CN1341444A - Health-care product with function of regulating blood sugar and its preparation method - Google Patents

Abstract

The present invention relates to a health-care product for regulating blood sugar and its preparation method. It is made up by using 3-30 portions of green tea, 5-60 portions of fresh bittersquash, 5-15 portions of mulberry leaf and 1-10 portions of astragalus root, Chinese yam, lycium berry and dried/fresh rehmannia as raw material through the processes of low-temp. extraction and refining. It is mainly used for reducing blood sugar and preventing diabetes.

Description

Have health product of blood sugar regulation effect and preparation method thereof

(1) technical field

The present invention relates to a kind of health product with blood sugar regulation effect, specifically it is that raw material is made the health product with blood sugar regulation effect with the Chinese herbal medicine.

The invention still further relates to the preparation method of these health product, belong to field of health care products.

(2) background technology

Diabetes are a kind of whole body chronic progressive diseases, all have this common feature of hyperglycemia.Clinical manifestation is a blood sugar increasing, the glucose in urine positive, and glucose tolerance minimizing and insulin discharge unusual.Classical symptom is " three-many-one-little ", i.e. polydipsia, polyphagia, polyuria and lose weight; It occurs with a series of complication in succession for a long time.

According to Diabetes mellitus, regulating and control high sugar is one of this sick key factor of prevention, by edible health product with blood sugar regulation health-care effect, make diabetic population have blood sugar lowering, improve clinical symptoms, for hyperglycemia tendency person (as impaired glucose tolerance, old people, obesity and hyperglycemia family history person is arranged) is arranged, can effectively prevent the generation of diabetes.

(3) technology contents

Task of the present invention in line with being the policy of assisting with the treatment of putting prevention first, provides a kind of health-caring capsule with blood sugar regulation health-care effect just, but makes the morbidity of people's prevent diabetes and improve the morbidity of diabetic population.

Task of the present invention realizes by following technical proposal:

A kind of health product with blood sugar regulation effect is characterized in that it is the capsule of being made by the following weight proportion raw material,

The bright Fructus Momordicae charantiae 5-60 of green tea 3-30 part part Folium Mori 5-15 part

Radix Astragali 1-10 part Rhizoma Dioscoreae 1-10 part Fructus Lycii 1-10 part Radix Rehmanniae 1-10 part.

The preparation method of health product is characterized in that it is undertaken by following step:

A) with 3-30 part green tea, 5-15 part Folium Mori, 1-10 part Radix Astragali, 1-10 part Fructus Lycii, 1-10 part Rhizoma Dioscoreae, 1-10 part Radix Rehmanniae mixes 6-8 times of water gaging of adding and after 60 minutes, by the centrifugal filtration of 150-200 order, collects filtrate 55-70 ℃ of following stirring and leaching, and filtering residue is standby;

B) the bright Fructus Momordicae charantiae of 5-60 part is removed capsule and seed afterwash, advance Juice squeezer and extrude natural juice and carry out centrifugalize, collect the Fructus Momordicae charantiae clear liquid, residue is standby;

C) again with the Fructus Momordicae charantiae clear liquid under＜5 ℃ of conditions, stir the ethanol that slowly adds＜5 ℃ down and make that to contain the alcohol amount be 70%, then under 4-6 ℃ of temperature, leave standstill 24 hours precipitation separations and clear liquor;

D) again the precipitation of (c) item is carried out lyophilization powder process, its clear liquor and (a) filtering residue and Fructus Momordicae charantiae (b) squeeze behind the juice residue and merge and mend ethanol, making ethanol content is 70%, stir to extract and filtered in 60 minutes, filtrate merges concentrating under reduced pressure with (a) filtrate again and becomes thick paste, spray drying powder process;

E) at last the lyophilized powder of (d) is mixed with spray drying powder,, incapsulate, be health product of the present invention through pelletize.

Consumer care ingredients of the present invention is summed up through a large amount of investigation and clinical practices, wherein:

Green tea: record in the Compendium of Material Medica " tea is bitter and tremble with fear, can pathogenic fire reducing, and the double again poison that can separate food and drink ", have health preserving, life lengthening effect.Folium Camelliae sinensis contains complex polysaccharide T.P.S and has obvious blood sugar lowering, the effect of raise immunity and reduction serum cholesterol and triglyceride.

Fructus Momordicae charantiae: in Compendium of Material Medica, put down in writing: " remove pathogenic heat, separate tired, clearing away heart-fire makes eye bright ".Through research for many years, Chinese scholars is isolated the active component that plant sterol, Charantin, P-insulin etc. have blood sugar reducing function from the fruit of Fructus Momordicae charantiae and seed, makes single or compound preparation is used for the treatment of diabetes.Chinese scholar from Fructus Momordicae charantiae, is successfully isolated blood sugar lowering functional component P-insulin and Charantin, and confirms that it truly has pharmacologic efficacy in regulating blood sugar level.

The present invention is based on Folium Camelliae sinensis, Fructus Momordicae charantiae, Folium Mori, be equipped with the Radix Astragali of tonifying Qi and lifting yang, spleen invigorating tonify deficiency, the smart Rhizoma Dioscoreae of reinforcing the kidney of taste, the Radix Rehmanniae of heat clearing away YIN nourishing, promoting the production of body fluid to quench thirst, the nourishing kidney tonifying liver makes eye bright, all multicomponents such as Fructus Lycii of lung moistening, has clearing heat and moistening lung, supplementing QI and nourishing YIN, the kidney invigorating and essence nourishing, the promoting the production of body fluid to quench thirst effect.

