CN101138577A - Lipoic acid health food and uses thereof - Google Patents
Lipoic acid health food and uses thereof Download PDFInfo
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Abstract
The invention provides a lipoic-acid health food product, including lipoic acid, bitter gourd extract, vitamin C, vitamin E, vitamin B<SUB>1</SUB>, vitamin B<SUB>2</SUB>, vitamin B<SUB>6</SUB>, vitamin D, zinc gluconate, a chromium picolinate and other edible supplementary materials. The clinical results of the health food product show that the invention can improve the symptoms of diabetes, prevent and cure diabetes.
Description
Technical field
The present invention relates to the health food technology field, be specifically related to a kind of thioctic acid health food and application thereof.
Background technology
Diabetes are comprehensive diseases of a kind of common multi-pathogenesis, are difficult to cure, and needs of patients is taken medicine for a long time, and diabetic complication often causes serious consequence.2004, in state-owned 5,000 ten thousand people endure diabetes to the fullest extent and torment, annual newly-increased diabetics 1,200,000 increases by 3000 people average every day.Diabetes have become No. three killer after cardiovascular and cerebrovascular disease and cancer.Diabetes are again " affluenza ", lifelong disease simultaneously.Along with rapid development of economy, improving constantly of people's living standard and health care consciousness more and more paid attention to hyperglycemia.Therefore the prophylactico-therapeutic measures of strengthening diabetes comes into one's own, and research prevents and treats the newtype drug of diabetes and the big event that health food is present association area.Non-medication treatment diabetes such as health food exploitation having become one of focus of current medical science, threpsology, food scientific research.
Have clear and definite antioxidation at present both at home and abroad, to be used for hypoglycemic health food fewer, and present hypoglycemic health food primary raw material is a Chinese crude drug, composition is numerous, hypoglycemic mechanism is indeterminate, certain hypoglycemic activity that truly has through the modern medicine proof, but can not quick acting, select that raw material is uneven, quality is unstable for use, promptly still do not have and a kind ofly can play effective and clear and definite anti-oxidation health, stay-in-grade health food fast diabetes.
The inventor finds that after deliberation thioctic acid and the reduzate dihydrolipoic acid that forms in vivo thereof have stronger antioxidation, but does not see that so far being used for conduct prevents and treats the health food of diabetes.
Summary of the invention
Inventor's technical problem to be solved is to use the thioctic acid preparation and has the diabetes of control health care foods.
The present invention adopts thioctic acid, Fructus Momordicae charantiae extract, vitamin C, vitamin E, vitamin B
1, vitamin B
2, vitamin B
6, vitamin D, zinc gluconate, chromium picolinate and edible adjuvant magnesium oxide, lactose, dextrin, starch, microcrystalline Cellulose, citric acid, Fructus Citri Limoniae essence etc. make health product, reaches good effect:
Below the effect of each component of the present invention is described below:
Thioctic acid: thioctic acid and the reduzate dihydrolipoic acid that forms in vivo thereof are powerful antioxidant.Thioctic acid can be removed hydroxyl free radical, hypochlorous acid, peroxide nitroso-group anion and singlet oxygen.Dihydrolipoic acid can be removed superoxides, hydroperoxyl radical, renewable thioredoxin, vitamin C and glutathion, and the latter has can make vitamin E obtain recycling.Usually, the reason that causes oxidative stress in the diabetes has several, comprises the forfeiture of saccharification, separating of transition metal and the anaerobic condition that diabetes organize cell to occur.The intravital lipid hydroperoxide level of patient, dna adduct level, carboxyl protein level all increase.And thioctic acid is particularly suitable for preventing and treating by the active product of chalcogen, nitrogen family and crosses the diabetic complication of containing and causing owing to Wheat Protein.Thioctic acid can be transferred glucose transporter-4 and impel cell membrane that the picked-up of glucose is increased, can improved-type diabetics body in glucose utilize situation.Every thioctic acid of discovering has significantly improved the state of an illness of diabetes, comprises cataractous formation, vascular lesion and polyneuropathy.
