CN103027300A - VE (Vitamin E) coenzyme Q10 composition for assisting to reduce blood fat and boosting immunity and preparation method thereof - Google Patents
VE (Vitamin E) coenzyme Q10 composition for assisting to reduce blood fat and boosting immunity and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a VE (Vitamin E) coenzyme Q10 composition for assisting to reduce blood fat and boosting immunity and a preparation method of the composition. The VE coenzyme Q10 composition comprises the following components in parts by weight: 0.5-5 part(s) of coenzyme Q10, 0.7-21 part(s) of vitamin E and 25-300 parts of granulesten. The preparation method for the composition comprises the following steps of: adding the materials to matrix which is mixed and dissolved with soybean oil and beewax; stirring and dissolving the materials in the matrix at about 50 DEG C; putting the mixture to a colloid mill for grinding and circulating until the mixture is uniform; and obtaining soft capsule preparation by carrying out the processes such as pelleting, shaping, pill-washing, drying in the air, drying, picking and the like. According to the VE coenzyme Q10 composition provided by the invention, the bioavailability and stability of the coenzyme Q10 are greatly increased; and the dual effects of assisting to reduce blood fat and boosting immunity are achieved.
Description
Technical field
The present invention relates to field of health care food, be specifically related to VE Co-Q10 composition and the preparation method of a kind of auxiliary antilipemic and enhancing immunity.
Background technology
According to World Health Organization's investigation, the whole world approximately has the people more than 35% to be in fatigue state, and especially middle-aged male crowd fatigue state person is up to 60-75%.Brainstrust is pointed out, continue overtired, long-term poor sleep consequence serious, cause pharyngo-laryngitis chronica, neck or the illnesss such as axillary gland swells and ache, DOMS, multiple non-arthritis arthralgia, giddy, dizziness, headache, and finally cause immunity degradation; And " burnout syndrome " given prominence to and deterioration more, thereby form a vicious circle.
The investigation of WHO shows, the people of true health only accounts for 5%, and the people who suffers from disease accounts for 20%, and 75% people is in sub-health state, and the people who is in sub-health state is in rising trend in many countries and regions.Another also shows for the investigation of health conditions that 16 crowds of provinces and cities of China carry out, and the ratio that the Pekinese is in " inferior health " state is 75.3%, and Shanghai is 73.49%, and Guangdong is 73.4l%, and the ratio of inferior health in Modern human populations is very high.And cause inferior health main, the most essential be that the human body autoimmune function is low.
Co-Q10 easily shortage crowd comprises: the content of (1) human body coenzyme Q 10 peaked the phase in the time of 20 years old, after this begin on a declining curve, and ubiquinone l0 concentration reduces obvious especially in the heart, the old man had reduced 57% than 20 years old young man's cardiac muscle Co-Q10 in 70 years old, so the elderly and the people who is engaged in vigorous exercise can lack Co-Q10.(2) Co-Q10 is the human body all cells indispensable important substance of function of bringing into normal play, and most of diseases all can make human body Co-Q10 content significantly descend, and replenishes the rehabilitation that ubiquinone l0 is of value to the various diseases patient.(3) some is identical owing to biosynthesis pathway in the body of ubiquinone l0 and cholesterol, therefore be used for the treatment of the higher HMG-CoA reductase inhibitor of cholesterolemia in the blocking-up Biosynthesis of cholesterol, also blocked the biosynthesis of Co-Q10, so when using such preparation, not only reduced cholesterolemia, also reduced simultaneously the level of blood Co-Q10, for the high cholesterol patient, can be by replenishing the side effect of Co-Q10 to avoid the HMG-CoA reduction inhibitor agent to bring.(4) because the generative process of ubiquinone l0 in human body is complicated, need at least 7 kinds of vitamin (VB
2, VB
3, VB
6, VB
12, VC, folic acid and pantothenic acid) and the 17 steps biosynthesis reaction that participates in of several trace element.In daily life, because being subject to the impact of various factors, unreasonable situation is taken in the nutrition of people's ubiquity, hindered thus the biosynthesis of ubiquinone l0, in fact the so-called normal contents level of the therefore common said body coenzyme Q 10 of people does not reach optimality criterion, from this angle, the normal person also needs to replenish a certain amount of exogenous Co-Q10, reaches the normal physiological level to guarantee the body coenzyme Q 10.
Can find out, to such an extent as to the elderly, Disease, sub-health population, athletes normal person etc. all have the demand of supplemented with exogenous Co-Q10.And, along with society is constantly progressive, social competition is growing more intense, cause social crowd in the face of keen competition without physically, mental high-pressure and the tired state of all being in, the health care consciousness of different crowd (comprising healthy population) strengthens gradually, it is ripe rational that the health care idea is tending towards, the consumer grows with each passing day to the demand of the product of enhancing immunity, and being in to a certain extent per capita needed by human material on the shortage level for this great majority of Co-Q10, exploitation Co-Q10 Related product is very necessary especially.
(1) Co-Q10
Co-Q10 has another name called " ubiquinone ", can both find its figure in each cell of living at us.The Co-Q10 structure is similar to vitamin E, and its content in human body can reduce with advancing age.More and more medical research shows, Co-Q10 helps:
1) cardioprotection: studies show that, the Co-Q10 content in heart failure patient cardiac muscle and the blood obviously reduces, and replenishes the cardiac function that Co-Q10 can obviously improve experimental heart failure animal and heart failure patient.Co-Q10 helps for cardiac muscle provides sufficient oxygen, prevention sudden heart disease, especially Co-Q10 performance key effect in the myocardial anoxia process.
