CN101850002B - Composition with function of improving nutritional anemia - Google Patents
Composition with function of improving nutritional anemia Download PDFInfo
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- CN101850002B CN101850002B CN2009102363244A CN200910236324A CN101850002B CN 101850002 B CN101850002 B CN 101850002B CN 2009102363244 A CN2009102363244 A CN 2009102363244A CN 200910236324 A CN200910236324 A CN 200910236324A CN 101850002 B CN101850002 B CN 101850002B
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Abstract
The invention discloses a composition with a function of improving nutritional anemia, which is prepared mainly with the following raw materials in parts by weight: 15-45 parts of gelatin, 15-45 parts of jujube, 2.5-7.5 parts of ginseng extract, 2.5-7.5 parts of angelica extract and 2-6 parts of iron nutrition enhancer. The composition provided by the invention contains high-quality traditional Chinese medicine for blood replenishment, and simultaneously the iron nutrition enhancer is added, the gelatin can nourish yin and supplement the blood, the jujube and the ginseng can tonify qi and nourish the blood, and the angelica can nourish the blood and provide nutrients. The adoption of the four components can tonify both yin and yang, and nourish the qi and blood. Therefore, the invention can effectively improve the immunity of the body, and has the function of supplementing the blood.
Description
Technical field
The present invention relates to a kind of compositions that has enhancing immunity, improves the nutritional anemia function.
Background technology
The human immune system is divided into " specific immunity and nonspecific immunity " two kinds.The former refers to tackle specially the defence capability of certain antibacterial, and is like the antibody to anti-tubercle bacillus, only effective to tulase.As for nonspecific immunity, be meant antibacterial and the viral defence capability that can both resist and eliminate them to any kind of, can resist a series of viruses such as cold virus like interferon." antibody " is a kind of immunoglobulin, and the people is sick sometimes but can recover for illness without medical help, and is exactly that antibody has been brought into play defense function.But when the human body internal protein was not enough, health just can't be made antibody, and the immunity of antibacterial is just weakened.Ancient Times in China medical science has had immunologic notion; Argument like " in healthy energy deposits; heresy can not be done " mentioned in " interior warp "; " healthy energy " wherein is promptly relevant with the immunologic function of human body, " pathogen " then with modern medicine in pathogenic microorganism, self denatured antigen and mutant cell similar.
Nutritional anemia is meant the necessary nutrient substance of hemopoietic for want of, like ferrum, folic acid, vitamin B12 etc., forms or erythrocytic generation deficiency, so that the low a kind of disease of hemopoietic function.Wherein be called " iron deficiency anemia " owing to lack the caused anemia of trace elements iron.Chinese medicine belongs to primary disease categories such as " asthenia ", " blood deficiency ".Think that blood derives from spleen, not enough at kidney and the source of vital function at all, produce anemia.The blood deficiency the five internal organs lose to be supported, and just deficiency of heart-blood can occur, Liver and kidney two common sympton the lighters show as skin, mucosal pallor or thanks to relate to the heart, liver two is dirty.
Modern society constantly increases owing to above many reasons cause hypoimmunity crowd quantity, and therefore, improve immunity in recent years and also become the topic that everybody often talks about, be the focus of everybody growing interest.Iron deficiency anemia is a kind of common Deficiency disease, and whole world anemia patient surpasses 2,000,000,000, and wherein 50% belongs to iron deficiency anemia, and the average anemia prevalence of China resident reaches 20.1%.Iron deficiency anemia is the ubiquitous a kind of Deficiency disease in the world today; Particularly China is owing to the reason of dietary structure; The incidence rate of iron deficiency anemia is very high, and it shows as weak, absent minded, pale complexion etc. had a strong impact on growth of children and adult's routine work.
At present, because hypoimmunity ubiquity and numerous worldwide, and along with the progress of society and the raising of people's living standard, people have begun to pay attention to daily health caring.Therefore, be that the health-product market of major function has a high potential with the enhancing immunity.Present product on the market is type of the enriching blood health food that pure Chinese medicine is processed mostly, and situation is also comparatively single.
Summary of the invention
The purpose of this invention is to provide a kind of compositions that has enhancing immunity, improves the nutritional anemia function.
