微流成像显微镜如何精准检测药物亚可见微粒

已将微流成像法收录为亚可见微粒的正交表征手段，多用于超标样品根因分析，来源：USP，2021 年 5 月。国内生物制药实验室普遍采用 “光阻法放行，微流成像显微镜做异常溯源” 的组合策略。"}}},"align":"","folded":false}},"FksxfzBCFdIRX7clxCCaR115e5g":{"id":"FksxfzBCFdIRX7clxCCaR115e5g","snapshot":{"type":"heading2","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+j"},"text":{"0":"微流成像显微镜核心原理与和传统方案对比"}}},"align":"","folded":false}},"DUX1f7luAdDRVXc4afupvILNBRZ":{"id":"DUX1f7luAdDRVXc4afupvILNBRZ","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+2w"},"text":{"0":"微流成像显微镜的核心逻辑为样品液体匀速通过扁平微流池，高速显微相机连续抓拍流动中每一颗微粒图像，软件完成粒径统计、形态分类，同时留存原始图片档案，实现计数 + 形貌鉴别同步完成。下表对比主流检测手段关键差异。"}}},"align":"","folded":false}},"KSWYf048kdtDQ1cfhjomyENZy8l":{"id":"KSWYf048kdtDQ1cfhjomyENZy8l","snapshot":{"type":"table","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","columns_id":["col21ac0586-8d10-5c8c-1d59-22f1cf0d7f0d","col0936de4c-59e3-58cd-3e57-37a4352f3a3c","col94fe1111-a01d-5687-68c9-9ba355ae2114","col66943b86-3ec7-6da1-b19e-c3a166d854b5"],"rows_id":["rowfea81c3b-6e83-aac9-539d-5716df78f5ff","row4978bc45-7698-24d6-8b02-4f1a1dcdda33","rowf80ca706-2bde-aa19-b3eb-95a40c605e64","row4f9cfafb-9650-8ffc-76d1-2ecfe485f7f9"],"column_set":{"col0936de4c-59e3-58cd-3e57-37a4352f3a3c":{"column_width":200},"col21ac0586-8d10-5c8c-1d59-22f1cf0d7f0d":{"column_width":200},"col66943b86-3ec7-6da1-b19e-c3a166d854b5":{"column_width":200},"col94fe1111-a01d-5687-68c9-9ba355ae2114":{"column_width":200}},"cell_set":{"row4978bc45-7698-24d6-8b02-4f1a1dcdda33col0936de4c-59e3-58cd-3e57-37a4352f3a3c":{"merge_info":{"row_span":1,"col_span":1},"block_id":"HDIQfUW7cdkuBMcU5fucFOZdrlx"},"row4978bc45-7698-24d6-8b02-4f1a1dcdda33col21ac0586-8d10-5c8c-1d59-22f1cf0d7f0d":{"merge_info":{"row_span":1,"col_span":1},"block_id":"NRVVfZ0aedguvFcOU5eptCRZxbm"},"row4978bc45-7698-24d6-8b02-4f1a1dcdda33col66943b86-3ec7-6da1-b19e-c3a166d854b5":{"merge_info":{"row_span":1,"col_span":1},"block_id":"MvGGfITW0d66abcqsAFaHLX0i47"},"row4978bc45-7698-24d6-8b02-4f1a1dcdda33col94fe1111-a01d-5687-68c9-9ba355ae2114":{"merge_info":{"row_span":1,"col_span":1},"block_id":"MDGOfS3dgduEKNcV1clcmxLMl15"},"row4f9cfafb-9650-8ffc-76d1-2ecfe485f7f9col0936de4c-59e3-58cd-3e57-37a4352f3a3c":{"merge_info":{"row_span":1,"col_span":1},"block_id":"CyLLfV37ddsCNQcVaaeooozAoP3"},"row4f9cfafb-9650-8ffc-76d1-2ecfe485f7f9col21ac0586-8d10-5c8c-1d59-22f1cf0d7f0d":{"merge_info":{"row_span":1,"col_span":1},"block_id":"AzEIfV89ddfszEcS24andjrzoFO"},"row4f9cfafb-9650-