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

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...

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

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