CN107951034B - Effervescent vitamin preparation and its preparing process - Google Patents
Effervescent vitamin preparation and its preparing process Download PDFInfo
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- CN107951034B CN107951034B CN201711254437.8A CN201711254437A CN107951034B CN 107951034 B CN107951034 B CN 107951034B CN 201711254437 A CN201711254437 A CN 201711254437A CN 107951034 B CN107951034 B CN 107951034B
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- parts
- effervescent
- preparation
- isoascorbate
- vitamin
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- 229960002920 sorbitol Drugs 0.000 description 1
- 238000012430 stability testing Methods 0.000 description 1
- 229940013618 stevioside Drugs 0.000 description 1
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 description 1
- 235000019202 steviosides Nutrition 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
- 235000019605 sweet taste sensations Nutrition 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 235000012222 talc Nutrition 0.000 description 1
- 238000009827 uniform distribution Methods 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
- A23L2/40—Effervescence-generating compositions
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
- A23L2/52—Adding ingredients
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Preparation or treatment thereof
- A23L2/52—Adding ingredients
- A23L2/60—Sweeteners
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/16—Inorganic salts, minerals or trace elements
-
- 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
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Nutrition Science (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Mycology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to the field of health care products, and particularly provides a vitamin effervescent preparation and a preparation method thereof. The vitamin effervescent preparation mainly adopts isoascorbic acid as an acid source. The vitamin effervescent preparation provided by the invention mainly adopts the isoascorbic acid as an acid source, and the isoascorbic acid is not easy to absorb moisture, so that the effervescent preparation is free from sticking during dry tabletting, good in tablet shape and high in tablet forming rate, the obtained effervescent preparation is not easy to absorb moisture and wet, no precipitate is generated during effervescence in water containing calcium ions, and the effervescent solution is clear and transparent; and as the isoascorbic acid is a green and efficient antioxidant, the effervescent preparation has good stability and is not easy to oxidize and lose efficacy in the storage process.
Description
Technical Field
The invention relates to the field of health care products, in particular to a vitamin effervescent preparation and a preparation method thereof.
Background
The effervescent preparation is a solid preparation containing effervescent disintegrant. So-called effervescent disintegrants are usually mixtures of organic acids and sodium bicarbonate (baking soda); when the effervescent tablet is put into water, the organic acid and the sodium bicarbonate are ionized under the action of the water and have double decomposition reaction to generate a large amount of carbon dioxide, so that the tablet is quickly disintegrated and melted, and sometimes, the tablet can roll up and down in the water due to bubbles generated by disintegration to accelerate the disintegration and the melting of the tablet; the carbon dioxide generated during disintegration is partially dissolved in drinking water, so that the drinking water has a steam-water aesthetic feeling when being drunk in the mouth. Compared with the traditional common solid preparation and liquid preparation, the effervescent tablet has the advantages of convenient carrying and use, uniform distribution in water and the like, has the characteristics of the solid preparation and the liquid preparation, and overcomes the defects of slow release of the solid preparation, inconvenient carrying of the liquid preparation and easy deterioration. In recent years, vitamin effervescent tablets have been produced at home and abroad, and contain a plurality of vitamins and effervescent tablet series products with different fruit flavors or only single component, and most of the products are special-shaped tablets, and the vitamin quantity required by a human body can be met by one tablet every day.
In the prior art for preparing the effervescent tablets, citric acid, malic acid, tartaric acid and the like are used as acid sources, carbonate or bicarbonate is used as a carbon dioxide source, and a filling agent, a flavoring agent, a lubricating agent, an adhesive, an auxiliary disintegrating agent and the like are added, and are uniformly mixed by a wet method or a dry method and then tabletted. When the effervescent tablets are prepared by a dry method, if citric acid or malic acid is used as an acid source, the citric acid or malic acid is easy to absorb moisture due to strong hygroscopicity, so that the effervescent tablets are sticky and have low tabletting rate in the tabletting process; if tartaric acid is used as the acid source, calcium tartrate precipitates when effervescing in water containing calcium ions, resulting in turbidity.
In view of the above, the present invention is particularly proposed.
Disclosure of Invention
The first purpose of the invention is to provide a vitamin effervescent preparation, which mainly adopts isoascorbic acid as an acid source, and the isoascorbic acid is not easy to absorb moisture, so that the effervescent preparation has no sticking during dry tabletting, good tabletting shape and high tabletting rate, the obtained effervescent preparation does not generate precipitate during effervescence in water containing calcium ions, and the effervescent solution is clear and transparent.
