CN115006363A - Oyster calcium carbonate chewable tablets and preparation method thereof - Google Patents
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Abstract
The invention belongs to the field of pharmaceutical preparations, and discloses oyster calcium carbonate chewable tablets and a preparation method thereof. According to the invention, the oyster calcium carbonate is protected by adopting the crosslinked povidone granulation coating to isolate citric acid, so that the reaction of the citric acid with calcium carbonate caused by easy moisture absorption is avoided, and the quality problem of the conventional oyster calcium carbonate chewable tablet caused by moisture absorption is effectively solved.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to oyster calcium carbonate chewable tablets and a preparation method thereof.
Background
The oyster calcium carbonate is prepared by using shells of marine organisms oysters as raw materials and calcining at high temperature, electrolyzing and activating, wherein the oyster shells contain more than 90 percent of calcium carbonate, are white powder in appearance, contain rich calcium and trace elements required by human bodies, such as manganese, zinc, silicon, phosphorus and the like, and are superior to the traditional calcium agent in solubility and absorption. Oyster calcium carbonate, also known as "activated calcium", originally originated in japan as a calcium supplement and is an excellent natural calcium source with biological and chemical activities. Nowadays, oyster calcium carbonate is widely applied to countries in Europe and America, is already collected in China, America, British and Japanese pharmacopoeias, and is clinically used as a calcium supplement preparation.
The oyster calcium carbonate chewable tablet has the pharmacological actions that calcium in the oyster calcium carbonate chewable tablet participates in the formation of bones and the reconstruction of bone tissues after fracture, maintains nerve transmission and muscle contraction, reduces the permeability of capillary vessels, maintains the normal osmotic pressure of the capillary vessels, also participates in a blood coagulation mechanism, maintains the acid-base balance of blood and the like. The product can be used for supplementing calcium for children, pregnant or lactating women, menopausal women, and the elderly. At present, each chewable tablet of oyster calcium carbonate contains 50 mg of oyster calcium carbonate calculated by calcium, and the auxiliary materials comprise citric acid, cane sugar, starch, aspartame, magnesium stearate, pigment (lemon yellow) and hydroxypropyl cellulose.
However, the existing oyster calcium carbonate chewable tablets are generally granulated by a wet method, citric acid in a formula of the oyster calcium carbonate chewable tablets is easy to absorb moisture to cause reaction with calcium carbonate, so that quality problems are caused, and the citric acid serving as a flavoring agent and an acid agent for promoting calcium absorption has a great effect on the chewable tablets and cannot be easily replaced. Therefore, there is a need for improvement and innovation of the existing production process of oyster calcium carbonate chewable tablets.
Disclosure of Invention
The invention provides an oyster calcium carbonate chewable tablet and a preparation method thereof, aiming at solving the problem that citric acid in the existing oyster calcium carbonate chewable prescription is easy to absorb moisture to cause reaction with calcium carbonate.
In order to achieve the purpose, the invention adopts the following technical scheme:
the first aspect of the invention provides a preparation method of oyster calcium carbonate chewable tablets, which adopts the core scheme that a hydroxypropyl methylcellulose (HPMC) ethanol solution is used as an adhesive to granulate and coat a mixture of oyster calcium carbonate, crospovidone and microcrystalline cellulose, and the coated oyster calcium carbonate particles and citric acid particles containing citric acid and auxiliary materials are uniformly mixed and then tableted to obtain the oyster calcium carbonate chewable tablets.
Preferably, the preparation of the oyster calcium carbonate particles comprises the following steps:
taking an ethanol solution of hydroxypropyl methylcellulose (HPMC) in a prescription amount as an adhesive, and carrying out top-spraying granulation on the mixture of oyster calcium carbonate, crospovidone and microcrystalline cellulose;
and taking hydroxypropyl methylcellulose (HPMC) or ethanol solution of the HPMC and the edible pigment as a coating solution according to the prescription amount, and carrying out bottom spray coating on the top spray granules to obtain the oyster calcium carbonate granules.
More preferably, the oyster calcium carbonate is micronized before being granulated and coated and is sieved by a 200-mesh sieve; and the oyster calcium carbonate particles after coating are sieved by a 16-mesh sieve.
Preferably, the concentration of the ethanol solution is 30-70%.
More preferably, the concentration of the ethanol solution is 40-65%.
