CN110575440A - Preparation method of calcium carbonate pharmaceutical composition - Google Patents
Preparation method of calcium carbonate pharmaceutical composition Download PDFInfo
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- CN110575440A CN110575440A CN201810585065.5A CN201810585065A CN110575440A CN 110575440 A CN110575440 A CN 110575440A CN 201810585065 A CN201810585065 A CN 201810585065A CN 110575440 A CN110575440 A CN 110575440A
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- calcium carbonate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
Abstract
The invention belongs to the technical field of medicines, and relates to a preparation method of a calcium carbonate composition, which comprises the steps of mixing calcium carbonate with a colorant and an adhesive, granulating, drying wet granules at 60 ℃, mixing the dried granules with a filler, a flavoring agent and a lubricant, and tabletting. The calcium carbonate chewable tablet can be effectively guaranteed to keep the taste and hardness unchanged within the period of validity, and the conditions that the hardness is increased and the taste is poor due to the moisture absorption process of sugar alcohol auxiliary materials after the calcium carbonate chewable tablet sold in the market is unsealed are effectively improved. And the process technology can be suitable for industrial production and has strong production applicability.
Description
Technical Field
The invention relates to a preparation method of a calcium carbonate pharmaceutical composition, and the pharmaceutical composition relates to a calcium carbonate chewable tablet. The preparation process is simple to operate, the conventional wet granulator is used for wet granulation, the process can effectively solve the problem that the hardness of the tablets is increased due to moisture absorption of the sorbitol during the storage in the period of validity, and the taste of the calcium carbonate chewable tablets is improved.
background
osteoporosis, is a bone disease caused by a variety of causes, bone tissue has normal calcification, calcium salt and matrix are in normal proportion, and metabolic bone lesions are characterized by the reduction of bone tissue amount in unit volume. In most osteoporosis, the reduction of bone tissue is mainly due to increased bone resorption. Is characterized by pain in the skeleton and susceptibility to fracture.
The chewable tablet has the unique advantages of removing the tablet, usually adding a flavoring agent into the chewable tablet to adjust the taste, having better mouthfeel and various colors and shapes, thereby being suitable for children, old people and patients with dysphagia.
calcium carbonate chewable tablets were first approved for marketing in the united kingdom in 1987 at 11 months for: 1) supplementation of high normal demand or dietary calcium deficiency; 2) can be used for the adjuvant treatment of osteoporosis.
patent publication No. CN 104490926 a calcium carbonate composition chewable tablet and a preparation method thereof have been rejected. Sorbitol is used as a filler in the auxiliary materials of the original grinding product, and the sorbitol is easy to absorb moisture, so that the taste of the tablet is poor after the hardness of the tablet is increased. The original products are bought for a plurality of times and researched, and the taste is not good, and the difference between the batches is large.
therefore, a suitable process is selected to improve the taste of the calcium carbonate chewable tablets.
at present, calcium carbonate chewable tablets sold in the market generally have the tendency that after the package is opened, the calcium tablets become hard gradually, influence the taste, are not beneficial to patients to chew (especially are not beneficial to chewable tablets of old people and children), and lose the advantages and product characteristics of the chewable tablets. The invention mainly solves the problems of hardening and changing taste of the calcium carbonate chewable tablet after the cover of the calcium carbonate chewable tablet is opened, improves the compliance of taking medicine by a patient and reduces the pain of the patient.
Disclosure of Invention
Object of the Invention
The invention aims to improve the hardening condition of the calcium carbonate chewable tablet after unsealing, ensure the taste, increase the compliance of patients and exert the advantages of the chewable tablet.
The invention provides a preparation method of calcium carbonate, which has the advantages of simple and convenient preparation process operation, mature production line and suitability for industrial production, and the prepared calcium carbonate chewable tablets have good taste.
Technical scheme
the preparation method of the calcium carbonate chewable tablet comprises the following steps:
a preparation method of a calcium carbonate pharmaceutical composition is characterized by comprising the following steps: a wet granulation process is used.
the chewable tablet is prepared from calcium carbonate raw materials, adhesive, filler, flavoring agent, lubricant and colorant.
The calcium carbonate chewable tablet is prepared from 1250 parts of calcium carbonate, 360 parts of sorbitol and 420 parts of adhesive, 30-50 parts of lubricant, 10-20 parts of lubricant, 0.1-1.0 part of coloring agent and 60-100 parts of flavoring agent.