2) promote Conversion of Energy, promote energy: it is the essential energy of cells survival (such as ATP) that Co-Q10 helps food conversion, makes cell keep optimum state, makes the people feel that energy is more abundant.
3) improve immunity, delay senility: Co-Q10 is the natural that cell self produces, and can stop the formation of free radical, helps to safeguard immune normal operation and delays senility;
4) superpower oxidation resistance can prevent effectively that low-density lipoprotein is oxidized and stick on the vascular wall, can prevent the hyperplasia of vascular smooth cell simultaneously, thereby plays prevention and supplemental treatment high fat of blood and atherosclerotic.
5) other: studies show that in recent years, Co-Q10 is alleviated periodontitis in prevention coronary heart disease, there is remarkable result treatment duodenal ulcer and gastric ulcer and allevating angina pectoris aspect.Also have simultaneously antitumor action, clinical for late period metastatic cancer certain curative effect is arranged.
Co-Q10 is one of most important coenzyme of human body, being mainly derived from food replenishes with body interior synthetic, it is a kind of nonspecific immunity strengthening agent of body, also have anti-oxidant and the radicals scavenging function, generation along with old and feeble and some disease, the amount of Co-Q10 is also in continuous minimizing, and the intake of suitable additional Co-Q10 is of value to the raising body immunity, and various diseases patient's rehabilitation.Co-Q10 is the pith of immune link, stimulating immune system that can nature, thus obtain wider benefit and resist effect.Zooscopy shows, Co-Q10 can increase quantity of leucocyte, strengthen the thymus gland vigor, excite immunoglobulin (Ig) and antibody quantity to increase, the multiplication capacity of the mouse spleen lymphocyte that raising ConA induces strengthens the mouse delayed allergy, activated mononuclear-macrophage phagocytic system, improve the NK cytoactive, thereby reduced the damage of radical pair immunocyte, strengthen the immunoloregulation function of mouse.
The oxidative modification of low-density lipoprotein (LDL) causes vascular endothelial dysfunction and foam cells to form, and is considered to the key that atherosclerotic begins and develops.Contain multiple different fat-soluble antioxidant among the LDL, easily oxidized.The census of population finds, hyperlipidemia patient, atherosclerotic, atherosclerotic people at highest risk's plasma C oQ
10H
2Level lower than the normal population.External additional experiment shows, additional Co-Q10 can significantly reduce LDL in the neurological susceptibility of external oxidation, prolongs the lag time of LDL oxidation.Therefore, can think that Co-Q10 plays an important role, and has the function of auxiliary antilipemic in anti-LDL oxidizing process.
(2) vitamin E
Many studies show that, vitamin E can affect immune system, on the one hand, vitamin E can stop the destruction of peroxidization and radical pair lymphoreticular cell, by stoping arachidonic oxidation reaction to affect the oxidative phosphorylation key enzyme and changing the lymphocyte membrane receptor function to suppress prostaglandin synthetic, strengthen humoral immunity; On the other hand, vitamin E can be strengthened cellular immunity, improves the quantity of cell immunocompetent and neutrophil.During TD, body immunity degradation to external world.Lymphocyte also reduces the reaction of cytokinin.During TD, MDA in the neutrophil cell film increases, cell is after discharging too much hydrogen peroxide, life-span shortens, the function of neutrophil cell is impaired, and mitosis reaction slows down in the lymphocyte, and t helper cell quantity reduces in the blood, suppressor T lymphocyte increases, and immunologic function descends.
Simultaneously, vitamin E is the nutrient of needed by human, can protect the integrality of body tissue structure, is important antioxidant in the body, can suppress platelet aggregation, prevents and treats dna damage, strengthens immunity of organism and keep normal reproductive function.Vitamin E plays an important role for the normal operation of keeping body immune system, and an amount of replenishing vitamins E can strengthen immunity of organisms.In addition, vitamin E has good antioxidation, except well keeping the human body different physiological roles, also can effectively protect the stability of Co-Q10, and both cooperatively interact, and plays the collaborative effect that strengthens immunity.
(3) the soybean lecithin effect that has emulsification, cut grease, can promote blood circulation, improve serum lipids, remove peroxide, make Blood Cholesterol and neutral fat content, reduce fat in the holdup time of blood vessel, promote the dissipation of atherosis spot, prevent the endangium damage that is caused by cholesterol.Take lecithin high fat of blood and high cholesterol are had significant effect, thereby can prevent and treat artery sclerosis.The emulsification of soybean lecithin has improved the dissolubility of Co-Q10 in oil simultaneously.
And in the prior art for Co-Q10, vitamin E, three kinds of combination of active principles prescriptions of soybean lecithin, have simultaneously auxiliary antilipemic and strengthen the health food of immunity or the research of medicine particularly rare.
A kind of Coenzyme Complex Q is disclosed among the CN00102765.4
10Nutrient and healthcare products are comprised of the raw material of following weight ratio: ubiquinone
101, active oxygen radical scavenger 0.1-1.The active oxygen radical scavenger is vitamin C, vitamin E, vitamin A, beta carotene, cromoci etc.
CN200710074140.3 discloses a kind of cardio-cerebralvascular diseases medicine for the treatment of, to make (consumption is weight percentage) by the raw material of following proportion: Co-Q10 (CoQ10) 10-30%, vitamin E (VE) 20-40%, soybean lecithin (PC) 30-60%.This application Co-Q10 and vitamin E consumption are excessive, confirm its security without the toxicity test, and it has the function of auxiliary antilipemic, enhancing immunity without the effect evidence.
Summary of the invention
The VE Co-Q10 composition and the preparation method that the purpose of this invention is to provide a kind of auxiliary antilipemic and enhancing immunity, through the antibody-producting cell number of mouse delayed allergy, mouse, the NK cytoactive of mouse, the ability that mouse monokaryon-macrophage carbon is cleaned up, improve the mouse lymphocyte conversion capability, improve the animal function tests such as mice serum HD50 value and prove, composition has the health-care efficacy that strengthens immunity among the present invention.Prove through the human clinical trial, composition has the health-care efficacy of auxiliary antilipemic among the present invention.
For achieving the above object, technical scheme of the present invention provides a kind of auxiliary antilipemic and strengthens VE Co-Q10 composition and the preparation method of immunity, it is characterized in that being formed by the raw material of following weight proportion: 0.5 ~ 5 part of Co-Q10,0.7 ~ 21 part of vitamin E, 25 ~ 300 parts of soybean lecithins.
Preferably, VE Co-Q10 composition and the preparation method of a kind of auxiliary antilipemic and enhancing immunity is characterized in that being comprised of the raw material of following weight proportion: 3.5 ~ 4.5 parts of Co-Q10s, 4 ~ 7 parts of vitamin Es, 50 ~ 150 parts of soybean lecithins.
Further preferred, VE Co-Q10 composition and the preparation method of a kind of auxiliary antilipemic and enhancing immunity is characterized in that being comprised of the raw material of following weight proportion: 4 parts of Co-Q10s, 5.6 parts of vitamin Es, 70.4 parts of soybean lecithins.
The various functional component raw materials that relate among the present invention, they are extensive use on market all, and the preparation of various raw materials is existing technology, and the product that obtains is difference to some extent on content of material just, and its various products all can practice in the present invention.
Auxiliary material available in VE Co-Q10 composition of the present invention and pharmacy and the food industry forms.
Co-Q10 has preferably dissolubility in edible oil and fat-soluble material, soybean lecithin and edible oil are the best carriers of Co-Q10, the combination of Co-Q10 and soybean lecithin and edible oil has increased its stable homogeneous in grease greatly, and has improved the bioavilability in its human body.Simultaneously, vitamin E is grease, is soluble in vegetable oil, and has the effect of protection Co-Q10 stability.The said composition good stability is placed for a long time material content and is changed littlely, is easy to preserve.
The present composition can be prepared into separately pharmaceutically acceptable preparation, also can make preparation with acceptable auxiliary material in pharmacy or the food industry, the preferred soft capsule of preparation.
Soft capsule provided by the invention is characterized in that, the supplementary material of the following weight proportion of soft capsule content forms: 0.5 ~ 5 part of Co-Q10,0.7 ~ 21 part of vitamin E, 25 ~ 300 parts of soybean lecithins, 0 ~ 100 part of vegetable oil, 0 ~ 15 part in beeswax.
Preferably, have the soft capsule of health care, it is characterized in that, the supplementary material of the following weight proportion of soft capsule content forms: 3.5 ~ 4.5 parts of Co-Q10s, 4 ~ 7 parts of vitamin Es, 50 ~ 150 parts of soybean lecithins, 50 ~ 85 parts of vegetable oil, 1 ~ 5 part in beeswax.
Further preferably, have the soft capsule of health care, it is characterized in that, the supplementary material of the following weight proportion of soft capsule content forms: 4 parts of Co-Q10s, vitamin E .5.6 part, 70.4 parts of soybean lecithins, 75.2 parts of vegetable oil, 4.8 parts in beeswax.
Vegetable oil of the present invention for soft capsule preparation auxiliary material commonly used, uses one or more in available soybean oil, corn oil, sunflower oil, olive oil, the peanut oil as diluent (dispersant).Beeswax of the present invention belongs to food additives or pharmaceutic adjuvant, for soft capsule preparation auxiliary material commonly used, uses as suspending agent, guarantees that raw material disperses in oil uniformly, avoids delaminating deposition, plays stabilization.
The rubber of soft capsule is comprised of glycerine and gelatin etc. usually, in the rubber of soft capsule, add the light screening materials such as titanium dioxide, lemon yellow, famille rose, so that soft capsule has good photostability, play protection against the tide, anti-oxygen, lucifuge effect, to improve the stability of functional component.
The preparation method of above-mentioned VE Co-Q10 composition soft comprises following steps:
(1) glue of preparation soft capsule rubber, preheating is incubated for subsequent use;
(2) take by weighing the recipe quantity vegetable oil, add beeswax, be heated to whole dissolvings, cooling, lasting stirring adds the recipe quantity soybean lecithin successively, continues stirring until whole dissolvings, and insulation continues to stir adding recipe quantity Co-Q10, vitamin E, stirring to grind and beat in the rearmounted colloid mill of dissolving is circulated to evenly also all by 100 mesh sieves, gets content;
(3) content and glue make soft capsule.
