Ambroxol hydrochloride freeze-dried powder injection and preparing method thereof

A technology of ambroxol hydrochloride and freeze-dried powder injection is applied in the field of preparation of ambroxol hydrochloride freeze-dried powder injection and ambroxol hydrochloride freeze-dried powder injection, and can solve problems such as the influence of main drug stability, unknown side effects and the like, Achieve the effect of easy dissolution, avoid interaction, and simple excipients

Active Publication Date: 2009-07-01
SHANDONG YUXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the above-mentioned ambroxol hydrochloride freeze-dried powder injection, when the auxiliary material components added in the main drug of ambroxol hydrochloride are complex, the stability of the main drug will be affected, and unknown side effects may be caused. And the side effect that brings, makes patient use safer, and the inventor provides a kind of ambroxol hydrochloride freeze-dried powder injection with simple prescription

Method used

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  • Ambroxol hydrochloride freeze-dried powder injection and preparing method thereof
  • Ambroxol hydrochloride freeze-dried powder injection and preparing method thereof
  • Ambroxol hydrochloride freeze-dried powder injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1 Preparation of freeze-dried powder containing 15 mg of ambroxol hydrochloride in each bottle, 1000 bottles in total.

[0046] The composition of the freeze-dried powder containing 15mg of ambroxol hydrochloride in each bottle:

[0047]

[0048] Dissolve 15g of ambroxol hydrochloride in sterile water for injection, stir to dissolve, weigh 100g of mannitol, add to the above solution, stir to dissolve, heat to 60°C, stir to dissolve, and use 0.1mol / L hydrochloric acid solution and 0.1mol / L sodium hydroxide solution to adjust the pH of the solution to 4.9, add sterilized water for injection to 2000mL, add 0.1% (g / mL) activated carbon, stir for 14 minutes, and then filter the liquid through a 0.22um filter membrane. The filtrate was divided into vials, placed in a freeze dryer that had been cooled to -20°C, and kept frozen at -20°C for 3 hours, then lowered to -45°C, vacuumed, and heated to -7°C, the time to maintain -7°C is 6 hours, and then continue to heat u...

Embodiment 2

[0049] Example 2 Preparation of freeze-dried powder containing 15 mg of ambroxol hydrochloride in each bottle, 1000 bottles in total.

[0050] The composition of the freeze-dried powder containing 15mg of ambroxol hydrochloride in each bottle:

[0051]

[0052] Dissolve 15g of ambroxol hydrochloride in sterile water for injection, stir to dissolve, weigh 150g of mannitol, add to the above solution, stir to dissolve, heat to 60°C, stir to dissolve, and use 0.1mol / L hydrochloric acid solution and 0.1mol / L sodium hydroxide solution to adjust the pH of the solution to 5.1, add sterilized water for injection to 2000mL, add 0.1% (g / mL) activated carbon, stir for 12 minutes, and then filter the medicinal solution through a 0.22um filter membrane. The filtrate was divided into vials, placed in a freeze dryer that had been cooled to -18°C, and kept frozen at -18°C for 3 hours, then lowered to -45°C, vacuumed, and heated to -10°C, the time to maintain -10°C is 6 hours, and then cont...

Embodiment 3

[0053] Example 3 Preparation of freeze-dried powder containing 15 mg of ambroxol hydrochloride in each bottle, 1000 bottles in total.

[0054] The composition of the freeze-dried powder containing 15mg of ambroxol hydrochloride in each bottle:

[0055]

[0056]

[0057] Dissolve 15g of ambroxol hydrochloride in sterile water for injection, stir to dissolve, weigh 68g of mannitol and add to the above solution, stir to dissolve, heat to 60°C, stir to dissolve, and use 0.1mol / L hydrochloric acid solution and 0.1mol / L sodium hydroxide solution to adjust the pH of the solution to 4.8, add sterilized water for injection to 2000mL, add 0.1% (g / mL) activated carbon, stir for 10 minutes, and then filter the medicinal solution through a 0.22um filter membrane. The filtrate is divided into vials, placed in a freeze dryer that has been cooled to -20°C, and kept frozen at -20°C for 3 hours, then lowered to about -45°C, vacuumed, and heated within 10 hours To -10°C, the time to maint...

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Abstract

The invention relates to a freeze-dried powder injection of ambroxol hydrochloride and a preparation method thereof. The freeze-dried powder injection is composed of ambroxol hydrochloride and mannitol, and the ambroxol hydrochloride freeze-dried powder injection is obtained by a freeze-drying process. Good stability, fast dissolution, and other indicators are in compliance with the regulations.

Description

technical field [0001] The invention relates to a freeze-dried powder injection of ambroxol hydrochloride and a preparation method of the freeze-dried powder injection of ambroxol hydrochloride, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Ambroxol hydrochloride, also known as Mushu phlegm, is a respiratory lubricating expectorant and mucolytic drug. It has the characteristics of promoting mucus elimination and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the secretion of mucus. Retention, thus significantly promoting expectoration and improving respiratory conditions. It can promote the secretion of pulmonary surfactant, the secretion of airway fluid and the movement of cilia. [0003] Ambroxol Hydrochloride (Ambroxol Hydrochloride), the chemical name is trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride, chemical structural formula: [00...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/137A61K47/10A61P11/10
Inventor 刘保起李明华张世伟
Owner SHANDONG YUXIN PHARMA CO LTD
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