Fructus Momordicae charantiae extract:, there are some researches show promptly that after reaching alloxan type diabetic rabbit normally and gavaging the Fructus Momordicae charantiae juice, its blood sugar level obviously reduces as far back as nineteen sixty.According to data at home and abroad, Fructus Momordicae charantiae effective ingredient Saponin class material has the obvious functions of blood sugar effect.Zhang Pingping in 1992 etc. show by zoopery, obvious to the animal pattern hypoglycemic activity, compare with control drug glyburide, its blood sugar reducing function slowly and lastingly, and the effect of glyburide group is stronger, irritates stomach blood glucose rise after 24 hours, meets or exceeds the preceding level of medication, infer that momordica saponins not only has direct para-insulin effect, but also the function that stimulates insulin to discharge is arranged.Wang Yongqing (balsam pear hypoglycemic effect research. Hunan Journal of Traditional Chinese Medicine, 1998,14 (6): 54-55) find that in balsam pear hypoglycemic effect research Fructus Momordicae charantiae extract has in various degree reduction effect to normal mouse blood sugar; Obviously reduce tissue of experimental diabetic mice blood glucose.Momordica saponins is by the effective ingredient that extracts in the Fructus Momordicae charantiae, has multiple biological activity.Sun Baoying etc. are in the pharmacodynamic experiment research of momordica saponins, and by high, medium and low dosage group administration normal rat, the result shows that momordica saponins has hypoglycemic activity to normal rat; The rat of drug treatment group and glyburide matched group, the result shows that momordica saponins has hypoglycemic activity to diabetes rat, its effect is better than the excellent blood that falls.Far away earlier grade of king found (momordica saponins hypoglycemic activity and Initial Study of Mechanism thereof in momordica saponins hypoglycemic activity and Initial Study of Mechanism thereof, aminoacid and living resources, 2001,23 (3): 42-45): momordica saponins is kept appropriate blood sugar concentration after can making the body feed, the supply body needs, prevent that blood glucose is too high, this effect may be partly relevant with glucocorticoid; The former of hypoglycemic activity two may be relevant with its participation regulatory enzyme activity therefore.In composition of the present invention, the shared better effects if of Fructus Momordicae charantiae extract and thioctic acid.
Vitamin C: vitamin C is a natural water-soluble antioxidant, participates in the biochemical reaction of many cells, and is essential by keeping health.The research data of Jiang Shengxian etc. shows that (diabetics serum vitamin C concentration changes the relation with blood fat, new medical science, 1994,25 (8): 402-404), diabetics serum Vc concentration obviously reduces than normal group, and the insulin-dependent patient reduces more remarkable.Diabetics serum Vc generally reduces, and corrects the back its glycolipid metabolism obstacle is clearly better, and this has important function to preventing the heart, brain, arteriorenal generation and development atherosis and peripheral vessels and neuropathy.Therefore diabetics replenishes Vc early and has the important clinical meaning except that basic glucose-lowering treatment.
Vitamin B
1: the oxidative deamination of acetone acid and Q one ketoglutaric acid reaction in the main involved in sugar metabolism of vitamin B1, more than two kinds of medication combined application both improved the circulation of neurotrophy blood vessel, increased neural Nutrition and Metabolism again, can significantly improve the remission rate of diabetic peripheral neuropathy, effective percentage is 87.5%, matched group is 41.6%, two group relatively significant difference (P＜0.05).In clinical use, low price is not seen obvious adverse reaction.
Vitamin B
2: vitamin B
2Have another name called riboflavin, Lututrin.The heart that main food source is an animal, liver, kidney, muscle, egg, breast etc., plant such as green vegetable and frumentum.Vitamin B
2For participating in the important nutrient of biological oxidation in the body, the clinical vitamin Bs such as preventing and treating angular cheilitis, glossitis, scrotitis, conjunctivitis, seborrheic dermatitis that is mainly used in
2Deficiency disease.In recent years find the new purposes of its control higher grade of blood glucose; Find again that in zoopery it has good participation effect to auxiliary blood sugar lowering.
Vitamin B
6: take the 50mg vitamin B every day
6, can stop the PD of diabetes, symptom is obviously alleviated.Diabetes have genetic predisposition, and its family member takes the 10mg vitamin B every day
6, can effectively prevent diabetes, vitamin B
6To preventing that gestational diabetes from also having positive effect.
Vitamin D: vitamin D for Autoimmune Diabetes comprise type 1 diabetes, adult's delayed Autoimmune Diabetes and of the same race be that the generation and the development of the diabetes sent out again after the islet transplantation has prevention or therapeutical effect, and the morbidity of type 1 diabetes is hanged down the vitamin D level with shortage, the serum of vitamin D and the vitamin D receptor gene pleiomorphism is relevant.Discover that in the use, D3 can stop or reduce the incidence rate of insulitis in the non-obese diabetes of Autoimmune Diabetes animal model (NOD) Mus, reduces the sickness rate of its spontaneous diabetes.Possible the mechanism of vitamin D prevention or treatment Autoimmune Diabetes is adjusting immunocyte such as helper T lymphocyte, dendritic cell, the lymphocytic activity of regulatory T, and the apoptosis of islet cells and immunocyte is had certain influence.
