CN102552247A - Composition of vitamin C and preparation method thereof - Google Patents
Composition of vitamin C and preparation method thereof Download PDFInfo
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- CN102552247A CN102552247A CN201210057860XA CN201210057860A CN102552247A CN 102552247 A CN102552247 A CN 102552247A CN 201210057860X A CN201210057860X A CN 201210057860XA CN 201210057860 A CN201210057860 A CN 201210057860A CN 102552247 A CN102552247 A CN 102552247A
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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 method for preparing.
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 is participated in the synthetic of amino acid metabolism, neurotransmitter, and matter synthetic between collagen protein and histiocyte, and is most important to health.Ascorbic major physiological function: promote the biosynthesis of ossein, help the healing sooner of tissue injury mouth, the metabolism of tyrosine and tryptophan in the promotion aminoacid; Prolong 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 of Cardiovascular is sick; Promote tooth and skeletal growth, prevent that dental bed is hemorrhage, strengthen the human body anti-stress ability and the immunity of environment to external world.And vitamin C melanin also capable of blocking forms, and can strengthen skin elasticity, and the prevention mottle has beautification function etc.Sodium ascorbate as supplementary and antioxidant, has no tart flavour, advantage soluble in water, and increased ascorbic stability.At present, Vitamin C preparation has various dosage forms such as ordinary tablet, chewable tablet, effervescent tablet, dispersible tablet, buccal tablet, injection.But, all have easy to change, easy degraded, poor stability to some extent, carry and use inconvenience and complex manufacturing defectives such as (chewable tablet, effervescent tablet, dispersible tablet, injection).In addition, the ascorbic sour and astringent bad sense of taste when contacting with taste bud, will be sent to cortical centre to the information of the pessimal stimulation of experiencing, and produces the bad sense of taste, causes the poor compliance of taking, and has influenced ascorbic clinical use.Therefore, people are increasingly high with portable demand to the taking of improving 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 accepted.Cover the adverse drug taste simultaneously, improve patient's compliance, be the target that the world of medicine makes great efforts always.Yet, beyond thought effect that the inventor has found calcium pantothenate and vitamin C combination results.Calcium pantothenate is for the human body skin care and improve aspects such as fatigue a lot of effects are arranged.Also be used for prevention and treatment that calcium pantothenate lacks (like malabsorption syndrome, ceylon sore mouth, coeliac disease, regional enteritis) in addition clinically, can relax the pigmentation of speckle freckle, sunburn, scytitis etc. simultaneously.When vitamin C and calcium pantothenate combination, can not only improve the defective of Vitamin C preparation, also increased purposes.Therefore, research vitamin C composition preparation is the problem of paying close attention to.
Summary of the invention
The technical problem that the present invention will solve is to overcome above-mentioned weak point, and research design carries taking convenience, rapid, the good stability of absorption onset, and portable vitamin C composition.
A kind of ascorbic compositions of the present invention, said compositions are pressed column weight amount per distribution ratio by active component and pharmaceutic adjuvant and are 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, said compositions is made up of following components by weight ratio: the 2000g/1000 bag
Compositions according to the invention is a granule, 1-3g (every bag).
The function of each component is following in the compositions according to the invention:
Said active component comprises: vitamin C, sodium ascorbate and calcium pantothenate.Wherein sodium ascorbate has antioxidant and ascorbic effect concurrently; Calcium pantothenate is for the human body skin care and improve aspect such as fatigue a lot of effects are arranged, and can relax the pigmentation of speckle freckle, sunburn, scytitis etc. simultaneously.
Said 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 use use also capable of being combined separately.Can improve the raw material flowability, eliminate Electrostatic Absorption, help pulverizing and the carrying out smoothly of taste masking coating.
Taste masked particle: form 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 use use also capable of being combined separately.Be formulated as water or alcoholic solution coating, reach the taste masking purpose.
Rectify the flavor granule: being granulated through fluidized-bed process with binder solution (containing correctives, plasticizer, spice, pigment) by suspensoid, filler and above-mentioned granule forms.
