Procaterol hydrochloride granule and preparation method thereof

A technology of procaterol hydrochloride, granules, applied in the field of medicine

Active Publication Date: 2017-09-22
HEILONGJIANG LONGDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] For the above-mentioned complicated technical problem that exists in the prior art, the purpose of the present invention is to provide a kind of new Procaterol Hydrochloride granule

Method used

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  • Procaterol hydrochloride granule and preparation method thereof
  • Procaterol hydrochloride granule and preparation method thereof
  • Procaterol hydrochloride granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1 Procaterol hydrochloride granule and its preparation process

[0030] Prescription: Procaterol hydrochloride 2g, lactose 13970g, hydroxypropyl methylcellulose 620g, croscarmellose sodium 550g by weight, calcium chloride 5080g, diethyl palmitoyl aspartate 2g .

[0031] Preparation Process:

[0032] 1) Take the prescribed amount of calcium chloride and pulverize it, pass through a 300-mesh sieve to obtain calcium chloride fine powder for later use;

[0033] 2) Take the prescribed amount of procaterol hydrochloride, lactose, hydroxypropyl methylcellulose, croscarmellose sodium, diethyl palmitoyl aspartate, mix by ball milling, and add 5ml of water per 1g of powder Add sterile water for injection at 900rpm to the mixed powder and stir for 0.3h to obtain a suspension;

[0034] 3) Use the calcium chloride fine powder obtained in step 1) as an excipient, and the suspension obtained in step 2) as a spray liquid, spray granulation on the top of the fluidized bed, th...

Embodiment 2

[0036] Example 2 Procaterol hydrochloride granule and its preparation process

[0037] Prescription: Procaterol hydrochloride 3 g, lactose 12650 g, hydroxypropyl methylcellulose 750 g, croscarmellose sodium 650 g by weight, calcium chloride 3940 g, diethyl palmitoyl aspartate Esters 4 g.

[0038] Preparation Process:

[0039] 1) Take the prescribed amount of calcium chloride and pulverize it, pass through a 300-mesh sieve to obtain calcium chloride fine powder for later use;

[0040] 2) Take the prescribed amount of procaterol hydrochloride, lactose, hydroxypropyl methylcellulose, croscarmellose sodium, diethyl palmitoyl aspartate, mix by ball milling, and add 5ml of water per 1g of powder Add sterile water for injection at 850rpm to the mixed powder and stir for 0.3h to obtain a suspension;

[0041] 3) Use the calcium chloride fine powder obtained in step 1) as an excipient, and the suspension obtained in step 2) as a spray liquid, spray granulation on the top of the fluid...

Embodiment 3

[0043] Example 3 Procaterol hydrochloride granule and its preparation process

[0044] Prescription: Procaterol hydrochloride 2 g, lactose 12800 g, hydroxypropyl methylcellulose 700 g, croscarmellose sodium 600 g by weight, calcium chloride 4500 g, diethyl palmitoyl aspartate 3g.

[0045] Preparation Process:

[0046] 1) Take the prescribed amount of calcium chloride and pulverize it, pass through a 300-mesh sieve to obtain calcium chloride fine powder for later use;

[0047] 2) Take the prescribed amount of procaterol hydrochloride, lactose, hydroxypropyl methylcellulose, croscarmellose sodium, diethyl palmitoyl aspartate, mix by ball milling, and add 5ml of water per 1g of powder Proportion Add sterile water for injection at 800 rpm to the mixed powder and stir for 0.3 h to obtain a suspension;

[0048] 3) Use the calcium chloride fine powder obtained in step 1) as an excipient, and the suspension obtained in step 2) as a spray liquid, spray granulation on the top of the ...

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Abstract

The invention belongs to the field of medicine, and relates to a procaterol hydrochloride granule and a preparation method thereof. The procaterol hydrochloride granule is prepared from procaterol hydrochloride and auxiliary materials at least prepared from lactose, hydroxypropyl methylcellulose, croscarmellose sodium, calcium chloride and palmityl diethylester aspartate. The granule is prepared by a fluidization spraying method; the calcium chloride is used as a master batch; a suspension prepared from the procaterol hydrochloride, mannitol, hydroxypropyl methylcellulose, croscarmellose sodium and palmityl diethylester aspartate is sprayed onto the surface of the calcium chloride master batch; the procaterol hydrochloride granule is obtained. The granule has the advantages that the dissolution is fast; the throat clamping is avoided; the content uniformity is high; the flowability is high; the moisture absorption performance and the friability are low; the stability is high. The preparation method has the advantages that the process is simple; the requirements on equipment are lower; the energy consumption is lower; the industrial production is convenient.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a procaterol hydrochloride granule and a preparation method thereof. Background technique [0002] Procaterol hydrochloride, English name Procaterol Hydrochloride, chemical name 5-(1-hydroxy-2-isopropylaminobutyl)-8-carboxyquinolone hydrochloride hemihydrate, molecular formula C 16 h 22 N 2 o 3 ·HCl·1 / 2H 2 0, molecular weight 335.83, CAS No. 62929-91-3, is a medium-effect β2 adrenoceptor agonist, has high selectivity to β2 adrenoceptors of bronchial smooth muscle, can relax bronchial smooth muscle, and has certain The anti-allergic effect and the effect of promoting airway cilia movement have been approved for the treatment of bronchial asthma, asthmatic bronchitis, acute bronchitis with increased bronchial reactivity, and chronic obstructive pulmonary disease. Clinical trials on procaterol hydrochloride used alone or in combination in the treatment of pneumonia have also...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4704A61K47/18A61K47/02A61P11/06A61P11/00
CPCA61K9/1617A61K9/167A61K31/4704
Inventor 杨晓晖左军杨贵滨张莉马晶汪红梅
Owner HEILONGJIANG LONGDE PHARMA CO LTD
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