CN101493446A - 一种检测样品或制品中游离聚乙二醇含量的方法 - Google Patents
一种检测样品或制品中游离聚乙二醇含量的方法 Download PDFInfo
- Publication number
- CN101493446A CN101493446A CNA2009100250059A CN200910025005A CN101493446A CN 101493446 A CN101493446 A CN 101493446A CN A2009100250059 A CNA2009100250059 A CN A2009100250059A CN 200910025005 A CN200910025005 A CN 200910025005A CN 101493446 A CN101493446 A CN 101493446A
- Authority
- CN
- China
- Prior art keywords
- polyglycol
- sample
- detector
- signal
- goods
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000002202 Polyethylene glycol Substances 0.000 title claims abstract description 49
- 229920001223 polyethylene glycol Polymers 0.000 title claims abstract description 49
- 238000000034 method Methods 0.000 title claims abstract description 21
- 238000001514 detection method Methods 0.000 claims abstract description 25
- 238000010812 external standard method Methods 0.000 claims abstract description 8
- 229920000151 polyglycol Polymers 0.000 claims description 82
- 239000010695 polyglycol Substances 0.000 claims description 82
- DTQVDTLACAAQTR-UHFFFAOYSA-N Trifluoroacetic acid Chemical compound OC(=O)C(F)(F)F DTQVDTLACAAQTR-UHFFFAOYSA-N 0.000 claims description 36
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 33
- 238000001704 evaporation Methods 0.000 claims description 29
- 230000008020 evaporation Effects 0.000 claims description 27
- 229910021642 ultra pure water Inorganic materials 0.000 claims description 14
- 239000012498 ultrapure water Substances 0.000 claims description 14
- 239000003814 drug Substances 0.000 claims description 10
- 238000012360 testing method Methods 0.000 claims description 9
- 238000010521 absorption reaction Methods 0.000 claims description 7
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 6
- 239000002537 cosmetic Substances 0.000 claims description 4
- 230000036541 health Effects 0.000 claims description 4
- 239000000945 filler Substances 0.000 claims description 3
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims description 3
- 239000000377 silicon dioxide Substances 0.000 claims description 3
- 230000000052 comparative effect Effects 0.000 claims description 2
- 239000000463 material Substances 0.000 claims description 2
- 230000004048 modification Effects 0.000 abstract description 14
- 238000012986 modification Methods 0.000 abstract description 14
- 238000004458 analytical method Methods 0.000 abstract description 5
- 238000004007 reversed phase HPLC Methods 0.000 abstract description 5
- 239000000126 substance Substances 0.000 abstract description 2
- 239000004698 Polyethylene Substances 0.000 abstract 1
- -1 polyethylene Polymers 0.000 abstract 1
- 229920000573 polyethylene Polymers 0.000 abstract 1
- 238000004366 reverse phase liquid chromatography Methods 0.000 abstract 1
- 102000004452 Arginase Human genes 0.000 description 18
- 108700024123 Arginases Proteins 0.000 description 18
- 239000000872 buffer Substances 0.000 description 15
- 125000000956 methoxy group Chemical group [H]C([H])([H])O* 0.000 description 10
- XBDQKXXYIPTUBI-UHFFFAOYSA-N dimethylselenoniopropionate Natural products CCC(O)=O XBDQKXXYIPTUBI-UHFFFAOYSA-N 0.000 description 6
- 102000004169 proteins and genes Human genes 0.000 description 6
- 108090000623 proteins and genes Proteins 0.000 description 6
