The specific embodiment
Below in conjunction with embodiments of the invention and test example the present invention is further described, but the present invention is not limited to embodiment, those of ordinary skills do some modification with technical solution of the present invention, still in protection domain of the present invention.
Embodiment 1-5: health food preparation of soft capsule of the present invention
The weight proportion of each raw material sees Table 1 among each embodiment.
Preparing the used auxiliary material of health food soft capsule of the present invention is the raw material of following weight parts:
Beeswax 0.5-2 part.
Table 1
Embodiment number |
Grape seed extract (kg) |
Oolong tea extract (kg) |
L-cn (kg) |
Wheat-germ oil (kg) |
Beeswax (kg) |
1 |
5 |
5 |
5 |
20 |
0.5 |
2 |
13 |
8 |
10 |
35 |
0.3 |
3 |
10 |
12 |
16 |
60 |
2 |
4 |
25 |
15 |
19 |
75 |
1 |
5 |
20 |
20 |
20 |
80 |
2 |
The source of primary raw material and quality standard are as follows among the embodiment:
1, grape seed extract Tianjin spike natural products Co., Ltd produces, and accord with Q/12BJ4963-2002 stipulates specification requirement, procyanidin content 95%.
2, oolong tea extract Hunan Jinnong Biological Resources Co., Ltd. produces, and accord with Q/OBEA001-2003 stipulates specification requirement, polyphenol content 〉=30%.
3, the good bright International Trade Corporation production in l-cn Tianjin meets the specification requirement of CB17787-1999 regulation, carnitine content 〉=30%.
4, wheat-germ oil Xuzhou Epson thing engineering company produces, and accord with Q/320307XAC01-2001 stipulates specification requirement.
Health food preparation of soft capsule method of the present invention is (with embodiment 3 is example, and other embodiment is except that raw material consumption difference, and the preparation method is substantially the same manner as Example 3):
1, chooses grape seed extract, oolong tea extract, l-cn, the wheat-germ oil that conforms to quality requirements, test, after meeting the requirements, leave and take standby according to respective standard.
2,60kg wheat-germ oil, 2kg beeswax are placed material-compound tank, after 35 ℃ of mixing of constant temperature are stirred, again 10kg grape seed extract, 12kg oolong tea extract, 16kg l-cn are added wherein, continue to stir to make in 20-30 minute and mix, 100 mesh sieves are squeezed in the degassing tank after filtering, and are under the 60-70mmHg vacuum at 35 ℃ of constant temperature, pressure, stir 30-45 minute at a slow speed with the degassing, squeeze into heat-preserving container after the degassing and get soft capsule content, be incubated under 35 ℃ of conditions in order to pelleting.
3, technology prepares the soft capsule packaging material routinely, and soft capsule content is sent into the pellet press pill, gets health food soft capsule of the present invention.
Test example 1: the anti-oxidation function check of health food of the present invention
Anti-oxidation function for examination health food of the present invention, with embodiment 3 gained 5kg health food soft capsule of the present invention (hereinafter to be referred as: soft capsule) send Harbin Medical University, according to " health food function assessment assessment process and method of inspection standard ", check its anti-oxidation function.Survey report is as follows:
1 materials and methods
1.1 sample: given the test agent soft capsule (lot number 040607) content is brown liquid, and is water insoluble, is dissolved in salad oil, the examination by sensory organs no abnormality seen.
1.2 experimental technique
1.2.1 animal used as test:
A cleaning level male Wistar old rats 40 (more than 12 monthly ages) be the test group animal, and 10 of 3 monthly ages cleaning grade male Wistar rats are as the normal control treated animal, all available from institute of oncology, Heilongjiang Province animal center.Aged group is divided into 4 groups at random by the serum MDA level, 10 every group.
1.2.2 dosage design
Test is divided into 5 groups, 10 of every treated animals, and wherein old rats is 4 groups, comprises aged control group and 3 test group; Other establishes a normal control group.Soft capsule human body recommended amounts is everyone 2.0g every day, and as becoming body weight for humans in 60kg, then RD is equivalent to the 0.033g/kg body weight.The design of animal experiment dosage is respectively 5,10,30 times that the people recommends consumption, and then basic, normal, high dosage is respectively the 0.17g/kg body weight, 0.33g/kg body weight and 1.00g/kg body weight.Given the test agent is that solvent is made into various dose concentration with the salad oil, irritate stomach volume filling stomach by the 10ml/kg body weight and give each test group animal, and control animals gives the isometric(al) salad oil, all animal continuous irrigation stomaches 30 days.
