CN106387918A - Vitamin C sodium effervescence formulation and preparation method thereof - Google Patents
Vitamin C sodium effervescence formulation and preparation method thereof Download PDFInfo
- Publication number
- CN106387918A CN106387918A CN201610757642.5A CN201610757642A CN106387918A CN 106387918 A CN106387918 A CN 106387918A CN 201610757642 A CN201610757642 A CN 201610757642A CN 106387918 A CN106387918 A CN 106387918A
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- CN
- China
- Prior art keywords
- sodium
- effervescent formulation
- effervescence
- effervescent
- preparation
- Prior art date
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- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 19
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- 239000002671 adjuvant Substances 0.000 description 2
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 2
- 239000001569 carbon dioxide Substances 0.000 description 2
- 229910002092 carbon dioxide Inorganic materials 0.000 description 2
- 239000007884 disintegrant Substances 0.000 description 2
- 239000003651 drinking water Substances 0.000 description 2
- 235000020188 drinking water Nutrition 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 description 2
- 235000011087 fumaric acid Nutrition 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 239000001630 malic acid Substances 0.000 description 2
- 235000011090 malic acid Nutrition 0.000 description 2
- 229960001855 mannitol Drugs 0.000 description 2
- 150000007524 organic acids Chemical class 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000013589 supplement Substances 0.000 description 2
- 229960001367 tartaric acid Drugs 0.000 description 2
- 238000010257 thawing Methods 0.000 description 2
- 150000003722 vitamin derivatives Chemical class 0.000 description 2
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 description 1
- 244000139693 Arctostaphylos uva ursi Species 0.000 description 1
- 235000012871 Arctostaphylos uva ursi Nutrition 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- UDIPTWFVPPPURJ-UHFFFAOYSA-M Cyclamate Chemical compound [Na+].[O-]S(=O)(=O)NC1CCCCC1 UDIPTWFVPPPURJ-UHFFFAOYSA-M 0.000 description 1
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 1
- 206010013786 Dry skin Diseases 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- 206010070840 Gastrointestinal tract irritation Diseases 0.000 description 1
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical compound C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 description 1
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 description 1
- OVBPIULPVIDEAO-UHFFFAOYSA-N N-Pteroyl-L-glutaminsaeure Natural products C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)NC(CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-UHFFFAOYSA-N 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- QIVBCDIJIAJPQS-UHFFFAOYSA-N Tryptophan Natural products C1=CC=C2C(CC(N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-UHFFFAOYSA-N 0.000 description 1
- 229930003427 Vitamin E Natural products 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 230000001476 alcoholic effect Effects 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 230000003712 anti-aging effect Effects 0.000 description 1
- 230000003064 anti-oxidating effect Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 235000006708 antioxidants Nutrition 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 235000013361 beverage Nutrition 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 229960003563 calcium carbonate Drugs 0.000 description 1
- FYHXNYLLNIKZMR-UHFFFAOYSA-N calcium;carbonic acid Chemical compound [Ca].OC(O)=O FYHXNYLLNIKZMR-UHFFFAOYSA-N 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 229940084030 carboxymethylcellulose calcium Drugs 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 229940013145 citric acid / tartaric acid Drugs 0.000 description 1
- 238000000748 compression moulding Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- MPTQRFCYZCXJFQ-UHFFFAOYSA-L copper(II) chloride dihydrate Chemical compound O.O.[Cl-].[Cl-].[Cu+2] MPTQRFCYZCXJFQ-UHFFFAOYSA-L 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 229920003020 cross-linked polyethylene Polymers 0.000 description 1
- 239000004703 cross-linked polyethylene Substances 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000035622 drinking Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 229960000304 folic acid Drugs 0.000 description 1
- 235000019152 folic acid Nutrition 0.000 description 1
- 239000011724 folic acid Substances 0.000 description 1
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 125000004435 hydrogen atom Chemical class [H]* 0.000 description 1
- -1 hydroxypropyl methyl Chemical group 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229940041616 menthol Drugs 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 238000005649 metathesis reaction Methods 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 238000000643 oven drying Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 238000005453 pelletization Methods 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 229920006316 polyvinylpyrrolidine Polymers 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 235000015424 sodium Nutrition 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 208000037816 tissue injury Diseases 0.000 description 1
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention belongs to the field of health-care products, and particularly relates to a vitamin C sodium effervescence formulation and a preparation method thereof. The vitamin C sodium effervescence formulation provided by the invention comprises acidic components, alkaline components, a filling agent, a correctant, a lubricant, an adhesive and a disintegration auxiliary. The effervescence formulation is an effervescent tablet agent or effervescence solid particles, is good in stability and free from irritant to the stomach and the intestinal tracts, and can be effectively used as a supplementing agent of vitamin C. The invention further discloses the preparation method of the effervescence formulation. The preparation method is simple to operate. The prepared vitamin C sodium effervescence formulation is smooth, clean and level in appearance, free from bubbling phenomena, large in effervescence particle size and low in hygroscopicity.