Its preferred preparation method is:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing vegetable oil, add beeswax, be heated to whole dissolvings about 80 ℃, placement cools to about 50 ℃, add the formula ratio soybean lecithin, continue stirring until whole dissolvings, insulation continues to stir adding formula ratio Co-Q10, vitamin E about 50 ℃, stirring to grind and beat in the rearmounted colloid mill of dissolving is circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, dry, dry, pick operation and make soft capsule.
Soft capsule dosage form provided by the invention has the following advantages:
(1) soybean lecithin in the soft capsule, soybean wet goods oiliness material have good dissolubility to Co-Q10 and vitamin E, can promote the absorption in human body, improve bioavilability.
(2) rubber of soft capsule is comprised of glycerine and gelatin etc., and wall is thicker, again without gas permeability.In the capsule material of soft capsule, add the light screening materials such as titanium dioxide, lemon yellow, famille rose, so that soft capsule has good photostability.Therefore soft capsule can effectively completely cut off contacting of functional component and light, air and moisture, plays protection against the tide, prevents oxygen, lucifuge effect, with the stability of raising functional component.
(3) soft capsule dosage form can effectively be protected active ingredient with respect to other formulations such as tablet, electuary, capsules, covers bad smell, and smooth in appearance is attractive in appearance, the characteristics such as is convenient for carrying and take.
We are mutually auxiliary with VE by Co-Q10, strengthen the effect of immune organ and immunocyte, remove simultaneously free radical, reduced the damage of radical pair immunocyte, reach the function that strengthens immunity.Mutually auxiliary with soybean lecithin by Co-Q10, reduce the human cholesterol content, because some is identical for the interior biosynthesis pathway of the body of ubiquinone l0 and cholesterol, therefore be used in the blocking-up Biosynthesis of cholesterol, also block the biosynthesis of Co-Q10, replenished the side effect of Co-Q10 to avoid the HMG-CoA reduction inhibitor agent to bring.
VE Co-Q10 health food of the present invention and preparation method are under modern medicine and pharmacology, nutrition theoretical direction, in conjunction with the characteristics of people self modern needs, screening verification, reasonable formula adopts advanced pharmaceutical technology to be prepared from, raw material is natural, edible safety, and effect is remarkable.Prove through animal experiment: the chmice acute toxicity test proves that this soft capsule belongs to nontoxic level, and genetic toxicity test is negative, and feeding trial had no toxic action in 30 days; Has the enhancing immunity function; Prove to have the health-care efficacy of auxiliary antilipemic through the human clinical trial.VE Co-Q10 health food provided by the invention and preparation method, dual curative effect and definite ingredients, suitable crowd are wide, and the market space is very large, has a good application prospect.
The specific embodiment
Below in conjunction with embodiment, the specific embodiment of the present invention is described in further detail.Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
Embodiment 1:
Content forms: Co-Q10 50g, vitamin E 210g, soybean lecithin 250g.
Softgel shell forms: gelatin 100: glycerine 40: titanium dioxide 0.7: lemon yellow 0.09: carmine 0.02: purified water 100
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing the formula ratio soybean lecithin, continue to stir and be heated to 50 ℃, insulation continue to stir adds formula ratio Co-Q10, vitamin E about 50 ℃, grind and beat in the rearmounted colloid mill of dissolving that stirs to be circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 1000.
(4) through packing, product inspection, obtain product.
Embodiment 2:
Content forms: Co-Q10 50g, natural VE 210g, soybean lecithin 3000g.
Softgel shell forms: gelatin 100: glycerine 40: titanium dioxide 0.7: lemon yellow 0.09: carmine 0.02: purified water 100
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing the formula ratio soybean lecithin, continue to stir and be heated to 50 ℃, insulation continue to stir adds formula ratio Co-Q10, natural VE about 50 ℃, grind and beat in the rearmounted colloid mill of dissolving that stirs to be circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 3000.
(4) through packing, product inspection, obtain product.
Embodiment 3:
Content forms: Co-Q10 50g, natural VE 7g, soybean lecithin 2800g.
Softgel shell forms: gelatin 100: glycerine 40: titanium dioxide 0.7: lemon yellow 0.09: carmine 0.02: purified water 100
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing the formula ratio soybean lecithin, continue to stir and be heated to 50 ℃, insulation continue to stir adds formula ratio Co-Q10, natural VE about 50 ℃, grind and beat in the rearmounted colloid mill of dissolving that stirs to be circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 3000.
(4) through packing, product inspection, obtain product.
Embodiment 4:
Content forms: Co-Q10 35g, natural VE 40g, soybean lecithin 500g.
Softgel shell forms: gelatin 100: glycerine 40: titanium dioxide 0.7: lemon yellow 0.09: carmine 0.02: purified water 100
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing the formula ratio soybean lecithin, continue to stir and be heated to 50 ℃, insulation continue to stir adds formula ratio Co-Q10, natural VE about 50 ℃, grind and beat in the rearmounted colloid mill of dissolving that stirs to be circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 1000.
(4) through packing, product inspection, obtain product.
Embodiment 5:
Content forms: Co-Q10 45g, natural VE 70g, soybean lecithin 1500g.
