CN102552247B - Composition of vitamin C and preparation method thereof - Google Patents
Composition of vitamin C and preparation method thereof Download PDFInfo
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- CN102552247B CN102552247B CN201210057860.XA CN201210057860A CN102552247B CN 102552247 B CN102552247 B CN 102552247B CN 201210057860 A CN201210057860 A CN 201210057860A CN 102552247 B CN102552247 B CN 102552247B
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Abstract
The invention provides a composition of vitamin C. The composition consists of the following active components and pharmaceutic adjuvants in percentage by weight: active components: 5-30% of vitamin C, 3.25-19.25% of vitamin C sodium and 0.2-0.8% of calcium pantothenate; and pharmaceutic adjuvants: 0.05-0.45% of lubricant, 1-9% of suspension, 30-80% of filler, 0.5-4.5% of binder, 0.05-2.45% of plasticizer, 0.2-0.8% of flavoring agent, 0.2-0.8% of spice, 0.2-0.8% of food colorant and 0.05-5.45% of coating material. The composition of vitamin C provided by the invention has good mouthfeel, is taken without water or with little water and is convenient to carry and use; and moreover, the composition has high stability, is quickly absorbed and takes effect quickly, improves the taking compliance, realizes dual functions of treatment and healthcare, and is particularly suitable for the children or old people and some patients with difficulty in swallowing. The composition of vitamin C provided by the invention is superior to the sugar coated tablet of vitamin C in both appearance and content. The stability of the composition of vitamin C provided by the invention is greatly improved. The preparation technology provided the invention is reasonable, easy to operate and suitable for industrial production. The composition of vitamin C has relatively good clinical effect and relatively high application values.
Description
Technical field
The present invention relates to pharmaceutical preparation.Be specifically related to a kind of ascorbic compositions and preparation method.
Background technology
Vitamin C and dehydrogenation vitamin C form a reversible oxidation-reduction system in vivo, and this system plays an important role in biological oxidation and reduction and Cellular respiration.Vitamin C participates in the synthetic of amino acid metabolism, neurotransmitter, and collagen protein and histiocyte interstitial is synthetic, most important to health.Ascorbic main Physiological Function: the biosynthesis that promotes ossein, be conducive to the healing sooner of tissue injury mouth, the metabolism of tyrosine and tryptophan in promotion aminoacid, extend the human body life-span, improve the utilization of ferrum, calcium and folic acid, improve fat and the particularly metabolism of cholesterol of lipoid, prevention cardiovascular diseases, promote the growth of tooth and skeleton, prevent that dental bed is hemorrhage, strengthen human body anti-stress ability and the immunity of environment to external world.And vitamin C also melanin capable of blocking forms, and can strengthen skin elasticity, prevention mottle, has beautification function etc.Sodium ascorbate as supplementary and antioxidant, has without tart flavour, advantage soluble in water, and increased ascorbic stability.At present, Vitamin C preparation has the various dosage forms such as ordinary tablet, chewable tablet, effervescent tablet, dispersible tablet, buccal tablet, injection.But, all there is to some extent easy to change, easy degraded, poor stability, carry and use the defect such as inconvenience and complex manufacturing (chewable tablet, effervescent tablet, dispersible tablet, injection).In addition, the ascorbic sour and astringent bad sense of taste, in the time contacting with taste bud, will be sent to cortical centre the information of the pessimal stimulation of experiencing, and produces the bad sense of taste, causes the poor compliance taken, has affected ascorbic clinical use.Therefore, people are more and more higher to improving taking and the portable demand of Vitamin C preparation.Especially for the patient of children's or elderly patient and some dysphagias, the granule dosage form product that can directly swallow is more prone to be accepted.Cover adverse drug taste simultaneously, improve patient compliance, be the target that the world of medicine makes great efforts always.But, beyond thought effect that the inventor has found calcium pantothenate and vitamin C combination results.Calcium pantothenate has a lot of effects for aspects such as human body skin care and improvement fatigues.Also lack clinically in addition prevention and the treatment of (as malabsorption syndrome, ceylon sore mouth, coeliac disease, regional enteritis) for calcium pantothenate, can relax the pigmentation of speckle freckle, sunburn, scytitis etc. simultaneously.When vitamin C and calcium pantothenate combination, can not only improve the defect of Vitamin C preparation, also increase purposes.Therefore, research vitamin C composition preparation is the problem of paying close attention to.
Summary of the invention
The technical problem to be solved in the present invention is to overcome above-mentioned weak point, research design carries taking convenience, absorb onset rapidly, good stability, and portable vitamin C composition.
