Tafluprost eye drop agent and preparation method thereof

A technology of tafluprost and eye drops, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of poor API solubility and stability, complex prescription composition, impurities, etc. Wait for the question

Inactive Publication Date: 2020-01-21
南京华盖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The purpose of the present invention is on the basis of the prior art, the prescription composition of existing tafluprost eye drops is complicated, API solubility and stability are poor, easy to decompose and packaging material has adsorption to it, each use Inconsistent doses and other problems, provide a preparation formulation with simple composition, and effectively improve the solubility and stability of API, and the use of polyethylene plastic packaging materials has basically no adsorption effect, which can be used in large-scale industrial production The method for easily realizing the preparation of tafluprost eye drops with high content, less impurities, stable and uniform liquid medicine, and high quality standard

Method used

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  • Tafluprost eye drop agent and preparation method thereof

Examples

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Effect test

Embodiment 1

[0050] Weigh 100g of methyl cellulose (MC), add it into a 10L predissolved tank containing 4L water for injection, use a heating mantle outside the predissolved tank (hot water can be passed through, cold water can control the temperature in the tank), stir at 10°C to completely dissolve and clarify, Then weigh 0.2 g of tafluprost and add it into the pre-dissolved bucket, and stir at 10° C. to dissolve completely. Weigh 2g of lauryl alcohol and dissolve it in 1L of 10°C water for injection, stir to disperse evenly, pour into the tafluprost aqueous solution prepared above, and continue to stir until the solution is clear. Transfer the solution in the pre-dissolved bucket to a 25L liquid mixing tank, add water for injection at about 10°C to make the total solution reach 18L, test the pH value of the solution to 5.0, continue stirring in the liquid mixing tank and maintain the temperature at 10°C , use the prepared 1mol / L sodium hydroxide aqueous solution to adjust its pH value t...

Embodiment 2

[0052]Weigh 600g of carboxymethylcellulose sodium (CMC-Na), add it into a 10L predissolved tank containing 6L water for injection, use a heating mantle outside the predissolved tank (hot water can be passed through, cold water can control the temperature in the tank), and stir at 20°C Completely dissolve and clarify, then weigh 0.5g of tafluprost and add it to the pre-dissolve bucket, and stir at 20°C to dissolve completely. Weigh 8g of oleic acid and dissolve it in 3L of 20°C water for injection, stir and disperse evenly, pour it into the tafluprost aqueous solution prepared above, and continue stirring until the solution is clear. Transfer the solution in the pre-dissolved bucket to a 25L liquid mixing tank, add water for injection at about 20°C to make the total solution reach 18L, test the pH value of the solution to 7.2, continue stirring in the liquid mixing tank and maintain the temperature at 20°C , use the prepared 1mol / L sodium hydroxide aqueous solution to adjust it...

Embodiment 3

[0054] Weigh 400g of hydroxypropylmethylcellulose (HPMC), add it into a 10L predissolved barrel containing 5L water for injection, use a heating mantle outside the predissolved barrel (hot water can be passed through, cold water can control the temperature in the canister), and stir at 15°C to dissolve completely After clarification, weigh 0.4g of tafluprost and add it into the pre-dissolved bucket, and stir at 15°C to dissolve completely. Weigh 5g of pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)]propionate and dissolve it in 2L of 15°C water for injection, stir and disperse evenly, and pour it into the above-prepared taflur In the plain aqueous solution, continue to stir until the solution is clear. Transfer the solution in the pre-dissolved barrel to a 25L liquid mixing tank, add water for injection at about 15°C to make the total solution reach 18L, and test the pH value of the solution to be 5.8. When the liquid mixing tank continues to stir and the temper...

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Abstract

The invention belongs to the field of bio-medicine, and discloses a tafluprost eye drop agent and a preparation method thereof. The eye drop agent take tafluprost as an active ingredient, a hydrophilic gel skeleton material is used as a skeleton and a solubilizer, the tafluprost eye drop agent further includes an antioxidant and a stabilizer, and the antioxidant and the stabilizer are macromolecular compounds. A process of the tafluprost eye drop agent improves the asepsis level of a product, the characteristics of simple preparation composition, easy, convenient and quick operation, high compatibility for medicinal packaging materials, low cost, stable properties of liquid medicine and high quality standard are achieved, and the tafluprost eye drop agent is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of biomedicine, in particular to a tafluprost eye drop and a preparation method thereof. Background technique [0002] Tafluprost eye drops, common name of eye drops: Tafluprost Eye Drops, molecular formula: C 25 h 34 f 2 o 5 , molecular weight: 452.53, its structural formula is: [0003] [0004] Tafluprost is a novel PGF2α derivative jointly developed by Santen Pharmaceutical, Asahi Glass, and Merck (licensed). First approved for marketing in Germany in 2008, it is used to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. At present, tafluprost has been marketed in many countries and regions, including the United States, the European Union, China, Japan, Singapore, etc. [0005] At present, there are about 66.8 million glaucoma patients in the world, and 5.2 to 6.7 million people are blind because of it. Glaucoma is the second most common ophthalmic disease in my coun...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/5575A61K47/32A61K47/36A61K47/38A61P27/06
CPCA61K9/0048A61K9/08A61K31/5575A61K47/32A61K47/36A61K47/38A61P27/06
Inventor 孙向阳朱景阳娄媛媛
Owner 南京华盖制药有限公司
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