Thymus gland pentapeptide oral intestine-dissolved formulated product and method of preparing the same and use thereof

A technology of enteric-coated preparations and thymus, which is applied in pill delivery, pharmaceutical formulations, peptide/protein components, etc., can solve the problems of specific indications, uncertainty of drug efficacy, and no route of thymopentin administration, so as to increase compliance Effect

Active Publication Date: 2008-01-23
CHENGDU DIAO JIUHONG PHARMA FAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since patients' compliance with injection preparations is much lower than that of oral preparations, the route of drug administration changes, and the specific indications and efficacy of the drug cannot be determined, and the types and dosages of excipients are different for different molecular weights and different types of peptides. Related reports on new drug routes of thymopentin

Method used

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  • Thymus gland pentapeptide oral intestine-dissolved formulated product and method of preparing the same and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The preparation of embodiment 1 Thymopentin enteric-coated tablet of the present invention

[0044] (1) Prescription of plain tablets (dosage per thousand tablets):

[0045] Thymopentin 5g, sodium deoxycholate 10g, glyceryl stearate 30g, polyacrylic acid cross-linked polymer 10g, aprotinin 7g, microcrystalline cellulose 100g, sodium carboxymethyl starch 10g, micropowder silica gel 10g, stearin Magnesium acid 10g.

[0046] (2) Coating agent formula:

[0047] Talcum powder 20g, propylene glycol 20g, acrylic resin 60g.

[0048] (3) Technology for the preparation of thymopentin enteric-coated tablets

[0049] a. Get Thymopentin and auxiliary materials in the following weight ratio:

[0050] Thymopentin 5g, sodium deoxycholate 10g, glyceryl stearate 30g, polyacrylic acid cross-linked polymer 10g, aprotinin 7g, microcrystalline cellulose 100g, sodium carboxymethyl starch 10g, micropowder silica gel 10g, stearin Magnesium acid 10g, pass No. 3 pharmacopoeia sieve respectiv...

Embodiment 2

[0053] The preparation of embodiment 2 Thymopentin enteric-coated tablets of the present invention

[0054] (1) Prescription of plain tablets (dosage per thousand tablets):

[0055] Thymopentin 15g, sodium cholate 10g, glyceryl stearate 15g, polyacrylic acid cross-linked polymer 10g, pepsin inhibitor 15g, lactose 300g, sodium alginate 20g, micropowder silica gel 10g, magnesium stearate 10g.

[0056] (2) Coating agent formula:

[0057] Talcum powder 20g, propylene glycol 20g, acrylic resin 60g.

[0058] (3) Process for preparing thymopentin enteric-coated tablets: refer to Example 1.

Embodiment 3

[0059] The preparation of embodiment 3 thymopentin enteric-coated tablets of the present invention

[0060] (1) Prescription of plain tablets (dosage per thousand tablets):

[0061] Thymopentin 50g, sodium deoxycholate 20g, glyceryl stearate 30g, polyacrylic acid cross-linked polymer 10g, sodium glycocholate 20g, mannitol 700g, low-substituted hydroxypropyl cellulose 50g, micropowder silica gel 10g, hard Magnesium fatty acid 10g.

[0062] (2) Coating agent formula:

[0063] Talcum powder 20g, propylene glycol 20g, acrylic resin 60g.

[0064] (3) Process for preparing thymopentin enteric-coated tablets: refer to Example 1.

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Abstract

The invention provides a Thymopentin Oral Enteric-coated Agent, which takes thymopentin of effective dosage as the active ingredient and enteric-coated agent as its accessories. Each dosage contains 5mg to 150 mg thymopentin. The invention also provides the preparation method and usage of the enteric-coated agent. The medicine effect tests prove that the medicine has the same indication and efficacy as the injections and can overcome that the gastrointestinal enzyme will easily degrade the thumopentin into amino acid and small peptide so as to lose the activity when orally taking the Thymopentin; the thumopentin can not easily penetrate the gastrointestinal mucosa, resulting in low bioavailability; and the liver has the First-pass effect on the thymopentin. The invention opens a new way to apply thumopentin and increases the patients' compliance.

Description

technical field [0001] The invention relates to an oral enteric-coated preparation of peptide drugs, in particular to an oral enteric-coated preparation prepared by using thymopentin as an active ingredient, and belongs to the field of medicines. Background technique [0002] At present, there are about 40 kinds of peptide drugs on the market at home and abroad. Peptide drugs are favored by patients because of their high activity, low dose, and low toxicity. However, when peptide drugs are taken orally, they are easily degraded into amino acids and small peptides by gastric acid and enzymes in the gastrointestinal tract and lose their activity, and are not easily absorbed by the human body through the gastrointestinal mucosa. There are characteristics such as the first-pass effect, which limits the oral administration of peptide drugs. Most of the existing peptide drug administration routes are in the form of injections, which is quite inconvenient to use. The half-life in t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K38/55A61K31/221A61K9/48A61K9/20A61K47/34A61K47/38A61P37/02A61K47/10
Inventor 叶兵武勇刘忠荣及元乔王若竹黄瑜岑国栋
Owner CHENGDU DIAO JIUHONG PHARMA FAB
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