The second purpose of the invention is to provide a preparation method of the vitamin effervescent preparation, the method has simple process and is suitable for mass production, and the prepared vitamin effervescent preparation has smooth appearance, no bubbling phenomenon, low hygroscopicity, clear and transparent effervescent liquid.
In order to achieve the above purpose of the present invention, the following technical solutions are adopted:
in a first aspect, the present invention provides an effervescent vitamin formulation which employs predominantly isotretinoin as the acid source.
The further preferable technical scheme is mainly prepared from the following raw materials in parts by mass: 120 parts of isoascorbic acid 105-59.5 parts, 49.5-59.5 parts of carbon dioxide source, 26-32 parts of sugar, 5-8 parts of lubricant, 2-11 parts of sweetener and 3-5 parts of edible essence.
The further preferable technical scheme is mainly prepared from the following raw materials in parts by mass: 115 parts of isotretinoin 107-containing acid, 50-59 parts of carbon dioxide source, 27-32 parts of sugar, 5-7 parts of lubricant, 4-10 parts of sweetener and 3.4-5 parts of edible essence.
The further preferable technical scheme is mainly prepared from the following raw materials in parts by mass: 114 parts of isotretinoin 108-containing material, 52-57 parts of carbon dioxide source, 27-30 parts of sugar, 6-7 parts of lubricant, 5-8 parts of sweetener and 3.4-4 parts of edible essence.
As a further preferable technical scheme, the raw material also comprises 20-40 parts by mass of the isoascorbate.
In a further preferred embodiment, the isoascorbate is at least one selected from sodium isoascorbate, potassium isoascorbate, zinc isoascorbate, magnesium isoascorbate, calcium isoascorbate, and ferrous isoascorbate.
In a more preferred embodiment, the carbon dioxide source is at least one selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, calcium bicarbonate, and calcium carbonate.
As a further preferred technical solution, the carbon dioxide source is a mixture of sodium bicarbonate and sodium carbonate;
preferably, 45-55 parts of sodium bicarbonate and 4.5-5.5 parts of sodium carbonate by mass.
As a further preferred embodiment, the sugar comprises sucrose;
preferably, the lubricant comprises polyethylene glycol 6000;
preferably, the sweetener comprises a proteoglycan and/or a D-ribose; further preferably, 2-5 parts by mass of glycoprotein and/or 2-6 parts by mass of D-ribose;
preferably, the flavourant comprises orange flavour.
In a second aspect, the invention provides a preparation method of the vitamin effervescent preparation, which comprises the following steps: the effervescent preparation is prepared by uniformly mixing the raw materials according to the formula ratio, and tabletting or granulating.
Compared with the prior art, the invention has the beneficial effects that:
the vitamin effervescent preparation provided by the invention mainly adopts the isoascorbic acid as an acid source, and the isoascorbic acid is not easy to absorb moisture, so that the effervescent preparation is free from sticking during dry tabletting, good in tablet shape and high in tablet forming rate, the obtained effervescent preparation is not easy to absorb moisture and wet, no precipitate is generated during effervescence in water containing calcium ions, and the effervescent solution is clear and transparent; and as the isoascorbic acid is a green and efficient antioxidant, the effervescent preparation has good stability and is not easy to oxidize and lose efficacy in the storage process.
The vitamin effervescent preparation has scientific and reasonable formula, moderate content of the isovitamin C, moderate acidity, fresh taste, easy disintegration, complete dissolution in water, clear and transparent effervescent liquid, good stability and long shelf life. The vitamin effervescent preparation has good solubility, is easy to be completely absorbed by human body, and is especially suitable for children who are difficult to swallow tablets and the elderly with deteriorated teeth; has effects in strengthening body constitution, improving immunity, promoting metabolism, resisting oxidation, and preventing cancer.
The preparation method of the vitamin effervescent preparation provided by the invention is simple in process and suitable for mass production, and the prepared vitamin effervescent preparation is smooth in appearance, free of foaming phenomenon, low in hygroscopicity, and clear and transparent in effervescent liquid. Particularly, no sticking phenomenon occurs in the tabletting process, the tablet shape is good, the appearance is smooth and flat, no expansion phenomenon occurs, and the quality guarantee period is long.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer.