8ffc-76d1-2ecfe485f7f9col66943b86-3ec7-6da1-b19e-c3a166d854b5":{"merge_info":{"row_span":1,"col_span":1},"block_id":"UDGUf27jxdISZbckloypEKKNrT2"},"row4f9cfafb-9650-8ffc-76d1-2ecfe485f7f9col94fe1111-a01d-5687-68c9-9ba355ae2114":{"merge_info":{"row_span":1,"col_span":1},"block_id":"PzDRfR4hsdCHU6cahoqcuJV0n2f"},"rowf80ca706-2bde-aa19-b3eb-95a40c605e64col0936de4c-59e3-58cd-3e57-37a4352f3a3c":{"merge_info":{"row_span":1,"col_span":1},"block_id":"WDP2f5kpqdBOU6c8mABeBKRZlZ8"},"rowf80ca706-2bde-aa19-b3eb-95a40c605e64col21ac0586-8d10-5c8c-1d59-22f1cf0d7f0d":{"merge_info":{"row_span":1,"col_span":1},"block_id":"UHLQfY013d37ixcFKS3c5ikvqFP"},"rowf80ca706-2bde-aa19-b3eb-95a40c605e64col66943b86-3ec7-6da1-b19e-c3a166d854b5":{"merge_info":{"row_span":1,"col_span":1},"block_id":"SzABfFU57dgltycKKW4mjmsttuF"},"rowf80ca706-2bde-aa19-b3eb-95a40c605e64col94fe1111-a01d-5687-68c9-9ba355ae2114":{"merge_info":{"row_span":1,"col_span":1},"block_id":"GtwAfAL08dbpvIcMQWWm6hovrJQ"},"rowfea81c3b-6e83-aac9-539d-5716df78f5ffcol0936de4c-59e3-58cd-3e57-37a4352f3a3c":{"merge_info":{"row_span":1,"col_span":1},"block_id":"XyKWf8ksvdENR2c5gqscHJNSiYZ"},"rowfea81c3b-6e83-aac9-539d-5716df78f5ffcol21ac0586-8d10-5c8c-1d59-22f1cf0d7f0d":{"merge_info":{"row_span":1,"col_span":1},"block_id":"JGQ0f9ktGdPU59cjmnzhIU13rad"},"rowfea81c3b-6e83-aac9-539d-5716df78f5ffcol66943b86-3ec7-6da1-b19e-c3a166d854b5":{"merge_info":{"row_span":1,"col_span":1},"block_id":"FNU8fafgrdtEJPcQYYcnpqFGqIL"},"rowfea81c3b-6e83-aac9-539d-5716df78f5ffcol94fe1111-a01d-5687-68c9-9ba355ae2114":{"merge_info":{"row_span":1,"col_span":1},"block_id":"OHMNf1cdrdANZ6c8lnBbOX8cmku"}}}},"JGQ0f9ktGdPU59cjmnzhIU13rad":{"id":"JGQ0f9ktGdPU59cjmnzhIU13rad","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["RP2afbiivdyDNZcdlAMiPV24t5b"]}},"RP2afbiivdyDNZcdlAMiPV24t5b":{"id":"RP2afbiivdyDNZcdlAMiPV24t5b","snapshot":{"type":"text","parent_id":"JGQ0f9ktGdPU59cjmnzhIU13rad","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+4"},"text":{"0":"检测方法"}}},"align":"","folded":false}},"XyKWf8ksvdENR2c5gqscHJNSiYZ":{"id":"XyKWf8ksvdENR2c5gqscHJNSiYZ","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["OR6kfpvHHdIJOUc07engzDNXuad"]}},"OR6kfpvHHdIJOUc07engzDNXuad":{"id":"OR6kfpvHHdIJOUc07engzDNXuad","snapshot":{"type":"text","parent_id":"XyKWf8ksvdENR2c5gqscHJNSiYZ","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+4"},"text":{"0":"核心优势"}}},"align":"","folded":false}},"OHMNf1cdrdANZ6c8lnBbOX8cmku":{"id":"OHMNf1cdrdANZ6c8lnBbOX8cmku","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["GCHNf1abpdCHQ0cfiwwdJYcppET"]}},"GCHNf1abpdCHQ0cfiwwdJYcppET":{"id":"GCHNf1abpdCHQ0cfiwwdJYcppET","snapshot":{"type":"text","parent_id":"OHMNf1cdrdANZ6c8lnBbOX8cmku","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+4"},"text":{"0":"固有局限"}}},"align":"","folded":false}},"FNU8fafgrdtEJPcQYYcnpqFGqIL":{"id":"FNU8fafgrdtEJPcQYYcnpqFGqIL","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["ZV29fmBCMdXcllcnszMcW02crow"]}},"ZV29fmBCMdXcllcnszMcW02crow":{"id":"ZV29fmBCMdXcllcnszMcW02crow","snapshot":{"type":"text","parent_id":"FNU8fafgrdtEJPcQYYcnpqFGqIL","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+4"},"text":{"0":"法规定位"}}},"align":"","folded":false}},"NRVVfZ0aedguvFcOU5eptCRZxbm":{"id":"NRVVfZ0aedguvFcOU5eptCRZxbm","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["ONZcfeptydzGKXc3cjopBEJWzZc"]}},"ONZcfeptydzGKXc3cjopBEJWzZc":{"id":"ONZcfeptydzGKXc3cjopBEJWzZc","snapshot":{"type":"text","parent_id":"NRVVfZ0aedguvFcOU5eptCRZxbm","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+3"},"text":{"0":"光阻法"}}},"align":"","folded":false}},"HDIQfUW7cdkuBMcU5fucFOZdrlx":{"id":"HDIQfUW7cdkuBMcU5fucFOZdrlx","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["BzO3f5abldyzMRcV2bddjvEPjQZ"]}},"BzO3f5abldyzMRcV2bddjvEPjQZ":{"id":"BzO3f5abldyzMRcV2bddjvEPjQZ","snapshot":{"type":"text","parent_id":"HDIQfUW7cdkuBMcU5fucFOZdrlx","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+c"},"text":{"0":"检测速度快，适合批量放行"}}},"align":"","folded":false}},"MDGOfS3dgduEKNcV1clcmxLMl15":{"id":"MDGOfS3dgduEKNcV1clcmxLMl15","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["NmrrfESTTdVapxcJMW1h9iknizM"]}},"NmrrfESTTdVapxcJMW1h9iknizM":{"id":"NmrrfESTTdVapxcJMW1h9iknizM","snapshot":{"type":"text","parent_id":"MDGOfS3dgduEKNcV1clcmxLMl15","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+i"},"text":{"0":"无法区分微粒材质，漏检半透明蛋白颗粒"}}},"align":"","folded":false}},"MvGGfITW0d66abcqsAFaHLX0i47":{"id":"MvGGfITW0d66abcqsAFaHLX0i47","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["JuHQfX167dbioucvKY3mghpqoAM"]}},"JuHQfX167dbioucvKY3mghpqoAM":{"id":"JuHQfX167dbioucvKY3mghpqoAM","snapshot":{"type":"text","parent_id":"MvGGfITW0d66abcqsAFaHLX0i47","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+d"},"text":{"0":"中国药典 0903 