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A kind of preparation method of erythromycin lactobionate solution and its salt-forming reaction device

A technology for erythromycin lactobionate and salt-forming reaction, which is applied in the preparation of sugar derivatives, feeding devices, chemical instruments and methods, etc. Low and other problems, to achieve the effect of solving the local acid is too high, reducing the local concentration and improving the stability

Active Publication Date: 2017-10-27
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The erythromycin lactobionate solution prepared by the existing preparation method of the erythromycin lactobionate solution has a lower content of the product after salification, and some raw and auxiliary materials are lost, resulting in a lower yield of erythromycin lactobionate, and the obtained Product quality is not stable

Method used

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  • A kind of preparation method of erythromycin lactobionate solution and its salt-forming reaction device
  • A kind of preparation method of erythromycin lactobionate solution and its salt-forming reaction device
  • A kind of preparation method of erythromycin lactobionate solution and its salt-forming reaction device

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] The preparation of embodiment 1 erythromycin lactobionate solution

[0089] Source of material:

[0090] Ion exchange resin column: 732 strong acid cation exchange resin column, synthesized in Shanghai Resin Factory Co., Ltd., each kilogram of 732 strong acid cation exchange resin column can handle up to 0.267kg sodium lactobionate each time. The filling height of the cation exchange resin column is 2000mm; the diameter is 350mm.

[0091] Preparation:

[0092] Preparation of lactobionic acid solution:

[0093] 1. Ion exchange resin column acid regeneration treatment: take 732 strong acid type cation exchange resin column, soak it with 2mol / L hydrochloric acid for 24 hours, then discharge the hydrochloric acid, then wash it with water for injection to pH5, and check that there is no Cl in the light inspection box - Backup.

[0094] Among them, Cl - The detection method and quality control standard are as follows: take 50mL of cleaning water for cleaning the ion exch...

Embodiment 2

[0119] The preparation of embodiment 2 erythromycin lactobionate solution

[0120] Source of material:

[0121] Ion exchange resin column: 732 strong acid cation exchange resin column, synthesized in Shanghai Resin Factory Co., Ltd., each kilogram of 732 strong acid cation exchange resin column can handle up to 0.267kg sodium lactobionate each time. The filling height of the cation exchange resin column is 1500mm; the diameter is 500mm.

[0122] Preparation:

[0123] Preparation of lactobionic acid solution:

[0124] 1. Ion exchange resin column acid regeneration treatment: take a 732 strong acid type cation exchange resin column, soak it in 3mol / L hydrochloric acid for 24 hours, then discharge the hydrochloric acid, then wash it with water for injection to pH6, and check that there is no Cl in the light inspection box - Backup.

[0125] Among them, Cl - The detection method and quality control standard are as follows: take 50mL of cleaning water for cleaning the ion exch...

Embodiment 3

[0145] The preparation of embodiment 3 erythromycin lactobionate solution

[0146] Source of material:

[0147] Ion exchange resin column: 732 strong acid cation exchange resin column, synthesized in Shanghai Resin Factory Co., Ltd., each kilogram of 732 strong acid cation exchange resin column can handle up to 0.307kg sodium lactobionate each time. The filling height of the cation exchange resin column is 2500mm; the diameter is 300mm.

[0148] The schematic diagram of the structure of the salt-forming reaction device is shown in figure 1 , figure 2 , Figure 4 , Figure 5 shown. As can be seen from the figure, the salt-forming reaction device includes a sample loading device and a reaction device; the sample loading device includes a liquid storage tank (1), a conduit (2) and a dripping device (3); The adding device (3) is communicated through the conduit (2), and a flow control device (4) is arranged between the conduit (2) and the liquid storage tank (1); the droppi...

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Abstract

The invention belongs to the technical field of pharmaceutical chemistry, and discloses a preparation method and salification reactor of an erythromycin lactobionate solution. The preparation method comprises the following steps: taking sodium lactobionate, and exchanging and separating through a cation-exchange resin column to prepare a lactobionic acid solution; taking erythromycin and water for injection, and mixing to obtain an erythromycin suspension; and taking the obtained lactobionic acid solution, dropwisely adding the lactobionic acid solution into the erythromycin suspension to perform salification reaction, diluting to a specific volume and decarbonizing, wherein the concentration of the erythromycin suspension is 60-120 mg / mL, the concentration of the lactobionic acid solution is 145-225 g / L, and the dropwise addition speed of the lactobionic acid solution is 320-380 mL / minute. The preparation method disclosed by the invention obviously enhances the erythromycin lactobionate yield, lowers the content of related substances, and stabilizes the quality of the erythromycin lactobionate solution.

Description

technical field [0001] The invention belongs to the technical field of medicinal chemistry, and in particular relates to a preparation method of erythromycin lactobionate solution and a salt-forming reaction device. Background technique [0002] Erythromycin lactobionate belongs to macrolide antibiotics, is water-soluble erythromycin lactobionate, has antibacterial activity against Staphylococcus, Streptococcus, Gram-positive bacilli; except for Bacteroides fragilis and Fusobacterium It also has antibacterial activity against various anaerobic bacteria other than Legionella, Campylobacter fetalis, certain spirochetes, Mycoplasma pneumoniae, Rickettsia and Chlamydia; Neisseria, Haemophilus influenzae, Bordetella pertussis can also be susceptible to erythromycin lactobionate. Erythromycin lactobionate is a bacteriostatic agent, but it also has a bactericidal effect on some bacteria at high concentrations. Studies have found that erythromycin lactobionate is absorbed and hydr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H17/08C07H1/00B01J19/00B01J4/00
CPCB01J4/001B01J19/00C07H1/00C07H17/08
Inventor 李全学余泽勇廖孝曙逯佩荣彭朝晖刘志军寻中华陈杨柳何东征刘思川万阳浴程志鹏葛均友
Owner HUNAN KELUN PHARMA