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Method for preparing phaescolosaxin oral administration dosage form

The technology for phytohemagglutinin and dosage form is applied in the field of preparation of phytohemagglutinin oral dosage form, which can solve the problems of low availability and poor treatment effect, and achieve the effects of good degradation effect, convenient application and simple preparation process.

Inactive Publication Date: 2008-10-29
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

[0020] A preparation method of oral dosage form of phytohemagglutinin, characterized in that the specific implementation steps are as follows:

[0021] (1) Add 40.0 mg of phytohemagglutinin to 12 ml of a solution with a pH of 4.5 to dissolve it (solution A);

[0022] (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);

[0023] (3) Take 152ml of polyglycerol-3-oleate, add solution B and stir to form 200ml, stirring speed: 500 rpm, time: 3.0 hours, temperature: 20°C (solution C);

[0024] (4) Add 500 mg of trehalose and 500 mg of egg white protein to solution C; mix well and store in the refrigerator.

[0025] Using this method to make phytohemagglutinin microspheres can increase the embedding rate of phytohemagglutinin to 75.6%, release 41.5% of the drug within 2 hours in artificial gastric juice, and release 88.2% of the drug in artif...

Embodiment 2

[0027] A preparation method of oral dosage form of phytohemagglutinin, characterized in that the specific implementation steps are as follows:

[0028] (1) Add 15.0 mg of natural phytohemagglutinin into 5 ml of a solution with pH=3.5 to dissolve it (Solution A);

[0029] (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 );

[0030] (3) Take 150ml of glycerol oleate, add the above B solution and mix it into 200ml; stirring speed: 1000 rpm; time: 2.5 hours; temperature: 18°C ​​(C solution);

[0031] (4) Add 100 mg trehalose and 200 mg bovine serum albumin to solution C, mix well, and store in the refrigerator.

[0032] Using this method to make phytohemagglutinin microspheres can increase the embedding rate of phytohemagglutinin to 86.1%, release 44.9.2% of the drug in artificial gastric juice within 2 hours, and release 82.6% of the drug in...

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PUM

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Abstract

The invention relates to a preparation method of a phytohemagglutinin oral preparation, the steps are as follows: (1) phytohemagglutinin is dissolved in water phase buffer solution, the pH value of the solution (A) is 2.5 to 7.0, the content of the phytohemagglutinin is 1.0 to 50.0 mg / ml; (2) the acid solution (A) containing the phytohemagglutinin is added in liquid non-ionic surfactant solution with the hydrophile-lipophile balance value HLB which is not less than 9 and not more than 15 or amphiphilic grease or mixed liquid of the two for mixing and forming the solution (B); (3) the solution (B) is added in liquid oil phase with the hydrophile-lipophile balance value HLB which is not less than 0 and not more than 9 or lipophilic emulsion or the mixed liquid of the oil phase and the lipophilic emulsion, the proportion of the solution (B) and the oil phase or the lipophilic emulsion or the mixed liquid is 1: 1 to 1: 9, the two solutions are stirred and mixed at the temperature of 5 to 30 DEG C, thus forming oil phase preparation (C); (4) a stabilizer is added. The phytohemagglutinin oral preparation improves the embedding rate of the phytohemagglutinin to 70 to 90 percent.

Description

technical field [0001] The invention belongs to the technical field of preparation of biological medicines, and in particular relates to a preparation method of an oral dosage form of phytohemagglutinin. Background technique [0002] Phytohemagglutinin mostly refers to the lectin extracted from Phaseolus Vulgaris such as red kidney bean (Redkidney bean) and gorse (P.Communis). After purification, the protein content is higher, and it has the function of coagulating red blood cells and promoting the differentiation, maturation and division of lymphocytes. Phytohemagglutinin is a broad-spectrum antiviral and immunomodulatory drug. Phytohemagglutinin is mainly a complex of oligosaccharide prosthetic groups and proteins composed of D-mannose and glucosamine derivatives. It belongs to high molecular glycoprotein substances . Phytohemagglutinin has the functions of anti-virus, promoting the recovery of bacterial infection and regulating the immune function of the body to achieve...

Claims

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Application Information

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IPC IPC(8): A61K38/16A61K9/10A61K47/42A61K47/36A61K47/34A61P31/12A61P37/02A61K47/14
Inventor 古长庆
Owner TIANJIN SHENGJI GRP CO LTD