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CaCO3 vitamin D3 preparation and preparation method thereof

A vitamin and calcium carbonate technology, applied in pill delivery, pharmaceutical formulations, active ingredients of aluminum/calcium/magnesium, etc., can solve the problem of difficult mixing of vitamin D3, sensitivity to light, heat, and oxygen, and unqualified content uniformity of vitamin D3 And other issues

Active Publication Date: 2018-12-18
CHINESE MEDICINES GUANGZHOU
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  • Claims
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AI Technical Summary

Problems solved by technology

[0006] Since the content of vitamin D3 required in calcium carbonate vitamin D3 preparations is low (100IU~800IU, equivalent to 2.5μg~20μg), the content of calcium carbonate is relatively high (500mg~2000mg), so vitamin D3 in calcium carbonate vitamin D3 preparations Difficult to mix evenly, prone to unqualified vitamin D3 content uniformity
Moreover, vitamin D3 has extremely poor stability, is sensitive to light, heat, and oxygen, and is easy to degrade

Method used

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  • CaCO3 vitamin D3 preparation and preparation method thereof
  • CaCO3 vitamin D3 preparation and preparation method thereof
  • CaCO3 vitamin D3 preparation and preparation method thereof

Examples

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preparation example Construction

[0035] Based on this, an embodiment of the present invention provides a calcium carbonate vitamin D3 preparation and a preparation method thereof. The preparation method of the calcium carbonate vitamin D3 preparation comprises the following steps S1-S5.

[0036] Step S1: providing raw materials, including calcium carbonate, vitamin D3, disintegrants, fillers, binders, lubricants and coating powders.

[0037] In one embodiment, the raw materials include 100 parts by weight of calcium carbonate, 0.0002-0.0005 parts by weight of vitamin D3, 4-10 parts by weight of disintegrants, 30-50 parts by weight of fillers, 10-20 parts by weight of binder, 2-5 parts by weight of lubricant and 4-10 parts by weight of coating powder.

[0038] Further, the disintegrant is at least one of sodium carboxymethyl starch, crospovidone and croscarmellose sodium, preferably sodium carboxymethyl starch. The filler is at least one of sorbitol and mannitol, preferably sorbitol. The binder is at least ...

Embodiment 1

[0065] A preparation method of calcium carbonate vitamin D3 chewable tablet, comprising the steps of:

[0066] 1) raw material is provided, and this raw material comprises the calcium carbonate of 100 weight parts, the vitamin D3 of 0.0003 weight part, the sodium starch glycolate of 6 weight parts, the sorbitol of 40 weight parts, the povidone K30 of 15 weight parts, the povidone K30 of 3 weight parts The magnesium stearate of 8 parts by weight, the Opadry Y-1-7000 of 8 parts by weight, the essence of 0.2 parts by weight and the aspartame of 0.1 parts by weight.

[0067] 2) Sieve the above-mentioned calcium carbonate, sodium carboxymethyl starch and sorbitol, and mix evenly to obtain a mixture. The above-mentioned povidone K30 is equally divided into two parts according to the mass equivalent, and a part of povidone K30 is dissolved in 75% (v / v) ethanol aqueous solution to prepare 75% (w / w) povidone K30 containing 15% (w / w) povidone K30 % (v / v) ethanol in water, as a binder s...

Embodiment 2

[0078] Embodiment 2 is substantially the same as Example 1, and the difference is that the raw materials of step 1) include the calcium carbonate of 100 parts by weight, the vitamin D3 of 0.0004 parts by weight, the sodium carboxymethyl starch of 10 parts by weight, the sorbic acid of 50 parts by weight Alcohol, the Povidone K30 of 10 parts by weight, the magnesium stearate of 5 parts by weight, the Opadry Y-1-7000 of 4 parts by weight, the essence of 0.1 parts by weight and the Aspartame of 0.2 parts by weight;

[0079] Step 2) Divide the above-mentioned povidone K30 into three equal parts according to the mass, take two parts in step 2), and take the remaining part in step 4).

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Abstract

The invention relates to a CaCO3 vitamin D3 preparation and a preparation method thereof. The CaCO3 vitamin D3 preparation is mainly prepared from coated pills, wherein the coated pill includes a pillcore, a medicine coating layer and a protective coating layer; the medicine coating layer and the protective coating layer successively coat the pill core. The pill core includes: CaCO3, a disintegrating agent, filler and a binder; the medicine coating layer includes: vitamin D3 and a binder; the protective coating layer is mainly prepared from coating powder. By dispersing the CaCO3 in the pillcore, containing the disintegrating agent and filler, of the coated pill and dispersing the vitamin D3 in the medicine coating layer coating the pill core, and binding the pill core with the medicinecoating layer through the binder and coating the pill with the protective coating layer, a problem of degradability of vitamin D3 is avoided, and uniformity of the CaCO3 and vitamin D3 is increased and stability of the vitamin D3 is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a calcium carbonate vitamin D3 preparation and a preparation method thereof. Background technique [0002] Calcium is an essential constant element for the human body and the most abundant inorganic element in the human body. The calcium content in the adult body accounts for about 1.5% to 2.0% of the body weight, and the total calcium content in the human body reaches 1200 to 1400g, of which 99% exists in bones and Teeth form the scaffold of the human body and become the storage pool of calcium in the body; the other 1% exists in soft tissues, intercellular space and blood, collectively known as miscible calcium pools, which maintain a dynamic balance with bone calcium. [0003] Calcium plays an important physiological regulatory role in the functioning of all cells in the human body. Calcium is an activator of more than 200 kinds of enzymes in the human body, so that...

Claims

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Application Information

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IPC IPC(8): A61K33/10A61K9/20A61P3/02A61K31/593
CPCA61K9/2059A61K9/209A61K31/593A61K33/10A61P3/02A61K2300/00
Inventor 黄宏轩卢林凤
Owner CHINESE MEDICINES GUANGZHOU
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