Description
Technical field
The invention belongs to field of health care products is and in particular to a kind of sodium ascorbate effervescent formulation and preparation method thereof.
Background technology
Vitamins c sodium is ascorbic sodium salt, and its physiological action is similar to ascorbic physiological action, is to participate in body
The important nutrient of metabolism, has following effect in organism metabolism：It not only can promote the biosynthesiss of collagen protein, has
Beneficial to the healing of tissue injury, and the metabolism of tyrosine and tryptophan can also be promoted, accelerate the deaminizating generation of albumen or peptides
Thank to effect, improve the utilization to ferrum, calcium and Folic Acid, increase body stress ability to external world etc..Pharmaceutically as vitamin C
Enriching substance, with supplement its take in deficiency, food and some beverages can be used as antioxidant, prevent Foods or drinkses
Variable color, spoiled.Sodium ascorbate is widely used in the fresh-keeping fixation of food and mould proof, adds in cosmetics for wrinkle resistant, anti-ageing
Always, Bearberry Extract, the dual-use function that there is vitimin supplement C and strengthen calcium absorption, stable performance, be with practical application and
The active component of development prospect.Vitamin C is stable in sour environment, but under heat, light, alkaline environment, particularly aerobic
Change the metal ion such as enzyme or copper trace, ferrum in the presence of, be oxidized easily degraded, and the oxidizable moisture absorption of exposed to air thus
Lost efficacy.Sodium ascorbate is readily soluble in water, loss on drying≤0.25%, and pH value is between 7～8.Compared with vitamin C, dimension life
The performance of plain C sodium is more stable, no longer has ascorbic highly acid simultaneously, and can take with multi-medicament simultaneously.
Effervescent formulation is a kind of solid preparation containing gas-producing disintegrant.So-called gas-producing disintegrant be typically organic acid and,
The mixture of sodium bicarbonate (sodium bicarbonate)；After effervescent tablet is put in water, organic acid and sodium bicarbonate are electric in the presence of water
From, and there is metathesis reaction, and produce great amount of carbon dioxide, make the rapid disintegrate of tablet and thawing, the bubble that disintegrate sometimes produces
Tablet also can be made to roll up and down in water, accelerate its disintegrate and thawing；The carbon dioxide producing during disintegrate is partially dissolved in drinking-water
In, make drinking-water when drinking in entrance, have the aesthetic feeling as soda pop.Compared with traditional ordinary solid preparation and liquid preparation, current effervescent
Piece have carry, easy to use, the advantages of being evenly distributed in water, with the feature of solid preparation and liquid preparation, simultaneously gram
Taken solid preparation discharges slow and liquid preparation shortcoming inconvenient to carry and apt to deteriorate.Vitaminss effervescent in recent years
Piece existing procucts at home and abroad, have containing multivitamin and different fruity or the effervescent tablet series of products only containing single component, produce
Product mostly are special-shaped tablets, a piece of daily amount that can meet needed by human body vitamin.
Through retrieval, still no sodium ascorbate effervescent formulation and Patents at present, many Chinese invention patent such as vitamin Cs
Effervescent tablet (application number：201310053196.6, authorize), a kind of vitamin C effervescent granule and preparation method thereof (application number：
201210347555.4, authorize) and a kind of component of vitamin C effervescent tablet and preparation (application number：201410757299.5, public
Open) etc., also it is only the research and development of concern vitamin C fizzy formulation and preparation method thereof.
Content of the invention
In view of this, the invention provides a kind of sodium ascorbate effervescent formulation, the technical solution adopted in the present invention is such as
Under：
A kind of sodium ascorbate effervescent formulation, including：Sodium ascorbate 2wt%～85wt%, acid ingredient 5wt%～
40wt%, alkaline components 5wt%～50wt%, filler 2wt%～80wt%, correctivess 0wt%～10wt%, lubricant
0wt%～7.5wt%, binding agent 0wt%～5wt% and help and collapse agent 0wt%～15wt%.
