Bromhexine hydrochloride composition freeze-dried powder for injection

A technology of bromhexine hydrochloride and freeze-dried powder injection, which is applied in the field of medicine and medicine manufacturing, can solve the problems of high risk of clinical use and acute renal failure, and achieve the goal of avoiding renal failure, enhancing solubility and high stability Effect

Inactive Publication Date: 2014-02-12
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The current bromhexine composition contains a variety of excipients, the more excipients, the greater the risk of clinical use of the drug, especially mannitol, almost all of the existing bromhexine freeze-dried powder injections contain mannitol, mannitol in Clinically at risk for acute renal failure

Method used

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  • Bromhexine hydrochloride composition freeze-dried powder for injection
  • Bromhexine hydrochloride composition freeze-dried powder for injection
  • Bromhexine hydrochloride composition freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1. Preparation of bromhexine hydrochloride composition freeze-dried powder for injection (specification: 4 mg, calculated as bromhexine hydrochloride), calculated in 1000 vials.

[0041] 1. Prescription:

[0042] Bromhexine Hydrochloride 4g

[0043] Chitosan Nanoparticles 3.6g

[0044] Water for injection 2000ml

[0045] 2. Preparation process:

[0046] (1) Slowly add 3.6g of chitosan nanoparticles into the prescribed amount of water for injection (theoretical loading is 2ml / bottle), and stir until dissolved while adding.

[0047] (2) Continue to add 4g of bromhexine hydrochloride and stir to dissolve until clear.

[0048] (3) Use sodium hydroxide to adjust the pH to 4.0, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then conduct decarburization circulation and filtration through titanium rods for 30 minutes; then conduct sterilization cycles through 0.45 μm and 0.22 μm Filtrate for 30 minutes; detect the content of t...

Embodiment 2

[0050] Example 2: Preparation of bromhexine hydrochloride composition freeze-dried powder for injection (specification: 4 mg, calculated as bromhexine hydrochloride), calculated in 1000 vials.

[0051] 1. Prescription:

[0052] Bromhexine Hydrochloride 4g

[0053] Chitosan Nanoparticles 4g

[0054] Water for injection 2000ml

[0055] 2. Preparation process:

[0056] (1) Slowly add 4g of chitosan nanoparticles into the prescribed amount of water for injection (theoretical loading is 2ml / bottle), and stir until dissolved while adding.

[0057] (2) Continue to add 4g of bromhexine hydrochloride and stir to dissolve until clear.

[0058] (3) Use sodium hydroxide to adjust the pH to 4.0, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then conduct decarburization circulation and filtration through titanium rods for 30 minutes; then conduct sterilization cycles through 0.45 μm and 0.22 μm Filtrate for 30 minutes; detect the content of the int...

Embodiment 3

[0060] Example 3. Preparation of bromhexine hydrochloride composition freeze-dried powder for injection (specification: 4 mg, calculated as bromhexine hydrochloride), calculated in 1000 vials.

[0061] 1. Prescription:

[0062] Bromhexine Hydrochloride 4g

[0063] Chitosan Nanoparticles 3.2g

[0064] Water for injection 2000ml

[0065] 2. Preparation process:

[0066] (1) Slowly add 3.2g of chitosan nanoparticles into the prescribed amount of water for injection (theoretical loading is 2ml / bottle), and stir until dissolved while adding.

[0067] (2) Continue to add 4g of bromhexine hydrochloride and stir to dissolve until clear.

[0068] (3) Use sodium hydroxide to adjust the pH to 4.0, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then conduct decarburization circulation and filtration through titanium rods for 30 minutes; then conduct sterilization cycles through 0.45 μm and 0.22 μm Filtrate for 30 minutes; detect the content of t...

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Abstract

The invention provides bromhexine hydrochloride composition freeze-dried powder for injection, which relates to the field of medicines and medicine manufacturing technology. The bromhexine hydrochloride composition freeze-dried powder for injection comprises the following raw material components in parts by weight: 1 part of bromhexine hydrochloride, 0.5-1.3 parts of chitosan nanoparticles and 5-10 parts of injection water. The bromhexine hydrochloride composition freeze-dried powder for injection provided by the invention has the advantages that: 1) the chitosan nanoparticles replace mannitol to serve as a skeleton agent of the freeze-dried powder for injection, the obtained product is good in shape, high in stability and capable of avoiding a kidney failure risk caused by clinic use of the mannitol; 2) the bromhexine hydrochloride is slightly soluble in water, the chitosan nanoparticles can also be used as a cosolvent of the hydrochloride bromhexine to improve the solubleness of the hydrochloride bromhexine and facilitate industrial production and clinic use; and 3) the chitosan nanoparticles have certain antibacterial activity, when being clinically used with the hydrochloride bromhexine, the chitosan nanoparticles can cooperatively treat respiratory tract infection accompanied with a symptom that viscous sputum is unlikely to expectorate caused by sensitive bacteria.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a bromhexine hydrochloride composition freeze-dried powder for injection. Background technique: [0002] Bromhexine hydrochloride, the chemical name is N-(2-amino-3,5-dibromobenzyl)-N-methylcyclohexylamine hydrochloride, very slightly soluble in water and ethanol, soluble in hot ethanol, insoluble In acetone, chloroform, odorless, tasteless. Its chemical structural formula is shown in the following formula. This product was first synthesized by Keck in 1963 and listed in 1965. my country began to produce it in 1973. It was first recorded in the 1977 edition of "Chinese Pharmacopoeia", and the name is bromhexylamine hydrochloride; "Chinese Pharmacopoeia" The 1985 version was renamed bromhexine hydrochloride. [0003] This strain is a new type of mucus-dissolving expectorant synthesized from the active ingredient fenacine proposed in the medicinal plant ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/137A61K47/36A61K31/722A61P11/10A61P11/12A61P31/04
Inventor 汪六一汪金灿程贤贵
Owner HAINAN WEI KANG PHARMA QIANSHAN
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