Preparation method of inhalation solution for treating respiratory diseases

A technology for solution and respiratory tract, applied in the field of preparation of inhalation solution, which can solve the problems that patients are difficult to take and the scope of clinical treatment is narrow, and achieve the effect of stable quality, simple production process and good process reproducibility

Inactive Publication Date: 2020-06-12
南京嘉晨医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The oral liquid prepared by this method does not contain preservatives, and has good physical and chemical stability and microbial stability, but also has the problem that it is difficult to take for patients with difficulty in swallowing and injection, and the scope of application of clinical treatment is relatively narrow

Method used

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  • Preparation method of inhalation solution for treating respiratory diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Ambroxol hydrochloride: 15g

[0047] Clenbuterol hydrochloride: 0.01g

[0048] Citric acid: 2.0g

[0049] Disodium hydrogen phosphate: 7.0g

[0050] Sodium chloride: 15.0g

[0051] Water for injection: up to 2000mL

[0052] (1) Dissolving citric acid and disodium hydrogen phosphate in water for injection with a total amount of 70% to obtain solution I for subsequent use;

[0053] (2) Sodium chloride is dissolved in 10% water for injection to obtain solution II for subsequent use;

[0054] (3) Add ambroxol hydrochloride and clenbuterol hydrochloride to I, stir until completely dissolved to obtain solution III;

[0055] (4) Then add the sodium chloride solution II to III, make up the water for injection to the full amount, stir and mix evenly.

[0056] Adjust pH to 5.0.

[0057] Filter with a 0.45μm filter element, and then filter with two 0.22μm filter elements; take a sample to detect the intermediate; the pH range is 4.5-5.5; the content is 97-103%.

[0058] Fill...

Embodiment 2

[0063] Ambroxol hydrochloride: 15g

[0064] Clenbuterol hydrochloride: 0.01g

[0065] Citric acid: 0.8g

[0066] Disodium hydrogen phosphate: 1.8g

[0067] Sodium chloride: 17.2g

[0068] Water for injection: up to 2000mL

[0069] (1) dissolving citric acid in water for injection of 70% of the total amount to obtain solution I for subsequent use;

[0070] (2) Sodium chloride is dissolved in 10% water for injection to obtain solution II for subsequent use;

[0071] (3) Disodium hydrogen phosphate is mixed with 500ml of 1mol / L solution to obtain solution III for subsequent use;

[0072] (4) Add ambroxol hydrochloride and clenbuterol hydrochloride to solution 1, stir until completely dissolved; then add solution II, stir, and mix well.

[0073] Use solution III to adjust the pH value to 5.0, make up the water for injection to the full amount, and mix well.

[0074] Use a 0.45μm filter element to filter, and then use two 0.22μm filter elements to filter. Sampling for detec...

Embodiment 3

[0080] Ambroxol hydrochloride: 30g

[0081] Clenbuterol hydrochloride: 0.02g

[0082] Citric acid: 2.0g

[0083] Disodium hydrogen phosphate: 7.0g

[0084] Sodium chloride: 15.0g

[0085] Water for injection: up to 2000mL

[0086] (1) dissolving citric acid and disodium hydrogen phosphate in water for injection with a total amount of 70% to obtain solution I for subsequent use;

[0087] (2) Sodium chloride is dissolved in 10% water for injection to obtain solution II for subsequent use;

[0088] (3) Add ambroxol hydrochloride and clenbuterol hydrochloride to I, stir until completely dissolved to obtain solution III;

[0089] (4) Then add the sodium chloride solution II to III, make up the water for injection to the full amount, stir and mix evenly.

[0090] Adjust pH to 5.0.

[0091] Use a 0.45μm filter element to filter, and then use two 0.22μm filter elements to filter. Sampling for detection of intermediates. The pH range is 4.5-5.5; the content is 97-103%.

[009...

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Abstract

The invention relates to the field of pharmaceutical preparations, and particularly relates to a preparation method of an inhalation solution for treating respiratory diseases. The inhalation solutionis composed of ambroxol hydrochloride, clenbuterol hydrochloride, a pH regulator, an isoosmotic adjusting agent and a solvent, wherein the ambroxol hydrochloride and the clenbuterol hydrochloride serve as active ingredients. The invention relates to the preparation method of the inhalation solution taking the ambroxol hydrochloride and the clenbuterol hydrochloride as the active ingredients, which is easy to operate, simple in process and suitable for commercial production. Aerosol inhalation administration is adopted, and the inhalation solution is suitable for patients who are difficult toswallow and inconvenient to inject. The inhalation solution disclosed by the invention has a remarkable effect in aspects of treating the respiratory diseases, bronchitis, and dyspnea caused by airwayobstructive diseases such as emphysema and the like.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of an inhalation solution for treating respiratory diseases with ambroxol hydrochloride and clenbuterol hydrochloride as active ingredients. Background technique: [0002] Respiratory system diseases, according to the statistics of the top ten major causes of death in some cities and rural areas of the country in 2006, respiratory system diseases (excluding lung cancer) accounted for the fourth cause of death in cities (13.1%), and the fourth in rural areas Three (16.4%). Due to factors such as air pollution, smoking, physical and chemical factors, biological factors caused by industrial economic development, and population aging, the incidence of respiratory diseases such as lung cancer, bronchitis, and bronchial asthma has increased significantly in recent years, and chronic obstructive pulmonary disease is at a high level. (more tha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/137A61P11/00A61P11/06A61P11/14A61P11/10
CPCA61K9/007A61K9/08A61K31/137A61P11/00A61P11/06A61P11/10A61P11/14A61K2300/00
Inventor 张用杰
Owner 南京嘉晨医药科技有限公司
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