Vitamin E, zinc: the experiment according to Yang Xuefeng etc. shows that (zinc and vitamin E are to the influence of diabetes rat vivo oxidation and nonenzymatic glycosylation, Chinese public health, 2002,18 (9): 1054-1055), replenish Zn and VE to diabetes rat, the serum insulin activity of rising diabetes rat that can be in various degree, the blood sugar lowering level.This and antioxidants such as Zn, VE can be protected the insulin beta cell, and the rising insulin active promotes that glucose metabolism is relevant.
Chromium picolinate: chromium is to keep the glycometabolic key factor of human body.Studies show that now chromium is the cofactor of insulin, promote the reaction between insulin and receptor.Chromium has tangible blood sugar reducing function to experimental diabetic rats, and chromium supplement can reduce insulin resistant, and prevention blood glucose obviously fluctuates, even can reduce spontaneous postprandial hypoglycemia.
Above-mentioned raw materials all can obtain by commercially available.Wherein Fructus Momordicae charantiae extract, chromium picolinate and thioctic acid should meet the following requirements:
(1) Fructus Momordicae charantiae extract meets table 1 regulation available from the four seas, Nantong plant essence company limited.
Table 1
| Project | Index |
| Character | Brown ceramic powder |
| Total Saponin, % 〉= | 1.0 |
| Moisture, %≤ | 5.0 |
| Arsenic (in As), mg/kg≤ | 1.0 |
| Plumbous (in Pb), mg/kg≤ | 5.0 |
| Hydrargyrum (in Hg), mg/kg≤ | 0.1 |
| Total plate count, cfu/g≤ | 1000 |
| Mycete, cfu/g≤ | 100 |
| Yeast, cfu/g≤ | 100 |
| Coliform, MPN/100g≤ | 40 |
| Pathogenic bacterium (Salmonella, shigella, staphylococcus aureus, Hemolytic streptococcus) | Must not detect |
(2) chromium picolinate should meet the regulation of table 2.
Table 2
| Project | Index |
| Content, % 〉= | 98.0～102.0 |
| Moisture, %≤ | 4.0 |
(3) thioctic acid should meet the regulation of table 3.
Table 3
| Project | Index |
| Content, % 〉= | 99.0 |
| Loss on drying, %≤ | 0.5 |
| Residue on ignition, %≤ | 0.1 |
| Heavy metal, ppm≤ | 20 |
| Chloride, %≤ | 0.02 |
| Fusing point | 62～63℃ |
The invention provides a kind of thioctic acid health food, it by following column weight reason proportion raw material form, every contain:
Thioctic acid 1～1000mg, Fructus Momordicae charantiae extract 100mg～1000mg, vitamin C 8mg～50mg, vitamin e1 mg～5mg, vitamin B
10.1mg～1mg, vitamin B
20.1mg～1mg, vitamin B
60.1mg～1mg, vitamin D 0.2 μ g～0.5 μ g, zinc gluconate 10mg～30mg, chromium picolinate 0.02mg～0.08mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Health food of the present invention can be made oral tablet, capsule, oral liquid, granule, pill or powder by the conventional formulation technology by above-mentioned composition.The present invention have prescription simple, draw materials extensively, cost is low and be furnished with nutrient that nutrient can improve the diabetes patient lacks advantages such as situation and auxiliary hyperglycemic and be particularly suitable for taking for a long time of hyperglycemia population.
Health food eating method of the present invention and amount: every day 2 times, each 2, use before the meal or with canteen.
Health food content major control index of the present invention: this product lipoic acid is 90.0%～110.0% of a labelled amount, contain total Saponin should more than or equal to labelled amount 100.0%, contain chromium picolinate 75.0%～125.0%.
Another object of the present invention has provided the application of above-mentioned thioctic acid health food in preventing and treating diabetes.
Thioctic acid health food clinic trial result of the present invention is as follows:
1. material and method
1.1 sample
Thioctic acid health food of the present invention provides by Jiangsu Tonghe Pharmaceutical Co., Ltd. for No. 1, No. 2, tablet form, and both outward appearances, taste are basic identical, the 550mg/ sheet.One of them is a health food of the present invention, and another is the comfort sheet, and the human oral recommended dose is every day 2 times, each 2.