第一法"}}},"align":"","folded":false}},"UHLQfY013d37ixcFKS3c5ikvqFP":{"id":"UHLQfY013d37ixcFKS3c5ikvqFP","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["CCPWf33codyAPRcZ79igppAAmGU"]}},"CCPWf33codyAPRcZ79igppAAmGU":{"id":"CCPWf33codyAPRcZ79igppAAmGU","snapshot":{"type":"text","parent_id":"UHLQfY013d37ixcFKS3c5ikvqFP","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+8"},"text":{"0":"膜过滤显微计数法"}}},"align":"","folded":false}},"WDP2f5kpqdBOU6c8mABeBKRZlZ8":{"id":"WDP2f5kpqdBOU6c8mABeBKRZlZ8","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["JQXYf8ertdIRYdcpBDIpKT4ataa"]}},"JQXYf8ertdIRYdcpBDIpKT4ataa":{"id":"JQXYf8ertdIRYdcpBDIpKT4ataa","snapshot":{"type":"text","parent_id":"WDP2f5kpqdBOU6c8mABeBKRZlZ8","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+h"},"text":{"0":"可直接观察微粒，适合有色、浑浊制剂"}}},"align":"","folded":false}},"GtwAfAL08dbpvIcMQWWm6hovrJQ":{"id":"GtwAfAL08dbpvIcMQWWm6hovrJQ","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["GzCOf1bgjdnqEHcHPPVkY9jqoqq"]}},"GzCOf1bgjdnqEHcHPPVkY9jqoqq":{"id":"GzCOf1bgjdnqEHcHPPVkY9jqoqq","snapshot":{"type":"text","parent_id":"GtwAfAL08dbpvIcMQWWm6hovrJQ","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+e"},"text":{"0":"人工操作，通量低，主观误差大"}}},"align":"","folded":false}},"SzABfFU57dgltycKKW4mjmsttuF":{"id":"SzABfFU57dgltycKKW4mjmsttuF","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["OJUXf2358dmwzIcQ2fsoHKR2y68"]}},"OJUXf2358dmwzIcQ2fsoHKR2y68":{"id":"OJUXf2358dmwzIcQ2fsoHKR2y68","snapshot":{"type":"text","parent_id":"SzABfFU57dgltycKKW4mjmsttuF","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+7"},"text":{"0":"药典仲裁第二法"}}},"align":"","folded":false}},"AzEIfV89ddfszEcS24andjrzoFO":{"id":"AzEIfV89ddfszEcS24andjrzoFO","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["XDOWf6ittdAMUZc7lqxmKMSSr6c"]}},"XDOWf6ittdAMUZc7lqxmKMSSr6c":{"id":"XDOWf6ittdAMUZc7lqxmKMSSr6c","snapshot":{"type":"text","parent_id":"AzEIfV89ddfszEcS24andjrzoFO","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+7"},"text":{"0":"微流成像显微镜"}}},"align":"","folded":false}},"CyLLfV37ddsCNQcVaaeooozAoP3":{"id":"CyLLfV37ddsCNQcVaaeooozAoP3","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["XLSTf3dpAdKT8kcuBEIlW07gwpp"]}},"XLSTf3dpAdKT8kcuBEIlW07gwpp":{"id":"XLSTf3dpAdKT8kcuBEIlW07gwpp","snapshot":{"type":"text","parent_id":"CyLLfV37ddsCNQcVaaeooozAoP3","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+i"},"text":{"0":"自动成像，可区分蛋白、硅油、玻璃碎屑"}}},"align":"","folded":false}},"PzDRfR4hsdCHU6cahoqcuJV0n2f":{"id":"PzDRfR4hsdCHU6cahoqcuJV