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Phenylephrine hydrochloride and chlorphenamine maleate preparation and preparation method thereof

A technology of renin and preparations, which is applied in the field of renin pheniramine preparations and its preparation, can solve the problems of impurities generated by addition reactions, achieve high product stability, quickly control cold symptoms, and improve safety and effectiveness

Inactive Publication Date: 2021-03-12
BRIGHT FUTURE PHARMA LAB LTD (CN)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The object of the present invention is to provide a kind of renin that amine preparation and preparation method thereof, aim at solving existing compound preparation, phenylephrine and chlorpheniramine maleate or brompheniramine maleate add The technical problem of the impurity generated by the reaction

Method used

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  • Phenylephrine hydrochloride and chlorphenamine maleate preparation and preparation method thereof
  • Phenylephrine hydrochloride and chlorphenamine maleate preparation and preparation method thereof
  • Phenylephrine hydrochloride and chlorphenamine maleate preparation and preparation method thereof

Examples

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preparation example Construction

[0047] The embodiment of the present invention provides a preparation method of renin iramine preparation, which comprises the following steps:

[0048] S1. Provide the first core, the first coating material, the second core and the second coating material. The first core is phenylephrine or a pharmaceutically acceptable salt thereof, and the second core is malaysia Chlorpheniramine and / or brompheniramine maleate;

[0049] S2. Coating the first core with the first coating material to obtain the first coating;

[0050] S3. Coating the second core with the second coating material to obtain the second coating;

[0051] S4. Mixing the first coating and the second coating to obtain a reniniramine preparation.

[0052] In the preparation method provided in the examples of the present invention, the first coating is obtained by coating phenylephrine, and the second coating is obtained by coating chlorpheniramine maleate and / or brompheniramine maleate. Coating, so as to realize the...

Embodiment 1

[0061] This embodiment provides a kind of renin iramine preparation (capsule) and preparation method thereof, and the steps are as follows:

[0062] (11) Phenylephrine hydrochloride coating:

[0063] (111) coating liquid preparation: 0.05kg Opadry AMB II is dispersed in purified water, and the preparation solid content concentration is the coating liquid of 8%;

[0064] (112) Coating: add 0.5kg of phenylephrine hydrochloride (100-325 mesh) to the fluidized bed, open the coating, the air inlet temperature is 50°C, the atomization pressure is 1.0bar, and the air inlet volume is 20m 3 / h, under the condition that the spray speed is 5g / min, phenylephrine hydrochloride is coated. After the coating is completed, pass through a 60-mesh sieve for granulation to obtain phenylephrine hydrochloride coated granules;

[0065] (12) brompheniramine maleate coating:

[0066] (121) Coating solution preparation: 0.05kg Opadry AMB II is dispersed in purified water, and the coating solution who...

Embodiment 2

[0074] This embodiment provides a kind of renin iramine preparation (capsule) and preparation method thereof, and the steps are as follows:

[0075] (21) Phenylephrine hydrochloride coating:

[0076] (211) Coating solution preparation: disperse 0.15kg Opadry II in purified water, and prepare a coating solution with a solid content concentration of 10%;

[0077] (212) Coating: Add 0.5kg of phenylephrine hydrochloride (100-325 mesh) to the fluidized bed, open the coating, the air inlet temperature is 60°C, the atomization pressure is 3.0bar, and the air inlet volume is 100m 3 / h, under the condition that the spray speed is 30g / min, phenylephrine hydrochloride is coated. After the coating is completed, pass through a 60-mesh sieve for granulation to obtain phenylephrine hydrochloride coated granules;

[0078] (22) Chlorpheniramine maleate coating:

[0079] (221) Coating solution preparation: disperse 0.15kg Opadry II in purified water, and prepare a coating solution with a sol...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a phenylephrine hydrochloride and chlorphenamine maleate preparation and a preparation method thereof. The phenylephrine hydrochloride and chlorphenamine maleate preparation comprises a mixture formed by a first coating and a second coating, wherein the first coating is composed of a first coreand a first coating film coating the surface of the first core, the second coating is composed of a second core and a second coating film coating the surface of the second core, the first core is phenylephrine or a pharmaceutically acceptable salt thereof, and the second core is chlorpheniramine maleate and / or bromopheniramine maleate. According to the phenylephrine hydrochloride and chlorphenamine maleate preparation disclosed by the invention, the first core and the second core are not in contact with each other, so that thorough isolation of phenylephrine from chlorpheniramine maleate and / or bromopheniramine maleate is realized, secondary amino groups on phenylephrine are prevented from reacting with maleate radicals, the obtained phenylephrine hydrochloride and chlorphenamine maleatepreparation has higher product stability, and the safety and effectiveness of clinical medication are improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a renin pheniramine preparation and a preparation method thereof. Background technique [0002] Flu is a common disease, and clinically at present the treatment of flu is still based on symptomatic treatment. Since a variety of symptoms are produced when a cold occurs, the use of compound preparations can target multiple cold symptoms at the same time, which has the advantage of comprehensive control. The ingredients of common anti-cold medicines mainly include chlorpheniramine maleate / brompheniramine maleate and phenylephrine. Chlorpheniramine maleate and brompheniramine maleate are antihistamines that can relieve symptoms such as runny nose, nasal congestion, and sneezing. Phenylephrine is a potent α-receptor agonist that selectively constricts blood vessels, relieves congestion and swelling of the nasopharyngeal mucosa, and relieves symptoms s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/50A61K47/38A61K47/32A61K45/06A61K31/4402A61K31/137A61P11/00
CPCA61K9/2866A61K9/284A61K9/5084A61K9/5042A61K9/5026A61K45/06A61K31/4402A61K31/137A61P11/00A61K2300/00
Inventor 邓家华曾学俊吴涛
Owner BRIGHT FUTURE PHARMA LAB LTD (CN)
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