1.2 the experimenter selects
1.2.1 standard of including in: age 18-65 year, selection state of an illness after diet control or oral antidiabetic drug treatment is more stable, do not need to change types of drugs and dosage, only take the adult type ii diabetes patient of unknown quantity, fasting glucose 〉=7.8mmol/L (140mg/dl) or 2h blood glucose 〉=11.1mmol/L (200mg/dl) after the meal; Also can select the hyperglycemia population of 2h blood glucose 〉=7.8mmol/L of 7.8mmol/L 〉=fasting glucose 〉=6.7mmol/L (120mg/dl) or 11.1mmol/L 〉=after the meal.
1.2.2 experimenter's exclusion standard: type i diabetes (insulin-dependent) patient; Age is at under-18s or complication such as severe cardiac, liver, kidney were arranged in 65 years old, serious gastroenteropathy, or be associated with other serious primary disease persons, the psychotic; Diabetes ketosis, ketoacidosis and the infected were arranged in nearly one month; Take glucocorticoid and often use other to influence the pharmacohistory person of blood glucose; Take the article relevant in a short time, have influence on judgement person as a result with being tried function.
1.3 experimental design and grouping
The double blind random grouping is adopted in this experiment, between group and self two kinds of control design.According to above-mentioned Standard Selection 104 routine type ii diabetes patients, by blood glucose, blood lipid level, sex, age, the course of disease, the kind of taking medicine (sulphur urine class and two croak classes) and carry out harmony and check, with the comparability between the assurance group.
1.4 test method
Before the test each experimenter is pressed sex, age, different labor intensity, ideal body weight, stipulate corresponding diet with reference to original living habit, each group of duration of test is adhered to diet control, and the former medicament categories mediating recipe amount of using is constant.Test in beginning on 05 02nd, 2005, test-meal group 52 examples, matched group 52 examples.The experimenter takes the sample that provided by Jiangsu Tonghe Pharmaceutical Co., Ltd. every day 2 times, each 2, takes continuously 30 days.
2. observation index
Each measures once every observation index when test-meal begins and finish.
2.1 safety indexes
2.1.1 general physical examination: perquisition and understand experimenter's situations such as spirit, sleep, diet, defecation, blood pressure before the test.
2.1.2 routine blood test: red blood cell count(RBC), numeration of leukocyte and classification, content of hemoglobin mensuration etc.
2.1.3 routine urinalysis: pH value, leukocyte, glucose in urine etc.
2.1.4 stool for routine.
2.1.5 hepatic function test: total serum protein (TP), albumin (ALB), paddy ammonia transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), mensuration.
2.1.6 kidney function test: serum urea nitrogen (BUN), creatinine (Cr), blood glucose (GLU) are measured.
2.1.7 Chest X-rays, electrocardiogram, ultrasound diagnosis (before the test).
2.2 observation index:
2.2.1 observation of symptoms: detailed medical history-taking, understand patient's diet situation, medicining condition, activity, observe main clinic symptoms such as thirsty polydipsia, polyuria, polyorexia, fatigue and weakness, add up integrated value by mild symptoms multiple integral (serious symptom 3 minutes, middle disease 2 minutes, light disease 1 minute) before and after test-meal, and improve (each doing well,improving is effectively more than 1 minute) with regard to its cardinal symptom, the improvement rate observes the symptoms.
2.2.2 blood sugar detection: the test-meal thing is unified to be the steamed bread that the smart powder of 100g is made, and surveys on an empty stomach and 2 hours after the meal blood glucose.
2.2.3 blood glucose insulin assay: survey serum insulin on an empty stomach.
2.2.4 urinary glucose determination: urina sanguinis is qualitative on an empty stomach, by-, ± ,+, ++, +++, ++ ++ amass 0,0.5,1,2,3,4 respectively, divide, statistics integrated value before and after test-meal.
3. the result judges
Effectively: fundamental symptoms obviously improves, fasting glucose or after the meal before and after the 2h blood sugar test self relatively, difference has significance, and descends 〉=10% before the test; Test back test-meal group blood glucose value or blood glucose decline percentage rate and matched group compare, and difference has significance.
Invalid: fundamental symptoms's thing obviously improves, fasting glucose or the preceding decline＜10% of test of 2h blood glucose after the meal.
