Ophthalmic composition as well as preparation method and application thereof

A technology of ophthalmic composition and water for injection, which is applied in the field of medicine and can solve problems such as adverse reactions, drug resistance, congestion, etc.

Active Publication Date: 2021-05-18
湖北远大天天明制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing antiviral ophthalmic drugs such as iodinidine, cytarabine and cyclocytidine are prone to drug resistance or obvious adverse reactions
Although the new antiviral drug ganciclovir eye drops has good spectrum antibacterial effect, long-term use of the drug will cause adverse reactions such as eyelid edema, conjunctival hyperemia, pain and burning sensation

Method used

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  • Ophthalmic composition as well as preparation method and application thereof
  • Ophthalmic composition as well as preparation method and application thereof
  • Ophthalmic composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (1) Preparation of ophthalmic composition

[0028] Add water for injection of 2 / 3 of the total amount into the batching tank, and start stirring. Add ganciclovir, olopatadine, sodium chloride (osmotic pressure regulator) and borax and boric acid (pH regulator) into the batching tank at a temperature of 65°C, stir until fully dissolved, and heat up to 99°C. Insulate and stir for 15 minutes, cool down to 80°C, add benzalkonium chloride (preservative) solution and polysorbate-80 solubilizer (), stir until completely dissolved, cool down to room temperature, and dilute to full volume to obtain the ophthalmic An ophthalmic composition of the following composition based on the total weight of the composition:

[0029]

[0030]

[0031] (2) Quality inspection of eye drops

[0032] The ophthalmic composition prepared in Example 1 was used as eye drops, and the accelerated stability investigation was carried out according to the "Chinese Pharmacopoeia" 2015 edition 9001 ...

Embodiment 2

[0040] (1) Preparation of ophthalmic composition

[0041] The preparation method of the ophthalmic composition of the present embodiment is the same as embodiment 1, and its composition is as follows in terms of the total weight of the ophthalmic composition:

[0042]

[0043] (2) Quality inspection of eye drops

[0044] The ophthalmic composition prepared in Example 2 was used as eye drops, and the accelerated stability investigation was carried out according to the stability inspection principle of the 9001 preparation of the "Chinese Pharmacopoeia" 2015 edition, and the test was carried out according to the test method described in Example 1. The results are shown in the table 2.

[0045] The ophthalmic composition of table 2 embodiment 2 is as the test result of eye drops

[0046]

[0047] As can be seen from Table 2, the ophthalmic composition prepared in Example 2 of the present invention meets the quality standard requirements of the Pharmacopoeia ophthalmic pre...

Embodiment 3

[0049] (1) Preparation of ophthalmic composition

[0050] The preparation method of the ophthalmic composition of the present embodiment is the same as embodiment 1, and its composition is as follows in terms of the total weight of the ophthalmic composition:

[0051]

[0052]

[0053] (2) Quality inspection of eye drops

[0054] The ophthalmic composition prepared in Example 3 was used as eye drops, and the accelerated stability investigation was carried out according to the stability inspection principle of the 9001 preparation of the "Chinese Pharmacopoeia" 2015 edition, and the test was carried out according to the test method described in Example 1. The results are shown in the table 3.

[0055] The ophthalmic composition of table 3 embodiment 3 is as the test result of eye drops

[0056]

[0057] As can be seen from Table 3, the ophthalmic composition prepared in Example 3 of the present invention meets the quality standard requirements of the Pharmacopoeia op...

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Abstract

The invention relates to an ophthalmic composition. The ophthalmic composition comprises ganciclovir and olopatadine, wherein the mass ratio of ganciclovir to olopatadine is (2-6): 1. The invention further relates to a preparation method of the ophthalmic composition. The method comprises the following steps of S1, mixing the ganciclovir, the olopatadine, an osmotic pressure regulator, a pH regulator and water for injection at the temperature of 90-100 DEG C to obtain a mixed solution; and S2, adding a solubilizer, a preservative and water for injection into the mixed solution at the temperature of 70-80 DEG C to obtain the ophthalmic composition. In addition, the invention further relates to application of the ophthalmic composition in preparation of a medicine for treating keratitis. Eye drops accommodating the ophthalmic composition have good anti-inflammatory and anti-virus effects, and can also avoid the adverse reaction symptoms such as eyelid edema, conjunctival congestion, pain, burning sensation of patients after long-term use.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to an ophthalmic composition and its preparation method and application. 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 China, 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. Although the new antiviral drug ganciclovir eye drops has good spectrum antibacterial effect, long-term use of the drug will cause adverse reactions such as eyelid edema, conjunctival hyperemia, pain and burning sensation. [0003] Therefore, the present problem is to provide an ophthalmic compo...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K47/04A61K31/335A61K31/522A61P27/02A61P31/12A61P29/00
CPCA61K9/0048A61K9/08A61K47/02A61K31/335A61K31/522A61P27/02A61P31/12A61P29/00A61K2300/00
Inventor 王超付欢刘晨曦万利鹏延静尹传忠梁琴
Owner 湖北远大天天明制药有限公司
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