CN105294886A - Removing method of N-vinyl pyrrolidone in povidone k30 - Google Patents
Removing method of N-vinyl pyrrolidone in povidone k30 Download PDFInfo
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- CN105294886A CN105294886A CN201510846165.5A CN201510846165A CN105294886A CN 105294886 A CN105294886 A CN 105294886A CN 201510846165 A CN201510846165 A CN 201510846165A CN 105294886 A CN105294886 A CN 105294886A
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- Prior art keywords
- povidone
- ultrafiltration
- vinyl pyrrolidone
- filtration membrane
- polyvidone
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Abstract
The invention relates to the technical field of pharmaceutical excipients, particularly to the field of removal of N-vinyl pyrrolidone impurities in povidone k30. A removing method of N-vinyl pyrrolidone in povidone k30 comprises the step of carrying out ultrafiltration after dissolving povidone k30 in purified water, wherein the operation conditions of ultrafiltration are as follows: the feeding pressure is 0.1-10 MPa, the feed liquid temperature is 10-30 DEG C, and the pore diameter of an ultrafiltration membrane is 0.1-5 [mu]m. According to the invention, povidone k30 is purified through using the ultrafiltration technology, so that the advantages that the production procedures are simple, the operation is convenient, the separation effect is good, the povidone k30 structure is not damaged, and the like, are achieved, N-vinyl pyrrolidone can be effectively removed, the problem that the N-vinyl pyrrolidone content exceeds the standard is solved, the purity of povidone k30 is improved, and the safe production of pharmaceutical excipients is favorably promoted.
Description
Technical field
The present invention relates to pharmaceutical excipient technical field, remove NVP impurity in polyvidone k30 specifically.
Background technology
NVP is the monomeric compound of synthesis polyvidone k30 polymkeric substance.In building-up process, have a small amount of NVP and inevitably do not form chain, or be decomposed into monomer N-vinyl pyrrolidone by polyvidone k30; Due to NVP cannot be made in building-up process to change polyvidone k30 polymkeric substance completely into, and according to the regulation of Chinese Pharmacopoeia 2015 editions, the NVP content in polyvidone k30 polymkeric substance needs to control within the specific limits.Therefore need to remove NVP.
Summary of the invention
According to Chinese Pharmacopoeia to NVP content limitation requirement in polyvidone k30 polymkeric substance, the object of the present invention is to provide a kind of minimizing technology of simple and feasible, to improve the purity of polyvidone k30 polymkeric substance.
The present invention adopts following technical scheme: the minimizing technology of NVP in polyvidone k30, described method be polyvidone k30 is dissolved in purified water after carry out ultrafiltration, wherein, the operational condition of described ultrafiltration is as follows:
A, feed pressure are 0.1 ~ 10MPa;
B, feed temperature are 10 ~ 30 DEG C;
C, described ultra-filtration membrane aperture are 0.1 ~ 5um.
In order to better realize the present invention, preferably: described ultra-filtration membrane aperture is 0.45um.
Preferably: described feed temperature is 20 ~ 25 DEG C.
Preferably: described feed velocity is 15 ~ 30mL/s.
Preferably: described ultra-filtration membrane material is any one in polyvinylidene difluoride (PVDF) (PVDF), tetrafluoroethylene (PTFE), polyethersulfone resin (PES), nylon, mixed fibre.
Preferably: described ultra-filtration membrane material is polyvinylidene difluoride (PVDF).
The present invention utilizes ultra-filtration technique to carry out removal of impurities to polyvidone k30, there is the advantages such as Production Flow Chart is simple, easy to operate, good separating effect, polyvidone k30 structure are not damaged, it is very desirable impurity-removing method, effectively can remove NVP, solve the problem of NVP content overproof, improve the purity of polyvidone k30, advantageously facilitate the safety in production of pharmaceutical excipient.
Embodiment
Further describe technical scheme of the present invention below, but described in claimed scope is not limited to.Below in conjunction with specific embodiment, elaboration detailed is further done to the present invention, but embodiments of the present invention are not limited to the scope that embodiment represents.These embodiments only for illustration of the present invention, but not for limiting the scope of the invention.In addition, after reading content of the present invention, those skilled in the art can do various amendment to the present invention, and these equivalent variations fall within appended claims limited range of the present invention equally.
Embodiment 1
Carry out ultrafiltration after polyvidone k30 is dissolved in purified water, wherein, the operational condition of described ultrafiltration is as follows: feed pressure is 0.1MPa; Feed temperature is 10 DEG C; Ultra-filtration membrane aperture is 0.1um; Feed velocity is 15mL/s; Described ultra-filtration membrane material is polyvinylidene difluoride (PVDF).
The content utilizing high performance liquid chromatography to detect the NVP before and after ultrafiltration finds, the content of NVP greatly reduces, and reaches the effect of removal of impurities.
