Ambroxol hydrochloride dry powder inhalant and preparation thereof

A technology of ambroxol hydrochloride dry powder and ambroxol hydrochloride, which is applied in the field of medicine, can solve problems such as air pollution, unfavorable therapeutic effects, and large side effects, and achieve high-efficiency therapeutic effects

Inactive Publication Date: 2008-07-09
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although injections can directly inject medicines into human blood and take effect relatively quickly, they still exert effects on the whole body, have large side effects, and bring certain pain and inconvenience to patients at the same time.
The aerosol conta...

Method used

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  • Ambroxol hydrochloride dry powder inhalant and preparation thereof
  • Ambroxol hydrochloride dry powder inhalant and preparation thereof
  • Ambroxol hydrochloride dry powder inhalant and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The present embodiment adopts the SD-1000 spray dryer of Japan EYELA Company.

[0022] Mix 2.5g (89.3%) of ambroxol hydrochloride and 0.3g (10.7%) of leucine and dissolve in 100mL of distilled water, adjust the pH to 6.0 with 0.1mol / L sodium hydroxide, and filter through a 0.2μm microporous membrane Afterwards, spray drying is carried out, and the process parameters are adopted: the inlet temperature is 110°C, and the spray speed is 1.8mL min -1 , pump pressure 170KPa, air flow 0.7m 3 min -1 Prepare the ambroxol hydrochloride dry powder inhaler, and fill the spray-dried powder in No. 3 capsules.

Embodiment 2

[0024] The present embodiment adopts the SD-1000 spray dryer of Japan EYELA Company.

[0025] Mix 2.5g (83.3%) of ambroxol hydrochloride and 0.5g (16.7%) of leucine and dissolve in 100mL of distilled water, adjust the pH to 6.0 with 0.1mol / L sodium hydroxide, and filter through a 0.2μm microporous membrane Afterwards, spray drying is carried out, and the process parameters are adopted: the inlet temperature is 110°C, and the spray speed is 1.8mL min -1 , pump pressure 170KPa, air flow 0.7m 3 min -1 Prepare the ambroxol hydrochloride dry powder inhaler, and fill the spray-dried powder in No. 3 capsules.

Embodiment 3

[0027] The present embodiment adopts the SD-1000 spray dryer of Japan EYELA Company.

[0028] Mix 2.5g (71.4%) of ambroxol hydrochloride and 1g (28.6%) of leucine and dissolve in 100mL of distilled water, adjust the pH to 6.0 with 0.1mol / L sodium hydroxide, and filter through a 0.2μm microporous membrane Carry out spray drying, adopt process parameters inlet temperature is 110 ℃, spray speed 1.8mL min -1 , pump pressure 170KPa, air flow 0.7m 3 min -1 Prepare the ambroxol hydrochloride dry powder inhaler, and fill the spray-dried powder in No. 3 capsules.

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Abstract

The present invention belongs to the medication technical field and discloses hydrochloric ambroxol dry powder inhalant and a preparation method thereof. The hydrochloric ambroxol dry powder inhalant consists of hydrochloric ambroxol, dispersion flow aid and thinner, the weight percentage of which is 60 percent to 90 percent of the hydrochloric ambroxol, 10 percent to 30 percent of the dispersionflow aid and 0 percent to 40 percent of the thinner. The present invention comprises the following steps that the hydrochloric ambroxol or the hydrochloric ambroxol and the dispersion flow aid or thehydrochloric ambroxol, the dispersion flow aid and the thinner are processed for spray drying to obtain powder body which is collected into a glutin or plastic capsule or into an aluminum-plastic bubble cap or is contained inside a large dosage dry powder absorbing device as the storehouse form. The present invention adopts the dry powder inhalant to ensure that the hydrochloric ambroxol is directly absorbed into respiratory tract and lung by a medication device to act directly inside the respiratory tract, so as to achieve the purpose of the safe and targeting treatment with quick result andhigh efficiency.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an ambroxol hydrochloride dry powder inhaler and a preparation method thereof. Background technique [0002] Respiratory system disease is one of the diseases that people are familiar with. According to the relevant statistical data of the Ministry of Health, the prevalence rate of respiratory system disease in my country is about 6.94%, that is, more than 80 million people in the country suffer from respiratory system disease every year. In terms of age, the old and the young are the age groups with a high incidence of respiratory diseases. Respiratory system diseases account for about 1 / 4 of internal medicine patients, bringing mental and physical pain to patients. In my country's population statistics, respiratory system diseases are the second cause of death, but there are not many clinically available drugs and Onset is slow. Therefore, timely and reasonable treatment is of ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/72A61K31/137A61K47/16A61P11/10
Inventor 唐星任亚超
Owner SHENYANG PHARMA UNIVERSITY
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