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Preparation of pig serum immunoglobulin microsphere novel dosage form

An immunoglobulin and porcine serum technology, which can be applied to non-active ingredients in medical preparations, antiviral agents, pharmaceutical formulations, etc., can solve the problems of poor treatment effect and low availability, and achieve convenient application, good degradation, Simple preparation process

Inactive Publication Date: 2012-09-19
TIANJIN SHENGJI GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if these biological drugs are directly taken in water or taken orally, due to the degradation and digestion of enzymes in the gastrointestinal tract and the absorption barrier of the intestinal tract, their utilization is very low and the therapeutic effect is poor.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] A method for preparing a new dosage form of porcine serum immunoglobulin microspheres, characterized in that the specific implementation steps are as follows:

[0018] (1) Add 50.0 mg of porcine serum immunoglobulin to 8 ml of a solution with a pH of 4.5 to dissolve it (solution A);

[0019] (2) Take 40.0ml of polyethylene glycol-8-glycerol caprylic acid / capric acid ester, add solution A and stir to make 48ml. Stirring speed: 500 rpm; time: 3.0 hours; temperature: 20°C (solution B);

[0020] (3) Take 152ml of polyglycerol-3-oleate, add solution B and stir to make 200ml, stirring speed: 500 rpm, time: 3.0 hours, temperature: 20°C (solution C); mix well and store in Chill in the refrigerator.

[0021] Adopting this method to make porcine serum immunoglobulin microspheres can increase the embedding rate of serum immunoglobulin to 81.2%, release 31.6% of drugs in artificial gastric juice within 2 hours, and release 82.5% of drugs in artificial intestinal juice. Intestina...

Embodiment 2

[0023] A method for preparing a new dosage form of porcine serum immunoglobulin microspheres, characterized in that the specific implementation steps are as follows:

[0024] (1) Add 20.0 mg of porcine natural leukocyte serum immunoglobulin to 10 ml of a solution with pH=3.5 to dissolve it (solution A);

[0025] (2) Take 14ml of Tween 80, 26ml of decaglycerol monocaprylate, mix well, then add solution A and mix, stir well; stirring speed: 1000 rpm; time: 2.5 hours; temperature: 18°C ​​(solution B );

[0026] (3) Take 150ml of glycerol oleate, add the above B solution and mix to make 200ml; stirring speed: 1000 rpm; time: 2.5 hours; temperature: 18°C ​​(solution C); mix well and store in the refrigerator.

[0027] Adopting this method to make porcine serum immunoglobulin microspheres can increase the embedding rate of serum immunoglobulin to 85.1%, release 33.3% of the drug within 2 hours in the artificial gastric juice, and 80.2% of the drug in the artificial intestinal juice...

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Abstract

The invention relates to a preparation method of new microsphere formulation pig serum immune globulin, which has the steps as follows: (1) the pig serum immune globulin is dissolved in an aqueous phase buffer solution, the pH value of the solution (A) is 2.5 to 7.0 and the content of the pig serum immune globulin is 0.5 to 10.0 mg / ml; (2) the acid solution (A) containing the pig serum immune globulin is added into a liquid nonionic type surfactant solution, the hydrophile-lyophile balance value of which is HLB being more than or equal to 9 and less than or equal to 15, or into amphipathic grease, or into the intermixture of the nonionic type surfactant solution and the amphipathic grease to be mixed as a solution (B); (3) the solution (B) is added into liquid oil phase with the hydrophile-lyophile balance value of HLB being more than or equal to 0 and less than or equal to 9, or into a lipophilic emulsifier, or into the intermixture of the oil phase and the lipophilic emulsifier. Theratio of the solution (B) and the intermixture ranges from 1:1 to 1:9 and the two solutions are stirred and mixed at the temperature of 5 DEG C to 30 DEG C to form an oil phase formulation (C); (4) astabilizing agent is added. The embedment ratio of the serum immune globulin is improved to 60 to 92 percent by adopting the preparation method of the invention.

Description

technical field [0001] The invention belongs to the preparation technology of biological medicine, in particular to a preparation method of a new dosage form of porcine serum immunoglobulin microspheres. Background technique [0002] Porcine serum immunoglobulin is an anti-infection substance produced by pigs, and antibody production is the most effective natural protection agent formed by pigs during the long evolution process against pathogen invasion. Immunoglobulins with antibody activity work together with immune cells and immune organs in the body to construct the five major functions of animal body immunity: (1) defense function, immune stabilization function, immune surveillance function, repair function, and the ability to interact with bacteria produced by plasma cells , The virus produces specific binding immunoglobulins. The function of immunoglobulin for pigs: improve the immunity of piglets, prevent disease infection; regulate gastrointestinal function, preven...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/395A61K9/16A61K47/34A61P31/12A61P31/04A61P37/04A61P1/12A61P1/00A61K47/14A61K47/26
Inventor 古长庆
Owner TIANJIN SHENGJI GRP CO LTD