CN105982071A - High-dose vitamin D3 oral preparation recipe - Google Patents
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Abstract
The present invention provides a high-dose vitamin D3 composition oral preparation and particularly a vitamin D3 oil preparation and a vitamin D3 soft capsule preparation. The dose range of the vitamin D3 is between 500 IU (12.5 [mu]g) and 50000 IU (1250 [mu]g). The high-dose vitamin D3 oral preparation is used for the treatment and prevention of vitamin D deficiency and osteoporosis, the fall prevention, and the treatments of depressions, hypertensions, metabolic syndromes, hyperlipidemia, and autoimmune diseases, and can also stabilize and reverse atherosclerosis and coronary plaque formation.
Description
Technical field
The present invention relates to high dose vitamin D to public health and the prevention of various disease or treatment.The invention provides effective preparation of vitamin D3, particularly vitamin D3 oil preparation and the preparation of vitamin D3 soft capsule.
Background technology
It is known that vitamin D helps the skeleton absorption to calcium, rickets is solvent (including edible oil).It is present in food, it is also possible to synthesized by being exposed to sunlight middle-ultraviolet lamp by human body skin.Sunlight is the important sources of vitamin D, and skin causes the synthesis of vitamin D by the ultraviolet in sunlight after being irradiated.Vitamin D has several existence form, and each activity is different.Ostelin is most active form in vitamin D.Vitamin D is converted into active hormone form by the help of liver and kidney.The vitamin D that skin produces or takes in food, needs to form the chemical conversion of 1,25 dihydroxy vitamin D, referred to as activated vitamin D at liver and kidney, and activated vitamin D has hormone function, and transmission message is to gastrointestinal tract, thus increases the absorption of calcium and phosphorus.Vitamin D is a kind of steroid hormone.The performance of vitamin D famine.Vitamin D is a kind of fatsoluble vitamin, water insoluble, is easily soluble in organic solvent (including edible oil).
The principal biological function of vitamin D is to maintain calcium and phosphorus at normal level, and by promoting the absorption of calcium, vitamin D contributes to being formed and maintaining the strong of skeleton.Vitamin D also with some other vitamin, mineral and hormone synergism, promote bone mineralising.If being deficient in vitamin D, skeleton will thinning, become fragile or deformity.Enough vitamin D pre-child-resistant can occur that osteomalacia occur in rickets, adult.
Research also indicates that, vitamin D may help to maintain healthy immune system, contributes to regulating growth and the differentiation of cell.
The thirties in last century, rickets is a great public health problem in the U.S., thus occurs in that milk fortification project, and every quart of (946ml) milk adds 10 micrograms (400IU) vitamin D.1 soupspoon cod-liver oil contains 1360 IU；The salmon that 3.5 ounces (28.35 grams) boil contains 360IU vitamin D.Seldom can see vitamin D reinforcing food on domestic market, part milk with the addition of vitamin D, and every 225ml adds 100IU vitamin D2 or D3.
Sunlight irradiation is the important sources of vitamin D, but season, geographic latitude, the different time of a day, cloud layer, smog and the sun-proof uv light exposure that affects, thus affect the synthesis of vitamin D.Such as 37 ° of northern areas of north latitude, the sunlight in November to February as annual in Beijing (north latitude 39 °-42 °) irradiates, and is just not enough to produce the synthesis of obvious vitamin D on skin.
Vitamin D2 is ergocalciferol, is the precursor of vitamin D3, and D2 is transformed into vitamin D3 and plays a role by somagenic need.D3 is cholecalciferol.It is obvious that D2 activity is not so good as vitamin D in D3 increasing serum less than D3, the D2 of same dose.It is D3 that sunlight irradiates make that human body produces.Vitamin D2 and D3 may be used to supplementing and food interpolation of vitamin D.