For achieving the above object, technical scheme of the present invention provides a kind of compositions of improving the nutritional anemia function that has, and is mainly processed by the material of following parts by weight: Colla Corii Asini: 15-45 part; Fructus Jujubae: 15-45 part; Radix Ginseng extract: 2.5-7.5 part; Radix Angelicae Sinensis extract: 2.5-7.5 part; Iron enriched nutrient: 2-6 part.Colla Corii Asini, Fructus Jujubae, Radix Ginseng extract, Radix Angelicae Sinensis extract, the iron enriched nutrient that the present invention adopts is standard extract or commercially available common commodity commonly used.
Compositions of the present invention is preferably mainly processed by the material of following parts by weight: 30 parts in Colla Corii Asini, 30 parts in Fructus Jujubae, 5 parts of Radix Ginseng extracts, 5 parts of Radix Angelicae Sinensis extracts, 4 parts of iron enriched nutrients.
Above-mentioned iron enriched nutrient is preferably small molecular organic acid iron salt complex, is selected from ferrous lactate, ferrous fumarate, ferric citrate and the sodium iron ethylenediaminetetraacetate one or more.Also can be inorganic iron such as ferrous sulfate; Or be aminoacid iron chelate, phosphoric acid salt iron enriched nutrient etc.
Compositions of the present invention, it also contains one or more the adjuvant that is selected from Mel, sucrose, glucose, maltose, xylitol, the potassium sorbate.
The various extracts that relate among the present invention be raw material of Chinese medicine through water carry or alcohol extraction after product; They are extensive use on market all; The preparation of various extracts is existing technology; The product that obtains is difference to some extent on material concentration just, and its various products all can practice in the present invention.Preferably contain total saponins >=10.0 weight % in the wherein said Radix Ginseng extract.Preferably contain polysaccharide >=12 weight % in the said Radix Angelicae Sinensis extract.
Further, the present invention provides a kind of nutritional anemia of improvement health care foods that has, and it contains each described compositions of claim 1-6.Remove and contain the combinations thereof beyond the region of objective existence, health food provided by the invention can add some flavoring agents, like fruit essence, sweeting agent etc. in right amount according to the taste hobby of consumer; Also can utilize the adjuvant or the carrier of some food stage, the food that is prepared into various industrialization, be prone to produces, is prone to transportation and carries, as have the health-caring biscuit that improves the nutritional anemia function etc.
Further, the present invention provides a kind of pharmaceutical preparation that improves the nutritional anemia function that has, and it contains above-mentioned compositions and pharmaceutically acceptable carrier.It can be acceptable tablet, pill, capsule, granule, electuary, oral liquid or syrup clinically.Be preferably oral liquid, its every 100mL product contains crude polysaccharides 0.6g, ferrum 50mg.
Compositions provided by the invention contains fine traditional blood tonic, adds iron enriched nutrient simultaneously, Colla Corii Asini nourishing YIN and supplementing blood in the side, and Fructus Jujubae, Radix Ginseng benefiting QI and nourishing blood, Chinese Angelica blood replonishing and battalion, four medicines share, and are that negative and positive are all mended, and QI and blood is two to be treated; Effectively human body immunity improving power has blood tonification effect.
The preferred small molecular organic acid iron salt of the present invention complex is an iron enriched nutrient of new generation, and it improves sideropenic effect and is superior to other chalybeates commonly used, can effectively improve iron deficiency crowd's HC, and is safe in utilization.In chalybeate, add tradition type of enriching blood Chinese medicines such as similar Radix Ginseng, can strengthen the effect that it improves nutritional anemia.The tradition blood tonic has the effect that chalybeate can not be compared aspect the iron deficiency anemia improving; It is remarkable to improving the iron deficiency anemia effect to select for use Chinese medicine and chalybeate compatibility to use; And the experimenter does not have obvious influence to its routine blood test and biochemical indicator after taking in chalybeate or Chinese medicine associating chalybeate, explains that Chinese medicine associating chalybeate is a kind of safe article of enriching blood.Five kinds of raw materials are used, and make product have good enhancing immunity and the effect that improves nutritional anemia.
Health food provided by the invention or medicine preferably occur with drink form, and it is aided with Mel and regulates taste, select advanced modern crafts preparation for use, have advantages such as purity height, exquisite workmanship, safety and sanitation, taking convenience, mouthfeel are good.Its product day obeys 2 times, takes 10mL at every turn.
The specific embodiment
Below in conjunction with embodiment, specific embodiments of the invention describes in further detail.Following examples are used to explain the present invention, but are not used for limiting scope of the present invention.
