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Folic acid oral film-dissolving agent and preparation method thereof

A technology of mouth-dissolving film and folic acid, which is applied in the direction of medical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems affecting the taste and achieve the effect of taking convenience

Active Publication Date: 2022-04-22
北京斯利安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the preparation process of mouth-dissolving film, folic acid needs to be dissolved and then coated. If the folic acid cannot be completely dissolved during the preparation process, there are particles after coating, which will affect the taste

Method used

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  • Folic acid oral film-dissolving agent and preparation method thereof
  • Folic acid oral film-dissolving agent and preparation method thereof
  • Folic acid oral film-dissolving agent and preparation method thereof

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preparation example Construction

[0042]According to another aspect of the present invention, it also relates to the preparation method of the above-mentioned folic acid oral film-dissolving agent, which is characterized in that, comprising:

[0043] a) mixing each component with water to obtain a drug-containing solution;

[0044] b) Carrying out vacuum degassing treatment on the drug-containing solution, coating, drying, and peeling to obtain a folic acid mouth-dissolving film.

[0045] In some embodiments, in step a):

[0046] Mixing the folic acid and the sodium lauryl sulfate under heating conditions to obtain a folic acid concentrated solution;

[0047] Mixing the copovidone with the water to obtain a polymer gel;

[0048] Mixing other ingredients with the polymer gel to obtain a glue;

[0049] The concentrated folic acid solution and the glue solution are mixed uniformly to obtain the drug-containing solution.

[0050] In some embodiments, the heating temperature is 50°C-70°C, for example 60°C.

[...

Embodiment 1

[0059] Table 1 Embodiment 1 each raw material component and content

[0060]

[0061] Preparation:

[0062] 1) Heat folic acid and solubilizer sodium lauryl sulfate to 50-70° C. and mix well to obtain a concentrated folic acid solution, which is set aside.

[0063] 2) Add the film-forming agent copovidone S-630 in warm water at 60° C. under stirring to obtain a polymer gel; the dosage ratio of the film-forming agent to warm water is 1 g: 10 mL.

[0064] 3) Add plasticizer triethyl citrate, disintegrant low-substituted hydroxypropyl cellulose (L-HPC), flavoring agent Moreira to copovidone S-630 polymer gel under stirring state Essence, stir well.

[0065] 4) In the state of stirring, add the folic acid concentrated solution and stir evenly to obtain the drug-containing solution.

[0066] 5) Carry out vacuum degassing treatment on the liquid medicine, and form a film (the film thickness is controlled at 85 μm); the vacuum degree of the vacuum degassing treatment is 0.095 M...

Embodiment 2

[0070] Table 2 Embodiment 2 each raw material component and content

[0071]

[0072] Preparation:

[0073] 1) Heat folic acid and solubilizer sodium lauryl sulfate to 50-70° C. and mix well to obtain a concentrated folic acid solution, which is set aside.

[0074] 2) Add the film-forming agent copovidone S-630 in warm water at 70° C. under stirring to obtain a polymer gel; the dosage ratio of the film-forming agent to warm water is 1 g: 15 mL.

[0075] 3) Add plasticizer triethyl citrate, disintegrant low-substituted hydroxypropyl cellulose (L-HPC), flavoring agent Moreira to copovidone S-630 polymer gel under stirring state Essence, stir well.

[0076] 4) In the state of stirring, add the folic acid concentrated solution and stir evenly to obtain the drug-containing solution.

[0077] 5) Carry out vacuum degassing treatment on the liquid medicine, and form a film (the film thickness is controlled at 70 μm); the vacuum degree of the vacuum degassing treatment is 0.093 M...

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a folic acid film-dissolving agent in the mouth and a preparation method thereof. The folic acid oral film-dissolving agent comprises the following raw materials by weight: 10-40 parts of folic acid, 10-55 parts of sodium lauryl sulfate, 15-40 parts of copovidone, 3-20 parts of low-substituted hydroxypropyl cellulose parts and 5 to 30 parts of triethyl citrate. The folic acid oral film-dissolving agent of the present invention can be dissolved in the oral cavity, partially absorbed in the oral cavity, does not need to drink water, and is convenient to take by selecting appropriate auxiliary materials and combining scientific dosage ratios.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a folic acid oral film-dissolving agent and a preparation method thereof. Background technique [0002] Folate deficiency refers to a clinical syndrome characterized by megaloblastic anemia caused by long-term insufficient intake or malabsorption of folic acid. Folate deficiency is a common disease, the main cause of which is related to insufficient intake of folic acid and malabsorption of folic acid. The main clinical symptoms include skin changes, oral discomfort, and abnormal fertility, which can lead to complications of megaloblastic anemia and psychoneurological abnormalities. At present, supplementary treatment is mainly carried out by drugs. [0003] Folic acid has many roles in the body, and it does so in different ways for different people. For example, for pregnant women, taking folic acid can prevent optic tube developmental deformities, which is often sa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/519A61K47/20A61K47/32A61K47/38A61K47/14A61P9/00A61P9/10A61P25/28
CPCA61K9/7007A61K31/519A61K47/20A61K47/32A61K47/38A61K47/14A61P9/00A61P9/10A61P25/28
Inventor 张蕾蔡正军李佳凯杨卓理
Owner 北京斯利安药业有限公司
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