In the calcium carbonate chewable tablet, the filler is sorbitol, the binder is povidone k30, the lubricant is magnesium stearate, the colorant is lemon yellow, and the flavoring agent is aspartame, isomaltulose and orange essence.
the preparation method of the calcium carbonate chewable tablet comprises the following steps:
mixing calcium carbonate with colorant and binder, making into soft mass, granulating, drying wet granules at 60 deg.C, mixing the dried granules with filler, correctant and lubricant, and tabletting.
the preparation method of the calcium carbonate chewable tablet comprises the following detailed steps in specific proportion:
Prescription: 1250g of calcium carbonate, 0.38g of lemon yellow, k3039.06g of povidone, 390g of sorbitol, 1g of aspartame, 2g of isomaltose, 10g of orange flavor essence and 13g of magnesium stearate.
The preparation method comprises the following steps:
1) sieving the auxiliary materials with a 30-mesh sieve to remove lumps.
2) adding 39.06g of povidone k30 into an appropriate amount of purified water with the concentration of the adhesive being 20 percent, adding 0.38g of lemon yellow after complete dissolution, continuing stirring for 20min, and then standing for 10 min.
3) the binder was added to 1250g of calcium carbonate to prepare a soft mass, 20 mesh granulation.
4) drying in a forced air drying oven at 60 deg.C until the water content is less than 1%, and grading.
5) And uniformly mixing the dry granules with 390g of sorbitol, 1g of aspartame, 2g of isomalt, 10g of orange flavor essence and 13g of magnesium stearate.
6) And (5) tabletting after determining the loading amount to obtain the finished product.
advantageous effects
1. Therefore, the preparation method of the calcium carbonate tablet in the field is generally as follows: the key point lies in the adding sequence of the sorbitol, because the fluidity, compressibility, adhesiveness and the like of the calcium carbonate are difficult to control after the calcium carbonate and the adhesive are separately granulated, the mode that the calcium carbonate and the sorbitol are mixed firstly and then the adhesive is added for granulation is adopted in the field, the calcium carbonate and the sorbitol are utilized for granulation by the interaction of the calcium carbonate and the sorbitol and the adhesive, the defects are avoided, but the tabletting is carried out after the granulation, the calcium carbonate tablet is easy to harden after being opened and packaged, the mouth feel is poor, and the tablet is difficult to take at the later stage.
Through a large number of experiments, the invention discovers that process control is an important factor influencing the hardness of the calcium tablet by accident, and specifically, the external addition method comprises the following steps: the calcium carbonate, adhesive and coloring agent are firstly granulated, then filler (sorbitol), lubricant (magnesium stearate) and flavoring agent (aspartame, isomaltose and orange flavor essence) are added, and the mixture is tabletted after being mixed. However, if the calcium carbonate and the binding agent are separately granulated, the flowability, the compressibility and the adhesiveness of the calcium carbonate are difficult to control, and the invention is a challenge of the invention.
2. adding povidone K30 in the amount of the prescription into purified water, stirring while adding, adopting a heat-preservation stirring barrel, dissolving completely to enable the weight volume percentage of the adhesive to be 20%, adding lemon yellow in the amount of the prescription, continuing stirring for 20min, and standing for 10min for later use. The invention compares the adhesives prepared by pure water and 95% ethanol respectively, and the result shows that the hardness and the stability of the adhesive prepared by pure water only meet the requirements.
The invention can be used for industrial production, is convenient to operate and simple in process, and the prepared calcium carbonate chewable tablet has good stability.
Detailed Description
the following examples are presented to further illustrate the claimed embodiments and are not intended to limit the invention.