Embodiment 1
Prescription Colla Corii Asini 150g, Fructus Jujubae 150g, Radix Ginseng extract 25g, Radix Angelicae Sinensis extract 25g, sodium iron ethylenediaminetetraacetate 20g, Mel 1000g, purified water 5000mL
1, pretreatment, dosing
Fructus Jujubae (available from the wide medical company limited of Anhui Bo, " pharmacopeia " one one) is clean with water wash, subsequent use.With Colla Corii Asini (available from the wide medical company limited of Anhui Bo; " pharmacopeia " one one), Radix Ginseng extract (available from Jilin Hongjiu Biotech Co., Ltd., total saponins >=10%), Radix Angelicae Sinensis extract (available from Xuancheng City's BAICAO industry and trade company limited, polysaccharide >=12%), (Beijing Vita Sci-tech Co., Ltd. provides sodium iron ethylenediaminetetraacetate; Ferrum 12.5-13.5%) after the assay was approved; Remove outer package, change clean area over to, subsequent use.The formula ratio Fructus Jujubae is put into jacketed pan, and the decocting that adds 10 times of amounts boiled 2 hours, crossed 200 mesh sieves while hot and must filtrate 1.It is for use that filtrating 1 is put into preparing tank.Colla Corii Asini is pulverized with the high velocity medicament pulverizer, the Colla Corii Asini powder is added the purified water molten, 200 mesh sieves filter, and get Colla Corii Asini liquid.
The satisfactory Radix Ginseng extract of formula ratio, Radix Angelicae Sinensis extract, sodium iron ethylenediaminetetraacetate are crossed 80 mesh sieves respectively, add in the preparing tank, heated and boiled 30min stirs and makes dissolving, crosses 200 mesh sieves while hot and must filtrate 2.With Mel and the Colla Corii Asini liquid mix homogeneously of filtrating 2 with formula ratio, purified water is settled to capacity, gets mixed liquor.Cold preservation was left standstill 24 hours, and flame filter press filters, and must filtrate 3.
2, fill
To filtrate 3 placements in cleaning and the clean rustless steel receiver of disinfectant, and in the plastic bottle easy to break that meets hygienic requirements, adjusting the loading amount specification is that 10mL/ props up with plastic bottle filling machine easy to break fill.
3, afterwards through sterilization, lamp inspection, packing, product inspection, obtain qualified products.
Embodiment 2
Prescription Colla Corii Asini 300g, Fructus Jujubae 300g, Radix Ginseng extract 50g, Radix Angelicae Sinensis extract 50g, sodium iron ethylenediaminetetraacetate 40g, Mel 2000g, purified water 10000mL
1, pretreatment, dosing
Fructus Jujubae (available from the wide medical company limited of Anhui Bo, " pharmacopeia " one one) is clean with water wash, subsequent use.With Colla Corii Asini (available from the wide medical company limited of Anhui Bo; " pharmacopeia " one one), Radix Ginseng extract (available from Jilin Hongjiu Biotech Co., Ltd., total saponins >=10%), Radix Angelicae Sinensis extract (available from Xuancheng City's BAICAO industry and trade company limited, polysaccharide >=12%), (Beijing Vita Sci-tech Co., Ltd. provides sodium iron ethylenediaminetetraacetate; Ferrum 12.5-13.5%) after the assay was approved; Remove outer package, change clean area over to, subsequent use.The formula ratio Fructus Jujubae is put into jacketed pan, and the decocting that adds 10 times of amounts boiled 2 hours, crossed 200 mesh sieves while hot and must filtrate 1.It is for use that filtrating 1 is put into preparing tank.Colla Corii Asini is pulverized with the high velocity medicament pulverizer, the Colla Corii Asini powder is added the purified water molten, 200 mesh sieves filter, and get Colla Corii Asini liquid.
The satisfactory Radix Ginseng extract of formula ratio, Radix Angelicae Sinensis extract, sodium iron ethylenediaminetetraacetate are crossed 80 mesh sieves respectively, add in the preparing tank, heated and boiled 30min stirs and makes dissolving, crosses 200 mesh sieves while hot and must filtrate 2.With Mel and the Colla Corii Asini liquid mix homogeneously of filtrating 2 with formula ratio, purified water is settled to capacity, gets mixed liquor.Cold preservation was left standstill 24 hours, and flame filter press filters, and must filtrate 3.
