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Sufentanil gel preparation and preparation method thereof

A gel preparation and prescription technology, applied in the field of sufentanil gel preparation and its preparation, to achieve the effects of improved absorption rate, improved penetration, and simple production process

Inactive Publication Date: 2014-05-14
王丽丽
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

There are few reports on other dosage forms in the existing literature

Method used

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  • Sufentanil gel preparation and preparation method thereof
  • Sufentanil gel preparation and preparation method thereof
  • Sufentanil gel preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020]

[0021] Preparation process

[0022] Put the carbomer in purified water with 50% of the total prescription and soak for 24 hours. Dissolve tromethamine in water with 10% of the total dosage of the prescription for subsequent use. Put sufentanil in ethanol and stir to disperse evenly, add tromethamine aqueous solution and stir to dissolve until the solution is completely clear, set aside. Stir and dissolve edetate disodium and the remaining purified water until there are no visible particles, and set aside; filter the swollen carbomer 940 through 120 mesh, and add the prescribed amount of propylene glycol, polyethylene glycol 400, edetate di Sodium solution and sufentanil solution are added to the carbomer. Stir for 15 minutes; add triethanolamine into the carbomer matrix, stir for 30 minutes, control the pH at 7.3-8.5, stop stirring, fill and package, and obtain susufentanil gel.

Embodiment 2

[0024] Sufentanil raw materials are prepared into sufentanil gel according to the following prescription:

[0025]

[0026] Put the carbomer in purified water with 50% of the total prescription and soak for 24 hours. Dissolve tromethamine in water with 10% of the total dosage of the prescription for subsequent use. Put sufentanil in ethanol and stir to disperse evenly, add tromethamine aqueous solution and stir to dissolve until the solution is completely clear, set aside. Stir and dissolve edetate disodium and the remaining purified water until there are no visible particles, and set aside; filter the swollen carbomer 940 through 120 mesh, and add the prescribed amount of propylene glycol, polyethylene glycol 400, edetate di Sodium solution and sufentanil solution are added to the carbomer. Stir for 15 minutes; add triethanolamine into the carbomer base, stir for 30 minutes, control the pH at 7.3-8.5, stop stirring, fill, pack, and obtain sufentanil gel.

Embodiment 3

[0028] Sufentanil raw materials are prepared into sufentanil gel according to the following prescription:

[0029]

[0030]

[0031] Put the carbomer in purified water with 50% of the total prescription and soak for 24 hours. Dissolve tromethamine in water with 10% of the total dosage of the prescription for subsequent use. Put sufentanil in ethanol and stir to disperse evenly, add tromethamine aqueous solution and stir to dissolve until the solution is completely clear, set aside. Stir and dissolve edetate disodium and the remaining purified water until there are no visible particles, and set aside; filter the swollen carbomer 940 through 120 mesh, and add the prescribed amount of propylene glycol, polyethylene glycol 400, edetate di Sodium solution and sufentanil solution are added to the carbomer. Stir for 15 minutes; add triethanolamine into the carbomer base, stir for 30 minutes, control the pH at 7.3-8.5, stop stirring, fill, pack, and obtain sufentanil gel.

[...

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Abstract

The invention provides a sufentanil gel preparation and a preparation method thereof. The gel preparation comprises the following components by weight percentage: sufentanil 0.05-0.25%, carbomer 940 0.3-1.5%, tromethamine 0.1-1.2%, ethanol 1-10%, propylene glycol 5-15%, polyethylene glycol 400 0.5-2.0%, disodium edetate 0.005-0.015%, and triethanolamine 1.0-2.5%. The invention uses tromethamine to dissolve sufentanil, so as to solve the insolubility problem of sufentanil free alkali in water, improve skin penetrability of sufentanil, increase transdermal absorption rate of sufentanil, greatly improve local pain therapeutic effect through local topic application, and provide a new drug delivery route to patients. The gel preparation is semisolid gel with good transdermal absorption, and sufentanil is completely dissolved and dispersed in the gel preparation, so as to be favor of pain relief of patients. The preparation process is simple, and the preparation quality is stable and reliable.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a sufentanil gel preparation and a preparation method thereof. Background of the invention [0002] Sufentanil chemical name: N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide , is a potent opioid analgesic, but also a specific μ-receptor agonist, and its affinity for μ-receptors is 7 to 10 times stronger than that of fentanyl. The analgesic effect of this product is several times stronger than that of fentanyl, and it has good hemodynamic stability, which can ensure sufficient myocardial oxygen supply at the same time. Its maximum effect occurs within minutes after intravenous administration. Among the pharmacological research results, an important aspect is the stability of the cardiovascular system. The EEG response is similar to that of fentanyl, and there are no side effects such as immunosuppression, hemolysis or histamine release. [0003...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/4535A61K47/18A61P29/00
Inventor 王丽丽刘燕王传林薛娟孙永国
Owner 王丽丽
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