0n2f","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["QstGfGQ1ddkvwLcMO12hgjkkimz"]}},"QstGfGQ1ddkvwLcMO12hgjkkimz":{"id":"QstGfGQ1ddkvwLcMO12hgjkkimz","snapshot":{"type":"text","parent_id":"PzDRfR4hsdCHU6cahoqcuJV0n2f","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+f"},"text":{"0":"不做法定放行判定，设备成本较高"}}},"align":"","folded":false}},"UDGUf27jxdISZbckloypEKKNrT2":{"id":"UDGUf27jxdISZbckloypEKKNrT2","snapshot":{"type":"table_cell","parent_id":"KSWYf048kdtDQ1cfhjomyENZy8l","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":["AwDPfQT4ddmmwBcQ19cddkuvgwH"]}},"AwDPfQT4ddmmwBcQ19cddkuvgwH":{"id":"AwDPfQT4ddmmwBcQ19cddkuvgwH","snapshot":{"type":"text","parent_id":"UDGUf27jxdISZbckloypEKKNrT2","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+i"},"text":{"0":"USP<1788.3>正交补充技术"}}},"align":"","folded":false}},"EDPVf08fkdltBEcLX4hiwDJNwQ1":{"id":"EDPVf08fkdltBEcLX4hiwDJNwQ1","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+4i"},"text":{"0":"微流成像显微镜最大价值不只是计数，而是通过圆形度、透明度、轮廓特征把微粒分类，直接定位微粒来源，区分是蛋白聚集、包材脱落还是生产引入外来杂质，来源：药物分析杂志，2021 年 4 月。某生物药企业质量实验室案例：批次光阻法检测结果接近限度，微流成像显微镜识别大量硅油滴，确认来源于预充针硅化工艺，帮助企业优化包材预处理流程。"}}},"align":"","folded":false}},"LHRZf5dmBdLMTZc2finpyBCHyHW":{"id":"LHRZf5dmBdLMTZc2finpyBCHyHW","snapshot":{"type":"heading2","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+g"},"text":{"0":"实操环节关键控制点，规避数据偏差"}}},"align":"","folded":false}},"DvvHfNR14dcpzOc05epgzCQXn5a":{"id":"DvvHfNR14dcpzOc05epgzCQXn5a","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+24"},"text":{"0":"微流成像属于图像类定量检测，流池清洁、样品前处理、取样体积、气泡控制直接决定结果可信度，很多实验室出现数据重复性差，问题多来源于样品前处理而非仪器本身。"}}},"align":"","folded":false}},"OJVWf7knvdIW3fcfioyhzMYbphh":{"id":"OJVWf7knvdIW3fcfioyhzMYbphh","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+3g"},"text":{"0":"依据 USP<1788.3>技术指引，测试前流池必须执行空白溶剂冲洗，空白计数要低于阈值再开展正式检测；样品不能剧烈涡旋，防止人为引入气泡和蛋白新聚集体；针对蛋白类制剂，要控制进样流速，避免剪切力诱导蛋白聚集，来源：USP，2021 年 5 月。"}}},"align":"","folded":false}},"QvAAfGNY4d4iqycHJLUc557eins":{"id":"QvAAfGNY4d4iqycHJLUc557eins","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+3x"},"text":{"0":"数据显示，同一单抗样品，剧烈涡旋 30 秒之后，≥10μm 蛋白微粒数量提升 2.7 倍，来源：药物分析杂志，2021 年 4 月。该组数据提醒检测人员，样品混匀操作流程需要写入 SOP，避免前处理造成假阳性超标。另外，微流成像属于图像统计方法，需要采集足够微粒数量，减少抽样偏差。"}}},"align":"","folded":false}},"EVX9fbhuDdR6cpcDPVVp47ilBpr":{"id":"EVX9fbhuDdR6cpcDPVVp47ilBpr","snapshot":{"type":"heading2","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+l"},"text":{"0":"微流成像显微镜在药物全生命周期中的应用场景"}}},"align":"","folded":false}},"EIX7f9mwCdRSSTc33gnfxxKNsYY":{"id":"EIX7f9mwCdRSSTc33gnfxxKNsYY","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+4e"},"text":{"0":"微流成像显微镜不替代药典法定放行方法，贯穿药物研发、工艺开发、稳定性考察、超标调查全流程。