Ambroxol hydrochloride composition for injection and preparation method thereof

A technology of ambroxol hydrochloride and composition, applied in the field of ambroxol hydrochloride composition for injection and preparation thereof, can solve problems such as no improvement, and achieve the effects of low production cost, uniform and accurate content, and simple preparation process

Inactive Publication Date: 2012-05-23
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] None of the existing known technologies propose improvements to the above defects

Method used

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  • Ambroxol hydrochloride composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] prescription:

[0060] Ambroxol Hydrochloride 150g

[0061] Mannitol 150g

[0062] Add water for injection to 20Kg

[0063] Preparation:

[0064] Put ambroxol hydrochloride and mannitol in the preparation tank, add water for injection, stir to make it completely dissolved and mix evenly, and adjust the pH value to 5.3 with 0.1mol / L hydrochloric acid and 0.1mol / L sodium hydroxide solution;

[0065] Sterile filtration, packing:

[0066] The prepared ambroxol hydrochloride solution is filtered through a microporous membrane into a sterile room, subpackaged in vials, and half stoppered;

[0067] Vacuum Freeze Drying:

[0068] a. Pre-freezing: put the subpackaged ambroxol hydrochloride liquid in a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the ambroxol hydrochloride liquid is completely frozen;

[0069] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the temperature of the col...

Embodiment 2

[0072] prescription:

[0073] Ambroxol Hydrochloride 150g

[0074] Mannitol 600g

[0075] Add water for injection to 20Kg

[0076] Preparation:

[0077] Put ambroxol hydrochloride and mannitol in the preparation tank, add water for injection, stir to make it completely dissolved and mix evenly, and adjust the pH value to 5.3 with 0.1mol / L hydrochloric acid and 0.1mol / L sodium hydroxide solution;

[0078] Sterile filtration, packing:

[0079] The prepared ambroxol hydrochloride solution is filtered through a microporous membrane into a sterile room, subpackaged in vials, and half stoppered;

[0080] Vacuum Freeze Drying:

[0081] a. Pre-freezing: put the subpackaged ambroxol hydrochloride liquid in a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the ambroxol hydrochloride liquid is completely frozen;

[0082] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the temperature of the col...

Embodiment 3

[0085] prescription:

[0086] Ambroxol Hydrochloride 150g

[0087] Mannitol 300g

[0088] Add water for injection to 20Kg

[0089] Preparation:

[0090] Put ambroxol hydrochloride and mannitol in the preparation tank, add water for injection, stir to make it completely dissolved and mix evenly, and adjust the pH value to 5.3 with 0.1mol / L hydrochloric acid and 0.1mol / L sodium hydroxide solution;

[0091] Sterile filtration, packing:

[0092] The prepared ambroxol hydrochloride solution is filtered through a microporous membrane into a sterile room, subpackaged in vials, and half stoppered;

[0093] Vacuum Freeze Drying:

[0094] a. Pre-freezing: put the subpackaged ambroxol hydrochloride liquid in a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the ambroxol hydrochloride liquid is completely frozen;

[0095] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the temperature of the col...

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PUM

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Abstract

The invention relates to an ambroxol hydrochloride composition for injection and a preparation method thereof. The composition contains ambroxol hydrochloride and mannitol. The preparation method comprises the steps of: (1) preparing: placing the ambroxol hydrochloride and the mannitol in a preparation tank according to the proportion of 1:(1-4), adding water for injection, and stirring to ensure that the ambroxol hydrochloride and the mannitol are completely dissolved and uniformly mixed; (2) aseptically filtering, split-charging and plugging half; and (3) freezing and drying in vacuum to obtain the ambroxol hydrochloride composition. The ambroxol hydrochloride composition provided by the invention has the advantages of simple prescription, advanced process, uniform and stable quality, completely moisture dryness and better re-solubility.

Description

technical field [0001] The present invention relates to an ambroxol hydrochloride composition for injection and a preparation method thereof. The ambroxol hydrochloride composition prepared by the method can be used for the preventive treatment of postoperative pulmonary complications, accompanied by sputum Acute and chronic respiratory diseases with abnormal fluid secretion and poor expectoration function, especially the expectorant treatment of acute exacerbation of chronic bronchitis and asthmatic bronchitis, as well as the treatment of premature infants and neonatal respiratory distress syndrome. Background technique [0002] The chemical name of ambroxol hydrochloride is trans-4-(2-amino-3,5-dibromobenzylamino)cyclohexanol hydrochloride. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 13 h 18 Br 2 N 2 O·HCl [0006] Molecular weight: 414.58. [0007] Ambroxol Hydrochloride (Ambroxol Hydrochloride) is a new generation of expectorant ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/137A61P11/00A61P11/10
Inventor 张建义叶东赵砚荣
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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