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Cetirizine and pseudoephedrine sustained-release capsule and preparation method thereof

A technology of sustained-release capsules and cetirizine hydrochloride, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc. Inhomogeneity, complex processing and other problems, to achieve the effect of improving pharmacokinetic characteristics, good reproducibility of drug release, and uniform drug release

Inactive Publication Date: 2012-06-20
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the problem of rapid release of cetirizine and sustained release of pseudoephedrine hydrochloride has been solved, the inner and outer tablets cannot release the drug effect at the same time
Chinese patent application number 200710179843.2 discloses a "cetirizine pseudoephedrine sustained-release capsule" technology, which is to first make quick-release microtablets of cetirizine hydrochloride and slow-release microtablets of pseudoephedrine hydrochloride, and then combine the two The micro-tablets are loaded into the capsule according to the ratio. Although the two drugs can release the drug effect at the same time, the volume of the two micro-tablets is relatively large, the shape is irregular, and it is inconvenient to fill, which may easily cause uneven drug release and unstable drug effect. , in addition, the process is complicated and the processing cycle is long

Method used

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  • Cetirizine and pseudoephedrine sustained-release capsule and preparation method thereof
  • Cetirizine and pseudoephedrine sustained-release capsule and preparation method thereof
  • Cetirizine and pseudoephedrine sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] ①Preparation of pseudoephedrine hydrochloride pills with the following weight ratio per 1000 capsules:

[0046] Pseudoephedrine Hydrochloride 120g

[0047] Dextrin 25g

[0048] Blank Ball Heart 30g

[0049] water 50g

[0050] Fully mix pseudoephedrine hydrochloride and dextrin evenly, then put the blank ball core into the multifunctional fluidized bed, and under the state of keeping the multifunctional fluidized bed rotating, gradually add the uniformly mixed materials under the wetting of water Into the multifunctional fluidized bed, wrapped on the blank core, and prepared into drug-containing pellets of pseudoephedrine hydrochloride.

[0051] Contain the following weight proportion system pseudoephedrine hydrochloride pellet coating by every 1000:

[0052] Pseudoephedrine Hydrochloride Pills 175g

[0053] Surelease (solid content 25%) 35g

[0054] water 23g

[0055] The drug-containing pellets were dried in an oven at 60°C. After drying, they were placed in a m...

Embodiment 2

[0070] ①Preparation of pseudoephedrine hydrochloride pills with the following weight ratio per 1000 capsules:

[0071] Pseudoephedrine Hydrochloride 120g

[0072] Dextrin 25g

[0073] Blank Ball Heart 30g

[0074] water 50g

[0075] Fully mix pseudoephedrine hydrochloride and dextrin evenly, then put the blank ball core into the multifunctional fluidized bed, and under the state of keeping the multifunctional fluidized bed rotating, gradually add the uniformly mixed materials under the wetting of water Into the multifunctional fluidized bed, wrapped on the blank core, and prepared into drug-containing pellets of pseudoephedrine hydrochloride.

[0076] Contain the following weight proportion system pseudoephedrine hydrochloride pellet coating by every 1000:

[0077] Pseudoephedrine Hydrochloride Pills 175g

[0078] Suris (25% solid content) 70g

[0079] water 46g

[0080] The drug-containing pellets were dried in an oven at 60°C. After drying, they were placed in a multi...

Embodiment 3

[0095] ①Preparation of pseudoephedrine hydrochloride pills with the following weight ratio per 1000 capsules:

[0096] Pseudoephedrine Hydrochloride 120g

[0097] Dextrin 25g

[0098] Blank Ball Heart 30g

[0099] water 50g

[0100] Fully mix pseudoephedrine hydrochloride and dextrin evenly, then put the blank ball core into the multifunctional fluidized bed, and under the state of keeping the multifunctional fluidized bed rotating, gradually add the uniformly mixed materials under the wetting of water Into the multifunctional fluidized bed, wrapped on the blank core, and prepared into drug-containing pellets of pseudoephedrine hydrochloride.

[0101] Contain the following weight proportion system pseudoephedrine hydrochloride pellet coating by every 1000:

[0102] Pseudoephedrine Hydrochloride Pills 175g

[0103] Suris (25% solid content) 140g

[0104] water 93g

[0105] The drug-containing pellets were dried in an oven at 60°C. After drying, they were placed in a mult...

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PUM

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Abstract

The invention discloses a cetirizine pseudoephedrine slow release capsule. Cetirizine hydrochloride is prepared to quick release pellets and pseudoephedrine hydrochloride is prepared to slow release pellets, in accordance with the weight proportion that each 1000 preparations contain 5g of cetirizine hydrochloride and 120g of pseudoephedrine hydrochloride, the two pellets are uniformly mixed and encapsulated; or the two pellets are encapsulated respectively in proportion. The quick release part of the cetirizine hydrochloride and the slow release part of the pseudoephedrine hydrochloride are synthesized together subsequent to being prepared to the pellets respectively, so as to prepare the capsule with two different medicine-releasing speeds, the medicine-releasing speed of each pellet isuniform and the medicine effect is steady. The capsule has the advantages of even and extensive distribution of the medicine in vivo subsequent to the administering, sufficient absorption of the medicine, small stimulation to gastrointestinal tracts and good reproducibility of the medicine-releasing rule, and improves, while maintaining the properties of rapid effecting and long half-life of the cetirizine, the pharmacokinetic properties of the pseudoephedrine hydrochloride to administer twice per day instead of having to administer four times per day, so that both reach the optimal cooperative curative effect.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular a cetirizine-pseudoephedrine slow-release capsule composed of a cetirizine hydrochloride quick-release preparation and a pseudoephedrine hydrochloride slow-release preparation and a preparation method thereof. Background technique [0002] According to statistics, about 59% of the population suffers from seasonal and perennial allergies, of which 30% are accompanied by nasal congestion. The cause is often due to exposure to allergens, which can lead to the production of specific IgE antibodies that bind to columnar cells and Basophil receptors, which in turn cause the release of histamine and other inflammatory mediators from mast cells and basophils, resulting in an immediate or early allergic response. Allergic rhinitis is a relatively common seasonal or long-term disease, and its clinical symptoms include nasal congestion, airflow obstruction, rhinorrhea, sneezing, itch...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/495A61K47/36A61K47/38A61P11/02A61P37/08A61K31/137
Inventor 曹瑞山吴康潘舒平徐田民
Owner QINGDAO HUANGHAI PHARM CO LTD
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