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Fludarabine phosphate freeze-dried powder injection and preparation method thereof

A technology for fludarabine phosphate and freeze-dried powder injection, which is applied in the field of fludarabine phosphate freeze-dried powder injection and its preparation, can solve the problem of increasing the type and content of impurities in freeze-dried powder injection, and the thermal stability of fludarabine phosphate. It can solve problems such as sexual influence and poor thermal stability of fludarabine phosphate, and achieve the effect of excellent stability, good clarity and full appearance.

Active Publication Date: 2012-07-18
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent 200710202969.7 discloses a fludarabine slow-release implant for treating solid tumors. The slow-release implant contains fludarabine, slow-release excipients and a certain amount of slow-release regulator. Sustained-release implants contain more excipients, which not only increases the type and content of impurities brought by excipients in the freeze-dried powder injection, but also increases the risk of excipients to the human body
[0009] However, in view of the poor thermal stability of fludarabine phosphate, its raw materials need to be stored in a cold place, and the conditions required in the preparation process of the injection are relatively high, and high-temperature terminal sterilization is required, which is harmful to fludarabine phosphate Therefore, fludarabine phosphate is not suitable for making injections that require high-temperature terminal sterilization.

Method used

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  • Fludarabine phosphate freeze-dried powder injection and preparation method thereof
  • Fludarabine phosphate freeze-dried powder injection and preparation method thereof
  • Fludarabine phosphate freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Add 1530ml of water for injection into the liquid mixing tank, and the temperature of the liquid mixing tank is 10°C, then add 50g of fludarabine phosphate, after fully stirring, add an appropriate amount of 5mol / L sodium hydroxide solution and stir until the fludarabine phosphate is completely Dissolve; then add 40g of mannitol, stir to make the medicinal solution into a clear solution; adjust the pH value of the medicinal solution to 7.7 with 5mol / L sodium hydroxide solution, add 270ml of water for injection, and mix well.

[0050] Add 5.4g of activated carbon to the clear solution, stir and absorb for 30 minutes, use a 0.45μm microporous filter membrane to filter and decarburize while decarburizing, 0.2μm filter membrane for primary sterilization and filtration, and 0.2μm filter membrane for secondary terminal Sterilize and filter, and put the obtained filtrate into the liquid medicine bottle for filling.

[0051] The filtrate is packed separately, each bottle contai...

Embodiment 2

[0057] Add 1360ml of water for injection into the liquid mixing tank, the temperature of the liquid mixing tank is 0°C, then add 50g of fludarabine phosphate, after fully stirring, add an appropriate amount of 5mol / L sodium hydroxide solution and stir until the fludarabine phosphate is completely Dissolve; then add 30g of mannitol, stir to make the medicinal solution into a clear solution; adjust the pH value of the medicinal solution to 7.2 with 5mol / L sodium hydroxide solution, add 240ml of water for injection, and mix well.

[0058] Add 4.8g of activated carbon to the clear solution, stir and absorb for 30 minutes, use a 0.45μm microporous filter membrane to filter and decarburize while decarburizing, 0.2μm filter membrane for one-time sterilization filtration and 0.2μm filter membrane for secondary terminal Sterilize and filter, and put the obtained filtrate into the liquid medicine bottle for filling.

[0059] The filtrate is packed separately, each bottle contains 25 mg ...

Embodiment 3

[0065] Add 1700ml of water for injection into the liquid mixing tank, the temperature of the liquid mixing tank is 15°C, then add 50g of fludarabine phosphate, after stirring thoroughly, add an appropriate amount of 5mol / L sodium hydroxide solution and stir until the fludarabine phosphate is completely Dissolve; then add 50g of mannitol, stir to make the medicinal solution into a clear solution; adjust the pH value of the medicinal solution to 8.2 with 5mol / L sodium hydroxide solution, add 300ml of water for injection, and mix well.

[0066]Add 6g of activated carbon to the clear solution, stir and absorb for 30 minutes, use a 0.45μm microporous filter membrane to filter and decarburize while decarburizing, 0.2μm filter membrane for primary sterilization and filtration, and 0.2μm filter membrane for secondary terminal removal Bacterial filtration, and the obtained filtrate is put into the liquid medicine bottle for filling.

[0067] The filtrate is packed separately, each bott...

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Abstract

The invention belongs to the technical field of medicines, and relates to a fludarabine phosphate freeze-dried powder injection and a preparation method thereof. The fludarabine phosphate freeze-dried powder injection consists of fludarabine phosphate and mannitol in a mass ratio of 1:(0.6-1.2). The method for preparing the fludarabine phosphate freeze-dried powder injection comprises the following steps of: adding water for injection into a liquid preparing tank, adding the fludarabine phosphate in a prescription amount, adding alkali, stirring until the mixture is dissolved completely; and adding the mannitol, regulating the pH value, adding active carbon for decolorizing, filtering for decolorizing, performing fine filtering by using a filter membrane, subpackaging, and performing freeze drying. The fludarabine phosphate freeze-dried powder injection has excellent formability, clarified appearance of solution to be frozen, high redissolution performance of freeze-dried products, high clarity after redissolution, low impurity content and moisture content, high stability and controllable quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a fludarabine phosphate freeze-dried powder injection and a preparation method thereof. Background technique [0002] Fludarabine phosphate, the chemical name is 9-β-D-arabinic acid-furanose-2-fluoroadenine-5-phosphate, and the molecular formula is C 10 h 13 F N 5 o 7 P, molecular weight is 365.21, its structural formula is: [0003] [0004] Fludarabine Phosphate is an antimetabolite fluorinated purine nucleoside analogue, it is highly selective to lymphocytes, it can inhibit the repair of DNA in quiescent cells and the synthesis of DNA in mitotic cells, and It has the effect of promoting the apoptosis of these cells, and has shown good curative effect, and is currently widely used in the treatment of various blood system diseases, especially chronic lymphocytic leukemia. Fludarabine phosphate improves the remission rate of the disease by promoting tumor cell apoptosis. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7076A61K47/10A61P7/00A61P35/02
Inventor 马鹰军钟正明
Owner HAINAN JINRUI PHARMA CO LTD
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