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Temperature-sensitive gel preparation, preparation method thereof and application of temperature-sensitive gel preparation to preventing transfer of calculus in lithotripsy

A temperature-sensitive gel and preparation technology, which is applied in the direction of pharmaceutical formulation, aerosol delivery, medical preparations containing active ingredients, etc., can solve the problems of gel strength, cohesion and low viscosity, which hinder convenience and effectiveness, The problem of complex injection operation is solved, and the effect of good adhesion, non-allergic, and reduced risk of injury is achieved

Active Publication Date: 2015-12-16
SAIKE SAISI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The gel preparation can be compatible with many types of lithotripsy (such as laser and mechanical lithotripsy) by being added to the ureter, effectively preventing the displacement of stones and stone fragments, reducing the operation time and complexity, but after research It was found that the gel formed in the lumen is not reversible, and it is difficult to clean after lithotripsy; the solution is to inject the two compositions into the lumen and gel in the lumen, and the two injections are complicated , It takes a certain amount of time to form a gel, and it is difficult for the two compositions to mix uniformly in the lumen, and the gel strength, cohesion and viscosity formed by it are all low, which directly hinders the convenience and effectiveness

Method used

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  • Temperature-sensitive gel preparation, preparation method thereof and application of temperature-sensitive gel preparation to preventing transfer of calculus in lithotripsy
  • Temperature-sensitive gel preparation, preparation method thereof and application of temperature-sensitive gel preparation to preventing transfer of calculus in lithotripsy
  • Temperature-sensitive gel preparation, preparation method thereof and application of temperature-sensitive gel preparation to preventing transfer of calculus in lithotripsy

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Embodiment 1

[0047] The formula of thermosensitive gel preparation is: poloxamer 40719.0wt%, poloxamer 1882.5wt%, chitosan hydrochloride 2.0wt%, sodium glycerophosphate 1.5wt%, hydroxypropyl cellulose 0.08wt%, carboxylate Methyl chitosan 0.02wt%, neutral buffer solution 74.9wt%; Described neutral buffer solution is made up of disodium hydrogen phosphate, sodium dihydrogen phosphate and water, and the content of these three kinds of compositions in thermosensitive gel preparation is: Sodium dihydrogen phosphate 0.02wt%, disodium hydrogen phosphate 0.22wt%, water 74.66wt%; wherein, the molecular weight of chitosan hydrochloride is 5×10 5 Da.

[0048] The preparation method of thermosensitive gel preparation is as follows:

[0049] Place the neutral buffer solution at 2-4°C for 7 hours, then slowly add it to the neutral buffer solution successively under vigorous stirring (the stirring speed is greater than 200rpm, the same below) (the addition speed is about 10g / min, the same below) ) polo...

Embodiment 2

[0051] The formula of thermosensitive gel preparation is: poloxamer 407 16.5wt%, chitosan hydrochloride 1.0wt%, sodium glycerophosphate 0.5wt%, sodium alginate 0.008wt%, carbomer 0.001wt%, sodium hyaluronate 0.001wt%, neutral buffer solution 81.99wt%; the neutral buffer solution is composed of disodium hydrogen phosphate, sodium dihydrogen phosphate and water, the content of these three components in the thermosensitive gel preparation is: sodium dihydrogen phosphate 0.0025 wt%, disodium hydrogen phosphate 0.028wt%, water 81.9595wt%; wherein, the molecular weight of chitosan hydrochloride is 2×10 6 Da.

[0052] The preparation method of thermosensitive gel preparation is as follows:

[0053] Place the neutral buffer solution at 2-4°C for 3 hours, then slowly add poloxamer, glycerophosphate, chitosan hydrochloride and synergistic excipients to the neutral buffer solution under vigorous stirring, When adding, ensure that the temperature of the neutral buffer solution is 2-4°C....

Embodiment 3

[0055] The formula of thermosensitive gel preparation is: poloxamer 40719.0wt%, chitosan hydrochloride 3.0wt%, magnesium glycerophosphate 2.5wt%, poloxamine 13070.1wt%, neutral buffer solution 75.4wt%; The neutral buffer solution is composed of disodium hydrogen phosphate, sodium dihydrogen phosphate and water. The content of these three components in the thermosensitive gel preparation is: 0.01wt% sodium dihydrogen phosphate, 0.11wt% disodium hydrogen phosphate, 75.28wt% water %; Wherein, the molecular weight of chitosan hydrochloride is 5×10 4 Da.

[0056] The preparation method of thermosensitive gel preparation is as follows:

[0057] Place the neutral buffer solution at 2-4°C for 3 hours, then slowly add poloxamer, glycerophosphate, chitosan hydrochloride and synergistic excipients to the neutral buffer solution under vigorous stirring, When adding, ensure that the temperature of the neutral buffer solution is 2-4°C. After adding the synergistic auxiliary materials, pla...

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Abstract

The invention discloses a temperature-sensitive gel preparation, a preparation method thereof and an application of the temperature-sensitive gel preparation to preventing the transfer of calculus in lithotripsy. The preparation is prepared from the following components by weight percent: 16.5 to 26.5 percent of poloxamer, 1.0 to 3.0 percent of chitosan hydrochloride, 0.5 to 2.5 percent of glycerophosphate, 0.01 to 1 percent of synergistic auxiliary materials, and 67.0 to 81.99 percent of neutral buffer solution. The preparation method is simple, and when used in the lithotripsy, the product has a good effect of preventing the transfer of the calculus, so that the damage risk of the lithotripsy on peripheral tissues can be alleviated; moreover, the product is convenient to wash and high in application value.

Description

technical field [0001] The invention relates to a temperature-sensitive gel and its preparation method and application, in particular to the application of the temperature-sensitive gel in preventing calculi transfer during lithotripsy. Background technique [0002] Urolithiasis is one of the common diseases in urology, ranking first among inpatients in urology. Epidemiological data from European and American countries show that 5% to 10% of people have urinary stones at least once in their lifetime, the annual new incidence rate is about 100 to 300 / 100,000 people, and the recurrence rate is 50% to 70%. The incidence of urinary calculi in my country is 1% to 5%, and it is as high as 5% to 10% in the South. Ureteral calculus is a kind of urolithiasis, which accounts for 33% to 54% of urinary calculi. The current treatment methods mainly include drug therapy, lithotripsy and surgery. In the case of lithotripsy, surgery is generally used for more serious situations that canno...

Claims

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Application Information

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IPC IPC(8): A61K31/77A61K9/06A61P13/04A61K31/722A61K31/047
Inventor 赵成如张雯雯袁坤山王歌今刘连涛姜丽娟
Owner SAIKE SAISI BIOTECH CO LTD
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