2, fill
To filtrate 3 placements in cleaning and the clean rustless steel receiver of disinfectant, and in the plastic bottle easy to break that meets hygienic requirements, adjusting the loading amount specification is that 10mL/ props up with plastic bottle filling machine easy to break fill.
3, afterwards through sterilization, lamp inspection, packing, product inspection, obtain qualified products.
Embodiment 3
Prescription Colla Corii Asini 450g, Fructus Jujubae 450g, Radix Ginseng extract 75g, Radix Angelicae Sinensis extract 75g, sodium iron ethylenediaminetetraacetate 60g, Mel 3000g, purified water 15000mL
1, pretreatment, dosing
Fructus Jujubae (available from the wide medical company limited of Anhui Bo, " pharmacopeia " one one) is clean with water wash, subsequent use.With Colla Corii Asini (available from the wide medical company limited of Anhui Bo; " pharmacopeia " one one), Radix Ginseng extract (available from Jilin Hongjiu Biotech Co., Ltd., total saponins >=10%), Radix Angelicae Sinensis extract (available from Xuancheng City's BAICAO industry and trade company limited, polysaccharide >=12%), (Beijing Vita Sci-tech Co., Ltd. provides sodium iron ethylenediaminetetraacetate; Ferrum 12.5-13.5%) after the assay was approved; Remove outer package, change clean area over to, subsequent use.The formula ratio Fructus Jujubae is put into jacketed pan, and the decocting that adds 10 times of amounts boiled 2 hours, crossed 200 mesh sieves while hot and must filtrate 1.It is for use that filtrating 1 is put into preparing tank.Colla Corii Asini is pulverized with the high velocity medicament pulverizer, the Colla Corii Asini powder is added the purified water molten, 200 mesh sieves filter, and get Colla Corii Asini liquid.
The satisfactory Radix Ginseng extract of formula ratio, Radix Angelicae Sinensis extract, sodium iron ethylenediaminetetraacetate are crossed 80 mesh sieves respectively, add in the preparing tank, heated and boiled 30min stirs and makes dissolving, crosses 200 mesh sieves while hot and must filtrate 2.With Mel and the Colla Corii Asini liquid mix homogeneously of filtrating 2 with formula ratio, purified water is settled to capacity, gets mixed liquor.Cold preservation was left standstill 24 hours, and flame filter press filters, and must filtrate 3.
2, fill
To filtrate 3 placements in cleaning and the clean rustless steel receiver of disinfectant, and in the plastic bottle easy to break that meets hygienic requirements, adjusting the loading amount specification is that 10mL/ props up with plastic bottle filling machine easy to break fill.
3, afterwards through sterilization, lamp inspection, packing, product inspection, obtain qualified products.
Test Example:
Adopt the product (called after " donkey-hide gelatin sea cucumber iron oral liquid ", Beijing Tongrentang Health Pharmaceutical Co., Ltd. produces) of optimization formula of the present invention (embodiment 2) preparation to carry out toxicity and function test.
Below, effect of the present invention is described through experimental data.
Toxicological test:
Test objective: whether the check product has toxicity.
Test material: sample: donkey-hide gelatin sea cucumber iron oral liquid, human body oral liquid recommended amounts are 20mL every day, become body weight for humans to press 60kg and calculate, and amount to dosage 0.333mL/kg/ days.Getting 5 times of concentrated solutions experimentizes.
Laboratory animal: cleaning level Kunming mouse, SD rat and feedstuff.
Experimental situation condition: temperature 22-24 ℃, humidity 52-58%.