Wherein, the content of described sodium ascorbate is preferably 20wt%～40wt%.
Preferably, described acid ingredient be tartaric acid, fumaric acid, malic acid, citric acid, anhydrous citric acid, in adipic acid
A kind of or arbitrarily several combinations.The content of described acid ingredient is preferably 25wt%～32wt%.
Preferably, described alkaline components are sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate, potassium carbonate, Calcium Carbonate, carbon
One of sour hydrogen calcium or arbitrarily several combinations.The content of described alkaline components is preferably 15wt%～25wt%.
Preferably, described help collapse agent be cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, Microcrystalline Cellulose,
One of Hydroxypropyl Cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, carboxymethylcellulose calcium or arbitrarily several
Combination.Described help collapse agent content be preferably 7wt%～10wt%.
Preferably, described filler be Lactose, Mannitol, micropowder silica gel, sucrose, starch, Sorbitol, hydroxypropyl methyl fine
One of dimension element, low-substituted hydroxypropyl cellulose, Microcrystalline Cellulose or arbitrarily several combinations.The content of described filler is excellent
Elect 20wt%～50wt% as.
Preferably, described correctivess be saccharin sodium, stevioside, HP- beta-schardinger dextrin-, cyclodextrin, glycyrrhizin, protein sugar,
One of xylitol, orange flavor, Mannitol, Sorbitol, menthol, erythritol, cyclamate, aspartame or arbitrarily several
The combination planted.The content of described correctivess is preferably 0.5wt%～2.5wt%.
Preferably, described lubricant is Macrogol 4000, polyethylene glycol 6000, micropowder silica gel, magnesium stearate, stearic acid
One of zinc, calcium stearate, Pulvis Talci, leucine, sodium lauryl sulphate or arbitrarily several combinations.Described lubricant
Content is preferably 0wt%～4wt%
Preferably, described adhesive be dehydrated alcohol, Macrogol 4000, polyethylene glycol 6000, polyvidone, starch slurry,
One of Polyvinylpyrrolidone, methylcellulose, hydroxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose or any
Several combinations.The content of described adhesive is preferably 1wt%～4wt%
Preferably, described effervescent formulation is effervescent tablet or effervescence solid granule.
Present invention also offers a kind of preparation method of sodium ascorbate effervescent formulation, including：
A) selection of raw material；B) sieve；C) mix；D) pelletize and be dried or tabletting；E) pack
Wherein, tabletting method is direct powder compression, wet granule compression tablet or dry granulation tabletting.
Compared with prior art, a kind of sodium ascorbate effervescent formulation provided by the present invention has advantages below：
1st, the sodium ascorbate effervescent formulation good stability that the present invention provides, no gastrointestinal irritation, can be effectively as dimension life
The enriching substance of plain C；
2nd, the preparation method of the sodium ascorbate effervescent formulation that the present invention provides sodium ascorbate effervescent simple to operate, prepared
Formulation aesthetics are bright and clean smooth, no foaming phenomena；Effervescent granularity is big, and hygroscopicity is low；
3rd, the dissolubility of the sodium ascorbate effervescent formulation that the present invention provides is good, is easily fully absorbed by human body, is particularly suitable for
It is difficult to swallow the child of tablet, that tooth is degenerated is designed for old people；Building body can be played, improve immunity of organisms, promotion
The nutrition health-care functions such as metabolism, antioxidation and prophylaxis of cancer.
Specific embodiment
Below in conjunction with the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described,
Obviously, described embodiment is only a part of embodiment of the present invention, rather than whole embodiments.Based in the present invention
Embodiment, the every other embodiment that those of ordinary skill in the art are obtained under the premise of not making creative work, all
Belong to the scope of protection of the invention.
Embodiment 1
(1) prescription
Sodium ascorbate 25wt%, tartaric acid 28wt%, sodium bicarbonate 17wt%, Lactose 20wt%, saccharin sodium 1wt%, orange
The anhydrous second of PVP k30 of taste essence 0.5wt%, PEG-40003wt%, sodium chloride 1.5wt%, micropowder silica gel 0.5wt%, 10%
Alcoholic solution 3.5wt%.
