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Atropine sulfate eye drops

A technology of atropine sulfate and eye drops, which is applied in the direction of making medicines into special physical or ingestible devices, inorganic non-effective ingredients, muscular system diseases, etc., can solve problems such as unfavorable long-term use and human eye irritation, and achieve It is beneficial to long-term use, reduces the efficacy of the drug, and eliminates the effect of adverse effects

Inactive Publication Date: 2020-10-30
安徽博诺美科生物医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The atropine sulfate eye drops approved for marketing in the United States is packaged in multiple doses, and a preservative (benzalkonium chloride) is added to it, and this substance is easy to irritate the human eyes, which is not conducive to long-term use

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0028] A kind of atropine sulfate eye drop, its raw material comprises: atropine sulfate 10mg, sodium chloride 0.810g, disodium hydrogen phosphate 0.014g, sodium dihydrogen phosphate 0.750g and water for injection 100ml;

[0029] The preparation process is as follows: in a sterile environment, weigh each raw material, add disodium hydrogen phosphate, sodium dihydrogen phosphate, atropine sulfate, and sodium chloride into an appropriate amount of water and stir to dissolve, then use the remaining water to constant volume and mix to obtain the pH =4.5, the osmotic pressure molar concentration ratio is 0.9, the solution of atropine sulfate concentration is 0.10mg / ml, filters again three times, adopts BFS full-automatic blow-fill-seal all-in-one machine to fill in the eye drop agent bottle, lamp inspection, packing obtains Atropine sulfate eye drops, wherein, the filling volume of atropine sulfate eye drops is 0.5ml / support; the filter membrane pore diameter of the first filtration...

Embodiment 2

[0031] A kind of atropine sulfate eye drops, its raw material comprises: atropine sulfate 10mg, sodium chloride 0.900g, disodium hydrogen phosphate 0.014g, sodium dihydrogen phosphate 0.700g and water for injection 100ml;

[0032] Wherein, the pH of atropine sulfate eye drops=5.0, the osmotic pressure molar concentration ratio is 1.0, and its preparation method is the same as embodiment 1.

Embodiment 3

[0034] A kind of atropine sulfate eye drop, its raw material comprises: atropine sulfate 10mg, sodium chloride 0.990g, disodium hydrogen phosphate 0.014g, sodium dihydrogen phosphate 0.650g and water for injection 100ml;

[0035] Wherein, the pH of atropine sulfate eye drops=5.5, the osmotic pressure molar concentration ratio is 1.1, and its preparation method is the same as embodiment 1.

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Abstract

The invention relates to atropine sulfate eye drops, which comprise the following raw materials: atropine sulfate, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and water,the pH value of the atropine sulfate eye drops is 4.5-5.5, and the concentration of atropine sulfate is 0.09-0.11 mg / ml. The product has the advantages of simple formula, good stability, no stimulation to human eyes and simple preparation process, and is beneficial to long-term use.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to atropine sulfate eye drops. Background technique [0002] Atropine sulfate is a colorless crystal or white crystal powder, easily soluble in water, atropine sulfate has poor stability, is sensitive to light, and is easily hydrolyzed under alkaline conditions. Its molecular formula is (C 17 h 23 NO 3 ) 2 ·H 2 SO 4 ·H 2 O, molecular weight is 694.84, and its structural formula is as shown in formula (I): [0003] [0004] At present, the dosage forms of atropine sulfate that have been listed in China include: tablets, injections, eye ointments and ophthalmic gels, etc., but atropine sulfate eye drops have not yet been listed in China. [0005] Atropine Sulfate Eye Drops was approved by the U.S. FDA in 1960. The trade name is Atropine Sulfate Ophthalmic Solution, USP, 1%. The specifications are: 2ml: 20mg, 5ml: 50mg and 15ml: 150mg. The indications are:...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/46A61K47/02A61P21/00A61P27/02A61P27/10A61J3/00
CPCA61K31/46A61K9/08A61K9/0048A61K47/02A61P27/10A61P27/02A61P21/00A61J3/00
Inventor 邹文许龙黄顺旺曹明成
Owner 安徽博诺美科生物医药有限公司
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