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Glimepiride delta crystal form and preparation method thereof

A technology of glimepiride and crystal form, which is applied in the field of medicine and can solve problems such as low solubility, poor dissolution rate, and low bioavailability

Inactive Publication Date: 2017-06-20
SHENZHEN NYCRIST TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Glimepiride is odorless, white or light yellow-white crystalline powder, soluble in N-methylpyrrolidone, N,N-dimethylacetamide, slightly soluble in dichloromethane, tetrahydrofuran, slightly soluble in 1,4-diox Hexacyclic, cyclohexanone, 1,2-dichloroethane, very slightly soluble in ethyl acetate, ethanol, isopropanol, insoluble in water, 1,4-butanediol, cyclohexane, n-heptane, Carbon tetrachloride is a BCS Ⅱ drug, its low solubility and poor dissolution rate are the main reasons for its low bioavailability

Method used

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  • Glimepiride delta crystal form and preparation method thereof
  • Glimepiride delta crystal form and preparation method thereof
  • Glimepiride delta crystal form and preparation method thereof

Examples

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Embodiment 1

[0070] Example 1: Preparation method of glimepiride δ crystal form

[0071] Add 1.077 g of glimepiride crystal form I to 1.7 ml of N-methylpyrrolidone, stir at 120°C until completely dissolved, crystallize at -24°C for 48 hours, and separate by filtration to obtain glimepiride δ crystal form.

Embodiment 2

[0072] Example 2: Preparation method of glimepiride δ crystal form

[0073] Add 1.077g of glimepiride crystal form I to 1.7ml of N-methylpyrrolidone, stir at 110°C until completely dissolved, crystallize at -40°C for 36 hours, thaw at room temperature, filter and separate to obtain glimepiride δ crystal form.

Embodiment 3

[0074] Example 3: Preparation method of glimepiride δ crystal form

[0075] Add 1.077g of glimepiride crystal form I to 1.7ml of N-methylpyrrolidone, stir at 100°C until completely dissolved, crystallize at -80°C for 24 hours, thaw at room temperature, filter and separate to obtain glimepiride δ crystal form.

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Abstract

The invention relates to a glimepiride delta crystal form. A preparation method of the glimepiride delta crystal form comprises the following steps of dissolving a glimepiride crystal form I in N-methyl pyrrolidone at the temperature of 100 to 120 DEG C; crystallizing at the temperature of 80 DEG C below zero to 0 DEG C, wherein in a crystallizing process, a glimepiride delta crystal form seed crystal can be added and the crystallizing time is 24 to 72 hours; and unfreezing at the normal temperature, and filtering to obtain a solid, i.e. the glimepiride delta crystal form. The glimepiride delta crystal form disclosed by the invention is different from the glimepiride crystal form in the existing literature in powder x-ray diffraction and differential scanning spectra, so that the solid form is completely different from the existing crystal form of the glimepiride.

Description

[0001] [technical field] [0002] The invention belongs to the field of medicine, and in particular relates to a glimepiride delta crystal form and a preparation method thereof. [0003] [Background technique] [0004] According to the recommendations of the World Health Organization (WHO) and the International Diabetes Federation (IDF) expert group, diabetes can be divided into four types: type 1, type 2, other special types, and gestational diabetes. Glimepiride, 1-[4-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)-ethyl]-benzenesulfonyl]- 3-(trans-4-methylcyclohexyl)-urea is a third-generation sulfonylurea hypoglycemic drug, mainly used for type 2 diabetic patients with poor blood sugar control after diet or exercise therapy. [0005] Glimepiride has the characteristics of fast, efficient, long-lasting, low dosage (2-4mg / d) and few side effects. In vivo and in vitro studies have found that glimepiride is the sulfonylurea drug with the strongest extrapancreatic effect...

Claims

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Application Information

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IPC IPC(8): C07D207/38
CPCC07D207/38C07B2200/13
Inventor 田芳安妮·齐默尔曼
Owner SHENZHEN NYCRIST TECH CO LTD
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