- 239000011541 reaction mixture Substances 0.000 description 6
- 239000000203 mixture Substances 0.000 description 5
- XANRGTLFBAJYDA-UHFFFAOYSA-N propanoic acid;pyrrolidine-2,5-dione Chemical compound CCC(O)=O.O=C1CCC(=O)N1 XANRGTLFBAJYDA-UHFFFAOYSA-N 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000004737 colorimetric analysis Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000012417 linear regression Methods 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 235000019260 propionic acid Nutrition 0.000 description 3
- IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 description 3
- 239000012146 running buffer Substances 0.000 description 3
- 229910001422 barium ion Inorganic materials 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 230000007062 hydrolysis Effects 0.000 description 2
- 238000006460 hydrolysis reaction Methods 0.000 description 2
- 229920002521 macromolecule Polymers 0.000 description 2
- 238000005374 membrane filtration Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 238000002798 spectrophotometry method Methods 0.000 description 2
- 230000004913 activation Effects 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 238000000137 annealing Methods 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 229910052788 barium Inorganic materials 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 230000001143 conditioned effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002270 exclusion chromatography Methods 0.000 description 1
- 239000003889 eye drop Substances 0.000 description 1
- 229940012356 eye drops Drugs 0.000 description 1
- 150000002334 glycols Chemical class 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 230000005847 immunogenicity Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 210000003000 inclusion body Anatomy 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 239000002502 liposome Substances 0.000 description 1
- 229920001427 mPEG Polymers 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000001819 mass spectrum Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 238000010606 normalization Methods 0.000 description 1
- 125000000466 oxiranyl group Chemical group 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 239000003223 protective agent Substances 0.000 description 1
- 238000001742 protein purification Methods 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 239000000376 reactant Substances 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000004153 renaturation Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 238000013207 serial dilution Methods 0.000 description 1
- 229940126586 small molecule drug Drugs 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000004611 spectroscopical analysis Methods 0.000 description 1
- 230000005477 standard model Effects 0.000 description 1
- 239000012086 standard solution Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 150000005846 sugar alcohols Polymers 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
Images
Abstract
Description
起始聚乙二醇浓度 | 游离聚乙二醇的信号峰面积 | 样品的稀释倍数Z | 游离的聚乙二醇浓度 | 修饰上的聚乙二醇摩尔浓度 | 精氨酸酶的摩尔浓度 | 精氨酸酶的修饰度 |
12(mg/ml) | 17520 | 2 | 3(mg/ml) | 4.5-7mol/l | 4.1-8mol/l | 11 |
