CN112107553A - Calcium carbonate effervescent tablet and preparation method thereof - Google Patents
Calcium carbonate effervescent tablet and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
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- A—HUMAN NECESSITIES
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
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Abstract
The invention discloses a calcium carbonate effervescent tablet and a preparation method thereof. The calcium carbonate effervescent tablet comprises the following components in parts by weight: 5 to 60 percent of calcium carbonate, 0 to 30 percent of other functional components, 1 to 10 percent of granulation excipient, 15 to 65 percent of acid source, 0 to 25 percent of alkali source, 10 to 60 percent of filling agent, 0.5 to 5 percent of flavoring agent and coloring agent and 0 to 10 percent of lubricating agent. The invention adopts a melt granulation method, uses a mixture of calcium carbonate and a granulation excipient adsorbed by an acid source, heats the mixture to enable the granulation excipient to melt and wrap calcium carbonate powder, and then cools and solidifies the calcium carbonate powder to prepare granules, and the granules are mixed with other materials to be tableted to obtain the calcium carbonate effervescent tablet. The calcium carbonate effervescent tablet prepared by the method can be put into water to quickly dissolve granules, granulation excipient enters the granules, so that calcium carbonate is quickly reduced into micro powder and can quickly and fully react with an acid source, and the obtained solution is clear and has no precipitate.
Description
Technical Field
The invention relates to the technical field of biological medicines, in particular to a calcium carbonate effervescent tablet and a preparation method thereof.
Background
Calcium is an essential element for living beings. In humans, there are proteins to which Ca2+ binds, in muscle, nerve, body fluid and bone. Calcium is the main inorganic component of human bone and teeth, and is also an essential element for neurotransmission, muscle contraction, blood coagulation, hormone release, milk secretion and the like. Calcium accounts for about 1.4% of the human body mass and participates in metabolism, and the increase of calcium loss along with the increase of the age cannot meet the requirement of calcium intake in daily food, so that additional calcium is needed.
Calcium carbonate is the most widely used calcium source in the fields of medicines and health foods because of its high calcium content, high safety and low cost. Conventional calcium carbonate preparations are mainly swallowed tablets and chewable tablets. Because the daily intake of calcium is large, the calcium carbonate tablets are large in size, difficult to swallow and strong in foreign body sensation after swallowing, and the chewable tablets are poor in taste. In addition, the common calcium carbonate tablet is mainly absorbed by ionized calcium produced by the reaction of calcium carbonate and gastric acid after being taken, consumes a large amount of gastric acid, is not favorable for gastric acid deficiency or middle-aged and elderly people, and can cause dyspepsia, abdominal distension and the like after being taken for a long time.
The calcium carbonate effervescent tablet can well solve the problems. When the effervescent calcium carbonate tablet is taken, calcium carbonate in water reacts with an acid source in the effervescent tablet to generate soluble ionic calcium, so that the problems of difficult taking, stomach acid consumption and the like are solved.
Although the calcium carbonate effervescent tablet is greatly improved compared with the common calcium carbonate tablet, the calcium carbonate effervescent tablet still has great defects. That is, a large amount of insufficiently reacted precipitates are generated after the effervescent reaction, which seriously affects the product quality.
Therefore, it is necessary to develop a new process to solve the above existing problems to improve the product quality.
Disclosure of Invention
The invention provides a calcium carbonate effervescent tablet and a preparation method thereof, wherein a melting granulation method is adopted, an acid source is utilized to adsorb a mixture of calcium carbonate and a granulation excipient through electrostatic action carried by calcium carbonate powder, and then the granulation excipient is heated at a proper temperature to melt and wrap the calcium carbonate powder, and then the calcium carbonate powder is cooled and solidified to prepare granules.
In order to achieve the purpose, the invention provides a calcium carbonate effervescent tablet which comprises the following components in percentage by weight:
the sum of the weight percentages of the components is 100 percent.