Each component Folium Mori in the prescription, the Radix Astragali, Rhizoma Dioscoreae, Fructus Lycii, the Radix Rehmanniae all contain anti-sugared active vegetable polysaccharides, as polysaccharides of Folium Mori, astragalus polysaccharides, Chinese yam polysaccharide, Fructus Lycii polysaccharide etc.Wherein astragalus polysaccharides APS-G has the effect of amphicheirality's blood sugar regulation.These health product are major ingredient with green tea and Fructus Momordicae charantiae, are equipped with Folium Mori, the Radix Astragali, Fructus Lycii, Rhizoma Dioscoreae, the Radix Rehmanniae etc., have strengthened the hypoglycemic activity of major ingredient.

Other components in Folium Camelliae sinensis, Fructus Momordicae charantiae, Rhizoma Dioscoreae and the prescription all contain abundant vitamin and trace element chromium.Chromium is the necessary trace element of human body, and+3 prices participate in intravital carbohydrate metabolism, and chromium is the ingredient of glucose tolerance factor, and glucose tolerance factor can be thought a kind of parahormone, can promote the blood glucose that raises to roll back normal value.Scarce chromium can make tissue that the sensitivity of insulin is reduced.The physiological action of insulin can be assisted or strengthen to chromium as a kind of " collaborative hormone ", influence body interior the physiological process of the insulin that relies on adjusting.The present invention can be human body and replenishes an amount of trace element, and replenishing stablizing the glycosuria blood glucose level in patients of chromium alleviates patient's symptom and promotion rehabilitation etc. and have obvious health care effect.One, health product testing result of the present invention () physical and chemical index: seeing Table 1 is provided by Beijing Sanitary and Antiepidemic Station

Physical and chemical index table 1 project standard index testing result net content allowed minus deviation %≤9 5.6 moisture g/100g≤7＜0.3 arsenic (AS), mg/kg≤0.3＜0.3 lead (Pb), mg/kg≤0.5＜0.5 bronze medal (Cu), mg/kg≤10 5.4 Gamma Hexaochlorocyclohexane, mg/kg≤0.2/clofenotane, mg/kg≤0.2/tea polyphenols, (%) 14-16 15.2 caffeine, g/kg≤10 8.9 selenium ug/100g/2.1 (two) microbiological indicators: see Table 2

Microbiological indicator table 2 project standard index testing result total plate count; Cfu/g≤30,000 70 coliforms, MPN/100g≤40 40 mould cfu/g≤25＜5 saccharomycete cfu/g≤25＜5 pathogenic bacteria (pathogenic entero becteria or pathogenic coccus) must not detect (three) functional component: see Table 3

Functional component table 3 project standard index testing result crude polysaccharides mg/g 70-80 75.9 total Saponin mg/g 4-6 4.4 (four) toxicological tests provide report by toxicity section of Beijing health and epidemic prevention station

1, acute oral toxicity test

Experimental animal is 40 of kunming mices, male and female half and half, body weight 18-22g divides four groups at random, each 5 of every group of male and female are subjected to that amount of reagent femalely is 2150,4640,10000,21500mg/kg.Bw, malely be 2150,4640,10000,21500mg/kg.Bv, per os is irritated stomach, observes for two weeks, and matched group is freely drunk water.

Result of the test: see Table 4

Acute oral toxicity test is table 4 dosage (mg/kg.Bw) 2,150 4,640 10,000 21500 sexes female 0/5 0/5 0/5 0/5 as a result

Male 0/5 0/5 0/5 0/5

* denominator is represented used number of animals, and molecule is represented the animal dead number

Female mice per os LD50 is greater than 21500mg/kg.Bw

Male mice per os LD50 is greater than 21500mg/kg.Bw

Conclusion:

Judge that according to acute toxicity grading criteria in " toxicological evaluation of food safety procedure and method " health product of the present invention belong to nontoxic level to chmice acute per os toxicity.

2, PCEMNR micronucleus test

Animal is 50 of kunming mices, male and female half and half, body weight 25-30g divides five groups at random, be subjected to amount of reagent 2500,5000,100008g/kg body weight, other establishes feminine gender, positive controls, and the positive gives cyclophosphamide 40mg/kgBW, the equal per os of animal subject and positive thing is irritated stomach, adopt 30 hours dose regimens, promptly twice dosing interval is 24 hours, after the last administration 6 hours.

Result of the test: see Table 5

PCEMNR micronucleus test table 5 dosage number of animals as a result increases the transfect cell number and has micronucleus cell to count (%) negative control female 55 * 1,000 10 2.0 of micronuclear rates (mg/kg.Bw) sex (only) (individual) (individual)

Male 55 * 1,000 10 2.0 low dosages (2500) female 55 * 1,000 8 1.6

Dosage (5000) female 55 * 1,000 7 1.4 in male 55 * 1,000 10 2.0

Male 55 * 1,000 8 1.6 high doses (10000) female 55 * 1,000 9 1.8

Male 55 * 1,000 6 1.2 positive controls female 55 * 1,000 247 49.4

Male 55 * 1,000 270 54.0

As seen from the table, each dosage group PCEMNR micronuclear rates and negative control group compare, and difference does not have significance, belong to range of normal value, and positive controls are compared with negative control group, and difference has utmost point significance (P＞0.01).The animal sensitivity is described, test is reliable.

Result of the test shows that health product of the present invention do not show damaging action to the mouse bone marrow cells chromosome, and the micronucleus test result is negative.

3, mouse sperm deformity test:

Animal is 25 of kunming mices, divides five groups at random, is subjected to amount of reagent 2500,5000,10000mg/kgBW, and per os is irritated stomach, once a day, continuous five days, put to death after 25 days, observe the sperm deformity incidence rate.

Result of the test: see Table 6

Mouse sperm deformity result of the test table 6 dosage number of animals is observed (%) negative control 55 * 1,000 55 33 22 0007 117 2.342500 55 * 1,000 30 18 13 0018 70 1.405000 55 * 1,000 46 20 13 1018 89 1.7810000 55 * 1,000 65 25 40014 99 1.98 positive control 55 * 1,000 212 40 11 108 17 289 5.78 of the two tail Wugous (individual) of fat end of reel double end of the teratocyte number distortion unsetting banana of number aberration rate (mg/kgBW) (only) sperm count

As seen from table, tried each dosage group of thing and compare with negative control group, difference does not have significance; Positive controls is compared with negative control group, and difference has significance (P＜0.01).The animal sensitivity is described, test is reliable.