1 μ g vitamin D is 40 IU.Chinese Soclety of Nutrition's version " DRIs " middle proposition in 2000, the recommended intake of Chinese residents Dietary Vitamin D is 200-400
IU/d(5-10 μ g/d), have increased slightly after revision in 2013, recommended intake is 400 IU-600 IU/d(10-15 μ g/d), average requirement 320 IU(8 μ g/d), can tolerate the highest intake 0-4 year is 1200IU/d(30 μ g/d), within more than 14 years old, be 2000IU(50 μ g/d).This dose is far below the suggestion of American Endocrine Society, and they advise that more than 1 years old every day of vitamin D is taken in and do not exceed 10000 IU(250 μ g/d).
Vitamin D too much can cause poisoning by vitamin D, shows as hypercalcemia, and now vitamin D level is at 150 more than ng/mL, Nausea and vomiting, inappetence, constipation, weakness often occurs and loses weight, and even causes mental disorder.Hypercalcemia can also cause cardiac rhythm abnormal and heterotopic calcification (body tissues, such as the calcium phosphorus precipitation of kidney).
Vitamin D can affect various health status directly or indirectly, therefore can prevent and treat a lot of disease.
Summary of the invention
Invention summary.The inventors discovered that, high dose vitamin D3 (cholecalciferol) preparation can bring many health benefits, and said preparation is that vitamin D3 is dissolved in edible oil, first-selected gelatin soft capsule, preferably drop, good selects dropping pill formulation；Every grain ball or soft capsule are containing between vitamin D3 500 IU～50000 IU, first-selected 1000 IU/ grains, preferably every 2000 IU/ grains, more preferably every 5000 IU/ grains, good select every 10000 IU/ grains, most preferably select every 50000IU/ grain, select additionally, every 500IU/ grain, 1500 IU/ grains, 2500 IU/ grains and 3000 IU/ grains are also good preparation specifications.It is every 500 IU by dripping solution (drop) preferred amounts measured, more preferably measures every 1000 IU, optimised quantity every 2000 IU, but be not limited to this specification.Said preparation is conducive to provide enough nutrition, prevent and treat vitamin D deficiency and the relevant disease caused thereof, and it is possibly used for fall prevention, accelerating union of bone fracture, the generation of prevention malignant tumor, prevents and treat Metabolic syndrome to seek peace reduction hyperlipemia, treat renal failure with vitamin D deficiency, prevention and treatment depression, resisting hypertension.The most important application of the present invention is in treatment, prevents and reverse renovascular high renin hypertension.Assess the effectiveness of vitamin D dosage according to serum content, desirable level is more than 30ng/mL, preferably 50
More than ng/mL, the upper limit is less than 150 ng/mL.Its serum levels is relevant to vitamin D intake；The inventors discovered that, Vitamin D preparation and enriched food on market generally cannot make serum levels reach expection desirable level.And the vitamin D3 preparation of the high dose of the present invention can reach.
Other preparation interested includes in the edible oil containing above-mentioned vitamin D3, adds other conjugated linoleic acid, prescription drugs (especially statins), omega-fatty acid, L-arginine, coenzyme Q10, nicotinic acid and other nutrient substance.
Detailed Description Of The Invention.Vitamin D deficiency is a worldwide epidemic diseases, and north of China is especially prominent.The present inventor studies discovery, Beijing area vitamin D deficiency (serum 25OHD level < 20 ng/mL) the most universal, find by 5531 Beijing residents being carried out investigation, vitamin D deficiency prevalence is up to 87.1%, famine (serum 25OHD < 10 ng/mL) up to 44.7%, women prevalence is higher than male, and teenager and old age are more common, and winter and spring, prevalence was higher than summer and autumn.
" DRIs " announced for up-to-date 2013 according to Chinese Soclety of Nutrition, recommending vitamin D intake is 400-600 IU/d(10-15 μ g/d), this suggestion is overly conservative, hinder the scientific research in vitamin D field, product development and dosage optimization, limit nutrition policy making, also it is unfavorable for assessing the risk factor of vitamin D deficiency, finds early and treat vitamin D deficiency.