In addition, when feed liquid stoste is extremely a small amount of by ultrafiltration, purified water dilution can be added, repeatedly can also repeat ultrafiltration.
Embodiment 2
Carry out ultrafiltration after polyvidone k30 is dissolved in purified water, wherein, the operational condition of described ultrafiltration is as follows: feed pressure is 2MPa; Feed temperature is 20 DEG C; Ultra-filtration membrane aperture is 0.45um; Feed velocity is 20mL/s; Described ultra-filtration membrane material is tetrafluoroethylene.
Embodiment 3
Carry out ultrafiltration after polyvidone k30 is dissolved in purified water, wherein, the operational condition of described ultrafiltration is as follows: feed pressure is 10MPa; Feed temperature is 25 DEG C; Ultra-filtration membrane aperture is 5um; Feed velocity is 30mL/s; Described ultra-filtration membrane material is polyethersulfone resin.
The content utilizing high performance liquid chromatography to detect the NVP before and after ultrafiltration finds, the content of NVP greatly reduces, and reaches the effect of removal of impurities.
Embodiment 4
Carry out ultrafiltration after polyvidone k30 is dissolved in purified water, wherein, the operational condition of described ultrafiltration is as follows: feed pressure is 0.1MPa; Feed temperature is 30 DEG C; Ultra-filtration membrane aperture is 5um; Feed velocity is 15mL/s; Described ultra-filtration membrane material is nylon.
Embodiment 5
Carry out ultrafiltration after polyvidone k30 is dissolved in purified water, wherein, the operational condition of described ultrafiltration is as follows: feed pressure is 5MPa; Feed temperature is 25 DEG C; Ultra-filtration membrane aperture is 5um; Feed velocity is 15mL/s; Described ultra-filtration membrane material is for mixed fine.
Claims (6)
1. the minimizing technology of NVP in polyvidone k30, is characterized in that, described method be polyvidone k30 is dissolved in purified water after carry out ultrafiltration, wherein, the operational condition of described ultrafiltration is as follows:
A, feed pressure are 0.1 ~ 10MPa;
B, feed temperature are 10 ~ 30 DEG C;
C, described ultra-filtration membrane aperture are 0.1 ~ 5um.
2. minimizing technology according to claim 1, is characterized in that, described ultra-filtration membrane aperture is 0.45um.
3. minimizing technology according to claim 1, is characterized in that, described feed temperature is 20 ~ 25 DEG C.
4., according to described minimizing technology arbitrary in claim 1-3, it is characterized in that, described feed velocity is 15 ~ 30mL/s.
5. according to described minimizing technology arbitrary in claim 1-3, it is characterized in that, described ultra-filtration membrane material is any one in polyvinylidene difluoride (PVDF), tetrafluoroethylene, polyethersulfone resin, nylon, mixed fibre.
6. minimizing technology according to claim 5, is characterized in that, described ultra-filtration membrane material is polyvinylidene difluoride (PVDF).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510846165.5A CN105294886A (en) | 2015-11-29 | 2015-11-29 | Removing method of N-vinyl pyrrolidone in povidone k30 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510846165.5A CN105294886A (en) | 2015-11-29 | 2015-11-29 | Removing method of N-vinyl pyrrolidone in povidone k30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105294886A true CN105294886A (en) | 2016-02-03 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510846165.5A Pending CN105294886A (en) | 2015-11-29 | 2015-11-29 | Removing method of N-vinyl pyrrolidone in povidone k30 |
Country Status (1)
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1073949A (en) * | 1991-12-05 | 1993-07-07 | Basf公司 | The preparation of ultrapure N-vinylpyrrolidone polymers |
| CN1712432A (en) * | 2005-08-02 | 2005-12-28 | 仲恺农业技术学院 | Method for eliminating residual monomer N-vinyl-pyrrolidone in polymer |
| CN101633706A (en) * | 2009-08-20 | 2010-01-27 | 华南理工大学 | N-vinylpyrrolidinone polymer solution purification method |
| CN102477110A (en) * | 2010-11-25 | 2012-05-30 | 中国科学院过程工程研究所 | Method for polymer latex washing by membrane process |
-
2015
- 2015-11-29 CN CN201510846165.5A patent/CN105294886A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1073949A (en) * | 1991-12-05 | 1993-07-07 | Basf公司 | The preparation of ultrapure N-vinylpyrrolidone polymers |
| CN1712432A (en) * | 2005-08-02 | 2005-12-28 | 仲恺农业技术学院 | Method for eliminating residual monomer N-vinyl-pyrrolidone in polymer |
| CN101633706A (en) * | 2009-08-20 | 2010-01-27 | 华南理工大学 | N-vinylpyrrolidinone polymer solution purification method |
| CN102477110A (en) * | 2010-11-25 | 2012-05-30 | 中国科学院过程工程研究所 | Method for polymer latex washing by membrane process |
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Application publication date: 20160203 |