Pentapeptide nose spraying agent for thymus gland, preparation method and application thereof

A thymus and preparation technology, which is applied in the direction of aerosol delivery, anti-inflammatory agents, antiviral agents, etc., can solve the problems of injection site infection, patient injection pain, etc., and achieve the effects of long storage time, low cost, and convenient use

Active Publication Date: 2008-12-10
HAINAN ZHONGHE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there are already dosage forms on the market as thymopentin injection and thymopentin for injection. Doctors and patients have brought a lot of trouble when using these dosage forms, such as disinfection of equipment before use by doctors, patients have to endure injection pain, injection site infection

Method used

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  • Pentapeptide nose spraying agent for thymus gland, preparation method and application thereof
  • Pentapeptide nose spraying agent for thymus gland, preparation method and application thereof
  • Pentapeptide nose spraying agent for thymus gland, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] The prescription is as follows:

[0078] Thymopentin: 25.0g

[0079] Sodium chloride: 7.5g

[0080] Citric acid monohydrate: 1.7g

[0081] Disodium hydrogen phosphate dihydrate: 3.0g

[0082] Benzalkonium chloride (50%): 0.2g

[0083] Add water for injection to: 1250ml

[0084]

[0085] Adjust the pH to 4.0-5.5 and make a total of 500 bottles

[0086] The preparation method of preparation of the present invention is as follows:

[0087] 1. Weigh the above-mentioned raw and auxiliary materials in the prescription amount into the sterilization container in the 100,000-class clean area;

[0088] 2. After adding an appropriate amount of water for injection, stir well until it is completely dissolved;

[0089] 3. Adjust the pH value to between 4.0 and 5.0 with 0.1M hydrochloric acid or sodium hydroxide;

[0090] 4. Add water for injection to the full amount;

[0091] 5. Transfer to the clean area of ​​10,000 grades, and fin...

Embodiment 2

[0095] quality control method

[0096] Thymopentin Nasal Spray

[0097] Xiongxianwutai Bipenwuji

[0098] Thymopentin Nasal Spray

[0099] This product is an aqueous solution of thymopentin. In terms of peptide content, it contains thymopentin (C 30 h 49 N 9 o 9 ) should be 90.0-110.0% of the marked amount.

[0100] 【Properties】This product is a colorless clear liquid.

[0101] 【identification】

[0102] (1) Take about 1mg of this product, add 1ml of water to dissolve, add biuret reagent (take 0.15g of copper sulfate, add 0.6g of potassium sodium tartrate, add 50ml of water, add 30ml of 10% sodium hydroxide solution under stirring, add 100ml of water , that is) 1ml, that is blue-purple.

[0103] (2), in the chromatogram recorded under the assay item, the retention time of the main peak of the test product should be consistent with the retention time of the main peak of the reference substance.

[0104] 【an examination】

[0105] The pH value of this product was deter...

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PUM

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Abstract

The invention relates to a nasal spraying agent of thymopentin, and a preparation method and applications thereof. The preparation is used in over18-year-old sufferers of chronic hepatitis B, various primary or secondary defect diseases of T cellular, certain autoimmune diseases, various diseases of low cellular immune function and adjutant therapy to tumours; the preparation consists of thymopentin, pharmaceutic adjuvant and water; the preparation method of the agent includes the steps of liquid preparation, degerming, split charging, stoppering, capping, package, etc. The medicament form overcomes the difficulty that polypeptide drugs are unsteady in water, thus keeping the activity of thymopentin well and having good stability; meanwhile, pain is not produced when the medicament form is used, thus being accepted by the general consumers.

Description

Technical field: [0001] The present invention relates to a pharmaceutical preparation for intranasal administration of thymopentin and its preparation process, and also relates to the use of the preparation for chronic hepatitis B patients over 18 years old and various primary or secondary T cell deficiency diseases , Some autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.), various diseases with low cellular immune function, and adjuvant therapy for tumors. Background technique: [0002] "Thymopoietin II" is a single polypeptide compound isolated from thymus hormone, consisting of 49 amino acids, and the peptide chain fragment composed of 5 amino acids has all the same physiological functions as "adenopoietin II", So just this pentapeptide fragment is called "thymopentin" (Thymopentin). [0003] Thymopentin is a two-way immunomodulator, and its pharmacological effects are roughly the functions of inducing T cell differentiation, promoting...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/08A61K9/12A61K47/24G01N30/02A61P1/16A61P31/20A61P37/02A61P37/04A61P35/00A61P29/00
Inventor 凌振宏宗永斌韦娟
Owner HAINAN ZHONGHE PHARM CO LTD
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