Liquid preparation containing penta peptide of thymus and preparing method

A liquid preparation, thymus technology, applied in anti-inflammatory agents, pharmaceutical formulations, antiviral agents, etc., can solve problems such as high cost, instability of polypeptide drugs affecting patient treatment, and drugs failing to reach therapeutic concentrations.

Inactive Publication Date: 2005-08-31
WEIXIN KAITAI MEDICINE TECH DEV BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The commonly used preparations of polypeptide and protein drugs are freeze-dried agents, but the freeze-drying preservation method has its own disadvantages: the freeze-drying process is not only costly, but also in the process of freeze-drying, the concentration of peptides and protein drugs may be too high, which may lead to unstable
The instability of peptide drugs

Method used

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  • Liquid preparation containing penta peptide of thymus and preparing method
  • Liquid preparation containing penta peptide of thymus and preparing method

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0017] Example 1, buffer solution on the effect of Thymopentin stability

[0018] Thymopentin solutions were prepared according to the buffer solutions listed in Table 1, with a concentration of 1 mg / ml. The resulting solution was sterilized by filtration with a microporous membrane to prepare 1 ml / support of injections. Put the sample into a thermostat at 45°C, and measure the content of the sample on the 0th day and the sample on the 10th day according to the following method.

[0019] sample

buffer

A

30mM acetate buffer, 5% mannitol, pH7.2

P

30mM Phosphate Buffer, 5% Mannitol, pH7.2

C

30mM citrate buffer, 5% mannitol, pH7.2

M

5% Mannitol, pH7.2

[0020] The content determination method adopts high-performance liquid chromatography, using octadecyl bonded silica gel as a filler, and phosphate buffer-methanol (60:40) at pH 7.0 as a mobile phase; the detection wavelength is 275nm. The num...

example 2

[0022] Example 2, the effect of the citrate buffer containing sodium chloride on the stability of thymopentin

[0023] In order to further investigate the stability of thymopentin in refrigerated conditions (4°C) in citrate buffer containing sodium chloride, a 1mg / ml thymopentin liquid preparation (pH7.2) was prepared, which contained 30mM lemon Salt buffer and 118mM NaCl, NaCl is the osmotic regulator. Store at 4°C and observe for 24 months, and measure the content of thymopentin at the 0th month, 3rd month, 6th month, 9th month, 12th month, 18th month, and 24th month according to the content determination method.

[0024] Based on the content of the sample at month 0 as 100%, calculate the content determination percentage of the sample at each time point. figure 2 Shows the results of the 24-month stability test of the sample at 4°C. The results showed that: under the condition of 4℃, the content of thymopentin in the citrate buffer containing sodium chloride had no signi...

example 3

[0025] Example 3, the preparation of the liquid formulation containing citrate buffer

[0026] Prescription: Thymopentin 1.0g

[0027] Sodium citrate 6.9g

[0028] Sodium chloride 8.8g

[0029] Add water for injection to 1000ml

[0030] Operation steps: Take about 600ml of water for injection and put it into an appropriate container, add 6.9g of sodium chloride and 8.8g of sodium citrate and stir until the solution is clear. Then 1.0 g of thymopentin was added under stirring (to prevent foaming) until all dissolved and clarified. The resulting solution was adjusted to pH 7.0-7.4 with 0.1M NaOH or 0.1M HCl. Add water for injection to 1000ml, stir until completely clear. The obtained solution is sterilized by filtration with a microporous filter membrane, and then packaged to make 1ml / support injections.

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Abstract

A liquid preparation containing thymopeptide-5 is disclosed. Its preparing process features that the buffering liquid of citrate is used to regulate pH=6.5-7.5, the sodium chloride is chosen as the optimal osmolarity regulator, and the stabilizer and protector are also used.

Description

technical field [0001] The invention relates to a novel liquid preparation containing thymopentin and a preparation method thereof. Background technique [0002] Thymopentin (TP5) is a synthetic pentapeptide, its amino acid sequence and structure are the same as the 32-36 amino acid components of thymopoietin (TP), that is, Arg-Lys-Asp-Val-Tyr, which is an important part of TP. functionally active part. TP5 can promote the differentiation and development of thymus and peripheral T cells, and has a bidirectional regulatory effect on the immune function of the body, and can make the immune response that is too high or too low tend to normal. Clinical studies have proved that thymopentin plays an important role in regulating the immune function of patients with low immune function and autoimmune diseases. [0003] Thymopentin is mainly used clinically for: immune dysfunction caused by malignant tumors; chronic hepatitis B and C and their complications; major surgery and sever...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/08A61P1/16A61P3/10A61P15/12A61P17/00A61P19/02A61P29/00A61P31/14A61P31/22A61P35/00A61P37/02A61P37/04
Inventor 张修建
Owner WEIXIN KAITAI MEDICINE TECH DEV BEIJING
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