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A kind of nanoemulsion oral solution containing propranolol or its salt and preparation method thereof

An oral solution, propranolol hydrochloride technology, applied in the direction of medical preparations containing active ingredients, emulsion delivery, medical preparations without active ingredients, etc., can solve the problems of poor safety and poor drug compliance, and achieve safety High stability, good stability, and high drug compliance

Active Publication Date: 2021-08-06
WUHAN CONFORM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by this invention is to overcome the disadvantages of poor drug compliance and poor safety of infants and young children caused by the bitter taste of propranolol hydrochloride oral solution in the prior art, and provide a kind of oral solution containing propranolol or its Salt nanoemulsion oral solution and preparation method thereof

Method used

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  • A kind of nanoemulsion oral solution containing propranolol or its salt and preparation method thereof
  • A kind of nanoemulsion oral solution containing propranolol or its salt and preparation method thereof
  • A kind of nanoemulsion oral solution containing propranolol or its salt and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Mix 0.4wt% propranolol hydrochloride, 7wt% simethicone, and 8wt% egg yolk lecithin evenly, and high-speed shear (2000rpm, 20min) at 55°C to obtain an oil phase; 0.12wt% adenosine monophosphate Mix well with water, high-speed shear (3000rpm, 15min) at 55°C to obtain the water phase; mix the oil phase and water phase evenly, perform high-speed shear (4000rpm, 15min) at 55°C, and then homogenize under high pressure for 7 Second, during the homogenization process, the temperature is controlled at 55° C., and the pressure is controlled at 700 bar to obtain a propranolol hydrochloride nanoemulsion oral solution with an average particle diameter of 256 nm and a pH value of 5.8.

Embodiment 2

[0069] Mix 0.4wt% propranolol hydrochloride, 5wt% omega 3, and 4wt% egg yolk lecithin evenly, and high-speed shear (3000rpm, 15min) at 55°C to obtain an oil phase; 0.2wt% adenomonophosphate Mix glycosides and water evenly, and shear at 55°C at high speed (3000rpm, 15min) to obtain the water phase; mix the oil phase and water phase evenly, perform high-speed shearing at 55°C (4000rpm, 15min), and then homogenize under high pressure 6 times, during the homogenization process, the temperature was controlled at 55° C., and the pressure was controlled at 800 bar to obtain a propranolol hydrochloride nanoemulsion oral solution with an average particle size of 197 nm and a pH value of 5.7.

Embodiment 3

[0071] Mix 0.4wt% propranolol hydrochloride, 5wt% omega 3, and 4wt% egg yolk lecithin evenly, and high-speed shear (6000rpm, 10min) at 55°C to obtain an oil phase; 0.05wt% adenomonophosphate Glycosides and water were mixed evenly, and high-speed shearing (3000rpm, 15min) was performed at 55°C to obtain the water phase; the oil phase and water phase were mixed, high-speed shearing (3000rpm, 15min) was performed at 55°C, and then high-pressure homogenization was performed for 5 Second, during the homogenization process, the temperature is controlled at 55° C., and the pressure is controlled at 600 bar to obtain a propranolol hydrochloride nanoemulsion oral solution with an average particle size of 203 nm and a pH value of 5.6.

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Abstract

The invention discloses a nanoemulsion oral solution containing propranolol or a salt thereof and a preparation method thereof, wherein the prescription of the nanoemulsion oral solution of propranolol or a salt thereof comprises: propranolol or a salt thereof; And pharmaceutically acceptable pharmaceutical excipients, said pharmaceutical excipients include: oil phase medium, emulsifier, taste masking agent, and purified water. The nanoemulsion oral solution containing propranolol or its salt is an oral taste-masking preparation with high compliance, high safety and good stability, which is suitable for taking for a long period of time for infants and young children, and meets the clinical needs.

Description

technical field [0001] The invention relates to a nanoemulsion oral solution containing propranolol or a salt thereof and a preparation method thereof. Background technique [0002] Propranolol hydrochloride oral solution is used for the treatment of infantile hemangioma, and the general treatment cycle is about 6 months. Oral solution of propranolol hydrochloride in common dosage forms has obvious bitterness, and the problem of poor drug compliance of infants and young children in the long-term administration process is particularly prominent. Insist on long-term administration and affect the therapeutic effect. For example, if a large amount of additives such as correctives or sweeteners are added to the prescription of propranolol hydrochloride oral solution, although the bitter taste can be improved, these additives may have adverse effects on the development of brains and kidneys of infants during long-term medication. Serious adverse effects, not suitable for long-te...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K47/26A61K47/24A61K47/12A61K31/138A61P35/00A61P9/06A61P9/10
CPCA61K9/0053A61K9/1075A61K31/138A61K47/12A61K47/24A61K47/26
Inventor 牟东升周小顺刘文双李进贺容丽汪哲多
Owner WUHAN CONFORM PHARMA CO LTD
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