(2) preparation method
Sodium ascorbate and tartaric acid sieve respectively, add Lactose to mix, with appropriate 10% PVP k30 dehydrated alcohol
Solution prepares soft material, and sieve prepared acid particles, granulate is dried in 40 DEG C of air dry ovens；Same method, using sodium bicarbonate with
Lactose is with being obtained alkali grain；Soda acid two kinds of particles adds appropriate PEG-4000, saccharin sodium, orange taste essence, micropowder silica gel, and mixing is all
Even rear tabletting.
(3) check
The sodium ascorbate effervescent tablet preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate experiment,
The results are shown in Table 1.
Table 1 inspection content and assay
It is found that the disintegrate in 3min of this disintegrating preparations, the pH value of solution scope after disintegrate is 3.8～4.8, and records this
The hardness of effervescent tablet is 5～10kgN.
Embodiment 2
(1) prescription
Sodium ascorbate 5wt%, Vitamin E 19wt%, tartaric acid 20wt%, sodium bicarbonate 15wt%, crosslinked polyethylene
Ketopyrrolidine 15wt%, Polyvinylpyrrolidone 5wt%, Lactose 17wt%, stevioside 1wt%, Polyethylene Glycol (PEG)
60003wt%.
(2) preparation method
Stevioside is added in Lactose makes it fully absorb, and crosses 30～40 mesh sieves, obtain lactose granule standby after being dried；Dimension life
The materials such as plain C sodium, tartaric acid, sodium bicarbonate, crospolyvinylpyrrolidone, Polyvinylpyrrolidone and polyethylene glycol 6000 are done
100 mesh sieves are crossed after dry.Take the lactose granule of recipe quantity with the method that equivalent is progressively increased add the sodium ascorbate of recipe quantity, tartaric acid,
Sodium bicarbonate, crospolyvinylpyrrolidone, Polyvinylpyrrolidone and PEG-6000.Mix homogeneously, tabletting obtains final product.
(3) check
The sodium ascorbate effervescent tablet preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate, find
The disintegrate in 3min of this disintegrating preparations, the pH value of solution scope after disintegrate be 4.0 ± 0.1, and record this effervescent tablet hardness be 7～
8kgN.
Embodiment 3
(1) prescription
Sodium ascorbate 60wt%, and citric acid/tartaric acid (mass ratio, 1:1) 17wt%, sodium carbonate/bicarbonate (quality
Ratio 1:9) 10wt%, and Lactose/Mannitol (mass ratio, 10:1) 10wt%, steviosin 0.2wt%, appropriate ethanol solution,
2.8wt%PEG-6000.
(2) preparation method
Sodium ascorbate, citric acid and tartaric acid are sieved respectively, then in the ratio mix homogeneously in prescription, plus in right amount
Ethanol solution is pelletized and is obtained wet grain I；It is molten that sodium carbonate, sodium bicarbonate, Lactose and Mannitol add appropriate dehydrated alcohol after mixing
Liquid is simultaneously pelletized and is obtained wet grain II；Wet grain I and II mixes after being dried, and adds steviosin and Polyethylene Glycol, mixes tabletting, finally gives
Effervescent tablet finished product.
(3) check
The sodium ascorbate effervescent tablet preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate, find
The disintegrate in 3min of this disintegrating preparations, the pH value of solution scope after disintegrate be 3.8～4.8, and record this effervescent tablet hardness be 5
～10kgN.
Embodiment 4
(1) prescription
Sodium ascorbate 5wt%, citric acid 38wt%, sodium carbonate 27wt%, starch 15wt%, Microcrystalline Cellulose 10wt%,
Dehydrated alcohol 4.5wt%, 0.5wt%PEG-4000.
(2) preparation method
Citric acid is mixed with sodium ascorbate, Microcrystalline Cellulose, and using 3wt% dehydrated alcohol as binding agent, 24 mesh are pelletized
Obtain wet grain I；Sodium carbonate starch mixes, and using 1.5wt% dehydrated alcohol as binding agent, 24 mesh are pelletized and obtained wet grain II.Wet grain I
With II after 40 DEG C of freeze-day with constant temperature, mixing, add PEG-4000, be sufficiently mixed, 6MPa pressure tabletting, obtain sodium ascorbate effervescent
Piece.
(3) check
The sodium ascorbate effervescent tablet preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate experiment,
Find the disintegrate in 120s of this disintegrating preparations, the pH value of solution scope after disintegrate is 4.2, and records the hardness of this effervescent tablet and be
6kgN.
