Calcium carbonate vitamin D3 composition and water-free-swallowing granules thereof

Abstract

The present invention relates to a calcium carbonate vitamin D3 composition and water-free-swallowing granules thereof, and belongs to the field of pharmaceutical preparations. According to the present invention, in the calcium carbonate vitamin D3 composition and the calcium carbonate vitamin D3 water-free-swallowing granules containing the composition or prepared from the composition, vitamin D3is fed in a vitamin D3 carrier manner; compared to the granules in the prior art, the granules of the present invention have the following advantages that the rapid water-free swallowing of the granules in the oral cavity cam be achieved, the taste is good, and the compliance of the user can be improved, such that the problems of poor content uniformity and poor stability of vitamin D3 in the preparation can be solved; and particularly compared to the existing calcium carbonate vitamin D3 preparation, the preparation of the present invention has the following advantages that the calcium carbonate content in the unit preparation is increased while the loading is lower than the loading of the traditional dosage form.

Description

technical field

[0001] The invention provides a calcium carbonate vitamin D 3 Composition and its anhydrous swallowable granules. It belongs to the field of pharmaceutical preparations. Background technique

[0002] Calcium carbonate preparations include calcium carbonate tablets, calcium carbonate chewable tablets, and calcium carbonate granules. The conventional process is to add disintegrants and flavoring agents to calcium carbonate granules and then fill them into stick packs or compress tablets. Taking calcium carbonate alone, the absorption is poor, vitamin D 3 Can assist calcium absorption, so the market of calcium carbonate vitamin D3 compound preparation is broader.

[0003] Vitamin D3 is insoluble in water, and unstable, sensitive to light and heat. In order to improve the solubility in oral compound preparations, the B-cyclodextrin inclusion complex is used to improve the solubility and stability of vitamin D3, and the vitamin D3-B-cyclodextrin inclusion comp...

Examples

Embodiment 1

[0032] According to the dosage of 500 units, the feeding is carried out:

[0033]

[0034]

[0035] Preparation Process:

[0036] 1. Wet granulation: mix calcium carbonate, sorbitol, sodium carboxymethyl cellulose, aspartame, etc. in a wet granulator to mix the materials, add 50% ethanol solution by spraying, and make The material is formed into sand grains to ensure the formability of the particles after the material is dried. Use a 20-mesh sieve for wet granulation.

[0037] Wherein, before mixing, the calcium carbonate is passed through a 100-mesh sieve, and the sorbitol is crushed through a 60-mesh sieve to ensure that the materials are evenly mixed.

[0038] 2. Drying: Control the material temperature: 40-50°C, control the dry moisture at the end of granulation: 1%-3%, and granulate the obtained granules through a 20-mesh sieve.

[0039] 3. Final mixing: adding flavoring auxiliary materials and mixing to obtain calcium carbonate vitamin D3 anhydrous swallowable g...

Embodiment 2

[0043] prescription:

[0044] According to the dosage of 400 units, the feeding is carried out:

[0045]

[0046] Preparation Process:

[0047] Mix calcium carbonate, sorbitol, starch 1500, and VD3 carrier in a wet granulator, add soft material made of 65% ethanol, and granulate with a 20-mesh sieve. Add maltodextrin 19D and citric acid into purified water to prepare a 50% top spray granulation solution, control the temperature in the fluidized bed top spray granulator at 40-50°C to top spray granulate the soft material, and control the temperature after drying. Moisture is 1%-3%. Sorted with a 20-mesh sieve, added sorbitol, sodium carboxymethylcellulose 7H4XF, citric acid, sucralose, and orange flavor, and mixed for 5 minutes.

[0048] Wherein, the sorbitol is crushed and passed through an 80-mesh sieve, and the citric acid is crushed and passed through a 60-mesh sieve.

[0049] The finished product has uniform granules, slightly cool taste, smooth swallowing, and good t...