1.2.3 reagent and instrument
MDA measures kit, SOD detection kit and GSH-Px detection kit and all purchases and build up bio-engineering research institute in Nanjing.Instrument is 722 type spectrophotometers.
1.2.4 experimental technique
Each treated animal is irritated the stomach various dose by designed dosage and tried thing every day, weighs weekly once, adjusts the stomach amount of irritating.Give continuously soft capsule sacrificed by decapitation animal after 30 days, get blood and prepare serum, finished lipid peroxide catabolite MDA (MDA) assay (TBA fluorescence method) in the serum, superoxide dismutase (SOD) vitality test (hydroxylamine assay) and glutathione peroxidase (GSH-Px) vitality test (DTNB method) in 24 hours, experimental technique is pressed the operation of kit specification.
1.3 data are handled
The gained data is carried out statistical disposition with variance analysis, carries out homogeneity test of variance earlier, and variance is neat, then calculates the F value, and the F value is more than or equal to F
0.05The time, organize a mean with three test group and old-age group and compare in twos; The data of abnormal or heterogeneity of variance are carried out the conversion of suitable variable, wait to satisfy normal state or variance are neat require after, add up with the data after changing.
2 results
2.1 influence to the serum mda content
Old rats is carried out random packet by the serum MDA level, and each treated animal serum MDA level sees Table 2
Irritate stomach and give the rats in test groups soft capsule after 30 days, lipid peroxide catabolite MDA content measurement result sees Table 3 in the animal blood serum.
From table 3 result as seen, the catabolite MDA level of aged control rats serum lipid peroxide is higher than normal control group (P<0.01), and give soft capsule after 30 days, test group animal blood serum mda content obviously reduces, and middle and high dosage treated animal is compared with aged treated animal all has significant difference (p<0.05).
Table 2
Group |
Dosage (g/kg.bw) |
Number of animals (only) |
MDA content (mmol/L) |
F |
p |
The normal control group |
- |
10 |
3.58±0.827 |
|
|
Low dose group |
0.17 |
10 |
5.36±1.166 |
|
>0.05 |
Middle dosage group |
0.33 |
10 |
5.49±1.246 |
|
>0.05 |
High dose group |
1.00 |
10 |
5.34±1.199 |
|
>0.05 |
Aged control group |
- |
10 |
5.80±2.273 |
6.250 |
|
Table 3
Group |
Dosage (g/kg.bw) |
Number of animals (only) |
MDA content (mmol/L) |
The q value |
p |
The normal control group |
- |
10 |
3.68±0.88
** |
5.69 |
<0.01 |
Low dose group |
0.17 |
10 |
4.78±1.60 |
|
|
Middle dosage group |
0.33 |
10 |
4.34±1.21
* |
3.96 |
<0.05 |
High dose group |
1.00 |
10 |
4.26±1.04
* |
4.17 |
<0.05 |
Aged control group |
- |
10 |
5.86±1.20 |
|
|
Annotate:
*With aged control group than p<0.05
*With aged control group than p<0.01
2.2 influence to the rat blood serum antioxidase activity
Irritate stomach and give test group animal soft capsule after 30 days, the measurement result of animal blood serum superoxide dismutase (SOD) vigor and glutathione peroxidase (GSH-Px) vigor sees Table 4.
By table 4 result as seen, aged control rats serum activity of SOD and GSH-Px vigor are starkly lower than the normal control group, (all p<0.01).When giving soft capsule after 30 days, two anti-oxidant vigors of three test group all raise, and still, three test group SOD vigor are compared with aged control group does not have significant difference; Middle and high dosage treated animal serum GSP-Hx vigor is compared with aged control group all has significant difference (p<0.05), shows that soft capsule has the effect of rising GSP-Hx vigor.
