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Composition of ambroxol hydrochloride and cysteine and preparation method thereof

A technology of ambroxol hydrochloride and cysteine, applied in the preparation of expectorant drugs, the field of ambroxol hydrochloride and cysteine ​​composition, can solve the problem of unsatisfactory water solubility of ambroxol hydrochloride, etc. problems, to achieve the effect of improving bioavailability, less clinical dosage, and easy storage and transportation

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

[0008] The object of the present invention is to provide a composition of ambroxol hydrochloride and cysteine, solve the problem of unsatisfactory water solubility of ambroxol hydrochloride, and further improve the safety of clinical medication

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] 1. Prescription:

[0056] Ambroxol Hydrochloride 15g

[0057] Cysteine ​​450g

[0058] Mannitol 70g

[0059] Add water for injection to 2000mL

[0060]

[0061] A total of 1000 sticks were prepared

[0062] 2. Preparation process:

[0063] 1) Weigh 15g of ambroxol hydrochloride and 450g of cysteine, place in a suitable container, add about 1500mL of water for injection, stir to make it completely dissolve;

[0064] 2) Add 70g of mannitol, stir to dissolve, add water for injection to 2000mL;

[0065] 3) Add 0.1% (g / mL) activated carbon for needles and stir for 30 minutes;

[0066] 4) Decarburization by Buchner funnel filtration, filtration by No. 4 vertical fusion filter ball, filtration by 0.22 μm filter membrane until clear;

[0067] 5) Check the clarity;

[0068] 6) determination of content;

[0069] 7) Filling, filling with a filling volume of 2mL per bottle;

[0070] 8) Sterilize by autoclaving at 121°C for 20 minutes;

[007...

Embodiment 2

[0076] 1. Prescription:

[0077] Ambroxol Hydrochloride 15g

[0078] Cysteine ​​300g

[0079] Lactose 70g

[0080] Add water for injection to 2000mL

[0081]

[0082] A total of 1000 sticks were prepared

[0083] 2. Preparation process: refer to Example 1.

Embodiment 3

[0085] 1. Prescription:

[0086] Ambroxol Hydrochloride 15g

[0087] Cysteine ​​150g

[0088] Lactose 70g

[0089] Add water for injection to 2000mL

[0090]

[0091] A total of 1000 sticks were prepared

[0092] 2. Preparation process: refer to 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 cysteine and a preparation method thereof. The weight ratio of the ambroxol hydrochloride and the cysteine in the composition ranges from 1: 30 to 30:1. The invention also provides the preparation method of the injection preparation of the composition, and application 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 cysteine, a preparation method and its application in the preparation of drugs for treating expectorant. 2. Background technology [0002] Ambroxol (Ambroxol) is the active metabolite of bromhexine. The expectorant drug has low toxicity, definite curative effect, and stronger expectorant effect than bromhexine. Its preparation method and pharmacological effects have been published in US Patent No. 3,536,713. The drug was used clinically in the form of hydrochloride in 1984. Its clinical application has been published in Respiration 51Suppl.1, 37 (1987). At present, ambroxol hydrochloride has been widely used in the treatment of respiratory diseases in many countries such as the United States, Britain, Germany, Japan and other countries, with excellent clinical effects, and its curative effect has been confirmed by clin...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K47/20A61K9/08A61J3/00A61P11/10
Inventor 车冯升郭维城贾中新霍彩霞孟宪慧
Owner HAINAN SIHUAN PHARMA
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