Background technology
Diabetes are a kind of comprehensive diseases, are called as " mothers of all kinds of diseases and ailments ".World today's diabetes are on the rise to the harm of human health, are the global the fifth-largest causes of the death, are the third-largest causes of the death after only being positioned at cancer and cardiovascular disease in China.There is the diabetes patient in China more than 3,000 ten thousand at present, and these data are also continuing growth.
Past people thinks no matter be type i diabetes, or type ii diabetes, all because lacking insulin in the patient body causes, so the treatment diabetes mainly are to promote insulin, to reduce the intravital blood glucose of patient.Yet, international in recent years medical research finds that but in fact the intravital insulin of type ii diabetes people is to secrete the state of containing, but these patients' health is to insulin insensitivity, even produce opposing, cause these insulins can not bring into play their due effects.Simultaneously, the blood glucose that continues to raise in the patient body makes insulin secretion more and more again, and these insulins of crossing Sheng are deposited in the patient body for a long time, in large quantities, can cause complication such as hyperlipidemia, obesity, hat sexually transmitted disease (STD).And really endanger the type ii diabetes patient health, and cause physical disabilities, so life-threatening disease these complication just.The United States Medicine man had approved this viewpoint in 1993, and the Britain physician had approved this viewpoint in 1998.Therefore, now the countries in the world medical circle begins the treatment type ii diabetes focused on the complication prevention this purpose also of the present invention just.
Have hypoglycemic marine health food both at home and abroad seldom at present, mainly be because: the hazardness of (1) type ii diabetes complication is just to be approved by world medical circle in recent years; (2) for a long time, people only get used to research and development dietetic therapy product from the animals and plants of land; (3) the science lifting manipulation of the health food of prevention type ii diabetes complication is still popularized at the end; (4) people get used to treating diabetes and the prevention of having ignored diabetes.
Some hypoglycemic health foods are based on electuary at present, require amount big, take inconvenience, and considerable part are the health product of developing at type i diabetes.The simple hypoglycemic health food of what is more important is difficult to the bounce-back of blood sugar control, because hyperlipidemia and obesity can be brought out the rising of blood glucose equally.
Present hypoglycemic health food primary raw material is a Chinese crude drug, and some vegetable category extracts are also arranged.But with prevention type ii diabetes complication is purpose, is that the hypoglycemic health food of primary raw material is seldom seen with the marine organism extract.
Summary of the invention
The object of the present invention is to provide a kind of instant effect, obvious results is the hypoglycemic health food of purpose with prevention type ii diabetes complication.
Solution of the present invention is based on the understanding of II diabetic complication and principle, and to the understanding of marine bioactivity thing, achieve with reference to modern pharmacological research, from marine organism extract, filter out have hard masses softening and resolving, blood stasis dispelling blood, material-sodium alginate that physiologically active is very strong, scientific composition, make the sensitivity of its performance human activin tissue to insulin, delay the process of digesting and assimilating to sugar, increase biological activity, reduction is to the absorption of fat, to reach the effect of blood sugar lowering and fat-reducing, effectively prevent the generation of II diabetic complication.
Health food of the present invention is made by following materials of weight proportions:
Sodium alginate 95.00~99.90
Organic chromium (III) 0.10~5.00.
The preferred weight proportioning of preparation health food of the present invention is:
Sodium alginate 98.00~99.90
Organic chromium (III) 0.10~2.00.
The above-mentioned hypoglycemic health food that is used for type ii diabetes by common process, can be made said multiple dosage form on the pharmaceutics, as capsule, granule, tablet or powder etc.
An important feature of the present invention is the mechanism of action that sodium alginate improves anti-sugar, at first be that food paste rises because of viscosity after taking in sodium alginate, thereby secondly the food and extend paste is the diffusion velocity that has reduced glucose in the small intestinal in the holdup time of gastric.Delayed the process of digesting and assimilating of sugar, increased the sensitivity of tissue, impelled blood glucose to descend insulin.Non-insulin-dependent diabetes mellitus (NIDDM) patient exists tissue that insulin sensitivity is reduced, i.e. insulin resistant.Scarce chromium then is one of important pathogenesis of NIDDM, by replenishing the chromium element, thereby a kind of complex one carbohydrate tolerance factor (GTF) that contains that lacks in NIDDM patient's body is replenished, and then playing the effect of blood sugar lowering, the organic chromium that the present invention selects for use is meant various drug additives and the employed organic chromium of health food nutrient (III) that comprises chromium picolinate, chromium gluconate, nicotinic acid chromium etc.
