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Bromhexine hydrochlorie injection, its preparation method and application

A technology of bromhexine hydrochloride and bromhexine hydrochloride, which is applied in the field of bromhexine hydrochloride injection and its preparation, can solve the problem of unstable content of raw material drug in injection, adverse effect of sterilization effect, disulfiram-like reaction of patients, etc. problems, to achieve the effect of stable and reliable product quality, safe and effective use, and safe use

Active Publication Date: 2013-02-20
HANKANG BIOCHEMICAL & PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the process of preparing bromhexine hydrochloride concentrated solution, ethanol needs to be used as solvent, but even under heating, ethanol has limited solubility to bromhexine hydrochloride, so a large amount of ethanol needs to be introduced in the injection, which makes bromhexine hydrochloride When Jixin injection is used in combination with antibiotics, it is likely to cause disulfiram-like reactions in patients, which is very harmful to the health of patients
[0006] Second, also due to the presence of ethanol in bromhexine hydrochloride injection, water and ethanol form an azeotrope during high temperature sterilization, which reduces the sterilization temperature and adversely affects the sterilization effect
[0007] Third, bromhexine hydrochloride concentrated solution may be cooled slightly, mixed with other carrier concentrated solutions, or diluted with water. Crystals of bromhexine hydrochloride may be precipitated and the crystallization amount is not fixed. After decolorization and filtration, the content of the raw material drug in the injection solution is unstable.

Method used

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  • Bromhexine hydrochlorie injection, its preparation method and application
  • Bromhexine hydrochlorie injection, its preparation method and application
  • Bromhexine hydrochlorie injection, its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1 bromhexine hydrochloride solubility research in water for injection

[0031] Accurately weigh 3 g of bromhexine hydrochloride sample, add 1000 ml of water for injection, shake for 20 minutes, no dissolution is seen, place it at room temperature, and observe bromhexine hydrochloride under 1500 lx fluorescent lamp at 30 minutes, 60 minutes, 120 minutes, 24 hours, 48 ​​hours and 72 hours respectively. The new dissolution situation, the results are as follows:

[0032] The solubility of table 1 bromhexine hydrochloride in water for injection (1)

[0033]

[0034] + means bromhexine hydrochloride precipitation can be detected

[0035] - Indicates no precipitation of bromhexine hydrochloride detected

[0036] Precisely weigh 3g of bromhexine hydrochloride sample, add 1000ml of water for injection, heat in a water bath at 70°C (with reflux condenser), stir at 60 rpm for 30min, most of it dissolves, and there is a small amount of precipitate. 60min, 120min, ...

Embodiment 2

[0046] Embodiment 2 bromhexine hydrochloride solubility research in glucose solution

[0047]Accurately weigh 3g of bromhexine hydrochloride sample, add 1000ml of 5% glucose injection, shake for 10min, partly dissolve, there is sediment, place at room temperature, respectively in 30min, 60min, 120min, 24h, 48h, 72h under 1500lx fluorescent lamp Next, observe the bromhexine hydrochloride dissolution situation, the results are as follows:

[0048] The solubility of table 4 bromhexine hydrochloride in glucose solution (1)

[0049]

[0050] + means bromhexine hydrochloride precipitation can be detected

[0051] - Indicates no precipitation of bromhexine hydrochloride detected

[0052] Accurately weigh 3g of bromhexine hydrochloride sample, add 1000ml of 5% glucose injection, heat in a water bath at 70°C (with a reflux condenser), stir at 60 rpm for 30min, and dissolve completely; place it at room temperature for 30min, 60min, and 120min respectively , 24h, 48h, 72h under t...

Embodiment 3

[0058] Example 3 Ultrasonic Treatment Stability Research in Bromhexine Hydrochloride Glucose Solution

[0059] Accurately weigh 3 g of bromhexine hydrochloride sample, add 1000 ml of 5% glucose injection, and dissolve completely by ultrasonic treatment (25 kHz, 100 w) at 30-40 °C for 50 min. Place it at room temperature, and observe the dissolution of bromhexine hydrochloride under 1500lx fluorescent lamp at 30min, 60min, 120min, 24h, 48h, and 72h respectively. The results are as follows:

[0060] The stability of bromhexine hydrochloride glucose solution after ultrasonic treatment of table 6

[0061]

[0062] + means bromhexine hydrochloride precipitation can be detected

[0063] - Indicates no precipitation of bromhexine hydrochloride detected

[0064] This group of experiments shows that ultrasonic treatment can make the bromhexine hydrochloride glucose solution not precipitated for more than 72 hours, indicating that ultrasonic treatment has a strong stabilizing eff...

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Abstract

The invention provides a bromhexine hydrochlorie injection, which contains bromhexine hydrochlorie and glucose and does not contain ethanol. Without ethanol, the injection can be used together with antibiotic drugs and has good stability. In accord with national regulations for pharmaceutical preparations, the injection has stable and reliable quality, and therefore can be used safely. The invention also provides a preparation method of the bromhexine hydrochlorie injection, comprising the steps of: preparing an isotonic water solution of glucose, then predissolving the bromhexine hydrochlorie in the isotonic water solution, and conducting an ultrasonic treatment. According to the method of the invention, the use of ethanol in the process of preparing a liquid preparation of bromhexine hydrochlorie can be avoided successfully, and possible adverse reactions during clinical application are avoided. With a process simple for operation, the method provided in the invention improves the stability of the injection.

Description

technical field [0001] The invention belongs to the technical field of pharmacy. Specifically, the present invention relates to a bromhexine hydrochloride injection and a preparation method thereof. Background technique [0002] Bromhexine Hydrochloride (Bromhexine Hydrochloride, N-(2-amino-3,5-dibromobenzyl)-N-methylcyclohexylamine hydrochloride) is the hydrochloride salt of a semi-synthetic ortholine derivative , the earliest active ingredient in the Indian folk expectorant and cough medicine Duckbill, first synthesized by Keck in 1963, and listed in 1965. It was launched in China in 1973. It is used for acute and chronic bronchitis, asthma, bronchiectasis, and emphysema. It is especially suitable for those who have difficulty coughing up white sticky phlegm and critical emergencies caused by extensive obstruction of small bronchi by sputum. It belongs to sticky phlegm. Dissolving medicine, which can change the viscous components of mucus, reduce the viscosity of sputum,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/137A61P11/10
Inventor 张凯杜玉民薛娜韩丰年马旭伟
Owner HANKANG BIOCHEMICAL & PHARMA CO LTD
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