Table 4
Group |
Dosage (g/kg.bw) |
Number of animals (only) |
SOD vigor (u/ml) |
The q value |
p |
GSH-Px vigor (u/ml) |
The q value |
p |
The normal control group |
- |
10 |
282.0±27.3
** |
4.98 |
<0.01 |
174.0±22.0
* |
5.32 |
<0.01 |
Low dose group |
0.17 |
10 |
254.0±35.4 |
|
|
148.0±30.9 |
|
|
Middle dosage group |
0.33 |
10 |
260.0±29.2 |
|
|
165.0±36.4
* |
4.32 |
<0.05 |
High dose group |
1.00 |
10 |
263.0±27.0 |
|
|
168.0±24.9
* |
4.59 |
<0.05 |
Aged control group |
- |
10 |
238.0±21.9 |
|
|
128.0±18.0 |
|
|
Annotate: compare p<0.05 with aged control group
*Compare p<0.01 with aged control group
Conclusion:
Tried old rats and given health food soft capsule of the present invention after 30 days, middle and high dosage treated animal mda content obviously reduces (all<0.05), illustrate that given the test agent has the reduction lipid peroxidation, middle and high dosage treated animal serum paddy Guang peptide peroxidase activity obviously raises (all<0.05), illustrates that given the test agent has the effect of rising antioxidase activity.According to anti-oxidation function zoopery criterion as a result in " health food function assessment assessment process and method of inspection standard ", assert health food soft capsule Wheat Protein of the present invention.
Test example 2: the anti-oxidation function human feeding trial of health food of the present invention
Anti-oxidation function for examination health food of the present invention, with 80000 (0.5g/ grain) health food soft capsules of the present invention of embodiment 3 gained (hereinafter to be referred as: soft capsule) send the disease prevention and control center, Hunan Province, according to " health food check and assessment technique standard " (version in 2003), check its anti-oxidation function.Survey report is as follows:
1 material and method
1.1 sample
No. 1, No. 2, the two is in full accord on packing, outward appearance, color and luster and mouthfeel, and one of them is a soft capsule, and another is a placebo, four of oral every days.
1.2 the experimenter selects
1.2.1 the standard of including in: 120 experimenters are selected from Changsha high mountain foot of a hill or mountain community, male or female.Age 45-65 year, physical condition is good, does not have obvious brain, the heart, liver, kidney, blood illness, does not have the trial volunteer of the history of taking medicine for a long time and guarantees to cooperate.
1.2.2 experimenter's exclusion standard: gestation or women breast-feeding their children, to the health food allergy sufferers; Merge to have the inclination, serious disease patients such as liver, kidney and hemopoietic system; Take the article relevant in a short time, have influence on judgement person as a result with being tried function; Do not meet the standard of including in, edible in accordance with regulations given the test agent can't be judged effect or data not umbra sound effect or security judgement person.
1.3 experimental design and grouping
Adopt two kinds of control design between self and group.Be divided into soft capsule test-meal group and placebo at random by experimenter's serum MDA (MDA), hepatocuprein (SOD), glutathione peroxidase (GSH-Px) level, and consider to influence result's principal element such as age, sex etc. as far as possible, carry out the harmony check, with the comparativity between the assurance group, carry out the test-meal test by double-blind study.
1.4 test method
The 120 routine trial volunteers that will meet the standard of including in and guarantee cooperate are divided at random and are subjected to examination group and control group.Be subjected to examination group and control group all to take 4 of sample every days, observed continuously 160 days.Duration of test does not change original eating habit, normal diet.
2 observation index
Each measures once every observation index when test-meal on-test and end.
2.1 safety indexes
General physical examination: perquisition and consult the healthy card of experimenter before the test, understand experimenter's situations such as spirit, sleep, diet, stool and urine, blood pressure, all experimenters are carried out conventional physical examination and necessary laboratory examination; Routine blood test: red blood cell count(RBC), white blood cell count(WBC), content of hemoglobin mensuration etc.; Routine urinalysis: ph value, leucocyte, glucose in urine etc.; Stool for routine: worm's ovum inspection etc.; Liver function test: total serum protein (TP), albumin (ALB), glutamic-pyruvic transaminase (ALT), cholesterol (CHOL), triglycerides (TG) are measured; Kidney function test: serum urea nitrogen (BUN), creatinine (Cr), blood sugar (GLU) are measured; Inspections such as electrocardiogram, Abdominal B type ultrasonography, Chest X-rays.
2.2 effect index
2.2.1 lipid peroxide content: variation and the MDA rate of descent of MDA before and after the viewing test.
MDA * 100% before MDA rate of descent=(MDA-test back MDA before the test)/test
2.2.2 hepatocuprein: variation and the SOD rate of rise of SOD before and after the viewing test.
SOD * 100% before SOD rate of rise=(SOD before the SOD-test of test back)/test
2.2.3 glutathione peroxidase: the variation of GSH-Px and the rate of rise of GSH-Px before and after the viewing test.
GSH-Px * 100% before the rate of rise of GSH-Px=(GSH-Px before the GSH-Px-test of test back)/test
3. statistical procedures
Data result represents with mean ± standard deviation, self paired data adopts paired t-test, between test group and the control 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.
