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A kind of preparation method of non-ionic cellulose eye drops

A non-ionic, eye drop technology, applied in the field of medicine, can solve problems such as time-consuming, affecting normal production, pollution, etc., and achieve good continuous effect

Active Publication Date: 2011-12-21
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The first of the above methods takes a long time, usually 6 to 12 hours. According to the requirements for eye drops in the appendix of the Chinese Pharmacopoeia 2010 edition, this product should be aseptic, because most eye drops are non-terminal sterilizers. Bacterial products, so if we want to achieve sterility, we must strengthen the control of the production process, and the long-term storage of the preparation solution is obviously not conducive to ensuring the sterility of the product; although the second method in the above method is shorter, but "washing The “slurry” process needs to be stirred quickly. It is difficult to ensure the uniformity of dispersion by using general stirring equipment. Transparent particles that are not fully swollen are prone to appear in the solution. These particles are easy to block the filter membrane during filtration, thereby affecting the normal production. To avoid When this happens, it is necessary to continue to stir the cooled solution for a long time, but this again faces the same contamination risk as the first method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Take 0.8g of boric acid, 2.4g of borax, 1.2g of sorbic acid, 0.8g of propylene glycol, 6.4g of sodium chloride, and 0.5g of disodium edetate, add them to 500ml of water for injection at 85°C, stir to dissolve, and High-speed shear dispersing emulsifier (model FM300, manufacturer: Shanghai Fluke Fluid Machinery Manufacturing Co., Ltd.), under high-speed shear conditions of 10,000 rpm, slowly add 5 g of hypromellose to the above solution, and continue shearing for 10 min. Add 500ml of water for injection at 20-30°C. After stirring evenly, sterilize and filter to obtain hypromellose eye drops as a colorless and clear liquid, with a pH value of 6.5 to 7.5, an osmotic pressure of 270 to 330 mOsm, and a viscosity of 12 to 30 mPa·s. The main drug content is 90.0%-110.0%.

Embodiment 2

[0030] Take 50L of water for injection at 85°C and place it in a shear tank, add 80g of boric acid, 240g of borax, 120g of sorbic acid, 80g of propylene glycol, 640g of sodium chloride, 50g of edetate disodium, and use a pipeline high-speed shearing dispersing emulsifier (Model: DE400, manufacturer: GEA Process Engineering Co., Ltd., UK) shear until completely dissolved, and slowly add 500g hypromellose to In the above solution, continue to shear for 20 minutes. Add 50L and 100L of water for injection at 20-30°C. After stirring evenly, sterilize, filter, and fill to obtain hypromellose eye drops as a colorless and clear liquid. The pH value is 6.5-7.5, the osmotic pressure is 270-330mOsm, and the viscosity is 12-30mpa. ·s, the main ingredient content is 90.0%-110.0%.

Embodiment 3

[0032]Take 4g of azithromycin and 2g of citric acid, add them to 400ml, dissolve in water for injection at 20-30°C, add 2g of sodium citrate to dissolve, take 0.4g of sodium bisulfite, and 0.8ml of benzalkonium bromide solution (5%), Add 2.88g of sodium chloride and 0.04g of edetate disodium into 500ml of water for injection (80-90°C) and dissolve in a batch-type high-speed shearing dispersing emulsifier (model: DE400, manufacturer: GEA Process, UK) Engineering Co., Ltd.), under the shearing condition of 13000rpm, slowly add 1.2g of hypromellose, shear for 5min, cool down to 20-30°C, pour the liquid containing azithromycin into the liquid containing hypromellose, and use 0.5 mol / L sodium hydroxide to adjust the pH value to 6.5, make up water for injection to 1000ml, and sterilize and filter to obtain the azithromycin eye drops containing hypromellose, which is a colorless and clear liquid with a pH value of 6.0-8.0. Pressure: 280-310mOsm, viscosity: 1-5mpa·s, main ingredient c...

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Abstract

The invention discloses a method for preparing eye drops containing non-ionic cellulose derivatives, which is suitable for laboratory preparation and mass industrial production. By the preparation method, the problems that the non-ionic cellulose derivatives are difficult to disperse and dissolve in cold water and have overlong swelling consumed time in the cold water after being dispersed in hotwater can be effectively solved; and by the method, the non-ionic cellulose derivatives are quickly and effectively dissolved, and the eye drops containing the non-ionic cellulose derivatives are efficiently prepared in laboratories or in an industrialization way.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of eye drops containing non-ionic cellulose. Background technique [0002] Hypromellose is a non-ionic cellulose derivative, part of methyl and part of polyhydroxypropyl ether of cellulose, widely used in the pharmaceutical industry because of its non-toxicity and high safety, soluble in cold water It forms a viscous solution whose properties are close to those of mucin in tears, so it can be used as artificial tears. [0003] In the pharmaceutical industry, non-ionic cellulose derivatives such as hypromellose can be used as the main drug to prepare artificial tears, and can also be used as a thickener for the production of other eye drops to thicken and prolong the drug in the eye. The effect of internal residence time. [0004] Non-ionic cellulose derivatives such as hypromellose are cellulose macromolecular substances, which are soluble in c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K45/00A61K31/717A61K47/38A61P27/04A61P27/02
Inventor 张丽娜李浩冬秦剑波刘敏如
Owner YANGTZE RIVER PHARM GRP CO LTD
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