example 1: and (3) adding auxiliary materials, wherein the adhesive concentration is 20% (the adhesive dosage is 39.06 mg/tablet):
the preparation process comprises the following steps:
1) Pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) preparing an adhesive: binder concentration 20%: adding povidone K30 of a prescription amount into a proper amount of purified water, stirring while adding, adopting a heat-preservation stirring barrel, adding lemon yellow of the prescription amount after completely dissolving, continuously stirring for 20min, and then standing for 10 min;
3) A granulation step: 1. putting the raw material medicines into a wet granulator; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) A total mixing step: mixing the granules obtained in step 3) with sorbitol, aspartame, isomalt, orange flavor essence and magnesium stearate uniformly to obtain total mixed granules;
5) Tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
example 2: adding auxiliary materials, wherein the concentration of the adhesive is 20% (the dosage of the adhesive is 30 mg/tablet):
The preparation process comprises the following steps:
1) pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) preparing an adhesive: binder concentration 20%: adding povidone K30 of a prescription amount into a proper amount of purified water, stirring while adding, adopting a heat-preservation stirring barrel, adding lemon yellow of the prescription amount after completely dissolving, continuously stirring for 20min, and then standing for 10 min;
3) A granulation step: 1. putting the raw material medicines into a wet granulator; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) A total mixing step: mixing the granules obtained in step 3) with sorbitol, aspartame, isomalt, orange flavor essence and magnesium stearate uniformly to obtain total mixed granules;
5) tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
example 3: and (3) adding auxiliary materials, wherein the concentration of the adhesive is 20% (the dosage of the adhesive is 45.06 mg/tablet):
The preparation process comprises the following steps:
1) pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) preparing an adhesive: binder concentration 20%: adding povidone K30 of a prescription amount into a proper amount of purified water, stirring while adding, adopting a heat-preservation stirring barrel, adding lemon yellow of the prescription amount after completely dissolving, continuously stirring for 20min, and then standing for 10 min;
3) A granulation step: 1. putting the raw material medicines into a wet granulator; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) A total mixing step: mixing the granules obtained in step 3) with sorbitol, aspartame, isomalt, orange flavor essence and magnesium stearate uniformly to obtain total mixed granules;
5) Tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
comparative example 1: adding in:
The preparation process comprises the following steps:
1) pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) preparing an adhesive: binder concentration 20%: adding povidone K30 of a prescription amount into a proper amount of purified water, stirring while adding, adopting a heat-preservation stirring barrel, adding lemon yellow of the prescription amount after completely dissolving, continuously stirring for 20min, and then standing for 10 min;
3) A granulation step: 1. putting the raw material medicine and sorbitol into a wet granulator and uniformly mixing; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) A total mixing step: mixing the granules obtained in step 3) with magnesium stearate, aspartame, isomaltose and orange flavor essence uniformly to obtain total mixed granules;
5) Tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
Comparative example 2: sorbitol auxiliary materials are added in part and are added in part (the ratio of the sorbitol to the sorbitol is 1: 4):
The preparation process comprises the following steps:
1) pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) preparing an adhesive: binder concentration 20%: adding povidone K30 of a prescription amount into a proper amount of purified water, stirring while adding, adopting a heat-preservation stirring barrel, adding lemon yellow of the prescription amount after completely dissolving, continuously stirring for 20min, and then standing for 10 min;
3) a granulation step: 1. mixing the raw materials with sorbitol in a wet granulator; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) a total mixing step: specifically, the particles obtained in the step 3) and additional auxiliary materials are uniformly mixed to obtain total mixed particles;
5) Tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
Comparative example 3: the binder was dissolved in a 95% ethanol solution:
The preparation process comprises the following steps:
1) pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) preparing an adhesive: binder concentration 20%: adding a proper amount of 95% ethanol into povidone K30 according to the formula amount, stirring while adding, adopting a heat-preservation stirring barrel, adding lemon yellow according to the formula amount after completely dissolving, continuously stirring for 20min, and then standing for 10 min;
3) a granulation step: 1. mixing the raw materials with sorbitol in a wet granulator; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) a total mixing step: specifically, the particles obtained in the step 3) and additional auxiliary materials are uniformly mixed to obtain total mixed particles;
5) Tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
Comparative example 4: the binder concentration was reduced by adjusting from a 20% povidone aqueous solution to a 10% povidone aqueous solution:
comparative example 5: the binder concentration was reduced by adjusting from a 20% povidone aqueous solution to a 30% povidone aqueous solution:
The preparation process comprises the following steps:
1) Pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) Preparing an adhesive:
comparative example 4 binder concentration 10%; comparative example 5 binder concentration 30%;
adding povidone K30 of a prescription amount into a proper amount of purified water, stirring while adding, adopting a heat-preservation stirring barrel, adding lemon yellow of the prescription amount after completely dissolving, continuously stirring for 20min, and then standing for 10 min;
3) a granulation step: 1. mixing the raw materials with sorbitol in a wet granulator; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) a total mixing step: specifically, the particles obtained in the step 3) and additional auxiliary materials are uniformly mixed to obtain total mixed particles;
5) tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
Comparative example 6: the dosage of the sorbitol is reduced from 390 mg/tablet to 300 mg/tablet
the preparation process comprises the following steps:
1) Pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) preparing an adhesive:
comparative example 4, the concentration of the adhesive is 20%, povidone K30 with the amount of the prescription is added into a proper amount of purified water, stirring is carried out while adding, a heat-preservation stirring barrel is adopted, after complete dissolution, lemon yellow with the amount of the prescription is added, stirring is continued for 20min, and then standing is carried out for 10 min;
3) a granulation step: 1. mixing the raw materials with sorbitol in a wet granulator; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) A total mixing step: specifically, the particles obtained in the step 3) and additional auxiliary materials are uniformly mixed to obtain total mixed particles;
5) Tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
Comparative example 7: the dosage of the sorbitol is increased from 390 mg/tablet to 450 mg/tablet
the preparation process comprises the following steps:
1) Pretreatment: sieving the auxiliary materials with a 30-mesh sieve, and removing lumps for later use;
2) preparing an adhesive:
Comparative example 4, the concentration of the adhesive is 20%, povidone K30 with the amount of the prescription is added into a proper amount of purified water, stirring is carried out while adding, a heat-preservation stirring barrel is adopted, after complete dissolution, lemon yellow with the amount of the prescription is added, stirring is continued for 20min, and then standing is carried out for 10 min;
3) A granulation step: 1. mixing the raw materials with sorbitol in a wet granulator; 2. adding the binder solution into a wet granulator; granulating, drying and finishing;
4) a total mixing step: specifically, the particles obtained in the step 3) and additional auxiliary materials are uniformly mixed to obtain total mixed particles;
5) tabletting: specifically, the granules obtained in the step 4) are pressed into tablets by a tablet press.
