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Ambroxol hydrochloride composition injection

A technology of ambroxol hydrochloride and composition, which is applied in the field of ambroxol hydrochloride composition injection and its preparation, can solve problems such as increasing production process, unstable performance, increasing production cost, etc., and achieves reducing discomfort, composition Simple, Highly Stable Effects

Active Publication Date: 2010-09-22
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because ambroxol hydrochloride is under oxidation or alkaline condition, performance is unstable, decomposes free ambroxol, and related substance increases in storage process, affects the quality and safety of medicine, in prior art, hydrochloric acid The pH of the solution of ambroxol is controlled at relatively low or adds stabilizer, improves the stability of ambroxol hydrochloride injection, but in the course of medication, because low pH can bring discomfort to human body, or use stabilizer, increased production process, but also increased production costs

Method used

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  • Ambroxol hydrochloride composition injection
  • Ambroxol hydrochloride composition injection
  • Ambroxol hydrochloride composition injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Prescription: 1000 sticks

[0054] Ambroxol Hydrochloride 16g

[0055] Citric acid 2.8g

[0056] Disodium hydrogen phosphate 4.9g

[0057] Sodium chloride 15g

[0058] Water for injection 1800ml.

[0059] Preparation:

[0060] In the ambroxol hydrochloride of recipe quantity, citric acid, disodium hydrogen phosphate, sodium chloride solution water for injection, wherein the consumption of water for injection is 70% of total water consumption, stirring makes it dissolve and measures pH between 5.5, then Add 0.02% activated carbon, stir at room temperature for about 10 minutes, filter to remove the activated carbon, then add water for injection to the full amount, and then carry out fine filtration, pot sealing, and sterilization.

Embodiment 2

[0062] Prescription: 1000 sticks

[0063] Ambroxol Hydrochloride 15g

[0064] Citric acid 3.0g

[0065] Disodium hydrogen phosphate 5.0g

[0066] Sodium chloride 14g

[0067] Water for injection 2000ml.

[0068] Preparation:

[0069] In the ambroxol hydrochloride of recipe quantity, citric acid, disodium hydrogen phosphate, sodium chloride solution water for injection, wherein the consumption of water for injection is 75% of total water consumption, stirring makes it dissolve and measures pH between 5.8, then Add 0.03% activated carbon, stir at room temperature for about 20 minutes, filter to remove the activated carbon, then add water for injection to the full amount, and then carry out fine filtration, pot sealing, and sterilization.

Embodiment 3

[0071] Prescription: 1000 sticks

[0072] Ambroxol Hydrochloride 16g

[0073] Citric acid 2.6g

[0074] Disodium hydrogen phosphate 5.3g

[0075] Sodium chloride 15g

[0076] Water for injection 2500ml.

[0077] Preparation:

[0078] In the ambroxol hydrochloride of prescription quantity, citric acid, disodium hydrogen phosphate, sodium chloride solution water for injection, wherein the consumption of water for injection is 70% of total water consumption, stirring makes it dissolve and measures pH between 6.7, then Add 0.02% activated carbon, stir at room temperature for about 20 minutes, filter to remove activated carbon, then add water for injection to the full amount, and then carry out fine filtration, pot sealing, and sterilization.

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PUM

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Abstract

The invention provides an ambroxol hydrochloride composition, which comprises the following components in parts by weight: 14-16 parts of ambroxol hydrochloride, 2.6-3.2 parts of citric acid, 4.8-6.0 parts of disodium hydrogen phosphate and 13-16 parts of sodium chloride. The components of the ambroxol hydrochloride injection prepared by the composition are simple. Under the condition with higher PH (5.5-7.0), the stability of ambroxol hydrochloride of the active medicine is higher, so the invention is suitable for the injecting of the human body, can reduce the uncomfortableness of a patient when the patient is injected.

Description

technical field [0001] The present invention relates to a kind of ambroxol hydrochloride composition, more specifically, relate to a kind of ambroxol hydrochloride composition injection and preparation method thereof. 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: [0004] [0005] Ambroxol hydrochloride is ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/12A61P11/10
Inventor 李明华李志滨沈文
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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