研发阶段，评估搅拌、冻融、高温、震荡条件诱导蛋白微粒生成情况；工艺开发阶段对比不同包材、不同灭菌工艺带来微粒负荷；稳定性试验中跟踪储存条件下亚可见微粒增长趋势；出现光阻法结果超标时，开展根因排查，区分外来杂质还是蛋白本身聚集。"}}},"align":"","folded":false}},"BTY5femsBdQR0ccjnwEmNRR6zii":{"id":"BTY5femsBdQR0ccjnwEmNRR6zii","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+3n"},"text":{"0":"很多药企在稳定性研究中，光阻法数值变化不明显，微流成像显微镜已经捕捉到蛋白聚集体数量上升，提前预警产品风险，来源：国家药审中心公开技术指导原则，2025 年 11 月。当样品颜色深、黏度高，光阻法无法测试，微流成像显微镜可作为辅助表征工具，弥补传统检测手段短板。"}}},"align":"","folded":false}},"OIQVfWahvdyFLPc39oxgBES5rix":{"id":"OIQVfWahvdyFLPc39oxgBES5rix","snapshot":{"type":"heading2","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+6"},"text":{"0":"实操 FAQ"}}},"align":"","folded":false}},"LDQ0f7lmBdGMNNcYY2amjxyJrTZ":{"id":"LDQ0f7lmBdGMNNcYY2amjxyJrTZ","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":2,"numToAttrib":{"0":["author","7592327302017452999"],"1":["bold","true"]}},"initialAttributedTexts":{"attribs":{"0":"*0*1+r*0|1+1*0+2p"},"text":{"0":"Q：微流成像显微镜结果可以直接作为药典放行判定依据吗？\nA：国内现行 2025 版中国药典通则 0903 法定放行依旧为光阻法和膜过滤显微计数，微流成像显微镜用于研究和异常溯源，不能直接作为批放行判定，来源：国家药典委员会，2025 版中国药典四部。"}}},"align":"","folded":false}},"AFHSf778ldyJQ2c8nnplDFQSuXY":{"id":"AFHSf778ldyJQ2c8nnplDFQSuXY","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":2,"numToAttrib":{"0":["author","7592327302017452999"],"1":["bold","true"]}},"initialAttributedTexts":{"attribs":{"0":"*0*1+i*0|1+1*0+1d"},"text":{"0":"Q：测试过程气泡如何和真实微粒区分？\nA：气泡圆形度极高，边缘带有高亮衍射环，依靠软件形态算法可区分，测试必须做溶剂空白，消除气泡干扰。"}}},"align":"","folded":false}},"UEP3f5gludxADOcQ2encxBHTnY0":{"id":"UEP3f5gludxADOcQ2encxBHTnY0","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":2,"numToAttrib":{"0":["author","7592327302017452999"],"1":["bold","true"]}},"initialAttributedTexts":{"attribs":{"0":"*0*1+n*0|1+1*0+1d"},"text":{"0":"Q：普通化药注射剂是否需要配置微流成像显微镜？\nA：普通小分子注射剂常规放行优先光阻法；蛋白、多肽、疫苗等生物制剂，建议配置用于稳定性与异常调查。"}}},"align":"","folded":false}},"AN1cfmxEIdMOYcccltDhFQU2pgv":{"id":"AN1cfmxEIdMOYcccltDhFQU2pgv","snapshot":{"type":"heading2","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+4"},"text":{"0":"参考文献"}}},"align":"","folded":false}},"BwESfX0ehdmqwJcKRVVgY0acifk":{"id":"BwESfX0ehdmqwJcKRVVgY0acifk","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":5,"numToAttrib":{"0":["author","7592327302017452999"],"1":["link","https