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Chloramphenicol ophthalmic preparation and method for preparing the same

An ophthalmic preparation and a technology for chloramphenicol, which are applied in the field of chloramphenicol ophthalmic preparations and their preparation, can solve the problems of complex packaging, high glycol content, poor solubility of chloramphenicol, etc. Effect

Inactive Publication Date: 2009-06-24
吴文耀
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Because chloramphenicol is unstable in aqueous solution, it is easy to decompose to produce related substances such as glycols, so the chloramphenicol eye drops currently on the market include those products that are marked with a validity period of two years in the packaging box and instruction manual. After being left for 8-10 months, according to the quality standard inspection of chloramphenicol eye drops in the second part of the Chinese Pharmacopoeia 2005 edition (the content is too low or the glycol content is too high)
Though present technology existing report solves the unstable technology of chloramphenicol eye drops, discloses a kind of dropping pill type chloramphenicol eye drops and preparation method thereof as CN 1872038A, but this technology does not solve the problem that chloramphenicol is dissolved in water. The problem of poor sex (chloramphenicol is slightly soluble in water), chloramphenicol is difficult to dissolve in the buffer when the patient uses it; and the packaging is complicated and inconvenient to use

Method used

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  • Chloramphenicol ophthalmic preparation and method for preparing the same
  • Chloramphenicol ophthalmic preparation and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] prescription:

[0012] β-cyclodextrin 8.78g

[0013] Chloramphenicol 2.5g

[0014] Boric acid 11g

[0015] Borax 1.2g

[0016] Ethyl p-hydroxybenzoate 0.3g

[0017] Sodium chloride 5g

[0018] Add water for injection to 1000ml

[0019] Preparation:

[0020] 1. Take about 150ml of water for injection, put it in a 400ml beaker, heat it to 60°C, add β-cyclodextrin under stirring, after dissolving, add chloramphenicol under heat preservation and stirring, and continue heat preservation and stirring for 2 hours after dissolving to obtain β-cyclodextrin chloramphenicol mixed solution.

[0021] 2. Take 850ml of water for injection, add boric acid, borax, ethyl p-hydroxybenzoate and sodium chloride, heat and stir to dissolve, then add the above-mentioned β-cyclodextrin chloramphenicol mixed solution, heat and sterilize, cool, and set container, filter and fill.

Embodiment 2

[0023] prescription:

[0024] β-cyclodextrin 8.78g

[0025] Chloramphenicol 2.5g

[0026] Boric acid 11g

[0027] Borax 1.2g

[0028] Ethyl p-hydroxybenzoate 0.3g

[0029] Sodium chloride 5g

[0030] Sodium Hyaluronate 1.0g

[0031] Add water for injection to 1000ml

[0032] Preparation:

[0033] 1. Take about 150ml of water for injection, put it in a 400ml beaker, heat it to 60°C, add β-cyclodextrin under stirring, after dissolving, add chloramphenicol under heat preservation and stirring, and continue heat preservation and stirring for 2 hours after dissolving to obtain β-cyclodextrin chloramphenicol mixed solution.

[0034] 2. Take 400ml of water for injection, add sodium hyaluronate to soak to dissolve it, take another 450ml of water for injection, add boric acid, borax, ethyl p-hydroxybenzoate and sodium chloride, heat and stir to dissolve, heat to sterilize, and cool to about 60°C, then add the above-mentioned β-cyclodextrin chloramphenicol mixed solution and so...

Embodiment 3

[0036] Take 1000ml of water for injection, put it in a 2000ml beaker, and heat it to 60°C; weigh 100g of β-cyclodextrin, and add it under stirring; then weigh 28.4g of chloramphenicol, add it into the above solution under stirring, and continue stirring , make it completely dissolved, continue to stir for 2 hours under heat preservation, let it cool, place it at 0-5°C for about 10 hours, filter to obtain a mixture of β-cyclodextrin and chloramphenicol, dry it in vacuum at low temperature, and use high-efficiency liquid phase The chloramphenicol content was determined to be 20.66%. Then prepare chloramphenicol eye drops according to the following prescription and preparation method:

[0037] prescription:

[0038] β-cyclodextrin chloramphenicol mixture 12.1g (containing chloramphenicol 2.5g)

[0039] Boric acid 11g

[0040] Borax 1.2g

[0041] Ethyl p-hydroxybenzoate 0.3g

[0042] Sodium chloride 5g

[0043] Add water for injection to 1000ml

[0044] Preparation:

[004...

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PUM

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Abstract

The invention relates to an ophthalmic preparation, which contains chloramphenicol and beta-cyclodextrin or derivatives thereof, and also optionally contains the prior additive and water. The ophthalmic preparation is characterized by comprising at least one beta-cyclodextrin or the derivatives thereof, the mol ratio of the content of the beta-cyclodextrin or the derivatives thereof to the content of the chloramphenicol is 1-2: 1, and an appropriate method is used to prepare the steady preparation. Compared with chloramphenicol eye drops which have come into the market at home and abroad, the ophthalmic preparation is steadier at normal temperature.

Description

technical field [0001] The invention relates to a chloramphenicol ophthalmic preparation and a preparation method thereof, in particular to a chloramphenicol ophthalmic preparation which contains special auxiliary materials and is prepared by a specific method and is more stable than the currently commercially available chloramphenicol eye drops. Background technique [0002] Chloramphenicol (Chloramphenicol, C 11 h 12 Cl 2 N 2 o 5 , molecular weight 323.13) is an amide alcohol antibiotic, the main antibacterial spectrum includes Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Neisseria gonorrhoeae, meningococcus, Haemophilus influenzae, Listeria, Brucella, sepsis Pasteurella hemorrhagic, Bacillus diphtheriae, Mycoplasma, Chlamydia, Rickettsia, Spirochetes and some anaerobes. Its eye drops are used to treat eye infections caused by Escherichia coli, Haemophilus influenzae, Klebsiella, Staphylococcus aureus, hemolytic streptococcus and other sen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/165A61K9/00A61K9/08A61K9/16A61K9/20A61K47/40A61P27/02A61P31/04
Inventor 吴文耀汪玲蔡葵
Owner 吴文耀
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