Vitamin dripping pill and preparation method thereof
Technical field
The present invention relates to vitamin dripping pill and preparation method thereof, belong to field of medicine preparing technology.
Background technology
Before human understanding to vitamin starts from more than 3000 year.The ancient Egyptian found that nyctalopia can be cured by some food at that time, though they and do not know what material has played medical function in the food, this is human to the dimmest understanding of vitamin.1912, scientist in Poland Feng Ke extracted from Testa oryzae and a kind ofly can treat beriberic whiteness.This material is called " nutrient that earns a bare living " by Feng Ke, be called for short Vitamin (vitamin), also claims vitamin.The research worker of countries in the world has been carried out extensive studies to the medical function of vitamin afterwards, finds that vitamin has increasing medical function.The confirmation that studies for a long period of time, vitamin is the indispensable nutrient of human body.If lack vitamin in the human body, will suffer from various diseases.Because vitamin follows enzyme participating in the metabolism of human body together, the function of human body is effectively regulated.As time goes on, increasing vitamin kind is familiar with by people and is found that vitamin has become extended familys.People line up them so that remember, and vitamin is aligned to tens kinds of L, P, U etc. by A, B, C always.Modern science further affirmed vitamin to the defying age of human body, prevent the effect of cardio-cerebral diseases such as arteriosclerosis, aspect such as anticancer.Occur increasing various vitamin and mineral tonic in the market, the sale of these tonics is undertaken by the advertisement of covering the sky and the earth often.But take good care of people's body problem, the notion of going back the neither one comparative maturity to how taking reasonable use vitamin and mineral.Especially to the absorption of some trace element, can not determine out the most rational consumption.Maximum difficulty is, Producer can't be determined the environment etc. of user's age, sex, health status and live and work.The people that live in bad living environment (sunshine amount is excessive, air pollution is serious, harsh climate etc.) want many to vitamin requirement.The people that physiology and psychological burden are overweight, the vitamin of consumption and mineral are also many than usual.The people of some monophagias (as vegetarian) is because vitamin and the mineral taken in the body are unbalanced, need regulate with more such tonics, and concerning the anemia of pregnant woman,, also not necessarily just can satisfy the needs of health fully to vitamin and mineral even eat profuse food.In the explanation of multivitamin and mineral tonic, what should be taken every day though indicate, but be difficult to say, this consumption is enough or not enough to concrete someone, because everyone concrete condition is different, and the excessive use vitamin may be addicted artificially, in case cut out, avitaminotic symptom can occur.
The vitamin medical application is to cure fatigue, and prevention is because of the caused vitamin deficiency of dietary unbalance; " loss " of the prevention vitamin (A, B, D, P P) when the physical culture purposes is prolonged exercise or training.Be combined into cocarboxylase with pyrophosphoric acid in vivo as vitamin B1, the involved in sugar metabolism forms acetone acid during shortage and lactic acid is piled up, and causes heart, nerve injury, and edema and serosity ooze out, and are called vitamin B1 deficiency; Vitamin B2 is the prothetic group composition of flavo-enzyme, works the hydrogen atom effect of transmitting in biological oxidation.Influence biological oxygen during shortage, cause glossitis, cheilitis, angular cheilitis, keratitis, conjunctivitis, scrotitis, seborrheic dermatitis etc.; Niacinamide usp is the ingredient of nadide and II, participates in biological oxidation, plays and passs the hydrogen effect, shows as dermatitis during shortage, diarrhoea, and dementias etc. claim pellagra; Vitamin B6 has the material of physiologically active in vivo with the ATP generation, the prothetic group that becomes plurality of enzymes participates in the metabolism of aminoacid and fat, shows as dysphoria during shortage, inappetence, vomiting, eye, seborrhea around nose and the mouth, glossitis, stomatitis; Calcium pantothenate is the coenzyme A precursor, involved in sugar, and fat, protein metabolism plays in metabolism and passs the acyl group effect, occurs the scorching hot syndrome of foot during shortage, enteritis or the like.
