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A kind of production technology of busulfan injection

A production process and busulfan technology, applied in the field of medicine, can solve problems such as difficult process and condensation of water vapor, and achieve the effect of reducing process process, reducing process steps, and strong controllability

Active Publication Date: 2018-12-25
KINDOS PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the freezing point of the excipient PEG400 is between 2-8°C, the process is difficult, and too low temperature will easily lead to the condensation of water vapor in the environment, which will eventually be brought into the product

Method used

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  • A kind of production technology of busulfan injection
  • A kind of production technology of busulfan injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] A production process of busulfan injection, comprising the following steps:

[0039] 1) Dry clean air, N 2 One or more of Ar and Ar pass into the liquid distribution isolator and isolated production line;

[0040] 2) According to the mass, add 67 parts of PEG400 into the liquid preparation tank, pass through dry and clean air, N 2 Add one or more of Ar to PEG400; add 1 part of N,N-dimethylacetamide to PEG400 to obtain a mixed solvent;

[0041] Adding 10 parts of N,N-dimethylacetamide to 0.6 parts of Busulfan bulk drug to obtain a concentrated solution of Busulfan;

[0042] 3) Add concentrated busulfan solution into the mixed solvent, use 12 parts of N,N-dimethylacetamide to rinse the container containing the raw material medicine, stir and filter to obtain the finished product.

Embodiment 2

[0044] A production process of busulfan injection, comprising the following steps:

[0045] 1) Dry clean air, N 2 One or more of Ar and Ar pass into the liquid distribution isolator and isolated production line;

[0046] 2) According to the mass, add 67 parts of PEG400 into the liquid preparation tank, pass through dry and clean air, N 2 Add one or more of Ar to PEG400; add 20 parts of N,N-dimethylacetamide to PEG400 to obtain a mixed solvent;

[0047] Add 1 part of N,N-dimethylacetamide to 0.6 part of Busulfan bulk drug to obtain Busulfan concentrated solution;

[0048] 3) Add concentrated busulfan solution into the mixed solvent, use 12 parts of N,N-dimethylacetamide to rinse the container containing the raw material medicine, stir and filter to obtain the finished product.

Embodiment 3

[0050]A production process of busulfan injection, comprising the following steps:

[0051] 1) Dry clean air, N 2 One or more of Ar and Ar pass into the liquid distribution isolator and isolated production line;

[0052] 2) According to the mass, add 67 parts of PEG400 into the liquid preparation tank, pass through dry and clean air, N 2 Add one or more of Ar to PEG400; add 10 parts of N,N-dimethylacetamide to PEG400 to obtain a mixed solvent;

[0053] Adding 5 parts of N,N-dimethylacetamide to 0.6 parts of Busulfan bulk drug to obtain a concentrated solution of Busulfan;

[0054] 3) Add concentrated busulfan solution into the mixed solvent, use 16 parts of N,N-dimethylacetamide to rinse the container containing the raw material medicine, stir and filter to obtain the finished product.

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PUM

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Abstract

The invention discloses a production technology for busulfan injection. The technology comprises the following steps that 1, one or more dry clean air, N2 and Ar are introduced into a dosing isolatorand an isolation production line; 2, by mass, 67 parts of PEG400 is added into a dosing tank, and one or more of dry clean air, N2 and Ar are introduced into the PEG400; 1-20 parts of N,N-dimethylacetamide is added into the PEG400 to obtain a mixed solvent; 1-10 parts of N,N-dimethylacetamide is added into 0.6 part of a busulfan crude drug to obtain a busulfan concentrated solution; 3, the busulfan concentrated solution is added into the mixed solvent, N,N-dimethylacetamide of the remaining recipe quantity is adopted for washing a container containing the crude drug, and stirring and filteringare performed to obtain a finished product.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a production process of busulfan injection. Background technique [0002] Currently, busulfan marketed preparations include busulfan tablets and busulfan injection. The active ingredient is busulfan, which is a crystalline powder with the following chemical structure: [0003] [0004] The water solubility of busulfan is extremely poor (slightly soluble in water), and it is easy to decompose when encountering water, which makes the oral absorption of busulfan tablets poor, the dose is large, and the active substance (carbenium ion) after degradation occurs in the intestinal tract Severe stomach irritation. Therefore, preparations currently on the market are mainly injections. [0005] According to the FDA Orange Book (August 2017 edition), there are only 4 manufacturers of Busulfan injection, the original research is Otsuka, and the trade name is BUSULFEX (Bai Shufei). The...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/10A61K47/18A61K31/255A61P35/02
CPCA61K9/0019A61K9/08A61K31/255A61K47/10A61K47/18
Inventor 屈倩倩史宣宇田欣欣
Owner KINDOS PHARM CO LTD
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