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Compound dichlorpseudomonas sustained-release pellets and preparation method thereof

A technology for sustained-release pellets and compound recipes, which are applied in the field of compound desloratadine/pseudoephedrine sustained-release pellets and their preparation, can solve problems such as dryness, energy consumption and the like, and achieve the effects of improving drug stability and bioavailability

Active Publication Date: 2021-06-01
GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the above-mentioned preparation process contains organic solvents, and the solvent-containing coating method is used, and there are safety, energy consumption, and environmental protection issues such as evaporation and recovery of solvents, anti-static and explosion-proof.

Method used

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  • Compound dichlorpseudomonas sustained-release pellets and preparation method thereof
  • Compound dichlorpseudomonas sustained-release pellets and preparation method thereof
  • Compound dichlorpseudomonas sustained-release pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The percentage in the prescription accounts for the ball core weight calculation with this component, and following each embodiment is identical.

[0049]

[0050]

[0051] Preparation Process:

[0052] Step 1: mix pseudoephedrine hydrochloride and microcrystalline cellulose evenly, add the liquid pre-formulated by binder and wetting agent, and knead the powder to make a moist and uniform soft material with certain plasticity;

[0053] Step 2: Put the soft material in the extruder to extrude, put the extruded product in the spheronizer to round, discharge and dry to get the pellet core;

[0054] Step 3: Place the ball core in a fluidized bed coating machine that can heat / insulate the atomized compressed gas, coat it with the hot melt mixture of the preheated and insulated lipid material and the porogen, and air-dry it, that is Obtain pseudoephedrine hydrochloride slow-release pellets;

[0055] Step 4: Continue to coat the pseudoephedrine hydrochloride slow-release...

Embodiment 2

[0065]

[0066]

[0067] Refer to Example 1 for the preparation process.

Embodiment 3

[0069]

[0070] Refer to Example 1 for the preparation process.

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PUM

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Abstract

The invention provides a compound desloratadine / pseudoephedrine (abbreviated as compound dichloropseudoephedrine) slow-release pellets and a preparation method thereof. The preparation of the compound dichloropseudoephedrine sustained-release pellets of the present invention is to adopt the extrusion spheronization method to prepare the pellet cores containing pseudoephedrine hydrochloride, and then utilize hot-melt coating technology to coat the pellet cores with slow-release layers and desloratadine-containing pellets in sequence. It is prepared as an immediate-release layer, and the coating material does not need to use any solvent. The composition of the lipid material and the hydrophilic polymer with surface activity involved in the present invention uses the hot-melt coating technology to prepare the compound dichloropseudoelphus slow-release pellets, which can not only make full use of the hot-melt coating technology, but also has the advantages of safety, environmental protection and energy saving. , high efficiency, can improve the advantages of drug stability and bioavailability, and can release the two drugs on demand and completely, the release curve is consistent with the reference preparation, and can be produced on a large scale.

Description

technical field [0001] The invention relates to a compound desloratadine / pseudoephedrine (compound dichloropseudoephedrine for short) slow-release pellet and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] Desloratadine (Desloratadine) is the active metabolite of Loratadine (Loratadine) deformation in the body, H without drowsiness 1 Receptor antagonists, new drugs for the treatment of seasonal allergic rhinitis, can effectively relieve clinical symptoms, are almost insoluble in water, easily soluble in chloroform and methyl (ethyl) alcohol, and have a long elimination half-life (about 27h). Second-rate. Pseudoephedrine (Pseudoephedrine) is an adrenergic receptor agonist, which can selectively shrink nasal mucosa blood vessels, relieve nasal congestion and runny nose. Its hydrochloride and sulfate are easily soluble in water, soluble in ethanol, and insoluble in ether, with a short half-life (approximately 7h) gener...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/14A61K31/4545A61K31/137A61P11/02A61P37/08
CPCA61K9/2031A61K9/2054A61K9/209A61K31/137A61K31/4545A61K2300/00
Inventor 梁超峰
Owner GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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