In a first aspect, there is provided in at least one embodiment an effervescent vitamin formulation employing predominantly isotretinoin as the acid source.
Isoascorbic acid, also known as Isovitamin C, D-erythorbic acid, is an optical isomer of vitamin C, has chemical properties similar to those of vitamin C, belongs to a water-soluble antioxidant, and has a pH value of 3.50 in a 0.1% aqueous solution and a pH value of 2.80 in a 1% aqueous solution.
The vitamin effervescent preparation mainly adopts the isoascorbic acid as an acid source, and the isoascorbic acid is not easy to absorb moisture, so that the effervescent preparation has the advantages of no sticking during dry tabletting, good tablet shape and high tablet forming rate, the obtained effervescent preparation is not easy to absorb moisture and wet, no precipitate is generated during effervescence in water containing calcium ions, and the effervescent liquid is clear and transparent; and as the isoascorbic acid is a green and efficient antioxidant, the effervescent preparation has good stability and is not easy to oxidize and lose efficacy in the storage process.
The vitamin effervescent preparation includes but is not limited to effervescent tablets or effervescent solid granules.
In a preferred embodiment, the composition is mainly prepared from the following raw materials in parts by mass: 120 parts of isoascorbic acid 105-59.5 parts, 49.5-59.5 parts of carbon dioxide source, 26-32 parts of sugar, 5-8 parts of lubricant, 2-11 parts of sweetener and 3-5 parts of edible essence.
In the present preferred embodiment, the amount of the isotretinoin is typically, but not limited to, 105 parts, 106 parts, 107 parts, 108 parts, 109 parts, 110 parts, 111 parts, 112 parts, 113 parts, 114 parts, 115 parts, 116 parts, 117 parts, 118 parts, 119 parts or 120 parts by mass.
The carbon dioxide source is mainly used for generating carbon dioxide bubbles when the effervescent preparation is disintegrated, so that the disintegration and melting of the effervescent preparation are accelerated. The carbon dioxide source includes, but is not limited to, at least one of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, calcium bicarbonate, or calcium carbonate. In the present preferred embodiment, the carbon dioxide source is typically, but not limited to, 49.5 parts, 50 parts, 51.5 parts, 52 parts, 52.5 parts, 53 parts, 53.5 parts, 54 parts, 54.5 parts, 55 parts, 55.5 parts, 56 parts, 56.5 parts, 57 parts, 57.5 parts, 58 parts, 58.5 parts, 59 parts, or 59.5 parts by mass.
The sugar can not only adjust the taste of the effervescent preparation, especially adjust the sour taste of the isoascorbic acid, but also increase the nutrition of the product, so that the effervescent preparation can not only supplement vitamins, but also supplement sugar and provide heat energy for human bodies. Sugars include, but are not limited to, at least one of sucrose, glucose, fructose, galactose, lactose, or maltose. In the present preferred embodiment, the sugar is typically, but not limited to, 26 parts, 26.5 parts, 27 parts, 27.5 parts, 28 parts, 28.5 parts, 29 parts, 29.5 parts, 30 parts, 30.5 parts, 31 parts, 31.5 parts, or 32 parts by mass.
The lubricant can reduce the friction force among raw material particles, so that the raw materials are more easily and uniformly mixed, and in addition, the adhesive force among the raw material particles can be reduced, so that the raw materials are not easy to generate sticking in the dry tabletting process, the forming quality is ensured, and the sheet-shaped surface is smoother and smoother. The lubricant includes, but is not limited to, at least one of polyethylene glycol 4000, polyethylene glycol 6000, aerosil, magnesium stearate, zinc stearate, calcium stearate, talc, leucine, or sodium lauryl sulfate. In the present preferred embodiment, the lubricant is typically, but not limited to, 5 parts, 5.2 parts, 5.4 parts, 5.6 parts, 5.8 parts, 6 parts, 6.2 parts, 6.4 parts, 6.6 parts, 6.8 parts, 7 parts, 7.2 parts, 7.4 parts, 7.6 parts, 7.8 parts, or 8 parts by mass.
