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Pseudoephedrine slow release pellets and preparation method thereof

A technology of sustained-release pellets and pseudoephedrine, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of poor drug release uniformity and large individual differences in pharmacokinetics of sustained-release tablets and other issues to achieve the effect of improving drug stability and bioavailability

Active Publication Date: 2019-07-05
GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the release uniformity of sustained-release tablets is poor, and the individual differences in pharmacokinetics in the body are relatively large; the preparation process of solvent-coated sustained-release pellets contains organic solvents, and the solvent-containing coating method is used, and there are evaporation and recovery of solvents, antistatic And explosion-proof and other safety, energy consumption, environmental protection and other issues

Method used

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  • Pseudoephedrine slow release pellets and preparation method thereof
  • Pseudoephedrine slow release pellets and preparation method thereof
  • Pseudoephedrine slow release pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] The percentage in the prescription accounts for the ball core weight calculation with this component, and following each embodiment is identical.

[0043]

[0044]

[0045] Preparation Process:

[0046] Step 1: Mix pseudoephedrine 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;

[0047] 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;

[0048] 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 Get pseudoephedrine slow-release pellets.

[0049] In step 2, the diameter of the sieve of the extruder is 0.5 mm to 1.5 mm, the rotation speed of the ...

Embodiment 2

[0058]

[0059]

[0060] Refer to Example 1 for the preparation process.

Embodiment 3

[0062]

[0063]Refer to Example 1 for the preparation process.

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Abstract

The invention provides pseudoephedrine slow release pellets and a preparation method thereof. The pseudoephedrine slow release pellets are prepared through the steps of preparing pseudoephedrine containing pellet cores by an extruding and rounding method, and sequentially coating a slow release layer on the pellet cores through a hot melting and coating technique, and coating materials do not needany solvents. Compositions of lipid materials, hydrophilic polymers having surface activity and the like are prepared into the pseudoephedrine slow release pellets through the hot melting and coatingtechnique, the advantages of the hot melting and coating technique being safe, environmentally-friendly, energy-saving, high-efficiency and capable of increasing medicine stability and biological availability can be exerted, the medicines can be released as needed and can be released completely, a release curve and a reference preparation have consistency, and large-scale production can be realized.

Description

technical field [0001] The invention relates to a pseudoephedrine sustained-release pellet and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] 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 (average 7h) generally administered 3 times a day. According to clinical needs, after making pseudoephedrine into a sustained-release drug delivery system, it is compounded with H1 receptor antagonists (such as fexofenadine hydrochloride and desloratadine) to synergistically relieve the symptoms of allergic rhinitis. In the United States, this kind of compound sustained-release tablet that can be made into a once-a-day administration is available. Etc., the slow-release pellet technology...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K9/52A61K47/38A61K47/10A61K31/137A61P11/02
CPCA61K9/5031A61K9/5089A61K31/137
Inventor 孙晶晶
Owner GUANGZHOU PHARMACEUTICAL INDUSTRIAL RESEARCH INSTITUTE
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