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Preparation method of thymopentin freeze-dried powder injection

A technology for freeze-dried powder injection and thymus, which is applied in the field of medicine, can solve the problems of long preparation cycle of thymopentin freeze-dried powder injection, poor product quality of thymopentin freeze-dried powder injection, high energy consumption and production cost, and achieves clarification. Good quality, shortened production cycle and low content of related substances

Active Publication Date: 2015-06-17
武汉华龙生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the quality of the existing thymopentin freeze-dried powder injection products is poor, mainly in poor stability, related substances exceeding the standard, poor clarity after reconstitution, easy to produce stratification during the freeze-drying process, and the appearance of the product is unqualified, etc. , In addition, the existing thymopentin freeze-dried powder injection has a long preparation cycle, high energy consumption and production costs

Method used

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  • Preparation method of thymopentin freeze-dried powder injection
  • Preparation method of thymopentin freeze-dried powder injection
  • Preparation method of thymopentin freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A preparation method of thymopentin freeze-dried powder injection, the method comprises the following steps:

[0023] 1) Weigh 40.0g of mannitol, dissolve it in about 300ml of freshly prepared (not more than 12 hours after preparation) water for injection at 20~30℃, weigh 1.0g of thymopentin, and use about 200ml of freshly prepared 20~30℃ water for injection Dissolve in water for injection, mix the above-mentioned two solutions, add water for injection to 500ml, and prepare a mixed solution of mannitol and thymopentin;

[0024] 2) Adjust the pH value of the mixed solution of mannitol and thymopentin to 6 with lactic acid with a mass concentration of 25%;

[0025] 3) Filter the solution after adjusting the pH value through a sterilized plate filter with a pore size of 0.22 μm and air tightness;

[0026] 4) Divide 0.5ml of the obtained filtrate into 3ml vials to obtain a semi-finished product, put it into a freeze dryer, and freeze-dry it. The steps are as follows:

[0...

Embodiment 2

[0032] A preparation method of thymopentin freeze-dried powder injection, the method comprises the following steps:

[0033] 1) Weigh 80.0g of mannitol, dissolve it in about 500ml of freshly prepared (not more than 12 hours after preparation) water for injection at 20~30℃, weigh 10.0g of thymopentin, and use about 500ml of freshly prepared 20~30℃ water for injection Dissolve in water for injection, mix the above-mentioned two solutions, add water for injection to 1000ml, and prepare a mixed solution of mannitol and thymopentin;

[0034] 2) Adjust the pH value of the mixed solution of mannitol and thymopentin to 7 with lactic acid with a mass concentration of 25%;

[0035] 3) Filter the solution after adjusting the pH value through a sterilized plate filter with a pore size of 0.22 μm and air tightness;

[0036] 4) Divide 1ml of the obtained filtrate into 3ml vials to obtain a semi-finished product, put it into a freeze dryer, and freeze-dry it. The steps are as follows:

[0...

Embodiment 3

[0041] Embodiment 3 Effect comparison of different pH regulators and pH value control ranges

[0042] The present invention optimizes the optimal pH regulator and pH value by comparing the clarity of the product under the two factors of pH regulator and pH value control range in the batching stage, and comparing the product content and related substances under different pH regulators. conditions, the results are shown in Table 1 and Table 2:

[0043] Table 1 Comparison of product clarity under different pH regulators and pH control ranges

[0044]

[0045] Note: The specific number of the solution is in parentheses.

[0046] Table 2 Comparison of product content and related substances under different pH regulators

[0047]

[0048] Tests have shown that when 25% lactic acid is used in the batching stage to adjust the pH value to 6~7, the clarity of the thymopentin freeze-dried product produced is better, and when 25% lactic acid is used as the pH regulator, the related...

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Abstract

The invention discloses a preparation method of thymopentin freeze-dried powder injection. The preparation method comprises following steps: 1) mannitol and thymopentin are dissolved in injection water so as to obtain a mannitol and thymopentin mixed solution, wherein the concentration of mannitol in the mixed solution is 8g / 100ml, and the concentration of thymopentin in the mixed solution is 0.2-1g / 100ml; 2) the pH value of the mannitol and thymopentin mixed solution is adjusted with a pH conditioning agent to 6 to 7; 3) after pH conditioning, the mixed solution is filtered by a filter membrane or a filter core of 0.22 micron; and 4) containers are filled with the mixed solution, partially stoppered, freeze dried, and completely stoppered under vacuum state; and then the covers are rolled so as to obtain the thymopentin freeze-dried powder injection. Clarity, appearance, and redissolving capacity of the thymopentin freeze-dried powder injection are excellent; water content and related material content are low; and quality is stable. The preparation method is capable of shortening production cycles of the thymopentin freeze-dried powder injection, and reducing energy consumption.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of thymopentin freeze-dried powder for injection. technical background [0002] Thymopentin (TP-5) is an effective part of thymopoietin II in thymus secretion, composed of five amino acids: arginine, lysine, aspartic acid, valine, and tyrosine. . It has the function of inducing and promoting the differentiation, maturation and activation of T lymphocytes and their subsets; it can regulate the proportion of T lymphocytes, regulate and enhance the immune function of human cells; it can promote the activation of mitogens in peripheral blood T Lymphocyte maturation increases the secretion of various lymphokines after T cells are activated by various antigens or mitogens, and increases the level of lymphokine receptors on T cells. Based on its many efficacy, Thymopentin has been widely used clinically to treat various diseases, such as chronic hepat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/08A61K47/10A61K47/12A61P1/16A61P31/20A61P37/02A61P37/04A61P35/00
Inventor 黄楚华王世民戴军宝
Owner 武汉华龙生物制药有限公司
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