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Calcium acetate pharmaceutical composition and preparation method and application thereof

A technology of calcium acetate and composition, applied in the field of calcium acetate pharmaceutical composition and preparation thereof, can solve problems such as inconsistent crystal forms, and achieve the effects of ensuring stability and avoiding dissolution behavior

Pending Publication Date: 2019-09-27
SHANDONG CHUANGXIN PHARMA RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So as to effectively solve the problem of inconsistency between the crystal form of the existing calcium acetate raw material and the reference preparation (trade name: CALCIUM ACETATE), and ensure product quality

Method used

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  • Calcium acetate pharmaceutical composition and preparation method and application thereof
  • Calcium acetate pharmaceutical composition and preparation method and application thereof
  • Calcium acetate pharmaceutical composition and preparation method and application thereof

Examples

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preparation example Construction

[0041] In yet another specific embodiment of the present invention, a method for preparing a calcium acetate pharmaceutical composition through crystal transformation is provided, and the operation steps are as follows:

[0042] (1) Take calcium acetate raw material according to the prescription, place it in a wet granulator, add 30%-95% ethanol to granulate, and the granulation state is that the granules are wet and bonded into agglomerates;

[0043] (2) Seal the wet granules, place them at room temperature for 0.5h-24h, and then wet the granules;

[0044] (3) The sized granules are dried at 60° C. to 150° C., and the moisture content is controlled to be 5% to 6.5%, and the granules are sized.

[0045] (4) Mix the obtained dry granules with the added excipients and lubricant in the prescription ratio evenly, and press into tablets to obtain calcium acetate tablets.

[0046] In yet another specific embodiment of the present invention, a method for preparing a calcium acetate ...

Embodiment 1

[0054] Calcium acetate tablet prescription: specification 667mg (in C 4 h 6 CaO 4 meter), the prescription quantity is 1000 tablets.

[0055] name Single dose mg / tablet g / 1000 tablets calcium acetate 667 700.321 polyethylene glycol 8000 10 10.003 Magnesium stearate 3.5 3.505

[0056] Preparation:

[0057] (1) Take calcium acetate raw material according to prescription, place in wet granulator, add 50% ethanol 320ml and carry out granulation, the state of granulation is that granule is wet, bonded into agglomerate;

[0058] (2) Seal the wet granules, place them at room temperature for 6 hours, and then wet the granules;

[0059] (3) Dry the sized granules at 130° C. for 2 hours, control the moisture range to 5%-6.5%, and granulate.

[0060] (4) Mix the obtained dry granules with polyethylene glycol 8000 and magnesium stearate according to the prescription ratio, and press into tablets to obtain calcium acetate tablets.

Embodiment 2

[0062] Calcium acetate tablet prescription: specification 667mg (in C 4 h 6 CaO 4 meter), the prescription quantity is 1000 tablets.

[0063]

[0064]

[0065] Preparation:

[0066] (1) Take calcium acetate raw material according to prescription, place in wet granulator, add 50% ethanol 300ml and carry out granulation, granulation state is that granule is wet, sticks into agglomerate;

[0067] (2) Seal the wet granules, place them at room temperature for 12 hours, and then wet the granules;

[0068] (3) Dry the sized granules at 120° C. for 6 hours, control the moisture range to 5%-6.5%, and granulate.

[0069] (4) Mix the obtained dry granules with polyethylene glycol 8000 and magnesium stearate according to the prescription ratio, and press into tablets to obtain calcium acetate tablets.

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Abstract

The invention provides a calcium acetate pharmaceutical composition and a preparation method and application thereof. According to the invention, calcium acetate of which the crystal form is inconsistent with that of the original trituration is used as a raw material for granulation, conversion of the crystal form of the calcium acetate is realized by adjusting granulation parameters and changing the concentration of ethanol granulation, storage time at a normal temperature in a sealed mode and the granule drying temperature, then the calcium acetate is mixed with pharmaceutical auxiliary materials allowed to be used pharmaceutically, tabletting is carried out, and the crystal form of the prepared calcium acetate tablets is consistent with that of a reference preparation (trade name: CALCIUM ACETATE), different dissolution behaviors, bioavailability and the like caused by inconsistent crystal forms are avoided, so that the stability and bioequivalence of the drug are ensured, and the calcium acetate pharmaceutical composition has high practical application value.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition of calcium acetate and its preparation method and application. Background technique [0002] The information disclosed in this background section is only intended to increase the understanding of the general background of the present invention, and is not necessarily taken as an acknowledgment or any form of suggestion that the information constitutes the prior art already known to those skilled in the art. [0003] Calcium is an important part of bones, teeth and other organs in the human body. Calcium plays an important role in blood coagulation, neuromuscular excitation, maintenance of cell membrane function, activation of enzyme reactions, and rapid secretion. When the needs of the body cannot be met, the calcium content, calcium balance, and calcium concentration gradient in the human body will change, resulting in calcium met...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/10A61K47/12A61K31/19A61P3/14A61P3/12
CPCA61K9/2013A61K9/2031A61K31/19A61P3/12A61P3/14
Inventor 江鸿赵利军吕传涛路静静张培培房凤玲
Owner SHANDONG CHUANGXIN PHARMA RES & DEV
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