More preferably, the concentration of the ethanol solution is 55-60%.
Preferably, the preparation of the citric acid particles comprises the following steps:
mixing citric acid with mannitol and sucrose according to a prescription amount, adding ethanol solution containing an auxiliary agent according to the prescription amount for granulation, and drying to obtain citric acid granules;
wherein the auxiliary agent is selected from one or a combination of more of edible essence, edible pigment and sodium glutamate.
More preferably, the citric acid, the mannitol and the sucrose are crushed before granulation and pass through a 80-mesh sieve; and sieving the granulated citric acid granules with a 16-mesh sieve.
More preferably, the drying process is as follows: drying with 70-75 deg.C hot air for 3-7 h.
More preferably, the drying process is: drying with 72-74 deg.C hot air for 4-6 h.
Preferably, the tabletting process is:
uniformly mixing oyster calcium carbonate particles, citric acid particles and a lubricant according to the prescription amount, and tabletting;
wherein the lubricant is selected from one or two of talcum powder and magnesium stearate.
More preferably, the preparation method of the oyster calcium carbonate chewable tablet specifically comprises the following steps:
preparation of oyster shell calcium carbonate particles
a. Micronizing oyster calcium carbonate, and sieving with 200 mesh sieve;
b. dissolving hydroxypropyl methylcellulose (HPMC) in ethanol solution, and sieving with 80 mesh sieve to obtain adhesive;
c. dissolving hydroxypropyl methylcellulose (HPMC) and edible pigment in ethanol solution, and sieving with 80 mesh sieve to obtain isolation coating solution;
d. uniformly mixing oyster calcium carbonate, microcrystalline cellulose and crospovidone according to the formula amount, putting the mixture into a granulating and coating pot, spraying an adhesive, and carrying out top spraying granulation;
e. passing the top-sprayed material through a 20-mesh screen to remove particles larger than 20 meshes;
f. putting the granules into a granulating and coating pot, spraying isolation coating liquid, and spraying coating on the bottom;
g. passing the coated material through a 16-mesh screen, and removing particles larger than 16 meshes to obtain particles I;
preparation of (di) citric acid granules
a. Crushing citric acid, mannitol and cane sugar in a prescription amount and sieving the crushed materials with a 80-mesh sieve;
b. dissolving the edible essence, the edible pigment and the sodium glutamate with the prescribed amount in an ethanol solution for later use;
c. placing the treated citric acid, mannitol and sucrose into a high-speed granulator, slowly stirring for 1-3 minutes, adding an ethanol solution containing an auxiliary agent, and rapidly granulating for 2-5 minutes;
d. spreading the wet granules on a plate, feeding the wet granules into a drying room, and drying the wet granules for 3 to 7 hours by adopting hot air at the temperature of between 70 and 75 ℃;
e. sieving the material with a 16-mesh sieve, and removing particles larger than 16 meshes to obtain particles II;
(III) tabletting
And mixing granule I, granule II, pulvis Talci and magnesium stearate, and tabletting to obtain Concha Ostreae calcium carbonate chewable tablet.
In a second aspect, the present invention provides an oyster calcium carbonate chewable tablet suitable for the above preparation method, which comprises the following components in terms of the prescribed amount (kg) per ten thousand tablets:
preferably, the oyster calcium carbonate chewable tablet prepared by the preparation method comprises the following components in terms of prescription amount (kg) of each ten thousand tablets:
preferably, the oyster calcium carbonate chewable tablet prepared by the preparation method comprises the following components in terms of prescription amount (kg) of each ten thousand tablets:
preferably, the edible essence is one or more of sweet orange oil, lemon oil and citrus oil; preferably, the flavoring essence is sweet orange oil.
Preferably, the edible pigment is one or more of carmine, lemon yellow and brilliant blue, the edible pigment is not required by the scheme, the amount of the edible pigment is different according to different pigments, for example, the amount of the edible pigment is 0.5 g/ten thousand pieces for the carmine, the amount of the edible pigment is 0.1 g/ten thousand pieces for the brilliant blue, and the amount of the edible pigment is 0.7 g/ten thousand pieces for the lemon yellow, and then the particles I and the particles II are respectively added according to the material proportion.