Embodiment 5
(1) prescription
Sodium ascorbate 10wt%, citric acid 12.5wt%, sodium carbonate/bicarbonate (1:9) 15wt%, Mannitol 35%,
Low-substituted hydroxypropyl cellulose 15wt%, 10% PVP ethanol solution 5wt%, PEG-6000 2.5wt%.
(2) preparation method
By sodium ascorbate, Mannitol, citric acid 22.5wt%, sodium carbonate/bicarbonate, Lactose and polyvinylpyrrolidine
After ketone crosses 100 mesh sieves respectively, progressively increased mix homogeneously with facing-up method equivalent, the appropriate PVP ethanol solution of additions is binding agent, prepares soft
Material, stirring cutting is obtained wet granular.40 DEG C of airpillow-dry obtain drying granule, add appropriate PEG-6000, Mannitol straight after mixing
Connect tabletting.
(3) check
The sodium ascorbate effervescent tablet preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate, find
The disintegrate in 100s of this disintegrating preparations, the pH value of solution scope after disintegrate is 3.8～4.8, and hardness is 8kgN.
Embodiment 6
(1) prescription
Sodium ascorbate 30wt%, citric acid 23.3wt%, sodium carbonate/bicarbonate (1:9) 20wt%, Lactose/Mannitol
(10:1) 23.7wt%, sucrose 0.2wt%, PEG-6000 2.8wt%, appropriate dehydrated alcohol.
(2) preparation method
Raw material sodium ascorbate and remaining adjuvant are respectively dried, pulverized 80 mesh sieves, in proportion by dried vitamin
C sodium, citric acid and sodium carbonate/bicarbonate mix homogeneously, add appropriate dehydrated alcohol, make soft material；Soft material is crossed 18 mesh sieves and is obtained
To wet grain, wet grain is less than 2.5% in 50 DEG C of oven drying 6h to moisture, dry granular crosses 16 mesh sieve granulate, then by granulate with
The mixed pressuring plates such as Lactose/Mannitol, sucrose, PEG-6000.
(3) check
The sodium ascorbate effervescent tablet preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate, find
The disintegrate in 3min of this disintegrating preparations, the pH value of solution scope after disintegrate be 3.8～4.8, and record this effervescent tablet hardness be 5～
10kgN.
Embodiment 7
(1) prescription
Sodium ascorbate 27wt%, tartaric acid 20wt%, potassium bicarbonate 25wt%, crospolyvinylpyrrolidone (PVPP)
6wt%, Polyvinylpyrrolidone (PVP k30) ethanol solution 2wt%, Lactose 17wt%, 1wt% stevioside, poly- second two
Alcohol 60002wt%.
(2) preparation method
After polyethylene glycol 6000 is melted, add potassium bicarbonate, stir, cooling crush, cross 80 mesh sieves, obtain poly- second two
Alcohol wrappage fine powder；Separately tartaric acid, sodium ascorbate, stevioside, crospolyvinylpyrrolidone, Lactose were waited 80 mesh sieves, gathered
Vinylpyrrolidone (PVP) ethanol solution is pelletized, and is dried, and mixes with Polyethylene Glycol wrappage fine powder, and tabletting obtains final product.
(3) check
The sodium ascorbate effervescent tablet preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate, find
The disintegrate in 3min of this disintegrating preparations, the pH value of solution scope after disintegrate be 3.8～4.8, and record this effervescent tablet hardness be 5～
10kgN.
Embodiment 8
(1) prescription
Sodium ascorbate 10wt%, citric acid 33.3wt%, sodium carbonate/bicarbonate (mass ratio, 1:9) 20wt%, breast
Sugar/Mannitol (mass ratio, 10:1) 33.7wt%, steviosin 0.2wt%, Polyvinylpyrrolidone (PVP) 2.3wt%, micropowder
Silica gel 0.5wt%.
(2) preparation method
Sodium ascorbate is pulverized, crosses 100 mesh sieves, add sodium carbonate/bicarbonate, steviosin, put in mixer, enter
Row stirring, adds Polyvinylpyrrolidone to mix, 12 mesh are pelletized, and wet grain is in 50 DEG C about aeration-dryings and whole by 14 mesh sieves
Grain；It is subsequently adding citric acid, Lactose/Mannitol, Polyvinylpyrrolidone, micropowder silica gel etc. to be mixed, after fully mixing, put
Enter compression molding in tablet machine, dry 2h, sterilization, packaging under the conditions of 60 DEG C, obtain final product sodium ascorbate effervescent tablet.
