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Preparation method of levobetaxolol hydrochloride eye drops

A technology of betaxolol and levohydrochloride, which is applied in the field of preparation of levobetaxolol hydrochloride eye drops, can solve the problems of many impurities, unstable system, and poor resuspension, and achieve high controllability Effect

Active Publication Date: 2018-05-25
ZHAOKE GUANGZHOU OPTHALMIC DRUG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Levobetaxolol hydrochloride eye drops is a sterile ophthalmic suspension, which is mainly used for the treatment of chronic open-angle glaucoma, lowering intraocular pressure or relieving eye muscle fatigue. The preparation process of this patent solves the problem of hydrochloric acid Levobetaxolol eye drops contain too many impurities, unstable system, poor resuspension and other production process problems

Method used

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  • Preparation method of levobetaxolol hydrochloride eye drops
  • Preparation method of levobetaxolol hydrochloride eye drops
  • Preparation method of levobetaxolol hydrochloride eye drops

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] 1) Preparation before production

[0026] Dispersion of Polystyrene Sulfonate and Swelling of Carbomer

[0027]

[0028] 2) Capsule filter 0.22μm (polyethersulfone material) treatment:

[0029] The integrity of the filter is tested before use. After passing the test, it is bagged together with the supporting equipment of the filter system (such as quick connectors, clamps, etc.), sent to the sterilizer, and sterilized at 121 ° C for 30 minutes as required, ready for use;

[0030] 3) Disposal of containers and production tools:

[0031] Production containers, utensils, silicone tubes, etc. are cleaned with purified water and water for injection, and then sterilized at 121°C for 30 minutes before use.

[0032] 4) The inner packaging material is transferred to the filling room:

[0033] In the general production area, remove the outer packaging from the inner packaging box, and transfer it to the C-level production area through the material transfer window; in the C-...

Embodiment 2

[0040] 1) Preparation before production

[0041] Dispersion of Polystyrene Sulfonate and Swelling of Carbomer

[0042]

[0043] 2) Capsule filter 0.22μm (polyethersulfone material) treatment:

[0044] The integrity of the filter is tested before use. After passing the test, it is bagged together with the supporting equipment of the filter system (such as quick connectors, clamps, etc.), sent to the sterilizer, and sterilized at 121 ° C for 30 minutes as required, ready for use;

[0045] 3) Disposal of containers and production tools:

[0046] Production containers, utensils, silicone tubes, etc. are cleaned with purified water and water for injection, and then sterilized at 121°C for 30 minutes before use.

[0047] 4) The inner packaging material is transferred to the filling room:

[0048] In the general production area, remove the outer packaging from the inner packaging box, and transfer it to the C-level production area through the material transfer window; in the C-...

Embodiment 3

[0055] 1) Preparation before production

[0056] Dispersion of Polystyrene Sulfonate and Swelling of Carbomer

[0057]

[0058] 2) Capsule filter 0.22μm (polyethersulfone material) treatment:

[0059] The integrity of the filter is tested before use. After passing the test, it is bagged together with the supporting equipment of the filter system (such as quick connectors, clamps, etc.), sent to the sterilizer, and sterilized at 121 ° C for 30 minutes as required, ready for use;

[0060] 3) Disposal of containers and production tools:

[0061] Production containers, utensils, silicone tubes, etc. are cleaned with purified water and water for injection, and then sterilized at 121°C for 30 minutes before use.

[0062] 4) The inner packaging material is transferred to the filling room:

[0063] In the general production area, remove the outer packaging from the inner packaging box, and transfer it to the C-level production area through the material transfer window; in the C-le...

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Abstract

The invention discloses a preparation method of levobetaxolol hydrochloride eye drops. The method includes: adding 0.5% of polystyrolsulfon acid into 5-15% of injection water, crushing, and stirring to obtain suspension; adding 0.2-0.6% of Carbomer into 15-20% of injection water, evenly stirring, and swelling; adding 0.5% of levobetaxolol hydrochloride and 2-6% of mannitol into 40% of injection water, heating, stirring for dissolving, and filtering to obtain mixed liquid A; adding the suspension into the mixed liquid A, and stirring and mixing to obtain mixed liquid B; adding the Carbomer solution after the swelling into the mixed liquid B, and stirring and mixing to obtain mixed liquid C; adding boric acid, edetate disodium, benzalkonium chloride and sodium lauroyl sarcosine into 15% of injection water, stirring for dissolving, filtering, adding the filtered liquid into the mixed liquid C, and stirring and mixing to obtain mixed liquid D; using 0.03-0.09% of pH regulator to regulate the pH of the mixed liquid D to be 6.5-7.5, adding injection water to achieve constant volume, stirring, heating, sterilizing, and cooling to obtain the levobetaxolol hydrochloride eye drops. The levobetaxolol hydrochloride eye drops are simple in preparation process and good in stability.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a preparation method of levobetaxolol hydrochloride eye drops. Background technique [0002] Levobetaxolol hydrochloride is the L-body of betaxolol hydrochloride, which belongs to β-adrenoceptor blocker. Compared with betaxolol hydrochloride, its effect of reducing intraocular pressure is much stronger than that of the latter. And it is safer, the amount of the two is similar, but the single-action effect is better than the latter. The levobetaxolol hydrochloride eye drops currently on the market is a sterile suspension developed by Alcon Company in Belgium, and its cardiopulmonary side effects are significantly less than those of the drug. Other beta-blockers. Because glaucoma mostly occurs in the elderly, and the elderly have more obstructive bronchial diseases and cardiovascular diseases, levobetaxolol will be more suitable for these patients, so the listing of levobetaxo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/20A61K47/32A61K47/26A61K31/138A61P27/06
CPCA61K9/0048A61K9/10A61K31/138A61K47/20A61K47/26A61K47/32
Inventor 李刚刘婧李小羿戴向荣殷雷凌娟
Owner ZHAOKE GUANGZHOU OPTHALMIC DRUG
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