By adopting the technical scheme, compared with the prior art, the invention has the following technical effects:
the preparation method comprises the steps of granulating a mixture of oyster calcium carbonate, crospovidone and microcrystalline cellulose by using an ethanol solution of hydroxypropyl methylcellulose (HPMC) as an adhesive, and coating the granules by using the ethanol solution of the HPMC as a coating solution to obtain oyster calcium carbonate granules; finally, mixing and tabletting the oyster calcium carbonate particles and the citric acid particles prepared by wet granulation. Namely, Hydroxypropyl Methylcellulose (HMPC) is adopted for granulating and coating to protect the oyster calcium carbonate so as to isolate citric acid, prevent the citric acid from easily absorbing moisture to cause reaction with the calcium carbonate, and effectively overcome the quality problem caused by moisture absorption of the conventional oyster calcium carbonate chewable tablets.
It is noted that the crospovidone (PVPP) in the invention is used as a disintegrant, the disintegrant is used because the dissolution rate is influenced by the coating of the isolating layer, the release of the main drug in the oral cavity can be accelerated by adding the disintegrant, and in addition, the adhesive and the coating material of the isolating layer both adopt hydroxypropyl methylcellulose (HPMC).
Detailed Description
The present invention will be described in detail and specifically with reference to the following examples to facilitate better understanding of the present invention, but the following examples do not limit the scope of the present invention.
Example 1 oyster calcium carbonate chewable tablets comprise the following ingredients in the amount prescribed per ten thousand tablets (kg):
the preparation method of the oyster calcium carbonate chewable tablet comprises the following steps:
preparation of oyster shell calcium carbonate particles
a. Micronizing oyster calcium carbonate, and sieving with 200 mesh sieve;
b. dissolving hydroxypropyl methylcellulose (HPMC) in ethanol solution, and sieving with 80 mesh sieve to obtain adhesive;
c. dissolving hydroxypropyl methylcellulose (HPMC) and edible pigment in ethanol solution, and sieving with 80 mesh sieve to obtain isolation coating solution;
d. uniformly mixing oyster calcium carbonate, microcrystalline cellulose and crospovidone according to the formula amount, putting the mixture into a granulating and coating pot, spraying an adhesive, and carrying out top spraying granulation;
e. passing the top-sprayed material through a 20-mesh screen to remove particles larger than 20 meshes;
f. putting the granules into a granulating and coating pot, spraying isolation coating liquid, and spraying coating on the bottom;
g. passing the coated material through a 16-mesh screen, and removing particles larger than 16 meshes to obtain particles I;
preparation of (di) citric acid granules
a. Crushing citric acid, mannitol and cane sugar in a prescription amount and sieving the crushed materials with a 80-mesh sieve;
b. dissolving the edible essence, the edible pigment and the sodium glutamate with the prescribed amount in an ethanol solution for later use;
c. placing the treated citric acid, mannitol and sucrose into a high-speed granulator, stirring at a low speed for 2 minutes, adding an ethanol solution containing an auxiliary agent, and granulating rapidly for 3 minutes;
d. spreading the wet granules on a plate, feeding the wet granules into a drying room, and drying the wet granules for 5 hours by adopting hot air at the temperature of 70-75 ℃;
e. sieving the material with a 16-mesh sieve, and removing particles larger than 16 meshes to obtain particles II;
(III) tabletting
And mixing the granules I, II, talcum powder and magnesium stearate uniformly, and tabletting to obtain the oyster calcium carbonate chewable tablet 1.
Example 2 oyster calcium carbonate chewable tablets, calculated per ten thousand tablets in terms of prescribed amount (kg), comprise the following components:
the preparation process of the oyster calcium carbonate chewable tablet is the same as the preparation process of the example 1.
Example 3 oyster calcium carbonate chewable tablets comprise the following ingredients in the amount prescribed per ten thousand tablets (kg):
the preparation process of the oyster calcium carbonate chewable tablet is the same as the preparation process of the example 1.
Example 4 oyster calcium carbonate chewable tablets comprise the following ingredients in the amount prescribed per ten thousand tablets (kg):
the preparation process of the oyster calcium carbonate chewable tablet is the same as the preparation process of the example 1.
Example 5 oyster calcium carbonate chewable tablets, calculated per ten thousand tablets in terms of prescribed amount (kg), comprise the following components:
the preparation process of the oyster calcium carbonate chewable tablet is the same as the preparation process of the example 1.
