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Bromhexine hydrochloride injection as well as preparation method and application thereof

A technology of bromhexine hydrochloride and injection, which is applied in the field of bromhexine hydrochloride injection and its preparation, and can solve the problems of increased overall cost, high cost, and increased breeding burden on farmers

Pending Publication Date: 2022-07-05
QINGDAO AGRI UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the patent CN104306329A does not contain glucose, it uses mannitol, xylitol, and sorbitol as stability to ensure the stability of bromhexine hydrochloride injection; but the cost of mannitol, xylitol, and sorbitol is relatively high, resulting in overall cost increase, increasing the breeding burden of farmers

Method used

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  • Bromhexine hydrochloride injection as well as preparation method and application thereof
  • Bromhexine hydrochloride injection as well as preparation method and application thereof
  • Bromhexine hydrochloride injection as well as preparation method and application thereof

Examples

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preparation example Construction

[0048] The present invention also provides the preparation method of the bromhexine hydrochloride injection described in the above technical scheme, comprising the following steps:

[0049] Deoxidize water for injection to obtain deoxygenated water for injection;

[0050] Mixing deoxygenation water for injection, methylparaben and propylparaben to obtain the initial mixture;

[0051] The initial mixture is mixed with DL-tartaric acid, and deoxygenated water for injection is added to nearly the full amount to obtain a middle mixture;

[0052] The intermediate mixture and bromhexine hydrochloride are mixed, and the pH value and quantification are adjusted successively to obtain the bromhexine hydrochloride injection.

[0053] In the present invention, unless otherwise specified, the raw materials used in the present invention are preferably commercially available products.

[0054]The present invention deoxidizes water for injection to obtain deoxygenated water for injection. ...

Embodiment 1

[0066] 10L bromhexine hydrochloride injection contains: bromhexine hydrochloride 30g, methylparaben 7g, propylparaben 3g, DL-tartaric acid 10g, and the balance is water for injection.

[0067] The above-mentioned preparation method of bromhexine hydrochloride injection for veterinary use, comprising:

[0068] Step 1, take 8L water for injection, heat and boil for 5 minutes, remove the oxygen in the water for injection, and control the residual oxygen to be less than 0.2%. During the deoxygenation process, nitrogen flushing protection is continuously carried out above the dosing tank to prevent oxygen redissolving.

[0069] Step 2, when the temperature of the deoxygenated water for injection drops to 80-90° C., add methylparaben and propylparaben, and stir until completely dissolved to obtain a primary mixture;

[0070] Step 3, when the temperature of the initial mixture drops to 40-50°C, add DL-tartaric acid, add deoxygenated water for injection to nearly the full amount, and...

Embodiment 2

[0075] The difference from Example 1 is: propyl p-hydroxybenzoate is 3.5 g, and the rest are the same as in Example 1.

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Abstract

The invention belongs to the technical field of bromhexine hydrochloride injection, and provides bromhexine hydrochloride injection as well as a preparation method and application thereof. According to the bromhexine hydrochloride injection provided by the invention, every 100 mL of the bromhexine hydrochloride injection consists of the following components: 0.1-1 g of bromhexine hydrochloride; the content of methyl p-hydroxybenzoate is 0.05 to 0.1 g; the content of propyl p-hydroxybenzoate is 0.01 to 0.06 g; the content of DL-tartaric acid is 0.1 to 0.35 g; a pH regulator and water for injection. The bromhexine hydrochloride injection provided by the invention takes methyl p-hydroxybenzoate and propyl p-hydroxybenzoate as bactericidal preservatives, so that the stability of the bromhexine hydrochloride injection is ensured under the condition of lower content.

Description

technical field [0001] The invention relates to the technical field of bromhexine hydrochloride injection, in particular to a bromhexine hydrochloride injection and a preparation method and application thereof. Background technique [0002] Bromhexine hydrochloride is a synthetic herbal active ingredient Drosophila derivative. It is mainly used in clinical medicine for respiratory system. It can act on bronchial glands, reduce the viscosity of sputum, and make phlegm. The liquid becomes thinner and easier to cough up. Clinically, it is mainly used for chronic bronchitis, asthma and other respiratory system diseases, and the sputum viscosity caused by it is too high, which is not easy to cough up. The drug can be absorbed rapidly, has high bioavailability, stable properties, and relatively high safety. Stomach discomfort such as nausea can be seen occasionally. At present, the application form of bromhexine hydrochloride in veterinary clinic is mainly soluble powder. The so...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/12A61K47/14A61P11/12
CPCA61K31/137A61K9/08A61K9/0019A61K47/14A61K47/12A61P11/12
Inventor 赵永达王丽华林姝君
Owner QINGDAO AGRI UNIV
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