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Salbutamol sulphate inhalation aerosol and preparation method thereof

A technology of salbutamol sulfate aerosol and salbutamol sulfate, which is applied in aerosol delivery, pharmaceutical formulations, respiratory diseases, etc., can solve the problem of no HFA aerosol, and achieve no toxic side effects, stable process and low cost Effect

Inactive Publication Date: 2014-01-22
江苏山信药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] According to the Montreal Protocol, Freon aerosols should be completely banned in my country in 2010. However, since there is no independent research and development capability of non-freon aerosols in China, there is still no HFA aerosol approved for marketing. Therefore, China must report to the International Environmental Contracting Organization every year Apply for Freon Quota

Method used

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  • Salbutamol sulphate inhalation aerosol and preparation method thereof
  • Salbutamol sulphate inhalation aerosol and preparation method thereof
  • Salbutamol sulphate inhalation aerosol and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] (1) Prescription

[0046]

[0047] (2) Preparation method

[0048] Mix albuterol and 2.5mol / L sulfuric acid evenly and pump into the reaction kettle, control the reaction temperature to 15°C, maintain a stirring speed of 900rpm / min, and control the reaction time for 10min. Filter the medicinal liquid and dry the fine salbutamol sulfate powder that obtains, see attached through powder electron microscope observation result. figure 1 The results of the particle size data of the pulverized albuterol sulfate measured by laser particle size analyzer are shown in the appendix figure 2 .

[0049] Take 2.84g of salbutamol sulfate, add it to 39.27g of absolute ethanol to dissolve, add 14.76g of oleic acid and mix evenly, then fill the aluminum can with 14.83g of HFA-113a, seal the aluminum can, and obtain the prepared sample.

Embodiment 2

[0051] (1) Prescription

[0052]

[0053]

[0054] (2) Preparation method

[0055] Mix albuterol and 5.0 mol / L sulfuric acid evenly and pump into the reaction kettle, control the reaction temperature to 15°C, maintain a stirring speed of 900rpm / min, and control the reaction time for 10min. Filter the liquid medicine and dry the fine salbutamol sulfate powder that obtains, see attached through powder electron microscope observation result. figure 1 The results of the particle size data of the pulverized albuterol sulfate measured by laser particle size analyzer are shown in the appendix figure 2 .

[0056] Take 2.84g of salbutamol sulfate, add it to 39.27g of absolute ethanol to dissolve, add 14.76g of oleic acid and mix evenly, then fill the aluminum can with 14.83g of HFA-227, seal the aluminum can, and obtain the prepared sample.

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Abstract

The invention relates to an inhalation aerosol medicine composition containing selective beta2-receptor stimulant salbutamol sulphate and a hydrofluoroalkane (HFA) propellant and a preparation method thereof. The inhalation aerosol medicine composition and the preparation method have the advantages that the preparation technology is simple and feasible, used raw materials and auxiliary materials have no toxic or side effects, the production cost is low, the prepared medicine has good particle size distribution and relatively high stability, and the quality and the human body bioavailability of the medicine are favorably improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a salbutamol sulfate inhalation aerosol and a preparation method thereof. Background technique [0002] In 1956, Charles Thiel et al. reported the use of a pressurized metered dose inhaler (pMDI) as a drug delivery device. This type of drug is used to treat asthma, chronic obstructive pulmonary disease (COPD), etc. that occur in the lungs, Diseases of the bronchi and trachea. Drugs using the pMDI drug delivery device can directly act on the target site, and have the characteristics of fast onset and high bioavailability; in addition, since this type of preparation is administered through the respiratory tract, the first-pass effect of the drug in the liver can be avoided; in addition, using The device is very convenient for administration, and the user's compliance is good. Due to the above special advantages, pMDI has been widely used since its invention. However, t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/137A61P11/00A61P11/06
Inventor 林山周绍华王松何达黄志诚
Owner 江苏山信药业有限公司
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