Comparative example 1 an oyster calcium carbonate chewable tablet comprises the following ingredients in terms of prescribed amounts (kg) per ten thousand tablets:
the preparation method of the oyster calcium carbonate chewable tablet comprises the following steps:
preparation of oyster shell calcium carbonate particles
a. Micronizing oyster calcium carbonate, and sieving with 200 mesh sieve;
b. dissolving hydroxypropyl methylcellulose (HPMC) in ethanol solution, and sieving with 80 mesh sieve to obtain adhesive;
c. dissolving hydroxypropyl methylcellulose (HPMC) and edible pigment in ethanol solution, and sieving with 80 mesh sieve to obtain isolation coating solution;
d. uniformly mixing oyster calcium carbonate and microcrystalline cellulose according to the prescription amount, putting the mixture into a granulation coating pot, spraying an adhesive, and carrying out top spraying granulation;
e. passing the top-sprayed material through a 20-mesh screen to remove particles larger than 20 meshes;
f. putting the granules into a granulating and coating pot, spraying isolation coating liquid, and spraying coating on the bottom;
g. passing the coated material through a 16-mesh screen, and removing particles larger than 16 meshes to obtain particles I;
preparation of (di) citric acid granules
a. Crushing citric acid, mannitol and cane sugar in a prescription amount and sieving the crushed materials with a 80-mesh sieve;
b. dissolving the edible essence, the edible pigment and the sodium glutamate with the prescribed amount in an ethanol solution for later use;
c. placing the treated citric acid, mannitol and sucrose into a high-speed granulator, stirring at a low speed for 2 minutes, adding an ethanol solution containing an auxiliary agent, and granulating rapidly for 3 minutes;
d. spreading the wet granules on a plate, feeding the wet granules into a drying room, and drying the wet granules for 5 hours by adopting hot air at the temperature of 70-75 ℃;
e. sieving the material with a 16-mesh sieve, and removing particles larger than 16 meshes to obtain particles II;
(III) tabletting
And mixing the granules I, II, talcum powder and magnesium stearate uniformly, and tabletting to obtain the oyster calcium carbonate chewable tablet 1.
Comparative example 2 an oyster calcium carbonate chewable tablet comprises the following ingredients in terms of prescribed amounts (kg) per ten thousand tablets:
the preparation process of the oyster calcium carbonate chewable tablet is the same as that of the comparative example 1.
Comparative example 3 a conventional oyster calcium carbonate chewable tablet comprises the following components in terms of the prescribed amount (kg) per ten thousand tablets:
prescription (10000 tablets)
According to the formula, the conventional oyster calcium carbonate chewable tablet is prepared by adopting a conventional wet granulation process and mainly comprises the following steps: (1) mixing mannitol, microcrystalline cellulose, sucrose, Concha Ostreae calcium carbonate, and citric acid, granulating at high speed with sodium glutamate and pigment water as humectant (ethanol is not added), mixing with magnesium stearate, pulvis Talci, and essence, and tabletting.
Stability test:
accelerated stability tests were conducted using the oyster calcium carbonate chewable tablets prepared in examples 1 to 5 using the novel process of the present invention as an experimental group, and using the oyster calcium carbonate chewable tablets prepared in comparative example 1, comparative example 2 and comparative example 3 using the existing wet granulation process as a control group, respectively, and the specific test data are shown in table 1 below.
TABLE 1 summary of accelerated stability test data
As can be seen from the accelerated stability experimental data in Table 1, after six months of accelerated investigation, the hardness and friability of the chewable tablets prepared by the novel process of the invention are obviously improved compared with the original method, and the quality problem caused by moisture absorption can be effectively avoided.
The embodiments of the present invention have been described in detail, but the embodiments are merely examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.
Claims (10)
1. A preparation method of oyster calcium carbonate chewable tablets is characterized in that a mixture of oyster calcium carbonate, crospovidone and microcrystalline cellulose is granulated and coated by taking an ethanol solution of hydroxypropyl methylcellulose (HPMC) as an adhesive, and the coated oyster calcium carbonate particles and citric acid particles containing citric acid and auxiliary materials are uniformly mixed and then tableted to obtain the oyster calcium carbonate chewable tablets.
