behavior activity, the mental status, breathing, genitals and crissum, fecaluria etc. are showed no obvious abnormalities change for all the other.

4.2 body weight and food ration

The each test point of duration of test, each group rat body weight increases normal, and food ration no abnormality seen changes, in table 9,10.

Table 9 gives the impact (g, X ± SD) of 2 kinds of compositionss on SD rat body weight

Table 10 gives the impact (g//cage) of 2 kinds of compositionss on SD rat food ration

5 conclusions

Compositions 1 group, compositions 2 groups, often organize 10 rats, male and female half and half, can carry out administration by administration volume (in 1 day, interval is administered twice for 4 hours, and single administration volume is 20mL/kg) by maximum.After administration in 7 day observation period, each group of rat has no moribund/death results, compositions 2 groups of rats occur outside transient loose stool and soft stool on the 2nd day in test, and all the other are respectively organized rat outward appearance sign, general status, inner directed behavior activity, the mental status, breathing, genitals and crissum, fecaluria etc. and are showed no obvious abnormalities change.Body weight increases and food ration also no abnormality seen.

In sum, under this experimental condition, SD rat dosage per os gavage can give 2 kinds of different compositionss with maximum, has no overt toxicity reaction.

Get above-described embodiment resulting composition, test for following clinical:

One, treatment target

Hyperglycemic patients 50 example; Hyperlipemic patients 50 example; Patients Suffering Diabetes With Hyperlipidemia 50 example.Be divided into treatment group and each 75 examples of matched group at random.

Two, instructions of taking

Treatment group takes embodiment resulting composition, every day 1 ~ 2 time, and every consumption per day 3g, serve on 20.

Matched group is Lipid modulating routinely, serve on 20.

Three, result

Compositions therapeutic effect provided by the invention: the effective percentage of hyperglycemic patients is reached to 96%, reaches 99% to the effective percentage of hyperlipemic patients, the effective percentage of Patients Suffering Diabetes With Hyperlipidemia reaches 98%, and matched group only reaches 66% to the effective percentage of hyperglycemic patients, reaches 56% to the effective percentage of hyperlipemic patients, 38% is reached to the effective percentage of Patients Suffering Diabetes With Hyperlipidemia.

Four, conclusion

Aloe, Fructus Momordicae charantiae, Radix Puerariae, propolis, Radix Notoginseng combine by compositions provided by the invention, respectively from islet cells reparation, insulin secretion accelerating, improve insulin resistant, glucosidase activity suppression, antioxidation, improve the many-sides such as blood microcirculation and play a role, between each component, mutual Synergistic, makes the auxiliary hyperglycemic of compositions, effect for reducing blood fat maximize.The health-care effect of said composition is good, application safety, obtained constant product quality, easy to use.Have remarkable health-care effect, its effect is better than matched group.

Claims (6)

1. one kind has the compositions of auxiliary hyperglycemic and effect for reducing blood fat, belong to medicines and health protection field, be made up of the component of following masses percentage composition: aloe full leaf xeraphium 40% ~ 70%, Fructus Momordicae charantiae extract 10% ~ 30%, Radix Puerariae extract 5% ~ 15%, propolis 5% ~ 15%, extract of panax notoginseng saponins 2% ~ 6%, the summation of above-mentioned each component is 100%.

2. compositions according to claim 1, is characterized in that: described aloe full leaf xeraphium to be polyoses content be 6 ~ 8% aloe full leaf xeraphium.

3. compositions according to claim 1, is characterized in that: described Fructus Momordicae charantiae extract to be total saponin content be 5 ~ 20% Fructus Momordicae charantiae extract.

4. compositions according to claim 1, is characterized in that: described Radix Puerariae extract to be general flavone content be 40 ~ 80% Radix Puerariae extract.

5. compositions according to claim 1, is characterized in that: described propolis is the propolis powder that chrysin content is not less than 2%.

6. compositions according to claim 1, is characterized in that: described extract of panax notoginseng saponins to be total saponin content be 75 ~ 85% extract of panax notoginseng saponins.