Ambroxol hydrochloride glucose injection and preparation method thereof

A technology for glucose injection and ambroxol hydrochloride, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of decreased content, increased pollution opportunities, poor chemical stability, etc. , to achieve the effect of reducing the level of thermal degradation, improving tolerance and improving stability

Active Publication Date: 2013-04-03
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the patent CN 200710059969.6 (a kind of ambroxol hydrochloride injection) a kind of ambroxol hydrochloride small-capacity injection (not containing glucose) is provided, and it adopts the method for controlling solution pH value and adding stabilizer to solve the problem of ambroxol hydrochloride in The problem of the increase of related substances under oxidative or alkaline conditions, but increases the complexity of the formulation, and the addition of surfactants also increases unsafe factors
Patent 200510118511.4 (high-dose ambroxol hydrochloride freeze-dried preparation and preparation method) provides a glucose-free ambroxol hydrochloride freeze-dried preparation

Method used

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  • Ambroxol hydrochloride glucose injection and preparation method thereof
  • Ambroxol hydrochloride glucose injection and preparation method thereof
  • Ambroxol hydrochloride glucose injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0063] Experimental Example 1 Ambroxol Hydrochloride Composition Injection Stability Experiment of the present invention

[0064] 1.1 Stability of Ambroxol Hydrochloride Glucose Injection:

[0065] Directly prepare Ambroxol Hydrochloride Glucose Injection according to conventional methods, promptly take by weighing the prescribed amount of glucose, Ambroxol Hydrochloride and place it in the liquid preparation tank, add water for injection to the full amount, measure pH, fill after filtration, seal at 121 Sterilize at ℃ for 12 minutes, and the test results are shown in Table 1.

[0066] Table 1 Quality Comparison of Ambroxol Hydrochloride Glucose Injection Before and After Sterilization

[0067]

[0068] As can be seen from Table 1, the quality of ambroxol hydrochloride glucose injection prepared with simple prescription and preparation method changes greatly before and after sterilization. The pH drops significantly, and the related substances increase significantly. When...

experiment example 2

[0119] Experimental example 2 Ambroxol hydrochloride glucose injection detection experiment of the present invention

[0120] The ambroxol hydrochloride glucose injection of the present invention prepared in Examples 1-6 was tested, and the results are shown in Table 12.

[0121] Table 12 Ambroxol hydrochloride glucose injection detection data of the present invention

[0122]

[0123] The following embodiments can all achieve the effects described in the above experimental examples.

Embodiment 1

[0124] The preparation of embodiment 1 injection

[0125] Ambroxol hydrochloride 0.15g glucose 50g

[0126] Weigh glucose and ambroxol hydrochloride and place them in a liquid mixing tank, add water for injection at 40°C to 1000ml, add hydrochloric acid to adjust the pH value to 3.8, measure the pH value and the content of ambroxol hydrochloride to pass, and filter through a 0.22μm micropore Membrane filtration until the medicinal solution is clear, filled, covered, sterilized at 121°C / 12min, ready to serve.

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Abstract

The invention discloses an ambroxol hydrochloride glucose injection and a preparation method thereof. The ambroxol hydrochloride glucose injection comprises the following components: ambroxol hydrochloride, glucose, water for injection, and a pH regulator. The preparation method for the injection comprises the following steps of: getting the water for injection, adding glucose for dissolving, adding active carbon to adsorb and decarburizing, putting filtrate to a diluted solution tank, adding ambroxol hydrochloride and all water for injection, stirring and dissolving, regulating the pH value of the solution, filtering the solution through a microfiltration membrane until the solution is clear, filling the clear solution, capping the filled solution and carrying out terminal sterilization; or weighing and adding glucose and ambroxol hydrochloride to a preparation tank; adding all water for injection, stirring and dissolving, regulating the pH value of the solution to a determined range, filtering the solution until the medical solution is clear after that the pH value of the solution and the content of the ambroxol hydrochloride and glucose are qualified, filling, capping and carrying out terminal sterilization to the clear solution to obtain the ambroxol hydrochloride glucose injection. The ambroxol hydrochloride glucose injection has good stability, medication safety and effectiveness and a simple process, and is applicable to large-scale industrial production.

Description

technical field [0001] The invention relates to a composition and a preparation method thereof, in particular to an ambroxol hydrochloride glucose injection and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride chemical name: trans 4-[(2-amino-3,5 dibromo-phenyl) methyl-amino] cyclohexanol, the structure is as follows: [0003] [0004] Ambroxol hydrochloride is a new generation of respiratory mucus regulator with superior expectorant effect. Ambroxol hydrochloride 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 retention of mucus, thus significantly promoting expectoration and improving respiratory conditions. It is suitable for acute and chronic respiratory diseases accompanied by abnormal sputum secretion and poor expectoration function. It is one of the widely used expectorant drugs in clinical practice, with...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/26A61P11/10
Inventor 蔡勤张令陶国碧
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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