Softgel shell forms: gelatin 100: glycerine 40: titanium dioxide 0.7: lemon yellow 0.09: carmine 0.02: purified water 100
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing the formula ratio soybean lecithin, continue to stir and be heated to 50 ℃, insulation continue to stir adds formula ratio Co-Q10, natural VE about 50 ℃, grind and beat in the rearmounted colloid mill of dissolving that stirs to be circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 2000.
(4) through packing, product inspection, obtain product.
Embodiment 6:
Content forms: Co-Q10 40g, natural VE 56g, soybean lecithin 704g.
Softgel shell forms: gelatin 100: glycerine 40: titanium dioxide 0.7: lemon yellow 0.09: carmine 0.02: purified water 100
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing the formula ratio soybean lecithin, continue to stir and be heated to 50 ℃, insulation continue to stir adds formula ratio Co-Q10, natural VE about 50 ℃, grind and beat in the rearmounted colloid mill of dissolving that stirs to be circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 1000.
(4) through packing, product inspection, obtain product.
Embodiment 7:
Content forms: Co-Q10 5g, vitamin E 100g, soybean lecithin 1000g.
Softgel shell forms: gelatin 100: glycerine 40: titanium dioxide 0.7: lemon yellow 0.09: carmine 0.02: purified water 100
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing the formula ratio soybean lecithin, continue to stir and be heated to 50 ℃, insulation continue to stir adds formula ratio Co-Q10, vitamin E about 50 ℃, grind and beat in the rearmounted colloid mill of dissolving that stirs to be circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 1000.
(4) through packing, product inspection, obtain product.
Embodiment 8:
Content forms: Co-Q10 50g, natural VE 7g, soybean lecithin 3000g, soybean oil 1000g, beeswax 150g.
Softgel shell forms: gelatin 100: glycerine 40: titanium dioxide 0.7: lemon yellow 0.09: carmine 0.02: purified water 100
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing soybean oil, add beeswax, be heated to whole dissolvings about 80 ℃, placement cools to about 50 ℃, add the formula ratio soybean lecithin, continue stirring until whole dissolvings, insulation continues to stir adding formula ratio Co-Q10, natural VE about 50 ℃, stirring to grind and beat in the rearmounted colloid mill of dissolving is circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 4000.
(4) through packing, product inspection, obtain product.
Embodiment 9:
Content forms: Co-Q10 40g, natural VE 56g, soybean lecithin 704g, soybean oil 752g, beeswax 48g.
Preparation technology is as follows:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing soybean oil, add beeswax, be heated to whole dissolvings about 80 ℃, placement cools to about 50 ℃, add the formula ratio soybean lecithin, continue stirring until whole dissolvings, insulation continues to stir adding formula ratio Co-Q10, natural VE about 50 ℃, stirring to grind and beat in the rearmounted colloid mill of dissolving is circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, the operation such as dry, dry, pick and make VE Co-Q10 composition soft, approximately 2000.
(4) through packing, product inspection, obtain product.
Embodiment 10:
Content forms: Co-Q10 35g, natural VE 70g, soybean lecithin 500g, soybean oil 500g, beeswax 10g.
Except content forms consumption, make approximately 1000 different with embodiment 9 outside, all the other are with embodiment 9.
Embodiment 11:
Content forms: Co-Q10 5g, natural VE 210g, soybean lecithin 250g, soybean oil 30g, beeswax 50g.
Except content forms consumption, make approximately 3000 different with embodiment 9 outside, all the other are with embodiment 9.
Embodiment 12:
Content forms: Co-Q10 45g, natural VE 40g, soybean lecithin 1500g, soybean oil 850g, beeswax 50g.
Except content forms consumption, make approximately 3000 different with embodiment 9 outside, all the other are with embodiment 9.
Embodiment 13:
Content forms: Co-Q10 40g, natural VE 150g, soybean lecithin 1000g, soybean oil 800g, beeswax 0.015g.
Except content form consumption and embodiment 9 different, all the other are with embodiment 9.
Embodiment 14:
Form: Co-Q10 40g, natural VE 56g, soybean lecithin (powder) 704g, converted starch 504, dolomol 16g.
Preparation technology is as follows:
(1) natural VE that takes by weighing formula ratio is dissolved in an amount of 95% ethanolic solution, and is for subsequent use;
(2) get formula ratio Co-Q10, converted starch, the mode that equivalent increases progressively mixes, mix with the formula ratio powder phospholipid again, the ethanolic solution that adds above-mentioned natural VE is that adhesive is granulated, dry, whole grain, add dolomol, mixing is made the 0.33g/ grain, 4000 in the capsulae vacuus of packing into.
(3) through packing, product inspection, obtain product.
The comparative example A:
Content forms: Co-Q10 50g, natural VE 100g, soybean lecithin 150g.
Except content forms consumption, make approximately 1000 different with embodiment 9 outside, all the other are with embodiment 9.
Comparative Examples B:
Content forms: Co-Q10 40g, vitamin E 20g, soybean oil 752g, beeswax 48g.
Except content composition, consumption and embodiment 9 were different, all the other were with embodiment 9.
Below data by experiment illustrate effect of the present invention.