The sweetening agent is mainly used for increasing the sweetness of the product, harmonizing the sour taste of the isoascorbic acid, enabling the taste of the product to be moderate and enhancing the edibility of the product. Sweeteners include, but are not limited to, at least one of aspartame, D-ribose, xylitol, cyclamate, mannitol, or sorbitol. In the preferred embodiment, the sweetener is typically, but not limited to, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, or 11 parts by mass part.
The edible essence is a mixture capable of endowing food fragrance to the product, and the taste of the product can be fresher and more unique after the edible essence is added. The flavoring essence includes, but is not limited to, at least one of juicy peach essence, orange essence, blackberry essence, strawberry essence, pineapple essence, apple essence, lychee essence, mango essence or lemon essence. In the preferred embodiment, typical but non-limiting amounts of flavorants are 3 parts, 3.2 parts, 3.4 parts, 3.6 parts, 3.8 parts, 4 parts, 4.2 parts, 4.4 parts, 4.6 parts, 4.8 parts, or 5 parts by weight.
The vitamin effervescent preparation in the preferred embodiment has the advantages of scientific and reasonable formula, moderate content of the isovitamin C, moderate acidity, fresh taste, easy disintegration, complete dissolution in water, clear and transparent effervescent liquid, good stability and long shelf life. The vitamin effervescent preparation has good solubility, is easy to be completely absorbed by human body, and is especially suitable for children who are difficult to swallow tablets and the elderly with deteriorated teeth; has effects in strengthening body constitution, improving immunity, promoting metabolism, resisting oxidation, and preventing cancer.
In a preferred embodiment, the composition is mainly prepared from the following raw materials in parts by mass: 115 parts of isotretinoin 107-containing acid, 50-59 parts of carbon dioxide source, 27-32 parts of sugar, 5-7 parts of lubricant, 4-10 parts of sweetener and 3.4-5 parts of edible essence.
In a preferred embodiment, the composition is mainly prepared from the following raw materials in parts by mass: 114 parts of isotretinoin 108-containing material, 52-57 parts of carbon dioxide source, 27-30 parts of sugar, 6-7 parts of lubricant, 5-8 parts of sweetener and 3.4-4 parts of edible essence.
By further optimizing the content of each raw material, the proportion of each raw material is more scientific and reasonable, so that the content of the vitamin C and the content of the sugar in the vitamin effervescent preparation are more moderate, the acidity is moderate, and the vitamin effervescent preparation is easier to disintegrate.
In a preferred embodiment, the raw material further comprises 20-40 parts by mass of an isoascorbate. The isoascorbyl salt is a salt formed by isoascorbyl acid and metal ions. The addition of the isoascorbate can increase the trace elements in the vitamin effervescent preparation, thereby supplementing the trace elements required by human body. In the present preferred embodiment, the amount of the isotretinoin C acid salt is typically, but not limited to, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, 31 parts, 32 parts, 33 parts, 34 parts, 35 parts, 36 parts, 37 parts, 38 parts, 39 parts or 40 parts by mass.
In a preferred embodiment, the isoascorbate is selected from at least one of sodium isoascorbate, potassium isoascorbate, zinc isoascorbate, magnesium isoascorbate, calcium isoascorbate, or ferrous isoascorbate. Typical but non-limiting examples of such salts of isotretinoin include: sodium isoascorbate, potassium isoascorbate, zinc isoascorbate, magnesium isoascorbate, calcium isoascorbate, ferrous isoascorbate, a mixture of sodium isoascorbate and potassium isoascorbate, a mixture of zinc isoascorbate and magnesium isoascorbate, a mixture of calcium isoascorbate and ferrous isoascorbate, a mixture of sodium isoascorbate, potassium isoascorbate and zinc isoascorbate, a mixture of magnesium isoascorbate, calcium isoascorbate and ferrous isoascorbate, and the like.
In a preferred embodiment, the carbon dioxide source is selected from at least one of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, calcium bicarbonate or calcium carbonate. Such sources of carbon dioxide typically, but not by way of limitation, include: sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, calcium bicarbonate, calcium carbonate, a mixture of sodium bicarbonate and sodium carbonate, a mixture of potassium bicarbonate and potassium carbonate, a mixture of calcium bicarbonate and calcium carbonate, a mixture of sodium bicarbonate, sodium carbonate, and potassium bicarbonate, a mixture of potassium carbonate, calcium bicarbonate, and calcium carbonate, and the like.
