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Composite thymosin enteric-coated tablet and preparation method thereof

A technology of thymosin and enteric-coated tablets, which is applied in the field of thymosin enteric-coated tablets and its preparation, can solve the problems of low release rate of thymosin preparations and high drug cost, and achieve the effects of good drug stability, simple preparation method, and integrity protection

Inactive Publication Date: 2015-09-09
H H T WHITE SWAN PHARMACY GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention aims to solve the problem of low release rate of existing thymosin preparations and high drug cost, and provides a compound thymosin enteric-coated tablet and its preparation method

Method used

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  • Composite thymosin enteric-coated tablet and preparation method thereof
  • Composite thymosin enteric-coated tablet and preparation method thereof
  • Composite thymosin enteric-coated tablet and preparation method thereof

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specific Embodiment approach 1

[0027] Specific embodiment 1: The complex thymosin enteric-coated tablet of this embodiment includes drug-loaded microspheres made of thymosin, theaflavin and enteric polymer excipients, polyethylene glycol 3350, microcrystalline cellulose and magnesium stearate, The mass ratio of thymosin, theaflavin and enteric polymer auxiliary materials in drug-loaded microspheres is 3:(0.5~1):(15~20), drug-loaded microspheres, polyethylene glycol 3350, microcrystalline cellulose and hard The mass ratio of magnesium fatty acid is 5:(0.75-0.85):(0.25-0.35):(0.05-0.07).

[0028] The preparation method of thymosin of the present embodiment is as follows:

[0029] A. Remove fat and fascia from animal thymus tissue, rinse and drain, then add 2 times the volume of acidic buffer solution with a pH of 2 to 5 to homogenate the thymus tissue, extract the homogenate at 50°C for 5 hours and heat to 80°C ℃, keep for 10min, cool down to 4℃ at a cooling rate of 20-25℃ / min, and store for 12-24h; the acid...

specific Embodiment approach 2

[0034] Embodiment 2: This embodiment is different from Embodiment 1 in that: the enteric polymer auxiliary material is Eudragit L-100. Others are the same as in the first embodiment.

specific Embodiment approach 3

[0035] Embodiment 3: This embodiment differs from Embodiment 1 or Embodiment 2 in that: the mass ratio of thymosin, theaflavin and enteric polymer excipients in the drug-loaded microspheres is 3:1:15. Others are the same as in the first or second embodiment.

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Abstract

The invention relates to a thymosin enteric-coated tablet and a preparation method thereof, in particular to a composite thymosin enteric-coated tablet and a preparation method thereof, and aims to solve the problems of low release rate and high drug cost of existing thymosin preparations. The enteric-coated tablet comprises a drug-carrying microsphere, polyethylene glycol 3350, microcrystalline cellulose and magnesium stearate. The drug-carrying microsphere is made of thymosin, theaflavin and an enteric polymer auxiliary material. The preparation method includes 1, mixing the thymosin with the theaflavin and the enteric polymer auxiliary material to obtain a mixture, and adding the mixture into cosolvent to dissolve to obtain co-dissolved solution; 2, adopting a high-voltage static sprayer to spray the co-dissolved solution obtained in the step 1 to a powder reception plate to finally obtain the drug-carrying microsphere; 3, evenly mixing the drug-carrying microsphere with the microcrystalline cellulose, the polyethylene glycol 3350 and the magnesium stearate and tableting the mixture to obtain the thymosin enteric-coated tablet. The thymosin enteric-coated tablet and the preparation method thereof have the advantages that thymosin immunity can be enhanced through composition of the theaflavin and the thymosin, dosage of thymosin bulk drugs is reduced, and release rate of the enteric-coated tablet is high.

Description

technical field [0001] The invention relates to a thymosin enteric-coated tablet and a preparation method thereof. Background technique [0002] Thymosin is a group of physiologically active polypeptides secreted by thymus tissue. Thymosin commonly used in clinical practice is a small molecular polypeptide with non-specific immune effect discovered and purified from calf thymus, which can be obtained by chemical synthesis and genetic engineering. [0003] The medicament prepared by using thymosin belongs to the immunomodulatory drug, which has the function of regulating and enhancing the immune function of human cells, and can promote the maturation of T lymphocytes in the peripheral blood after mitogen activation; the indications are 1. For patients with chronic hepatitis B ; 2. Various primary or secondary T cell deficiency diseases (such as: congenital immunodeficiency disease in children); 3. Some autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythema...

Claims

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Application Information

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IPC IPC(8): A61K38/22A61K9/22A61K47/34A61K47/38A61P37/04A61P37/02A61K31/353
Inventor 杨慧芦旭升冯媛肖颖于凯陈竹王巍董志玲吕雪
Owner H H T WHITE SWAN PHARMACY GRP
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