Another important feature of the present invention is that the sodium alginate in this health food is the very high dietary fiber of purity, is the macromolecule block compound that manna alditol and manna guluronic acid are formed, and has generally to entangle the plain not available physicochemical property of dimension.The effect that stops lipid to absorb is arranged.In addition, can make free movement of the bowels, thereby reduce sodium, water retention, thereby receive that edema alleviates, the effect of weight loss.
Health food effective component of the present invention in addition is clear and definite, and steady quality is easy to control.Effective component purity height, so instant effect, effect is obvious.
Health food of the present invention is by clinical trial, and the result shows to have following advantage:
1, to select sodium alginate for use be primary raw material in the present invention, and effective component is clear and definite, and component is few.Flat flavor, instant.Natural having no side effect meets state food health legislation regulation.
2, component of the present invention does not contain other nutrient substance, and used sodium alginate belongs to highly purified plant edibility fiber, and satiety is arranged, and has fat-reducing effect preferably.
3, the present invention has a better role to glycosuria patient polyphagia, polydipsia, polyuria, cardinal symptom such as weak.
4, the present invention has comparatively significantly blood sugar lowering effect, and does not have side effects of pharmaceutical drugs.
5, the present invention can effectively prevent the generation of II diabetic complication.
The present invention is further illustrated below in conjunction with embodiment.
Embodiment 1
Health food of the present invention is made by following materials of weight proportions:
Sodium alginate 98.00%
Organic chromium (III) 2.00%.
Said components is made capsular production method is: (1) dry with sodium alginate and organic chromium (III), be crushed to the above fineness of 80 orders; (2) above-mentioned powder component is mixed in proportion after, press filled capsules operation filled capsules, the bottling, the packing.Use the auxilliary photograph of gamma ray, sterilize, sterilize, the actual absorption dosage of product is 5.0KGY.
Embodiment 2
Health food of the present invention is made by following materials of weight proportions:
Sodium alginate 99.90%
Organic chromium (III) 0.10%.
Said components is made capsular production method is: (1) dry with sodium alginate and organic chromium (III), be crushed to the above fineness of 80 orders; (2) above-mentioned powder component is mixed in proportion after, press filled capsules operation filled capsules, the bottling, the packing.Use the auxilliary photograph of gamma ray, sterilize, sterilize, the neat amount of the actual absorption of product is 5.0KGY.
Clinical observation report
The present invention observes at the specified hospital clinical of health ministry, adopt counter point between own control and group, 60 routine hyperglycemia examination trenchermans are divided into test-meal group and matched group at random, every group 30 example, viewing duration is former take the hypoglycemic medicine kind and dosage constant, the test-meal group adds food health food of the present invention, and matched group is with the food placebo.After one month, its result shows that the present invention has the effect of blood sugar lowering, fasting glucose decline 1.04 ± 1.67mmol/L, post-prandial glycemia decline 0.90 ± 2.21mmol/L, wherein effective 19 examples, total effective rate 63.33%, matched group fasting glucose and post-prandial glycemia descend all not obvious, effective percentage 10 examples wherein, there were significant differences for 33.33%, two group of contrast of total effective rate.Before and after the test-meal, blood, routine urinalysis and blood biochemistry index illustrate that all in normal range health food of the present invention is harmless to examination trencherman health.
Instructions of taking: 3/time, day clothes 3 times, ante cibum or (medicine) being taken before meal are used.Clinical test results such as table 1, table 2, table 3, table 4, table 5, table 6, table 7, table 8.
Table 1 for observe last as situation relatively.
By table 1, table 2 as seen, every index no significant difference before two groups of test-meals has comparability.
Table 3 is the variation of clinical symptoms before and after the test-meal.
Table 4 compares for effect.
By table 5 as seen, after one month, health food group fasting glucose decline 1.04mmol/L of the present invention, the matched group fasting glucose descends not obvious, and two groups are compared no significant difference.
