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Determination method of dissolution curve of glimepiride tablets in dissolution medium with pH of 1.2

A technology of glimepiride tablet and dissolution medium, which is applied in the field of drug analysis and can solve the problems of inability to distinguish

Pending Publication Date: 2021-06-15
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Both of these situations are indistinguishable due to being too fast and too slow

Method used

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  • Determination method of dissolution curve of glimepiride tablets in dissolution medium with pH of 1.2
  • Determination method of dissolution curve of glimepiride tablets in dissolution medium with pH of 1.2
  • Determination method of dissolution curve of glimepiride tablets in dissolution medium with pH of 1.2

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0162] Embodiment 1: the assay method of stripping curve

[0163] (1) Reference preparation and sample to be tested:

[0164] Reference preparation: reference preparation 1, specification 1mg;

[0165] Samples to be tested: Glimepiride Dispersible Tablet 1, Glimepiride Dispersible Tablet 2, Glimepiride Dispersible Tablet 3.

[0166] (2) Detection method:

[0167] 1. Preparation of dissolution medium (both take the preparation of 1000ml as an example):

[0168] Hydrochloric acid solution of pH 1.2 containing 0.04% SDS: Measure 7.65ml of hydrochloric acid with a graduated cylinder and dilute it to 1000ml with water, then add 0.4g of sodium lauryl sulfate and stir well to obtain a hydrochloric acid solution of pH 1.2 containing 0.04% SDS .

[0169] 2. Dissolution method:

[0170] Using the paddle method, measure 900ml of dissolution medium and place them in dry dissolution cups, raise the temperature. After the temperature of the dissolution medium rises to 37°C±0.5°C, the s...

Embodiment 2

[0179] Embodiment 2: the assay method of stripping curve

[0180] (1) Reference preparation and sample to be tested:

[0181] Reference preparation: reference preparation 2, specification 2mg;

[0182] Samples to be tested: Glimepiride Dispersible Tablet 4, Glimepiride Dispersible Tablet 5, Glimepiride Dispersible Tablet 6.

[0183] (2) Detection method:

[0184] 1. Preparation of dissolution medium (both take the preparation of 1000ml as an example):

[0185] Hydrochloric acid solution of pH 1.2 containing 0.1% SDS: Use a graduated cylinder to measure 7.65ml of concentrated hydrochloric acid and dilute it to 1000ml with water, then add 1.0g of sodium lauryl sulfate and stir well to obtain hydrochloric acid of pH 1.2 containing 0.1% SDS solution.

[0186] 2. Stripping method: the rotating speed is 50 rpm, and all the other are the same as in Example 1.

[0187] 3. Dissolution testing method: the reference substance solution is as follows, and the rest are the same as in E...

Embodiment 3

[0195] Embodiment 3: the assay method of stripping curve

[0196] (1) Reference preparation and sample to be tested: with embodiment 1.

[0197] (2) Detection method:

[0198] 1. Preparation of dissolution medium (both take the preparation of 1000ml as an example):

[0199] Hydrochloric acid solution of pH 1.2 containing 0.05% SDS: use a graduated cylinder to measure 7.65ml of hydrochloric acid and dilute it to 1000ml with water, then add 0.5g of sodium lauryl sulfate and stir well to obtain a hydrochloric acid solution of pH 1.2 containing 0.05% SDS .

[0200] 2. Dissolution method: with embodiment 2.

[0201] 3. Dissolution testing method: same as in Example 1.

[0202] 4, calculation formula: with embodiment 1.

[0203] (3) Dissolution curve results:

[0204] The dissolution profile results are shown in Table 8.

[0205] Table 8: Dissolution profile of Example 3 (Glimepiride Dispersible Tablet-1mg)

[0206]

[0207]

[0208] The f of glimepiride dispersible ta...

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Abstract

The invention provides a determination method for a dissolution curve with distinguishing power of glimepiride tablets. According to the determination method, the dissolution curve with distinguishing power is determined through tests such as dissolution medium screening and stirring paddle rotating speed. Through tests in the aspects of specificity, solution stability, filter membrane influence factors and the like, the process for detecting the dissolution rate by high performance liquid chromatography is optimized. The determination method of the dissolution curve provided by the invention can well evaluate the dissolution behavior difference between an imitated preparation and an original developed preparation, investigates the influence of the change of a glimepiride tablet prescription or process on in-vitro release, and has good in-vivo and in-vitro consistency in a bioequivalence test; the method is of great significance in accelerating the research and development of generic drugs and ensuring the quality and curative effect of the drugs.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for measuring the dissolution curve of glimepiride tablets, especially glimepiride dispersible tablets, in a pH 1.2 dissolution medium. Background technique [0002] Glimepiride is the third-generation sulfonylurea oral hypoglycemic drug, the chemical name is 1-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1 -formamido)-ethyl]-benzenesulfonyl]-3-(trans-4-methylcyclohexyl)-urea, suitable for type 2 diabetes mellitus whose blood sugar cannot be adequately controlled by diet control, exercise therapy and weight loss , the structural formula is as follows. [0003] [0004] Glimepiride tablets were developed by Sanofi and imported to China in 2005. The trade name is Amoli (reference preparation). Amoli can lower fasting blood sugar and postprandial blood sugar. The main mechanism of action is to stimulate pancreatic beta cells Secretes insulin, and can increase the se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 张彩娟王洁敏张芳刘文静杨婷婷
Owner CSPC OUYI PHARM CO LTD
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