4. statistical procedures
Data result represents with mean ± standard deviation, self paired data adopts paired t-test, between test-meal group and the matched group under the prerequisite of homogeneity of variance, mean relatively adopts t check in groups, otherwise adopt the t check after carrying out satisfying homogeneity of variance after variable transforms, if variance is still uneven, adopt rank test.
5. result
Double-blind method is observed and is finished to make known: take No. 1 person and be health food of the present invention, take No. 2 persons and be placebo.5.1 ordinary circumstance: after test in 30 days, the test-meal group has 2 routine experimenters deleted because of judging curative effect, and matched group has 1 routine experimenter to take because of interruption to be subjected to test product deleted.Last efficiency test crowd test-meal group 50 examples, matched group 51 examples.Check experimenters such as routine blood test, hepatic and renal function, Chest X-rays, electrocardiogram, B ultrasonic are all in normal range before the test, and the grouping situation sees Table 1, and the preceding two groups of patient ages of test-meal, the course of disease, blood glucose, blood lipid level and the equal no significant difference of medicinal situation have comparability.Routine urinalysis, stool routine examination there is no unusually before and after the test-meal.
Data relatively as table 1 test-meal was last
| Project | Matched group | The test-meal group |
| Example number man/woman's age (year) course of disease (year) fasting glucose (mmol/L) is 2h blood glucose (mmol/L) cholesterol (mmol/L) after the meal | 51 21/30 47.82±5.83 6.02±2.24 9.68±2.16 12.87±2.04 4.55±0.58 | 50 24/26 47.34±4.65 5.92±2.36 9.65±2.06 12.82±2.08 4.54±0.64 |
| Not medication (example) sulphanylureas (example) biguanides (example) sulphanylureas+biguanides (example) other (examples) | 1 15 16 19 0 | 0 16 17 17 0 |
5.2 effect is observed
5.2.1 observation of symptoms: by table 2,3 as seen, take and tried thing 30 days, test-meal group clinical symptoms has clear improvement (P＞0.05), compares with matched group, and difference has significance meaning (P＜0.05).
Table 2 clinical symptoms integration statistics (x ± SD)
| Group | Example number (n) | Before the test-meal | After the test-meal |
| Matched group test-meal group | 51 50 | 5.25±3.29 5.32±3.32 | 4.92±3.02 2.36±2.18*# |
Annotate: compare relatively P＜0.05 of P＜0.05# and matched group before * and the test-meal
Table 3 clinical symptoms is improved situation
| Symptom | Matched group (n=51) | Test-meal group (n=50) | Improvement rate (%) | |||||
| The example number | Effectively | Invalid | The example number | Effectively | Invalid | Matched group | The test-meal group | |
| Thirsty polydipsia polyorexia fatigue and weakness polyuria | 31 30 26 28 | 4 5 4 4 | 27 25 22 24 | 33 29 24 29 | 26 23 21 22 | 7 6 3 7 | 12.90 16.67 15.38 14.29 | 78.79 79.31 87.50 75.86 |
5.2.2 clinical observation:
See Table 4, take and tried thing 30 days, test-meal group clinical observation total effective rate is 86.00%, with matched group (15.69%) comparing difference significance meaning (P＜0.05) is arranged.
Table 4 clinical observation effect relatively
| Group | Example number (n) | Effectively | Invalid | Total effective rate (%) |
| Matched group | 51 | 8 | 43 | 15.69 |
| The test-meal group | 50 | 43 | 7 | 86.00# |
Annotate: # and matched group be P＜0.05 relatively
5.2.3 fasting glucose
Shown that by table 5 self relatively compares before fasting glucose and the test-meal after the test-meal of test-meal group, difference has significance meaning (P＜0.05), and the preceding comparing difference of fasting glucose and test-meal does not have significance after the matched group test-meal.Compare between group, fasting glucose no significant differences before two groups of test-meals, test-meal group fasting glucose and matched group compare after the test-meal, and difference has significance meaning (P＜0.05), and blood glucose fall and matched group compare, and difference has significance meaning (P＜0.05).Illustrate that health food of the present invention has the effect of the fasting glucose of reduction.