The inventor have observed that, the nutrition intake amount that Chinese Soclety of Nutrition is recommended, for vast majority of people, serum D3 can only achieve 20ng/mL (50 nmol/L) level, it is impossible to reaches the horizontal 50ng/mL of expection of inventor
(125 nmol/L)。
Different Individual condition, needs various dose to can be only achieved certain Serum Vitamin D level, as overweight people needs the dosage of common people 3 times to can be only achieved same serum levels.The nutrition intake amount that Chinese Soclety of Nutrition is recommended does not accounts for any specified conditions.
Being affected by " DRIs ", in domestic existing Vitamin D preparation, vitamin D medicine and health food dosage are up to 400IU(10 μ g), dosage is the most on the low side；And, a lot of preparations contain vitamin A simultaneously, for both mixture, as containing vitamin A 1500 IU, vitamin D 400 IU, if increasing taking dose, will necessarily take too much vitamin A simultaneously, Excess free enthalpy vitamin A is unfavorable to bone health to have ample evidence to show, can cause vitamin A poisoning.
Inquiry State Food and Drug Administration's medicine and health food data base, domestic oral vitamin D formulations includes two classes, one class is vitamin D2 solid tablet, capsule and drop pill, is respectively 5000 IU/ grains (1250 μ g), 100 IU-400 IU(2.5-10 μ g containing vitamin D2)/grain；Another kind of for vitamin D3 sheet, other become burst or soft capsules to the addition of calcium or multivitamin etc., vitamin d3 levels is at 50-400 IU(1.25-10 μ g) between/grain, have no that content is at 400 IU(10 μ g) more than vitamin D3 oral formulations.
Vitamin D oral formulations on domestic market is solid tablet, capsule, drop pill, the multiple multivitamin tablet of addition and a small amount of soft capsule preparation, effective ingredient is vitamin D2 or vitamin D3, and the vitamin D3 of maximum dose level is 400 IU(10 μ g).Content is not had to equal to or higher than 500 IU(12.5 μ g on market) vitamin D3 oral formulations.
On domestic market, vitamin D reinforcing food is little, and some vitamin D reinforcing milk, the vitamin D of interpolation is D2 or D3, and vitamin D dosage is the lowest, it is impossible to blood level is brought up to the desired desirable level of inventor.
The preparation of the present invention is the vitamin D3 preparation of high-load, can effectively correct vitamin D deficiency, the disease that treatment vitamin D deficiency is relevant.
High-load vitamin D3 preparation of the present invention be drop pill, soft capsule, by dripping solution (drop) and the solid tablet of metering, soft capsule that first-selection is dissolved in edible oil and by the solution dripping metering.
The present invention uses vitamin D3, is not vitamin D2, and the activity of vitamin D3 is higher than vitamin D2.
First-selection of the present invention uses vitamin D3 to be dissolved in edible oil rather than solid tablet, and the bioavailability of oil preparation is the highest.Solid tablet absorbs than oil preparation and reduces 50% or less.It also avoid the shortcoming that in the vitamin D that various diet adds, biological activity variation is the biggest.
High-load vitamin D3 formulation dosage scope of the present invention is that every grain ball or soft capsule are containing vitamin D3
Between 500 IU～50000 IU, dosage first-selection 1000
IU/ grain, preferably every 2000 IU/ grains, more preferably every 5000
IU/ grain, good selects every 10000 IU/ grains, most preferably selects every 50000IU/ grain, additionally, every 500IU/ grain, 1500 IU/ grains, 2500 IU/ grains and 3000 IU/ grains are also that good preparation specification selects.
High-load vitamin D3 drop preferred amounts of the present invention is every 500 IU, more preferably measures every 1000 IU, optimised quantity every 2000 IU, but is not limited to this specification.
High-load vitamin D3 drop of the present invention and soft capsule usage be first-selection once a day, but be not limited to once a day, its preferred usage is to arrive 1 times a week 5 times a week, and certain formulations (such as 50000IU/ grain) has once every two weeks as good choosing.
The inventor have observed that, the beneficial effect dosage of vitamin D3 is ten to the Radix Achyranthis Bidentatae of the vitamin intake of Chinese Soclety of Nutrition's once proposed recommendations, and serum 25OHD
Concentration is also far below toxic level.