It is face-to-face that office staff or every day and computer go up in society at present, carrying briefcase every day runs between client and company, also want regular overtime work and go on business, so, symptoms such as the whole body lazyness is tired, absent-minded, detest full of beard examination topic, complexion is poor, sleep is had a sleepless night, had a short fuse are comed one after another, therefore some people adheres to taking every day multivitamin, but in the selection of vitamin, often lack judgment, just know that probably vitamin is helpful to health, after adhering to having taken some months, feel and refuse to obey and do not have difference.So think that vitamin will be grown exactly and eat that the onset of vitamin own is exactly slow.Which type of vitamin suitable oneself on earth? analyze theoretically, fully the multivitamin that absorbs should make the people begin to feel that energy promotes after taking a stage, after continuing to take, can allow human body maintain on the good health level.In 13 kinds of main vitamins finding up to now, except vitamin A, D, E belong to the fatsoluble vitamin, all the other all belong to water soluble vitamins, and water soluble vitamins claims the energy type vitamin.As vitamin B group, they mainly undertaking the help human body from food, release energy, participate in reducing fat acid and produce power, improve effects such as nervous function, so vitamin B group lessening fatigue, alleviating aspect such as compression of nerves and playing the part of indispensable key player.Aspect safety, water miscible dimension C and vitamin B group safety are higher, a bit are not easy to excrete to cause what consequence even dosage is high; Vitamin A, D (fatsoluble vitamin) then are the vitamin of two kinds of comparisons " danger ", relatively are likely to accumulate in the body fat, and excessive taking for a long time can the toxigenicity reaction.(B1.B2, B6 B12.) are the vitamin that human body can be experienced to vitamin B group, if replenished the multivitamin that contains B family composition every day, but tired, nervous, in the aspect short time such as emotion control not be improved significantly, be exactly the problem that a vitamin absorbs
The rational vitamin compound preparation that studies science is people's pressing for of living and prevent and cure diseases.
Vitamin preparation is extensive use of clinically at present, a large amount of clinical practices show that vitamin is an effective and safe drug, special pharmacological action and therapeutic effect are arranged clinically, for using vitamin scientifically and rationally, increase clinical vitamin drug formulation, the advantage of performance modern medicinal agents, the pharmaceutics achievement in research of uses advanced, we have developed vitamin dripping pill.
Summary of the invention
The objective of the invention is to propose vitamin dripping pill and preparation method thereof, increasing vitamin drug formulation clinically, and the dosage form advantage of performance vitamin prescription advantage and drop pill.
The prescription of the vitamin dripping pill that the present invention proposes consists of:
The preparation method of the vitamin dripping pill with above-mentioned prescription that the present invention proposes may further comprise the steps:
1. vitamin raw materials is pulverized (except the liquid vitamin), porphyrize reaches more than 150 orders, mix raw material A, standby.
2. get the drop pill substrate of formula ratio, behind the heating and melting, add antioxidant, get substrate fused solution B after stirring evenly, standby.
3. raw material A and the surfactant with formula ratio adds among the fused solution B, after being mixed into homodisperse liquid, move into the system of dripping in the control equipment of dripping, temperature is controlled at 70-85 ℃, splashes in the refrigerated condensed fluid (0 ℃ to-20 ℃), pulls drop condensed fluid to the greatest extent out, wipe ball, dry, coated or coating not, coated drop pill or common drop pill (not coating).
In the said method vitamin be that in vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D2, vitamin D3, vitamin E, vitamin K1, nicotinic acid, nicotiamide, folic acid, rutin, calcium pantothenate, folic acid, the biotin one or more mix to use.
In the said method vitamin, the amount ranges of vitamin is in per 1000 ball drop pill: vitamin B1: 0.005g~10g, vitamin B2: 0.005g~10g, vitamin B6: 0.001g~10g, vitamin B12: 0.0001g~0.5g, vitamin C: 0.005~30g, vitamin D2: 0.001~10g, vitamin D3: 0.001~15g, vitamin E: 0.002g~30g, vitamin K1: 0.005~10g, nicotinic acid: 0.005~30g, nicotiamide: 0.005~30g, folic acid: 0.0001~5g, rutin: 0.0001~5g, calcium pantothenate: 0.005g~10g, biotin: 0.0001g~0.5g.
In the said method drop pill substrate be that Macrogol 4000, polyethylene glycol 6000, Polyethylene Glycol 9300, polyoxyethylene monostearate, sodium stearate, poloxamer, stearic acid, glyceryl monostearate, worm are cured, in the hydrogenated vegetable oil one or more mix and use.
