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A kind of ophthalmic composition and its preparation method and application

An ophthalmic composition and water for injection technology, applied in the field of medicine, can solve problems such as pain and burning sensation, adverse reactions, drug resistance, etc., achieve good effects, avoid eyelid edema, and have anti-inflammatory and antiviral effects.

Active Publication Date: 2022-05-20
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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  • A kind of ophthalmic composition and its preparation method and application
  • A kind of ophthalmic composition and its preparation method and application
  • A kind of ophthalmic composition and its preparation method and application

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 present invention relates to an ophthalmic composition, which comprises ganciclovir and olopatadine; wherein, the mass ratio of ganciclovir to olopatadine is (2‑6):1. The present invention also relates to a preparation method of an ophthalmic composition, comprising: step S1, mixing ganciclovir, olopatadine, an osmotic pressure regulator, a pH regulator and water for injection at a temperature of 90-100°C , to obtain a mixed solution; step S2, at a temperature of 70-80° C., adding a solubilizer, a preservative and water for injection to the mixed solution to obtain the ophthalmic composition. In addition, the present invention also relates to the application of the ophthalmic composition in the preparation of medicines for treating keratitis. The eye drops containing the ophthalmic composition provided by the invention not only have good anti-inflammatory and anti-viral effects, but also can avoid adverse reaction symptoms such as eyelid edema, conjunctival hyperemia, pain and burning sensation in patients with 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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Patent Type & Authority Patents(China)
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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