Method for improving turbidity of spectinomycin hydrochloride product

Abstract

The invention discloses a method for improving the turbidity of a spectinomycin hydrochloride product. The method comprises the following steps: A, performing rough filtration: filtering spectinomycin hydrochloride fermentation liquor by using oxalic acid through a plate frame to obtain a filtrate; B, adsorbing: adding EDTA-2Na into the filtrate, and adsorbing through large-aperture weak-acid cation exchange resin to obtain adsorption saturated resin; C, desorbing: backwashing the resin water with saturated adsorption, and then carrying out desorption by using 2.0-4.0% hydrochloric acid to obtain a desorption solution; D, decolorizing: decolorizing with activated carbon to obtain a decolorized solution; E, concentrating: carrying out ultra-nanofiltration to obtain a concentrated solution; and F, crystallizing and drying: crystallizing, filtering and drying to obtain finished product powder. The purpose of reducing protein and calcium and magnesium ions is achieved by adding EDTA-2Na into spectinomycin hydrochloride filtrate, the pH value is controlled to be alkalescent in the resin adsorption process, and it is guaranteed that EDTA is in an anionic state to be subjected to a complexation reaction with calcium and magnesium ions and is discharged out of a system along with adsorption waste liquid.

Description

technical field [0001] The invention belongs to the field of production of veterinary drug preparations, and in particular relates to a method for improving the turbidity of spectinomycin hydrochloride products. Background technique [0002] Spectinomycin hydrochloride (spectinomycin) is a broad-spectrum aminoglycoside antibiotics, fermented by Streptomyces spectiformis, it has antibacterial effect on Gram-positive bacteria and Gram-negative bacteria. With the increase of powder injection products in the market, the quality requirements for spectinomycin hydrochloride products are constantly increasing. It is mainly manifested in the aggregation of small molecular proteins in the presence of calcium and magnesium ions to produce flocs, which affects the turbidity of the product. Clogged syringe needle. [0003] Streptomyces spectabilis produces a large amount of protein during the fermentation process. Although a variety of impurity removal processes are used in the extract...

AI Technical Summary

Problems solved by technology

With the increase of powder injection products in the market, the quality requirements for spectinomycin hydrochloride products are constantly increasing. It is mainly manifested in the aggregation of small molecular proteins in the presence of calcium and magnesium ions to produce flocs, which affects the turbidity of the product. clogged syringe needle

[0003] Streptomyces spectabilis produces a large amount of protein during the fermentation process. Although a variety of impurity removal processes are used in the extraction process, such as: plate frame, ceramic membrane, ion exchange, ultra-nanofiltration, etc., the impurities in the feed solution cannot be removed. Removal of small molecular proteins, aggregation occurs under the action of metal ions to form a protein gel, which remains in the product with the precipitation of crystals during the process of elution and crystallization, thereby affecting the turbidity

[0004] At present, there are many methods for the separation and purification of spectinomycin hydrochloride, but none of them can guarantee the quality of the final product

Based on the current production situation, the main problems of these processes are: ①The production process is prone to bacterial contamination; ②The yield is low; the cost is high; ③The adsorption capacity of the resin is low, and the adsorption saturation is insufficient; ⑤Affected by the concentration polarization, the concentration titer of the nanofiltration process cannot be improved, which restricts the production capacity and yield of the primary crystallization process; ⑥The product quality is unstable, such as the isomer content exceeds the standard, the turbidity is unqualified, and the color grade of the solution is not good Qualified, particle size does not meet the requirements, etc.

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