In a preferred embodiment, the carbon dioxide source is a mixture of sodium bicarbonate and sodium carbonate. The sodium bicarbonate and the sodium carbonate can provide sodium element for the effervescent preparation and supplement sodium for human bodies.
Preferably, 45-55 parts of sodium bicarbonate and 4.5-5.5 parts of sodium carbonate by mass. Typical but non-limiting contents of the above sodium bicarbonate are 45 parts, 46 parts, 47 parts, 48 parts, 49 parts, 50 parts, 51 parts, 52 parts, 53 parts, 54 parts or 55 parts by mass; typical but non-limiting amounts of sodium carbonate are 4.5 parts, 4.6 parts, 4.7 parts, 4.8 parts, 4.9 parts, 5 parts, 5.1 parts, 5.2 parts, 5.3 parts, 5.4 parts, or 5.5 parts. The calculation standard of the sodium bicarbonate and the sodium carbonate is the same as that of the other raw materials, for example, when the sodium bicarbonate is 45-55 g, the content of the isotretinoin is 105-120 g.
In a preferred embodiment, the sugar comprises sucrose. The sucrose instant sugar is divided into white granulated sugar, brown granulated sugar, soft white sugar, rock sugar, crude sugar (yellow sugar) and the like, and has rich sources and low price.
Preferably, the lubricant comprises polyethylene glycol 6000. Polyethylene glycol 6000(PEG-6000) is a mixture of ethylene oxide and water, has average molecular weight of 6000 and molecular formula of HO (CH)2CH2O)nH, wherein n represents the average number of oxyethylene groups. Polyethylene glycol 6000 is nontoxic, nonirritating, water-soluble and lubricating.
Preferably, the sweetener comprises a proteoglycan and/or a D-ribose. The aspartame mainly takes products such as aspartame, stevioside and the like as aggregates, and the aspartame is completely the same as the sucrose flavor by a scientific formula and an advanced process of molecular combination; the sweet taste is pure, bright, fresh and cool, and the phenomena of greasy taste, heavy feeling due to sugar sweetness, acid regurgitation and the like caused in the oral cavity and the stomach are avoided; meanwhile, the aspartame is a sweetener meeting the low calorific value. D-nucleusThe sugar has a molecular formula of C5H10O5The five-carbon monosaccharide is an important five-carbon monosaccharide, is an important component substance of ribonucleic acid (RNA) and ATP (Adenosine Triphosphate), and plays an important role in the formation of life.
More preferably, 2 to 5 parts by mass of glycoprotein and/or 2 to 6 parts by mass of D-ribose. Typical but non-limiting contents of the proteoglycan are 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts or 5 parts by mass; typical, but non-limiting, amounts of D-ribose are 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, or 6 parts. The calculation standard of the proteoglycon and the D-ribose is the same as that of the other raw materials, for example, when the carboproteoglycon is 2-5 g, the content of the isotretinoin is 105-120 g.
Preferably, the flavourant comprises orange flavour. The orange essence is also called sweet orange essence, and refers to liquid or solid particles with sweet orange fragrance, and the addition of the orange essence can increase the sweet smell of the effervescent preparation, so that the effervescent preparation is fresh and delicious.
In a second aspect, there is provided in at least one embodiment a method of preparing an effervescent vitamin formulation as described above, comprising the steps of: the effervescent preparation is prepared by uniformly mixing the raw materials according to the formula ratio, and tabletting or granulating. The preparation method of the vitamin effervescent preparation is simple in process and suitable for mass production, and the prepared vitamin effervescent preparation is smooth in appearance, free of foaming phenomenon, low in hygroscopicity, and clear and transparent in effervescent liquid. Particularly, no sticking phenomenon occurs in the tabletting process, the tablet shape is good, the appearance is smooth and flat, no expansion phenomenon occurs, and the quality guarantee period is long.
Preferably, the method further comprises the step of sieving each raw material, wherein the sieve is preferably 100-150 meshes. Sieving can ensure that the particle sizes of the raw materials are approximately at the same level, thereby facilitating subsequent tabletting or granulating.
The present invention will be described in further detail with reference to examples and comparative examples.
Example 1
(1) Prescription
The weight portion of the material is as follows: 115 parts of isoascorbic acid, 48 parts of sodium bicarbonate, 4.8 parts of sodium carbonate, 29 parts of sucrose, 3 parts of PEG-60007 parts of orange essence and 5 parts of aspartame.
