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Method for purifying dinoprostone

A technology of dinoprostone and nanofiltration, applied in the field of biopharmaceuticals

Active Publication Date: 2020-11-10
开封康诺药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In the application document of CN201911326101.7, it is mentioned that prostaglandin E2 is prepared by enzymatic catalysis to obtain a reaction liquid, but there is no suitable method for separating and purifying high-purity dinoprostone from the reaction liquid

Method used

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  • Method for purifying dinoprostone
  • Method for purifying dinoprostone
  • Method for purifying dinoprostone

Examples

Experimental program
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Effect test

Embodiment 1

[0044] A method for purifying dinoprostone, comprising the steps of:

[0045] S1, the enzymatic reaction solution of dinoprostone is successively passed through a ceramic membrane microfiltration with a pore size of 100nm, a hollow fiber column ultrafiltration with a molecular weight cut-off of 5000Da and a nanofiltration membrane nanofiltration with a molecular weight cut-off of 150Da to obtain a nanofiltration solution;

[0046] S2, upper chromatographic column (column height is 40cm, inner diameter is 3.5cm, the filling height of packing material is 26cm, column bed volume is 250mL) with nanofiltrate upper chromatography column (column height is 15% ethanol with the volume fraction of 3 times column bed volumes) Aqueous solution pre-washing, then eluting with 45% ethanol aqueous solution (the flow rate of pre-washing and elution is 10ml / min), online monitoring with ultraviolet detector in the elution process, detection wavelength is 210nm, when elution When the ultraviolet ...

Embodiment 2

[0048] The sample loading flow rate of prewashing, elution, and nanofiltrate is 12ml / min, and the amount of dinoprostone in the nanofiltrate per 1ml of filler is 3.934mg (that is, the sample amount of dinoprostone is 983.4mg), and other With embodiment 1.

Embodiment 3

[0050] The sample loading flow rate of prewashing, elution, and nanofiltrate is 15ml / min, and the amount of dinoprostone in the nanofiltrate per 1ml of filler is 3.96mg (that is, the sample amount of dinoprostone is 990.6mg), and other With embodiment 1.

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Abstract

The invention discloses a method for purifying dinoprostone. The method comprises the following steps: S1, taking enzymatic reaction liquid of dinoprostone, and sequentially carrying out microfiltration, ultrafiltration and nanofiltration treatment to obtain nanofiltration liquid; S2, feeding the nanofiltration liquid into a chromatographic column, pre-washing the liquid with a solution A, eluating the liquid with a solution B and collecting an eluant, removing the solvent to acquire dinoprostone, wherein a filler of the chromatographic column is silica gel Unisil 10 to 120 C18. The inventioncan effectively separate and purify the enzymatic reaction liquid of the dinoprostone, and the obtained dinoprostone is high in purity and yield.

Description

technical field [0001] The invention relates to the technical field of biopharmaceuticals, in particular to a method for purifying dinoprostone. Background technique [0002] Dinoprostone (referred to as prostaglandin E2, PGE2) is a natural prostaglandin, which has a contraction effect on the uterus of all stages of pregnancy, and is used to promote cervical ripening during full-term pregnancy (starting from the 38th week of pregnancy), and its cervical Bishop score is less than Or equal to 6 points, the head of the single fetus is presented, there are indications for induction of labor and no maternal and child contraindications. [0003] At present, dinoprostone is often prepared by chemical synthesis. There are few methods for preparing dinoprostone by enzymatic catalysis. In the application document of CN201911326101.7, it is mentioned that prostaglandin E2 is prepared by enzymatic catalysis to obtain a reaction solution, but there is no suitable method for separating ...

Claims

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Application Information

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IPC IPC(8): C07C405/00
CPCC07C405/00C07C2601/08
Inventor 王伟金永红潘丽英普坤林子荣
Owner 开封康诺药业有限公司
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