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Bortezomib pharmaceutic composition for injection

A technology of bortezomib and composition, which is applied in the field of bortezomib pharmaceutical composition for injection, and can solve problems such as poor solubility and poor stability of bortezomib

Active Publication Date: 2013-06-12
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to solve the technical problem of poor stability and poor solubility of bortezomib, the invention provides a bortezomib pharmaceutical composition

Method used

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  • Bortezomib pharmaceutic composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The following prescriptions were used: bortezomib 35 mg; cysteine ​​175 mg; mannitol 175 mg.

[0033] Preparation:

[0034] Add 2ml of tert-butanol to the raw material of bortezomib, ultrasonically dissolve it at room temperature for 5 minutes to completely dissolve, take the excipients and add 9ml of water to dissolve, combine with the above bortezomib solution, filter through a 0.22μm membrane and pack, each 1ml to 5ml Freeze-dry in neutral borosilicate glass freeze-drying vials, fill with nitrogen and press cap out of the box.

Embodiment 2

[0036] The following prescriptions were used: bortezomib 35mg; cysteine ​​175mg.

[0037] The preparation method is the same as in Example 1.

Embodiment 3

[0039] The following prescriptions were used: bortezomib 35mg; cysteine ​​350mg.

[0040] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention provides a bortezomib pharmaceutic composition, and aims to solve the technical problem that the stability and dissolubility of the bortezomib are poor. The pharmaceutic composition contains bortezomib and amino acid in the mass ratio of 1:(2-100). By using the bortezomib pharmaceutic composition for injection, the dissolubility of the bortezomib can be effectively improved, and the effect is equivalent or superior to that of the products in the market. The bortezomib pharmaceutic composition is safe and non-irritant, the preparation cost is low, the preparation method is simple, and the stability is superior to that of the existing bortezomib preparation. The bortezomib pharmaceutic composition is favorable for industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to the field of pharmaceutical preparations. The invention relates to a bortezomib pharmaceutical composition for injection. Background technique [0002] Bortezomib is a dipeptidyl boronic acid compound, which was approved by the FDA for marketing on May 19, 2003. Its trade name is "Velcade" and it is a freeze-dried powder for injection. For the treatment of relapsed and refractory multiple myeloma. The solubility of the bortezomib raw material in water is only 0.076mg / ml, the solubility of the raw material drug is low, and the direct preparation cannot reach a suitable concentration. Appropriate solubilization techniques need to be employed. [0003] [0004] The listed product "Wanke" adopts the technology of patents WO02059130 and WO2002059131. This patent employs complexes of bortezomib and sugars, including condensed sugars such as mannitol and sorbitol. This patent mixes bortez...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/05A61K31/69A61K47/18A61P7/00A61P35/00
Inventor 刘翠艳庄红林王彦卜利超耿佳郭文敏杨汉煜王丙林滑明丽范运筹王燕娇刘娜纪德华安印华郭小丰赵倩
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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