Test example 1: a routine examination of calcium carbonate tablets is given in the following table:
TABLE 1 examination results of calcium carbonate chewable tablets
and (4) conclusion: the granular state, material moisture, tabletting process, hardness and friability of the three prescription tablets in examples 1-3 are not obviously changed after being placed for 10 days, and the taste is consistent with that of the original ground reference preparation; the mouth feel of the comparative examples 1 to 3 is good after 0 day, but in the process of placing, the hardness of the tablet is obviously increased due to the moisture absorption effect of the sugar alcohol auxiliary materials, and the chewing mouth feel is seriously influenced. The method for adding the auxiliary materials has greater advantages than the method for adding the auxiliary materials into the granules, and stability tests show that the situation that the tablet is hardened in the process of placing by the aid of the external adding method cannot occur.
As can be seen from comparative examples 4 to 5, the concentration of the binder was 10% or 30%, and the granulation could not be performed normally, and the industrial production requirements could not be satisfied. The concentration of the binder was 20% as the optimum concentration.
As shown in comparative examples 6-7, sorbitol is a key adjuvant, and its use amount is too high or too low, which causes the problem of production feasibility, so the preferred range of sorbitol is 360-420 parts.
test example 2: stability test
taking the sample 2 box obtained in the embodiment 3 of the invention, carrying out accelerated stability inspection after thermomagnetic seal packaging according to the guideline of stability test of XIXC raw material medicine and pharmaceutical preparation in appendix XIXC 2015 edition, wherein the conditions are 40 ℃ plus or minus 2 ℃ and RH75 percent plus or minus 5 percent, and sampling at 0 month, 1 month, 2 months and 3 months after placement to inspect the physicochemical properties, and the results are shown in Table 3.
TABLE 5 stability test results for calcium carbonate chewable tablets
test results show that the sample prepared by the method has good stability and basically consistent physicochemical properties with a reference preparation sample; stability was not investigated because of the unsatisfactory results of the physicochemical properties of the tablets of the comparative examples.
Claims (3)
1. a preparation method of a calcium carbonate pharmaceutical composition is characterized by comprising the following steps: the formula of the calcium carbonate pharmaceutical composition comprises 1250 parts of calcium carbonate, 360 parts of sorbitol, 420 parts of adhesive, 1-2 parts of lubricant, 10-20 parts of lubricant, 0.1-1.0 part of colorant and 60-100 parts of flavoring agent, and the calcium carbonate pharmaceutical composition comprises the following steps:
mixing calcium carbonate with colorant and adhesive, granulating, drying at 60 deg.C, mixing with filler, correctant and lubricant, and tabletting.
2. the method for preparing a calcium carbonate pharmaceutical composition according to claim 1, wherein the calcium carbonate pharmaceutical composition comprises: the preparation method of the adhesive comprises the following steps: adding povidone K30 in the amount of the prescription into purified water, stirring while adding, adopting a heat-preservation stirring barrel to ensure that the weight of the adhesive accounts for 20% of the total solution after the adhesive is completely dissolved, adding lemon yellow in the amount of the prescription, continuously stirring for 20min, and standing for 10min for later use.
3. The process for preparing a calcium carbonate pharmaceutical composition according to claim 1 or 2, wherein: the filling agent is sorbitol, the adhesive is povidone k30, the lubricant is magnesium stearate, the colorant is lemon yellow, and the flavoring agent is aspartame, isomaltulose and orange essence.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113616706A (en) * | 2021-09-02 | 2021-11-09 | 江苏盛世康禾生物技术有限公司 | Liver-protecting immunity-enhancing Chinese herbal medicine preparation and preparation method thereof |
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