(3) check
The sodium ascorbate effervescent tablet preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate, find
This effervescent tablet finishes in 2min effervescent, the pH value of solution scope after disintegrate be 4.3, and record this effervescent tablet hardness be 6.5kgN.
Embodiment 9
(1) prescription
Sodium ascorbate 10wt%, and citric acid/malic acid/fumaric acid (mass ratio, 12:1:0.28) 33.2wt%, carbonic acid
Calcium/sodium bicarbonate (mass ratio, 1:3) 20wt%, and Lactose/Mannitol (mass ratio, 10:1) 33.7wt%, steviosin 0.3wt%,
Polyethylene glycol 6000 2.3wt%, micropowder silica gel 0.5wt%.
(2) preparation method
Take sodium ascorbate and remaining adjuvant, mix, pelletizing obtains final product effervescent granule.
(3) check
The sodium ascorbate effervescent granule preparing in step (2) is placed in water (15 DEG C, 100mL) and carries out disintegrate, send out
Now this disintegrating preparations disintegrate in 3min, the pH value of solution scope after disintegrate is 4.0, and hardness is 6kgN.
Claims (10)
1. a kind of sodium ascorbate effervescent formulation is it is characterised in that include：
2. effervescent formulation according to claim 1 is it is characterised in that described acid ingredient is tartaric acid, fumaric acid, Fructus Mali pumilae
One of acid, citric acid, anhydrous citric acid, adipic acid or arbitrarily several combinations.
3. effervescent formulation according to claim 1 is it is characterised in that described alkaline components are sodium bicarbonate, sodium carbonate, carbon
One of sour potassium, potassium bicarbonate, potassium carbonate, Calcium Carbonate, calcium bicarbonate or arbitrarily several combinations.
4. effervescent formulation according to claim 1 is it is characterised in that described filler is Lactose, Mannitol, micropowder silicon
One of glue, sucrose, starch, Sorbitol, hydroxypropyl methyl cellulose, low-substituted hydroxypropyl cellulose, Microcrystalline Cellulose or
Arbitrarily several combinations.
5. effervescent formulation according to claim 1 is it is characterised in that described correctivess are saccharin sodium, stevioside, chlorination
Sodium, HP- beta-schardinger dextrin-, cyclodextrin, glycyrrhizin, protein sugar, sucrose, xylitol, orange flavor, Mannitol, Sorbitol, Herba Menthae
One of alcohol, erythritol, cyclamate, aspartame or arbitrarily several combinations.
6. effervescent formulation according to claim 1 is it is characterised in that described lubricant is Macrogol 4000, poly- second two
Alcohol 6000, micropowder silica gel, magnesium stearate, zinc stearate, calcium stearate, Pulvis Talci, leucine, in sodium lauryl sulphate one
Plant or arbitrarily several combinations.
7. effervescent formulation according to claim 1 is it is characterised in that described adhesive is dehydrated alcohol, Polyethylene Glycol
4000th, polyethylene glycol 6000, polyvidone, starch slurry, Polyvinylpyrrolidone, methylcellulose, hydroxymethyl cellulose, ethyl are fine
One of dimension element, hydroxypropyl cellulose or arbitrarily several combinations.
8. effervescent formulation according to claim 1 it is characterised in that described help collapse agent be cross-linking sodium carboxymethyl cellulose,
Crospolyvinylpyrrolidone, Microcrystalline Cellulose, Hydroxypropyl Cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, carboxylic first
One of base cellulose calcium or arbitrarily several combinations.
9. effervescent formulation according to claim 1 is it is characterised in that described effervescent formulation is effervescent tablet or effervescence solid
Grain.
10. a kind of preparation method of the sodium ascorbate effervescent formulation described in one of claim 1 to 9 is it is characterised in that described
Preparation method comprises the following steps：
A) selection of raw material；B) sieve；C) mix；D) pelletize and be dried or tabletting；E) pack
Wherein, tabletting method is direct powder compression, wet granule compression tablet or dry granulation tabletting.
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| CN114306129B (en) * | 2022-01-10 | 2024-06-07 | 山东中大药业有限公司 | Effervescent tablet for cleaning oral cavity and preparation method thereof |
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