4. the result judges
4.1 between group statistical significance is arranged more all after each effect observation index test front and back self comparison and the test-meal, can judge this index positive.
4.2 each experimental result positive in lipid peroxide content, hepatocuprein, three experiments of glutathione peroxidase, the decidable given the test agent has the anti-oxidation function effect.
5. result
Double-blind study is observed and is finished to make known: take No. 1 person and be soft capsule, take No. 2 persons and be placebo.
5.1 ordinary circumstance: initial trial crowd's test group 60 examples, control group 60 examples, after test in 160 days, test group has 2 routine experimenters not screened out entirely because of judging curative effect or data, control group has 1 routine experimenter to take because of interruption to be subjected to test product, last efficiency test crowd test group 58 examples, control group 59 examples.Before and after the test-meal, experimenter's mental status, sleep state, stool and urine situation no abnormality seen.The test-meal group: man/woman is 17/41, and the age is 53.03 ± 6.20, control group: man/woman is 17/42, and the age is 53.12 ± 5.45.
5.2 security is observed
5.2.1 blood and hepatic and renal function
See Table 5,6.Eat and tried thing after 160 days, all in normal range (NR), the prompting soft capsule does not have obvious damage to body health for test-meal group and control group blood picture, routine urinalysis, stool routine examination and biochemical indicator.
5.2.2 electrocardiogram, Abdominal B type ultrasonography, Chest X-rays inspection are all in normal range (NR).
5.3 effect is observed
Serum MDA, the horizontal situation of change of SOD, GSH-Px see Table 7,8,9 before and after the test-meal test.Before the test, control group and test-meal group serum MDA, SOD, GSH-Px level compare, and the P value is pointed out between two groups to have comparativity all greater than 0.05.Test back test-meal group serum GSH-Px vigor is than control group significantly raise (P<0.05).Test-meal group serum GSH-Px improves 10.71% before the experiment after the test-meal, and both comparing differences have conspicuousness (P<0.05), and serum MDA reduces by 0.82% before the test, and serum activity of SOD raises 2.60% before the test.
Routine blood test index situation of change before and after table 5 test-meal (x ± s)
Changes of biochemical indexes situation before and after table 6 test-meal (x ± s)
Conclusion:
The experimenter takes and is tried thing after 160 days, the result shows: test-meal group SOD in serum, GSH-Px vigor improve 2.60%, 10.71% before the test respectively after the test-meal, reduce by 0.82% before serum MDA is tried, wherein the GSH-Px vigor significantly improves (P<0.05) before the test.Test back test-meal group serum GSH-Px vigor is than control group significantly raise (P<0.05).Safety indexes such as blood, urine, stool routine examination, hepatic and renal function, electrocardiogram, B ultrasonic are all in normal range (NR) before and after the test-meal, and do not find bad reaction.The The above results prompting submitted sample GSH-Px vigor experimental result positive has the anti-oxidation function effect.
Serum MDA, SOD, GSH-Px level self are relatively before and after table 7 test-meal
Annotate:
*With comparison P<0.05 before the test-meal
Two groups of serum MDAs, SOD, GSH-Px levels compare after table 8 test-meal
Index |
Control group |
The test-meal group |
P |
MDA(nmol/mL) |
3.71±0.60 |
3.67±0.74 |
>0.05 |
SOD(NU/ml) |
131.02±11.20 |
133.37±12.70 |
>0.05 |
GSH-Px (unit of activity) |
105.88±10.15 |
114.15±13.73 |
<0.05 |
Serum MDA, SOD, GSH-Px rate of change before and after table 9 test-meal
Index |
Control group |
The test-meal group |
MDA reduced rate (%) |
-0.82 |
0.82 |
SOD rate of rise (%) |
0.82 |
2.60 |
GSH-Px rate of rise (%) |
2.71 |
10.71 |
Test example 3: the weight losing function test of health food of the present invention
Weight losing function for examination health food of the present invention, with embodiment 3 gained 0.5g/ grains * 12 * 1335 plates health food soft capsule of the present invention (hereinafter to be referred as: soft capsule) send monitoring of hygiene inspection center, Jilin Province, according to " health food check and assessment technique standard " (version in 2003), in the second portion function assessment evaluation test method of health food function assessment assessment process and method of inspection standard, " 15, the weight losing function method of inspection " check its weight losing function.Survey report is as follows:
One, test objective: detect and be subjected to the influence of food to fat body weight and body fat content
Two, materials and methods:
1 sample proterties: oval soft capsule, content are brown liquid.