Preferably, the ratio of the calcium carbonate powder to the granulation excipient is 10:1-2: 1.
Preferably, the ratio of the calcium carbonate powder to the granulation excipient is 8:1-5: 1.
Preferably, the granulation excipient is one or more of sorbitol, xylitol, erythritol, mannitol, isomalt and polyethylene glycol.
Preferably, the granulation excipient is one or more of sorbitol, xylitol and polyethylene glycol 6000.
Preferably, the acid source is one or more of citric acid, tartaric acid, malic acid and fumaric acid.
Preferably, the acid source is one or more of citric acid and malic acid; the alkali source is one or more of sodium carbonate and sodium bicarbonate.
Preferably, the alkali source is one or more of sodium carbonate, sodium bicarbonate, potassium carbonate and potassium bicarbonate.
Preferably, the filler is one or more of sugar alcohol, sucrose, glucose, fructose, lactose and natural fruit powder.
Preferably, the filler is one or more of sugar alcohol, sucrose and natural fruit powder.
Preferably, the sugar alcohol is one or more of sorbitol, xylitol, erythritol, mannitol and isomalt.
Preferably, the flavoring agent is one or a combination of edible essence and sweetener.
Preferably, the sweetener is one or more of aspartame, sucralose, stevioside and mogroside.
Preferably, the lubricant is one or more of polyethylene glycol and leucine.
Preferably, the lubricant is polyethylene glycol 6000.
Preferably, the other functional components are one or more of magnesium, iron, zinc, vitamin D and vitamin K.
Preferably, the other effective components are one or more of magnesium carbonate, vitamin D3 and vitamin K2.
The invention also provides a preparation method of the calcium carbonate effervescent tablet, which comprises the following steps:
step one, crushing the granulation excipient, sieving the crushed granulation excipient with a standard sieve of 100-200 meshes to obtain granulation excipient powder, uniformly mixing the granulation excipient powder with calcium carbonate powder, and sieving the mixture with a standard sieve of 100-200 meshes to obtain a mixture;
step two, fully mixing the first mixture with an acid source, and sieving the mixture through a standard sieve with 20 meshes to obtain a second mixture;
step three, heating and mixing step two, cooling to room temperature after the granulation excipient is completely melted and wrapped with calcium carbonate powder, and sieving by a 20-target standard sieve to obtain granules I; wherein, whether the granulation excipient is completely melted and wrapped with the calcium carbonate powder is confirmed by observation.
And step four, uniformly mixing the granules I with the rest materials, and tabletting to obtain the calcium carbonate effervescent tablets.
Preferably, in the first step, the granulation excipient powder has an average particle size of 150 μm or less and the calcium carbonate powder has an average particle size of 15 μm or less.
Preferably, in the second step, the average particle size of the acid source is not less than 250 μm.
Preferably, in the third step, the heating temperature is 80-120 ℃, and the heating time is 5-60 min.
The calcium carbonate raw material is very fine powder which cannot be directly used for tabletting and needs to be prepared into granules. The calcium carbonate granule in the traditional effervescent tablet is prepared by granulating the calcium carbonate with conventional binder such as carboxymethylcellulose sodium, hydroxypropyl methylcellulose, polyvinylpyrrolidone, etc., and the wetting agent is usually water or ethanol; the second method is to granulate the calcium carbonate along with the acid source with a binder, which avoids the introduction of moisture and therefore the wetting agent is usually selected from high ethanol concentrations. The two methods have the defects that if free water is introduced by taking water as a solvent, the stability of the product is not favorable, and the process cost of the product is increased and the production has greater safety risk by taking high-concentration ethanol as the solvent. Most importantly, the calcium carbonate in the particles prepared by the method is tightly combined with the harder particles, so that the problem of incomplete reaction of the calcium carbonate to generate precipitation during brewing is caused.
The invention adopts a melting granulation method, utilizes an acid source to adsorb the mixture of calcium carbonate and a granulation excipient through the electrostatic action carried by calcium carbonate powder, and then heats the mixture at a proper temperature to melt the granulation excipient to wrap the calcium carbonate powder, and then cools and solidifies the calcium carbonate powder to prepare the granules.