Judge that according to mice sperm malformation test evaluation criterion in " toxicological evaluation of food safety procedure and method " health product of the present invention are in being subjected to the amount of reagent scope, to the effect of mouse propagation cell not damaged, result of the test is negative.

4, Salmonella reversion test

The mouse typhus sramana third constellations bacterium TA97, TA98, TA100, the TA102 that select for use the Salmonella reversion test chamber to obtain are four kinds of bacterial strains.

Every blood sample is to establish positive control and negative control in addition for 0.001mg, 0.005mg, 0.05mg, 5mg

Result of the test

4-1 participates in method statistical result: see Table 7

Salmonella reversion test participates in method statistical result table 7

Annotate: 1.TA97, TA98, TA102 do not add positive thing fenaminosulf 50/ ware of S-9

2.TA97, TA98, the TA100 positive thing that adds S-9 is with 2-aminofluorene 10/ ware

3.TA100 do not add positive thing sodium azide 1.5/ ware of S-9

4.TA102 the positive thing that adds S-9 is with 1,8-dihydroxyanthraquinone 50/ ware

4-2 testing site examination method result: see Table 8

Testing site examination method is table 8 as a result

The result:

(1), acute mouthful of LD50 of female, male mice be greater than the 2150mg/kg body weight, belongs to nontoxic grade;

(2), the negative result of mouse marrow cell micro nuclear test;

(3), the negative result of mouse sperm distortion test

(4) Ameg tests negative result.(5) 30 days feeding trials: provide report by Beijing Sanitary and Antiepidemic Station, 80 of experimental animal Wisear kind rats, male and female half and half, body weight 60-80g divides three dosage groups and negative according to group at random, and per os irritates that stomach dosage is 500,5000,10000mg/kgBW, continuous 30 days, detect index.

Result of the test:

1, to the influence of rat body weight, sees Table 9

To the 4th week of the 3rd week the 2nd week initial the 1st week of body weight of the other number of animals of table 9 gender group as a result that influences of rat body weight

( ) ( g ) ( g ) ( g ) ( g ) ( g ) 10 64.8±6.0 91.4±6.8 118.9±15.0 144.2±21.5 159.4±25.0 10 64.6±6.1 90.3±7.2 116.6±12.0 142.5±16.2 152.3±22.6 10 65.3±5.9 88.7±8.4 109.1±12.5 139.2±13.4 149.4±15.1 10 65.2±7.1 87.1±11.0 104.7±17.2 125.2±25.5 141.9±23.9 10 65.7±8.4 88.4±10.4 105.8±13.7 122.3±13.8 135.6±14.5 10 64.6±8.2 90.1±5.2 103.9±9.7 121.8±6.9 133.3±12.6 10 64.0±9.5 84.4±11.1 96.4±12.7 113.1±10.9 124.9±12.4 10 64.4±8.7 81.2±11.5 93.3±16.0 108.4±18.2 119.5±20.3

By table 9 as seen, each test group and control animals body weight gain are good, tried thing rat body weight is not seen harmful effect.

2, to the influence of rat total foodstuff utilization rate, see Table 10

Rat total foodstuff utilization rate influenced the other number of animals weight gain of table 10 gender group food-intake food utilization P value

(only) be (g) (%) the male high dose 10 69.5 in dosage 10 70.1 ± 11.6 349.7 ± 34.5 18.5 ± 3.0＞0.05 ± 19.0 355.3 ± 27.3 19.3 ± 0.9＞0.05 in the female control group 10 94.6 ± female middle dosage 10 81.9 in 24.7 358.4 ± 61.1 26.2 ± 3.5 female low dosages 10 87.7 ± 23.3 327.2 ± 45.8 26.8 ± 2.9＞0.05 ± 15.9 358.1 ± 64.0 25.9 ± 1.8＞0.05 female high doses 10 76.7 ± 23.2 315.2 ± 12.6 24.5 ± 3.4＞0.05 male control groups 10 69.8 ± 16.4 347.8 ± 19.2 20.0 ± 4.0 male low dosages 10 68.7 ± 12.7 357.8 ± 35.3 19.2 ± 2.2＞0.05 heros (g)

By table 10 result as seen, duration of test, each test group animal food utilization rate is compared with matched group, and through variance analysis, difference does not have significance (P＞0.05), illustrates that being tried thing does not have obviously the rat food utilization and influence.

3, to the influence of rat blood index: see Table 11

Rat blood is learned the other number of animals hemoglobin of table 11 gender group (g/L) the red blood cell count(RBC) numeration of leukocyte as a result that influences of index

(only) (* 10 ¹²/ L) (* 10 ⁹/ L) the male high dose 10 148.5 in dosage 10 152.1 ± 12.08 8.62 ± 0.48 11.59 ± 1.97 ± 10.74 8.64 ± 0.69 10.38 ± 2.33 in the female control group 10 154.1 ± female middle dosage 10 151.4 in 9.53 7.58 ± 1.90 9.33 ± 2.67 female low dosages 10 158.3 ± 8.67 8.88 ± 0.66 11.90 ± 1.58 ± 7.85 8.59 ± 0.37 9.59 ± 1.61 female high doses 10 148.1 ± 4.93 8.68 ± 1.01 9.92 ± 2.46 male control groups 10 144.4 ± 10.93 7.89 ± 1.19 10.06 ± 2.11 male low dosages 10 152.9 ± 9.99 8.75 ± 0.51 14.07 ± 2.97 heros

By table 11 result as seen, female, hero is respectively organized rat hemoglobin, red blood cell count(RBC) and numeration of leukocyte all in range of normal value, points out this sample that hematological indices is not had obvious influence.