Suspensoid: include but not limited to that microcrystalline Cellulose-carboxymethyl starch sodium (RC-591), sodium carboxymethyl cellulose (CMC sodium), polyvinylpyrrolidone (PVP), HUANGJIAO are former, carboxymethyl starch sodium (CMS sodium), hydroxypropyl emthylcellulose (HPMC) etc.; Can use use also capable of being combined separately.In granule, play the suspendible function of stabilizer.
Filler: include but not limited to mannitol, sorbitol, maltose, microcrystalline Cellulose, glucose, sucrose, lactose, dextrin etc., can use separately, also can make up use.
Binding agent: include but not limited to hydroxypropyl cellulose (HPC-L), HPMC, PVP, starch, dextrin, methylcellulose, alginic acid and alginate etc., can use use also capable of being combined separately.Be formulated as water or alcoholic solution binding agent according to arts demand as pelletize.
Correctives: include but not limited to saccharin sodium, Aspartane, lactose, fructose, sucrose, steviosin, mannitol, xylitol etc., can use use also capable of being combined separately.On the taste masking basis, play flavored action.
Plasticizer: include but not limited to polyethylene glycol 6000 (PEG6000), Macrogol 4000 (PEG4000), triethyl citrate, spermol etc., can use use also capable of being combined separately.Play and improve the particle appearance effect.
Spice: include but not limited to essence, Herba Menthae, vanillin, ethyl vanillin etc., can use use also capable of being combined separately.Play and improve olfactory sensation and be easier to effect that the people is accepted.
Pigment: the acceptable pigment in pharmaceuticals industry and food industry for nature or synthetic, include but not limited to lemon yellow, sunset yellow, Radix Dauci Sativae pigment, curcumin etc., can use separately, use also capable of being combined plays and improves the particle appearance effect.Can make particle appearance more beautiful, be easier to make the people to accept.
Another object of the present invention has provided a kind of ascorbic preparation method of composition.
The method of the invention comprises core granule preparation, taste masked particle preparation and rectifys the flavor preparation of granules, specifically comprises the following steps:
(1) core granule preparation:
With the abundant mix homogeneously of vitamin C, sodium ascorbate, calcium pantothenate and lubricant, then mixture being crushed to particle diameter is 25-50um, processes core granule;
(2) taste masked particle preparation:
The core granule of (one) is placed fluidized-bed coating machine, and with the continuous spray coating of the ethanol solution (concentration 5-10%) of macromolecule coating material preparation, granule is crossed 80 mesh sieves behind the coating, processes taste masked particle; Set discharge rate 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of EATs; 50 ℃ of dry 15min behind the coating.
(3) rectify the flavor preparation of granules
The taste masked particle of (two) mixed with suspensoid, filler be placed on fluid bed; In addition binding agent, plasticizer, correctives, spice and the pigment of water or dissolve with ethanol are processed the solution of 3-9%, hydrojet continuously, spray back in 40-50 ℃ of hot air drying, discharging, mistake 20 mesh sieves promptly get and rectify the flavor granule.
Adopt the Aluminum-plastic composite bag packing to get final product (every bag weight 1-3g) according to the specification of taking requirement.
The present invention processes granule with the compositions of vitamin C, sodium ascorbate and calcium pantothenate, and substep is processed core granule, taste masked particle, rectified the flavor granule, and good effect is arranged.The present invention at first processes core granule with vitamin C, sodium ascorbate can prevent that vitamin C receives oxygen, moisture and influences stability, has significantly improved the stability of vitamin C composition.Further the macromolecule coating material is wrapped in the drug particles surface of disagreeable taste, thereby has reduced medicine stripping in the oral cavity, reach the taste masking purpose.Process at last and rectify the flavor 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 low amounts of water; Need not to chew; Can get into stomach by swallowing power, the vitamin C in the compositions, sodium ascorbate and calcium pantothenate form the fine grained of high degree of dispersion in gastric juice, improved bioavailability.Because present composition mouthfeel is good, absorb soon, help the patient and take, increase compliance.The beauty and health care functions such as pigmentation that also have treatment calcium pantothenate deficiency disease simultaneously concurrently and relax speckle, freckle, sunburn, scytitis.Do not see at present the relevant report of the present composition and granule dosage form as yet.
