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Preparation method of compound ipratropium bromide solution for inhalation

A technology of ipratropium bromide solution, applied in the field of preparation of compound ipratropium bromide solution for inhalation, to achieve the effect of ensuring stability

Pending Publication Date: 2022-07-05
成都普什制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Based on this, it is necessary for the salbutamol sulfate synthesis process in the existing compound ipratropium bromide solution to produce more impurities, and a method for preparing the compound ipratropium bromide solution for inhalation is provided

Method used

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  • Preparation method of compound ipratropium bromide solution for inhalation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] formula

[0021] Material name Dosage ipratropium bromide 0.5mg (press C 20 H 30 BrNO 3 count)

salbutamol sulfate 2.5mg (press C 13 H 21 NO 3 count)

Sodium chloride 22.0mg Dilute hydrochloric acid 1.0mg Water for Injection Add to 2.5ml

[0022] Table 1

[0023] Preparation method: 1) Add 75% water for injection to the liquid preparation tank, and cool the temperature of the water for injection to below 40°C;

[0024] 2) Take water for injection with a total amount of 5%, cool down to 50°C to 70°C, add sodium chloride, stir and dissolve until it becomes clear, then pour it into a liquid preparation tank and stir for 5 minutes, and add dilute hydrochloric acid under continuous stirring to obtain The first acidic solution, and adjust the pH of the solution to 3.2;

[0025] 3) Take the water for injection with a total amount of 1.8% that has been cooled to room temperature, add ipratropium bromide while st...

Embodiment 2

[0029] formula

[0030] Material name Dosage ipratropium bromide 0.5mg (press C 20 H 30 BrNO 3 count)

salbutamol sulfate 2.5mg (press C 13 H 21 NO 3 count)

Sodium chloride 22.0mg Dilute hydrochloric acid 1.0mg Water for Injection Add to 2.5ml

[0031] Table 2

[0032] Preparation method: 1) Add 75% water for injection to the liquid preparation tank, and cool the temperature of the water for injection to below 40°C;

[0033] 2) Take water for injection with a total amount of 5%, cool down to 50°C to 70°C, add sodium chloride, stir and dissolve until it becomes clear, then pour it into a liquid preparation tank and stir for 5 minutes, and add dilute hydrochloric acid under continuous stirring to obtain The first acidic solution, and adjust the pH of the solution to 3.2;

[0034] 3) Take the water for injection with a total amount of 1.8% that has been cooled to room temperature, add ipratropium bromide while st...

Embodiment 3

[0038] formula

[0039] Material name Dosage ipratropium bromide 0.5mg (press C 20 H 30 BrNO 3 count)

salbutamol sulfate 2.5mg (press C 13 H 21 NO 3 count)

Sodium chloride 22.0mg Dilute hydrochloric acid 1.0mg Water for Injection Add to 2.5ml

[0040] table 3

[0041] Preparation method: 1) Add 75% water for injection to the liquid preparation tank, and cool the temperature of the water for injection to below 40°C;

[0042] 2) Take water for injection with a total amount of 5%, cool down to 50°C to 70°C, add sodium chloride, stir and dissolve until it becomes clear, then pour it into a liquid preparation tank and stir for 5 minutes, and add dilute hydrochloric acid under continuous stirring to obtain The first acidic solution, and adjust the pH of the solution to 3.8;

[0043] 3) Take the water for injection with a total amount of 1.8% that has been cooled to room temperature, add ipratropium bromide while st...

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Abstract

The invention relates to a preparation method of a compound ipratropium bromide solution for inhalation, which comprises the following steps: S1, adding injection water accounting for 75% of the total preparation amount into a liquid preparation tank, and cooling the injection water to below 40 DEG C; s2, taking injection water accounting for 5% of the total preparation amount, cooling to 50-70 DEG C, adding sodium chloride, stirring, pouring into a liquid preparation tank, uniformly stirring, and adding diluted hydrochloric acid to obtain a first acidic solution; s3, taking injection water which accounts for 1-3% of the total preparation amount and is cooled to room temperature, adding ipratropium bromide, stirring, pouring into a liquid preparation tank, and uniformly stirring; s4, taking the injection water which accounts for 7-15% of the total preparation amount and is cooled to room temperature, adding diluted hydrochloric acid to obtain a second acidic solution, adding salbutamol sulfate while stirring, stirring and dissolving until the solution is clear, and pouring the solution into a liquid preparation tank for stirring; and S5, adding the remaining water for injection according to the prescription amount to the total preparation amount, stirring until the solution is uniformly stirred, adjusting the pH value of the solution to 3.0-3.5, and uniformly stirring.

Description

technical field [0001] The invention relates to the technical field of drug synthesis, in particular to a preparation method of a compound ipratropium bromide solution for inhalation. Background technique [0002] Compound ipratropium bromide solution for inhalation, this product is suitable for patients who need a combination of multiple bronchodilators for the treatment of reversible bronchospasm related to airway obstructive diseases. Its active ingredient is ipratropium bromide and salbutamol sulfate, and its chemical formula is C respectively 20 H 30 BrNO 3 and (C 13 H 21 NO 3 ) 2·H 2 SO 4 . [0003] The salbutamol sulfate raw material required for the preparation is obtained by chemical synthesis, and the synthesis process produces many impurities, which easily causes the quality of the finished product after the preparation to fail to meet its quality standards, thereby affecting the safety and effectiveness of the product. Therefore, control is extremely cri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/46A61K47/02A61P11/08A61K31/137
CPCA61K31/46A61K31/137A61K9/08A61K47/02A61K9/007A61P11/08A61K2300/00
Inventor 甘元龙王卫国熊全红江志伟
Owner 成都普什制药有限公司
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