Fasting glucose variation before and after table 5 test-meal (mmol/L, x ± SD)
| Group | The example number | Before the test-meal | After the test-meal | The blood glucose fall | The decline percentage rate |
| Matched group test-meal group | 51 50 | 9.68±2.16 9.65±2.06 | 9.62±2.12 8.62±1.87*# | 0.06±0.22 1.03± 0.43*# | 0.62 10.67 |
Annotate: compare relatively P＜0.05 of P＜0.05 # and matched group before * and the test-meal
5.2.4 2h blood glucose after the meal
By table 6 as seen, self relatively comparison before 2h blood glucose and the test-meal after the test-meal of test-meal group, difference has significance meaning (P＜0.05); Relatively, difference has significance meaning (P＜0.05) before 2h blood glucose fall and the test-meal after the meal; 2h blood glucose and 2h blood glucose fall and matched group comparison after the meal after the meal, difference all has significance meaning (P＜0.05).
2h changes of blood glucose (mmol/L, x ± SD) after the meal before and after table 6 test-meal
| Group | The example number | Before the test-meal | After the test-meal | The blood glucose fall | The decline percentage rate |
| Matched group | 51 | 12.87± 2.04 | 12.84±2.04 | 0.04±0.44 | 0.31 |
| The test-meal group | 50 | 12.82± 2.08 | 11.75±1.73*# | 1.07± 0.76*# | 8.35 |
Annotate: compare relatively P＜0.05 of P＜0.05 # and matched group before * and the test-meal
5.2.5 glucose in urine
Shown that by table 7 self relatively compares before glucose in urine and the test-meal after the test-meal of test-meal group, difference has significance meaning (P＜0.05); The preceding comparing difference of glucose in urine and test-meal does not have significance after the matched group test-meal.Relatively, glucose in urine does not have significant difference before two groups of test-meals between group, and test-meal group and matched group comparing difference have significance meaning (P＜0.05) after the test-meal.Point out health food of the present invention can reduce glucose in urine.
The variation of glucose in urine before and after table 7 test-meal (integrated value, x ± SD)
| Group | Example number (n) | Before the test-meal | After the test-meal |
| Matched group test-meal group | 51 50 | 2.12±1.42 2.16±1.31 | 2.06±1.41 1.18±0.96*# |
Annotate: compare relatively P＜0.05 of P＜0.05 # and matched group before * and the test-meal
5.2.6 serum insulin levels
See Table before and after 8, two groups of test-meals the serum fasting insulin no matter self relatively still between group relatively, difference there are no significant meaning.Point out health food of the present invention that serum insulin is not had influence.
The variation of serum fasting insulin before and after table 8 test-meal (mmol/L, x ± SD)
| Group | Example number (n) | Before the test-meal | After the test-meal |
| Matched group test-meal group | 51 50 | 22.59±4.95 22.39±4.75 | 22.38±4.85 22.47±4.66*# |
5.2.7 blood fat
Seeing Table self relatively to reach before and after 9 liang of groups cholesterol, triglyceride, the high density lipoprotein test does not more all have obviously change between group, point out health food of the present invention that blood fat is not had influence.
Change of blood sugar before and after table 9 test-meal (mmol/L, x ± SD)
| Project | Matched group (n=51) | Test-meal group (n=50) | ||
| Before the test-meal | After the test-meal | Before the test-meal | After the test-meal | |
| Cholesterol (TC) triglyceride (TG) high density lipoprotein (HDL-C) | 4.55±0.58 1.51±0.44 1.42±0.27 | 4.38±0.66 1.50±0.33 1.40±0.29 | 4.54±0.64 1.54±0.39 1.40±0.30 | 4.46± 0.62 1.52± 0.36 1.41± 0.30 |
5.3 security inspection: blood and hepatic and renal function
By table 10,11 as seen, eat and tried thing 30 days, two groups of routine blood tests, routine urinalysis (except the glucose in urine), stool routine examination and the every detection indexs of hepatic and renal function illustrate that all in normal range health food of the present invention does not have obvious damage to body health before and after the test-meal.