4, to the result that influences of rat leukocyte classification: see Table 12

Rat leukocyte classification influenced that the other number of animals lymphocyte of table 12 gender group (%) is had a liking for acid, had a liking for alkali, the mononuclear cell neutrophilic granulocyte

(only) be the male high dose 10 71.38 in dosage 10 70.36 ± 5.00 10.47 ± 1.58 19.17 ± 5.33 ± 3.71 9.19 ± 1.28 19.43 ± 3.11 in (%) the female control group 10 68.33 ± female middle dosage 10 68.93 in 8.65 10.93 ± 2.11 20.74 ± 7.23 female low dosages 10 73.49 ± 6.58 8.68 ± 0.99 17.83 ± 6.12 ± 5.36 9.35 ± 1.24 21.72 ± 5.22 female high doses 10 68.09 ± 3.17 9.99 ± 2.57 21.92 ± 2.79 male control groups 10 69.61 ± 6.76 10.85 ± 2.32 19.54 ± 5.15 male low dosages 10 71.04 ± 4.06 9.05 ± 1.41 19.91 ± 3.05 heros (%)

By the listed result of table 12 as seen, each test group and control animals lymphocyte, have a liking for acid, have a liking for alkali, mononuclear cell and neutrophilic granulocyte measured value all in range of normal value, illustrate that being tried thing does not have obviously above-mentioned every index and influence.

5, to the influence of rat biochemical indicator: see Table 13

Table 13

To the influence property treated animal of rat biochemical indicator count glutamate pyruvate transaminase glutamic oxaloacetic transaminase, GOT blood urea nitrogen creatinine T-CHOL triglyceride blood glucose total protein albumin not (only) (U/L) (U/L) (mmol/L) (U/L) (mmol/L) (mol/L) (mmol/L) (g/L) (g/L) female right

According to

10 47.2 ± 6.84 146.4 ± 12.93 6.59 ± 1.82 101.7 ± 5.45 1.58 ± 0.18 0.27 ± 0.08 6.97 ± 0.59 74.9 ± 3.93 35.2 ± 0.92 female low 10 43.8 ± 4.32 143.7 ± 12.75 6.06 ± 0.66 100.7 ± 5.08 1.58 ± 0.18 0.36 ± 0.04 6.78 ± 0.76 67.1 ± 2.13 34.9 ± 1.10 female in 10 41.7 ± 4.90 131.4 ± 10.33 6.22 ± 0.66 102.9 ± 4.89 1.45 ± 0.16 0.33 ± 0.06 6.23 ± 0.37 67.3 ± 2.98 34.6 ± 1.26 female high by 10 41.1 ± 5.57 132.5 ± 13.01 6.40 ± 1.42 98.3 ± 9.58 1.58 ± 0.22 0.28 ± 0.06 5.72 ± 0.59 71.7 ± 3.62 33.7 ± 1.89 male right

According to

10 48.5 ± 3.98 150.4 ± 14.39 5.90 ± 0.54 97.2 ± 4.76 1.63 ± 0.20 0.37 ± 0.07 6.81 ± 0.63 66.8 ± 2.30 33.8 ± 1.48 male high by 10 42.4 ± 8.36 144.9 ± 16.66 6.13 ± 0.70 90.2 ± 4.54 1.63 ± 0.27 0.30 ± 0.10 6.17 ± 0.39 66.2 ± 2.49 34.0 ± 0.94 in 10 51.6 ± 4.50 156.3 ± 12.33 6.23 ± 1.30 96.8 ± 3.82 1.55 ± 0.25 0.23 ± 0.12 7.15 ± 1.14 71.8 ± 4.84 33.5 ± 1.35 male low 10 47.9 ± 7.34 147.8 ± 17.87 5.97 ± 0.67 97.4 ± 4.38 1.61 ± 0.21 0.63 ± 0.16 6.56 ± 0.47 67.8 ± 2.97 34.0 ± 1.33 heros

By the listed result of table 13 as seen, each test group and control animals are surveyed every biochemical indicator all at the normal value model

In enclosing, illustrate that being tried thing does not have obviously above-mentioned every biochemical indicator and influence.6, to the influence of the dirty body of rat: see Table 14

The dirty body of rat influenced the other number of animals heart/body of table 14 gender group (%) liver/body spleen/body kidney/body testis/body

（ ） （ ％ ） （ ％ ） （ ％ ） （ ％ ） 10 0.46±0.07 3.7±0.6 0.35±0.05 0.95±0.05 1.4±0.1 10 0.43±0.07 3.9±0.6 0.32±0.07 0.95±0.04 1.3±0.2 10 0.43±0.08 3.9±0.5 0.31±0.04 0.94±0.03 1.5±0.1 10 0.47±0.06 4.1±0.6 0.38±0.08 0.96±0.09 1.4±0.2 10 0.44±0.07 4.0±0.4 0.32±0.03 0.99±0.05 10 0.46±0.07 4.3±0.3 0.29±0.03 0.96±0.05 10 0.47±0.06 3.9±0.5 0.31±0.04 0.94±0.03 10 0.47±0.10 4.2±0.5 0.30±0.09 1.05±0.09。

By the table result as seen, each dirty/body of each test group and control animals is than not seeing significant change, and through variance analysis, difference does not have significance (P＞0.05), illustrate tried thing to rat dirty/body is than no obvious the influence.

7, the result of histopathologic examination: this this result of the test shows, except that negative control and low dose group individual animal occur the slight kidney hydronephrosis, each dosage treated animal liver, kidney, stomach, intestinal, testis, ovary all do not have through histopathologic examination sees that obvious toxic pathology changes.