Test method:
Through acute toxicity test in mice (get 5 times of concentrated solutions of donkey-hide gelatin sea cucumber iron oral liquid to mice by the long-pending disposable per os filling of the mice stomach of giving of the filling body of stomach of 20mL/kgbw), (five dosage are established in test to Salmonella reversion test; Be respectively 5000 μ g/ wares, 1000 μ g/ wares, 200 μ g/ wares, 40 μ g/ wares, 8 μ g/ wares; Establish simultaneously from beaming back the contrast of change, solvent control and positive mutagens), the PCEMNR micronucleus test is (with the positive contrast of the cyclophosphamide of 0.04g/kgbw dosage; The negative contrast of distilled water; 3 dosage of test group are respectively 5 times of concentrated solution 10.0g/kgbw, 5.0g/kgbw, 2.5g/kgbw; Get 5 times of concentrated solution 25.0g of donkey-hide gelatin sea cucumber iron oral liquid, 12.5g, 6.25g adding distil water to 50mL; Press the 0.20mL/10gbw volume to mice and at interval irritated stomach 2 times in 24 hours), mouse sperm deformity tests (with the positive contrast of the cyclophosphamide of 0.04g/kgbw dosage; The negative contrast of distilled water, 3 dosage of test group are respectively 5 times of concentrated solution 10.0g/kgbw, 5.0g/kgbw, 2.5g/kgbw, get 5 times of concentrated solution 25.0g of donkey-hide gelatin sea cucumber iron oral liquid, 12.5g, 6.25g adding distil water to 50mL; The test solution that receives that is made into corresponding dosage is given mouse stomach), 30 days feeding trials (get 5 times of concentrated solution 66.7mL of donkey-hide gelatin sea cucumber iron oral liquid, 100.0mL, 133.3mL adding distil water and are settled to 200mL; Matched group gives the equal-volume distilled water, irritates stomach every day once, continuous 30 days) carry out toxicology test evaluation.
Result of the test:
1, acute oral toxicity test: the maximum tolerated dose (MTD) of female, male Kunming mouse greater than 26.2g/kg.bw (20mL/kg.bw is equivalent to 300 times of human body recommended amounts), is belonged to nontoxic level.
2, genetic toxicity test: Salmonella reversion test, PCEMNR micronucleus test and mouse sperm deformity result of the test are all negative.
3,30 days feeding trials: (dosage of amounting to into stock solution is respectively 16.67mL/kg.bw, 25.00mL/kg.bw, 33.33mL/kg.bw with 5 times of concentrated solution 3.33mL/kg.bw of donkey-hide gelatin sea cucumber iron oral liquid, 5.00mL/kg.bw, 6.67mL/kg.bw dosage; Be equivalent to human body respectively and recommend 50,75,100 times of metering) irritated stomach 30 days to rat oral; Experimental session; Each treated animal growth promoter is good, and each dosage of sample is to rat body weight, body weight gain, average food-intake and food utilization do not make significant difference (P＞0.05).The experiment end; Each dose groups hematological indices (hemoglobin, erythrocyte sum, packed cell volume, total number of blood platelet, total white blood cells and classification), blood biochemistry index (serum glutamic pyruvic transminase, glutamic oxaloacetic transaminase, GOT, total protein, albumin, cholesterol, triglyceride, blood urea nitrogen, creatinine, blood glucose), dirty body ratio (testis/body weight ratio of liver/body, spleen/body, kidney/body ratio and male Mus) compare there was no significant difference (P＞0.05) with corresponding matched group.Gross anatomy is not seen the abnormal change relevant with sample with tissue pathology checking.Under this experiment condition, in the 3.33mL/kg.bw-6.67mL/kg.bw dosage range, do not see that the nursing in 30 days of 5 times of concentrated solutions of donkey-hide gelatin sea cucumber iron oral liquid has obvious toxic-side effects to rat.
Function test:
Test objective: whether the check product has enhancing immunity, improves the increased functionality immunity function of nutritional anemia:
Test material: sample: the donkey-hide gelatin sea cucumber iron oral liquid, pitchy liquid, 10mL/ props up, and cool place, ventilation, the preservation of dry place are put in sealing.
Experimental animal: 200 of cleaning level Male Kunming strain mice, body weight is 18-22g.
Experimental situation condition: barrier system.Temperature 22-24 ℃, humidity 52-58%.
Dosage is selected and sample treatment: establish the basic, normal, high dosage of donkey-hide gelatin sea cucumber iron oral liquid and be respectively 1.67mL/kgbw, 3.33mL/kgbw, 10.00mL/kgbw (be equivalent to respectively human body RD 5,10,30 times).When basic, normal, high dosage receives the test solution preparation, get 16.7mL, 33.3mL, 100mL donkey-hide gelatin sea cucumber iron oral liquid adding distil water respectively to 200mL, matched group is given isopyknic distilled water; Give animal subject respectively and irritate stomach; Irritate stomach every day once, irritate the long-pending 0.2mL/10gbw of being of body of stomach, continuous 30 days.
Key instrument and reagent: animal platform chessboard, analytical balance, clean bench, CO2 gas incubator, centrifuge, 722 spectrophotometers, constant water bath box, ELIASA, microscope etc.
