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Ganciclovir ophthalmic gel and its prepn. method

A technology of gel preparation and ophthalmic gel, which is applied in the direction of non-active ingredient medical preparations, pharmaceutical formulas, antiviral agents, etc., and can solve the problems of difficult control of dosage, low bioavailability, and short duration of drug efficacy, etc. problems, to achieve the effect of avoiding drug loss, reducing the dosage and prolonging the time limit of action

Inactive Publication Date: 2006-11-29
湖北科益药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main problem of eye drops is that the bioavailability is low, about 95% of the active drug will be lost, the drug effect is maintained for a short time, and the administration is frequent. Generally, it is prescribed to administer 3 to 5 times / day, but in actual application, it can be as much as 10-20 times / day, the dosage is not easy to control, and the pharmacological peaks and valleys are prominent due to the inconvenience of administration at night; and the matrix in the ointment can cause blurred vision due to its transparency and refractive index

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] per 1000g gel

[0016] Ganciclovir 1.5g (pure)

[0017] Carbomer 3.0g

[0018] Mannitol 15.0g

[0019] 10% sodium hydroxide solution 10.0g~100.0g

[0020] Benzalkonium Bromide 0.075g

[0021] Add distilled water to 1000.0g

[0022] Take the prescribed amount of carbomer, add an appropriate amount of distilled water to swell; in addition, dissolve the main ingredients of the prescribed amount of ganciclovir, mannitol, benzalkonium bromide, etc. in distilled water, stir to dissolve, and pass through a 0.30 μm microporous membrane After bacterial filtration, add the filtrate to the carbomer matrix, adjust the pH to 7.0-8.5 with 10% sodium hydroxide solution, add distilled water to a sufficient amount, stir to form a uniform gel, sterilize at 115°C for 30 minutes, and take a sample Measure the pH value and content, and after passing the test, aseptically fill it to obtain the product.

Embodiment 2

[0024] per 1000g gel

[0025] Ganciclovir 1.5g (pure)

[0026] Carbomer 5.0g

[0027] Mannitol 10.0g

[0028] 10% sodium hydroxide solution 10.0g~100.0g

[0029] Benzalkonium Chloride 0.075g

[0030] Add distilled water to 1000.0g

[0031] Take the prescription amount of carbomer, add appropriate amount of distilled water to swell; in addition, dissolve the prescription amount of main ingredients such as ganciclovir, mannitol, and paraben in distilled water, stir to dissolve, and sterilize through a 0.30 μm microporous membrane After filtering, add the filtrate to the carbomer matrix, adjust the pH to 7.0-8.5 with 10% sodium hydroxide solution, add distilled water to a sufficient amount, stir to form a uniform gel, sterilize at 115°C for 30 minutes, and take samples for measurement After the pH value and content are up to standard, it is aseptically filled to obtain the product.

Embodiment 3

[0033] per 1000g gel

[0034] Ganciclovir 2.0g (pure)

[0035] Hydroxypropyl Cellulose 10.0g

[0036] Sodium chloride 10.0g

[0037] Triethanolamine 30.0g~100.0g

[0038] Paraben 0.2g

[0039] Add distilled water to 1000.0g

[0040] Take the prescription amount of hydroxypropyl cellulose, add appropriate amount of distilled water to swell; in addition, dissolve the prescription amount of the main drug ganciclovir, sodium chloride, benzalkonium chloride, etc. in distilled water, stir to dissolve, and pass through 0.30μm micropore After the filter membrane is sterilized and filtered, add the filtrate to the hydroxypropyl cellulose matrix, adjust the pH to 7.0-8.5 with triethanolamine, add distilled water to a sufficient amount, stir to form a uniform gel, and sterilize at 115°C for 30 minutes. Sampling is taken to measure the pH value and content, and after passing the test, it is aseptically filled to obtai...

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PUM

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Abstract

An eye gel of Ganciclovir for treating viral keratitis is proportionally prepared from ganciclovir and eye gel matrix through mixing Ganciclovir, eye gel matrix and water, stirring, regulating pH value, adding water, stirring and sterilizing.

Description

technical field [0001] The invention belongs to an anti-herpes virus medicine, in particular to a ganciclovir ophthalmic gel preparation and a preparation method. Background technique [0002] Viral disease is an infectious disease that seriously endangers human health, and is one of the infectious diseases with the highest incidence in the world. Herpes simplex keratitis (HSK) caused by herpes simplex virus type 1 (HSV-1) is the The most common viral infection can involve the sclera, conjunctiva, and uvea, and is also latent, characterized by recurrent attacks, resulting in visual impairment. HSV is the main cause of eye infection in developing countries. When the eye or other parts of the body are repeatedly infected, the virus migrates up to the trigeminal ganglion, where it lurks on sensory neurons or directly in the cornea. When the immune state of the body changes, or is stimulated by mental trauma, endocrine disorders and other reasons, it often recurs. In severe cas...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/08A61K31/513A61K47/30A61K47/36A61P31/12A61P27/02
Inventor 李开兰王登美刘红陈历胜黄汉明熊增慧
Owner 湖北科益药业股份有限公司
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