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Application of the sulfur-butyl ether-belta-cyclodextrin in eyedrops of chloramphenicol and method thereof

A technology of sulfobutyl ether and application method, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, which can solve the problems of non-conformity with quality requirements, low solubility, and chloramphenicol eye drops. Solve problems such as agent precipitation, achieve thermal stability, improve stability, and reduce hemolysis

Inactive Publication Date: 2009-10-07
昆明振华制药厂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But beta-cyclodextrin can cause chloramphenicol eye drops to precipitate in storage due to its low solubility in water, which does not meet the quality requirements of chloramphenicol eye drops Pharmacopoeia (2005 edition)

Method used

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  • Application of the sulfur-butyl ether-belta-cyclodextrin in eyedrops of chloramphenicol and method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0107] Drug composition:

[0108] Chloramphenicol 2.625g / L

[0109] Borax 0.625g / L

[0110] Boric acid 17g / L

[0111] Phenylmercury acetate 0.02g / L

[0112] SBE-β-CD 20g / L

[0113] Water up to 1L

[0114] Standard: the content of chloramphenicol diol shall not exceed 8%, and p-nitrobenzaldehyde shall not exceed 0.5%.

[0115] Preparation method:

[0116] 1. Put the formula amount of chloramphenicol and SBE-β-CD into 150mL water, stir for 30 minutes to fully dissolve and mix evenly, then place it for later use;

[0117] 2. Put the formula amount of borax and boric acid into 300mL water, stir to dissolve them fully, and set aside;

[0118] 3. Put the formula amount of phenylmercuric acetate (or benzalkonium bromide, thimerosal) into 500mL water, stir well to dissolve it, place it for later use;

[0119] 4. Put the solutions in the above steps 1, 2, and 3 together into a container, stir for 10 minutes to mix them evenly, add water to 1L, fill them into a small bottle, and...

Embodiment 2

[0121] In the drug component, the dosage of SBE-β-CD is 10g / L, and the other ingredients and preparation method are the same as in Example 1.

Embodiment 3

[0123] In the drug component, the dosage of SBE-β-CD is 5g / L, and the other ingredients and preparation method are the same as in Example 1.

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Abstract

The present invention is application of the sulfur-butyl ether-belta-cyclodextrin in eyedrops of chloramphenicol and method thereof. Adding sulfur-butyl ether -belta-cyclodextrin into formula of the eyedrops of chloramphenicol, the addition is 10-80 g / L. The invention finds SBE-belta-CD (sulfur-butyl ether -belta-cyclodextrin) for improving stability of the eyedrops of chloramphenicol by a series of experiments, capable of improving dissolvability of the chloramphenicol for six times, and because of inclusion of the cavity structure to chloramphenicol, blocking chloramphenicol hydrolysis reaction catalyzed by various ions in solution effectively, degradation of the chloramphenicol in aqueous solution is greatly relieved, by experiments, accelerating for six months and normal temperature storing for 24 months, every index of the chloramphenicol eyedrops still conforms to request of the standard, content of chloramphenicol glycol is less than 8%, content of methyl aldehyde is 0, so stability of the chloramphenicol eyedrops is greatly improved.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to the application and method of sulfobutyl ether-beta-cyclodextrin in chloramphenicol eye drops. Background technique [0002] Chloramphenicol is D-threo-(-)-N-[α-(hydroxymethyl)-β-hydroxy-p-nitrophenethyl]-2,2-dichloroacetamide. It is white needle-like or slightly yellow-green needle-like, long flaky crystal or crystalline powder, bitter in taste, easily soluble in methanol, ethanol, acetone, propylene glycol; slightly soluble in water. [0003] Chloramphenicol, discovered in 1947, is a broad-spectrum antibiotic produced by Streptomyces venezuela, and it is also the world's first fully chemically synthesized antibiotic. Due to its wide antibacterial spectrum, good effect and low cost, it has been widely used in various dosage forms, such as tablets, capsules, oral suspensions, solutions, ointments, oils, injection powders and ophthalmic preparations. Clinical, but because it i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/48A61K31/165A61P27/02A61K47/69
Inventor 郭文李俊董维
Owner 昆明振华制药厂有限公司
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