Research find, take vitamin D3 4000 IU(100 μ g/d long-term every day), this dosage be Chinese Soclety of Nutrition recommend can tolerate the highest intake, serum 25OHD
Level can reach 38 ng/mL(96
Nmol/L)；Take vitamin D3 10000 IU(250 μ g/d every day), this dosage be American Endocrine Society suggestion can tolerate the highest intake, serum 25OHD level can reach 88
Ng/mL(220 nmol/L), hypercalcemia and other untoward reaction all do not occur.The present inventor's clinic is applied 600,000 unit vitamin D3 single oral treatment vitamin D deficiencies, does not also find hypercalcemia and other any untoward reaction.
The most important breakthrough of the present invention is, coronary plaque is formed patient only vitamin D 3, evidence suggests that heart CT scoring speckle reduces, and prompting is probably heretofore unknown minimizing speckle and is formed, the effect that even reverse plaque is formed.
Calcification is the mark that atheromatous plaque is formed, the indirect measure yardstick that calcium level occurs as speckle.Internal vitamin D and calcium metabolism have complex relationship, it is evident that both function influences are to skeleton, and on this basis, vitamin D level result has influence on the blood vessel at plaque place.
It is presently recommended that intake (food additive amount) is hundreds of unit (10 μ g), and the vitamin D3 effective dose suppressing speckle to form (stable even reverse plaque) is upper kilounit (100 μ g), differs an order of magnitude.
Dosage form.The vitamin D3 of liquid form includes oil, drop pill, soft capsule, suspension, microcapsule, capsule and strengthening liquid (such as: milk and orange juice), and oil preparation is more first-selected, makes drop pill on this basis and soft capsule is more preferably to select.
Described in high-load vitamin D3 of the present invention, oil is edible oil, including, but not limited to Semen Maydis oil, soybean oil, Oleum Arachidis hypogaeae semen, Oleum Cocois, olive oil, Oleum Helianthi, salad oil and other edible oil that is natural and that be processed further, add the adjuvants such as gelatin, glycerol and pure water, but it is not limited to these adjuvants, makes soft capsule or drop pill.
Vitamin D3 preparation of the present invention is to add food, health food or " dietetic food ".
Use vitamin D3 treatment and/or prevention method
The range of application of vitamin D3.Vitamin D has treatment and prevention effect to human diseases, and existing document and inventor also observe directly in clinical course: include but not limited to: 1) promote bone health, prevent rickets, osteomalacia；2) muscle strength is increased, fall prevention, treat lumbago and backache, limbs pain；3) prevent and treat osteoporosis；4) prophylaxis of cancer (particularly breast carcinoma, bladder, prostate, colon)；(5) accelerating union of bone fracture；6) antidepressant；7) to renal vascular hypertension, the resisting hypertension of high renin hypertension；8) metabolism syndrome；9) hyperlipemia；10) treatment of patients with renal failure vitamin D deficiency.
Other situations that the Vitamin D preparation applied according to the present invention and dosage may be benefited, including improving function of immune system, flu-prevention and many autoimmune diseases, such as rheumatoid arthritis, psoriasis, type 1 diabetes etc.；Cardiovascular disease, including cardiovascular disease prevention, prevent and treat atherosclerosis and speckle；Prevention and treatment adolescent acne；Prevention of stroke.Other application of Vitamin D preparation according to the present invention also include diabetes mellitus prevention, treatment male erectile dysfunction (ED improves blood flow) and antenatal care.
Effective dose
Effective dose varies with each individual, different race, sexs, age, body weight, season are different with residing geographical position different, also with treatment or the disease difference difference of prevention, the invention provides recommendation Serum Vitamin D3 horizontal extent (minimum and maximum).
In the clinical practice that prevention of arterial plaque is formed, the inventors discovered that serum D3 level is about 50
About ng/mL is effective.Gradually strengthening less than effect during 50 ng/mL, occur, substantially increase to 50ng/mL effect time between 40-45ng/mL, act on the least during below 20ng/mL, the formation effect suppressing plaque in serum during 25 hydroxyvitamin D (25OHD) about 50ng/mL is obvious.