Evaluation criterion according to 30 days feeding trials among " toxicological evaluation of food safety procedure and method " 15193.13-94 is judged, health product of the present invention are during 30 days feeding trials, each animal subject body weight gain is good, each test and control animals there is no food utilization, routine blood test, biochemical indicator and dirty/body ratio are had a significant effect, histopathologic examination does not also see that the histopathology relevant with being tried thing changes, and its maximum no-effect dose is greater than 10000mg/kgBW (be people's recommended amounts 100 times).

(6) blood sugar lowering effect human feeding trial:

Provide report by Xiyuan Hospital, Chinese Medicine Academy of China

1, study subject: type ii diabetes people 60 examples, age 35-65 year, no severe cardiac Liver and kidney etc. and disease are sent out disease, divide at random to be subjected to examination group and matched group, each group adopts own control design, between two groups be between control design.

2, diagnostic criteria: reference WHO tentative standard (the very sugared method of venous plasma) in 1980: diabetic symptom is arranged, any time blood glucose 〉=11.1mmol/L (200mg/dl) or fasting glucose 〉=7.8mol/L (140mg/di).

3, test-meal method: 60 routine diabeticss, divide two groups at random, former take the hypoglycemic medicine kind and dosage constant, add respectively the food health product of the present invention, every day 3 times, each 4.

4, effect criterion:

Formulate with reference to " new Chinese medicine clinical research guideline ".

Produce effects: fundamental symptoms disappears, fasting glucose≤7.2mmol/L (130mg/di); Or blood glucose descends 〉=30% before the treatment.

Effectively: fundamental symptoms obviously improves, fasting glucose≤8.3mmol/L (130mg/di); Or blood glucose descends 〉=10% before the treatment.

Invalid: fundamental symptoms does not have obvious improvement, and fasting glucose descends and do not reach above-mentioned standard.

5, result of the test:

5-1, physical data:

Observe 60 examples altogether, be subjected to examination group male 7 examples, women's 23 examples, minimum 35 years old of age, the oldest 65 years old, average 56.83 years old, average course of disease 8.14 years; Matched group male 5 examples, women's 25 examples, minimum 36 years old of age, maximum 65 years old, average 57.8 years old, average course of disease 6.50, the person that is the type ii diabetes.

5-2, blood sugar lowering effect:

5-2-1, empty stomach and post-prandial glycemia compare: see Table 15

Before and after two groups of test-meals on an empty stomach and 2 hours after the meal blood glucose relatively (mmol/L, the table 15 of X ± SD)

Empty stomach and blood glucose comparison in 2 hours after the meal before and after two groups of test-meals (mmol/L, X ± SD)

2 hours after the meal blood glucose of table 15 grouping fasting glucose

Before the test-meal after the test-meal before the difference test-meal after the test-meal difference be subjected to examination group 9.38 ± 2.93 8.83 ± 2.82-0.55 ± 1.27* 13.78 ± 4.38 11.57 ± 3.44-2.21 ± 2.60** matched groups 9.10 ± 2.72 9.60 ± 2.80 0.50 ± 2.14# 14.43 ± 5.44 13.74 ± 5.04-0.69 ± 2.95#

Contrast #P＜0.05 between own control * P＜0.05***P＜0.001 group

After one month, be subjected to the examination group fasting glucose 0.55mmol/L that on average descends, 2 hours after the meal blood glucose 2.21mmol/L that on average descends; It is not obvious that the matched group fasting glucose descends, 2 hours after the meal blood glucose 0.6mmol/L that on average descends, and two groups relatively have notable difference.

5-3-2, fasting glucose, glucose in urine, urine ketoboidies compare: see Table 16

In before the test-meal back fasting glucose and glucose in urine urine ketoboidies change relatively (before the table 16 project example number test-meal of X ± SD) in the test-meal before in after the difference test-meal before and after difference GLU (mmol/L) 30 9.38 ± 2.93 9.09 ± 3.13-0.29 ± 1.48 8.83 ± 2.82-0.55 ± 1.27*

(30) (9.10 ± 2.72) (9.60 ± 3.02) (0.51 ± 2.23) (9.60 ± 2.80) (0.50 ± 2.14) # glucoses in urine (mg/L) 30 86.67 ± 194.73 18.33 ± 33.43

(30) (78.33 ± 191.49) (163.33 ± 342.64) urine ketoboidies 30--

(30) (-) (-)

Contrast #P＜0.05 between () matched group own control * P＜0.05 group

Be subjected to examination group test-meal fasting glucose in mid-term that decline is promptly arranged, after one month, the 0.55mmol/L that on average descends, matched group descends not obvious, and two groups of contrasts have notable difference (P＜0.05).

The 5-2-3 carbohydrate tolerance changes; See Table 17

Carbohydrate tolerance changes that (mmol/L is before the routine number test-meal of table 17 grouping of X ± SD) before the test-meal before and after the test-meal

Post-prandial glycemia-fasting glucose post-prandial glycemia-fasting glucose is subjected to examination to organize 30 4.40 ± 3.09 2.74 ± 1.86 matched group 30 5.33 ± 3.42 4.15 ± 3.54 liang group contrast carbohydrate tolerance variation no significant difference.The 5-2-4 serum insulin compares: see Table 18

Relatively (μ u/ml, X ± SD) table 18 divided into groups 2 hours after the meal on an empty stomach two groups of empty stomach serum insulins

Be subjected to examination group 13.95 ± 7.80 14.45 ± 7.96 27.22 ± 10.43 23.48 ± 14.82 after the test-meal before the test-meal after the test-meal before the test-meal

(N=27) (N=29) (N=27) (N=30) matched group 13.55 ± 6.23 13.23 ± 6.03 26.58 ± 15.95 25.73 ± 16.67

(N=23) (N=26) (N=30) (N=28) 5-2-5 blood sugar lowering effect comparison: see Table 19

Blood glucose value effect statistical table 19 grouping produce effects enabledisable total effective rates (%) are subjected to examination group example several 5 16 9 21

