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Preparation method of ultrahigh water-soluble chlortetracycline hydrochloride

A chlortetracycline hydrochloride, water-soluble technology, applied in the field of preparation of ultra-high water-soluble chlortetracycline hydrochloride, can solve the problems of increased impurity content, poor long-term stability, easy discoloration, etc., and achieves increased contact area and increased Biological activity, the effect of increasing the specific surface area

Pending Publication Date: 2022-04-05
PUCHENG CHIA TAI BIOCHEM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The solubility of chlortetracycline hydrochloride in water at room temperature is about 0.4g / 100ml, which belongs to the "slightly soluble" range defined by the Codex Veterinary Medicine, which greatly limits the application of chlortetracycline hydrochloride in breeding and the development of related dosage forms
[0003] Currently commercially available chlortetracycline hydrochloride soluble powder, due to the hygroscopicity of excipients, compatibility with chlortetracycline, etc., lead to instability of chlortetracycline, increased impurity content, easy to change color, which affects the stability of the preparation and the later stage. The therapeutic effect of the
Existing research on the solubility of chlortetracycline hydrochloride, for example, adopts chlortetracycline hydrochloride as raw material in the Chinese patent application CN104622811A, by adding lauryl sulfate sodium salt and ethylenediaminetetraacetic acid disodium salt, improved aureomycin hydrochloride The absorption rate and bioavailability of the main drug, but the long-term stability of the product is still poor
[0004] In summary, there are many ways to improve the solubility of chlortetracycline hydrochloride. The common method is to use auxiliary materials to improve the solution environment to promote the dissolution of chlortetracycline hydrochloride, or to change the crystal structure of chlortetracycline hydrochloride to increase dissolution. To a certain extent, the solubility of aureomycin hydrochloride is improved, but the improvement of solubility is not significant or the cost is too high

Method used

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  • Preparation method of ultrahigh water-soluble chlortetracycline hydrochloride
  • Preparation method of ultrahigh water-soluble chlortetracycline hydrochloride
  • Preparation method of ultrahigh water-soluble chlortetracycline hydrochloride

Examples

Experimental program
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Effect test

Embodiment 1

[0059] The preparation method of ultrahigh water-soluble aureomycin hydrochloride comprises the steps:

[0060] 1) Acidification of fermentation broth:

[0061] Cool the chlortetracycline fermentation broth to 2°C, and add purified water equivalent to 1.0 times the volume of the chlortetracycline fermentation broth;

[0062] Then add oxalic acid at a ratio of 2.0 g per 100 mL of aureomycin fermentation broth, and adjust the pH to 1.3 with hydrochloric acid;

[0063] Then add yellow blood salt sodium in a ratio of 0.15g per 100mL aureomycin fermentation broth, and stir for 25min;

[0064] Then add zinc sulfate at a ratio of 0.2 g per 100 mL of aureomycin fermentation broth, and stir for 25 min;

[0065] The obtained acidified solution is subjected to plate and frame pressure filtration, the filtrate is collected, the mycelia residue is washed with acid water having a pH of 1.5, the filtrate and the lotion are combined, the plate and frame re-filtration is performed, and the r...

Embodiment 2

[0083] The preparation method of ultrahigh water-soluble aureomycin hydrochloride comprises the steps:

[0084] 1) Acidification of fermentation broth:

[0085] Cool the chlortetracycline fermentation broth to 0°C, and add purified water equivalent to 1.2 times the volume of the chlortetracycline fermentation broth;

[0086] Then add oxalic acid at a rate of 1.5 g per 100 mL of aureomycin fermentation broth, and adjust the pH to 1.4 with hydrochloric acid;

[0087] Add yellow blood salt sodium at a ratio of 0.1 g per 100 mL of aureomycin fermentation liquid, and stir for 20 min;

[0088] Then add zinc sulfate at a ratio of 0.1 g per 100 mL of aureomycin fermentation broth, and stir for 20 min;

[0089] The obtained acidified solution is subjected to plate and frame pressure filtration, the filtrate is collected, the mycelia residue is washed with acid water having a pH of 1.5, the filtrate and the lotion are combined, the plate and frame re-filtration is performed, and the r...

Embodiment 3

[0107] The preparation method of ultrahigh water-soluble aureomycin hydrochloride comprises the steps:

[0108] 1) Acidification of fermentation broth:

[0109] Cool the chlortetracycline fermentation broth to 5°C, and add purified water equivalent to 0.5 times the volume of the chlortetracycline fermentation broth;

[0110]Then add oxalic acid at a ratio of 2.5 g per 100 mL of aureomycin fermentation liquid, and adjust the pH to 1.2 with hydrochloric acid;

[0111] Then add yellow blood salt sodium in a ratio of 0.2 g per 100 mL of aureomycin fermentation broth, and stir for 30 min;

[0112] Then add zinc sulfate at a rate of 0.3 g per 100 mL of aureomycin fermentation broth, and stir for 30 min;

[0113] The obtained acidified solution is subjected to plate and frame pressure filtration, the filtrate is collected, the mycelia residue is washed with acid water having a pH of 1.5, the filtrate and the lotion are combined, the plate and frame re-filtration is performed, and t...

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Abstract

The invention discloses a preparation method of ultrahigh water-soluble chlortetracycline hydrochloride. The preparation method specifically comprises the following steps: 1) acidifying fermentation liquor; 2) double salt; 3) coarse crystallization; 4) extracting; (5) recrystallizing; (6) performing high-pressure homogenization: performing high-pressure homogenization treatment on the material obtained in the step (1) by taking purified water as a dispersion medium according to a water-material ratio of 1: (1-1.5) for 10-12 times; and 7) spray drying: carrying out spray drying treatment on the material obtained in the previous step, controlling the feeding frequency to be 20Hz and the air inlet temperature to be 175-180 DEG C to obtain the ultrahigh water-soluble chlortetracycline hydrochloride.

Description

technical field [0001] The invention belongs to the technical field of veterinary drugs, and in particular relates to a preparation method of ultrahigh water-soluble aureomycin hydrochloride. Background technique [0002] Chlortetracycline hydrochloride, also known as chlortetracycline hydrochloride, has the same antibacterial spectrum as tetracycline, and its curative effect on penicillin-resistant Staphylococcus aureus is slightly stronger than tetracycline. Now it is mainly used to treat conjunctivitis, trachoma, etc. The solubility of chlortetracycline hydrochloride in water at room temperature is about 0.4g / 100ml, which belongs to the "slightly soluble" range defined by the Codex Veterinary Medicine, which greatly limits the application of chlortetracycline hydrochloride in breeding and the development of related dosage forms. [0003] Currently commercially available chlortetracycline hydrochloride soluble powder, due to the hygroscopicity of excipients, compatibility...

Claims

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Application Information

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IPC IPC(8): C07C231/12C07C231/24C07C237/26
CPCY02A50/30
Inventor 张君启宁富豪黄小毛陈浩然吴新芝杨占英李书至朱正江
Owner PUCHENG CHIA TAI BIOCHEM
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