Embodiment 3

[0051] According to the dosage of 400 units, the feeding is carried out:

[0052] prescription:

[0053]

[0054]

[0055] Preparation Process:

[0056] Same as Example 2 preparation process.

[0057] Among them: the wet granulation part of the sorbitol particle size is below 80 mesh sieve; the fluidized bed granulation process, the taste-masking auxiliary material is used to coat the granules. The particle size of citric acid and sorbitol for flavoring should be over 60 mesh after pulverization.

[0058] Result: uniform taste, smooth swallowing without water, and good flavor modification effect.

technical field

[0001] The invention provides a calcium carbonate vitamin D 3 Composition and its anhydrous swallowable granules. It belongs to the field of pharmaceutical preparations. Background technique

[0002] Calcium carbonate preparations include calcium carbonate tablets, calcium carbonate chewable tablets, and calcium carbonate granules. The conventional process is to add disintegrants and flavoring agents to calcium carbonate granules and then fill them into stick packs or compress tablets. Taking calcium carbonate alone, the absorption is poor, vitamin D 3 Can assist calcium absorption, so the market of calcium carbonate vitamin D3 compound preparation is broader.

[0003] Vitamin D3 is insoluble in water, and unstable, sensitive to light and heat. In order to improve the solubility in oral compound preparations, the B-cyclodextrin inclusion complex is used to improve the solubility and stability of vitamin D3, and the vitamin D3-B-cyclodextrin inclusion comp...

Examples

Embodiment 1

[0032] According to the dosage of 500 units, the feeding is carried out:

[0033]

[0034]

[0035] Preparation Process:

[0036] 1. Wet granulation: mix calcium carbonate, sorbitol, sodium carboxymethyl cellulose, aspartame, etc. in a wet granulator to mix the materials, add 50% ethanol solution by spraying, and make The material is formed into sand grains to ensure the formability of the particles after the material is dried. Use a 20-mesh sieve for wet granulation.

[0037] Wherein, before mixing, the calcium carbonate is passed through a 100-mesh sieve, and the sorbitol is crushed through a 60-mesh sieve to ensure that the materials are evenly mixed.

[0038] 2. Drying: Control the material temperature: 40-50°C, control the dry moisture at the end of granulation: 1%-3%, and granulate the obtained granules through a 20-mesh sieve.

[0039] 3. Final mixing: adding flavoring auxiliary materials and mixing to obtain calcium carbonate vitamin D3 anhydrous swallowable g...

Embodiment 2

[0043] prescription:

[0044] According to the dosage of 400 units, the feeding is carried out:

[0045]

[0046] Preparation Process:

[0047] Mix calcium carbonate, sorbitol, starch 1500, and VD3 carrier in a wet granulator, add soft material made of 65% ethanol, and granulate with a 20-mesh sieve. Add maltodextrin 19D and citric acid into purified water to prepare a 50% top spray granulation solution, control the temperature in the fluidized bed top spray granulator at 40-50°C to top spray granulate the soft material, and control the temperature after drying. Moisture is 1%-3%. Sorted with a 20-mesh sieve, added sorbitol, sodium carboxymethylcellulose 7H4XF, citric acid, sucralose, and orange flavor, and mixed for 5 minutes.

[0048] Wherein, the sorbitol is crushed and passed through an 80-mesh sieve, and the citric acid is crushed and passed through a 60-mesh sieve.

[0049] The finished product has uniform granules, slightly cool taste, smooth swallowing, and good t...

Embodiment 3

[0051] According to the dosage of 400 units, the feeding is carried out:

[0052] prescription:

[0053]

[0054]

[0055] Preparation Process:

[0056] Same as Example 2 preparation process.

[0057] Among them: the wet granulation part of the sorbitol particle size is below 80 mesh sieve; the fluidized bed granulation process, the taste-masking auxiliary material is used to coat the granules. The particle size of citric acid and sorbitol for flavoring should be over 60 mesh after pulverization.

[0058] Result: uniform taste, smooth swallowing without water, and good flavor modification effect.

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