(2) Preparation method
The materials are crushed and respectively sieved by a 120-mesh sieve, and the materials are uniformly mixed and then tabletted.
(3) Examination of
The isovitamin C effervescent tablet prepared in the step (2) is put in water (15 ℃, 100mL) for disintegration experiment, and the results are shown in Table 1.
The result shows that the effervescent tablet has a tablet forming rate of more than 85 percent, disintegrates within 1.5min, the pH range of the disintegrated solution is 4.0-4.3, and the hardness of the effervescent tablet is 5-10 kgN.
Table 1: the results of the measurement of the tablet shape, the disintegration time and the like of 10 batches of effervescent tablets
The results show that the effervescent tablet has good tablet shape and no sticking phenomenon in the production process, the effervescent tablet is quickly disintegrated when being effervesced, the medicine is completely dissolved, the clarity of the solution is good, and the effervescent tablet meets the requirements of 2015 edition of Chinese pharmacopoeia (namely Chinese pharmacopoeia).
From the above 10 batches, 3 batches of samples were randomly picked for stability testing. During the test, the effervescent tablets are hermetically packaged by a plastic bag and an aluminum foil bag, and are placed in an environment with the temperature of 40 ℃ and the relative humidity of 75% for 3 months, and samples are respectively taken at the end of each month to measure related indexes, and the results are shown in table 2.
Table 2: effervescent tablet stability test results
The results of the stability test of the isovitamin C effervescent tablets in the table 2 show that the effervescent tablets have no obvious change in the indexes such as appearance, taste, content, acidity, disintegration time limit and the like compared with the initial values after being placed in a high-temperature and high-humidity environment for 3 months, which shows that the effervescent tablets prepared by the invention have good stability.
Example 2
Prescription:
the weight portion of the material is as follows: 105 parts of isoascorbic acid, 45 parts of sodium bicarbonate, 4.5 parts of sodium carbonate, 26 parts of sucrose, 3 parts of PEG-60005 parts of orange essence and 2 parts of aspartame.
The preparation method and the test method are the same as those of example 1, and the test results are shown in tables 3 and 4.
Table 3: the results of the measurement of the tablet shape, the disintegration time and the like of 10 batches of effervescent tablets
Table 4: effervescent tablet stability test results
Example 3
Prescription:
the weight portion of the material is as follows: 125 parts of isoascorbic acid, 55 parts of sodium bicarbonate, 5.5 parts of sodium carbonate, 32 parts of sucrose, 5 parts of PEG-60008 parts of orange flavor and 5 parts of aspartame.
The preparation method and the test method were the same as in example 1, and the test results are shown in tables 5 and 6.
Table 5: the results of the measurement of the tablet shape, the disintegration time and the like of 10 batches of effervescent tablets
Table 6: effervescent tablet stability test results
Example 4
Prescription:
the weight portion of the material is as follows: 115 parts of isoascorbic acid, 50 parts of sodium bicarbonate, 5 parts of sodium carbonate, 28 parts of sucrose, PEG-60006.4 parts, 4 parts of orange flavor and 3.5 parts of aspartame.
The preparation method and the test method were the same as in example 1, and the test results are shown in tables 7 and 8.
Table 7: the results of the measurement of the tablet shape, the disintegration time and the like of 10 batches of effervescent tablets
Table 8: effervescent tablet stability test results
Example 5
Prescription:
the weight portion of the material is as follows: 105 parts of isoascorbic acid, 4.2 parts of D-ribose, 45 parts of sodium bicarbonate, 4.5 parts of sodium carbonate, 26 parts of sucrose, PEG-60005.6 parts, 3 parts of orange flavor and 3 parts of aspartame.
The preparation method and the test method were the same as in example 1, and the test results are shown in tables 9 and 10.
Table 9: the results of the measurement of the tablet shape, the disintegration time and the like of 10 batches of effervescent tablets
Table 10: effervescent tablet stability test results
Example 6
Prescription:
the weight portion of the material is as follows: 118 parts of isoascorbic acid, 20 parts of calcium isoascorbic acid, 50 parts of sodium bicarbonate, 5 parts of sodium carbonate, 27 parts of sucrose, 3 parts of PEG-60008 parts of orange essence and 5 parts of aspartame.
The preparation method and the test method were the same as in example 1, and the test results are shown in tables 11 and 12.