%3A%2F%2Fwww.chp.org.cn"],"2":["link","https%3A%2F%2Fdoi.usp.org%2FUSPNF%2FUSPNF_M12537_02_01.html"],"3":["link","https%3A%2F%2Fywfzz.yiwu.org.cn%2FCN%2F10.16155%2Fj.0254"],"4":["link","https%3A%2F%2Fwww.sciencedirect.com%2Fscience%2Farticle%2Fpii%2FS0022354921002646"]}},"initialAttributedTexts":{"attribs":{"0":"*0+1g*0*1+m*0|1+1*0+2u*0*2+1d*0|1+1*0+1q*0*3+18*0|1+s*0+4v*0*4+1v"},"text":{"0":"[1] 国家药典委员会。中国药典 2025 版四部通则 0903 不溶性微粒检查法，国家药典委员会官网，https://www.chp.org.cn\n[2] USP<1788.3>Flow Imaging Method for the Determination of Subvisible Particulate Matter，美国药典官方数据库，https://doi.usp.org/USPNF/USPNF_M12537_02_01.html\n[3] 郭莎，武刚，崔永霏.2 种型号微流成像分析仪测定微粒标准品及单抗样品的结果对比，药物分析杂志，2021‑04‑25，https://ywfzz.yiwu.org.cn/CN/10.16155/j.0254‑1793.0254‑1793.2021.04.013\n[4] Sha Qiu. Subvisible Particle Analysis of 17 Monoclonal Antibodies Approved in China Using Flow Imaging and Light Obscuration，Journal of Pharmaceutical Sciences，2021‑09‑19，https://www.sciencedirect.com/science/article/pii/S0022354921002646"}}},"align":"","folded":false}},"KIISf2hsHdQVaicovFMgWZ29pbe":{"id":"KIISf2hsHdQVaicovFMgWZ29pbe","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":2,"numToAttrib":{"0":["author","7592327302017452999"],"1":["italic","true"]}},"initialAttributedTexts":{"attribs":{"0":"*0+1*0*1+1*0+5*0*1+1*0+d"},"text":{"0":"\\\\ 标签：\\\\ 亚可见微粒、微流成像检测"}}},"align":"","folded":false}},"SLZafacpxdEHMUc0fhrktBEEyOT":{"id":"SLZafacpxdEHMUc0fhrktBEEyOT","snapshot":{"type":"text","parent_id":"PiG0dF0IToBhWHxGt0zcixDXn6s","comments":[],"revisions":[],"locked":false,"hidden":false,"author":"7592327302017452999","children":[],"text":{"apool":{"nextNum":1,"numToAttrib":{"0":["author","7592327302017452999"]}},"initialAttributedTexts":{"attribs":{"0":"*0+1i"},"text":{"0":"如果你希望进一步打磨这篇新媒体稿件，工作任务模式可以完成备选标题、配图构思、图文排版与合规校验，要不要使用？"}}},"align":"","folded":false}}},"payloadMap":{"RHU8fbpyCdEPRUc9opwoHQ03Cgo":{"level":1},"KsFLfS1ghduyKQcU005bhsADjNQ":{"level":1},"BVZ3fesyzdHKY0c14ddpehuwxzB":{"level":1},"DUX1f7luAdDRVXc4afupvILNBRZ":{"level":1},"RP2afbiivdyDNZcdlAMiPV24t5b":{"level":1},"OR6kfpvHHdIJOUc07engzDNXuad":{"level":1},"GCHNf1abpdCHQ0cfiwwdJYcppET":{"level":1},"ZV29fmBCMdXcllcnszMcW02crow":{"level":1},"ONZcfeptydzGKXc3cjopBEJWzZc":{"level":1},"BzO3f5abldyzMRcV2bddjvEPjQZ":{"level":1},"NmrrfESTTdVapxcJMW1h9iknizM":{"level":1},"JuHQfX167dbioucvKY3mghpqoAM":{"level":1},"CCPWf33codyAPRcZ79igppAAmGU":{"level":1},"JQXYf8ertdIRYdcpBDIpKT4ataa":{"level":