A kind of ascorbic compositions of the present invention, described compositions is pressed column weight amount per distribution ratio by active component and pharmaceutic adjuvant and is formed:
(1) active component:
Vitamin C 5～30%
Sodium ascorbate 3.25～19.25%
Calcium pantothenate 0.2～0.8%
；
(2) pharmaceutic adjuvant
Preferably, a kind of vitamin C composition of the present invention, described compositions is grouped into by the one-tenth of following weight proportion: 2000g/1000 bag
Compositions of the present invention is granule, 1-3g (every bag).
In compositions of the present invention, the function of each component is as follows:
Described active component comprises: vitamin C, sodium ascorbate and calcium pantothenate.Wherein sodium ascorbate has antioxidant and ascorbic effect concurrently; Calcium pantothenate has a lot of effects for aspects such as human body skin care and improvement fatigues, can relax the pigmentation of speckle freckle, sunburn, scytitis etc. simultaneously.
Described pharmaceutic adjuvant comprise lubricant, suspensoid, filler, binding agent, plasticizer,
Correctives, spice, food coloring, coating material.
Lubricant: include but not limited to magnesium stearate, calcium stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium lauryl sulphate, Stepanol MG, Pulvis Talci etc., can be used alone, also use capable of being combined.Can improve raw material mobility, eliminate Electrostatic Absorption, be conducive to carrying out smoothly of pulverizing and taste masking coating.
Taste masked particle: formed by the taste masking of coating type macromolecular material coating.
Coating material: include but not limited to acrylic resin L-100, ethyl cellulose, hypromellose, polyvinylpyrrolidone, methylcellulose, gelatin, arabic gum, zein, sodium alginate, chitosan etc., can be used alone, also use capable of being combined.Be formulated as water or alcoholic solution coating, reach taste masking object.
Taste masking granule: by suspensoid, filler and above-mentioned for granule binder solution (containing correctives, plasticizer, spice, pigment) granulate and form through fluidized-bed process.
Suspensoid: include but not limited to that microcrystalline Cellulose-carboxymethyl starch sodium (RC-591), sodium carboxymethyl cellulose (CMC sodium), polyvinylpyrrolidone (PVP), Xanthan gum are former, carboxymethyl starch sodium (CMS sodium), hydroxypropyl emthylcellulose (HPMC) etc., can be used alone, also use capable of being combined.In granule, play suspendible stabilizing agent.
Filler: include but not limited to mannitol, sorbitol, maltose, microcrystalline Cellulose, glucose, sucrose, lactose, dextrin etc., may be used alone, can also be used in combination.
Binding agent: include but not limited to hydroxypropyl cellulose (HPC-L), HPMC, PVP, starch, dextrin, methylcellulose, alginic acid and alginate etc., can be used alone, also use capable of being combined.Need to be formulated as water or the alcoholic solution binding agent as pelletize according to technique.
Correctives: include but not limited to saccharin sodium, Aspartane, lactose, fructose, sucrose, steviosin, mannitol, xylitol etc., can be used alone, also use capable of being combined.On taste masking basis, play flavored action.
Plasticizer: include but not limited to polyethylene glycol 6000 (PEG6000), Macrogol 4000 (PEG4000), triethyl citrate, spermol etc., can be used alone, also use capable of being combined.Play and improve particle appearance effect.
Spice: include but not limited to essence, Herba Menthae, vanillin, ethyl vanillin etc., can be used alone, also use capable of being combined.Play and improve olfactory sensation and be easier to the effect that people is accepted.
Pigment: for the acceptable pigment in pharmaceuticals industry and food industry of nature or synthetic, include but not limited to lemon yellow, sunset yellow, Radix Dauci Sativae pigment, curcumin etc., can be used alone, also use capable of being combined plays and improves particle appearance effect.Can make particle appearance more beautiful, be easier to make people to accept.
Another object of the present invention has been to provide a kind of ascorbic preparation method of composition.
The method of the invention comprises core granule preparation, taste masked particle preparation and the preparation of taste masking granule, specifically comprises the following steps:
(1) core granule preparation:
Vitamin C, sodium ascorbate, calcium pantothenate are fully mixed homogeneously with lubricant, and then mixture being crushed to particle diameter is 25-50um, makes core granule;
(2) taste masked particle preparation:
The core granule of (one) is placed in to fluidized-bed coating machine, and with ethanol solution (concentration 5-10%) spray coating continuously of macromolecule coating material preparation, after coating, granule is crossed 80 mesh sieves, makes taste masked particle; Set discharge rate 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of inlet temperature; 50 ℃ of dry 15min after coating.
