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Oral folic acid instantly-dissolved membrane and preparation method thereof

An oral instant film and folic acid technology, which is applied in the fields of medical formulas, medical preparations containing active ingredients, metabolic diseases, etc., can solve the problems of complex preparation process, high cost of injections, pain of patients, etc., and achieve simple preparation method and medication compliance High reliability and low cost effect

Inactive Publication Date: 2014-11-05
天津市聚星康华医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, injections are costly and inconvenient to use, which brings pain to patients.
[0005] Chinese patent CN 102309464 A discloses a folic acid tablet and its preparation method. The preparation process is complex, and the possibility of pollution in the preparation process is increased after two sieves. Moreover, the entire preparation process takes a long time and reduces the efficiency.

Method used

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  • Oral folic acid instantly-dissolved membrane and preparation method thereof
  • Oral folic acid instantly-dissolved membrane and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 6

[0026] Each tablet contains 0.4 mg of folic acid, and the preparation method of every 1000 tablets of folic acid oral instant film comprises the following steps:

[0027] (1) Take by weighing hydroxypropylmethylcellulose E-5, dextrin, sucralose, glycerin, low-substituted hydroxypropylcellulose, folic acid according to Example 1 of Table 1;

[0028] (2) After mixing folic acid, sucralose, dextrin, hydroxypropylmethylcellulose E-5, and low-substituted hydroxypropylcellulose evenly, add 28.08g of purified water, stir evenly, swell for about 30 minutes, add Stir the glycerin evenly, let it sit for 30 minutes, make it completely swell, degas, and apply a film;

[0029] (3) Dry at 60° C. for 30 minutes, remove the film, and cut it according to the specification to obtain a folic acid oral instant film with a specification of 0.4 mg.

[0030] Evaluation: The appearance is light yellow uniform film; good film-forming property, average toughness; fast dissolution, no peculiar smell in...

Embodiment 7

[0032] Each tablet contains 0.4 mg of folic acid, and the preparation method of every 1000 tablets of folic acid oral instant film comprises the following steps:

[0033] (1) Take by weighing hydroxypropyl methylcellulose E-15, mannitol, sucralose, polyethylene glycol 400, pregelatinized starch, folic acid according to Example 2 of Table 1;

[0034] (2) Mix folic acid, sucralose, mannitol, hydroxypropyl methylcellulose E-15, and pregelatinized starch evenly, add 27.82g of purified water, stir evenly, swell for 30 minutes, and add polyethylene glycol 400 Stir evenly, let it stand for 10 minutes, make it completely swell, degas, and coat;

[0035] (3) Dry at 50° C. for 50 minutes, remove the film, and cut it according to the specification to obtain a folic acid oral instant film with a specification of 0.4 mg.

[0036] Evaluation: The appearance is relatively uniform and light yellow diaphragm; easy to release the film, good toughness; fast dissolution, no peculiar smell.

Embodiment 8

[0038] Each tablet contains 0.4 mg of folic acid, and the preparation method of every 1000 tablets of folic acid oral instant film comprises the following steps:

[0039] (1) Take by weighing hydroxypropylmethylcellulose E-5, sodium carboxymethylcellulose, mannitol, sucrose, microcrystalline cellulose, glycerol, folic acid by the embodiment 3 of table 1;

[0040] (2) After mixing folic acid, sucrose, mannitol, hydroxypropylmethylcellulose E-5, sodium carboxymethylcellulose, and microcrystalline cellulose, add 31.04g of purified water, stir evenly, swell for 60 minutes, add Stir the glycerin evenly, let it sit for 50 minutes, make it completely swell, degas, and apply a film;

[0041] (3) Dry at 70° C. for 10 minutes, remove the film, and cut it according to the specification to obtain a folic acid oral instant film with a specification of 0.4 mg.

[0042] Evaluation: Uniform appearance; good mold release, good toughness; slow dissolution, almost no peculiar smell.

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Abstract

The invention discloses a preparation method of an oral folic acid instantly-dissolved membrane, and the method comprises the following steps: (1) weighing raw materials and auxiliary materials comprising a film-forming material, a filler, a sweetening agent, a plasticizer, a disintegrating agent and folic acid; (2) evenly mixing the folic acid, the sweetening agent, the disintegrating agent, the filler and the film-forming material, adding purified water, stirring evenly; after full swelling, adding the plasticizer, placing for completely swelling, degassing, and coating; and (3) drying, demoulding, cutting to obtain the oral folic acid instantly-dissolved membrane. The oral folic acid instantly-dissolved membrane tastes good, the oral folic acid instantly-dissolved membrane can be taken without drinking water, and can be instantly dissolved in the oral cavity without first pass effect, medication compliance of patients is high, and the need of the use of special flavoring agent is eliminated. The preparation method is simple, short in time and low in cost.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a folic acid oral instant film and a preparation method thereof. Background technique [0002] my country is one of the countries with a high incidence of birth defects in the world. Experts at home and abroad pointed out that such birth defects can be avoided. As long as women of childbearing age supplement the appropriate amount of folic acid every day, most of the babies with neural tube defects can be prevented. [0003] Folic acid is a water-soluble B vitamin, which plays an extremely important role in the division and growth of cells, the synthesis of nucleic acids, amino acids, and proteins, and is an indispensable nutrient for fetuses and pregnant women. The first trimester is a critical period for fetal organ system differentiation and placenta formation. At this time, folic acid deficiency can lead to fetal neural tube defects, and even spina bifida or congenita...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/519A61P3/02A61P7/06A61P25/00
Inventor 赵伟王红霞康静李化淋
Owner 天津市聚星康华医药科技有限公司
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