2 animals used as test: 50 of cleaning level male Wistar kind rats, body weight 136.1~153.6 true g are provided animal production licence number: SCXK-(Ji) 2003-0001 by preclinical medicine institute of Jilin University zoopery center.
Feeding environment: room temperature 20-22 ℃, relative humidity are 55-65%, and single cage is raised.
Feed resource: the living animal used as test feed factory of Changchun Lvyuan District benefit, production licence number: SCXK-(Ji) 2003-2004; This animal housing occupancy permit number: the moving word 10-7201 of doctor.
3 high fat nutrient fodders: basal feed 80%, lard 10%, yolk powder 10%.
4 test methods:
4.1 give the object space formula of being tried: per os is irritated stomach.
4.2 dosage design: recommended amounts is every day 2 times, each 2, and every 0.5g, become body weight for humans to press the 60kg design, then every day 0.033g/kgBW, be the dosage of basic, normal, high three dosage groups with 1,5,25 times of recommended amounts, promptly 0.033,0.167,0.833g/kgBW.The thing that tried of each dosage group is diluted to desired concn with soya-bean oil.
4.3 operating procedure:
Choose 50 of healthy male Wistar rats, be divided into 5 groups at random by body weight, 10 every group, promptly blank group, model control group and basic, normal, high three are tried agent amount group.Model control group and three dosage groups give high fat nutrient fodder, and the blank group gives basal feed.Three test group are irritated the thing that tried that stomach gives various dose, and two control groups filling stomach gives the soya-bean oil with volume, irritates the stomach amount and is 1ml/100gBw.Experimental session, it is principle that the animal feed administered dose is eaten up with most of animals, weighs when experiment finishes, cuts open the belly and get body fat (testis and perinephric fat pad) and weigh, and calculates fat/body ratio.All experimental datas all adopt " SPSS 10.0 " software to carry out variance analysis.
Three, result
3.1 soft capsule sees Table 10 to the influence of rat body weight, food ration, food overall utilization.
The influence of table 10 pair rat body weight, food ration, food overall utilization
Annotate: blank group and model control group compare: #P<0.05, ##P<0.01
Each experimental group and fat model control group compare:
*P<0.05,
*P<0.01
From table 10 as seen, the model control group rat body weight is higher than the blank group, difference has highly significant, the fat model manufacturing success of animal is described, all be lower than model control group and feed each rats in test groups body weight of raising high fat nutrient fodder simultaneously, learn check by statistics, middle and high dosage group rat body reason is lower than model control group and difference has conspicuousness (P<0.05).There are no significant for difference between blank group and model control group and each the dosage group rat food ration.
Four conclusions:
This zoopery is established 0.033g/kg, 0.167g/kg, 0.833g/kgBW as basic, normal, high three dosage groups, be equivalent to 1 times, 5 times, 25 times of human body recommended amounts respectively, result of the test shows: test model control group body weight in latter stage is higher than the blank group, and difference has conspicuousness (P<0.01), and fat model establishment is described; The body weight of testing last middle and high dosage group is lower than model control group and difference has conspicuousness (P<0.01), and the body fat of high dose group weighs less than control group, the soft capsule animal weight losing function result of the test positive.
Test example 4: the weight losing function human feeding trial of health food of the present invention
Weight losing function for examination health food of the present invention, with embodiment 3 gained 0.5g/ grains * 12 * 1335 plates health food soft capsule of the present invention (hereinafter to be referred as: soft capsule) send monitoring of hygiene inspection center, Jilin Province, according to " health food check and assessment technique standard " (version in 2003), in the second portion function assessment evaluation test method of health food function assessment assessment process and method of inspection standard, " the 15 weight losing function method of inspection " makes the weight losing function human feeding trial.Survey report is as follows:
1 material and method
1.1 the oval soft capsule of sample, content is a brown liquid, the 0.5g/ grain.
1.2 study subject is selected the trial volunteer of simple obesity, through the just clinical examinations such as routine, B ultrasonic, electrocardiogram and the fluoroscopy of chest of X line of hepatic and renal function, blood urine, get rid of merge intentionally, serious disease persons such as liver, kidney and hemopoietic system; Get rid of the mental patient; Get rid of and take the article relevant in a short time, have influence on judgement person the result with being tried function; And constitutional index (BMI) 〉=30, or total fatty percentage reaches man>25%, woman>30%, totally 100 as study subject.