The upper limit as effective range, it should be noted that in some area, people irradiate (being such as positioned at Costa Rica of north latitude 10 °) only by sunlight, it is possible to obtain serum levels vitamin D 80ng/mL.
Study according to inventor, take in sufficient Dietary Vitamin D(such as oiliness 2000
IU vitamin D3), reach expection serum D3 >
30ng/mL (75nmol/L) level, and the nutrition intake amount that Chinese Soclety of Nutrition is recommended for up-to-date 2013 is 400-600 IU/d, observation is studied according to foreign literature and the present inventor, this dosage range is for vast majority of people, serum D3 can only achieve 20ng/mL (50 nmol/L) level, it is impossible to reaches expection level.
For reversing arteriosclerosis, it is proposed that vitamin D3 dosage be 1000 to 10000 IU/sky, or 50000
IU, weekly or twice.It is preferably used and is dissolved in oil formulation rather than powder and solid tablet.
Present inventors have observed that, oral oiliness vitamin D3 improves blood fat effect, reduces triglyceride, improves high density lipoprotein (" good cholesterol "), reduces low density lipoprotein, LDL (" bad cholesterol ").
Reduce level of inflammation and blood pressure level after oral D3, it appears that advantageously reduce arteriosclerosis, developed by CT and heart and mark, therefore significantly reduce coronary heart disease risk.
Other preparations of vitamin D
The combination preparation of imagination, including 1) vitamin D and conjugate linolenic acid (CLA) combine；(2) vitamin D combines (such as antihypertensive drug) with prescription drugs；3) vitamin D and omega-fatty acid；4) with other nutrients, such as calcium etc..
The vitamin D of imagination and fatty acid composition (including deriving from ocean fishes, Semen Lini, krill or the EPA(eicosapentaenoic acid of marine algae oil), DHA(docosahexenoic acid), DPA(clupanodonic acid), with ALA(alpha-linolenic acid), content of fatty acid need not be enumerated, but includes fatty acid concentration ratio (every gram of oil milligram containing EPA:DHA): 250:450；200:600；500:200 and 400:200.
Adjuvant used by Vitamin D preparation, coloring agent and the stabilizer of the present invention of imagination, need not enumerate at this, including, but not limited to following instance, including: emulsifying agent: Apis wax and lecithin；Stabilizer: vitamin E, ascorbyl palmitate, Herba Rosmarini Officinalis extract；Natural dyeing agent (capsule): such as redwood；With the nutritional labeling of vitamin D combination, need not enumerate at this, representative instance includes following additive or emulsifying nutrition: (i): mineral: calcium, zinc, chromium, magnesium and selenium；(ii) vitamin: beta-carotene, vitamin A, E and B race；(iii) nutritional labeling: phylloxanthin, zeaxanthin, resveratrol.
Embodiment 1: vitamin D3 and edible oil, adds that gelatin, G & W make soft capsule, and every vitamin d3 levels is 1000
IU、2000 IU、5000
IU, 10000 and 50000
IU.Usage can be administered orally every day 1；Every 50000
The soft capsule of IU, can weekly 1 or every two weeks 1 be administered orally.
Embodiment 2: vitamin D3 and edible oil mixed diluting are made by the solution (drop) dripping metering, every containing vitamin D3 500 IU, 1000
IU or 2000 IU, usage every day 1 or few drops are administered orally.
List of references:
1. journey is righteous and courageous. " DRIs " 2013 revised edition brief introduction. and Journal of Nutrition .2014;36(4):313-317.
2.Holick MF, Binkley NC,
Bischoff-Ferrari HA, et al.Evaluation, treatment, and prevention of vitamin D
deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(7):1911-30.
3.Zhiwei Ning, Shufan Song, Li Miao, et al. Vitamin D status and Seasonal
variation in Beijing residents, Poster 067. 7th International conference on
osteoporosis and bone research 2014. Xiamen, China. October16-19,2014.
4. peaceful will is big, Miao Li, Liu Jia, waits .60 ten thousand unit vitamin D3 single oral to treat vitamin D deficiency. China's osteoporosis and bone mineral content disease magazine .2014; 7(4);
320-324.
