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Tropicamide ophthalmic temperature-sensitive in-situ gel and preparation method thereof

A tropicamide ophthalmic and in situ gel technology, which is applied in sensory diseases, aerosol delivery, liquid delivery, etc., can solve the problems of short duration of eye drops, increase the number of administrations, etc., and prolong the residence time , Improve compliance and facilitate medication

Inactive Publication Date: 2014-08-06
THE SECOND AFFILIATED HOSPITAL ARMY MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The eye drops also have the short duration and need to increase the number of administrations to maintain the drug concentration

Method used

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  • Tropicamide ophthalmic temperature-sensitive in-situ gel and preparation method thereof
  • Tropicamide ophthalmic temperature-sensitive in-situ gel and preparation method thereof
  • Tropicamide ophthalmic temperature-sensitive in-situ gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～16

[0022] Examples 1-16, preparation of tropicamide ophthalmic temperature-sensitive in situ gel

[0023] Prescription composition: see Table 1.

[0024] General preparation method: Dissolve the prescribed amount of ethylparaben, NaCl, HPMC K4M or HPMC E50 in water for injection, then sprinkle the prescribed amount of F127 and F68 on the liquid surface of the solution, and place it at 4°C to make the swelling become clear, Agglomerate-free, uniformly dispersed transparent solution, then add the prescribed amount of tropicamide, ultrasonically stir at 4°C until dissolved, and then the tropicamide ophthalmic temperature-sensitive in-situ gel is obtained.

[0025] Table 1 Prescription of tropicamide ophthalmic temperature-sensitive in situ gel (by mass percentage)

[0026]

[0027]

experiment example 1

[0028] Experimental example 1. Determination of phase transition temperature of tropicamide ophthalmic temperature-sensitive in situ gel

[0029] Take 1ml of the tropicamide ophthalmic temperature-sensitive in-situ gel prepared in Examples 1-16 respectively into a glass test tube, insert a precision thermometer, and completely immerse the mercury bulb of the thermometer in the gel, and then place the glass test tube at a constant temperature. After equilibrating in the water bath for 10 minutes, slowly raise the temperature at a certain rate, keep tilting the test tube to about 60°, and observe the fluidity of the contents. The phase transition temperature of tear fluid before dilution, that is, the phase transition temperature under storage conditions. Each sample was measured 5 times continuously and the average value was taken.

[0030] Weigh NaCl6.78g, NaHCO 3 2.18g, KCl1.38g and CaCl.2H 2 O0.084g, add ultrapure water to dissolve, and then dilute to 1000ml with ultrapur...

experiment example 2

[0034] Experimental example 2. Rheological study on the phase transition process of tropicamide ophthalmic temperature-sensitive in situ gel

[0035] A Kinexus Pro rotational rheometer from Malvern, UK is used, with a flat 40mm rotor and a gap of 0.5mm.

[0036] 1. Selection of linear viscoelastic region

[0037] The characteristic parameters of a substance can only be obtained when its linear viscoelastic region is measured, so first determine the linear viscoelastic region of the preparation, that is, the stress range that does not change with strain. Experimental conditions: 1~100Pa, constant temperature 34℃, frequency 1Hz. Experimental sample: tropicamide ophthalmic temperature-sensitive in-situ gel prepared in Example 1. The result is as figure 1 As shown, because a larger shear stress is likely to cause shock damage to the preparation, and a small shear stress experiment error is larger, therefore, the stress before tear dilution is selected as 10Pa, and the stress af...

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Abstract

The invention discloses tropicamide ophthalmic temperature-sensitive in-situ gel. The prescription of the tropicamide ophthalmic temperature-sensitive in-situ gel consists of the following components in percentage by mass: 0.25 percent of tropicamide, 20 to 21 percent of poloxamer 407, 5 to 9 percent of poloxamer 188, 0.5 to 1 percent of adhesive material, 0.9 percent of osmotic pressure regulator, 0.01 to 0.05 percent of preservative and the balance of water for injection. The gel has proper phase-transition temperature, and can be applied in a liquid state at room temperature to form gel at the ocular surface temperature, so that administration of patients is facilitated and the retention time of the medicine in the eyes can be prolonged; and due to addition of the adhesive material, the viscosity and the biological adhesion property of the preparation are improved, medicine release is delayed, the bioavailability of the medicine is further improved, the administration frequency can be reduced, and the compliance and the therapeutic effect of the patients are improved.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a new drug preparation and a preparation method thereof. Background technique [0002] At present, commonly used ophthalmic formulations include eye drops, ophthalmic ointments and ophthalmic gels. After the eye drops are instilled into the eye, only 5% of the dose is absorbed into the eye due to the loss of the conjunctiva and nasolacrimal duct, and it is necessary to increase the number of administrations to maintain the drug concentration; eye ointments usually use oily materials as the base, and the greasy feeling Strong, blurred vision after use; ophthalmic gel is based on hydrophilic polymer as the carrier, has good biocompatibility, and is in a semi-solid state, which can prolong the action time of the drug and reduce the number of medications. The dosage of the medicine is not easy to control and it is easy to cause eye scratches during administration. [0003] Ophthalmic thermosen...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K31/4409A61K47/38A61K47/34A61P27/02A61P27/10A61K47/10
Inventor 张恩娟李曼邢茂胡雪莲
Owner THE SECOND AFFILIATED HOSPITAL ARMY MEDICAL UNIV
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