Method for producing lysine acetate for injection

A technology of lysine acetate and a production method, which is applied in the field of manufacturing lysine for injection, can solve the problem that amino acid heteroacid cannot be effectively removed, bacterial endotoxin is difficult to reach the standard for injection, histidine and lysine Unsatisfactory separation effect and other problems, to achieve the effect of environmental protection, good production efficiency, and improved light transmittance

Active Publication Date: 2011-11-02
汕头市佳禾生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a drug, there are strict restrictions on amino acid congeners (ie, miscellaneous acids) and bacterial endotoxins (ie, pyrogens produced), but amino acid miscellaneous acids cannot be effectively purified from lysine purified by ion exchange and activated carbon purification processes. Removal, bacterial endotoxin is difficult to meet the standard for injection
The amino acid heteroacids of industrial lysine hydrochloride usually contain a small amount of neutral amino acids and basic amino acids such as histidine. Because the isoelectric points of histidine and lysine are very close, although there are related reports on the separation of mixed amino acids, However, the separation effect of histidine and lysine in basic amino acids is not ideal

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Get 182.5Kg of industrial lysine hydrochloride and dissolve it in 1000L of water, add the JK008 produced by Anhui Sanxing Resin Technology Co., Ltd., an evenly porous strong acid cation exchange resin column with an effective particle size of 0.40-0.60mm, and control the flow rate to 5L / L resin per hour. When the ninhydrin test shows that lysine flows out, the liquid addition is stopped, and the remaining solution flowing out of the recovery column is recycled.

[0024] Add 300L pure water to the resin column to wash the resin column until the chloride ion content in the effluent is ≤0.02%. Then add 0.03mol / L ammonia water for elution, and control the flow rate to 5L / L resin per hour. When the ninhydrin test has amino acid outflow, start to collect the amino acid miscellaneous acid, stop collecting the amino acid miscellaneous acid when there is no amino acid outflow during the ninhydrin test, and collect about 60L amino acid miscellaneous acid feed liquid. Then add 0....

Embodiment 2

[0030] Get 182Kg industrial lysine hydrochloride and be dissolved in 1000L water, carry out the operation identical with embodiment 1, the ammoniacal liquor concentration of eluting lysine is changed to 3.0mol / L, and flow velocity is changed into 8L / L resin hour, obtains acetic acid lysine The amino acid product is 196Kg, and the total yield of lysine is 96%.

[0031] The following table lists embodiment 1 raw material and product part physical and chemical index:

[0032] Physical and chemical indicators raw material Chinese Pharmacopoeia 2010 Edition product purity 97% Lysine HCl ≥98.5% Lysine Acetate 99.8% Lysine Acetate Light transmittance (C=10, H 2 O) 80% ≥98% 99% Total Amino Acid Content 1.3~1.6% ≤0.2% ＜0.1% of which: histidine 0.85% ＜0.01% Alanine 0.13% ＜0.01% Leucine 0.12% ＜0.01% Isoleucine 0.10% ＜0.01% Bacterial endotoxin About 1000EU / g

[0033] As can be seen from the...

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Abstract

The invention discloses a method for producing lysine acetate for injection, comprising the following steps of: preparing industrial hydrochloric acid lysine into aqueous solution; after adsorbing and saturating through balanced hole strong acid cation exchange resin; using 0.01-0.05 mol / L of ammonia water to elute neutral amino acid heteroacid; then, using 0.5-1 mol / L of ammonia water to elute histidine; finally, using 1.5-5 mol / L of ammonia water to elute lysine; filtering through an ultra-filtration membrane; filtering through a nano-filtration membrane; concentrating and crystallizing; and obtaining the lysine acetate for injection. The better separation effect and production efficiency can be achieved. The contents of the amino acid heteroacid and bacterial endotoxin in the product are very low. The light transmission rate of the solution is greatly improved. The purity of the product can reach above 99.8%. The quality exceeds the quality standard for injection of Chinese pharmacopoeia.

Description

technical field [0001] The invention relates to a production method of lysine for injection, in particular to a production method of lysine acetate for injection. Background technique [0002] L-Lysine is one of the essential amino acids for the human body, because it is not only a basic nutrient for human health, but also has anti-inflammatory and analgesic effects, liver cell protection, immunity enhancement, and anti-tumor effects in disease treatment. . Medical compound amino acid injection can not only provide patients with essential nutrients, but also has good effects in treating burns, liver diseases, kidney diseases, encephalopathy, etc. Lysine is one of the main raw materials for compound amino acid injection. Due to the poor chemical stability of lysine, it was often used as lysine hydrochloride in the early stage. The compound amino acid infusion prepared with lysine hydrochloride has high chloride ion content, and some patients are not suitable for it. Theref...

Claims

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Application Information

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IPC IPC(8): C07C229/26C07C227/18C07C53/10C07C51/41C07C51/43
Inventor 袁爱国张楚扬陈德苞邢珣斐
Owner 汕头市佳禾生物科技有限公司
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