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Clofarabine pharmaceutical composition freeze-dried powder injection and preparation method thereof

A technology for freeze-dried powder injection and clofarabine, which is applied in the field of drug synthesis and preparation, can solve the problems of poor stability, unsuitability for storage, and low solubility of freeze-dried products, and achieves good resolubility and clarity, and the product can be reconstituted. Good solubility and stability

Active Publication Date: 2011-05-25
山东罗欣乐康制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, a large dose of solubilizer is usually added to the prescription or a preparation scheme to increase the solubility of clofarabine with a specific acid, but the solubilizer Tween, polyethylene glycol, poloxamer, propylene glycol and poly Oxyethylene castor oil, etc. have certain hemolytic properties, and some solubilizers such as polyoxyethylene castor oil can also cause severe allergic reactions, and the pain caused often requires the addition of benzyl alcohol
Simultaneously, because the clofarabine freeze-dried powder injection provided by the prior art has low solubility in water, the stability of the obtained freeze-dried product is not good, and it is not suitable for storage.

Method used

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  • Clofarabine pharmaceutical composition freeze-dried powder injection and preparation method thereof
  • Clofarabine pharmaceutical composition freeze-dried powder injection and preparation method thereof
  • Clofarabine pharmaceutical composition freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] This embodiment relates to clofarabine pharmaceutical composition freeze-dried powder injection and its preparation method.

[0090] 1. Prescription of clofarabine pharmaceutical composition freeze-dried powder injection

[0091] Specification: 20mg / bottle

[0092] Raw material name dosage

[0093] Clofarabine (dried and pure) 20g

[0094] Mannitol 200g

[0095] Sodium bicarbonate 40g

[0096] Hydrochloric acid amount

[0097] Add water for injection to 10000ml

[0098] Makes 1000 bottles

[0099] 2. Preparation method

[0100] (1) take respectively the clofarabine and sodium bicarbonate of recipe quantity, mix it homogeneously, obtain the solid mixture of clofarabine and sodium bicarbonate;

[0101] (2) Add 80% water for injection of the prescription amount to the solid mixture obtained in step (1), heat while stirring, so that the temperature of the solution rises to 60° C., keep stirring to dissolve the solid mixture; add the manna of the prescription amount ...

Embodiment 2

[0108] This embodiment relates to the prescription and preparation method of clofarabine pharmaceutical composition freeze-dried powder injection

[0109] 1. Prescription of clofarabine pharmaceutical composition freeze-dried powder injection

[0110] Specification: 10mg / bottle

[0111] Raw material name Feed amount

[0112] Clofarabine (dried and pure) 10g

[0113] Mannitol 200g

[0114] Sodium bicarbonate 40g

[0115] Hydrochloric acid amount

[0116] Add water for injection to 10000ml

[0117] Makes 1000 bottles

[0118] 2. Preparation method

[0119] (1) take respectively the clofarabine and sodium bicarbonate of recipe quantity, mix it homogeneously, obtain the solid mixture of clofarabine and sodium bicarbonate;

[0120] (2) Add 70% water for injection of the prescribed amount to the solid mixture obtained in step (1), heat while stirring, so that the temperature of the solution rises to 70° C., keep stirring to dissolve the solid mixture; add the manna of the pr...

Embodiment 3

[0127] This embodiment relates to the prescription and preparation method of clofarabine pharmaceutical composition freeze-dried powder injection

[0128] 1. Prescription of clofarabine pharmaceutical composition freeze-dried powder injection

[0129] Specification: 30mg / bottle

[0130] Raw material name Feed amount

[0131] Clofarabine (dried and pure) 30g

[0132] Mannitol 300g

[0133] Sodium bicarbonate 60g

[0134] Hydrochloric acid amount

[0135] Add water for injection to 10000ml

[0136] Makes 1000 bottles

[0137] 2. Preparation method

[0138] (1) take respectively the clofarabine and sodium bicarbonate of recipe quantity, mix it homogeneously, obtain the solid mixture of clofarabine and sodium bicarbonate;

[0139](2) Add 80% water for injection of the prescription amount to the solid mixture obtained in step (1), heat while stirring, so that the temperature of the solution rises to 80° C., keep stirring to dissolve the solid mixture; add the manna of the p...

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Abstract

The invention provides a clofarabine pharmaceutical composition freeze-dried powder injection which is prepared by freeze-drying 10-30 parts by weight of clofarabine, 100-300 parts by weight of mannitol, 20-60 parts by weight of sodium bicarbonate, pH regulator and water for injection. The clofarabine pharmaceutical composition freeze-dried powder injection is a white or almost white loose mass orpowder with good stability and good product redissolution property. The invention also provides a preparation method of the clofarabine pharmaceutical composition freeze-dried powder injection with simple method and strong operability.

Description

technical field [0001] The invention belongs to the field of drug synthesis and preparation, and more specifically, the invention relates to a clofarabine pharmaceutical composition freeze-dried powder injection and a preparation method thereof. Background technique [0002] Clofarabine (trade name: Clolar) is a second-generation purine nucleotide analog developed by Genzyme Corporation of the United States. On December 28, 2004, the U.S. FDA quickly approved and approved it for the treatment of children with refractory or relapsed Patients with acute lymphoblastic leukemia (ALL) who have received at least 2 treatments before but are ineffective. This product was launched in the United States for the first time in January 2005. As the only chemotherapy drug that can be specifically used for childhood leukemia, it has a high overall remission rate in the treatment of leukemia, is well tolerated, and has no unpredictable adverse reactions. In the second year, in May 2006, the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7076A61K47/10A61P35/02C07H19/173
Inventor 李明华张明法高菲菲
Owner 山东罗欣乐康制药有限公司
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