Calcium carbonate D3 chewable tablets for children calcium supplement, and preparation method of chewable tablets

A technology of calcium carbonate and chewable tablets, applied in the field of pharmaceutical preparations, can solve the problems of inconvenience for children to chew and take, astringent taste and gritty feeling, complicated preparation process, etc., and achieves good quality stability, alleviating gritty feeling, and production process operation. simple effect

Active Publication Date: 2017-05-10
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The taste of calcium carbonate is poor, with astringent taste and gritty feeling, which is difficult for users, especially children, to accept; vitamin D 3 The proportion in the prescription is very low (usually 0.001% ~ 0.05%), so it is a challenge to meet the requirements of drug content uniformity standards
[0005] Wyeth Pharmaceuticals Children's Formula Calcium Carbonate D 3 Chewable tablet (Ⅱ) (Caltrate D) has a gritty taste in the mouth, the weight of the tablet is about 1.65g, and the hardness is above 150N, which is not convenient for children to chew and take
[0006] Chinese patent CN 103845357 A discloses a vitamin D calcium chewable tablet for children’s calcium supplementation and its preparation method. The chewable and fruity taste is convenient for children to take orally. However, there are many kinds of auxiliary materials in the prescription, which are relatively complicated. French granulation process, long operation cycle
New dosage forms of vitamin D and calcium carbonate with improved content uniformity are achieved by changing formulations, raw material specifications and manufacturing processes, but the preparation process is cumbersome and not easy to industrialize

Method used

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  • Calcium carbonate D3 chewable tablets for children calcium supplement, and preparation method of chewable tablets
  • Calcium carbonate D3 chewable tablets for children calcium supplement, and preparation method of chewable tablets
  • Calcium carbonate D3 chewable tablets for children calcium supplement, and preparation method of chewable tablets

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Calcium Carbonate D 3 Chewable tablets are composed of the following components by mass percentage:

[0038]

[0039] The required raw and auxiliary materials have passed the inspection, vitamin D 3 The powder is passed through a 60-mesh sieve, mannitol and magnesium stearate are passed through a 80-mesh sieve; the calcium carbonate is made into a 70% suspension, and the maltodextrin is made into a 50% aqueous solution, and then the two are mixed evenly ; Calcium carbonate and malt paste mixed solution (solid content about 66%) are spray-dried to make calcium carbonate maltodextrin embedment particles using a pressure atomizer; the aperture of the atomizer is 4mm, and the air inlet temperature is 140 °C, the exhaust air temperature is 105 °C; after drying, the granules are sieved with a 40-mesh sieve; vitamin D 3 The powder and mannitol are mixed evenly by equal amount addition method; put the granulated calcium carbonate maltodextrin embedding particles in the squ...

Embodiment 2

[0041] Calcium Carbonate D 3 Chewable tablets are composed of the following components by mass percentage:

[0042]

[0043]

[0044]The required raw and auxiliary materials have passed the inspection, vitamin D 3 The powder is passed through a 60-mesh sieve, mannitol and magnesium stearate are passed through a 80-mesh sieve; the calcium carbonate is made into a 70% suspension, and the maltodextrin is made into a 50% aqueous solution, and then the two are mixed evenly ; Calcium carbonate and malt paste mixed solution (solid content about 66%) are spray-dried to make calcium carbonate maltodextrin embedment particles using a pressure atomizer; the aperture of the atomizer is 4mm, and the air inlet temperature is 135 °C, the exhaust air temperature is 100 °C; after drying, the granules are sieved with a 40-mesh sieve; vitamin D 3 The powder and mannitol are mixed evenly by equal amount addition method; put the granulated calcium carbonate maltodextrin embedding particles...

Embodiment 3

[0046] Calcium Carbonate D 3 Chewable tablets are composed of the following components by mass percentage:

[0047]

[0048] The required raw and auxiliary materials have passed the inspection, vitamin D 3 The powder is passed through a 60-mesh sieve, mannitol and magnesium stearate are passed through a 80-mesh sieve; the calcium carbonate is made into a 70% suspension, and the maltodextrin is made into a 50% aqueous solution, and then the two are mixed evenly ; Calcium carbonate and malt paste mixed solution (solid content about 65%) are spray-dried to make calcium carbonate maltodextrin embedment particles using a pressure atomizer; the aperture of the atomizer is 4mm, and the air inlet temperature is 130 °C, the exhaust air temperature is 95 °C; after drying, the granules are sieved with a 40-mesh sieve; vitamin D 3 The powder and mannitol are mixed evenly by equal amount addition method; put the granulated calcium carbonate maltodextrin embedding particles in the squa...

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Abstract

The invention discloses calcium carbonate D3 chewable tablets for children calcium supplement, and a preparation method of the chewable tablets. The chewable tablets are prepared from the following components: calcium carbonate, vitamin D3 powder, maltodextrin, mannitol, magnesium stearate and essence. The preparation method comprises the following steps: (1) checking the needed raw materials and auxiliary materials, and respectively carrying out pretreatment on the qualified materials for later use; (2) preparing the calcium carbonate into suspension liquid, preparing the maltodextrin into a water solution, and evenly mixing the suspension liquid and the water solution; (3) carrying out spray drying to prepare maltodextrin-embedded calcium carbonate granules; (4) finishing the granules; (4) blending all the materials; (6) measuring the content of an intermediate, tabletting and bottling. After a spray drying technology is adopted, the gritty texture of the calcium carbonate can be effectively improved by embedding the calcium carbonate by using the maltodextrin; by adopting a direct tabletting technology, the production technology is greatly simplified; the calcium carbonate D3 chewable tablets are moderate in hardness, thus being suitable for children to chew.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a calcium carbonate D for calcium supplementation for children 3 The prescription composition of the chewable tablet and its preparation method. Background technique [0002] In 2007, the Chinese Nutrition Society put forward the "Reference Intake of Dietary Nutrients for Chinese Residents" based on the survey data of the National Nutrition Society, the occurrence of nutritional diseases, and foreign data. The AIs (mg / d) of calcium for Chinese people is 0-0.5 300 for 0.5-1 years old, 400 for 0.5-1 years old, 600 for 1-3 years old, 800 for 4-6 years old, 800 for 7-10 years old, 1000 for 11-13 years old, 1000 for 14-17 years old, and 1000 for 18-49 years old 800, 1000 for over 50 years old, 800 for early pregnancy, 1000 for mid-term, 1200 for late pregnancy, 1200 for lactating mothers; the RNIs of vitamin D are 10 μg for 0-10 years old, 5 μg for 11-49 years old...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/10A61K31/593A61K9/20A61K47/36A61K47/26A61P3/02
Inventor 吴学萍何淑旺刘长涛王凤英王英新李树英王文笙
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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