The inventor verifies the technical effect of the invention through experiments. The following experiments are only some examples of the experiments in the present invention, and do not cover all the experiments in the present invention.
Experiment one: calcium carbonate powder to granulation excipient ratio and granulation excipient particle size selection
The experimental method comprises the following steps: calcium carbonate powder and granulating excipients with different particle sizes are mixed with an acid source according to the table according to different addition ratios, and the mixture is heated in an oven at the temperature of 80-120 ℃ to observe the granulating effect of the mixture.
Watch 1
From the table one, it can be seen that the granulation effect is better when the weight ratio of the calcium carbonate powder to the granulation excipient is 10:1-2:1, and the effect is best when the weight ratio of the calcium carbonate powder to the granulation excipient is 8:1-5: 1.
Experiment two: selection of particle size of calcium carbonate and acid source
The experimental method comprises the following steps: according to the experimental scheme shown in the second table, under the condition that the proportions of calcium carbonate powder, granulating excipient and acid source are consistent, calcium carbonate powder with different particle sizes and acid source are selected and uniformly mixed, heating and melting are carried out in an oven at 80-120 ℃ for granulation, tabletting is carried out, 200ml of water is added, and the precipitation condition after the effervescent solution is kept stand for 4 hours is observed.
Watch two
The second table shows that the particle size of the granulation excipient powder, the particle size of the calcium carbonate and the particle size of the acid source have great influence on the granulation effect and the clarity of the effervescent tablet solution, and experimental results show that the effect is better when the average particle size of the granulation excipient powder is less than or equal to 150 mu m, the average particle size of the calcium carbonate powder is less than or equal to 15 mu m and the average particle size of the acid source is more than or equal to 250 mu m, and the calcium carbonate effervescent tablet without precipitation can be prepared. In addition, other components such as filler, flavoring agent, lubricant and other functional components are added on the basis of the experimental prescription, and the same effect can be still achieved.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments of the present invention without any creative effort belong to the protection scope of the present invention.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.
Example one
1000 calcium carbonate effervescent tablets are prepared, and the formula is as follows:
wherein the calcium carbonate powder has an average particle size of 10 μm and the anhydrous citric acid has an average particle size of 300 μm.
The preparation method comprises the following steps: pulverizing xylitol (granulation excipient) and sieving with 120 mesh standard sieve to obtain granulation excipient powder with average particle diameter of 120 μm to obtain a mixture;
mixing the first mixture with calcium carbonate powder, sieving with a 100-mesh sieve, mixing with anhydrous citric acid, and sieving with a 20-mesh sieve to obtain a second mixture;
placing the mixed powder II into an oven, setting the temperature of the oven at 110 ℃, heating for 50min, cooling to room temperature, and sieving with a 20-mesh standard sieve to obtain a granule I;
mixing the granule I, vitamin D3 dry powder, vitamin K2, xylitol, mannitol, edible essence, and polyethylene glycol 6000 to obtain a total mixture; and (4) tabletting the total mixture to obtain the calcium carbonate effervescent tablets.
Example two
1000 calcium carbonate effervescent tablets are prepared, and the formula is as follows:
wherein the calcium carbonate powder has an average particle size of 10 μm and the anhydrous citric acid has an average particle size of 300 μm.
The preparation method comprises the following steps: pulverizing xylitol, sieving with 120 mesh standard sieve to obtain granulation excipient powder with average particle size of 120 μm to obtain a mixture;
mixing the first mixture with calcium carbonate powder, sieving with a 100-mesh sieve, mixing with anhydrous citric acid, and sieving with a 20-mesh second mixture;
placing the mixed powder II into an oven, setting the oven temperature at 110 ℃, heating for 50min, cooling to room temperature, and sieving with a 20-mesh standard sieve to obtain a granule I;
mixing the granule I, vitamin D3, magnesium carbonate, sodium bicarbonate, mannitol, edible essence, sucralose and beta carotene to obtain a total mixture; and (4) tabletting the total mixture to obtain the calcium carbonate effervescent tablets.