The variation of routine blood test before and after table 10 test-meal (x ± SD)
| Project | Matched group (n=51) | Test-meal group (n=50) | ||
| Before the test-meal | After the test-meal | Before the test-meal | After the test-meal | |
| Erythrocyte (* 10 12/ L) leukocyte (* 10 9/ L) hemoglobin (g/L) routine urinalysis (except the glucose in urine) stool routine examination | 4.69 ± 0.44 6.11 ± 1.36 131.75 ± 12.47 is normal | 4.71 ± 0.47 6.05 ± 1.49 132.02 ± 12.01 is normal | 4.74 ± 0.51 6.07 ± 1.44 132.78 ± 15.22 is normal | 4.76 ± 0.48 6.25 ± 1.45 133.80 ± 16.77 is normal |
The variation of liver, renal function before and after table 11 test-meal (x ± SD)
| Project | Matched group (n=51) | Test-meal group (n=50) | ||
| Before the test-meal | After the test-meal | Before the test-meal | After the test-meal | |
| Total serum protein (g/L) serum albumin (g/L) glutamate pyruvate transaminase (u/L) glutamic oxaloacetic transaminase, GOT (u/L) blood urea nitrogen (mmol/L) creatinine (mmol/L) | 72.79±4.61 46.61±4.41 25.29±10.37 24.08±8.65 4.52±0.84 111.78± 13.23 | 72.89±5.20 47.08±4.87 25.78±9.25 26.20±9.50 4.41±0.86 113.16± 13.94 | 72.57±4.87 46.88±4.94 25.96±8.91 25.14±9.30 4.48±0.78 109.76± 16.62 | 73.02±3.60 47.07±3.55 24.26±7.77 27.04±8.71 4.56±0.64 111.52± 13.54 |
Conclusion
Adopt counter point between own control and group, the trial volunteer of selecting to meet experimental condition is taken and is tried thing, and viewing duration is adhered to diet control, and former treatment Rezulin species mediating recipe amount is constant.The result shows after 30 days: health food of the present invention has the improvement effect to the diabetes main clinic symptoms, total effective rate is 86.00% (matched group is 15.69%), self relatively reach test-meal group and matched group comparison after the test-meal before and after fasting glucose, post-prandial glycemia and the glucose in urine test-meal, difference descends 8.35%, and serum insulin levels is not had obvious influence; Routine blood test and the every monitoring index of liver function do not have obviously change all in normal range before and after the test-meal, health food of the present invention are described to the healthy no obvious damage of experimenter, and have the function of the sugared quiet disease of control.
The specific embodiment
Every of embodiment 1:(contains following component)
Thioctic acid 1mg, Fructus Momordicae charantiae extract 1000mg, vitamin C 50mg, vitamin E 5mg, vitamin B
11mg, vitamin B
21mg, vitamin B
61mg, vitamin D 0.5 μ g, zinc gluconate 30mg, chromium picolinate 0.08mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
According to a conventional method through granulate, behind dry, the tabletting promptly.
Every of embodiment 2:(contains following component)
Thioctic acid 10mg, Fructus Momordicae charantiae extract 800mg, vitamin C 40mg, vitamin E 4mg, vitamin B
10.8mg, vitamin B
20.8mg, vitamin B
60.8mg, vitamin D 0.4 μ g, zinc gluconate 20mg, chromium picolinate 0.06mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Every of embodiment 3:(contains following component)
Thioctic acid 50mg, Fructus Momordicae charantiae extract 600mg, vitamin C 30mg, vitamin E 4mg, vitamin B
10.8mg, vitamin B
20.8mg, vitamin B
60.8mg, vitamin D 0.4 μ g, zinc gluconate 20mg, chromium picolinate 0.06mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Every of embodiment 4:(contains following component)
Thioctic acid 200mg, Fructus Momordicae charantiae extract 500mg, vitamin C 30mg, vitamin E 3mg, vitamin B
10.6mg, vitamin B
20.6mg mg, vitamin B
60.6mg mg, vitamin D 0.3 μ g, zinc gluconate 15mg, chromium picolinate 0.04mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Every of embodiment 5:(contains following component)
Thioctic acid 200mg, Fructus Momordicae charantiae extract 400mg, vitamin C 30mg, vitamin E 3mg, vitamin B
10.4mg, vitamin B
20.4mg, vitamin B
60.4mg, vitamin D 0.3 μ g, zinc gluconate 15mg, chromium picolinate 0.04mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Every of embodiment 6:(contains following component)
Thioctic acid 400mg, Fructus Momordicae charantiae extract 300mg, vitamin C 30mg, vitamin E 3mg, vitamin B
10.4mg, vitamin B
20.4mg, vitamin B
60.4mg, vitamin D 0.3 μ g, zinc gluconate 15mg, chromium picolinate 0.04mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Every of embodiment 7:(contains following component)
Thioctic acid 600mg, Fructus Momordicae charantiae extract 200mg, Catergen 0mg, vitamin E2 mg, vitamin B
10.2mg, vitamin B
20.2mg, vitamin B
60.2mg, vitamin D 0.3 μ g, zinc gluconate 10mg, chromium picolinate 0.03mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Every of embodiment 8:(contains following component)
Thioctic acid 800mg, Fructus Momordicae charantiae extract 100mg, vitamin C 10mg, vitamin E2 mg, vitamin B
10.2mg, vitamin B
20.2mg, vitamin B
60.2mg, vitamin D 0.2 μ g, zinc gluconate 10mg, chromium picolinate 0.02mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Every of embodiment 9:(contains following component)
Thioctic acid 1000mg, Fructus Momordicae charantiae extract 100mg, vitamin C 8mg, vitamin e1 mg, vitamin B
10.1mg, vitamin B
20.1mg, vitamin B
60.1mg, vitamin D 0.2 μ g, zinc gluconate 10mg, chromium picolinate 0.02mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Below be better embodiment of the present invention:
Embodiment 10 (every contains following component)
Thioctic acid 100mg, Fructus Momordicae charantiae extract 160mg, vitamin C 10mg, vitamin e1 .75mg, vitamin B
10.15mg, vitamin B
20.15mg, vitamin B
60.15mg, vitamin D 0.5 μ g, zinc gluconate 16.075mg, chromium picolinate 0.05625mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with embodiment 1.
