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Composition of ambroxol hydrochloride and arginine and preparation method thereof

A technology of ambroxol hydrochloride and arginine, applied in the field of medicine, can solve the problems of water solubility and stability of side effects, influence of main drug stability, and high dosage of auxiliary materials, and achieves excellent appearance, low packaging material requirements, and bioavailability. high effect

Inactive Publication Date: 2010-06-30
HAINAN SIHUAN PHARMA +1
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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 ingredients of the auxiliary materials added in the main drug of ambroxol hydrochloride are complex, the stability of the main drug is affected, and when the amount of added auxiliary materials is high, unknown side effects may be caused
In order to overcome the side effects caused by the complex components of auxiliary materials or the high dosage and the problems of poor water solubility and stability of ambroxol hydrochloride, to make patients use safer and lower cost, the inventor provides a kind of ambroxol hydrochloride Composition with arginine and preparation method thereof

Method used

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  • Composition of ambroxol hydrochloride and arginine and preparation method thereof
  • Composition of ambroxol hydrochloride and arginine and preparation method thereof
  • Composition of ambroxol hydrochloride and arginine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Ambroxol Hydrochloride 15g

[0036] Arginine 0.15g

[0037] Lactose 70g

[0038] Add water for injection to 2000mL

[0039]

[0040] A total of 1000 bottles were made

[0041] Weigh 15g of ambroxol hydrochloride and 0.15g of arginine, put them in a suitable container, add about 1500mL of water for injection, stir to dissolve completely, add 70g of lactose, stir to dissolve, add water for injection to 2000mL, add 0.1% (g / mL) activated carbon for injection and stirred for 30 minutes, filtered through a Buchner funnel to decarbonize, filtered through a No. 4 vertical fusion filter ball, filtered through a 0.22 μm filter membrane until clear, and filled in antibiotic glass at a volume of 2 mL per bottle Bottles are half-plugged with butyl rubber stoppers, plated, and sent to pre-freezing boxes for pre-freezing treatment. When the temperature of the material drops to 10-20°C below the eutectic point, quickly take out the sample to the freeze-dr...

Embodiment 2

[0043] Ambroxol Hydrochloride 15g

[0044] Arginine 0.15g

[0045] Mannitol 70g

[0046] Add water for injection to 2000mL

[0047]

[0048] A total of 1000 bottles were made

[0049] Weigh 15g of ambroxol hydrochloride and 0.15g of arginine, put them in a suitable container, add about 1500mL of water for injection, stir to dissolve completely, add 70g of mannitol, stir to dissolve, add water for injection to 2000mL, and the rest are the same as Example 1.

Embodiment 3

[0051] Ambroxol Hydrochloride 15g

[0052] Arginine 0.75g

[0053] Lactose 70g

[0054] Add water for injection to 2000mL

[0055]

[0056] A total of 1000 bottles were made

[0057] Weigh 15g of ambroxol hydrochloride and 0.75g of arginine, put them in a suitable container, add about 1500mL of water for injection, stir to dissolve completely, add 70g of lactose, stir to dissolve, add water for injection to 2000mL, and implement the rest in the same way example 1.

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Abstract

The invention belongs to the technical field of medicine, in particular to a composition of ambroxol hydrochloride and arginine and a preparation method thereof. The weight ratio of the ambroxol hydrochloride and the arginine in the composition is 1:0.01 to 0.8. The invention also provides a preparation method of freeze-dried powder preparation of the composition, and a use of the composition in the preparation of expectorant drugs.

Description

1. Technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a composition of ambroxol hydrochloride and arginine, a preparation method thereof, and an application in preparation of drugs for treating expectorant. 2. Background technology [0002] Ambroxol (Ambroxol) is the active metabolite of bromhexine, the chemical name is trans-4-[(2-amino-3,5-dibromophenyl)]cyclohexanol, which is a respiratory lubricating expectorant Drugs and mucolytic drugs have the characteristics of promoting mucus elimination and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, 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. Its preparation method and pharmacological effects have been published in US Patent No. 3,536,...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K47/16A61K9/19A61J3/02A61P11/10
Inventor 车冯升郭维城贾中新霍彩霞孟宪慧
Owner HAINAN SIHUAN PHARMA
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