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Thymosin enteric-coated tablet and preparation method thereof

A technology of thymosin and enteric-coated tablets, applied in the directions of pill delivery, pharmaceutical formulations, peptide/protein components, etc., can solve the problems of fluctuation in the therapeutic effect of thymosin, fluctuation in intestinal absorption, difficulty in realization, etc. The method is simple and the effect of reducing the difficulty of preparation

Active Publication Date: 2020-06-19
H H T WHITE SWAN PHARMACY GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the inconsistent pH environment of the human intestinal tract, such as the pH of the duodenum is about 5.5, the pH of the colon is about 6.5, and the ileum is about 7, there are obvious fluctuations in the intestinal absorption of thymosin enteric-coated preparations, resulting in fluctuations in the therapeutic effect of thymosin. Fluctuation, in order to avoid fluctuations in the absorption of thymosin in the intestine, it is necessary to realize the release and absorption of thymosin in a specific part of the intestine, which is not only difficult to achieve, but also very costly
[0004] Tormentic acid, a 19α-hydroxyursane-type pentacyclic triterpenoid compound, has anti-oxidation, anti-cancer, anti-inflammatory and analgesic properties, antibacterial, lipid-lowering, inhibition of platelet aggregation, and hypoglycemia However, the effects of palinginic acid on the absorption and immunomodulatory activity of thymosin enteric-coated preparations have not been reported yet.

Method used

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  • Thymosin enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: A kind of thymosin enteric-coated tablet

[0021] Thymosin 10g, Potentinic acid 8g, microcrystalline cellulose 150g, Tween-80 2g, hydroxypropyl methylcellulose 60g, carboxymethyl starch sodium 30g, magnesium stearate 2g, Opadry-94 appropriate amount, Prepare as follows:

[0022] (1) Raw material preparation: take each raw material according to the formula, pulverize thymosin and pollentinic acid, pass through a 60-mesh sieve respectively, mix them, and set aside;

[0023] (2) Granulation: mix the mixed powder obtained in step (1) with microcrystalline cellulose, Tween 80, hydroxypropyl methylcellulose, and sodium carboxymethyl starch, then add an appropriate amount of ethanol to make a soft material, and pass through 14 mesh After sieving and granulating, dry, pass through a 12-mesh sieve for granulation, add the formula amount of magnesium stearate and mix evenly to obtain a mixed powder;

[0024] (3) Tablet core, the mixed powder obtained in step (2) i...

Embodiment 2

[0026] Embodiment 2: A kind of thymosin enteric-coated tablet

[0027] Thymosin 10g, Potentinic acid 8g, microcrystalline cellulose 150g, Tween-80 2g, hydroxypropyl methylcellulose 60g, carboxymethyl starch sodium 30g, magnesium stearate 2g, Opadry-94 appropriate amount, Prepare as follows:

[0028] (1) Raw material preparation: take each raw material according to the formula, pulverize thymosin and pollentinic acid, pass through a 60-mesh sieve respectively, and set aside;

[0029] (2) Granulation: mix microcrystalline cellulose, Tween 80, hydroxypropyl methylcellulose, sodium carboxymethyl starch, and divide it into two parts: mixture 1 and mixture 2, wherein mixture 1 and mixture 2 The weight ratio is 5:4. Mix mixture 1 and thymosin, mixture 2 and pallinic acid separately, add appropriate amount of ethanol to make soft materials, pass through 14 mesh sieves to granulate and dry, pass through 12 mesh sieves for granulation, and obtain granules 1 and granule 2, mix granule ...

Embodiment 3

[0032] Embodiment 3: A kind of thymosin enteric-coated tablet

[0033] Thymosin 10g, Potentinic acid 8g, microcrystalline cellulose 150g, Tween-80 2g, hydroxypropyl methylcellulose 10g, carboxymethyl starch sodium 30g, magnesium stearate 2g, Opadry-94 appropriate amount, Prepare according to the method of Example 1 to obtain thymosin enteric-coated tablets of the present invention.

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Abstract

The present invention relates to a thymosin enteric-coated tablet and a preparation method thereof. The thymosin enteric-coated tablet comprises thymosin, tormentic acid, a pharmaceutically acceptablecarrier, an enteric coating, and an optional absorption enhancer. The addition of the tormentic acid in the thymosin enteric-coated tablet can effectively solve a problem of fluctuation of release degrees of the thymosin in the intestine due to pH changes, also has a considerable promotion effect on activity of the thymosin, and further enhances an immune regulation effect.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a thymosin enteric-coated tablet and a preparation method thereof. Background technique [0002] Thymosin (Thymosin), also known as thymosin, is a group of polypeptides secreted by thymus tissue, which has the activities of inducing T cell differentiation and maturation, enhancing T cell response to antigens, and thus enhancing the body's ability to resist diseases. Wide range of immune function regulation drugs with significant curative effect, suitable for the treatment of various primary or secondary diseases and tumors with low cellular immune function. Thymosin can be extracted from animal thymus or artificially synthesized. Artificially synthesized thymosin includes thymopentin and thymosin α1. Among them, thymosin α1 is more widely used due to its high purity and longer half-life, and is currently widely used in clinical practice. The used Jitai, Mai...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/34A61K9/32A61K38/22A61K31/56A61K47/36A61K47/26A61P37/02A61P37/04
CPCA61K9/2018A61K9/205A61K9/284A61K9/286A61K9/2866A61K31/56A61K38/2292A61P37/02A61P37/04A61K2300/00
Inventor 高博乔旭李宗宝刘旭仲伟强薛孟姝肖颖赵妍金宁佳时昀冯媛李玥曹宇林根雨
Owner H H T WHITE SWAN PHARMACY GRP
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