A method for determining related substances in voglibose raw materials and preparations

A technology for voglibose and related substances, which is applied in the field of determination of related substances in voglibose raw materials and preparations, and can solve problems such as complex operations, affecting peak conditions, and affecting substance detection
CN111855841BActive Publication Date: 2022-06-14CISEN PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
CISEN PHARMA
Publication Date
2022-06-14

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Abstract

The invention discloses a method for determining related substances in voglibose raw materials and preparations. The present invention utilizes 1-phenyl-3-methyl-5-pyrazolone to carry out pre-column derivatization of voglibose and its related substances, and adopts high-performance liquid chromatography to measure voglibose in raw materials and preparations related substances. The invention can separate the related substances of voglibose, and effectively control the quality of voglibose raw materials and preparations. The determination method of the invention has strong specificity, high accuracy, high precision, good durability, and convenient operation, and can effectively control the quality of raw materials and preparations in actual production.
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Description

Technical field

[0001] The present invention belongs to the field of drug quality detection technology, particularly relates to a voglipose raw material and formulation of the relevant substance determination method. Background

[0002] Vogliglibose phosphate is a new generation of α-glucosidase inhibitors that inhibit the disaccharide hydrolase (α-glucosidase) that breaks down disaccharides into monosaccharides in the intestine, thereby delaying the digestion and absorption of sugars, thereby improving postprandial hyperglycemia. The results of the determination of exhaled hydrogen after administration of sucrose load in healthy adults confirmed that the drug has an inhibitory effect on blood glucose elevation at clinical doses. When normal rats are administered orally, this product inhibits the increase in blood glucose after starch, maltose and sucrose loads, and has no inhibitory effect on the increase in blood sugar after glucose, fructose and lactose loads. The study of the...

Claims

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