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 200910025005 CN101493446B (zh) | 2009-02-16 | 2009-02-16 | 一种检测样品或制品中游离聚乙二醇含量的方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 200910025005 CN101493446B (zh) | 2009-02-16 | 2009-02-16 | 一种检测样品或制品中游离聚乙二醇含量的方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN101493446A true CN101493446A (zh) | 2009-07-29 |
CN101493446B CN101493446B (zh) | 2011-08-31 |
Family
ID=40924147
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN 200910025005 Active CN101493446B (zh) | 2009-02-16 | 2009-02-16 | 一种检测样品或制品中游离聚乙二醇含量的方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN101493446B (zh) |
Cited By (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102507824A (zh) * | 2011-11-01 | 2012-06-20 | 北京三元基因工程有限公司 | 聚乙二醇修饰蛋白质的修饰位点分析方法 |
CN104931637A (zh) * | 2015-06-25 | 2015-09-23 | 吉林大学 | 一种生物样本中peg含量的测定方法 |
CN104991016A (zh) * | 2015-06-25 | 2015-10-21 | 吉林大学 | 一种生物样本中peg化药物的定量测定方法 |
CN105300972A (zh) * | 2015-10-10 | 2016-02-03 | 煤炭科学技术研究院有限公司 | 一种含酚含油复杂体系中乙二醇含量的测定方法 |
CN107219317A (zh) * | 2017-06-22 | 2017-09-29 | 广东省测试分析研究所(中国广州分析测试中心) | 一种快速测定聚乙二醇衍生物的分子量及其分布和杂质含量的方法 |
CN109682901A (zh) * | 2019-03-01 | 2019-04-26 | 重庆派金生物科技有限公司 | 聚乙二醇化蛋白类药物的平均修饰度测定方法 |
CN111855878A (zh) * | 2020-06-28 | 2020-10-30 | 中国食品药品检定研究院 | 一种克服质量歧视效应的聚乙二醇测定方法及应用 |
CN113092605A (zh) * | 2021-03-22 | 2021-07-09 | 中国日用化学研究院有限公司 | 一种用于低分子量聚乙二醇检测的分析方法 |
CN114405298A (zh) * | 2021-12-27 | 2022-04-29 | 苏州艾博生物科技有限公司 | 纯化聚乙二醇类缀合脂质的方法 |
CN114778712A (zh) * | 2022-03-21 | 2022-07-22 | 天津键凯科技有限公司 | 一种聚乙二醇脂质及含有该脂质的脂质纳米粒含量的检测方法 |
CN116223677A (zh) * | 2023-03-08 | 2023-06-06 | 浙江萃泽医药科技有限公司 | 一种美洛昔康粉末制剂中聚乙二醇400含量检测方法 |
CN117214342A (zh) * | 2023-10-18 | 2023-12-12 | 江苏诺和必拓新药研发有限公司 | 一种注射液胶束溶液中胶束浓度的测定方法 |
CN114405298B (zh) * | 2021-12-27 | 2024-05-14 | 苏州艾博生物科技有限公司 | 纯化聚乙二醇类缀合脂质的方法 |
-
2009
- 2009-02-16 CN CN 200910025005 patent/CN101493446B/zh active Active
Cited By (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102507824A (zh) * | 2011-11-01 | 2012-06-20 | 北京三元基因工程有限公司 | 聚乙二醇修饰蛋白质的修饰位点分析方法 |
CN102507824B (zh) * | 2011-11-01 | 2013-10-09 | 北京三元基因工程有限公司 | 聚乙二醇修饰蛋白质的修饰位点分析方法 |
CN104931637A (zh) * | 2015-06-25 | 2015-09-23 | 吉林大学 | 一种生物样本中peg含量的测定方法 |
CN104991016A (zh) * | 2015-06-25 | 2015-10-21 | 吉林大学 | 一种生物样本中peg化药物的定量测定方法 |
CN104991016B (zh) * | 2015-06-25 | 2017-04-05 | 吉林大学 | 一种生物样本中peg化药物的定量测定方法 |
CN105300972A (zh) * | 2015-10-10 | 2016-02-03 | 煤炭科学技术研究院有限公司 | 一种含酚含油复杂体系中乙二醇含量的测定方法 |
CN107219317A (zh) * | 2017-06-22 | 2017-09-29 | 广东省测试分析研究所(中国广州分析测试中心) | 一种快速测定聚乙二醇衍生物的分子量及其分布和杂质含量的方法 |
CN109682901A (zh) * | 2019-03-01 | 2019-04-26 | 重庆派金生物科技有限公司 | 聚乙二醇化蛋白类药物的平均修饰度测定方法 |
CN111855878A (zh) * | 2020-06-28 | 2020-10-30 | 中国食品药品检定研究院 | 一种克服质量歧视效应的聚乙二醇测定方法及应用 |
CN113092605A (zh) * | 2021-03-22 | 2021-07-09 | 中国日用化学研究院有限公司 | 一种用于低分子量聚乙二醇检测的分析方法 |
CN114405298A (zh) * | 2021-12-27 | 2022-04-29 | 苏州艾博生物科技有限公司 | 纯化聚乙二醇类缀合脂质的方法 |
CN114405298B (zh) * | 2021-12-27 | 2024-05-14 | 苏州艾博生物科技有限公司 | 纯化聚乙二醇类缀合脂质的方法 |
CN114778712A (zh) * | 2022-03-21 | 2022-07-22 | 天津键凯科技有限公司 | 一种聚乙二醇脂质及含有该脂质的脂质纳米粒含量的检测方法 |
CN116223677A (zh) * | 2023-03-08 | 2023-06-06 | 浙江萃泽医药科技有限公司 | 一种美洛昔康粉末制剂中聚乙二醇400含量检测方法 |
CN116223677B (zh) * | 2023-03-08 | 2023-07-28 | 浙江萃泽医药科技有限公司 | 一种美洛昔康粉末制剂中聚乙二醇400含量检测方法 |
CN117214342A (zh) * | 2023-10-18 | 2023-12-12 | 江苏诺和必拓新药研发有限公司 | 一种注射液胶束溶液中胶束浓度的测定方法 |
CN117214342B (zh) * | 2023-10-18 | 2024-01-26 | 江苏诺和必拓新药研发有限公司 | 一种注射液胶束溶液中胶束浓度的测定方法 |
Also Published As
Publication number | Publication date |
---|---|