1.3 taking dose and method recommend dose to be everyone (adult) every day 2 times, each 2, are consistent before experimenter's daily life, eating habit and amount of exercise and the test during the test-meal.
1.4 experimental design is according to weight losing function human feeding trial regulation in " the health food function assessment is estimated and method of inspection standard " of Ministry of Public Health's version in 2003, the experimenter adopts two kinds of control design between self and group.According at random, the requirement of double blinding divides into groups, body weight, body fat weight by the experimenter are divided into test-meal group and control group at random, and consider to influence result's principal element such as age, sex, diet, moving situation etc. as far as possible, have comparativity to guarantee two groups.Test group is taken given the test agent, test group 50 people, and the age, wherein the male sex was 15 between 27 years old-45 years old, 35 of women, control group adopts blank, control group 50 people, the age is between 27 years old-45 years old, wherein the male sex is 14,36 of women, and it is 35 days that sample gives the time.Guarantee during off-test that every group of experimenter's number is no less than 50 examples,, two groups of means are relatively adopted t-check in groups, when P<0.05, think that difference has conspicuousness the pairing t-check of own control data before and after experimentizing.
1.5 key instrument lever scale (RGZ-120 type, Wujin, Jiangsu Province city weighing apparatus factory), body composition analyzer (Model 310e), cycle ergometer (Model 818E), heart rate monitor.
1.6 observation index
1.6.1 safety indexes
Situations such as general symptom spirit, sleep, diet, stool and urine, heart rate, blood pressure; Blood, urine, just routine inspection; Liver, kidney function test; Electrocardiogram, Abdominal B type ultrasonography (liver, courage, pancreas, spleen, kidney) are checked, the Chest X-rays of X line; Blood uric acid, urine ketoboidies.
1.6.2 its functional attributes
1.6.2.1 measure height and weight and basis of calculation overweight degree:
Adult SBW (kg)=[height (cm)-100] * 0.9
1.6.2.2 body fat total amount (kg) and fatty percentage (%) are measured;
Body composition analyzer is measured body fat content.
1.6.2.3 subcutaneous fat thickness measuring:
B ultrasonic method (analytical unit is mm) is measured, and measures the site for 1 and sees Table 11:
Table 11
The A point |
Right deltoid muscle lower edge arm outside mid-point |
The B point |
Right angulus inferior scapulae |
The C point |
The other 3cm of right navel |
The F point |
Right bone Ant sup |
1.6.2.4 waistline, abdominal circumference and hip circumference are measured:
Adopt tape measure (cm) to measure.Waistline is measured the abdomen girth of flat navel, and hip circumference is measured the girth with both sides greater trochanter of femur level.
2 results
2.1 study subject screening is included standard in according to the experimenter, 100 experimenter's objects are all as the experimenter, the equal unmanned ablation experiment of duration of test test group and control group, the requirement of being in order.
2.2 subjective symptoms during taking, finds no bad reaction according to experimenter's readme situation, mental status, sleep, stool and urine situation no abnormality seen before and after the experimenter tests.
2.3 safety indexes
2.3.1 electrocardiogram, B ultrasonic, Chest X-rays and other
Experimenter's electrocardiogram, the fluoroscopy of chest of X line, Abdominal B type ultrasonography check result show no obvious abnormalities before the test, heart rate, blood pressure, urine, just routine inspection no abnormality seen variation before and after the test, the check result of twice heart rate, blood pressure all in range of normal value, sees Table 12.
Table 12 couple human heart rate, blood pressure, routine urinalysis, the just influence of routine
|
Number |
Heart rate (inferior/min) |
Systolic pressure (mmHg) |
Diastolic pressure (mmHg) |
Routine urinalysis |
The urine ketoboidies |
Just conventional |
Range of normal value |
|
60~100 |
90~140 |
60~90 |
- |
- |
- |
Test group (preceding) |
50 |
77.6±11.7 |
111.1±8.0 |
76.3±5.6 |
No abnormality seen |
- |
No abnormality seen |
Test group (back) |
50 |
76.6±10.8 |
109.2±8.7 |
76.0±6.6 |
No abnormality seen |
- |
No abnormality seen |
Control group (preceding) |
50 |
77.4±12.7 |
112.9±9.3 |
78.0±6.5 |
No abnormality seen |
- |
No abnormality seen |
Control group (back) |
50 |
79.7±12.2 |
112.1±7.6 |
77.0±7.6 |
No abnormality seen |
- |
No abnormality seen |
2.3.2 blood routine inspection
The measurement result of experimenter's red blood cell count(RBC), white blood cell count(WBC), content of hemoglobin, platelet count all in range of normal value, does not have significantly change before and after the test, sees Table 13.
