Ambroxol hydrochloride solution for inhalation

A technology of ambroxol hydrochloride and solution, which is applied in the field of medicine and can solve problems such as low utilization rate and slow onset of action

Inactive Publication Date: 2017-05-31
HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral preparations are more convenient to use, but slow onset, low utilization rate, accompanied by nausea, vomiting, indigestion and other gastrointestinal adverse reactions

Method used

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  • Ambroxol hydrochloride solution for inhalation
  • Ambroxol hydrochloride solution for inhalation
  • Ambroxol hydrochloride solution for inhalation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021]

[0022] Process:

[0023] (1) Add the prescribed amount of citric acid and sodium citrate into 80% of the prescribed amount of water for injection, stir to dissolve, add the prescribed amount of sodium chloride, and stir to dissolve completely;

[0024] (2) Add the prescribed amount of ambroxol hydrochloride, stir to dissolve, and add water for injection to the full amount;

[0025] (3) Add 0.03% (w / v) charcoal for needles, stir at 80°C for 10 minutes, filter through a 0.45 μm membrane to decarbonize, add water for injection to the full amount, stir and mix well, and prepare for filling;

[0026] (4) Measure the content and pH of the intermediate, and the pH of the intermediate is 4.93;

[0027] (5) Fine filtration with 0.22μm microporous membrane, each 2ml filled in ampoules, filled with nitrogen in the ampoules before filling and sealed;

[0028] (6) Sterilization: Sterilize at 121°C for 15 minutes (F 0 >12).

Embodiment 2

[0030]

[0031] Process:

[0032] (1) Add the prescribed amount of edetate disodium, citric acid, and disodium hydrogen phosphate into 80% of the prescribed amount of water for injection, stir to dissolve, add the prescribed amount of sodium chloride, and stir to dissolve completely;

[0033] (2) Add the prescribed amount of ambroxol hydrochloride, stir to dissolve, and add water for injection to the full amount;

[0034] (3) Add 0.05% (w / v) charcoal for needles, stir at 70°C for 15 minutes, filter through a 0.45 μm membrane to decarbonize, add water for injection to the full amount, stir and mix well, and prepare for filling;

[0035] (4) Measure the content and pH of the intermediate, and the pH of the intermediate is 5.20;

[0036] (5) Fine filter with 0.22μm microporous membrane, fill each 2ml bottle into an ampoule, fill the ampoule with nitrogen before filling, and seal it by melting. ;

[0037] (6) Sterilization: Sterilize at 121°C for 15 minutes (F 0 >12).

Embodiment 3

[0039]

[0040] Process:

[0041] (1) Add the prescribed amount of potassium dihydrogen phosphate and ambroxol hydrochloride into 80% of the prescribed amount of water for injection, stir to dissolve, add the prescribed amount of disodium hydrogen phosphate, and stir to dissolve completely;

[0042] (2) Add the prescribed amount of sodium chloride, stir to dissolve, and add water for injection to the full amount;

[0043] (3) Add 0.1% (w / v) charcoal for needles, stir at 60°C for 5 minutes, filter through a 0.45 μm membrane to decarbonize, add water for injection to the full amount, stir and mix well, and prepare for filling;

[0044] (4) Measure the content and pH of the intermediate, and the pH of the intermediate is 5.12;

[0045] (5) Fine filtration with 0.22μm microporous membrane, each 2ml filled in ampoules, filled with nitrogen in the ampoules before filling and sealed;

[0046] (6) Sterilization: Sterilize at 121°C for 15 minutes (F 0 >12).

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Abstract

The invention relates to an ambroxol hydrochloride solution for inhalation and a preparation method thereof. Ambroxol hydrochloride is used as an active ingredient. The ambroxol hydrochloride solution belongs to a sterile inhalation preparation capable of being used for treating diseases such as bronchial asthma, chronic bronchitis, emphysema, pulmonary heart diseases, pulmonary infection and COPD (chronic obstructive pulmonary diseases).

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to an inhalation solution of ambroxol hydrochloride and a preparation method thereof. Background technique [0002] The respiratory diseases referred to in the present invention mainly include acute and chronic lung diseases. [0003] Respiratory system disease is one of the common and frequently-occurring diseases that endanger people's health in modern society. Many factors such as air pollution and smoking make chronic obstructive pulmonary disease at home and abroad, including chronic bronchitis, emphysema, bronchial asthma and other lung diseases. The incidence rate has been at a high level. [0004] The solution for inhalation is sprayed into the patient's mouth to form a drug mist. The drug components in the mist adhere to the respiratory epithelium and penetrate into the cells to exert drug effects. The drug is administered by inhalation, which is easy to operate and can...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/137A61P11/00
CPCA61K9/0078A61K9/12A61K31/137
Inventor 闫冉陆慧傅华锋楼金芳衣丽娜
Owner HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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