Table 11: the results of the measurement of the tablet shape, the disintegration time and the like of 10 batches of effervescent tablets
Table 12: effervescent tablet stability test results
Comparative example 1
Prescription:
the weight portion of the material is as follows: 105 parts of citric acid, 45 parts of sodium bicarbonate, 4.5 parts of sodium carbonate, 26 parts of sucrose, 3 parts of PEG-60005 parts of orange essence and 2 parts of aspartame.
The preparation method and the test method were the same as in example 1, and the test results are shown in Table 13.
Table 13: the results of the measurement of the tablet shape, the disintegration time and the like of 10 batches of effervescent tablets
Comparative example 2
Prescription:
the weight portion of the material is as follows: 105 parts of tartaric acid, 45 parts of sodium bicarbonate, 4.5 parts of sodium carbonate, 26 parts of sucrose, 3 parts of PEG-60005 parts of orange essence and 2 parts of aspartame.
The preparation method and the test method were the same as in example 1, and the test results are shown in Table 14.
Table 14: the results of the measurement of the tablet shape, the disintegration time and the like of 10 batches of effervescent tablets
From the test results in tables 3, 13 and 14, it can be seen that when isoascorbic acid was replaced with citric acid, the molded tablets were poor in quality and had sticking, the tablet forming rate was below 80%, and the weight difference did not meet the specifications due to poor tablet quality and sticking; after the isoascorbic acid is replaced by tartaric acid, the tablet forming rate is below 85 percent, the disintegration time is longer, and precipitates in the disintegrated solution are in a turbid state. Therefore, the vitamin effervescent preparation mainly taking the isoascorbic acid as the acid source has the advantages of no sticking, good tablet shape, high tablet forming rate, short disintegration time and clear and transparent effervescent liquid. In addition, as can be seen from the stability test results of the examples, the effervescent formulation of the present invention has good stability and is not easily deteriorated by oxidation during storage.
While particular embodiments of the present invention have been illustrated and described, it would be obvious that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.
Claims (6)
1. A vitamin effervescent preparation is characterized in that isoascorbic acid is mainly used as an acid source; the composite material is mainly prepared from the following raw materials in parts by mass: 120 parts of isoascorbic acid 105-40 parts of isoascorbic acid salt, 49.5-59.5 parts of carbon dioxide source, 26-32 parts of sugar, 5-8 parts of lubricant, 2-11 parts of sweetener and 3-5 parts of edible essence; the carbon dioxide source is a mixture of sodium bicarbonate and sodium carbonate, and the mixture comprises 45-55 parts of sodium bicarbonate and 4.5-5.5 parts of sodium carbonate in parts by weight;
the isoascorbate is at least one of sodium isoascorbate, potassium isoascorbate, zinc isoascorbate, magnesium isoascorbate, calcium isoascorbate, or ferrous isoascorbate;
the sugar comprises sucrose;
the sweetener comprises 2-5 parts of protein sugar and/or 2-6 parts of D-ribose.
2. The vitamin effervescent preparation according to claim 1, which is characterized by being mainly prepared from the following raw materials in parts by mass: 115 parts of isotretinoin 107-containing acid, 50-59 parts of carbon dioxide source, 27-32 parts of sugar, 5-7 parts of lubricant, 4-10 parts of sweetener and 3.4-5 parts of edible essence.
3. The vitamin effervescent preparation according to claim 1, which is characterized by being mainly prepared from the following raw materials in parts by mass: 114 parts of isotretinoin 108-containing material, 52-57 parts of carbon dioxide source, 27-30 parts of sugar, 6-7 parts of lubricant, 5-8 parts of sweetener and 3.4-4 parts of edible essence.
4. An effervescent vitamin formulation according to any one of claims 1 to 3, wherein the lubricant comprises polyethylene glycol 6000.
5. An effervescent vitamin formulation according to any one of claims 1 to 3, wherein the flavourant comprises orange flavour.
6. A process for the preparation of an effervescent vitamin formulation as claimed in any one of claims 1 to 5, comprising the steps of: the effervescent preparation is prepared by uniformly mixing the raw materials according to the formula ratio, and tabletting or granulating.
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| DE10359790A1 (en) * | 2003-12-19 | 2005-07-21 | Bayer Healthcare Ag | Effervescent preparation of a basic pharmaceutically active substance |
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