Propranolol hydrochloride gel preparation for external use and preparation method and application thereof

A technology of propranolol hydrochloride and gel preparation, which is applied in the field of medicine, can solve problems such as bradycardia, hypoglycemia, and adverse effects, and achieve the effects of improving stability, high drug loading, and good skin penetration

Active Publication Date: 2016-03-30
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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  • Propranolol hydrochloride gel preparation for external use and preparation method and application thereof
  • Propranolol hydrochloride gel preparation for external use and preparation method and application thereof
  • Propranolol hydrochloride gel preparation for external use and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Weigh 4g of propranolol hydrochloride and 0.05g of sorbic acid, add an appropriate amount of water, heat the resulting mixture with a water bath to dissolve it completely, then add 15g of poloxamer 407, stir mechanically to make it swell completely; Ketone and 8g propylene glycol, stir to make it completely miscible, the resulting solution is added to the gel matrix that is dissolved in propranolol hydrochloride, under the mechanical stirring condition of 500 revs / min, stir 10 minutes, make propranolol hydrochloride Napolol gel preparation for external use (the total amount of the prescription is based on 100g). The gel preparation is uniform milky white, semi-solid gel, with a pH value of 5.24, and the average droplet diameter after being diluted 100 times is 306.6nm. After the sample is placed in a sealed container at 25°C±2°C for one month: there is no significant change in the appearance and properties, pH value, and particle size of the sample.

Embodiment 2

[0037] Weigh 10g of propranolol hydrochloride and 0.05g of sorbic acid, add an appropriate amount of water, heat the resulting mixture in a water bath to dissolve it completely, then add 15g of poloxamer 407, and stir mechanically to completely swell; Ketone and 8g propylene glycol, stir to make it completely miscible, the resulting solution is added to the gel matrix that is dissolved in propranolol hydrochloride, under the mechanical stirring condition of 500 revs / min, stir 10 minutes, make propranolol hydrochloride Napolol gel preparation for external use (the total amount of the prescription is based on 100g). The gel preparation is uniform milky white, semi-solid gel, with a pH value of 5.17, and the average droplet diameter after being diluted 100 times is 301.9nm. After the sample is placed in a sealed container at 25°C±2°C for one month: there is no significant change in the appearance and properties, pH value, and particle size of the sample.

Embodiment 3

[0039] Weigh 16g of propranolol hydrochloride and 0.05g of sorbic acid, add appropriate amount of water, heat the resulting mixture in a water bath to make it completely dissolved, then add 15g of poloxamer 407, stir mechanically to make it swell completely; Ketone and 8g propylene glycol, stir to make it completely miscible, the resulting solution is added to the gel matrix that is dissolved in propranolol hydrochloride, under the mechanical stirring condition of 500 revs / min, stir 10 minutes, make propranolol hydrochloride Napolol gel preparation for external use (the total amount of the prescription is based on 100g). The gel preparation is in the form of a uniform milky white semi-solid gel, with a pH value of 4.89, and the average droplet diameter after being diluted 100 times is 307.5nm. After the sample is placed in a sealed container at 25°C±2°C for one month: there is no significant change in the appearance and properties, pH value, and particle size of the sample.

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Abstract

The invention provides a propranolol hydrochloride gel preparation for external use and a preparation method and application thereof. The propranolol hydrochloride gel preparation for the external use contains at least 3% by weight of propranolol hydrochloride. The propranolol hydrochloride gel preparation for the external use has good stability and skin permeability and has a significant curative effect on treatment and prevention of infantile hemangioma located in different subcutaneous depths.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular, the invention relates to an external gel preparation of propranolol hydrochloride and a preparation method and application 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 cry...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/138A61K47/34A61K47/22A61K47/14A61K47/10A61P35/00
Inventor 周小顺蔡育牟东升刘芝梅贺容丽李进
Owner WUHAN CONFORM PHARMA CO LTD
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