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Production technology of Fenofibric acid

A technology of fenofibric acid and production process, which is applied in the field of medicine, can solve the problems of large crystallization loss and low yield of fenofibric acid, and achieve the effects of improving purity, ensuring stable quality and safety control, and superior purity

Active Publication Date: 2014-07-16
CHENGDU YILUKANG MEDICAL TECH & SERVICE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The main purpose of the present invention is to provide a new fenofibric acid production process with high fenofibric acid yield for the large loss of crystallization link in the above-mentioned prior art, which leads to low fenofibric acid yield

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] (1) Under alkaline conditions, 4-chloro-4'-hydroxybenzophenone undergoes a condensation reaction with chloroform and acetone to generate fenofibric acid, and the reaction solution is separated and purified to obtain crude fenofibric acid;

[0023] The specific operation is as follows:

[0024] Add 1kg of raw materials 4-chloro-4'-hydroxybenzophenone, 1.46kg of sodium hydroxide, and 8L of acetone into a 30L reactor; Keep stirring for 1 hour. Then slowly drop the mixed solution of chloroform and acetone in the reactor, wherein chloroform 1.15kg, acetone 2L, titration time is 2 hours. After dripping, the temperature of the reaction solution was raised to 55-57°C, and kept at reflux for 3 hours; then, the reaction solution was heated in a water bath, and the reaction solution was concentrated to dryness under reduced pressure at a constant temperature of 45°C. Then, add 10L of pure water and 2.5L of dichloromethane to the concentrate, and stir for 1 hour; separate the liq...

Embodiment 2

[0029] Except for the dissolution and crystallization process, the crystallization solution added to the crude fenofibric acid and the dissolution temperature, the operating steps of this example are exactly the same as those of Example 1.

[0030] In the process of dissolution and crystallization in this embodiment, the crude product of fenofibric acid was added in an amount of 20 g, and the crystallization solution was methanol in an amount of 110 ml, which was dissolved at 64°C.

[0031] The refined fenofibric acid obtained in this example has a final product of light yellow crystals with a weight of 13.6 g. The yield of the product is 68%, and the product purity is 99.815%.

Embodiment 3

[0033] Except for the dissolution and crystallization process, the crystallization solution added to the crude fenofibric acid and the dissolution temperature, the operating steps of this example are exactly the same as those of Example 1.

[0034] In the dissolution and crystallization process of this embodiment, the crude product of fenofibric acid was added in an amount of 20 g, the crystallization solution was ethanol, and the dosage was 160 ml, which was dissolved at 57°C.

[0035]The refined fenofibric acid obtained in this example has a final product of off-white crystals with a weight of 14.4gg, a product yield of 72%, and a product purity of 99.811%.

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Abstract

The invention belongs to the technical field of medicine and discloses a production technology of Fenofibric acid. The production technology mainly comprises the following steps that (1) under an alkaline condition, a condensation reaction is conducted through 4-chlorine-4'-hydroxybenzophenone, trichloromethane and acetone so that the Fenofibric acid can be generated and after separation and purification are conducted on reaction liquid, the crude Fenofibric acid is obtained; (2) a crystal solution is added to the crude Fenofibric acid obtained in the step (1) and dissolution and crystallization are conducted to obtain the refined Fenofibric acid; the crystal solution is a mixed solution composed of one or more of methyl alcohol, alcohol, acetone, toluene, acetonitrile and ethyl acetate. According to the production technology of the Fenofibric acid, solvent for separating and purifying the crude product and technological parameters are optimized and the recovery rate and the purity of the crude product are greatly improved. According to the production technology, great optimization and adjustment are conducted on crystallization solvent and a crystallization condition in the following refined purification process. Compared with the prior art, the recovery rate of the medicine-level pure Fenofibric acid is increased by 10% to 20%.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a production process of fenofibric acid. Background technique [0002] Fenofibric acid (English name: fenofibric acid) its main component and its chemical name are 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionic acid, and its molecular formula is C 17 h 15 ClO 4 , This product is a clofibrate derivative blood lipid regulating drug. [0003] Fenofibric acid is a blood lipid-lowering drug that can significantly reduce serum cholesterol, triglycerides and increase high-density lipoprotein. Main purposes: combined with statins in the treatment of mixed dyslipidemia; severe hypertriglyceridemia; primary hypercholesterolemia or mixed dyslipidemia. [0004] This product is a blood lipid regulating drug derived from clofibrate, which is the in vivo metabolite of fenofibrate. It can reduce blood low-density lipoprotein by inhibiting the formation of very low-density lipoprotein and ...

Claims

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Application Information

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IPC IPC(8): C07C59/90C07C51/43C07C51/00
CPCC07C51/093C07C51/43C07C59/90
Inventor 彭超
Owner CHENGDU YILUKANG MEDICAL TECH & SERVICE
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