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Bromhexine Hydrochloride aseptic freeze-drying formulation for injection and its preparation method

A technology of bromhexine hydrochloride and freeze-dried preparation, applied in the field of sterile freeze-dried preparation of bromhexine hydrochloride for injection and preparation thereof, can solve the time and conditions of poor stability of dosage form, inconvenient for long-distance transportation, long-term preservation and storage Limitation and other issues to prevent degradation and improve bioavailability

Inactive Publication Date: 2004-12-29
马小歧
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral tablets are easy to cause adverse reactions such as nausea and stomach discomfort after use by patients, and can be directly used for bromhexine hydrochloride injection for intravenous infusion, which avoids adverse reactions after oral dosage forms are taken, and is convenient for clinical use, but there are The disadvantage of poor stability of the dosage form, and the storage time and conditions are greatly limited, which is not convenient for long-distance transportation and long-term storage

Method used

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  • Bromhexine Hydrochloride aseptic freeze-drying formulation for injection and its preparation method
  • Bromhexine Hydrochloride aseptic freeze-drying formulation for injection and its preparation method

Examples

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Effect test

Embodiment 1

[0026] Embodiment 1: the specification of 4mg / bottle. The formula of 1000 bottles of bromhexine hydrochloride sterile freeze-dried preparation for injection is:

[0027] 4g of bromhexine hydrochloride, 70g of mannitol, appropriate amount of citric acid, and water for injection were added to 2000ml, and a total of 1000 bottles were made.

[0028] Preparation:

[0029] 1) Weigh 70g of mannitol according to the prescription, add an appropriate amount of water for injection, stir to dissolve, add 0.2% (m / v) activated carbon for injection, stir well, keep warm in a hot water bath for 20-30 minutes, and then use a filter to Decarbonize by primary filtration, wash twice with a small amount of water for injection, and combine the filtrates to obtain the excipient formulation;

[0030] 2) Take 4 g of bromhexine hydrochloride, add about 3 / 4 of the amount of water for injection to dissolve it, adjust the pH value to 2.0-3.5 with 0.1 mol / L phosphoric acid, and obtain bromhexine hydrochl...

Embodiment 2

[0037] Embodiment 2: 4mg / bottle specification. The formula of 1000 bottles of bromhexine hydrochloride sterile freeze-dried preparation for injection is:

[0038] 4.0g of bromhexine hydrochloride, 70g of glucose, 100g of mannitol, appropriate amount of phosphoric acid, and water for injection were added to 2000ml, and a total of 1000 bottles were prepared.

[0039] Preparation:

[0040] 1) Weigh 70g of glucose and 100g of mannitol according to the prescription, add an appropriate amount of water for injection, stir to dissolve, add 0.2% (m / v) activated carbon for injection, stir evenly, keep warm in a hot water bath for 20-30 minutes, and use The filter is pre-filtered and decarbonized, washed twice with a small amount of water for injection, and the filtrate is combined to obtain the excipient formulation;

[0041] 2) Take 4.0 g of bromhexine hydrochloride according to the prescription, add about 3 / 4 of the amount of water for injection to dissolve it, adjust the pH value t...

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Abstract

The present invention discloses freeze dried bromhexine hydrochloride preparation for injection and its preparation process. The preparation consists of bromhexine hydrochloride as active component, excipient, acidity regulator and injection water. The preparation process includes preparing clear water solution of water insoluble bromhexine hydrochloride with the acidity regulator, adding excipient and freeze drying. The freeze dried bromhexine hydrochloride preparation has raised sability, high bioavailability, less oxidating degradation, no upset reaction and clinical use convenience.

Description

technical field [0001] The invention relates to a dosage form of bromhexine hydrochloride and a preparation method thereof, in particular to a sterile freeze-dried preparation of bromhexine hydrochloride for injection and a preparation method thereof. Background technique [0002] Bromhexine hydrochloride belongs to mucolytic drugs, which can change the viscous components of sputum, reduce the viscosity of sputum, and make sputum easy to cough up. It has been used clinically for many years since it was launched in 1965. Production began in China in 1973, and it has become the first-selected expectorant in clinical practice at home and abroad. Pharmacopoeias of Great Britain, France, Germany, Holland, Switzerland, Italy, Portugal, and China have all been recorded. This product mainly acts on the mucus-producing cells of the mucous glands of the trachea and bronchi, making them secrete small molecular proteins with low viscosity, and thus restores the rheological properties o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/137A61P11/10
Inventor 马小歧
Owner 马小歧
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