Vitamin C composition of the present invention can be used to the disease (like vitamin C deficiency, gingival hemorrhage, epistaxis) of preventing and treating hypovitaminosis C to cause; Also can be used for the enhancing body resistance; The prevention heart, cerebrovascular; During to wound healing phase, organism fatigue, in the gestation, lactication phase, disease after being ill convalescent period etc. the low and habitual abortion of muscle power, the auxiliary treatment of infertility and cutaneous pigmentation etc.The present invention is a granule, has overcome the defective of the existing dosage form of vitamin C.Preparation technology of the present invention is reasonable, and is easy and simple to handle, is suitable for suitability for industrialized production.Clinical effectiveness and bigger using value are preferably arranged.
The specific embodiment
For vitamin C composition according to the invention and method for preparing are described better, be described further in conjunction with embodiment.
Embodiment 1
Method for preparing:
1) vitamin C, vitamin C-Na, calcium stearate is fully evenly mixed, and be crushed to particle diameter 25-50um, obtain core granule.
2) with 1) core granule place fluidized-bed coating machine (unit type SFP-01), acrylic resin L100 and dehydrated alcohol 316.25g are formulated as 8% alcoholic solution as serosity, continuously spray coating; Set discharge rate 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of EATs; 50 ℃ of dry 15min behind the coating.
3) with 2) granule is crossed 80 mesh sieves and is obtained taste masked particle behind the coating;
4) with 3) granule mixes with microcrystalline Cellulose, microcrystalline Cellulose-sodium carboxymethyl cellulose and is placed on fluid bed (unit type MP-01); Water (concrete amount? 447.5g) dissolving HPC-L, PEG6000, saccharin sodium, essence and lemon yellow; Be mixed with 5%HPC solution as binding agent; The setting spouting liquid is 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of EATs with the mode hydrojet of top spray, have sprayed the back in 40-50 ℃ of hot air drying, and 20 mesh sieves are crossed in discharging, promptly get and rectify the flavor granule;
5) packing: strong flavor granule 4) is packaged as the 1g/ bag with Aluminum-plastic composite bag.
Embodiment 2
Method for preparing:
According to embodiment 1 said preparation technology's operation, the plastic-aluminum combined packed 2g/ bag of packing specification.
Embodiment 3
Method for preparing:
According to embodiment 1 said preparation technology's operation, the plastic-aluminum combined packed 3g/ bag of packing specification.
Embodiment 4
Method for preparing:
According to embodiment 1 said preparation technology's operation, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 5
Method for preparing:
According to embodiment 1 said preparation technology's operation, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 6
Method for preparing:
According to embodiment 1 said preparation technology's operation, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 7
Method for preparing:
According to embodiment 1 said preparation technology's operation, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 8
Method for preparing:
According to embodiment 1 said preparation technology's operation, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 9
Method for preparing:
According to embodiment 1 said preparation technology's operation, the plastic-aluminum combined packed 1g/ bag of packing specification.
Embodiment 10 study on the stability
The ascorbic composition granule that makes according to embodiment 1-9; Place and investigated indexs such as taste, appearance character, Vitamin C content under the condition in 60 ℃/10 days; The result shows steady quality (seeing the following form); And obviously be superior to 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 on outward appearance and content, all is superior to the vitamin C coated tablet.Ascorbic composition stable property of the present invention has greatly improved.
Claims (10)
1. an ascorbic compositions is characterized in that, said compositions is pressed column weight amount per distribution ratio by active component and pharmaceutic adjuvant and formed:
(1) active component:
Vitamin C 5～30%
Sodium ascorbate 3.25～19.25%
Calcium pantothenate 0.2～0.8%
；
(2) pharmaceutic adjuvant
2. a vitamin C composition is characterized in that, said compositions is grouped into by the one-tenth of following weight: the 2000g/1000 bag
3. a kind of ascorbic compositions according to claim 1 and 2 is characterized in that said compositions is a granule, every bag of 1-3g/.
4. a kind of ascorbic compositions according to claim 1; It is characterized in that said lubricant is selected from one or more in magnesium stearate, calcium stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium lauryl sulphate, Stepanol MG or the Pulvis Talci.
