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Folic acid enteric preparation composition and preparation method thereof

A technology of enteric-coated preparations and compositions, which is applied in the field of folic acid enteric-coated preparations and compositions and its preparation, and can solve problems such as adverse reactions of folic acid and no related reports on folic acid enteric-coated preparations and compositions, and achieve good stability and safety Improve and reduce the effect of side effects

Inactive Publication Date: 2010-02-10
北京瑞伊人科技发展有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] 3. Adverse reactions of folic acid
[0022] According to the search results of relevant patents and prior art literature, there is no relevant report on the composition of folic acid enteric preparations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 (A1)

[0035] Enteric-coated tablets

[0036] prescription:

[0037] Folic acid 5.0g

[0038] Lactose 25g

[0039] Sodium Carboxymethyl Starch 25g

[0040] Starch 45g

[0041] 25% PVP anhydrous ethanol solution

[0042] Magnesium Stearate 0.5%

[0043]

[0044] Make 1000 pieces

[0045] Preparation Process:

[0046] Pass folic acid, lactose, sodium carboxymethyl starch and starch through an 80-mesh sieve, respectively, for later use, weigh starch, lactose, and sodium carboxymethyl starch according to the recipe quantity, put them in a mixer, and mix them evenly with the bulk drug in an equal-volume increment method. Homogenize, add an appropriate amount of 25% PVP anhydrous ethanol solution, granulate, granulate, dry at 40-45°C, add 0.5% magnesium stearate to the dry granules and mix well, use a rocking granulator to pass through a 16-mesh sieve to granulate. Carry out content determination, determi...

Embodiment 2

[0047] Example 2 (A2)

[0048] Enteric-coated soft capsules

[0049] prescription:

[0050] Folic acid 0.2g

[0051] Microcrystalline Cellulose 100g

[0052] 20% ethanol solution appropriate amount

[0053]

[0054] Makes 1000 capsules

[0055] Preparation Process:

[0056] Pass the folic acid and crystal cellulose through 80-mesh sieve respectively, weigh the folic acid and crystal cellulose according to the prescription amount, mix them in a mixer for 10-15 minutes, add 20% ethanol solution to make a soft material, and make it in a granulator grain. The granules prepared above were dried at 50° C. for 30 min. Then pass through a swinging granulator, and use a 20-mesh sieve to sieve the granules. The content of the mixed granules is determined, and the filling range of the enteric-coated soft capsule shell is determined. After passing the inspection, pack.

Embodiment 3

[0057] Example 3 (A3)

[0058] Enteric-coated hard capsules

[0059] prescription:

[0060] Folic acid 1.0g

[0061] Dextrin 96g

[0062] 5% starch slurry appropriate amount

[0063]

[0064] Made into 1000g grains

[0065] Preparation Process:

[0066] Pass the folic acid and dextrin through 80-mesh sieve respectively, weigh the folic acid and dextrin according to the prescription amount, put them in a mixer and mix them for 10-15 minutes, add 5% starch slurry in an appropriate amount to make a soft material, granulate in a granulator, and granulate Dry at 50°C for 30 minutes, then pass through a swing granulator, and sieve the granules with a 20-mesh screen. The content of the mixed granules is determined, and the filling capacity of the enteric-coated hard capsule shell is determined. After passing the inspection, pack.

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PUM

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Abstract

The invention discloses a folic acid enteric preparation composition and a preparation method thereof. The composition is mainly prepared from folic acid raw material medicine and proper accessories.The folic acid enteric preparation composition provided by the invention is effective and safe for the improvement of a folic acid preparation, and has the advantages of little stimulation to the stomach so as to reduce the side reaction and the like compared with folic acid stomach tablets. The folic acid enteric preparation composition is particularly applied to pregnant women and patients withstomach upset diseases. The invention provides a new dosage form which is safer and has identical treatment effect; and the preparation process has quality controllability and good stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a group of folic acid enteric-coated preparation compositions and a preparation method thereof. Background technique [0002] Folic acid is a water-soluble B vitamin composed of pteridine, para-aminobenzoic acid and glutamic acid residues, also known as vitamin M; it is an essential substance for the growth and reproduction of body cells. It can help protein metabolism; and with vitamin B 12 Together to promote the formation and maturation of red blood cells, it is an indispensable substance for the manufacture of red blood cells. In the body, folic acid acts in the form of tetrahydrofolate, which is involved in the synthesis and transformation of purine nucleic acid and pyrimidine nucleotide in the body. Folic acid plays an important role in the production of nucleic acid (ribonucleic acid, deoxyribonucleic acid), and is a necessary substance for the human body to use sugar and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/519A61P7/06A61P15/00A61P35/00A61P9/10
Inventor 安英张慧英张玲玲
Owner 北京瑞伊人科技发展有限公司
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