By table 6 as seen, after one month, 2 hours after the meal blood glucose decline 0.90mmol/L of health food group of the present invention, the blood glucose decline in 2 hours after the meal of own control significant difference, matched group is not obvious, and two groups relatively have notable difference.
Table 7 compares for Blood Lipid before and after the test-meal.
By table 8 as seen, before and after two groups of test-meals, the every index of blood testing is all in normal range.
Situation comparison as table 1 observation is last (X ± SD)
The grouping example other course of disease blood glucose of several years rheological properties (mmol/L)
(example) (year) men and women's (year) 2 hours after the meal on an empty stomach
Of the present invention group 30 53.93 ± 7.37 12 18 6.60 ± 4.45 10.17 ± 2.77 14.13 ± 2.90
Matched group 30 53.70 ± 8.38 13 17 5.70 ± 4.06 10.45 ± 3.59 14.15 ± 4.84
Table 2 examination trencherman takes the hypoglycemic medicine situation
Dividing into groups, routine number sulphanylureas biguanides sulphur urea+take by the biguanides end
Of the present invention group 30 10 785
Matched group 30 8895
The variation of clinical symptoms before and after table 3 test-meal
Symptom produce effects (example) is (example) invalid (example) improvement rate % effectively
Matched group observation group of matched group observation group of matched group observation group of matched group observation group
Polydipsia 213765 45.45 61.54
Polyuria 1079 10 6 44.44 60.00
Weak 1138 11 5 26.67 64.29
Polyphagia 2145 10 4 37.50 60.00
Table 4 effect relatively
Organize routine enabledisable total effective rate
Other numerical example is counted % example number % %
Of the present invention group 30 19 63.33 11 36.67 63.33#
Matched group 30 10 33.33 20 66.67 33.33
Contrast #<0.5 between group
Fasting glucose comparison before and after the table 5 liang group test-meal (mmol/L, X ± SD)
The grouping fasting glucose
Difference after the test-meal before the test-meal
Of the present invention group 10.17 ± 2.77 9.14 ± 2.74-1.04 ± 1.67**
Matched group 10.45 ± 3.59 10.00 ± 3.37-0.44 ± 1.90
Own control * * P<0.01
Blood glucose comparison in 2 hours after the meal before and after the table 6 liang group test-meal (mmol/L, X ± SD)
2 hours after the meal blood glucose divides into groups
Difference after the test-meal before the test-meal
Of the present invention group 14.13 ± 2.90 13.23 ± 3.34-0.90 ± 2.21*
Matched group 14.15 ± 4.84 14.64 ± 4.77-0.49 ± 2.86#
Contrast #P<0.05 between own control * P<0.05 group
Blood Lipid comparison before and after table 7 test-meal (X ± SD)
Of the present invention group of (n=30) matched group (n=30)
Before the project test-meal after the test-meal before the test-meal after the test-meal
TC(mmol/L) 4.88±1.12 5.01±1.00 4.51±0.89 4.56±0.86
TC(mmol/L) 1.77±0.89 1.69±0.83 1.58±0.93 1.55±0.86
Blood safety index variation comparison before and after table 8 test-meal (X ± SD)
Of the present invention group of (n=30) matched group (n=30)
Before the project test-meal after the test-meal before the test-meal after the test-meal
TP(g/L) 74.75±3.67 73.88±3.98 75.46±4.86 74.89±5.14
ALB(g/L) 44.06±2.39 44.33±2.33 44.61±1.84 44.46±2.24
ALT(u/L) 17.60±10.57 16.70±9.92 17.07±10.08 18.60±11.82
AST(u/L) 20.46±4.81 18.97±5.53 21.97±9.35 20.37±9.11
UREA(mmol/L) 6.40±1.71 5.85±1.07 6.48±1.62 5.19±1.07
CRE(umo1/L) 92.59±12.83 90.60±12.67 90.70±15.52 91.30±12.42
HGB(g/L) 138.9±13.56 139.5±14.39 141.7±22.86 141.3±17.85
RBC(×10
12/L) 4.78±0.41 4.84±0.34 4.75±0.69 4.78±0.55
WBC(×10
9/L) 6.65±1.19 6.58±1.25 6.32±1.83 6.58±1.42