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Novel crystal form of metformin hydrochloride and preparation method thereof

A technology of metformin hydrochloride and crystal form, applied in the field of preparation of new crystal form and crystal form of metformin hydrochloride, can solve the problems of difficult crystallization control, difficult elution of impurities, low crystal melting point, etc. The effect of less impurity adsorption and high transparency

Inactive Publication Date: 2011-08-17
SHOUGUANG FUKANG PHARMA
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

However, in the existing metformin hydrochloride refining technology, its product crystals are slender, soft, and low in density, and the adsorption of impurities is difficult to elute, and the tablet hardness is not high when the preparation is compressed.
[0003] In patent CN101450920A, the crude product of metformin hydrochloride is refined with 3 times purified water to obtain crystals with large particles, but the melting point of the crystals is low, there are air gaps in the crystals, and the crystals are not dense enough
[0004] The metformin hydrochloride raw material has a relatively narrow supersaturation metastable zone during crystallization, and it is difficult to control its sudden formation of a large number of crystal nuclei during the cooling and crystallization process, so crystallization control is more difficult

Method used

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  • Novel crystal form of metformin hydrochloride and preparation method thereof
  • Novel crystal form of metformin hydrochloride and preparation method thereof
  • Novel crystal form of metformin hydrochloride and preparation method thereof

Examples

Experimental program
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Embodiment 1

[0016] Put 100Kg of metformin hydrochloride crude product into the reaction tank, add 230Kg of 70% ethanol solution to the crystallization tank, after adding, cover the feeding port tightly, turn on the steam to heat, heat to 72°C, reflux for 2-3 hours, check Whether it is fully soluble or not, press filter while it is hot into another special column crystallization tank, first turn on circulating water to cool down, and then freeze to cool down. During the cooling process, the temperature should be controlled and lowered by one degree every 20 minutes. At the same time, frequency conversion to control the speed Between 25 revolutions per minute, the temperature was lowered to below minus -10°C, the material was shaken and washed to obtain 92Kg of refined crystals with a yield of 92%. After testing, the physical and chemical properties meet the requirements of the United States Pharmacopoeia USP32.

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Abstract

The invention relates to a novel crystal form of metformin hydrochloride and a preparation method thereof. The preparation method comprises the following steps of: in a cylindrical flow barrel crystallization tank body serving as special crystallization equipment, dissolving crude metformin hydrochloride in an ethanol solution with the concentration of 70-80 percent; and cooling in the control process to obtain the novel crystal form of the metformin hydrochloride.

Description

technical field [0001] The invention belongs to the technical field of medicine and chemical industry, and in particular relates to a new crystal form of metformin hydrochloride, and also relates to a preparation method of the crystal form. Background technique [0002] Metformin hydrochloride is a biguanide hypoglycemic drug. Biguanides are internationally recognized as safe and effective oral hypoglycemic agents, and are currently the most widely used oral hypoglycemic agents in the world for diabetics. Its unique hypoglycemic mechanism is that it does not stimulate and effectively protects damaged islets, significantly reduces postprandial hyperglycemia, and does not induce hypoglycemia, and has a better effect on obese patients. But in the existing metformin hydrochloride refining technology, its product crystal is slender, soft, low density, impurity adsorption is difficult to wash off, and shows the shortcomings such as tablet hardness is not high when preparation tab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C279/26C07C277/08
Inventor 宋伟国宋成刚张福建王福洲
Owner SHOUGUANG FUKANG PHARMA
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