CN101493446B (zh) | 2011-08-31 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN101493446B (zh) | 一种检测样品或制品中游离聚乙二醇含量的方法 | |
CN105431733B (zh) | 用于检测硫酸化寡糖的分析方法 | |
CN101650347B (zh) | 一种同时测定饲用酸化剂中多种有机酸含量的方法 | |
CN102539564B (zh) | 奥硝唑注射液杂质的检测方法及含量测定方法 | |
CN103487518B (zh) | 注射用盐酸克林霉素杂质的检测方法及含量测定方法 | |
Al-Rimawi et al. | Analysis of azithromycin and its related compounds by RP-HPLC with UV detection | |
CN106841413A (zh) | 一种替格瑞洛对映异构体、非对映异构体的分离检测方法 | |
Vennard et al. | Sugar profile method by high-performance anion-exchange chromatography with pulsed amperometric detection in food, dietary supplements, pet food, and animal feeds: First action 2018.16 | |
Chi et al. | Preparation of phenyl-boronic acid polymer monolith by initiator-free ring-opening polymerization for microextraction of sulfamethoxazole and trimethoprim from animal-originated foodstuffs | |
CN104777243A (zh) | 一种同时测定半夏中有机酸、核苷和麻黄碱的hplc方法 | |
RU2416792C1 (ru) | Способ количественного определения ципрофлоксацина в лекарственных препаратах | |
CN116794184B (zh) | 一种单一聚合度的聚乙二醇及同系杂质的检测方法 | |
CN110849994B (zh) | 一种利伐沙班中有关物质的分离方法 | |
CN103487521A (zh) | 甲磺酸帕珠沙星注射液右旋异构体的检测方法 | |
CN104950047A (zh) | 用于检测制剂中盐酸美金刚或其类似物的含量、溶出度或释放度的方法 | |
CN103645151A (zh) | 一种快速测定大观霉素发酵液或成品中大观霉素含量的方法 | |
CN102269749A (zh) | 一种猴头菌片中腺苷含量的检测方法 | |
CN105004803A (zh) | 一种分离测定托伐普坦中多个杂质的液相色谱方法 | |
CN109738554A (zh) | 固相萃取-液相色谱联用测定水中微量苯乙酸的方法 | |
CN102243215A (zh) | 一种水溶性葡甘露聚糖的检测方法 | |
CN104215718A (zh) | Triton X-100含量的高效液相色谱检测方法 | |
Iqbal et al. | An RP-HPLC-UV method with SPE for cefotaxime in all-in-one total parenteral nutritional admixtures: application to stability studies | |
CN101169395A (zh) | 化妆品中氢化可的松的高效液相色谱检测方法 | |
CN103487520A (zh) | 甲磺酸帕珠沙星注射液右旋异构体的手性固定相检测法 | |
CN106248831A (zh) | 一种高效液相色谱测定泰拉霉素含量的方法 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
ASS | Succession or assignment of patent right |
Owner name: JIANGSU SIMCERE PHARMACEUTICAL CO., LTD. Effective date: 20150624 |
|
C41 | Transfer of patent application or patent right or utility model | ||
TR01 | Transfer of patent right |
Effective date of registration: 20150624 Address after: 210042 Xuanwu Avenue, Jiangsu, Nanjing, No. 699 -18 Patentee after: Jiangsu Simcere Pharmaceutical Research Company Limited Patentee after: Jiangsu Simcere Pharmaceutical Co., Ltd. Address before: 210042 Xuanwu Avenue, Jiangsu, Nanjing, No. 699 -18 Patentee before: Jiangsu Simcere Pharmaceutical Research Company Limited |
|
C41 | Transfer of patent application or patent right or utility model | ||
TR01 | Transfer of patent right |
Effective date of registration: 20160727 Address after: 210042 Xuanwu District, Xuanwu District, Jiangsu, Nanjing No. 699 -18 Patentee after: Jiangsu Simcere Pharmaceutical Co., Ltd. Address before: 210042 Xuanwu Avenue, Jiangsu, Nanjing, No. 699 -18 Patentee before: Jiangsu Simcere Pharmaceutical Research Company Limited Patentee before: Jiangsu Simcere Pharmaceutical Co., Ltd. |
|
TR01 | Transfer of patent right |
Effective date of registration: 20201224 Address after: 570311 No. 2 Yaogu No. 3 Road, Xiuying District, Haikou City, Hainan Province Patentee after: Hainan Simcere Pharmaceutical Co.,Ltd. Address before: 210042 699 Xuanwu Road, Xuanwu District, Nanjing, Jiangsu -18 Patentee before: JIANGSU SIMCERE PHARMACEUTICAL Co.,Ltd. |
|
TR01 | Transfer of patent right |