Effect rate (%) 16.67 53.33 30.00 70.00 matched groups example several 4 11 15 15

Effect rate (%) 13.33 36.67 50.00 50.005-2-6 doing well,improving situations: see Table 20

Cardinal symptom is improved information slip 20 symptoms example digital display effect enabledisable improvement rate (%) polyphagia 24 0 16 8 66.67

(22) (0) (9) (13) (40.91) polydipsia 22 4 14 4 81.82

(24) (1) (9) (14) (41.67) polyuria 15 276 60.00

(21) (1) (8) (12) (42.86) tired 24 699 62.50

(25) (3) (7) (15) (40.00) weak 20 398 60.00

(16) (1) (6) (9) (43.75) frequent urination at night 21 2 13 6 71.43

(16) (1) (6) (9) (43.75) () matched group

Aspect each cardinal symptom improves, be subjected to the examination group all to be better than matched group.5-2-7 clinical symptoms integration statistics: see Table 21

Clinical symptoms integration statistics (is subjected to examination to organize 30 27.50 ± 18.56 16.27 ± 12.76***, 13.27 ± 10.21*** matched groups, 30 27.57 ± 15.95 21.67 ± 13.89***, 19.13 ± 13.62*** own control * * * P＜0.001 after the test-meal in the test-meal before the routine number test-meal of table 21 grouping of X ± SD)

Be subjected to examination group and matched group that the effect that improves clinical symptoms is all arranged.5-2-8, Blood Lipid situation: see Table 22

Relatively (X ± SD) table 22 project is subjected to examination group (n=30) matched group (n=30) to Blood Lipid before and after the test-meal

Before the test-meal after the test-meal before the test-meal after the test-meal TC (mmol/L) 3.97 ± 0.22 4.04 ± 0.19 4.09 ± 0.81 3.97 ± 0.69TG (mmol/L) 1.59 ± 0.84 1.70 ± 1.11 2.06 ± 1.40 1.92 ± 1.16HDL-C (mmol/L) 1.54 ± 0.26 1.41 ± 0.33 1.30 ± 0.28 1.44 ± 0.29 be subjected to examination group and matched group to blood fat every all do not have obviously influence.5-2-9, blood safety index observing: relatively (X ± SD) table 23 project is subjected to examination group (n=30) matched group (n=30) to the variation of blood safety index before and after seeing Table 23 test-meals

(27.36 ± 17.71 30.95 ± 31.61 24.18 ± 15.61 23.90 ± 13.09AST of μ/L) (42.06 ± 12.95 44.99 ± 14.99 38.23 ± 13.78 38.51 ± 13.69UREA (mmol/L), 5.82 ± 1.72 6.37 ± 1.74 5.68 ± 1.28 5.71 ± 1.61Cre (μ mol/L), 70.05 ± 8.56 77.17 ± 9.65 76.36 ± 13.69 74.66 ± 12.50HGB (g/L), 157.47 ± 13.78 146.67 ± 18.80 145.47 ± 13.44 151.00 ± 15.17RBC (* 10 of μ/L) of TP (g/L) 75.06 ± 4.89 74.22 ± 3.77 76.62 ± 7.00 76.92 ± 5.43ALB (g/L) 50.69 ± 3.11 50.31 ± 2.30 48.85 ± 2.21 49.18 ± 2.63ALT after the test-meal before the test-meal after the test-meal before the test-meal¹²/ L) 5.33 ± 0.49 5.49 ± 0.63 5.17 ± 0.49 5.35 ± 0.74WBC (* 10 ⁹/ L) 8.38 ± 1.32 6.92 ± 1.34 6.24 ± 1.61 6.32 ± 1.40

Before and after two groups of test-meals, the every index of blood testing is all in normal range.

5-2-10, Chest X-rays, electrocardiogram, ultrasound diagnosis: the experimenter is all in normal range.Conclusion:

Health product of the present invention have the effect that comparatively significantly reduces empty stomach and post-prandial glycemia.Be subjected to the examination group fasting blood sugar 0.55 ± 1.27mmol/L that descends, the post-prandial glycemia 2.21 ± 2.60mmol/L that descends, produce effects 5 examples wherein, effective 16 examples, total effective rate 70.00%; It is not obvious that the matched group fasting blood sugar descends, the post-prandial glycemia 0.69 ± 2.95mmol/L that descends, produce effects 4 examples wherein, effective 11 examples, total effective rate 50.00%; Two groups relatively there were significant differences, illustrates that these health product have certain effect to the type ii diabetes blood sugar lowering.

2. after the test-meal health product of the present invention to cardinal symptoms such as type ii diabetes examination trencherman polyphagia, polydipsia, polyuria, tired, weak, frequent urination at nights, have a better role.

3. after the test-meal health product of the present invention, inspection indexs such as hemoglobin, erythrocyte, leukocyte, total serum protein, albumin, glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, inosine, carbamide and routine urinalysis are every are all in normal range, and this product is described, and the trencherman is healthy to have no adverse effects to trying.

In the test-meal process, do not observe allergy and other untoward reaction.