Toxicological test:
Test objective: whether check product and comparative example A have toxicity
The soft capsule that test material: embodiment 9, comparative example A make
Sample: embodiment 9, the oral recommended amounts of human body is the 0.8g/ grain, every day 2 times, each 1.The comparative example A, the oral recommended amounts of human body is the 0.3g/ grain, every day 2 times, each 1.Become body weight for humans to press 60kg and calculate, embodiment 9 amounts to dosage 0.0267g/kgbw(0.0267 gram/kg body weight), the comparative example A amounts to dosage 0.01g/kgbw(0.01 gram/kg body weight).Getting soft capsule content tests.
Animal used as test: SPF level ICR mouse and SD rat.
Experimental situation condition: SPF barrier level.
Test method:
Carry out the toxicology evaluation by acute toxicity test in mice, Salmonella reversion test, PCEMNR micronucleus test, mouse sperm deformity test and 30 days feeding trials.
Result of the test:
1, anxious poisons mouth toxicity test result:
9 couples of embodiment are female, the maximum tolerated dose (MTD) of male ICR mouse is all greater than 20.0g/kgbw, belong to nontoxic level.
The comparative example A to the maximum tolerated dose (MTD) of female, male ICR mouse all greater than 10.0g/kgbw, the nontoxic level in true border.
2, as a result Salmonella reversion test, PCEMNR micronucleus test, mouse sperm deformity result of the test of three genetic toxicity tests, embodiment 9, comparative example A are all negative.
3,30 days feeding trial results:
Embodiment 9 duration of test, animal growth is good, and each dosage group body weight, weightening finish, food utilization, routine blood test index, blood biochemistry index, internal organs weight in wet base and internal organs/body weight ratio and control group compare, no significant difference (P〉0.05).Gross anatomy has no the abnormal change relevant with sample with tissue pathology checking.
Comparative example A's low dose group duration of test, animal growth is good, and each dosage group body weight, weightening finish, food utilization, routine blood test index, blood biochemistry index, internal organs weight in wet base and internal organs/body weight ratio and control group compare, no significant difference (P〉0.05).Gross anatomy has no the abnormal change relevant with sample with tissue pathology checking.
The middle and high dosage group of comparative example A duration of test, death in various degree appears in animal, and body weight, weightening finish, food utilization, routine blood test index, blood biochemistry index, internal organs weight in wet base and internal organs/body weight ratio and control group relatively have notable difference (P＜0.05).
Function test:
Test objective: whether the check product has the function that strengthens immunity.
Test material:
The soft capsule that sample: embodiment 9 makes, the oral recommended amounts of human body is the 0.8g/ grain, every day 2 times, each 1.Become body weight for humans to press 60kg and calculate, amount to dosage 0.0267g/kgbw.Getting soft capsule content tests.
Experimental animal: the female ICR mouse of SPF level, body weight is 18-22g, totally 192.
Experimental enviroment condition: SPF barrier system.
Dosage is selected and sample treatment: establish basic, normal, high dosage and be respectively 0.13g/kgbw, 0.27g/kgbw, 0.80g/kgbw(and be equivalent to respectively 5,10,30 times of human body RD).Basic, normal, high dosage is subjected to test solution when configuration, gets respectively soft capsule content 0.53g, 1.07g, 3.20g adds vegetable oil and is settled to 40mL, and control group gives isopyknic vegetable oil, every day gavage once, the gavage volume is 0.1mL/10gbw, continuous 30 days.
Key instrument and reagent: animal platform balance, assay balance, clean bench, CO2gas incubator, autoclave, filter, centrifuge, 722 spectrophotometers, constant water bath box, ELIASA, microscope etc.
Test method: mouse lymphocyte transformation experiment, antibody-producting cell detection, the mensuration of HD50 value, the mouse carbon of inducing by internal organs/weight ratio pH-value determination pH, delayed allergy, ConA is cleaned up the determination experiment that experiment, Turnover of Mouse Peritoneal Macrophages engulf chicken red blood cell experiment, NK cytoactive etc., carries out assessment of function.
Result of the test:
Per os is given and the VE Co-Q10 health food content of mouse 0.13g/kgbw, 0.27g/kgbw, 0.80g/kgbw dosage 30 days.Experimental result shows, basic, normal, high dosage group all can improve spleen lymphocyte proliferation ability and the serum hemolysin of mouse; Middle and high dosage group all can improve the antibody-producting cell number of mouse; High dose group can improve the NK cytoactive of mouse.Each dosage group is cleaned up phagocytic index, peritoneal macrophage phagocytic index, Peritoneal macrophage function, spleen/body weight ratio and thymus gland/body weight ratio to swelling degree of the paw, the monocytes/macrophages carbon of mouse and is all had no significant effect.Judge that according to " health food check and assessment technique standard " this sample has the function that strengthens immunity.
Concrete result of the test data see the following form:
Table 1 sample is on the impact of mouse delayed allergy (DTH)
By as seen from Table 1, the swelling degree of the paw of each dosage group mouse and control group be there was no significant difference (P〉0.05) relatively.
The impact that the mouse spleen lymphocyte conversion capability that table 2 sample is induced mouse ConA is tested
By as seen from Table 2, the spleen lymphocyte proliferation ability of basic, normal, high dosage group mouse and control group relatively have significant difference (P＜0.01 or P＜0.05).
Table 3 sample is on the impact of mouse antibodies cellulation number
By as seen from Table 3, the antibody-producting cell number of middle and high dosage group mouse and control group relatively have significant difference (P＜0.01 or P＜0.05).
