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Efficient thymosin enteric-coated tablets and thymosin for injection

A technology of thymosin and enteric-coated tablets, applied in the field of medicine, can solve the problems of not easily permeable through biological membranes, large molecular weight, loss of activity, etc., and achieve the effects of good safety, high bioavailability, and increased permeability

Active Publication Date: 2011-09-07
西安迪赛生物药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, since thymosin is a polypeptide substance with a large molecular weight and poor fat solubility, it is not easy to pass through biomembranes, especially when thymosin is taken orally, it is easily degraded into amino acids and small peptides by enzymes in the gastrointestinal tract and loses its activity.

Method used

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  • Efficient thymosin enteric-coated tablets and thymosin for injection
  • Efficient thymosin enteric-coated tablets and thymosin for injection
  • Efficient thymosin enteric-coated tablets and thymosin for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1, the preparation of compound thymosin enteric-coated tablet

[0029] Prescription composition:

[0030]

[0031]

[0032] Preparation:

[0033] 1. Preparation of tablet core

[0034] Thymosin, mannitol, microcrystalline cellulose, poloxamer, cross-linked PVP, and sodium carboxymethyl starch in the prescription were respectively passed through a 65-mesh sieve and set aside. Mix the sieved excipients evenly, then add the sieved thymosin and the uniformly mixed excipients in equal amounts and mix evenly. Biotin was dissolved in 50ml of ethanol, and the prescribed amount of Tween-80 was added to dissolve into a homogeneous solution. Use the ethanol solution as a binder to make a soft material, granulate with a 20-mesh sieve, and dry. After the intermediate is qualified, the granules are sized with an 18-mesh sieve, and the prescribed amount of magnesium stearate and micronized silica gel are added, mixed evenly, and compressed into tablets.

[0035] ...

Embodiment 2

[0039] Embodiment two, the pharmacodynamics test of compound thymosin enteric-coated tablet

[0040] The effect of thymosin enteric-coated tablets on the formation rate of E rosette in mice.

[0041] 1. Experimental materials

[0042] 1.1 Animals: Kunming mice, half ♀♂ and half ♀♂, weighing 22±2g, provided by the Experimental Animal Center of Xi’an Jiaotong University School of Medicine. Quality certificate: Shanyi Dongzhengzi No. 08-18.

[0043] 1.2 Drugs:

[0044] Hydrocortisone acetate injection (specification: 5ml: 25mg, manufacturer: Dandong Yichuang Pharmaceutical Co., Ltd., batch number: 070305), thymosin injection specification: 2ml: 20mg, manufacturer: Xi'an Disay Biological Pharmaceutical Co., Ltd. company, batch number: 071220), thymosin enteric-coated capsules (specification: 5mg, manufacturer: Shanghai Baolong Pharmaceutical Co., Ltd., batch number: 061108), compound thymosin enteric-coated tablets.

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PUM

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Abstract

The invention relates to a drug composite of thymosin and biotin and a preparation thereof, such as a thymosin enteric-coated tablet and a thymosin preparation used for injection, in particular to the thymosin enteric-coated tablet, which comprises thymosin, tween 80 and poloxamer, wherein, the weight ratio of the tween 80 and the poloxamer is 1: 1-20, and 1:8 is preferable; and the weight ratio of poloxamer and the thymosin is 0.2-20:1. In addition, the invention also relates to the application of the drug composite or the preparation, such as the application to the treatment of chronic hepatitis, viral hepatitis and cirrhosis, a variety of primary or secondary T lymphocyte deficiency, autoimmune diseases, low cell immune function related diseases and to the adjuvant treatment of neoplastic disorder or to the preparation of corresponding drugs. Especially, the thymosin enteric-coated tablet can be promptly released in the enteron so as to enhance the drug absorption rate and greatly increase the bioavailability of the drug.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of thymosin and biotin and preparations thereof, especially thymosin enteric-coated tablets and thymosin preparations for injection. In addition, the present invention also relates to the application of the above pharmaceutical composition or preparation, such as for the prevention and / or treatment of chronic hepatitis, viral hepatitis and liver cirrhosis, various primary or secondary T lymphocyte deficiency diseases, autoimmune Diseases, diseases related to low cellular immune function, etc. or the use of preparing corresponding drugs. Background technique [0002] The thymus is an important immune organ of the human body, which can secrete a variety of important hormones, such as thymopoietin and thymosin. Among them, thymosin (also known as thymosin, thymosin) is a group of polypeptides with physiological activity secreted by thymus t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/17A61K9/19A61K9/20A61K9/48A61P1/16A61P7/00A61P31/14A61P31/20A61P37/02A61P35/00A61K31/4188
Inventor 吴建中
Owner 西安迪赛生物药业有限责任公司