EXAMPLE III
1000 chewable calcium carbonate tablets were prepared, with the following formulation:
wherein the calcium carbonate powder has an average particle size of 15 μm and the anhydrous citric acid has an average particle size of 250 μm.
The preparation method comprises the following steps: pulverizing xylitol, and sieving with 100 mesh standard sieve to obtain granulation excipient powder with average particle size of 150 μm;
mixing the first mixture with calcium carbonate powder, sieving with a 100-mesh sieve, mixing with anhydrous citric acid, and sieving with a 20-mesh sieve to obtain a second mixture;
placing the mixed powder II into an oven, setting the temperature of the oven at 110 ℃, heating for 50min, cooling to room temperature, and sieving with a 20-mesh standard sieve to obtain a granule I;
mixing the granules I, the vitamin D3 dry powder, mannitol, edible essence, beta carotene and sucralose to obtain a total mixture; and (4) tabletting the total mixture to obtain the calcium carbonate effervescent tablets.
Example four
1000 calcium carbonate effervescent tablets are prepared, and the formula is as follows:
wherein the calcium carbonate powder has an average particle size of 15 μm and the anhydrous citric acid has an average particle size of 250 μm.
The preparation method comprises the following steps: pulverizing xylitol, and sieving with 100 mesh standard sieve to obtain granulation excipient powder with average particle size of 150 μm;
mixing the first mixture with calcium carbonate powder, sieving with a 100-mesh sieve, mixing with anhydrous citric acid and L-malic acid, and sieving with a 20-mesh sieve;
placing the mixed powder II into an oven, setting the oven temperature at 110 ℃, heating for 50min, cooling to room temperature, and sieving with a 20-mesh standard sieve to obtain a granule I;
mixing the granule I, vitamin D3, magnesium carbonate, sodium bicarbonate, isomaltitol, edible essence, and aspartame to obtain a total mixture; and (4) tabletting the total mixture to obtain the calcium carbonate effervescent tablets.
EXAMPLE five
1000 calcium carbonate effervescent tablets are prepared, and the formula is as follows:
wherein the calcium carbonate powder has an average particle size of 15 μm and the anhydrous citric acid has an average particle size of 250 μm.
The preparation method comprises the following steps: pulverizing xylitol, and sieving with 100 mesh standard sieve to obtain granulation excipient powder with average particle size of 150 μm;
mixing the first mixture with calcium carbonate powder, sieving with a 100-mesh sieve, mixing with anhydrous citric acid, and sieving with a 20-mesh second mixture;
placing the mixed powder II into an oven, setting the oven temperature at 110 ℃, heating for 50min, cooling to room temperature, and sieving with a 20-mesh standard sieve to obtain a granule I;
mixing the granule I, vitamin D3, sucrose, sorbitol, mixed fruit powder, edible essence, stevioside, and polyethylene glycol to obtain a total mixture; and (4) tabletting the total mixture to obtain the calcium carbonate effervescent tablets.
EXAMPLE six
1000 calcium carbonate effervescent tablets are prepared, and the formula is as follows:
wherein the calcium carbonate powder has an average particle size of 15 μm and the anhydrous citric acid has an average particle size of 250 μm.
The preparation method comprises the following steps: pulverizing xylitol, and sieving with 100 mesh standard sieve to obtain granulation excipient powder with average particle size of 150 μm;
mixing the first mixture with calcium carbonate powder, sieving with a 100-mesh sieve, mixing with anhydrous citric acid, and sieving with a 20-mesh second mixture;
placing the mixed powder II into an oven, setting the oven temperature at 110 ℃, heating for 50min, cooling to room temperature, and sieving with a 20-mesh standard sieve to obtain a granule I;
mixing the granules I, sucrose under direct pressure, sorbitol, potassium bicarbonate, sodium bicarbonate, edible essence, stevioside and polyethylene glycol to obtain a total mixture; and (4) tabletting the total mixture to obtain the calcium carbonate effervescent tablets.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (16)
1. A calcium carbonate effervescent tablet is characterized in that: comprises the following components in percentage by weight:
the sum of the weight percentages of the components is 100 percent.
