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A kind of ophthalmic pharmaceutical composition

A composition and drug technology, applied in the field of ophthalmic pharmaceutical compositions, can solve the problems of inability to effectively control heavy metal content, unclear action mechanism, unsatisfactory and the like, meet clinical treatment needs, relieve eye dryness, protect The effect of corneal epithelial histiocytes

Active Publication Date: 2019-11-29
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

At present, in order to prevent the above symptoms, viscous polymer solutions such as hypromellose, chondroitin sulfate, and hyaluronic acid are often used as artificial tears to improve the state of the tear layer, but the therapeutic effect has certain limitations and cannot satisfactory
In recent years, the market has gradually introduced ophthalmic preparations that add traditional Chinese medicines, such as: borneol, flavescens, frankincense, Bupleurum, Codonopsis, chrysanthemum, Lingxiaohua, and white peony to relieve eye dryness. The mechanism is not yet clear, and the content of heavy metals cannot be effectively controlled, so it is still necessary to study a safer and more effective composition to protect the tear layer of the eye from damage

Method used

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  • A kind of ophthalmic pharmaceutical composition
  • A kind of ophthalmic pharmaceutical composition
  • A kind of ophthalmic pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Preparation of eye drops containing polyvinyl alcohol with a mass concentration of 0.15%, a pH value of 6.5 to 7.0, and an osmolarity ratio of 1.0, the steps are as follows:

[0041] (1) Accurately weigh 1.2 g of polyvinyl alcohol as described in Table 1, add it to a 100L batching tank, raise the temperature to 130°C, and dissolve it in water for injection at a stirring rate of 90r / min to obtain solution A;

[0042] (2) Accurately weigh 0.25g D-glucosamine, 10.21g glycerin, 0.48g sodium chloride, 0.90g disodium hydrogen phosphate and 0.79g sodium dihydrogen phosphate in sequence, and add them to a 50L batching tank with a stirring rate of 90r / min , after being dissolved in water for injection, solution B was obtained, which was transferred to a 100L batching tank;

[0043] (3) Add water for injection to 800mL of the combined solution C, stir evenly, pass through a 5μm titanium rod filter, 0.45μm microporous membrane, 0.22μm microporous membrane, and aseptically fill to ...

Embodiment 16

[0056] The composition eye liquid preparations prepared in Examples 1 to 15 were tested according to the quality requirements for ophthalmic preparations stipulated in Part Four of the Pharmacopoeia of the People's Republic of China (2015 Edition), and the test results are shown in Table 2 and Table 3.

[0057] Table 2 Embodiment 1-15 part inspection results

[0058]

[0059] Table 3 Embodiment 1-15 part inspection results

[0060]

[0061] It can be seen from Table 2 and Table 3 that the prepared Examples 1 to 15 all meet the quality requirements for ophthalmic preparations stipulated in Part Four of the Pharmacopoeia of the People's Republic of China (2015 Edition).

Embodiment 17

[0063] The composition ophthalmic solution preparation that embodiment 1 to 15 is prepared is carried out clinical test, randomly selects the symptom caused by tear reduction, tiredness, dry eye, Sjogren's syndrome, keratoconjunctivitis sicca, Stein-John II corneal surgery including eyelid insufficiency or sensory nerve palsy, concomitant strain conjunctivitis, viral conjunctivitis, laser keratectomy, cataract surgery and 900 patients with eye dryness symptoms caused by wearing contact lenses etc. were randomly divided into 18 groups, and groups 1-15 corresponded to using the composition eye liquid preparations prepared in 1-15 in the examples respectively, and the control group 1 Use the composition eye liquid preparation prepared in Comparative Example 1, the matched group 2 uses the composition eye liquid preparation prepared in Comparative Example 2, the matched group 3 uses the composition eye liquid preparation prepared in Comparative Example 3, and the matched group 3 us...

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Abstract

The present invention relates to an ophthalmic pharmaceutical composition. The composition includes polyvinyl alcohol and D-glucosamine. In terms of mass percentage, the content of the D-glucosamine in the composition is 0.015 wt % to 0.04 wt %; preferably, the content of the D-glucosamine in the composition is 0.02 wt % to 0.035 wt %.

Description

technical field [0001] The present invention relates to an ophthalmic pharmaceutical composition. Background technique [0002] With the rapid development of economy and society, the air environment is getting worse and worse, which has contributed to the increasing number of ophthalmic diseases, especially for people who have been exposed to smog for a long time. The tear layer of the eyes is easily damaged, causing dry eyes, swelling and pain and other symptoms. At present, in order to prevent the above symptoms, viscous polymer solutions such as hypromellose, chondroitin sulfate, and hyaluronic acid are often used as artificial tears to improve the state of the tear layer, but the therapeutic effect has certain limitations and cannot satisfactory. In recent years, the market has gradually introduced ophthalmic preparations that add traditional Chinese medicines, such as: borneol, flavescens, frankincense, Bupleurum, Codonopsis, chrysanthemum, Lingxiaohua, and white peony...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/765A61K47/26A61P27/02
CPCA61K9/0048A61K9/08A61K31/765A61K47/26
Inventor 付欢刘锐延静邓罡陈璐王超
Owner 湖北远大天天明制药有限公司
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