(7) blood sugar regulation Function detection

Provide report by Beijing Sanitary and Antiepidemic Station

Select to grow up 40 of female mices divide four groups at random according to blood glucose, i.e. negative control group and tried basic, normal, high three dosage of thing is respectively 100,1000,3000mg/kgBW, and continuous 14 days, matched group was drunk distilled water.The result is as follows: 1, to the influence of normal mouse fasting glucose: see Table 24

The fasting glucose after the fasting glucose administration that influences before the table 24 group dosage number of animals administration as a result to the normal mouse fasting glucose

(mg/kgBW) (only) (mmol/L) dosage group 1,000 10 5.25 ± 1.03 5.37 ± 1.11 high dose group 3,000 10 5.25 ± 1.04 5.42 ± 1.05 in (mmol/L) matched group-10 5.25 ± 1.13 5.29 ± 1.15 low dose group 100 10 5.26 ± 0.99 5.35 ± 1.01

By the listed result of table 24 as seen, compare with negative control group, the empty stomach value of being tried each dosage group administration front and back of thing does not all have the difference of tool statistical significance.2, to the influence of alloxan induced hyperglycemia model mice blood glucose: see Table 25

Influence to alloxan induced hyperglycemia model mice blood glucose: before the administration of table 25 group dosage number of animals after the fasting glucose administration fasting glucose give glucose blood glucose difference after 2 hours

(mg/kgBW) (only) (mmol/L) (mmol/L) (mmol/L) (mmol/L) hyperglycemia model--dosage group 1,000 10 13.2 ± 1.87 10.6 ± 1.53*, 16.7 ± 2.89** 6.1 ± 1.45* high dose group 3,000 10 13.1 ± 1.92 9.7 ± 1.87**, 14.6 ± 3.10** 4.9 ± 1.35** phenformin 50 10 13.1 ± 1.90 9.4 ± 1.92** 13.9 ± 3.36** 4.5 ± 1.61** in 10 13.0 ± 2.01 13.2 ± 3.26 21.0 ± 4.32 7.8 ± 1.74 control group low dose group 100 10 13.1 ± 1.84 12.4 ± 2.04 20.6 ± 3.36 8.2 ± 1.71

Annotate: compare with the hyperglycemia model matched group: * P＜0.05; * P＞0.01

By the listed result of table as seen, respectively organize the difference that fasting blood sugar does not have the tool statistical significance before the administration.And compare with the hyperglycemia model matched group, after middle dosage group and the high dose group administration fasting glucose and give glucose after 2 hours blood glucose all obviously reduce, learn check by statistics, difference has significance or highly significant.Simultaneously, two indexs of this of insoral group also obviously reduce, and through check, difference has highly significant.

Observation is tried thing the result of the test that the normal mouse fasting glucose influences is shown, the fasting blood sugar of each treated animal is in the forward and backward difference of all not having the tool statistical significance of administration, illustrates that this is tried thing and the fasting glucose of normal mouse is not had influences.

The result of the test that observation is tried hyperglycemia mouse blood sugar that thing causes alloxan and influences shows, after the administration of middle and high dosage group fasting glucose and give glucose after 2 hours the difference of blood glucose and fasting glucose all be starkly lower than the hyperglycemia model matched group, through check, difference tool statistical significance.Point out this to be tried thing mice fasting glucose and the carbohydrate tolerance reduction that alloxan causes all had certain regulating action.Conclusion:

Normal mouse blood sugar is not had influence, and rising of hyperglycemia model mouse blood sugar and carbohydrate tolerance reduction that alloxan is caused have regulating action.

(8) stability test: provide report by food section of Beijing Sanitary and Antiepidemic Station

The result is as follows: see Table 26

Stability test testing result table table 26

960606 960818 960929 980816 980912 981010 ( mg/kg ) ＜0.30＜0.30＜0.30＜0.30＜0.30＜0.30 ( mg/kg ) ＜0.50＜0.50＜0.50＜0.50＜0.50＜0.50 ( mg/kg ) 5.4 6.2 5.9 6.1 6.4 5.5 ( μg/100g ) 2.8 1.8 1.2 2.8 2.2 2.1 ( ％ ) 5.6 5.4 5.5 5.4 5.1 5.0 ( g/kg ) 8.9 8.3 7.8 8.6 9.2 8.1 ( ％ ) 15.2 15.2 14.6 15.0 15.3 15.0 ( mg/g ) 4.4 4.5 4.7 4.7 4.4 4.7 ( mg/g ) 75.9 70.9 74.8 78.2 79.4 77.7 ( ％ ) 9.3 8.3 10.2 9.0 9.6 9.5VitC ( mg/100g ) 23.2 22.3 21.4 25.2 23.3 24.8 ( cfu/g ) ＜5＜5＜5＜5＜5＜5 ( cfu/g ) ＜5＜5＜5＜5＜5＜5 ( cfu/g ) 70 50 70 170 230 120 40＜30＜30＜30＜30＜30 ( MPN/100g )

Conclusion: health product 960606,960818,960929,980816,980912,981010 preserved 2 years at ambient temperature, through physics and chemistry, Micro biological Tests, the prompting the index of examining steady quality in the shelf-life in 2 years.

Owing to take technique scheme, make the technology of the present invention compared with the prior art have following advantage and effect:

A) the present invention studies show that the Fructus Momordicae charantiae with good antihypelipidemic active substance with modern science, and green tea tea and Folium Mori are equipped with the blood-sugar lowering tcm drug component, the natural health-care products that forms with unique low-temperature extraction process by scientific process, have clearing heat and moistening lung, supplementing QI and nourishing YIN, the kidney invigorating and essence nourishing, the function of promoting the production of body fluid to quench thirst.

B) adopt extract at low temperature technology can preserve polysaccharide polypeptide alkaloid and Saponin isoreactivity component and the active organic chromium that falls blood Chinese medicine preferably, can keep the normal glucose tolerance of body effectively, promote the blood glucose that raises to roll back normal level, keeping the stable of blood glucose, is the science preparation of preventing and treating diabetes and improving the diabetic population symptom.

C) because health product of the present invention have the health-care effect of blood sugar regulation, make diabetic population have blood sugar lowering, improve clinical condition, for oriented hyperglycemia tendency person, as the impaired glucose tolerance old people, obese people and hyperglycemia family history person is arranged can effectively prevent the generation of diabetes.

D) show by a large amount of blood sugar lowering effect human feeding trials, cardinal symptoms such as type ii diabetes examination trencherman polyphagia, polydipsia, polyuria, tired, weak, nocturia are had a better role.

E) preparation method science, material combination is reasonable, adopts the Chinese herbal medicine of integration of edible and medicinal herbs, has no side effect.

