Method for preparing interleukin-11 semi-finished product solution, and products thereof

A technology of interleukin and semi-finished products, which is applied in the direction of peptide/protein components, medical preparations containing active ingredients, blood diseases, etc., can solve the problems of low solubility, unstable activity, and reduced clinical use, and achieve quantitative accuracy and clarity Good, the effect of reducing the amount of clinical use

Active Publication Date: 2010-09-22
EAST CHINA UNIV OF SCI & TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is to overcome the defects of low solubility of interleukin-11, easy to produce precipitation, preparation opalescence, unstable activity and other defects in the preparation of the existing interleukin-11 semi-finished product solution, and to provide a new interleukin-11 The preparation method of the semi-finished product solution, which overcomes the defects of the prior art, is beneficial to promote the dissolution of interleukin-11, eliminate tiny filamentous precipitates and preparation opalescence, keep the activity stable, and reduce the amount of clinical use

Method used

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  • Method for preparing interleukin-11 semi-finished product solution, and products thereof
  • Method for preparing interleukin-11 semi-finished product solution, and products thereof
  • Method for preparing interleukin-11 semi-finished product solution, and products thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Weigh 30g of glycine (injection-grade pharmaceutical excipient) as an additive, and dissolve the measured interleukin-11 stock solution (calculated and added according to the concentration of the stock solution, the final concentration of interleukin-11 is 0.75mg / ml) in phosphate buffer solution with a final concentration of 10mM (prepared by 2.18 grams of pharmaceutical grade sodium dihydrogen phosphate dodecahydrate and 0.61 grams of disodium hydrogen phosphate dihydrate, pH7.0), stir to obtain a mixed solution; adjust the concentration of the mixed solution with sodium hydroxide of 0.1mol / L pH value to 9.5; add water for injection to 1.0L, stir and mix to obtain product 1.

Embodiment 2

[0015] Weigh 30g of glycine (injection-grade pharmaceutical excipient) as an additive, and dissolve the measured interleukin-11 stock solution (calculated and added according to the concentration of the stock solution, the final concentration of interleukin-11 is 0.75mg / ml) in phosphate buffer solution with a final concentration of 10mM (prepared by 2.18 grams of pharmaceutical grade sodium dihydrogen phosphate dodecahydrate and 0.61 grams of disodium hydrogen phosphate dihydrate, pH7.0), stir to obtain a mixed solution; adjust the concentration of the mixed solution with sodium hydroxide of 0.1mol / L pH value to 8.0; add water for injection to 1.0L, stir and mix to obtain product 2.

Embodiment 3

[0017] Weigh 30g of glycine (injection-grade pharmaceutical excipient) as an additive, and dissolve the measured interleukin-11 stock solution (calculated and added according to the concentration of the stock solution, the final concentration of interleukin-11 is 0.75mg / ml) in phosphate buffer solution with a final concentration of 10mM (prepared from 2.18 grams of pharmaceutical grade sodium dihydrogen phosphate dodecahydrate and 0.61 grams of disodium hydrogen phosphate dihydrate, pH 7.0), stir to obtain a mixed solution; adjust the pH value of the mixed solution with 0.1mol / L hydrochloric acid to 6.0; add water for injection to 1.0L, stir and mix to obtain product 3.

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Abstract

The invention discloses a method for preparing an interleukin-11 semi-finished product solution, and products thereof. The method comprises the following steps of: dissolving interleukin-11 into a phosphate buffer, adding glycin, and stirring to obtain the mixed solution; adjusting the pH value of the mixed solution; supplementing injection water to fix volume, and stirring to obtain the interleukin-11 semi-finished product solution, wherein the pH value of the mixed solution is adjusted to 8.0-9.5 by using diluted alkaline or is adjusted to 1.0-6.0 by using diluted acid. The method better solves the problems of accumulation and settlement of the interleukin-11 in the preparing, sterile filtering and packaging processes of the semi-finished product. The prepared semi-finished product solution is clear and transparent, and has no opalescence, and the volume of the protein of the main drug is accurately fixed. The sterile filtration of the prepared semi-finished product solution semi-finished product solution is easy to implement, the filter membrane can not be blocked, and the accumulation and settlement can not be caused during the packaging process of the semi-finished product. The clearness of the finished product is good after redissolution, no flocky precipitate or opalescence can be produced, the stable activity is maintained, and the use quantity is reduced in clinic.

Description

technical field [0001] The invention relates to a preparation method of an interleukin-11 preparation, in particular to a preparation method of an interleukin-11 semi-finished solution and a product prepared by the preparation method, and belongs to the field of interleukin-11 preparations. Background technique [0002] Human interleukin-11 is a cytokine that can directly stimulate the proliferation of bone marrow hematopoietic stem cells and megakaryotic progenitor cells, induce the maturation and differentiation of megakaryotic progenitor cells, increase the production of platelets in vivo, and thereby increase the blood platelet count without significant changes in platelet function. Clinical studies have shown that the mature megakaryotic progenitor cells after using this product are completely normal in ultrastructure, and the morphology, function and lifespan of the generated platelets are consistent with those produced naturally. Mature human interleukin 11 is compose...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/20A61K9/19A61P7/00
Inventor 秦玉峰尤金花张元兴周祥山
Owner EAST CHINA UNIV OF SCI & TECH
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