5. a kind of ascorbic compositions according to claim 1; It is characterized in that said coating material is selected from one or more in acrylic resin L-100, ethyl cellulose, hypromellose, polyvinylpyrrolidone, methylcellulose, gelatin, arabic gum, zein, sodium alginate or the chitosan.
6. a kind of ascorbic compositions according to claim 1; It is characterized in that said suspensoid is selected from that microcrystalline Cellulose-carboxymethyl starch sodium, sodium carboxymethyl cellulose, polyvinylpyrrolidone, HUANGJIAO are former, in the carboxymethyl starch sodium, hydroxypropyl emthylcellulose one or more; Filler is selected from one or more in mannitol, sorbitol, maltose, microcrystalline Cellulose, glucose, sucrose, lactose or the dextrin.
7. a kind of ascorbic compositions according to claim 1 is characterized in that said binding agent is selected from one or more in hydroxypropyl cellulose, HPMC, PVP, starch, dextrin, methylcellulose, alginic acid or the alginate; Correctives is selected from one or more in saccharin sodium, Aspartane, lactose, fructose, sucrose, steviosin, mannitol or the xylitol; Plasticizer is selected from one or more in polyethylene glycol 6000, Macrogol 4000, triethyl citrate or the spermol.
8. a kind of ascorbic compositions according to claim 1 is characterized in that said spice is selected from one or more in essence, Herba Menthae, vanillin or the ethyl chinese cymbidium; Pigment is selected from one or more in lemon yellow, sunset yellow, Radix Dauci Sativae pigment or the curcumin.
9. an ascorbic preparation method of composition according to claim 1 or claim 2 is characterized in that this method comprises the following steps:
(1) core granule preparation:
With the abundant mix homogeneously of vitamin C, sodium ascorbate, calcium pantothenate and lubricant, then mixture being crushed to particle diameter is 25-50um, processes core granule;
(2) taste masked particle preparation:
The core granule of (one) is placed fluidized-bed coating machine, with the ethanol solution concentration 5-10% of macromolecule coating material preparation, continuous spray coating, granule is crossed 80 mesh sieves behind the coating, processes taste masked particle;
(3) rectify the flavor preparation of granules
The taste masked particle of (two) mixed with suspensoid, filler be placed on fluid bed; In addition binding agent, plasticizer, correctives, spice and the pigment of water or dissolve with ethanol are processed the solution of 3-9%, hydrojet continuously, spray back in 40-50 ℃ of hot air drying, discharging, mistake 20 mesh sieves promptly get and rectify the flavor granule.
10. according to the said ascorbic preparation method of composition of claim 9, it is characterized in that the coating in the preparation of said step (two) taste masked particle is: discharge rate 10g/min, atomisation pressure 0.5MPa, intake 1m
3/ min, 80 ℃ of EATs; 50 ℃ of dry 15min behind the coating.
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Cited By (4)
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| CN103099787A (en) * | 2013-02-19 | 2013-05-15 | 青岛正大海尔制药有限公司 | Vitamin C dry suspension |
| 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 |
| US20210353530A1 (en) * | 2015-12-30 | 2021-11-18 | Samyang Holdings Corporation | Mucoadhesive pharmaceutical composition and preparation method therefor |
| RU2776298C1 (en) * | 2021-10-20 | 2022-07-18 | Евгений Викторович Альшев | Biologically active food additives based on ascorbic acid and stevia extract |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103099787A (en) * | 2013-02-19 | 2013-05-15 | 青岛正大海尔制药有限公司 | Vitamin C dry suspension |
| CN103099787B (en) * | 2013-02-19 | 2014-06-25 | 青岛正大海尔制药有限公司 | Vitamin C dry suspension |
| US20210353530A1 (en) * | 2015-12-30 | 2021-11-18 | Samyang Holdings Corporation | Mucoadhesive pharmaceutical composition and preparation method therefor |
| US11839684B2 (en) * | 2015-12-30 | 2023-12-12 | Samyang Holdings Corporation | Mucoadhesive pharmaceutical composition and preparation method therefor |
| 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 |
| RU2776298C1 (en) * | 2021-10-20 | 2022-07-18 | Евгений Викторович Альшев | Biologically active food additives based on ascorbic acid and stevia extract |
Also Published As
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| CN102552247B (en) | 2014-05-28 |
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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. |