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Ganciclovir eye drops and preparation method thereof

A technology of ganciclovir and eye drops, which is applied in the field of medicine, can solve problems such as poor water solubility, easy crystallization, and affecting use, and achieve the effects of less systemic side effects, strong buffering capacity, and increased stability

Inactive Publication Date: 2012-02-08
南京恒道医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Single achiclovir also has disadvantages. Its water solubility is poor, and its solubility in water at 25°C is only 0.13%. The prepared 0.1% eye drops are prone to crystallization in cold seasons, which affects the use.
The dosage of 3.0% eye ointment is too large, which increases the incidence of adverse reactions
Secondly, like other nucleoside antiviral drugs, achiclovir ophthalmic preparations will also appear drug-resistant strains after repeated use for a long time

Method used

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  • Ganciclovir eye drops and preparation method thereof
  • Ganciclovir eye drops and preparation method thereof
  • Ganciclovir eye drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1: Excipient compatibility investigation

[0017] 1: Ganciclovir 0.1g, water for injection 100ml

[0018] 2: Ganciclovir 0.1g, Tween-800.1g, water for injection 100ml

[0019] 3: Ganciclovir 0.1g, poloxamer 10g, water for injection 100ml

[0020] 4: Ganciclovir 0.1g, Mannitol 5g, Water for injection 100ml

[0021] 5: Ganciclovir 0.1g, sodium chloride 0.9g, water for injection 100ml

[0022] 6: Ganciclovir 0.1g, boric acid buffer system, water for injection 100ml

[0023] 7: Ganciclovir 0.1g, phosphate buffer system, water for injection 100ml

[0024] 8: Ganciclovir 0.1g, 5% benzalkonium bromide 1.5g, water for injection 100ml

[0025] 9: Ganciclovir 0.1g, 5% benzalkonium bromide 0.2%, water for injection 100ml

[0026] Measure the pH value after the above prescription is equipped, the list is as follows

[0027]

[0028] Table 1

[0029] It can be seen from the table that the other auxiliary materials except borate buffer system and phosphate buff...

Embodiment 2

[0031]

[0032] Steps:

[0033] 1. Weigh ganciclovir, add water 150ml, add Tween-800.2g, stir to dissolve;

[0034] 2. Weigh 10g of mannitol and add it to the above solution, stir to dissolve it;

[0035] 3. Weigh boric acid and borax to the above solution, stir and dissolve, then add benzalkonium bromide;

[0036] 4. Add water for injection, dilute to 200ml, shake well;

[0037] 5. Microporous membrane filtration sterilization, packaging.

Embodiment 3

[0039]

[0040] Steps:

[0041] 1. Weigh 10g of poloxamer, add 100ml of cold water to dissolve;

[0042] 2. Weigh 0.2g of ganciclovir, add 50ml of water for injection to dissolve;

[0043] 3. Mix the above two solutions and add phosphate buffer;

[0044] 4. Add mannitol and benzalkonium bromide to the above solution, stir to dissolve and mix;

[0045] 5. Add water for injection, dilute to 200ml, shake well;

[0046] 6. Microporous membrane filter sterilization, packaging.

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PUM

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Abstract

The invention aims at providing a ganciclovir antiviral new medicament for eye with high efficiency, low toxicity, strong selectivity and good stability, and a preparation method thereof. The medicament provided by the invention comprises 0.1wt% of ganciclovir used as a main medicament, and a cosolvent, an iso-osmotic regulator, a pH regulator, a preservative and water for injection used as auxiliary agents. Compared with the prior art, the medicament has the following advantages that: a boric acid buffer, namely a mixed solution of boric acid and borax is adopted, and the buffer has strong buffering capability and is highly soluble in water; and poloxamer is selected as the cosolvent, and multiple data show that the poloxamer improves the inherent quality of the medicament, increases the preparation stability, reduces the irrigation of anti-inflammation analgesic to eyes, has no hemolysis action as compared with tween-80, has no interference to the bacteriostatic action of the preservative, and has very significant effect on reducing the irritation of medicament to eyes.

Description

technical field [0001] The invention relates to a proportioning method of ganciclovir eye drops and a brand-new preparation process, belonging to the technical field of medicine. Background technique [0002] Viral keratitis is caused by herpes simplex type I virus infection of the family Herpesviridae. It is a common multiple disease that seriously endangers human eye health. The blindness rate of uncured patients is extremely high. In my country, nearly 5 million patients are infected with viruses every year. Blindness or loss of vision due to keratitis. Existing antiviral ophthalmic drugs such as iodinidine, cytarabine and cyclocytidine are prone to drug resistance or obvious adverse reactions. The 0.1% acyclovir eye drops and 3.0% eye ointment developed by Hubei Institute of Pharmaceutical Industry have good curative effect in the clinical treatment of herpes simplex keratitis. Since they were identified and put into production in 1983, the annual clinical use has been 1...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/522A61P27/02A61P31/12
Inventor 黄迎春张卉
Owner 南京恒道医药科技股份有限公司
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