In the said method antioxidant be that in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, tertiary butyl-4-hydroxy methyl phenyl ethers anisole, the vitamin C one or more mix to use or do not use antioxidant.
In the said method surfactant be: one or more in lecithin, fatty glyceride, fatty acid Pyrusussuriensis smooth (span), Polysorbate (tween), polyoxyethylene fatty acid ester, polyoxyethylene aliphatic alcohol ether, the poloxamer mix to use or do not use surfactant.
In the said method condensed fluid be: one or more in liquid paraffin, dimethicone, the vegetable oil mix to use.
In the said method coating material be: one or more among HPMC, HPC, PVP, AEA, zein, polyacrylic resin, ethyl cellulose, cellulose acetate, CAP, HPMCP, the PVAP add certain adjuvant and make coating solution or do not use coating material.
The preparation process of said method is all finished in the place that meets pharmaceutical production, development GMP condition.
By the coated drop pill of method for preparing or not in the coated drop pill vitamin content be 0.05mg/ ball~30mg/ ball, ball heavily is 10mg/ ball~100mg/ ball.
The characteristics and the advantage of drop pill that the present invention proposes and preparation method thereof are as follows:
1, the multivitamin that first physical property is differed greatly is prepared into drops, is the new practice of pharmaceutics, has increased vitamin clinical application dosage form, satisfies the needs of clinical prevention disease better.
2. the preparation process of drop pill is scientific and reasonable, the bioavailability height; With PEG, poloxamer etc. is that vitamin fine powder during carrier will be filled a prescription is made solid dispersion, the dissolution rate height, and good absorbing has guaranteed the high dispersion of medicine.
3, increase and guaranteed stability of drug.After medicine and substrate fusion, reduce with the air contact area, be difficult for oxidation, substrate is non-water thing, helps increasing stability of drug; After drop pill is coated, with external isolation, be not subjected to effects such as water in air branch, oxygen, it is rotten and the clothing layer is firmly smooth to be difficult for the moisture absorption, and having overcome vitamin draws moist strong deficiency, has guaranteed stability of drug.
4. packaging technique being introduced in the preparation process of drop pill, is the new development of drop pill technology of preparing.
5. simple, the processing ease of production equipment, weight differential is little, and cost is low, and no dust helps labor protection.
The specific embodiment
Embodiment one
(1) prescription:
(2) preparation method
Get 4740mg polyethylene glycol 6000 and 3160mg Macrogol 4000, behind the heating and melting, add the tertiary butyl-4-hydroxy methyl phenyl ethers anisole of 2mg, after fully stirring evenly, add 1000mg vitamin B1,1000mg vitamin B2,100mg vitamin B12 fine powder, be mixed into homodisperse liquid after, move into the system of dripping in the control equipment of dripping, 80 ℃ of insulations, splash into (-2 ℃ to-8 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry, with 3%HPMC coating solution coating.Contain vitamin 2.1mg in every drop pill.
Embodiment two
(1) prescription:
(2) preparation method
Get 23940mg polyethylene glycol 6000 and 15960mg Macrogol 4000, behind the heating and melting, the thick liquid that adds 1000mg vitamin B1,1000mg vitamin B2,1000mg vitamin B6,100mg vitamin B12,5000mg vitamin C fine powder and 2000mg vitamin E, fully be mixed into homodisperse liquid after, move into the system of dripping in the control equipment of dripping, 80 ℃ of insulations, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry, with HPC coating solution coating.Contain compound vitamin 10.1mg in every drop pill.
Embodiment three
(1) prescription:
(2) preparation method
Get the 61300mg polyethylene glycol 6000, behind the heating and melting, the thick liquid that adds 1000mg vitamin B1,1000mg vitamin B2,1000mg vitamin B6,200mg vitamin B12,5000mg vitamin C, 1000mg nicotinic acid, 1000mg nicotiamide fine powder and 2000mg vitamin E, fully be mixed into homodisperse liquid after, move into the system of dripping in the control equipment of dripping, 75 ℃ of insulations, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry, with PVP coating solution coating.Contain vitamin B12 .2mg in every drop pill.
