Low-concentration tropane drug eye drops and preparation method

A low-concentration, eye-drop technology, applied in the field of pharmaceuticals, can solve problems such as follicular conjunctivitis, eyelid skin eczema, and eye margin congestion and erosion, local allergic reactions, poor patient compliance, and affecting treatment.

Inactive Publication Date: 2018-07-31
胡敏
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The atropine sulfate eye drops of this prescription is owing to main agent concentration height, is 0.5% (w/v) to 2% (w/v), can cause follicular conjunctivitis on the one hand, eyelid skin eczema and Local allergic reactions such as eye congestion a

Method used

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  • Low-concentration tropane drug eye drops and preparation method
  • Low-concentration tropane drug eye drops and preparation method
  • Low-concentration tropane drug eye drops and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The present embodiment provides a kind of low-concentration tropane drug eye drops, which comprises the following components: atropine sulfate 0.02% (w / v), sodium hyaluronate 0.35% (w / v), sodium chloride 0.75% (w / v), ethylparaben 0.01% (w / v), adjust the pH to 4.6 with phosphate buffer, and the balance is water for injection.

[0032] The preparation method of this low-concentration tropane drug eye drop comprises the steps:

[0033] S1. Weigh ethylparaben according to the proportion and dissolve it in water for injection at 75°C to obtain solution 1;

[0034] S2. Take sodium chloride according to the proportion and dissolve it in solution 1, and cool to obtain solution 2;

[0035] S3, taking sodium hyaluronate according to the proportion and fully dissolving it in solution 2 to obtain solution 3;

[0036] S4, take sulfuric acid by proportioning and take tropine and dissolve in solution 3 to obtain solution 4;

[0037] S5. Filter the solution 4, add water for injectio...

Embodiment 2

[0039] The present embodiment provides a low-concentration tropane drug eye drop, which comprises the following components: atropine sulfate 0.05% (w / v), sodium hyaluronate 0.01% (w / v), β-cyclodextrin 0.3% (w / v), sodium chloride 0.90% (w / v), ethylparaben 0.05% (w / v), adjust the pH to 6.2 with phosphate buffer, and the balance is water for injection.

[0040] The preparation method of this low-concentration tropane drug eye drop comprises the steps:

[0041] S1. Weigh β-cyclodextrin according to the proportion and dissolve it in water for injection, then weigh atropine sulfate and add it, place it in an ultrasonic vibration cleaning machine, and mix ultrasonically for 30 minutes, so that the atropine sulfate is completely clathrated by β-cyclodextrin, Obtain solution 1;

[0042] S2. Weigh the ethylparaben according to the proportion and dissolve it in water for injection at 40°C to obtain solution 2;

[0043] S3. Take sodium chloride according to the proportion and dissolve i...

Embodiment 3

[0048] The present embodiment provides a low-concentration tropane drug eye drop, which comprises the following components: atropine sulfate 0.0009% (w / v), sodium hyaluronate 0.05% (w / v), β-cyclodextrin 2% (w / v), sodium chloride 0.86% (w / v), ethylparaben 0.05% (w / v), adjust the pH to 5.8 with phosphate buffer, and the balance is water for injection.

[0049] The preparation method of this low-concentration tropane drug eye drop comprises the steps:

[0050] S1. Weigh β-cyclodextrin according to the proportion and dissolve it in water for injection, then weigh atropine sulfate and add it, place it in an ultrasonic vibration cleaning machine, and mix ultrasonically for 30 minutes, so that the atropine sulfate is completely clathrated by β-cyclodextrin, Obtain solution 1;

[0051] S2. Weigh the ethylparaben according to the proportion and dissolve it in water for injection at 45°C to obtain solution 2;

[0052]S3. Take sodium chloride according to the proportion and dissolve it...

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Abstract

The invention belongs to the technical field of drugs, and particularly relates to low-concentration tropane drug eye drops. The low-concentration tropane drug eye drops are prepared from 0.0005-0.5%of tropane drug, 0-10% of solute which achieves inclusion and is capable of reducing irritation, 0.01-5% of solute which increases the viscosity of drug liquid, an acidifying or alkalizing agent, an osmotic regulation agent, 0.01-0.05% of bacteriostatic agent and the balance water for injection, wherein the use amount of the acidifying or alkalizing agent enables the pH to be adjusted to be 4.0-6.5, and the use amount of the osmotic regulation agent enables the osmotic pressure to be regulated to 280-330 mOsm/L. The preparation method comprises the steps of S1, the solute which achieves inclusion and is capable of reducing irritation is weighed in proportion and solved into water, the tropane drug is added, and ultrasonic mixing is conducted for 30 minutes in an ultrasonic shake cleaning machine, so that the tropane drug is included by the solute which achieves inclusion and is capable of reducing irritation; S2, ethylparaben, sodium chloride and sodium hyaluronate are weighed in proportion and solved into the water for injection at 40-75 DEG C; S3, the solutions obtained in S1 and S2 are mixed; S4, filtration, sterilization and subpackage are conducted, and the low-concentration tropane drug eye drops are obtained.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a low-concentration tropane drug eye drop and a preparation method thereof. Background technique [0002] Atropine sulfate eye drops are included in the second edition of Western Medicine Preparations in the "Chinese Hospital Preparation Standards", which have three concentrations of 0.5%, 1% and 2%. The prescription composition is as follows: [0003] [0004] Preparation method: Dissolve ethylparaben in an appropriate amount of hot water for injection, add sodium chloride to dissolve, let cool, add atropine sulfate to dissolve, filter, add water for injection from the filter to make 1000mL, stir well, 100 Sterilize by circulating steam at ℃ for 30 minutes, and then pack aseptically. [0005] Functions and purposes: Mydriasis. Used to check fundus and corneal ulcers, keratitis, iridocyclitis. The atropine sulfate eye drops of this prescription is owing to mai...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/69A61K47/36A61P27/10A61K31/46
CPCA61K9/0048A61K9/08A61K31/46A61K47/36A61K47/6951A61P27/10
Inventor 胡敏朱勤周圆白兆平
Owner 胡敏
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