Table 4 sample is on the impact of mice serum hemolysin
By as seen from Table 4, the serum hemolysin of basic, normal, high dosage group mouse and control group relatively have significant difference (P＜0.01 or P＜0.05).
Table 5 sample is cleaned up the impact of phagocytic index to mouse monokaryon-macrophage carbon
By as seen from Table 5, the monocytes/macrophages carbon of each dosage group mouse is cleaned up relatively there was no significant difference (P〉0.05) of phagocytic index and control group.
Table 6 sample is engulfed the impact of the ability of chicken red blood cell on Turnover of Mouse Peritoneal Macrophages
By as seen from Table 6, the peritoneal macrophage phagocytic percentage of each dosage group mouse and phagocytic index and control group relatively there are no significant difference (P〉0.05).
Table 7 sample is on the impact of NK cells in mice activity
By as seen from Table 7, the NK cytoactive of high dose group mouse and control group relatively have significant difference (P＜0.05).
Clinical testing:
Test objective: whether the check product has the function of auxiliary antilipemic, and carries out Contrast on effect with Comparative Examples B.
Test material:
The soft capsule that sample: embodiment 9, Comparative Examples B make, the oral recommended amounts of embodiment 9 human bodies is the 0.8g/ grain, every day 2 times, each 1.The oral recommended amounts of Comparative Examples B human body is the 0.43g/ grain, every day 2 times, each 1.
Experimenter: 18-65 year, simple dyslipidemia person.As, 2 serum total cholesterols (TC) are 〉=5.2mmol/L or serum levels of triglyceride (TG) 〉=1.65mmol/L in half a year.
Experimental design and grouping: by experimenter's blood lipid level, consider as far as possible the factors such as age, sex, diet, be divided at random test-meal group and control group, every group of 60 examples, test-meal group are taken embodiment 9 samples, and control group adopts the contrast of Comparative Examples B sample.Time of Administration 30 days.
Result of the test:
(1) security is observed
Test-meal group 60 examples, control group 60 examples.After test in 30 days, test group has 1 routine experimenter to take because of interruption screened out by test product, and control group has 1 routine experimenter to take because of interruption screened out by test product.Last efficiency test crowd test group 59 examples, control group 59 examples.The test-meal group: male/female is 33/26, and the age is (52.04 ± 7.96) year; Control group: male/female is 32/27, and the age is (51.84 ± 7.84) year.
Before and after the test-meal, the no abnormality seens such as experimenter's spirit, sleep, diet, stool and urine, blood pressure; Abdominal B type ultrasonography, electrocardiogram, x-ray fluoroscopy of chest detect all in normal range (NR).The forward and backward test-meal group of test-meal sample and control group routine urinalysis, stool routine examination and routine blood test changing value are all in normal range (NR).
(2) functional observation
Serum TC, the horizontal situation of change of TG see Table 8 and table 9 before and after the test-meal test.Before the test, control group and test-meal group serum TC, TG level compare, and the difference not statistically significant (P〉0.05), point out between two groups to have comparativity.Compare before TC, TG and the test-meal after the test-meal of test-meal group, difference has statistical significance (P＜0,05), compares after TC, TG and the control group test after the test of test-meal group, and difference has statistical significance (P＜0,05).The HDL-C level has no obvious change (P〉0.05) before and after the test-meal.
Judge that according to " health food check and assessment technique standard " this product has the function of auxiliary antilipemic, its lipid-lowering effect is better than Comparative Examples B.
Concrete result of the test data see the following form:
Serum TC, TG, HDL-C level before and after table 8 experimenter tests
Annotate: with before the test-meal relatively:
*P＜0.05; With after the control group test-meal relatively: #P＜0.05
Serum TC, TG, HDL-C situation of change before and after table 9 experimenter
Stability test
Test objective: check product stability
The soft capsule that test material: embodiment 9 makes (three batches) is packaged as commercially available bottled.
Test method: at 37 ~ 40 ℃, under the 75% relative humidity condition, placed 6 months.Respectively three batch samples are examined entirely according to company standard in 0 month, June.
Result of the test: through authoritative institution's check, the result all meets the requirement of quality standard.
Concrete result of the test data see the following form:
Zero moon result:
6th month result:
Claims (10)
1. an auxiliary antilipemic and strengthen the VE Co-Q10 composition of immunity is characterized in that being comprised of the raw material of following weight proportion: 0.5 ~ 5 part of Co-Q10,0.7 ~ 21 part of vitamin E, 25 ~ 300 parts of soybean lecithins.
2. the VE Co-Q10 composition of a kind of auxiliary antilipemic as claimed in claim 1 and enhancing immunity is characterized in that being comprised of the raw material of following weight proportion: 3.5 ~ 4.5 parts of Co-Q10s, 4 ~ 7 parts of vitamin Es, 50 ~ 150 parts of soybean lecithins.
3. the VE Co-Q10 composition of a kind of auxiliary antilipemic as claimed in claim 1 and enhancing immunity is characterized in that being comprised of the raw material of following weight proportion: 4 parts of Co-Q10s, 5.6 parts of vitamin Es, 70.4 parts of soybean lecithins.