2. The calcium carbonate effervescent tablet of claim 1, wherein the ratio of the calcium carbonate powder to the granulation excipient is 10:1-2: 1.
3. The calcium carbonate effervescent tablet of claim 1, wherein the ratio of calcium carbonate powder to granulation excipient is 8:1-5: 1.
4. Calcium carbonate effervescent tablet according to claim 1, wherein the granulation excipient is one or a combination of sorbitol, xylitol, erythritol, mannitol, isomalt, polyethylene glycol.
5. Calcium carbonate effervescent tablet according to claim 1, wherein the acid source is one or a combination of citric acid, tartaric acid, malic acid, fumaric acid.
6. The calcium carbonate effervescent tablet of claim 1, wherein the alkali source is one or more of sodium carbonate, sodium bicarbonate, potassium carbonate, and potassium bicarbonate.
7. Calcium carbonate effervescent tablet according to claim 1, wherein the filler is one or a combination of sugar alcohols, sucrose, glucose, fructose, lactose, natural fruit powder.
8. Calcium carbonate effervescent tablet according to claim 7, wherein the sugar alcohol is one or more of sorbitol, xylitol, erythritol, mannitol, and isomalt.
9. The calcium carbonate effervescent tablet according to claim 1, wherein the flavoring agent is one or more of flavoring essence and sweetener.
10. The calcium carbonate effervescent tablet according to claim 9, wherein the sweetener is one or more of aspartame, sucralose, stevioside, mogroside.
11. Calcium carbonate effervescent tablet according to claim 1, wherein the lubricant is one or a combination of polyethylene glycol and leucine.
12. Calcium carbonate effervescent tablet according to claim 1, wherein the other effective ingredients are one or a combination of more of magnesium, iron, zinc, vitamin D, vitamin K.
13. A preparation method of calcium carbonate effervescent tablets is characterized by comprising the following steps:
step one, crushing the granulation excipient, sieving the crushed granulation excipient with a standard sieve of 100-200 meshes to obtain granulation excipient powder, uniformly mixing the granulation excipient powder with calcium carbonate powder, and sieving the mixture with a standard sieve of 100-200 meshes to obtain a mixture;
step two, fully mixing the first mixture with an acid source, and sieving the mixture by a standard sieve of 10 meshes to 40 meshes to obtain a second mixture;
step three, heating and mixing the mixture II, cooling the mixture to room temperature, and screening the mixture through a standard sieve of 20 meshes to obtain granules I;
and step four, uniformly mixing the granules I with the rest materials, and tabletting to obtain the calcium carbonate effervescent tablets.
14. The method of claim 13, wherein in step one, the granulation excipient powder has an average particle size of 150 μm or less and the calcium carbonate powder has an average particle size of 15 μm or less.
15. The method according to claim 13, wherein in the second step, the average particle diameter of the acid source is not less than 250 μm.
16. The preparation method according to claim 13, wherein in the third step, the heating temperature is 80-120 ℃ and the heating time is 5-60 min.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106138005A (en) * | 2016-08-05 | 2016-11-23 | 贵州汉方药业有限公司 | Good calcium carbonate vitamin C effervescent tablet of a kind of effervesce effect and preparation method thereof |
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2020
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106138005A (en) * | 2016-08-05 | 2016-11-23 | 贵州汉方药业有限公司 | Good calcium carbonate vitamin C effervescent tablet of a kind of effervesce effect and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 宋龙: "碳酸钙泡腾制剂研究进展", 《北京联合大学学报》 * |
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