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Oral film for treating infantile hemangioma and preparation method thereof

A technology of infantile hemangioma and oral film, which is applied in the field of pharmaceutical preparations, can solve problems such as adverse effects, hypoglycemia, and bradycardia, and achieve the effects of improving acceptance, accurate quantitative administration, and increasing adhesion

Active Publication Date: 2021-04-30
WUHAN CONFORM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, oral propranolol may cause side effects such as hypotension, hypoglycemia, bradycardia, etc., especially with potential adverse effects on the nervous system of infants and young children.

Method used

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  • Oral film for treating infantile hemangioma and preparation method thereof
  • Oral film for treating infantile hemangioma and preparation method thereof
  • Oral film for treating infantile hemangioma and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1, preliminary experiment

[0052] (1. Purpose

[0053] Investigate the effect of the film-forming material polyvinyl alcohol polyethylene glycol copolymer (BASF company, pharmaceutical excipient approval number F20110024) and hydroxypropyl cellulose on the film-forming properties

[0054] (2) Methods and results

[0055] According to the water-soluble characteristics of hydroxypropyl cellulose, and considering that hydroxypropyl cellulose (HPC) is a temperature-sensitive cellulose derivative, too high a temperature will destroy the structure of hydroxypropyl cellulose or even To make it lose its viscosity, add water to swell and dissolve it, and prepare it with a mass concentration of 2.5%, 5%, 7.5%, and 10%, respectively, and the temperature increases (60°C, 70°C, 80°C, 90°C) when dissolving A series of hydroxypropyl cellulose film-forming solutions were spread on petri dishes by homogenate casting film-forming method, and dried naturally, and the appeara...

Embodiment 2

[0069] Embodiment 2, prescription and preparation of propranolol hydrochloride oral film

[0070]Table 2 Prescription:

[0071]

[0072] preparation:

[0073] (1) Add the film-forming material into purified water, heat to 70°C, and stir to dissolve;

[0074] (2) Add propranolol hydrochloride, plasticizer and flavoring agent into purified water, heat to 70°C, and stir to dissolve;

[0075] (3) Add the mixture obtained in step (1) into the mixture obtained in step (2), and stir for 10 min;

[0076] (4) removing the air bubbles in the mixed liquid obtained in step (3);

[0077] (5) The mixed liquid obtained in step (4) is lowered to room temperature, the coating thickness is set to be 60-180 μm, and the film is coated with a film coating machine;

[0078] (6) The film obtained in the step (5) was dried at 50° C. until the water content was 3% by mass, and the film was peeled off, dosed, and packaged sequentially, so as to obtain the oral film of propranolol hydrochloride. ...

Embodiment 3

[0079] Embodiment 3, prescription and preparation of propranolol hydrochloride oral film

[0080] Table 3 Prescription:

[0081]

[0082] preparation:

[0083] (1) Mix the two components of the film-forming material, add to purified water, heat to 75°C, and stir to dissolve;

[0084] (2) Add propranolol hydrochloride, plasticizer and flavoring agent into purified water, heat to 75°C, and stir to dissolve;

[0085] (3) Add the mixture obtained in step (1) into the mixture obtained in step (2), and stir for 8 minutes;

[0086] (4) removing the air bubbles in the mixed liquid obtained in step (3);

[0087] (5) The mixed liquid obtained in step (4) is lowered to room temperature, the coating thickness is set to be 60-180 μm, and the film is coated with a film coating machine;

[0088] (6) The film obtained in the step (5) was dried at 55° C. until the water content was 6% by mass, and the film was peeled off, dosed, and packaged sequentially, so as to obtain the oral film o...

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Abstract

The invention provides an oral film for treating infantile hemangioma and a preparation method thereof. The oral film for treating infantile hemangioma includes a β-receptor blocker and pharmaceutically acceptable auxiliary materials. The drug content of each tablet of the oral film is accurate, and convenient and accurate quantitative administration can be realized, which is convenient for children to take medicine to ensure curative effect, and is completely suitable for industrialized mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an oral film for treating infantile hemangioma and a preparation method thereof. Background technique [0002] Infantile hemangioma is a common benign tumor caused by endothelial cell proliferation. The incidence of neonatal hemangioma is about 1.1% to 2.6%. Although most hemangiomas can regress spontaneously, the regression period is long and may last for 5 to 7 years. About 20% of hemangiomas cannot regress naturally, and various complications may occur, such as ulcers, bleeding, infection, etc. Hemangiomas occurring in special parts, such as the periorbital, glottis, and perineum, are likely to cause dysfunction, growth and development restriction, and even life-threatening in severe cases, bringing great pain to children. Treat early and aggressively. The current treatment methods for infantile hemangioma mainly include cryotherapy, laser, oral medicine a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K31/138A61K47/24A61K47/38A61K47/32A61K47/10A61K47/26A61P35/00
CPCA61K9/006A61K31/138A61K47/10A61K47/24A61K47/26A61K47/32A61K47/38
Inventor 周小顺牟东升蔡育贺容丽李进
Owner WUHAN CONFORM PHARMA CO LTD
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