Test method: clean up the determination experiment that experiment, Turnover of Mouse Peritoneal Macrophages engulf chicken red blood cell experiment, NK cytoactive through internal organs/weight ratio pH-value determination pH, delayed allergy, the inductive mouse lymphocyte transformation experiment of ConA, antibody-producting cell detection, the mensuration of half hemolysis value, mice carbon and carry out assessment of function.
Concrete experimental result data sees the following form:
Table 1 donkey-hide gelatin sea cucumber iron oral liquid is to the influence of mice delayed allergy (DTH) (x ± S)
Through the variance test of homogeneity; It is neat that each organizes mice swelling degree of the paw variance; One factor analysis of variance shows; Between each group significant difference (P=0.004) is arranged relatively totally. further carry out comparing in twos between a plurality of dose groups and matched group mean with the Dunnett method, the result shows that middle and high dose groups mice swelling degree of the paw all is significantly higher than matched group (distinguishing P＜0.05, P＜0.01). point out sample can improve the ability of mice delayed allergy.
The influence that table 2 donkey-hide gelatin sea cucumber iron oral liquid is tested the mouse lymphocyte conversion capability (x ± S)
Through the variance test of homogeneity, each organizes mouse lymphocyte multiplication capacity heterogeneity of variance, is lost and checks demonstration, between each group significant difference (P=0.000) is arranged relatively totally.Further use Tamhane ' sT2 check to compare in twos, the result shows that middle and high dose groups mouse lymphocyte conversion capability is significantly higher than matched group (P＜0.05). the prompting sample can significantly improve the lymphocyte transformation ability of mice.
Table 3 donkey-hide gelatin sea cucumber iron oral liquid is to the influence of mouse antibodies cellulation number (x ± S)
Through the variance test of homogeneity, each organizes the mice hemolysis plaque, and to count variance neat, and one factor analysis of variance shows between each group significant difference (P=0.002) is arranged relatively totally.Further carry out comparing in twos between a plurality of dose groups and matched group mean with the Dunnett method, the result shows that middle and high dose groups mice hemolysis plaque digital display work is higher than matched group (P＜0.05, P＜0.01 respectively). the prompting sample can significantly improve the antibody-producing capacity of mice.
The influence of table 4 donkey-hide gelatin sea cucumber iron oral liquid control mice NK cytoactive (x ± S)
Through the variance test of homogeneity, it is neat that each organizes the active square root arcsine of NK cells in mice conversion value variance, and one factor analysis of variance shows between each group significant difference (P=0.000) is arranged relatively totally.Further carry out comparing in twos between a plurality of dose groups and matched group mean with the Dunnett method, the result shows that middle and high dose groups NK cells in mice activity is significantly higher than matched group (table 3 is seen in P＜0.001).The prompting sample can significantly improve the NK cytoactive of mice.
Result of the test:
Per os gives the donkey-hide gelatin sea cucumber iron oral liquid 30 days of mice 1.67mL/kg.bw, 3.33mL/kg.bw, 10.00mL/kg.bw dosage; 3.33mL/kg.bw, 10.00mL/kg.bw dosage can significantly improve the inductive mouse lymphocyte conversion capability of delayed allergy, ConA, antibody-producting cell number and the NK cytoactive of mice, the ability that each dosage is cleaned up ability and macrophage phagocytic chicken red blood cell to weight of mice, thymus/body weight ratio, spleen/body weight ratio, half hemolysis value, mice carbon does not all make significant difference.According to criterion in " health food check and assessment technique standard " (version in 2003), prompting is under this experiment condition, and the donkey-hide gelatin sea cucumber iron oral liquid has the enhancing immunity effect.
Improve nutritional anemia animal function:
Test material: sample: the donkey-hide gelatin sea cucumber iron oral liquid, pitchy liquid, 10mL/ props up, and cool place, ventilation, the preservation of dry place are put in sealing.
Experimental animal: 50 of cleaning level SD female ablactation rats.
Experimental situation condition: barrier system.Temperature 22-24 ℃, humidity 52-58%.
Dosage is selected and sample treatment: establish the basic, normal, high dosage of donkey-hide gelatin sea cucumber iron oral liquid and be respectively 1.67mL/kgbw, 3.33mL/kgbw, 10.00mL/kgbw (be equivalent to respectively human body RD 5,10,30 times) and low ferrum matched group.When low, middle dosage received the test solution preparation, sample thief stock solution 33.3mL, 66.7mL donkey-hide gelatin sea cucumber iron oral liquid adding distil water were to 200mL respectively, and matched group is given isopyknic deionized water; Give animal subject respectively and irritate stomach; Irritate stomach every day once, irritate the long-pending 1.0mL/100gbw of being of body of stomach, continuous 30 days.