(3) taste masking granule preparation
The taste masked particle of (two) is mixed and is placed on fluid bed with suspensoid, filler; Binding agent, plasticizer, correctives, spice and the pigment of another water or dissolve with ethanol, make the solution of 3-9%, hydrojet continuously, and after having sprayed, in 40-50 ℃ of hot air drying, discharging, crosses 20 mesh sieves, obtains taste masking granule.
Adopt Aluminum-plastic composite bag packing to get final product (the weight 1-3g of every bag) according to the specification of taking requirement.
The present invention is by the compositions granulation agent of vitamin C, sodium ascorbate and calcium pantothenate, and substep is made core granule, taste masked particle, taste masking granule, has good effect.First the present invention makes vitamin C, sodium ascorbate core granule can prevent that vitamin C is subject to oxygen, moisture and affects stability, has significantly improved the stability of vitamin C composition.Further macromolecule coating material is wrapped in to the drug particles surface of disagreeable taste, thereby has reduced medicine stripping in oral cavity, reach taste masking object.Finally make taste masking granule, make the granule sense of taste of the present invention, mouthfeel good, dosage is accurate.In addition, granule of the present invention is easy to carry and takes, and does not need water or only needs a small amount of water, without chewing, can enter stomach by swallowing power, the fine grained that height of formation disperses in gastric juice of vitamin C, sodium ascorbate and the calcium pantothenate in compositions, has improved bioavailability.Because present composition mouthfeel is good, absorb soon, be conducive to patient and take, increase compliance.Also have treatment calcium pantothenate deficiency disease simultaneously concurrently and relax the beauty and health care functions such as pigmentation of speckle, freckle, sunburn, scytitis.Have not yet to see the relevant report of the present composition and granule dosage form.
Vitamin C composition of the present invention can be used for the disease (as vitamin C deficiency, gingival hemorrhage, epistaxis) of preventing and treating hypovitaminosis C to cause, also can be used for enhancing body resistance, the prevention heart, cerebrovascular, low and the habitual abortion of the muscle power such as convalescent period after being ill during to During Wound Healing, organism fatigue, in gestation, lactication phase, disease, the auxiliary treatment of infertility and cutaneous pigmentation etc.The present invention is granule, has overcome the defect of the existing dosage form of vitamin C.Preparation technology of the present invention is reasonable, easy and simple to handle, is suitable for suitability for industrialized production.There are good clinical effectiveness and larger using value.
The specific embodiment
For vitamin C composition of the present invention and preparation method are described better, be described further in conjunction with the embodiments.
Embodiment 1
Preparation method:
1) vitamin C, vitamin C-Na, calcium stearate are fully mixed evenly, and are crushed to particle diameter 25-50um, obtain core granule.
2) by 1) core granule be placed in fluidized-bed coating machine (unit type SFP-01), acrylic resin L100 and dehydrated alcohol 316.25g are formulated as to 8% alcoholic solution as serosity, continuously spray coating; Set discharge rate 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of inlet temperature; 50 ℃ of dry 15min after coating.
3) by 2) granule is crossed 80 mesh sieves and is obtained taste masked particle after coating;
4) by 3) granule mixes with microcrystalline Cellulose, microcrystalline Cellulose-sodium carboxymethyl cellulose and is placed on fluid bed (unit type MP-01), water (specifically amount? 447.5g) dissolve HPC-L, PEG6000, saccharin sodium, essence and lemon yellow, be mixed with 5%HPC solution as binding agent, setting spouting liquid is 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of inlet temperature, by the mode hydrojet of top spray, after having sprayed, in 40-50 ℃ of hot air drying, discharging, crosses 20 mesh sieves, obtains taste masking granule;
5) packing: taste masking granule 4) is packaged as 1g/ bag with Aluminum-plastic composite bag.
Embodiment 2
Preparation method:
According to preparation technology's operation described in embodiment 1, the plastic-aluminum combined packed 2g/ bag of packing specification.
Embodiment 3
Preparation method:
According to preparation technology's operation described in embodiment 1, the plastic-aluminum combined packed 3g/ bag of packing specification.