Embodiment four
(1) prescription:
(2) preparation method
Get 49080mg polyethylene glycol 6000 and 32720mg Macrogol 4000, behind the heating and melting, add the 1000mg vitamin B1, the 1000mg vitamin B2, the 1000mg vitamin B6, the 200mg vitamin B12, the 10000mg vitamin C, 1000mg nicotinic acid, the 1000mg nicotiamide, the thick liquid of 1000mg calcium pantothenate fine powder and 2000mg vitamin E, the Tween 80 of 800mg, the tertiary butyl-4-hydroxy methyl phenyl ethers anisole of 4mg, after fully being mixed into homodisperse liquid, move into the system of dripping in the control equipment of dripping, 78 ℃ of insulations, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry, promptly with 2.5%HPMC coating solution coating.Contain vitamin 18.2mg in every drop pill.
Embodiment five
(1) prescription:
(2) preparation method
Get 4740mg polyethylene glycol 6000 and 3160mg Macrogol 4000, behind the heating and melting, add the tertiary butyl-4-hydroxy methyl phenyl ethers anisole of 2mg, after fully stirring evenly, add 1000mg vitamin B1,1000mg vitamin B2,100mg vitamin B12 fine powder, after being mixed into homodisperse liquid, moving into to drip and drip system, 80 ℃ of insulations in the control equipment, splash into (-2 ℃ to-8 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry promptly.Contain vitamin 2.1mg in every drop pill.
Embodiment six
(1) prescription:
(2) preparation method
Get 23940mg polyethylene glycol 6000 and 15960mg Macrogol 4000, behind the heating and melting, the thick liquid that adds 1000mg vitamin B1,1000mg vitamin B2,1000mg vitamin B6,100mg vitamin B12,5000mg vitamin C fine powder and 2000mg vitamin E, after fully being mixed into homodisperse liquid, moving into to drip and drip system, 80 ℃ of insulations in the control equipment, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry promptly.Contain compound vitamin 10.1mg in every drop pill.
Embodiment seven
(1) prescription:
(2) preparation method
Get the 61300mg polyethylene glycol 6000, behind the heating and melting, the thick liquid that adds 1000mg vitamin B1,1000mg vitamin B2,1000mg vitamin B6,200mg vitamin B12,5000mg vitamin C, 1000mg nicotinic acid, 1000mg nicotiamide fine powder and 2000mg vitamin E, after fully being mixed into homodisperse liquid, moving into to drip and drip system, 75 ℃ of insulations in the control equipment, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry promptly.Contain vitamin B12 .2mg in every drop pill.
Embodiment eight
(1) prescription:
(2) preparation method
Get 49080mg polyethylene glycol 6000 and 32720mg Macrogol 4000, behind the heating and melting, add the 1000mg vitamin B1, the 1000mg vitamin B2, the 1000mg vitamin B6, the 200mg vitamin B12, the 10000mg vitamin C, 1000mg nicotinic acid, the 1000mg nicotiamide, the thick liquid of 1000mg calcium pantothenate fine powder and 2000mg vitamin E, the Tween 80 of 800mg, the tertiary butyl-4-hydroxy methyl phenyl ethers anisole of 4mg, after fully being mixed into homodisperse liquid, move into the system of dripping in the control equipment of dripping, 78 ℃ of insulations, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry promptly.Contain vitamin 18.2mg in every drop pill.
Embodiment nine
(1) prescription:
(2) preparation method
Get 49374mg polyethylene glycol 6000 and 32916mg Macrogol 4000, behind the heating and melting, add the 1000mg vitamin B1, the 1000mg vitamin B2, the 1000mg vitamin B6, the 200mg vitamin B12, the 10000mg vitamin C, the 5mg vitamin D2, the 5mg vitamin D3,200mg folic acid, the 20mg biotin, 1000mg nicotinic acid, the 1000mg nicotiamide, the thick liquid of 1000mg calcium pantothenate fine powder and 2000mg vitamin E, the tertiary butyl-4-hydroxy methyl phenyl ethers anisole of 4mg, after fully being mixed into homodisperse liquid, move into the system of dripping in the control equipment of dripping, 78 ℃ of insulations, splash into dimethicone (-1 ℃ to-10 ℃), drip and make ball 1000 balls, wipe ball, dry, promptly with 6.5% zein coating solution coating.Contain vitamin 17.71mg in every drop pill.
Embodiment ten
(2) preparation method
Get 39000mg polyethylene glycol 6000 and 1000mg stearic acid, behind the heating and melting, add 10000mg vitamin B1 fine powder, fully be mixed into homodisperse liquid after, move into the system of dripping in the control equipment of dripping, 78 ℃ of insulations, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry, promptly.Contain vitamin B1 10mg in every drop pill.