Key instrument and reagent: 722 spectrophotometers, RF-540 fluorophotometer.
Test method: free protoporphyrin determination experiment carries out assessment of function in the detection through hemoglobin, the erythrocyte.
Concrete experimental result data sees the following form:
Table 5 donkey-hide gelatin sea cucumber iron oral liquid is to the influence of rat hemoglobin content (x ± S)
Through the variance test of homogeneity, before each organizes rat test, test back content of hemoglobin variance is neat, one factor analysis of variance shows, is tried respectively to organize rat hemoglobin content no significant difference (P) 0.05 before the thing).Tried thing after 30 days; Each organizes rat hemoglobin content, and overall relatively there were significant differences (P=0.000). further carry out comparing in twos between a plurality of dose groups and matched group mean with the Dunnett method; The result shows that three dose groups rat hemoglobin content all significantly raise (P＜0.001) than matched group, and three dose groups hemoglobin front and back rising amplitudes on average surpass 10.0g/L.
Table 6 donkey-hide gelatin sea cucumber iron oral liquid to the influence of free protoporphyrin content in the rat erythrocyte (x ± S, ug/L)
Through the variance test of homogeneity, it is neat that each organizes the protoporphyrin content variance of dissociating in the rat erythrocyte, and one factor analysis of variance shows between each group significant difference (P=0.004) is arranged relatively totally.Further carry out comparing in twos between a plurality of dose groups and matched group mean with the Dunnett method, the result shows that free protoporphyrin content significantly reduces (P＜0.05 or P＜0.01) than matched group in three dose groups rat erythrocyte
Improve the nutritional anemia human feeding trial:
Test objective: whether the check product has the function of improving nutritional anemia
Test material: sample: donkey-hide gelatin sea cucumber iron oral liquid No. 1, No. 2, the two is basically identical on packing, outward appearance, color and luster and mouthfeel, and one of them is the donkey-hide gelatin sea cucumber iron oral liquid, and another is a placebo.
Human oral every day twice, each 10mL.
Key instrument, reagent and test environment require: electrocardiogram, B ultrasonic scanner, blood counting instrument, sphygomanometer, RF-540 fluorophotometer, ACS180 gold robotics luminescence immunoassay appearance etc.Test method: adopt two kinds of EXPERIMENTAL DESIGN of contrast between self and group.To meet the standard of including in and guarantee the trial volunteer of compatibility test, be divided into test-meal group and matched group at random, consider the principal element such as age, the economic situation etc. that influence the result as far as possible, carry out the harmony check, with the comparability between the assurance group.Took continuously 85 days, and carried out the test-meal test by blind method.Duration of test does not change original dietary habit, normal diet.
Concrete experimental result data sees the following form:
The crowd was tried thing after 85 days; Content of hemoglobin changes the content of hemoglobin of seeing the preceding two groups of crowds of table 7. test does not have significant difference (P＞0.05); Test back test group hemoglobin raises to some extent, before and after self and with compare difference significance (P＜0.05) arranged. test group crowd tests average rising 11.04g/L. before the experiment of last hemoglobin
The variation of hemoglobin before and after table 7 test (g/L, x ± S)
A: compare with matched group, difference has significance, P＜0.05
B: relatively there was a significant difference with self, P＜0.05.
Visible by table 8, free protoporphyrin concentration there was no significant difference (P＞0.05) in the edible donkey-hide gelatin sea cucumber iron oral liquid proerythrocyte, free protoporphyrin lowering of concentration in the test group erythrocyte of test back, before and after self and with compare difference significance (P＜0.05) arranged.
The interior free protoporphyrin level of erythrocyte before and after table 8 test (ug/L, x ± S)
A: compare with matched group, difference has significance, P＜0.05
B: relatively there was a significant difference with self, P＜0.05.
Result of the test:
Behind the edible donkey-hide gelatin sea cucumber iron oral liquid, test-meal group hemoglobin is compared with matched group and before testing, and difference has significance (P＜0.05), and relatively preceding with test, rising value＞10.0g/L; Free protoporphyrin lowering of concentration in test group crowd's erythrocyte is compared with matched group and before testing, and difference has significance (P＜0.05); SF is not seen obvious change (P＞0.05) after the test-meal.According to criterion in " health food detects and the assessment technique standard " (version in 2003), prompting donkey-hide gelatin sea cucumber iron oral liquid has the nutritional anemia of improvement function (adult).
