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Quality detection method of melbine glipizide preparation

A technology of metformin glipizide and quality testing method, which is applied in the field of medicine, can solve the problems of inapplicable testing, adverse effects of patients, and not containing glipizide, etc., and achieves easy operation, strong specificity, and reproducibility Good results

Active Publication Date: 2014-01-15
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The relevant substances are detected in the standards of "Glipizide", "Glipizide Tablets" and "Glipizide Capsules" in the 2010 edition of the Chinese Pharmacopoeia, and the detection wavelength is 225nm, but there is no compound preparation containing glipizide quality inspection method
[0005] The amount of glipizide in metformin glipizide preparations is relatively small compared to metformin hydrochloride, and the quality detection method for glipizide-related substances in the prior art is not suitable for the detection of glipizide-related substances in compound preparations, and is out of compliance. The related substances of glipizide have serious adverse effects on patients, therefore, it is imperative to invent a scientifically reasonable and effective quality detection method for metformin glipizide preparations

Method used

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  • Quality detection method of melbine glipizide preparation
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  • Quality detection method of melbine glipizide preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 2

[0182] Embodiment 1 Determination of Related Substances of Metformin Glipizide Tablets

[0183] Glipizide 2.5g, Metformin Hydrochloride 250g, Microcrystalline Cellulose 149g, Povidone K 30 10g, sodium carboxymethyl starch 36g, magnesium stearate 2.5g are made into 1000 tablets according to the conventional process;

[0184] Glipizide related substances:

[0185] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix V D).

[0186] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; ammonium dihydrogen phosphate solution (weigh 0.575g ammonium dihydrogen phosphate and 4.32g sodium octane sulfonate, add water to 1000ml, use three Ethylamine adjusted the pH to 7.0±0.05)-acetonitrile (84:16) as mobile phase; detection wavelength was 275nm; column temperature: 30°C.

[0187] Determination method Take an appropriate amount of fine powder of this product (approximately equi...

Embodiment 2 2

[0188] Example 2 Determination of Related Substances in Metformin Glipizide Capsules

[0189] Glipizide 2.5g, metformin hydrochloride 500g, microcrystalline cellulose 297g, povidone K 30 23.6g, sodium carboxymethyl starch 72g, magnesium stearate 4.9g were made into 1000 capsules according to the conventional process;

[0190] Glipizide related substances:

[0191] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix V D).

[0192] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; ammonium dihydrogen phosphate solution (weigh 0.575g ammonium dihydrogen phosphate and 4.32g sodium octane sulfonate, add water to 1000ml, use three Ethylamine adjusted the pH to 7.0±0.05)-acetonitrile (84:16) as mobile phase; detection wavelength was 275nm; column temperature: 30°C.

[0193] Determination method Take an appropriate amount of fine powder of the content of this product (a...

Embodiment 3 2

[0197] Example 3 Determination of Related Substances in Metformin Glipizide Enteric-Coated Capsules

[0198] Glipizide 2.5g, metformin hydrochloride 500g, microcrystalline cellulose 297g, povidone K 30 23.6g, 72g of sodium carboxymethyl starch, and 4.9g of magnesium stearate are packed into enteric-coated capsule shells according to the conventional process, and made into 1000 capsules;

[0199] Determine according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix V D).

[0200] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; ammonium dihydrogen phosphate solution (weigh 0.575g ammonium dihydrogen phosphate and 4.32g sodium octane sulfonate, add water to 1000ml, use three Ethylamine adjusted the pH to 7.0±0.05)-acetonitrile (84:16) as mobile phase; detection wavelength was 275nm; column temperature: 30°C.

[0201] Determination method Take an appropriate amount of fine powder of...

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Abstract

The invention discloses a quality detection method of a melbine glipizide preparation, belonging to the technical field of medicine. The quality detection method is mainly used for the quality detection of glipizide relevant matters of the melbine glipizide preparation. The method has the advantages of strong specificity, good repeatability, high precision, convenient operation and no interference of other main drugs and auxiliary materials, can be used for preferably detecting the quality of the melbine glipizide preparation, and truly ensure the safety, the efficiency and the controllability of clinical medication. The invention also can be combined with other methods to together detect the quality of the melbine glipizide preparation.

Description

technical field [0001] The invention discloses a quality detection method of metformin glipizide preparation, which belongs to the technical field of medicine. Background technique [0002] There are about 30 million diabetic patients in my country, of which type Ⅱ accounts for more than 90%. According to the latest report of foreign analysts, the prevalence of diabetes worldwide and the rapid development of new drugs for treating type I and type II diabetes will increase the market for diabetes drugs by 16% every year. [0003] Glipizide tablets are used for the treatment of type 2 diabetes, and the combination of glipizide and metformin hydrochloride is used for the first-line and second-line treatment of patients with type 2 diabetes. [0004] The relevant substances are detected in the standards of "Glipizide", "Glipizide Tablets" and "Glipizide Capsules" in the 2010 edition of the Chinese Pharmacopoeia, and the detection wavelength is 225nm, but there is no compound pr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 曹相林陈婧魏墨玺陈红燕张丽娟
Owner BEIJING SIHUAN KEBAO PHARM CO LTD