The measurement result of experimenter's lymph percentage (LYMP%), monocyte percentage (MONO%), neutrophil leucocyte percentage (NEUT%), acidophil percentage (EO%), basocyte percentage (BASO%) increases in range of normal value before and after the test, do not have significantly change, see Table 14.
The influence (1) of table 13 pair human body routine blood test
|
Number |
Red blood cell count(RBC) (10
12/L)
|
White blood cell count(WBC) (10
9/L)
|
Content of hemoglobin (g/L) |
Platelet count (10
9/L)
|
Range of normal value |
|
3.5~5.5 |
4.0~10.0 |
110~160 |
100~300 |
Test group (preceding) |
50 |
4.7±0.3 |
6.6±1.3 |
140.9±12.7 |
228.4±51.3 |
Test group (back) |
50 |
5.0±0.5 |
6.5±1.2 |
141.8±13.9 |
292.0±75.9 |
Control group (preceding) |
50 |
4.8±0.4 |
6.9±1.4 |
143.0±13.5 |
225.7±54.4 |
Control group (back) |
50 |
5.1±0.5 |
6.7±1.0 |
145.6±13.2 |
284.9±86.7 |
The influence (2) of table 14 pair human body routine blood test
|
Number |
LYMP% |
MONO% |
NEUT% |
EO% |
BASO% |
Range of normal value |
|
20~40 |
3~8 |
50~70 |
0.5~5 |
0~1 |
Test group (preceding) |
50 |
34.4±9.5 |
7.7±2.0 |
55.4±9.9 |
2.1±1.8 |
0.4±0.2 |
Test group (back) |
50 |
33.6±6.7 |
7.2±1.7 |
56.8±7.4 |
2.1±1.4 |
0.4±0.2 |
Control group (preceding) |
50 |
33.7±8.6 |
7.7±1.8 |
56.2±8.8 |
2.0±1.8 |
0.4±0.2 |
Control group (back) |
50 |
33.8±7.1 |
7.1±1.7 |
56.7±7.8 |
2.0±1.3 |
0.4±0.2 |
2.3.3 blood parameters is measured
The every biochemical indicator creatinine of experimenter (CRE), urea nitrogen (BUN), uric acid (URIC), glutamic-pyruvic transaminase (ALT), glutamic-oxalacetic transaminease (AST) all in normal range (NR), do not have significantly change before and after the test, see Table 15.
The influence (1) of table 15 pair blood of human body biochemistry
|
Number |
CRE (mmol/L) |
BUN (mmol/L) |
URIC (umol/L) |
ALT (U/L) |
AST (U/L) |
Range of normal value |
|
40~120 |
2.5~7.0 |
90~420 |
0~40 |
0~40 |
Test group (preceding) |
50 |
72.8±12.5 |
4.5±1.1 |
246.5±60.2 |
19.4±10.6 |
20.6±6.1 |
Test group (back) |
50 |
69.6±10.1 |
4.3±1.3 |
244.9±58.7 |
16.4±7.0 |
22.6±4.9 |
Control group (preceding) |
50 |
70.1±12.7 |
4.9±1.2 |
246.6±48.2 |
17.3±9.6 |
22.0±5.2 |
Control group (back) |
50 |
72.7±11.7 |
4.4±1.3 |
261.8±71.0 |
18.7±11.3 |
23.7±4.7 |
The every biochemical indicator total protein of experimenter (TP), albumin (ALB), globulin (G), albumins/globulins ratio (A/G) before and after the test, all in range of normal value, do not have significantly and change, the results are shown in Table 16.
The influence (2) of table 16 pair blood of human body biochemistry
|
Number |
TP (g/L) |
ALB (g/L) |
G (g/L) |
A/G |
Range of normal value |
|
60~80 |
35~35 |
20~35 |
1.5~2.5 |
Test group (preceding) |
50 |
76.7±5.1 |
45.9±3.0 |
30.7±3.2 |
1.5±0.2 |
Test group (back) |
50 |
75.1±3.6 |
48.1±2.4 |
27.1±3.4 |
1.8±0.3 |
Control group (preceding) |
50 |
76.7±5.1 |
46.2±2.9 |
30.5±3.6 |
1.5±0.2 |
Control group (back) |
50 |
74.9±3.8 |
47.8±3.0 |
27.1±3.7 |
1.8±0.3 |
2.3.4 exercise tolerance test
Test back experimenter's maximal oxygen uptake does not reduce, and illustrates that experimenter's endurance (being aerobic capacity) does not descend, and sees Table 17.