5.Ross AC,Manson
JE,Abrams SA, et al. The 2011 Dietary Reference Intakes for Calcium and Vitamin
D: What Dietetics Practitioners Need to Know. J Am Diet Assoc. 2011; 111:
524-527.。
Claims (13)
1. the compositions containing vitamin D3, content range is at 500 IU(12.5 μ g)-50000 IU(1250 μ g) between.
2., according to claim 1, described vitamin D3 compositions is dissolved in edible oil.
3., according to claim 1, described vitamin D3 compositions is with gelatin soft capsule form.
4., according to claim 1, described vitamin D3 compositions is with solid tablet form.
5., according to claim 1, described vitamin D3 compositions is with by the solution form dripping metering.
6., according to claim 1, described vitamin D3 compositions is with dripping pill type.
7., according to claim 1, described vitamin D3 composition dosage scope is at 1000 IU(25 μ g)-50000 IU(1250 μ g) between.
8., according to claim 1, described vitamin D3 composition dosage scope is at about 500 IU(12.5 μ g)-2000 IU(50 μ g) between.
9. according to claim 1, described vitamin D3 compositions IU(50 μ g Han vitamin D3 about 2000)-5000IU(125 μ g) between.
Vitamin D3 compositions the most according to claim 1, possibly together with conjugated linoleic acid, statins, resisting hypertension, omega-fatty acid, L-arginine, nutrient, coenzyme Q10, or nicotinic acid.
11., according to claim 10, form including omega-3 fatty acid and vitamin D3.
12. vitamin D3 compositionss according to claim 1, the Therapeutic Method that application effective dose treatment mammal arteriosclerosis and coronary plaque are formed.
13. vitamin D3 compositionss according to claim 1, use effective dose, treat and prevent the vitamin D deficiency of mammal；Treatment osteoporosis, treatment or fall prevention；Treatment depression；Treat and prevent hypertension, Metabolic syndrome seeks peace hyperlipemia；Prevention and treatment autoimmune disease.
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| CN106723064A (en) * | 2016-12-13 | 2017-05-31 | 广州富诺健康科技股份有限公司 | A kind of vitamin D3Soft capsule and preparation method thereof |
| CN106901379A (en) * | 2017-03-11 | 2017-06-30 | 深圳泰乐德营养与健康有限公司 | A kind of vitamin health food of auxiliary prevention of cardiovascular disease |
| CN106923346A (en) * | 2017-03-10 | 2017-07-07 | 深圳泰乐德营养与健康有限公司 | A kind of selected B B-complex health products and application thereof |
| CN107136514A (en) * | 2017-05-23 | 2017-09-08 | 深圳泰乐德营养与健康有限公司 | One kind is by vitamin D, K and vitamin B12The nutrient composition of composition |
| CN108403703A (en) * | 2018-06-04 | 2018-08-17 | 桑艳红 | A kind of vitamine D3 soft capsule and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106723064A (en) * | 2016-12-13 | 2017-05-31 | 广州富诺健康科技股份有限公司 | A kind of vitamin D3Soft capsule and preparation method thereof |
| CN106923346A (en) * | 2017-03-10 | 2017-07-07 | 深圳泰乐德营养与健康有限公司 | A kind of selected B B-complex health products and application thereof |
| CN106901379A (en) * | 2017-03-11 | 2017-06-30 | 深圳泰乐德营养与健康有限公司 | A kind of vitamin health food of auxiliary prevention of cardiovascular disease |
| CN107136514A (en) * | 2017-05-23 | 2017-09-08 | 深圳泰乐德营养与健康有限公司 | One kind is by vitamin D, K and vitamin B12The nutrient composition of composition |
| CN107136514B (en) * | 2017-05-23 | 2021-02-26 | 深圳奥萨制药有限公司 | A health food containing vitamin D, K and vitamin B12Composed nutrient composition |
| CN108403703A (en) * | 2018-06-04 | 2018-08-17 | 桑艳红 | A kind of vitamine D3 soft capsule and preparation method thereof |
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Application publication date: 20161005 |
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