4. a preparation that has auxiliary antilipemic and strengthen the health care of immunity is characterized in that being prepared from by available auxiliary material in each described VE Co-Q10 composition and pharmacy and the food industry among the claim 1-3.
5. the preparation that has auxiliary antilipemic and strengthen the health care of immunity as claimed in claim 4 is characterized in that, described preparation is soft capsule.
6. the preparation that has auxiliary antilipemic and strengthen the health care of immunity as claimed in claim 5, it is characterized in that, described soft capsule content is comprised of the supplementary material of following weight proportion: 0.5 ~ 5 part of Co-Q10,0.7 ~ 21 part of vitamin E, 25 ~ 300 parts of soybean lecithins, 0 ~ 100 part of vegetable oil, 0 ~ 15 part in beeswax.
7. the preparation that has auxiliary antilipemic and strengthen the health care of immunity as claimed in claim 6, it is characterized in that, described soft capsule content is comprised of the supplementary material of following weight proportion: 3.5 ~ 4.5 parts of Co-Q10s, 4 ~ 7 parts of vitamin Es, 50 ~ 150 parts of soybean lecithins, 50 ~ 85 parts of vegetable oil, 1 ~ 5 part in beeswax.
8. the preparation that has auxiliary antilipemic and strengthen the health care of immunity as claimed in claim 7, it is characterized in that, described soft capsule content is comprised of the supplementary material of following weight proportion: 4 parts of Co-Q10s, vitamin E .5.6 part, 70.4 parts of soybean lecithins, 75.2 parts of vegetable oil, 4.8 parts in beeswax.
9. such as each described preparation that has auxiliary antilipemic and strengthen the health care of immunity of claim 6-8, it is characterized in that vegetable oil in the described soft capsule content is selected from one or more in soybean oil, corn oil, sunflower oil, olive oil, the peanut oil.
10. such as each described preparation method with auxiliary antilipemic and preparation of the health care that strengthens immunity among the claim 6-9, it is characterized in that, may further comprise the steps:
(1) glue of preparation soft capsule rubber, preheating is incubated for subsequent use;
(2) take by weighing the recipe quantity vegetable oil, add beeswax, be heated to whole dissolvings, cooling, lasting stirring adds the recipe quantity soybean lecithin successively, continues stirring until whole dissolvings, and insulation continues to stir adding recipe quantity Co-Q10, vitamin E, stirring to grind and beat in the rearmounted colloid mill of dissolving is circulated to evenly also all by 100 mesh sieves, gets content;
(3) content and glue make soft capsule.
11 preparation methods according to claim 10 is characterized in that comprising the steps:
(1) get gelatin, glycerine, titanium dioxide, lemon yellow, famille rose, purified water and in changing the glue tank, change glue, qualified glue is put in the laminated heat-preserving bucket that is preheated to 50-60 ℃, for subsequent use;
(2) take by weighing vegetable oil, add beeswax, be heated to whole dissolvings about 80 ℃, placement cools to about 50 ℃, add the formula ratio soybean lecithin, continue stirring until whole dissolvings, insulation continues to stir adding formula ratio Co-Q10, vitamin E about 50 ℃, stirring to grind and beat in the rearmounted colloid mill of dissolving is circulated to evenly also all by 100 mesh sieves, gets content;
(3) get content and glue and carry out pelleting, capsule and pill through typing, wash ball, dry, dry, pick operation and make soft capsule.
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| CN103211217A (en) * | 2013-04-25 | 2013-07-24 | 福建永生活力生物工程有限公司 | Healthy soft capsule with function of enhancing immunity and preparation method thereof |
| CN103519172A (en) * | 2013-10-17 | 2014-01-22 | 新疆天海绿洲农业科技股份有限公司 | Soft capsule containing jujube, American ginseng and sea buckthorn seed oil |
| CN105124590A (en) * | 2015-09-23 | 2015-12-09 | 威海紫光金奥力生物技术有限公司 | Coenzyme Q10 soft capsule for enhancing immunity |
| CN106389375A (en) * | 2016-08-18 | 2017-02-15 | 安士生物科技（中山）有限公司 | A coenzyme Q<10> soft capsule preventing oxidation and relieving physical fatigue and a preparing method thereof |
| CN106562937A (en) * | 2016-10-20 | 2017-04-19 | 山东健康源生物工程有限公司 | Coenzyme Q10 soft capsule and preparation method thereof |
| CN114009762A (en) * | 2021-11-01 | 2022-02-08 | 欣安贝药业科技盐城有限公司 | Coenzyme Q10 soft capsule for enhancing immunity and preparation method thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103211217A (en) * | 2013-04-25 | 2013-07-24 | 福建永生活力生物工程有限公司 | Healthy soft capsule with function of enhancing immunity and preparation method thereof |
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| CN106389375A (en) * | 2016-08-18 | 2017-02-15 | 安士生物科技（中山）有限公司 | A coenzyme Q<10> soft capsule preventing oxidation and relieving physical fatigue and a preparing method thereof |
| CN106562937A (en) * | 2016-10-20 | 2017-04-19 | 山东健康源生物工程有限公司 | Coenzyme Q10 soft capsule and preparation method thereof |
| CN114009762A (en) * | 2021-11-01 | 2022-02-08 | 欣安贝药业科技盐城有限公司 | Coenzyme Q10 soft capsule for enhancing immunity and preparation method thereof |
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