(4) specific embodiment:

Embodiment 1:

With green tea 3kg, mulberry leaf 15kg,, Radix Astragali 1kg, fruit of Chinese wolfberry 10kg, Chinese yam 1kg, dried rhizome of rehmannia 10kg, Add water 240kg after the mixing, stirring extraction under 55 ℃ of temperature after 60 minutes, material is by the centrifugal mistake of 150 orders Filtrate is collected in filter, and filter residue is stand-by, gets bright balsam pear 5kg again, goes capsule and seed to clean into Juice squeezer, extrudes Normal juice, Carry out centrifugation, collect the balsam pear stillness of night, residue is stand-by, and the balsam pear clear liquid stirs under＜5 ℃ of conditions and slowly adds Enter＜5 ℃ ethanol, making ethanol content is 70%, leaves standstill 24 hours under 4-6 ℃ of temperature then, separates Precipitation and clarified solution, it is stand-by that the precipitation of separating is carried out freeze drying powder process, its clarified solution and aforementioned filter residue and The balsam pear residue merges, and adds ethanol, and the content that makes ethanol is 70%, and stir to extract after 60 minutes and filter, Filtrate and aforesaid filtrate are merged, and reduced pressure concentration becomes thick paste, spray-drying powder process, and what will precipitate at last is cold Freeze xeraphium and mix with spray dried powder, incapsulate through granulation, be health products of the present invention.

Embodiment 2:

With green tea 20kg, mulberry leaf 10kg, Radix Astragali 5kg, fruit of Chinese wolfberry 5kg, Chinese yam 5kg, dried rhizome of rehmannia 5kg adds water 350kg after the mixing, stirring extraction under 65 ℃ of temperature after 60 minutes, material is by 180 order centrifugal filtrations, collect filtrate, filter residue is stand-by, gets bright balsam pear 40kg again, go capsule and seed to clean into Juice squeezer, extrude Normal juice, carry out centrifugation, collect the balsam pear stillness of night, residue is stand-by, the balsam pear clear liquid stirs the ethanol that slowly adds＜5 ℃ under＜5 ℃ of conditions, making ethanol content is 70%, leaves standstill 24 hours under 4-6 ℃ of temperature then, precipitation separation and clarified solution, it is stand-by that the precipitation of separating is carried out freeze drying powder process, and its clarified solution and aforementioned filter residue and balsam pear residue merge, and add ethanol, the content that makes ethanol is 70%, stir to extract after 60 minutes and filter, filtrate and aforesaid filtrate are merged, reduced pressure concentration becomes thick paste, spray-drying powder process, what will precipitate at last is cold

With green tea 30kg, mulberry leaf 5kg, Radix Astragali 10kg, fruit of Chinese wolfberry 1kg, Chinese yam 10kg, dried rhizome of rehmannia 1kg, mixed Add water 450kg after closing, stirring extraction under 70 ℃ of temperature after 60 minutes, material passes through 200 order centrifugal filtrations, Collect filtrate, filter residue is stand-by, gets bright balsam pear 6kg again, goes capsule and seed to clean into Juice squeezer, extrudes Normal juice, advances The balsam pear stillness of night is collected in the row centrifugation, and residue is stand-by, the balsam pear clear liquid under＜5 ℃ of conditions, stirs slowly adding＜5 ℃ ethanol, making ethanol content is 70%, leaves standstill 24 hours then precipitation separation under 4-6 ℃ of temperature And clarified solution, it is stand-by that the precipitation of separating is carried out freeze drying powder process, and its clarified solution and aforementioned filter residue and balsam pear are residual Slag merges, and adds ethanol, and the content that makes ethanol is 70%, stirs to extract after 60 minutes and filters, with filtrate Merge with aforesaid filtrate, reduced pressure concentration becomes thick paste, and spray-drying powder process is at last with the freeze dried powder that precipitates Mix with spray dried powder, incapsulate through granulation, be health products of the present invention.

Claims (1)

1, a kind of health product with blood sugar regulation effect is characterized in that it is the capsule of being made by the following weight proportion raw material,

The bright Fructus Momordicae charantiae 5-60 of green tea 3-30 part part Folium Mori 5-15 part

Radix Astragali 1-10 part Rhizoma Dioscoreae 1-10 part Fructus Lycii 1-10 part Radix Rehmanniae 1-10 part.The preparation method of health product according to claim 1 is characterized in that it is undertaken by following step:

A) with 3-30 part green tea, 5-15 part Folium Mori, 1-10 part Radix Astragali, 1-10 part Fructus Lycii, 1-10 part Rhizoma Dioscoreae, 1-10 part Radix Rehmanniae mixes 6-8 times of water gaging of adding and after 60 minutes, by the centrifugal filtration of 150-200 order, collects filtrate 55-70 ℃ of following stirring and leaching, and filtering residue is standby;

B) the bright Fructus Momordicae charantiae of 5-60 part is removed capsule and seed afterwash, advance Juice squeezer and extrude natural juice and carry out centrifugalize, collect the Fructus Momordicae charantiae clear liquid, residue is standby;

C) again with the Fructus Momordicae charantiae clear liquid under＜5 ℃ of conditions, stir the ethanol that slowly adds＜5 ℃ down and make that to contain the alcohol amount be 70%, then under 4-6 ℃ of temperature, leave standstill 24 hours precipitation separations and clear liquor;

D) again the precipitation of (c) item is carried out lyophilization powder process, its clear liquor and (a) filtering residue and Fructus Momordicae charantiae (b) squeeze behind the juice residue and merge and mend ethanol, making ethanol content is 70%, stir to extract and filtered in 60 minutes, filtrate merges concentrating under reduced pressure with (a) filtrate again and becomes thick paste, spray drying powder process;

E) at last the lyophilized powder of (d) is mixed with spray drying powder,, incapsulate, be health product of the present invention through pelletize.