Embodiment 4
Preparation method:
According to preparation technology's operation described in embodiment 1, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 5
Preparation method:
According to preparation technology's operation described in embodiment 1, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 6
Preparation method:
According to preparation technology's operation described in embodiment 1, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 7
Preparation method:
According to preparation technology's operation described in embodiment 1, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 8
Preparation method:
According to preparation technology's operation described in embodiment 1, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 9
Preparation method:
According to preparation technology's operation described in embodiment 1, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 10 study on the stability
The ascorbic composition granule making according to embodiment 1-9, be placed in and under condition, investigate the indexs such as taste, appearance character, Vitamin C content in 60 ℃/10 days, result shows steady quality (seeing the following form), and be obviously better than vitamin C coated tablet (produced by Changzhou City No.4 Pharmaceutical Factory Co., Ltd., lot number is 20100701,20100702,20110301) (seeing the following form two):
Table one
Table two
Table one and table two show significantly, and no matter ascorbic compositions of the present invention from outward appearance and content, is all better than vitamin C coated tablet.Ascorbic composition stable of the present invention has greatly improved.
Claims (1)
1. a vitamin C composition, is characterized in that, described compositions is grouped into by the one-tenth of following weight:
Preparation method:
1) vitamin C, sodium ascorbate, calcium pantothenate, calcium stearate are fully mixed evenly, and are crushed to particle diameter 25-50 μ m, obtain core granule;
2) by 1) core granule be placed in fluidized-bed coating machine, unit type SFP-01, is formulated as 8% alcoholic solution as serosity using acrylic resin L100 and dehydrated alcohol 316.25g, continuously spray coating; Set discharge rate 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of inlet temperature; 50 ℃ of dry 15min after coating;
3) by 2) granule is crossed 80 mesh sieves and is obtained taste masked particle after coating;
4) by 3) granule mixes and is placed on fluid bed with microcrystalline Cellulose, microcrystalline Cellulose-sodium carboxymethyl cellulose, unit type MP-01, water 447.5g dissolves HPC-L, PEG6000, saccharin sodium, essence and lemon yellow, be mixed with 5%HPC solution as binding agent, setting spouting liquid is 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of inlet temperature, by the mode hydrojet of top spray, after having sprayed, in 40-50 ℃ of hot air drying, discharging, crosses 20 mesh sieves, obtains taste masking granule;
5) packing: taste masking granule 4) is packaged as 1g/ bag with Aluminum-plastic composite bag.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210057860.XA CN102552247B (en) | 2012-03-07 | 2012-03-07 | Composition of vitamin C and preparation method thereof |
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| CN201210057860.XA CN102552247B (en) | 2012-03-07 | 2012-03-07 | Composition of vitamin C and preparation method thereof |
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| CN102552247B true CN102552247B (en) | 2014-05-28 |
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| CN103099787B (en) * | 2013-02-19 | 2014-06-25 | 青岛正大海尔制药有限公司 | Vitamin C dry suspension |
| KR101882820B1 (en) * | 2015-12-30 | 2018-07-30 | 주식회사 삼양바이오팜 | Mucoadhesive pharmaceutical composition and preparation method thereof |
| CN110115384A (en) * | 2018-02-06 | 2019-08-13 | 浙江新维士生物科技有限公司 | Vitamin C composition and the method and vitamin C coated slow release piece for preparing vitamin C coated slow release piece |
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| CN1593411A (en) * | 2004-01-15 | 2005-03-16 | 范敏华 | Speckle removing pharmaceutical composition |
| CN1327838C (en) * | 2004-07-08 | 2007-07-25 | 北京科信必成医药科技发展有限公司 | Vitamin C oral disintegration tablet and its preparing method |
| CN1785179A (en) * | 2004-12-10 | 2006-06-14 | 北京昭衍博纳新药研究有限公司 | Compounding chewable vitamin tablets and its prepn. method |
| CN100438778C (en) * | 2005-01-20 | 2008-12-03 | 北京科信必成医药科技发展有限公司 | Health food with hypoxia preventing and anti-fatigue function and preparation technique thereof |
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Application publication date: 20120711 Assignee: Pharmaceutical Co., Ltd., Changzhou Pharmaceutical Factory No.4 Assignor: Changzhou City No.4 Pharmaceutical Factory Co., Ltd. Contract record no.: 2017320000019 Denomination of invention: Composition of vitamin C and preparation method thereof Granted publication date: 20140528 License type: Exclusive License Record date: 20170223 |
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Effective date of registration: 20170522 Address after: 213018 No. 567 Wu Cheng Road, Changzhou, Jiangsu Patentee after: Pharmaceutical Co., Ltd., Changzhou Pharmaceutical Factory No.4 Address before: 213004 Jiangsu province Changzhou City Palace Road No. 168 Patentee before: Changzhou City No.4 Pharmaceutical Factory Co., Ltd. |