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A kind of preparation method of picantron maleate sterile powder for injection

A technology of picentan maleate and sterile powder, which is applied in the directions of powder delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Low efficiency and other problems, to achieve the effect of less insoluble particles, avoiding degradation, and increasing the phase transition temperature

Active Publication Date: 2019-01-04
HUBEI LIYI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Most of the existing aseptic powders of picantron maleate are prepared by freeze-drying method. We found in our research that improper selection of freeze-drying carrier and process will cause picantron maleate to transform into sterile powder during the freeze-drying process. Setting powders that degrade during storage resulting in reduced stability
In addition, the sublimation and desorption temperature of the existing freeze-drying process is too low, resulting in long freeze-drying cycle and low production efficiency

Method used

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  • A kind of preparation method of picantron maleate sterile powder for injection
  • A kind of preparation method of picantron maleate sterile powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Piceatron maleate and lactose are dissolved in tert-butanol aqueous solution (10wt%) to prepare a solution. In this solution, the concentration of picatron maleate is 8 mg / ml, and the concentration of lactose is 65 mg / ml. Adjust the pH value of the solution to 3.5±0.2 with an acid, perform sterile filtration, and freeze-dry the filtrate.

[0029] The freeze-drying procedure is:

[0030] 1) Pre-freezing: reduce the temperature of the filtrate to -40°C and freeze for 4 hours;

[0031] 2) Sublimation stage: under vacuum conditions, raise the temperature to -18°C and keep it warm for 10 hours;

[0032] 3) Analytical drying: under vacuum conditions, the temperature was raised to 30° C. and kept for 5 hours.

Embodiment 2

[0034] Piceatron maleate and lactose are dissolved in tert-butanol aqueous solution (5wt%) to prepare a solution. In this solution, the concentration of picatron maleate is 5 mg / ml, and the concentration of lactose is 10 mg / ml. Adjust the pH value of the solution to 5.5±0.2 with an acid, perform sterile filtration, and freeze-dry the filtrate.

[0035] The freeze-drying procedure is:

[0036] 1) Pre-freezing: lower the temperature of the filtrate to -38°C and freeze for 5 hours;

[0037] 2) Sublimation stage: under vacuum conditions, raise the temperature to -16°C and keep it warm for 7 hours;

[0038] 3) Analytical drying: under vacuum conditions, the temperature was raised to 25° C. and kept for 6 hours.

Embodiment 3

[0040] Picantron maleate and lactose are dissolved in tert-butanol aqueous solution (30wt%) to prepare a solution, the concentration of picantron maleate in this solution is 15mg / ml, and the concentration of lactose is 100mg / ml, then adjusted with hydrochloric acid The pH value of the solution is 2.5±0.2, it is sterilized and filtered, and the filtrate is freeze-dried.

[0041] The freeze-drying procedure is:

[0042] 1) Pre-freezing: lower the temperature of the filtrate to -42°C and freeze for 3 hours;

[0043] 2) Sublimation stage: under vacuum conditions, raise the temperature to -20°C and keep it warm for 13 hours;

[0044] 3) Analytical drying: under vacuum conditions, the temperature was raised to 35° C. and kept for 3 hours.

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Abstract

The present invention discloses a preparation method of pylitaxel maleate sterile powder for injection. The method is to prepare a solution by dissolving pipisantron maleate and lactose in a tert-butyl alcohol aqueous solution. The concentration of Shanqiong is 5~15mg / ml, the concentration of lactose is 10~100mg / ml, then the pH value of the solution is adjusted to 2.5~5.5, sterilized and filtered, and the filtrate is freeze-dried to obtain. The invention can improve the stability and solubility of pixantron maleate and shorten the production cycle.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a preparation method of picantron maleate sterile powder for injection. Background technique [0002] Pixantrone is a derivative of mitoxantrone, which belongs to the azaxanthedione class of antineoplastic drugs. Its mechanism of action is similar to that of mitoxantrone. It can be embedded in the DNA of cells and inhibit topoisomerase II. The results of existing clinical experiments show that picatron is an effective anticancer drug, and when using the same effective dose as mitoxantrone, picatron has almost no cardiotoxicity. [0003] Picantone can form a salt with 2 molecules of maleic acid or hydrochloric acid, and can also form a salt with 1 molecule of hydrochloric acid. Currently on the market is picantron maleate, which was developed by Cell Therapeutics, Inc. of the United States. [0004] The molecular formula of picantone maleate is C ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/473A61K47/26A61P35/00
CPCA61K9/0019A61K9/19A61K31/473A61K47/26
Inventor 熊景辉余丹汪旭东洪华云戴正琳李旻方征远李瑛
Owner HUBEI LIYI PHARM TECH CO LTD