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Phenobarbital oral cavity instant membrane and preparation method thereof

A technology of oral instant film and phenobarbital, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the complex preparation process of orally disintegrating tablets and orally dissolving tablets , Oral liquid is inconvenient to carry, unfavorable quantitative administration and other issues

Active Publication Date: 2015-12-16
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Compared with the prior art, the technical solution of the present invention is that the phenobarbital oral instant film of the present invention is easy to carry, can quickly dissolve in the oral cavity, and release the drug without swallowing with water; it has good drug compliance, and is especially suitable for newborns and swallowing It is difficult for patients to take it, with stable quality and rapid onset of effect; it solves the problem of slow onset of phenobarbital tablets, inconvenient taking, inconvenient oral liquid carrying, and unfavorable quantitative administration; the preparation process of orally disintegrating tablets and orally dissolving tablets is complex, Disadvantages such as requiring special equipment

Method used

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  • Phenobarbital oral cavity instant membrane and preparation method thereof
  • Phenobarbital oral cavity instant membrane and preparation method thereof
  • Phenobarbital oral cavity instant membrane and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Each tablet contains 10mg of phenobarbital, and the composition of 1000 tablets of phenobarbital oral instant film is:

[0015]

[0016] The preparation method is as follows:

[0017] 1) Add phenobarbital into water, adjust the pH to 6-7 with 1-5% sodium hydroxide under stirring, and set aside;

[0018] 2) The film-forming material is added to the above solution, and stirred evenly to obtain a polymer gel, which is set aside;

[0019] 3) Add plasticizer and saliva stimulating agent to the polymer gel and stir evenly;

[0020] 3) degassing, evenly coating the medicinal solution on the stainless steel plate with a film coating machine;

[0021] 4) Heating and drying, the heating and drying temperature is 30-70° C., and cutting to obtain the oral instant film.

Embodiment 2

[0023] Each tablet contains 7.5mg of phenobarbital, and the composition of 1000 tablets of phenobarbital oral instant film is:

[0024]

[0025]

[0026] The preparation method is as follows:

[0027] 1) Add phenobarbital into water, adjust the pH to 6-7 with 1-5% sodium hydroxide under stirring, and set aside;

[0028] 2) The film-forming material is added to the above solution, and stirred evenly to obtain a polymer gel, which is set aside;

[0029] 3) Add plasticizer and saliva stimulating agent to the polymer gel and stir evenly;

[0030] 3) degassing, evenly coating the medicinal solution on the stainless steel plate with a film coating machine;

[0031] 4) Heating and drying, the heating and drying temperature is 30-70° C., and cutting to obtain the oral instant film.

Embodiment 3

[0033] Each tablet contains 5 mg of phenobarbital, and the composition of 1000 tablets of phenobarbital oral instant film is:

[0034]

[0035] The preparation method is as follows:

[0036] 1) Add phenobarbital into water, adjust the pH to 6-7 with 1-5% sodium hydroxide under stirring, and set aside;

[0037] 2) The film-forming material is added to the above solution, and stirred evenly to obtain a polymer gel, which is set aside;

[0038] 3) Add plasticizer and saliva stimulating agent to the polymer gel and stir evenly;

[0039] 3) degassing, evenly coating the medicinal solution on the stainless steel plate with a film coating machine;

[0040] 4) Heating and drying, the heating and drying temperature is 30-70° C., and cutting to obtain the oral instant film.

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PUM

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Abstract

The invention belongs to the field of pharmaceutic preparations, particularly relates to a phenobarbital oral cavity instant membrane and a preparation method thereof. The instant membrane comprises the following components in parts by weight: 5-10 parts of phenobarbital, 10-50 parts of a film-forming material, 1-10 parts of a plasticizer and 1-6 parts of a saliva irritant. According to the phenobarbital oral cavity instant membrane and the preparation method thereof, provided by the invention, due to the form of the membrane, drug administration can be carried out without water, the membrane can melt quickly in the oral cavity, that drugs are hidden in or spat out from the oral cavity of a patient is avoided, and the medication compliance of the patient is improved; besides, the main drugs of the instant membrane prepared by adopting the preparation method provided by the invention can be uniformly dispersed in a film-forming material, the finished product is good in appearance, the main drugs can quickly dissolve and is good in stability, the dosage of the product is accurate, dust flying in the production process is hardly caused, and the problem of labor protection and environmental pollution is solved.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a phenobarbital oral instant film and a preparation method thereof. Background technique [0002] In medicine, the jaundice of newborns under the full moon (within 28 days of birth) is called neonatal jaundice. It is a disease characterized by jaundice on the skin, mucous membranes and sclera. The disease can be divided into physiological and pathological. Physiological jaundice appears 2 to 3 days after birth, peaks at 4 to 6 days, subsides at 7 to 10 days, and lasts longer in premature infants. Except for a slight loss of appetite, there are no other clinical symptoms. If jaundice occurs 24 hours after birth, the daily serum bilirubin rises more than 5 mg / dl or >0.5 mg / dl per hour; the duration is long, full-term infants > 2 weeks, premature infants > 4 weeks and still persist, even If the jaundice continues to deepen or aggravates or reappears after subs...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/515A61K47/36A61K47/42A61K47/32A61K47/38A61K47/34A61P1/16
Inventor 何勇吴宗好高永好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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