2. The process for preparing oyster calcium carbonate chewable tablets according to claim 1, wherein the preparation of the oyster calcium carbonate granules comprises the following steps:
taking an ethanol solution of hydroxypropyl methylcellulose (HPMC) in a prescription amount as an adhesive, and carrying out top-spraying granulation on the mixture of oyster calcium carbonate, crospovidone and microcrystalline cellulose;
and taking hydroxypropyl methylcellulose (HPMC) or ethanol solution of the HPMC and the edible pigment as a coating solution according to the prescription amount, and carrying out bottom spray coating on the top spray granules to obtain the oyster calcium carbonate granules.
3. The process for the preparation of chewable oyster calcium carbonate tablets according to claim 1 or 2, wherein the oyster calcium carbonate is micronized before granulation coating and sieved through a 200 mesh sieve; and the oyster calcium carbonate particles after coating are sieved by a 16-mesh sieve.
4. The process for the preparation of chewable oyster calcium carbonate tablets according to claim 1 or 2, characterized in that the concentration of the ethanol solution is between 30 and 70%.
5. The process for preparing chewable oyster calcium carbonate tablets according to claim 1, wherein the preparation of the citric acid granules comprises the following steps:
mixing citric acid with mannitol and sucrose according to a prescription amount, adding ethanol solution containing an auxiliary agent according to the prescription amount for granulation, and drying to obtain citric acid granules;
wherein the auxiliary agent is selected from one or a combination of more of edible essence, edible pigment and sodium glutamate.
6. The method for preparing oyster calcium carbonate chewable tablets according to claim 5, wherein the citric acid, mannitol and sucrose are crushed and sieved through a 80-mesh sieve before granulation; and sieving the granulated citric acid granules with a 16-mesh sieve.
7. The method for preparing the oyster calcium carbonate chewable tablet of claim 5, wherein the drying process comprises: drying with 70-75 deg.C hot air for 3-7 h.
8. The process for preparing chewable oyster calcium carbonate tablets according to claim 1, wherein the tabletting process comprises:
evenly mixing oyster calcium carbonate particles, citric acid particles and a lubricant according to the prescription amount, and tabletting;
wherein the lubricant is selected from one or two of talcum powder and magnesium stearate.
9. The preparation method of the oyster calcium carbonate chewable tablet of claim 1, which comprises the following steps:
preparation of oyster shell calcium carbonate particles
a. Micronizing oyster calcium carbonate, and sieving with 200 mesh sieve;
b. dissolving hydroxypropyl methylcellulose (HPMC) in ethanol solution, and sieving with 80 mesh sieve to obtain adhesive;
c. dissolving hydroxypropyl methylcellulose (HPMC) and edible pigment in ethanol solution, and sieving with 80 mesh sieve to obtain isolation coating solution;
d. uniformly mixing oyster calcium carbonate, microcrystalline cellulose and crospovidone according to the formula amount, putting the mixture into a granulation coating pot, spraying an adhesive, and performing top spraying granulation;
e. passing the top-sprayed material through a 20-mesh screen, and removing particles larger than 20 meshes;
f. putting the granules into a granulating and coating pot, spraying isolation coating liquid, and spraying coating on the bottom;
g. passing the coated material through a 16-mesh screen, and removing particles larger than 16 meshes to obtain particles I;
preparation of (di) citric acid granules
a. Crushing citric acid, mannitol and cane sugar in a prescription amount and sieving the crushed materials with a 80-mesh sieve;
b. dissolving the edible essence, the edible pigment and the sodium glutamate with the prescribed amount in an ethanol solution for later use;
c. placing the treated citric acid, mannitol and sucrose into a high-speed granulator, slowly stirring for 1-3 minutes, adding an ethanol solution containing an auxiliary agent, and rapidly granulating for 2-5 minutes;
d. spreading the wet granules on a plate, feeding the wet granules into a drying room, and drying the wet granules for 3 to 7 hours by adopting hot air at the temperature of between 70 and 75 ℃;
e. sieving the material with a 16-mesh sieve, and removing particles larger than 16 meshes to obtain particles II;
(III) tabletting
And mixing granule I, granule II, pulvis Talci and magnesium stearate, and tabletting to obtain Concha Ostreae calcium carbonate chewable tablet.
10. Oyster calcium carbonate chewable tablets for use in the preparation process according to any one of claims 1 to 9, characterized in that they comprise, per ten thousand tablets of prescribed quantity (kg):
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