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Inhalable pharmaceutical composition containing procaterol hydrochloride

A technology of procaterol hydrochloride and inhaled drugs, which is applied in the field of medicine, can solve the problems of slow oral onset and low bioavailability, achieve the effects of ensuring dosage, reducing the production of related substances, and improving safety and effectiveness

Pending Publication Date: 2021-07-16
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

[0005] β2 receptor agonists have certain specificities as bronchodilator drugs. They are slow to take effect when taken orally and have low bioavailability. There are gastrointestinal adverse reactions such as nausea, vomiting, and indigestion.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Weigh 0.2g of Procaterol Hydrochloride, add it to pre-dissolve in a 2L container containing 1L of water for injection, stir to dissolve, then add 5g of L-tartaric acid, 15g of sodium chloride, stir to dissolve, and prepare Procaterol Hydrochloride above Add water for injection to the solution to 1.6L, adjust the pH value of the solution to 3.5 with sodium hydroxide solution, add water for injection to make the volume to 2L, and continue stirring for 15 minutes to obtain the obtained product. Sampling test, properties: colorless clear liquid; pH: 3.5; osmotic pressure: 289mOsmol / kg; content: 100.2%; related substances: maximum simple impurities 0.02%, total impurities 0.04%.

Embodiment 2

[0024] Weigh 0.2g of Procaterol Hydrochloride, add it into a 2L container containing 1L of water for injection to pre-dissolve, stir to dissolve, then add 5g of citric acid and 15g of potassium chloride, stir to dissolve, and prepare Procaterol Hydrochloride above Add water for injection to the solution to 1.6L, adjust the pH value of the solution to 3.5 with sodium citrate solution, add water for injection to make the volume to 2L, and continue stirring for 15 minutes to obtain the obtained product. Sampling test, properties: colorless clear liquid; pH: 3.5; osmotic pressure: 284mOsmol / kg; content: 99.8%; related substances: maximum simple impurities 0.02%, total impurities 0.04%.

Embodiment 3

[0026] Weigh 0.2 g of Procaterol Hydrochloride, add it into a 2 L container containing 1 L of water for injection for pre-dissolution, stir to dissolve, then add 1.5 g of sodium metabisulfite and 89 g of glucose, stir to dissolve, and add Procaterol Hydrochloride solution prepared above to Water for injection to 1.6L, and hydrochloric acid solution to adjust the pH value of the solution to 3.4, add water for injection to make the volume to 2L, and continue to stir for 15min to obtain the obtained product. Sampling test, properties: colorless clear liquid; pH: 3.4; osmotic pressure: 291mOsmol / kg; content: 99.5%; related substances: maximum simple impurities 0.02%, total impurities 0.04%.

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PUM

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Abstract

The invention belongs to the technical field of medicines, and relates to an inhalable pharmaceutical composition containing procaterol hydrochloride. The inhalable pharmaceutical composition comprises procaterol hydrochloride and one or more pharmaceutic adjuvants suitable for inhalation administration. The inhalable pharmaceutical composition can be used for treating diseases such as bronchial asthma, asthmatic bronchitis, acute bronchitis accompanied with increased bronchial reactivity, chronic obstructive pulmonary disease (COPD) and the like.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of Procaterol Hydrochloride suitable for inhalation. Background technique [0002] With the rapid development of modern science and technology, the process of industrialization has accelerated, the problem of environmental pollution has become increasingly prominent, and the air quality has gradually deteriorated. Respiratory diseases have become one of the major diseases in the world. Common respiratory diseases include bronchial asthma, bronchitis, chronic obstructive pulmonary disease (COPD) and other diseases. In recent years, the incidence has been on the rise, posing a serious threat to human health and life safety. [0003] β2 receptor agonist is one of the therapeutic drugs for this type of respiratory system diseases. It is a kind of bronchodilator that can excite the β2 receptors distributed on the smooth muscle of the airway to...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/08A61K9/12A61K31/4704A61K47/02A61K47/12A61K47/26A61P11/08
CPCA61K31/4704A61K9/0078A61K47/02A61K47/26A61K47/12A61P11/08
Inventor 周鑫祝修权朱景阳孙向阳
Owner 南京华盖制药有限公司
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