Below be best embodiment of the present invention, its integrated cost and effect are best:
Example 11 (every contains following component)
Thioctic acid 20mg, Fructus Momordicae charantiae extract 160mg, vitamin C 10mg, vitamin e1 .75mg, vitamin B
10.15mg, vitamin B
20.15mg, vitamin B
60.15mg, vitamin D 0.5 μ g, zinc gluconate 16.075mg, chromium picolinate 0.05625mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
Flaking method is with example 1.
Claims (4)
1. thioctic acid health food, it is characterized in that it by following materials of weight proportions form, every contain:
Thioctic acid 1～1000mg, Fructus Momordicae charantiae extract 100mg～1000mg, vitamin C 8mg～50mg, vitamin e1 mg～5mg, vitamin B
10.1mg～1mg, vitamin B
20.1mg～1mg, vitamin B
60.1mg～1mg, vitamin D 0.2 μ g～0.5 μ g, zinc gluconate 10mg～30mg, chromium picolinate 0.02mg～0.08mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
2. thioctic acid health food, it is characterized in that it by following materials of weight proportions form, every contain:
Thioctic acid 100mg, Fructus Momordicae charantiae extract 160mg, vitamin C 10mg, vitamin e1 .75mg, vitamin B
10.15mg, vitamin B
20.15mg, vitamin B
60.15mg, vitamin D 0.5 μ g, zinc gluconate 16.075mg, chromium picolinate 0.05625mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
3. thioctic acid health food, it is characterized in that it by following materials of weight proportions form, every contain:
Thioctic acid 20mg, Fructus Momordicae charantiae extract 160mg, vitamin C 10mg, vitamin e1 .75mg, vitamin B
10.15mg, vitamin B
20.15mg, vitamin B
60.15mg, vitamin D 0.5 μ g, zinc gluconate 16.075mg, chromium picolinate 0.05625mg, magnesium oxide 40mg, lactose 157.918mg, dextrin 50mg, starch 38.75mg, microcrystalline Cellulose 20mg, citric acid 20mg, Fructus Citri Limoniae essence 15mg.
4. a thioctic acid is prevented and treated application in the health food of diabetes in preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200610030785A CN100577183C (en) | 2006-09-04 | 2006-09-04 | Lipoic acid health food and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200610030785A CN100577183C (en) | 2006-09-04 | 2006-09-04 | Lipoic acid health food and application thereof |
Publications (2)
| Publication Number | Publication Date |
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| CN101138577A true CN101138577A (en) | 2008-03-12 |
| CN100577183C CN100577183C (en) | 2010-01-06 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109528734A (en) * | 2019-01-24 | 2019-03-29 | 华纳时代健康科技（武汉）股份有限公司 | A kind of compound nutritional composition and preparation method thereof |
| CN109745359A (en) * | 2019-03-08 | 2019-05-14 | 储殷 | Be conducive to keep blood glucose balance and prevent diabetes and its composition of complication and preparation method thereof |
-
2006
- 2006-09-04 CN CN200610030785A patent/CN100577183C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109528734A (en) * | 2019-01-24 | 2019-03-29 | 华纳时代健康科技（武汉）股份有限公司 | A kind of compound nutritional composition and preparation method thereof |
| CN109745359A (en) * | 2019-03-08 | 2019-05-14 | 储殷 | Be conducive to keep blood glucose balance and prevent diabetes and its composition of complication and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100577183C (en) | 2010-01-06 |
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