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Folic acid pharmaceutical composition for preventing administration

A composition and folic acid technology, applied in the field of medicine, can solve the problems of increasing impurity content and affecting the storage stability of preparations, and achieve the effects of reducing production time, reducing waste of human resources and improving output

Inactive Publication Date: 2014-10-29
YANTAI ZHONGZHOU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, in the preparation method of the folic acid preparation disclosed in the literature, wet granulation is used in the production process, which affects the storage stability of the preparation and increases the content of impurities, etc.

Method used

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  • Folic acid pharmaceutical composition for preventing administration
  • Folic acid pharmaceutical composition for preventing administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Preparation of 0.4 mg / tablet folic acid tablets Take 10 g of folic acid, 2820 g of microcrystalline cellulose, 400 g of low-substituted hydroxypropyl cellulose, 150 g of methyl cellulose, 20 g of polyethylene glycol 6000, and 20 g of aspartame Pass through 100-200 mesh sieves respectively, take the above-mentioned components after sieving and mix evenly, dry granulate, pass through 24 mesh sieves, add 600020g of polyethylene glycol passed through 100-200 mesh sieves, mix evenly, measure the particle content, press Tablet, hardness 5~7kgf, pack, test, get finished product, get this method product and carry out disintegration experiment according to the requirement of two parts dispersible tablet of Chinese Pharmacopoeia 2010 edition, the product of present embodiment dissolves completely within 3 minutes in water.

Embodiment 2

[0025] Example 2 Preparation of 0.4 mg / tablet folic acid tablets Take 10 g of folic acid, 2900 g of microcrystalline cellulose, 500 g of low-substituted hydroxypropyl cellulose, 200 g of methyl cellulose, 40 g of polyethylene glycol 6000, and 200 g of β-cyclodextrin 1. Aspartame is 10g, passed through 100-200 mesh sieve respectively, take the above-mentioned components after sieving and mix evenly, dry granulate, pass through 20 mesh sieve, add 600020g of polyethylene glycol passed through 100-200 mesh sieve, Mix evenly, mix evenly, measure particle content, press tablet, hardness 5~7kgf, pack, test, get finished product, take the product of this method to carry out experiment according to the requirement of the second part dispersible tablet of Chinese Pharmacopoeia 2010 edition, the product of this embodiment is in water 3 Dissolves completely within minutes.

Embodiment 3

[0026] Example 3 Preparation of 0.4 mg / sheet folic acid tablets Take 10 g of folic acid, 2820 g of microcrystalline cellulose, 500 g of low-substituted hydroxypropyl cellulose, 100 g of polyvinylpyrrolidone K30, 20 g of polyethylene glycol, 200 g of β-cyclodextrin, 10g of aspartame is passed through a 100-200 mesh sieve, and the above-mentioned components after sieving are mixed evenly, dry granulated, passed through a 24-mesh sieve, and 600-20g of polyethylene glycol passed through a 100-200 mesh sieve is added, and mixed evenly , measure granule content, press tablet, hardness 5~7kgf, pack, test, get finished product, take the product of this method to carry out experiment according to the requirement of the second part dispersible tablet of Chinese Pharmacopoeia 2010 edition, the product of this embodiment dissolves completely in water within 3 minutes .

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Abstract

The invention relates to a folic acid pharmaceutical composition for preventing administration, and a preparation method thereof. A preparation of the composition adopts a dry granulation process, so that the manufacturing process is simplified, the energy consumption and the total production cost can be reduced, the output per unit time, the product quality and the like are improved, and the stability of the medicine storage period and the clinical safe medication are kept.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular, it provides a folic acid pharmaceutical composition for prophylactic administration and a preparation method thereof. Background technique [0002] The current published literature has reported that folic acid capsules and tablets can prevent fetal congenital neural tube defects (anencephaly, spina bifida); prevent fetal cleft lip and palate; prevent birth defects such as fetal congenital heart disease and other body surface deformities; prevent pregnant women, Lactating mother and fetal anemia. [0003] However, the currently marketed folic acid preparations (such as: Silian folic acid tablets) usually contain starch and lactose in their prescriptions. In addition, in the preparation method of the folic acid preparation disclosed in the literature, wet granulation is used in the production process, which affects the storage stability of the preparation and increases the content ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K47/38A61K47/40A61K9/20A61K9/48A61P25/00A61P7/06A61P9/00
Inventor 邹翔
Owner YANTAI ZHONGZHOU PHARMA CO LTD
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