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Preservative-free horse tetanus immune globulin preparation for injection and preparation method thereof

An immunoglobulin, preservative-free technology, applied in the field of medicine, can solve problems such as high pollution and preservative toxicity, and achieve the effect of reducing the degree of susceptibility to pollution

Inactive Publication Date: 2016-10-26
玉溪九洲生物技术有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the concentration of preservatives in preparations is low and their use is safer, the toxicity of preservatives in preparations has been controversial
Due to the high protein content of tetanus antitoxin, there is a high risk of contamination in the removal of preservatives. Therefore, all domestic tetanus antitoxins contain preservatives

Method used

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  • Preservative-free horse tetanus immune globulin preparation for injection and preparation method thereof
  • Preservative-free horse tetanus immune globulin preparation for injection and preparation method thereof
  • Preservative-free horse tetanus immune globulin preparation for injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0039] A preparation method for an equine tetanus immune globulin preparation for injection without preservatives, comprising the steps of:

[0040] Step (1), extract IgG: operate at normal temperature, horse plasma VL, dilute horse plasma with 2VL of 0.85% sodium chloride aqueous solution to obtain horse plasma dilution; add 16% (m / v) ammonium sulfate solid powder, stir until dissolved, let stand for 2h, filter; take the filtrate, add 13% (m / v) ammonium sulfate solid powder according to the volume of the filtrate, then stir until dissolved, let stand for 2h, filter , take the precipitate;

[0041] Step (2), digestion and heating denaturation: dissolve the precipitate obtained in step (1) with a mass concentration of 0.85% sodium chloride aqueous solution to a volume of 2V L, adjust the pH to 2.9 with 2M hydrochloric acid, add 0.06VL pepsin aqueous solution, Incubate at 30±1°C for 1.5h; the concentration of the pepsin aqueous solution is 100 enzyme units / ml;

[0042] Then a...

Embodiment 2

[0050] A preparation method for an equine tetanus immune globulin preparation for injection without preservatives, comprising the steps of:

[0051] Step (1), extract IgG: operate at normal temperature, horse plasma V L, dilute horse plasma with 0.85% sodium chloride aqueous solution with a mass concentration of 3 V L to obtain horse plasma dilution; add 18% ( m / v) of ammonium sulfate solid powder, stirred until dissolved, left standstill for 18 hours, and filtered; took the filtrate, added 15% (m / v) ammonium sulfate solid powder according to the volume of the filtrate, then stirred until dissolved, and left standstill for 18 hour, filter, and get the precipitate;

[0052] Step (2), digestion and heating denaturation: dissolve the precipitate obtained in step (1) with a mass concentration of 0.85% sodium chloride aqueous solution to a volume of 3V L, adjust the pH to 3.3 with 2M hydrochloric acid, add 0.06VL pepsin aqueous solution, Incubate at 30±1°C for 2 hours; the concent...

Embodiment 3

[0061] A preparation method for an equine tetanus immune globulin preparation for injection without preservatives, comprising the steps of:

[0062] Step (1), extracting IgG: operate at normal temperature, horse plasma V L, dilute horse plasma with 2.5 V L of 0.85% sodium chloride aqueous solution to obtain horse plasma dilution; add 17% ( m / v) of ammonium sulfate solid powder, after stirring until dissolved, let it stand for 8h, filter; take the filtrate, add 14% (m / v) ammonium sulfate solid powder according to the volume of the filtrate, then stir until dissolved, then let stand for 12h, Filter and get the precipitate;

[0063] Step (2), digestion and heating denaturation: dissolve the precipitate obtained in step (1) with a mass concentration of 0.85% sodium chloride aqueous solution to a volume of 2.5V L, adjust the pH to 3 with 2M hydrochloric acid, add 0.06VL pepsin aqueous solution, Incubate at 30±1°C for 1.8h; the concentration of the pepsin aqueous solution is 140 en...

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Abstract

The invention relates to a preservative-free horse tetanus immune globulin preparation and a preparation method thereof, and belongs to the technical field of medicines. The preparation method comprises the following eight steps: extracting IgG, performing digestion and heating degeneration, extracting F(ab')2, adsorbing with alum to remove impurities, performing ultrafiltration, purifying by column chromatography, preparing a stock solution and preparing the preparation. The tetanus antitoxin renewal replacement product prepared by the process, namely horse tetanus immune globulin F(ab')2, has a specification of 1500IU / 0.75ml per bottle, has the protein content less than or equal to 50g / L, and does not contain preservative. By adopting the process, the key technical point of removing preservative from the product can be solved, and the easily polluted degree of the product can be reduced. Clinical tests verify that the adverse response incidence rate of the horse tetanus immune globulin preparation is reduced to lower than or equal to 10 percent from 40-60 percent that of traditional tetanus antitoxin, and the safety is far higher than that of the traditional tetanus antitoxin.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preservative-free equine tetanus immunoglobulin preparation for injection and a preparation method thereof. Background technique [0002] Tetanus is an acute infectious disease characterized by muscle tonic spasms caused by Clostridium tetani invading human wounds, growing and multiplying in an anaerobic environment, producing neurotropic exotoxins and causing muscle tonic spasms throughout the body. Due to the high incidence rate of tetanus, it is difficult to treat after the onset, and the mortality rate reaches 20% to 50%. Both the World Health Organization and various countries advocate a strategy based on prevention. Therefore, one of the popular preventive measures for tetanus in my country is that children should be vaccinated against tetanus before the age of 6; in addition, all patients with deep trauma due to various reasons will be given preventive teta...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K9/08A61K47/18A61K47/02A61P31/04C07K16/12C07K16/06C12P21/06C07K1/36C07K1/34C07K1/30C07K1/18
CPCA61K39/39516A61K9/0019A61K9/08A61K47/02A61K47/183C07K1/18C07K1/30C07K1/34C07K1/36C07K16/065C07K16/1282C12P21/06
Inventor 李景玉陈孝婷石碧珠
Owner 玉溪九洲生物技术有限责任公司