Embodiment 11
(1) prescription:
(2) preparation method
Get 25000mg polyethylene glycol 6000 and 10000mg Macrogol 4000, behind the heating and melting, add 5000mg vitamin B2 fine powder, 500mg stearic acid, fully be mixed into homodisperse liquid after, move into the system of dripping in the control equipment of dripping, 78 ℃ of insulations, splash into dimethicone (-5 ℃ to-15 ℃), drip and make ball 1000 balls, wipe ball, dry, promptly with AEA coating solution coating.Contain vitamin B2 5mg in every drop pill.
Embodiment 12
(1) prescription:
(2) preparation method
Get 24000mg polyethylene glycol 6000 and 16000mg Macrogol 4000, behind the heating and melting, add 10000mg vitamin B6 fine powder, after fully being mixed into homodisperse liquid, moving into to drip and drip system, 80 ℃ of insulations in the control equipment, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry promptly.Contain vitamin B6 10mg in every drop pill.
Embodiment 13
(1) prescription:
(2) preparation method
Get 54000mg polyethylene glycol 6000 and 36000mg Macrogol 4000, behind the heating and melting, add 30000mg vitamin C fine powder, after fully being mixed into homodisperse liquid, moving into to drip and drip system, 80 ℃ of insulations in the control equipment, splash into (-2 ℃ to-8 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry promptly.Contain vitamin C 30mg in every drop pill.
Embodiment 14
(1) prescription:
(2) preparation method
Get 25000mg poloxamer and 15000mg Macrogol 4000, behind the heating and melting, add the folic acid of 5000mg, the tertiary butyl-4-hydroxy methyl phenyl ethers anisole of 2.5mg, fully be mixed into homodisperse liquid after, move into the system of dripping in the control equipment of dripping, 80 ℃ of insulations, splash into (-2 ℃ to-8 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry, with 3.5%HPMC coating solution coating.Contain folic acid 5mg in every drop pill.
Embodiment 15
(1) prescription:
(2) preparation method
Get 15000mg glyceryl monostearate and 10000mg poloxamer, behind the heating and melting, add calcium pantothenate fine powder 5000mg and 600mg Tween 80, be mixed into homodisperse liquid after, move into the system of dripping in the control equipment of dripping, 80 ℃ of insulations, splash into (-5 ℃ to-10 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry, with 3%HPC coating solution coating.Contain calcium pantothenate 5mg in every drop pill.
Embodiment 16
(1) prescription:
(2) preparation method
Get 45000mg polyethylene glycol 6000 and 25000mg Macrogol 4000, behind the heating and melting, add 25000mg nicotinic acid fine powder, 5000mg stearic acid, fully mixing moves into the system of dripping in the control equipment of dripping, 78 ℃ of insulations, splash into dimethicone (-5 ℃ to-15 ℃), drip and make ball 1000 balls, wipe ball, dry, promptly with 13.5%AEA coating solution coating.Contain nicotinic acid 25mg in every drop pill.
Embodiment 17
(1) prescription:
(2) preparation method
Get 45000mg polyethylene glycol 6000 and 25000mg Macrogol 4000, behind the heating and melting, add 25000mg nicotiamide fine powder, 5000mg stearic acid, fully mixing moves into the system of dripping in the control equipment of dripping, 78 ℃ of insulations, splash into dimethicone (-5 ℃ to-15 ℃), drip and make ball 1000 balls, wipe ball, dry, promptly with 13.5%AEA coating solution coating.Niacinamide-containing 25mg in every drop pill.
Embodiment 18
(1) prescription:
(2) preparation method
Get 5970mg polyethylene glycol 6000 and 3980mg Macrogol 4000, behind the heating and melting, add the tertiary butyl-4-hydroxy methyl phenyl ethers anisole of 3mg, after fully stirring evenly, add 50mg vitamin B12 fine powder, after fully being mixed into homodisperse liquid, moving into to drip and drip system, 80 ℃ of insulations in the control equipment, splash into (-2 ℃ to-8 ℃) in the liquid paraffin, drip and make ball 1000 balls, wipe ball, dry promptly.Contain vitamin B12 0.05mg in every drop pill.