The above only is a preferred implementation of the present invention; Should be pointed out that for those skilled in the art, under the prerequisite that does not break away from know-why of the present invention; Can also make some improvement and retouching, these improvement and retouching also should be regarded as protection scope of the present invention.
Claims (8)
1. one kind has the compositions of improving the nutritional anemia function, it is characterized in that, its active component is processed by the material of following parts by weight: Colla Corii Asini: 15-45 part; Fructus Jujubae: 15-45 part; Radix Ginseng extract: 2.5-7.5 part; Radix Angelicae Sinensis extract: 2.5-7.5 part; Iron enriched nutrient: 2-6 part contains total saponins >=10.0 weight % in the said Radix Ginseng extract; Contain polysaccharide >=12 weight % in the said Radix Angelicae Sinensis extract.
2. compositions as claimed in claim 1 is characterized in that, its active component is processed by the material of following parts by weight: 30 parts in Colla Corii Asini, 30 parts in Fructus Jujubae, 5 parts of Radix Ginseng extracts, 5 parts of Radix Angelicae Sinensis extracts, 4 parts of iron enriched nutrients.
3. according to claim 1 or claim 2 compositions is characterized in that said iron enriched nutrient is a small molecular organic acid iron salt complex, is selected from ferrous lactate, ferrous fumarate, ferric citrate and the sodium iron ethylenediaminetetraacetate one or more.
4. according to claim 1 or claim 2 compositions is characterized in that, it also contains one or more the adjuvant that is selected from Mel, sucrose, glucose, maltose, xylitol, the potassium sorbate.
5. one kind has the nutritional anemia of improvement health care foods, it is characterized in that, it contains each described compositions of claim 1-4.
6. one kind has the pharmaceutical preparation that improves the nutritional anemia function, it is characterized in that, it contains each described compositions of claim 1-4 and pharmaceutically acceptable carrier.
7. pharmaceutical preparation as claimed in claim 6 is characterized in that, said preparation is acceptable tablet, pill, capsule, granule, oral liquid or syrup clinically.
8. pharmaceutical preparation as claimed in claim 7 is characterized in that, said preparation is an oral liquid, and its every 100mL product contains crude polysaccharides 0.6g, ferrum 50mg.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102397525B (en) * | 2011-11-11 | 2013-08-07 | 完美（中国）有限公司 | Chinese medicinal composition with function of improving nutritional anemia and preparation method thereof |
| CN102823857A (en) * | 2012-08-30 | 2012-12-19 | 吉林天强制药有限公司 | Ginseng donkey-hide gelatin healthcare food |
| CN103461616A (en) * | 2013-10-09 | 2013-12-25 | 北京绿源求证科技发展有限责任公司 | Food blood-nourishing tea dissolved medicine for improving alimentary anemia |
| CN104397693A (en) * | 2014-11-28 | 2015-03-11 | 哈尔滨墨医生物技术有限公司 | Tablets for improving alimentary anemia and production method thereof |
| CN105105148A (en) * | 2015-09-23 | 2015-12-02 | 威海紫光金奥力生物技术有限公司 | Method for producing gelatina nigra preparation for improving nutritional anemia |
| CN105999159B (en) * | 2016-06-27 | 2020-03-24 | 深圳太太药业有限公司 | Brown sugar and saussurea involucrata composition and preparation method thereof |
| CN109090617A (en) * | 2018-08-02 | 2018-12-28 | 湖北和格复合骨胶原生物科技有限公司 | It is a kind of to have effects that the formulation product of qi-supplementing, blood-engendering |
| CN111658708A (en) * | 2020-06-23 | 2020-09-15 | 珠海宝德润生健康科技有限公司 | Composition for improving anemia symptoms and preparation method and application thereof |
| CN114129647B (en) * | 2021-12-08 | 2022-11-25 | 江西广恩和药业股份有限公司 | Oral liquid and preparation method thereof |
| CN116870067A (en) * | 2023-08-10 | 2023-10-13 | 上海纳米技术及应用国家工程研究中心有限公司 | Traditional Chinese medicine composition for relieving VB12 malabsorption and preparation method thereof |
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