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Pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and manufacturing method thereof

A technology of chlorpheniramine acid and anisodine, which is applied in the direction of medical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of inconvenient taking of children patients, large tablet hardness, Children are not suitable for other problems, to achieve the effect of improving bioavailability, accelerating absorption and shortening dissolution time

Active Publication Date: 2012-07-25
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, oral preparations often need to be taken with water or the tablets are very hard, which will be difficult for patients with dysphagia or inconvenient water intake, especially for children. It is very inconvenient to take. Hyoscine and chlorpheniramine maleate orally disintegrating tablets are made of a variety of excipients and disintegrating agents, and are compressed using a traditional tablet machine. The disintegration time in the human oral cavity takes at least 30 seconds, and There is a feeling of sand in the mouth, and it is not suitable for children

Method used

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  • Pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and manufacturing method thereof
  • Pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and manufacturing method thereof
  • Pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Prescription: 1000 tablets

[0037]

[0038] Dissolve the prescription amount of anisodine hydrobromide and chlorpheniramine maleate in purified water of 70%-80% of the total amount of prescription water, heat and stir under stirring and add the prescription amount of mannitol, three Sucralose, dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, according to children's hydrobromic acid Anisodine and chlorpheniramine maleate composition freeze-dried orally disintegrating tablet specifications, after determining the loading volume, the combined medicinal solution is divided into medicine dishes according to the loading volume, and put into a freeze-drying box , freezing the medicinal solution, and after drying the orally disintegrating tablets of the combination of anisodine hydro...

Embodiment 2

[0040] Prescription: 1000 tablets

[0041]

[0042] Dissolve the prescription amount of anisodine hydrobromide and chlorpheniramine maleate in purified water of 70%-80% of the total amount of prescription water, heat and stir under stirring and add the prescription amount of mannitol, three Sucralose, dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, according to children's hydrobromic acid Anisodine and chlorpheniramine maleate composition freeze-dried orally disintegrating tablet specifications, after determining the loading volume, the combined medicinal solution is divided into medicine dishes according to the loading volume, and put into a freeze-drying box , freezing the medicinal solution, and after drying the orally disintegrating tablets of the combination of anisodine hydro...

Embodiment 3

[0044] Prescription: 1000 tablets

[0045]

[0046] Dissolve the prescription amount of anisodine hydrobromide and chlorpheniramine maleate in purified water of 70%-80% of the total amount of prescription water, heat and stir under stirring and add the prescription amount of mannitol, three Sucralose, dissolve the prescribed amount of gelatin in purified water with 20% of the prescribed water consumption, heat until completely dissolved, combine the above two solutions and stir evenly, adjust the pH value to 5.5-6.5 with sodium bicarbonate, according to children's hydrobromic acid Anisodine and chlorpheniramine maleate composition freeze-dried orally disintegrating tablet specifications, after determining the loading volume, the combined medicinal solution is divided into medicine dishes according to the loading volume, and put into a freeze-drying box , freezing the medicinal solution, and after the lyophilized orally disintegrating tablets of the children's anisodine hydr...

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Abstract

The invention discloses pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets and a manufacturing method of the pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets, relating to the technical field of pharmaceuticals and pharmaceuticals manufacturing methods. The pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets comprise the following components by weight: 1.47-2% anisodamine hydrobromide, 0.14-0.2% chlorpheniramine maleate, 64-90% mannitol, 6-10% gelatin and 0.2-0.3% sucralose. The manufacturing method adopts the above components to manufacture the pediatric compound anisodamine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablets. The freeze-dried orally disintegrating tablets have simple components, need no water for administration, do not need to be chewed, havea disintegration time of less than 2 minutes in an oral cavity of a human body, have the advantages of rapid absorption, high bioavailability, low intestinal tract residues, low hepatic first pass effect, less side effects and good mouthfeel, and are especially suitable for infant patients.

Description

Technical field: [0001] The invention relates to the technical field of medicines and medicine preparation methods, in particular to a children's compound anisodine hydrobromide and chlorpheniramine maleate freeze-dried orally disintegrating tablet and a preparation method thereof. Background technique: [0002] Anisodine hydrobromide is an anticholinergic drug that blocks M-cholinergic receptors. The effect is similar to or slightly weaker than that of atropine. It has the functions of relaxing smooth muscle, relieving vasospasm, improving microcirculation, and has analgesic effect. However, the effect of dilating the pupil and inhibiting the secretion of the gland is relatively weak, and rarely causes symptoms of central nervous system excitement. Clinically used for the following diseases: 1. Infectious toxic shock; 2. Vascular disease; 3. Various neuralgia; 4. Smooth muscle spasm; 5. Vertigo; 6. Fundus eye disease; 7. Sudden deafness, etc.; 8. It can be used in the tr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/46A61K31/4402A61K9/20A61K47/26A61P29/00A61P25/04A61P31/16
Inventor 汪金灿李祖红汪六一
Owner HAINAN WEI KANG PHARMA QIANSHAN
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