Eyedrop preparation and preparation method thereof

A preparation and eye instillation technology, applied in the field of medicine, can solve the problems of blurred vision and poor patient compliance, and achieve the effects of improving drug stability, facilitating medication, and improving local bioavailability

Inactive Publication Date: 2009-09-23
SUN YAT SEN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to factors such as tear drainage and short residence time, eye drops generally only have a bioavailability of 1-10%, while eye ointments generally cause blurred vision and poor patient compliance.

Method used

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  • Eyedrop preparation and preparation method thereof
  • Eyedrop preparation and preparation method thereof
  • Eyedrop preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The eye drop preparation described in this embodiment is an eye drop solution, based on 100 g, containing 0.10 g of doxycycline, 1.00 g of hydroxypropyl-β-cyclodextrin, and 0.10 g of sodium bisulfite, pH 5.5-6.0 .

[0033] Preparation method: Take doxycycline hydrochloride (containing 0.10g of doxycycline), 1.00g of hydroxypropyl-β-cyclodextrin, add a small amount of distilled water until moist, fully grind in a mortar for 3 hours, add an appropriate amount of distilled water to dilute, Obtain light yellow clear doxycycline clathrate solution, add sodium bisulfite 0.10g, add distilled water to 100g, adjust the pH value in the process to be 5.0-6.0 (pH regulator can be disodium hydrogen phosphate, dihydrogen phosphate sodium, sodium hydroxide, or sodium bicarbonate), membrane filter sterilization, doxycycline eye drops.

Embodiment 2

[0035] The eye drop preparation described in this embodiment is an eye drop solution, based on 100 g, containing 0.10 g of doxycycline, 1.00 g of hydroxypropyl-β-cyclodextrin, and 0.10 g of sodium bisulfite, pH 5.5-6.0 .

[0036] Preparation method: Take 1.00 g of hydroxypropyl-β-cyclodextrin and dissolve it in 10 g of distilled water to obtain a solution of hydroxypropyl-β-cyclodextrin; take doxycycline (containing 0.10 g of doxycycline monohydrate ), dispersed in about 5.0 g of distilled water, slowly added dropwise to the hydroxypropyl-β-cyclodextrin solution while stirring, and ultrasonicated for 3 hours to obtain a pale yellow clear doxycycline inclusion compound solution. By phase dissolution and X-ray diffraction analysis, as figure 1 and figure 2 . in, figure 1 (A) doxycycline monohydrate (B) hydroxypropyl-β-cyclodextrin (C) physical mixture of doxycycline monohydrate and hydroxypropyl-β-cyclodextrin (1:24 w / w) (D) Doxycycline monohydrate hydroxypropyl-β-cyclode...

Embodiment 3

[0040] The eye drop preparation described in this example is a temperature-sensitive in-situ gel eye drop, containing 0.03 g of doxycycline, 0.90 g of hydroxypropyl-β-cyclodextrin, and poloxamer 407 in 100 g. 16.00g, sodium bisulfite 0.10g, pH 5.5-6.0.

[0041] Preparation method: Take 0.90 g of hydroxypropyl-β-cyclodextrin, dissolve it in 10 g of distilled water to obtain a solution of hydroxypropyl-β-cyclodextrin; take doxycycline (containing 0.03 g of doxycycline monohydrate ), dispersed in about 1.5 g of distilled water, slowly added dropwise to the hydroxypropyl-β-cyclodextrin solution while stirring, and ultrasonicated for 3 hours to obtain a light yellow clear doxycycline inclusion complex solution, which was solution A.

[0042] Take 16.00g of Poloxamer 407, slowly disperse it into 50g of distilled water, and store it in cold storage for 12-24h until a clear and uniform solution is formed, which is solution B.

[0043] Fully mix the above solution A with solution B, a...

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Abstract

The invention discloses a doxycycline eyedrop preparation and a preparation method thereof. The doxycycline eyedrop preparation comprises 0.03 to 0.5 wt percent of doxycycline, distilled water, hydroxypropyl-beta-cyclodextrin and an antioxidant and has a pH value of 5.0 to 6.0, wherein the weight ratio of doxycycline to hydroxypropyl-beta-cyclodextrin is 1: (1 to 50). The doxycycline eyedrop preparation can improve the dissolubility, the dissolving rate and the stability of doxycycline medicines.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to an eye drop preparation and a preparation method thereof. Background technique [0002] Dry eye is a general term for a class of diseases that cause ocular discomfort and ocular surface damage due to abnormal tear quality and (or) quantity and abnormal tear dynamics. It is one of the most common ocular surface diseases. The clinical manifestations are dryness, burning, physical sensation, itching, blurred vision, red eyes and visual fatigue. Severe dry eye can also cause severe damage to vision such as keratitis, corneal neovascularization, and corneal ulcer, and its impact on people's quality of life has attracted more and more attention. Its occurrence is closely related to blepharitis and meibomian gland dysfunction. [0003] Current research suggests that dry eye may be a type of non-infectious inflammatory disease in nature, so anti-inflammation has become a new direction ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/65A61K47/40A61K47/34A61K9/08A61J3/00A61P27/02A61K47/10
Inventor 吴传斌何子昕梁丹
Owner SUN YAT SEN UNIV
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