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Procaterol hydrochloride solution for inhalation and preparation method thereof

A technology of procaterol hydrochloride and solution, applied in the field of medicine, can solve the problems of unfavorable drug stability, easy oxidation, short validity period, etc., and achieves the effects of simple and feasible preparation method, reduced generation of impurities, and improved safety.

Inactive Publication Date: 2021-07-23
南京华盖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, because Procaterol hydrochloride is easily oxidized in the presence of moisture and air, the preparation of liquid preparations is not conducive to its drug stability. At present, various methods are being devoted to research at home and abroad to overcome its easy oxidation and short validity period.

Method used

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  • Procaterol hydrochloride solution for inhalation and preparation method thereof
  • Procaterol hydrochloride solution for inhalation and preparation method thereof
  • Procaterol hydrochloride solution for inhalation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 a kind of procaterol hydrochloride solution for inhalation

[0025] Prescription composition:

[0026] Procaterol hydrochloride 0.2g;

[0027] L-tartaric acid 6g;

[0028] Sodium chloride 14g;

[0029] The pH regulator is 1% sodium hydroxide solution;

[0030] Add water for injection to make 2000ml.

[0031] Preparation:

[0032] S1. Take 80% of the prescribed amount of water for injection, add the main drug of the prescribed amount, fill with nitrogen, and stir for 30 minutes;

[0033] S2, add the L-tartaric acid of formula quantity, stir until completely dissolving;

[0034] S3, add the sodium chloride of formula quantity, stir until completely dissolving;

[0035] S4, using 1% sodium hydroxide solution to control the pH value of the solution at 3.4;

[0036] S5, add water for injection until the total amount of the solution is the total amount prepared, and stir the solution evenly;

[0037] S6, passing the obtained solution successively through...

Embodiment 2

[0039] Embodiment 2 a kind of procaterol hydrochloride solution for inhalation

[0040] Prescription composition:

[0041] Procaterol hydrochloride 0.2g;

[0042] Citric acid 6g;

[0043] Potassium chloride 14g;

[0044] The pH regulator is 1% sodium hydroxide solution;

[0045] Add water for injection to make 2000ml.

[0046] Preparation:

[0047] S1. Take 80% of the prescribed amount of water for injection, add the main drug of the prescribed amount, fill with nitrogen, and stir for 30 minutes;

[0048] S2, add the citric acid of formula quantity, stir until completely dissolving;

[0049] S3, add the potassium chloride of formula quantity, stir until completely dissolving;

[0050] S4, use 1% sodium hydroxide solution to control the pH value of the solution at 3.5;

[0051] S5, add water for injection until the total amount of the solution is the total amount prepared, and stir the solution evenly;

[0052] S6, passing the obtained solution through a 0.45 μm filter...

Embodiment 3

[0053] Embodiment 3 a kind of procaterol hydrochloride solution for inhalation

[0054] Prescription composition:

[0055] Procaterol hydrochloride 0.2g;

[0056] Sodium metabisulfite 5g;

[0057] Glucose 89g;

[0058] The pH regulator is 1% hydrochloric acid solution;

[0059] Add water for injection to make 2000ml.

[0060] Preparation:

[0061]S1. Take 80% of the prescribed amount of water for injection, add the main drug of the prescribed amount, fill with nitrogen, and stir for 30 minutes;

[0062] S2, add the sodium metabisulfite of formula quantity, stir until completely dissolving;

[0063] S3, add the glucose of formula quantity, stir until completely dissolved;

[0064] S4, using 1% hydrochloric acid solution to control the pH value of the solution at 3.6;

[0065] S5, add water for injection until the total amount of the solution is the total amount prepared, and stir the solution evenly;

[0066] S6, passing the obtained solution successively through 0.45 ...

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Abstract

The invention belongs to the technical field of medicines, and relates to a procaterol hydrochloride solution and a preparation method thereof. The procaterol hydrochloride solution for inhalation is composed of an active component procaterol hydrochloride, an osmotic pressure regulator, a stabilizer, a pH regulator and water for injection. The preparation method has the advantages of stable product, simple and feasible process and convenience in industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a procaterol hydrochloride solution for inhalation and a preparation method thereof. Background technique [0002] β2 receptor agonists are a class of asthma treatment drugs that can stimulate the β2 receptors distributed on the smooth muscle of the airway to produce bronchodilation. According to its duration of action, it can be divided into short-acting and long-acting β2-receptor agonists, and long-acting β2-receptor agonists can be divided into two types: quick-acting and slow-acting. Renbuterol, formoterol, and salmeterol. [0003] Procaterol Hydrochloride Hemihydrate, chemical name: 5-(1-hydroxy-2-isopropylaminobutyl)-8-hydroxy-2(1H)-quinolone hydrochloride hemihydrate, molecular formula: C 16 h 22 N 2 o 3 .HCl.1 / 2H 2 O, molecular weight: 335.83, its structural formula is: [0004] [0005] Procaterol hydrochloride is a long-acting β2 receptor agonist...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4704A61K9/72A61K9/08A61K47/02A61K47/12A61P11/06A61P11/00
CPCA61K31/4704A61K9/007A61K9/08A61K47/02A61K47/12A61P11/06A61P11/00
Inventor 周鑫祝修权朱景阳孙向阳
Owner 南京华盖制药有限公司