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A kind of ethambutol hydrochloride salt crystallization method

A technology of ethambutol hydrochloride and ethambutol, which is applied in chemical instruments and methods, preparation of organic compounds, organic chemistry, etc., can solve problems such as high cost, decreased total yield, suppressed production capacity, etc., and achieves low cost , Improving the effect of purity and high yield

Active Publication Date: 2015-11-18
GUANGZHOU BAIYUNSHAN MINGXING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The purity of ethambutol hydrochloride is greatly affected by the bulk drug, because in the salt-forming process, existing techniques are difficult to prevent impurities from entering the final product. Therefore, in the prior art, it is necessary to synthesize ethylamine hydrochloride that reaches the pharmacopoeia standard purity Butanol generally chooses two ways: one is to strictly purify the ethambutol raw material to make it more than 99% pure, and the hydrochloride prepared from such a raw material can generally have a purity of more than 99%, but such Purification is very difficult, especially when the purity of ethambutol is closer to 99%, the purification is more difficult, so the cost is extremely high; the second is to use general purity ethambutol to form a salt first, and then to obtain the salt after many times Repeated purification to make its purity reach 99%; no matter which method is used, it will greatly increase the production cost. At the same time, repeated purification will reduce the total yield of the reaction and inhibit the production capacity of the enterprise.
[0005] In the prior art, there is no easy and cheap ethambutol hydrochloride salt-forming crystallization method, so that the purity of ethambutol hydrochloride prepared by it can reach the standard of the Pharmacopoeia

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1~11

[0029] The ethambutol hydrochloride synthesis of embodiment 1~11 is carried out as follows,

[0030] S1. Dissolve 100kg of ethambutol raw material in ethanol, transfer the obtained ethambutol ethanol solution to a container, adjust the temperature of the system, then slowly add hydrochloric acid ethanol solution dropwise under stirring, so that the pH value is controlled at 3.5~4 ;

[0031] S2. Control the cooling speed of the system and the drop-off temperature, keep warm at the drop-off temperature for 30 minutes, filter under reduced pressure, wash with an appropriate amount of absolute ethanol for 4 times, and dry the filter residue at 70-80°C after draining to obtain the ethyl alcohol hydrochloride Ambutol;

[0032] In step S1., among the ethambutol raw materials used, the purity of ethambutol is 94%.

[0033] S1. Medium system temperature, S2. Medium cooling rate, drop-off temperature are shown in Table 1.

[0034] Table 1

[0035]

[0036] As can be seen f...

Embodiment 12~15

[0046] The ethambutol hydrochloride synthesis of embodiment 12~15 is carried out as follows,

[0047] S1. Dissolve 150kg of ethambutol raw material in ethanol, and transfer the obtained ethambutol ethanol solution into a container, adjust the system temperature to 80°C, then slowly add hydrochloric acid ethanol solution dropwise under stirring, so that the pH value is controlled at 3.5 ~4;

[0048] S2. Control the cooling rate of the system at 6°C / 30min and the drop-off temperature at 8°C, keep warm at the drop-off temperature for 30 minutes, filter under reduced pressure, wash with an appropriate amount of absolute ethanol for 4 times, and dry the filter residue at 70-80°C after draining , to obtain the ethambutol hydrochloride;

[0049] In step S1., among the ethambutol raw materials used, the purity of ethambutol is shown in Table 3.

[0050] table 3

[0051]

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Abstract

The present invention discloses a method of salt hydrochloride into a salt crystalline.The cryptation method of ethanylene hydrochloride hydrochloric acid hydrochloride can improve the purity of the achine hydrochloride hydrochloride hydrochloride in the process of system temperature, cooling speed, and falling machine through strict control, so that the low -purity ethylene butanol raw material can be used.The medicine can produce a oleidine hydrochloride taitol that meets the standard of the drug, and reaches a higher yield.Lower cost.

Description

technical field [0001] The invention belongs to the field of preparation of anti-tuberculosis drugs, in particular to a salt-forming crystallization method of ethambutol hydrochloride. Background technique [0002] Ethambutol hydrochloride is an anti-tuberculosis drug. The drug has a strong inhibitory effect on Mycobacterium tuberculosis, but has no obvious effect on other bacteria, and has no cross-resistance with other anti-tuberculosis drugs. It is widely applicable to various types of tuberculosis and pulmonary tuberculosis. External tuberculosis. [0003] Ethambutol hydrochloride is a kind of hydrochloride of ethambutol dextrorotary form, which is prepared by salting ethambutol dextrorotary form and hydrochloric acid. The ethambutol molecule contains two chiral carbon atoms and has three optical isomers. The activity of the dextrorotary form against Mycobacterium tuberculosis is 12 times that of the mesoform, and 200-500 times that of the levorotatory form. Use its de...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C215/14C07C213/08
Inventor 黎洪高建胜司徒少金黄子健潘碧妍
Owner GUANGZHOU BAIYUNSHAN MINGXING PHARM CO LTD
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