The influence of table 17 pair human body tolerance
|
Number |
HRrest (inferior) |
Motion stable state heart rate (inferior) |
Recovered heart rate (inferior) in 1 minute |
Load (kg.m/min) |
Maximal oxygen uptake (L) |
Test group (preceding) |
50 |
77.6±11.7 |
134.2±8.9 |
107.8±7.2 |
366.6±44.3 |
2.3±0.4 |
Test group (back) |
50 |
76.6±10.8 |
136.4±7.2 |
109.9±6.5 |
372.2±40.2 |
2.3±0.3 |
Control group (preceding) |
50 |
77.4±12.7 |
134.8±9.2 |
106.0±6.6 |
353.2±37.8 |
2.3±0.4 |
Control group (back) |
50 |
79.7±12.2 |
133.8±7.8 |
108.2±7.0 |
368.6±43.2 |
2.4±0.3 |
Pairing t-check (t value) |
- |
0.454 |
1.320 |
1.597 |
0.632 |
1.004 |
Pairing t-check (p value) |
- |
0.652 |
0.193 |
0.117 |
0.530 |
0.321 |
T-check (t value) in groups |
- |
1.317 |
1.738 |
1.244 |
0.431 |
1.622 |
T-check (p value) in groups |
- |
0.191 |
0.085 |
0.217 |
0.667 |
0.108 |
Annotate: pairing t-verifies as before and after the test group relatively, and t-verifies as test group and compares with control group in groups
2.4 its functional attributes
2.4.1 body weight, body fat total amount and fatty percentage are measured, and see Table 18.
2.4.2 subcutaneous fat thickness and body enclose mensuration, see Table 19.
3 conclusions
100 routine simple obesity experimenters take health food soft capsule of the present invention after 35 days on request, test-meal group weight average decline 2.0 ± 2.8kg, body fat content decline 1.8 ± 1.5kg, waistline decline 2.8 ± 1.5cm, navel side and bone Ant sup reduce 1.7 ± 0.7mm and 1.4 ± 0.8mm respectively in four points of subcutaneous fat, test-meal group and control group compare after test-meal group self relatively reaches test-meal, and difference has conspicuousness (P<0.05); Experimenter's exercise tolerance and other healthy index of correlation obviously do not change before and after the test, and got rid of meals and motion influence to weight losing function, according to the criterion in " health food check and assessment technique standard " (version in 2003) of Ministry of Public Health's promulgation, health food soft capsule of the present invention has antiobesity action.
The influence of table 18 pair human body body weight, body fat
|
Number |
Body weight (kg) |
BMI (kg/m
2)
|
Overweight degree (%) |
Body fat total amount (kg) |
Body fat percentage (%) |
Test group (preceding) |
50 |
81.2±6.6 |
30.0±2.7 |
37.8±16.1 |
26.2±2.8 |
32.3±2.6 |
Test group (back) |
50 |
79.2±6.4 |
29.3±2.8 |
34.5±16.8 |
24.4±2.7 |
30.9±2.8 |
The front and back difference |
|
2.0±2.8 |
0.7±1.0 |
3.3±4.7 |
1.8±1.5 |
1.4±1.4 |
Control group (preceding) |
50 |
82.2±5.5 |
29.8±2.4 |
35.5±13.6 |
25.9±2.8 |
31.5±2.3 |
Control group (back) |
50 |
82.1±5.4 |
29.8±2.4 |
35.4±13.6 |
25.7±2.4 |
31.3±2.1 |
Pairing t-check (t value) |
- |
5.105 |
5.029 |
4.958 |
8.276 |
7.356 |
Pairing t-check (p value) |
- |
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
T-check (t value) in groups |
- |
-2.462 |
-1.002 |
-0.308 |
-2.527 |
-0.894 |
T-check (p value) in groups |
- |
0.016 |
0.319 |
0.759 |
0.013 |
0.374 |
Notes: the t-that matches compares before and after verifying as test: test group and control group were relatively after t-verified as and tests in groups.
The influence that table 19 pair human body subcutaneous fat thickness and body enclose
Annotate: pairing t-compares before and after verifying as experimental group; Test group and control group were relatively after t-verified as and tests in groups