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Pharmaceutical composition, preparation method and application thereof

A composition and drug technology, applied in the field of medicine, to achieve the effects of good safety, improved pharmacokinetic properties, and rapid onset of action

Inactive Publication Date: 2010-12-22
SINOPHARM GUANGDONG GLOBAL PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the current market, there is no report about the pharmaceutical composition for the combined use of fexofenadine and pseudoephedrine

Method used

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  • Pharmaceutical composition, preparation method and application thereof
  • Pharmaceutical composition, preparation method and application thereof
  • Pharmaceutical composition, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] This embodiment provides a preferred prescription and coating layer screening example of the typical preparation of the present invention sustained-release pellet capsule:

[0046]The formulation screening work was carried out through the in vitro release characteristics of the drug. The stability and release of the trial product were investigated, and the following formulation process was developed. The dosage form of sustained-release pellets and capsules was developed, which is a multi-unit sustained-release drug. According to the characteristics of pellets, the fluidized bed coating technology was used for sample development.

[0047] (1) Prescription:

[0048] Ingredients Prescription (g)

[0049] Fexofenadine Hydrochloride 60

[0050] Pseudoephedrine hydrochloride 120

[0051] Ethyl cellulose 180

[0052] Hypromellose 60

[0053] Make 1000 capsules.

[0054] (2) Determination of the release rate of pseudoephedrine hydrochloride and the screening of the coat...

Embodiment 2

[0065] This example provides a method for preparing a typical formulation of the invention.

[0066] (1) Pseudoephedrine hydrochloride drug layer:

[0067] 1. Raw material ratio

[0068] table 3

[0069] raw material name

weight ratio

Pseudoephedrine hydrochloride

500

hypromellose

1

[0070] 2. Preparation of pseudoephedrine hydrochloride drug layer

[0071] Dissolve hypromellose in water, add pseudoephedrine hydrochloride (PSD), and stir until dissolved. spare.

[0072] 3. Fluidized bed (fluidized bed) feeding operation

[0073] Put 1000g of blank sugar pills into the coating machine, adjust the air volume and sleeve position to a proper fluidization state, spray the above suspension, adjust the spray speed to make the bed temperature 32-35°C.

[0074] (2) Isolation layer:

[0075] 1. Raw material ratio

[0076] Table 4

[0077] raw material name

weight ratio

hypromellose

1

talcum powder

...

Embodiment 3

[0108] This embodiment provides the sustained-release pellet capsules of embodiment 1 or 2 and loratadine pseudoephedrine sustained-release tablets to carry out multi-center randomized double-blind double-dummy positive drug parallel controlled trials and results for evaluating Feso pseudoephedrine sustained-release capsules Efficacy and safety in the treatment of allergic rhinitis and colds.

[0109] The comparison results in the group before and after the two groups of drug treatment are as follows:

[0110] 3.1. After the two groups of subjects received different test drugs, the total score of the disease decreased significantly compared with the baseline level on the 7th day and the 14th day of drug use (p<0.0001).

[0111] FAS analysis results:

[0112] On the 7th day of medication: the total effective rate of the test group was 92.92%, and the marked rate was 45.13%; the total effective rate of the control group was 89.19%, and the marked rate was 38.74%.

[0113] On t...

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Abstract

The invention relates to a pharmaceutical composition, a preparation method and application thereof. The invention provides a sustained release capsule which contains fexofenadine or pharmaceutically acceptable salt thereof and pseudo-ephedrine or pharmaceutically acceptable salt thereof, wherein the pseudo-ephedrine or the pharmaceutically acceptable salt thereof is a sustained release part, and the fexofenadine or the pharmaceutically acceptable salt thereof is an ordinary release part. The invention also provides the preparation method of the sustained release capsule and the application of the capsule in preparing drugs for treating allergic rhinitis, chronic urticaria and influenza. Compared with tablets, the sustained release capsule is easy to be absorbed, and has the advantages of rapid action, smaller individual difference of blood concentration, less irritation on gastrointestinal tracts, less possibility of drug collapse, good safety and larger dose flexibility.

Description

technical field [0001] The invention belongs to the technical field of medicine. Specifically, the present invention relates to a pharmaceutical composition of an H1 histamine receptor antagonist and an α-adrenoceptor agonist and a preparation method thereof. More specifically, the present invention relates to a pharmaceutical combination of fexofenadine or a pharmaceutically acceptable salt thereof and pseudoephedrine or a pharmaceutically acceptable salt thereof and a preparation method thereof. Background technique [0002] Allergic rhinitis is an allergic disease that occurs in the nasal mucosa, characterized by nasal itching, sneezing, hypersecretion, and swelling of the nasal mucosa. Clinically, antihistamines are commonly used drugs for the treatment of allergic rhinitis. Fexofenadine hydrochloride tablets are a new generation of non-sedating antihistamines, which have receptor selectivity, clear action targets, rapid metabolism, and relatively low adverse reactions....

Claims

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Application Information

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IPC IPC(8): A61K31/445A61K31/137A61K9/52A61P37/08A61P11/02A61P17/00A61P31/00A61P11/00
Inventor 张霖泽向飞军温新国黄凤鸣卢克伟黄掌欣安穗伟高永坚王晓玲
Owner SINOPHARM GUANGDONG GLOBAL PHARMA CO LTD
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