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Method for investigation of release degree of ibuprofen-pseudoephedrin hydrochloride sustained-release preparation

A technology of sustained-release preparations and release rate, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve the problems of checking the release rate of unrecorded compound sustained-release preparations, affecting the release of active ingredients, and not being able to effectively control the pH value of the dissolution medium, etc. Achieve obvious social and economic benefits, high sensitivity, and simple operation

Active Publication Date: 2014-11-05
广州法尔麦兰药物技术有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The 2010 edition of the Chinese Pharmacopoeia included 37 varieties for checking the release rate, but they were all single-component determinations, and did not include the release rate inspection of compound sustained-release preparations. For example, referring to the dissolution test under the single-component item, the commonly used buffer The liquid system is used as the dissolution medium. During the release of the active ingredient of the drug, the pH value of the dissolution medium changes, and vice versa, it will obviously affect the release of the active ingredient.
The commonly used buffer system cannot effectively control the pH value of the dissolution medium during the release process of the sustained-release agent, and a suitable surfactant should be added. However, there is no literature on the release of compound sustained-release preparations using surfactants at home and abroad. to report

Method used

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  • Method for investigation of release degree of ibuprofen-pseudoephedrin hydrochloride sustained-release preparation
  • Method for investigation of release degree of ibuprofen-pseudoephedrin hydrochloride sustained-release preparation
  • Method for investigation of release degree of ibuprofen-pseudoephedrin hydrochloride sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Example 1: Determination of the release rate of Buluo pseudoeba sustained-release capsules (batch number 11020340) (the release medium does not contain lecithin, and the concentration of phosphate buffer is 0.05mol / L)

[0047] (1), preparation of release medium: take 10.00g of lecithin and dissolve it in 100ml ethanol to obtain a lecithin stock solution with a concentration of 100mg / ml, accurately measure 60ml of lecithin stock solution and an appropriate amount of 0.05mol / L Put phosphate buffer (pH6.00±0.05) in a flask, and remove ethanol by rotary evaporation to obtain a lecithin solution. Add the lecithin solution in the flask to the phosphate buffer, supplement the phosphate buffer to 6L, and mix well , adjust the pH to 6.00±0.05 with 1mol / L sodium hydroxide solution, heat to 42.0°C and degas for 5 minutes before use. The preparation method of the 0.05 mol / L phosphate buffer solution is as follows: 68.05 g of potassium dihydrogen phosphate is weighed and dissolved i...

Embodiment 2

[0056] Example 2: Determination of the release rate of Buluo pseudoeba sustained-release capsules (batch number 11020340) (the release medium contains 0.1% lecithin, and the concentration of phosphate buffer is 0.05mol / L)

[0057] (1), preparation of release medium: take 10.00g of lecithin and dissolve it in 100ml ethanol to obtain a lecithin stock solution with a concentration of 100mg / ml, accurately measure 60ml of lecithin stock solution and an appropriate amount of 0.05mol / L Put phosphate buffer (pH6.00±0.05) in a flask, and remove ethanol by rotary evaporation to obtain a lecithin solution. Add the lecithin solution in the flask to the phosphate buffer, supplement the phosphate buffer to 6L, and mix well , adjust the pH to 6.00±0.05 with 1mol / L sodium hydroxide solution, heat to 42.0°C and degas for 5 minutes before use; Prepared by potassium dihydrogen, adjust the pH value with 1mol / L sodium hydroxide solution.

[0058] (2), take 6 Buluo pseudoephedrine sustained-releas...

Embodiment 3

[0066] Example 3: Determination of the release rate of Buluo pseudoeba sustained-release capsules (batch number 11020340) (the release medium contains 0.2% lecithin, and the concentration of phosphate buffer is 0.05mol / L)

[0067](1), preparation of release medium: take 20.00g of lecithin and dissolve it in 200ml ethanol to obtain a lecithin stock solution with a concentration of 100mg / ml, accurately measure 120ml of lecithin stock solution and an appropriate amount of 0.05mol / L Put phosphate buffer (pH6.00±0.05) in a flask, and remove ethanol by rotary evaporation to obtain a lecithin solution. Add the lecithin solution in the flask to the phosphate buffer, supplement the phosphate buffer to 6L, and mix well , adjust the pH to 6.00±0.05 with 1mol / L sodium hydroxide solution, heat to 42.0°C and degas for 5 minutes before use; Prepared by potassium dihydrogen, adjust the pH value with 1mol / L sodium hydroxide solution.

[0068] (2), take 6 Buluo pseudoephedrine sustained-releas...

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Abstract

The invention discloses a method for investigation of a release degree of an ibuprofen-pseudoephedrin hydrochloride sustained-release preparation. A phosphate buffer solution added with lecithin is used as a release medium, an ibuprofen-pseudoephedrin hydrochloride sustained-release preparation is put into a rotation basket, the release medium is added into a dissolution cup, and a temperature of the release medium and a rotation rate of the rotation basket are controlled so that the ibuprofen-pseudoephedrin hydrochloride sustained-release preparation can release the compound ingredients in the release medium under the control. A comparison between release degrees of the ibuprofen-pseudoephedrin hydrochloride sustained-release preparation in a release medium without lecithin and in the release medium with lecithin proves that after use of an appropriate amount of lecithin in the phosphate buffer solution, release degrees of pseudoephedrine hydrochloride and ibuprofen in the ibuprofen-pseudoephedrin hydrochloride sustained-release capsule can be controlled in a limited range. The invention provides the method for investigation of a release degree of the compound sustained-release preparation by a surfactant. The method can provide important technical basis for finally establishing quality standards, can provide prompting information for prescription design, production control and clinical administration and has obvious social and economic benefits.

Description

Technical field: [0001] The invention relates to the field of drug analysis and detection, in particular to a method for investigating the release rate of a sustained-release preparation of buprofen pseudoephus. Background technique: [0002] The release rate refers to the rate and degree of drug release from sustained-release preparations, controlled-release preparations, enteric-coated preparations, and transdermal patches under specified conditions. Surfactant refers to a substance that can significantly change the interface state of its solution system by adding a small amount. The general rule <1092> of the US Pharmacopoeia 36 and the "Dissolution Test of Common Oral Solid Preparations" issued by the Center for Drug Evaluation of the China Food and Drug Administration "Technical Guidance Principles" proposes that for poorly water-soluble drugs, a suitable dissolution medium with strong discrimination should be selected, and appropriate surfactants can be added to ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 叶汝汉张怡王晓燕伍迪科彭蕾蒋志军黄小棠
Owner 广州法尔麦兰药物技术有限公司
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