1},"GzCOf1bgjdnqEHcHPPVkY9jqoqq":{"level":1},"OJUXf2358dmwzIcQ2fsoHKR2y68":{"level":1},"XDOWf6ittdAMUZc7lqxmKMSSr6c":{"level":1},"XLSTf3dpAdKT8kcuBEIlW07gwpp":{"level":1},"QstGfGQ1ddkvwLcMO12hgjkkimz":{"level":1},"AwDPfQT4ddmmwBcQ19cddkuvgwH":{"level":1},"EDPVf08fkdltBEcLX4hiwDJNwQ1":{"level":1},"DvvHfNR14dcpzOc05epgzCQXn5a":{"level":1},"OJVWf7knvdIW3fcfioyhzMYbphh":{"level":1},"QvAAfGNY4d4iqycHJLUc557eins":{"level":1},"EIX7f9mwCdRSSTc33gnfxxKNsYY":{"level":1},"BTY5femsBdQR0ccjnwEmNRR6zii":{"level":1},"LDQ0f7lmBdGMNNcYY2amjxyJrTZ":{"level":1},"AFHSf778ldyJQ2c8nnplDFQSuXY":{"level":1},"UEP3f5gludxADOcQ2encxBHTnY0":{"level":1},"BwESfX0ehdmqwJcKRVVgY0acifk":{"level":1},"KIISf2hsHdQVaicovFMgWZ29pbe":{"level":1},"SLZafacpxdEHMUc0fhrktBEEyOT":{"level":1}},"extra":{"channel":"saas","pasteRandomId":"023d8ea3-a4a2-40e9-a268-e0abf29d0dcd","mention_page_title":{},"external_mention_url":{},"isEqualBlockSelection":true},"isKeepQuoteContainer":false,"selection":[{"id":1,"type":"block","recordId":"PiG0dF0IToBhWHxGt0zcixDXn6s"},{"id":2,"type":"block","recordId":"DABEfS3hmdAJU8cflwGaMXbipjx"},{"id":4,"type":"block","recordId":"TszFfGV7bdgrxLc00dqevDGGmHM"},{"id":5,"type":"block","recordId":"KsFLfS1ghduyKQcU005bhsADjNQ"},{"id":6,"type":"block","recordId":"BVZ3fesyzdHKY0c14ddpehuwxzB"},{"id":7,"type":"block","recordId":"FksxfzBCFdIRX7clxCCaR115e5g"},{"id":8,"type":"block","recordId":"DUX1f7luAdDRVXc4afupvILNBRZ"},{"id":9,"type":"block","recordId":"KSWYf048kdtDQ1cfhjomyENZy8l"},{"id":26,"type":"block","recordId":"EDPVf08fkdltBEcLX4hiwDJNwQ1"},{"id":27,"type":"block","recordId":"LHRZf5dmBdLMTZc2finpyBCHyHW"},{"id":28,"type":"block","recordId":"DvvHfNR14dcpzOc05epgzCQXn5a"},{"id":29,"type":"block","recordId":"OJVWf7knvdIW3fcfioyhzMYbphh"},{"id":30,"type":"block","recordId":"QvAAfGNY4d4iqycHJLUc557eins"},{"id":31,"type":"block","recordId":"EVX9fbhuDdR6cpcDPVVp47ilBpr"},{"id":32,"type":"block","recordId":"EIX7f9mwCdRSSTc33gnfxxKNsYY"},{"id":33,"type":"block","recordId":"BTY5femsBdQR0ccjnwEmNRR6zii"},{"id":34,"type":"block","recordId":"OIQVfWahvdyFLPc39oxgBES5rix"},{"id":35,"type":"block","recordId":"LDQ0f7lmBdGMNNcYY2amjxyJrTZ"},{"id":36,"type":"block","recordId":"AFHSf778ldyJQ2c8nnplDFQSuXY"},{"id":37,"type":"block","recordId":"UEP3f5gludxADOcQ2encxBHTnY0"},{"id":38,"type":"block","recordId":"AN1cfmxEIdMOYcccltDhFQU2pgv"},{"id":39,"type":"block","recordId":"BwESfX0ehdmqwJcKRVVgY0acifk"},{"id":40,"type":"block","recordId":"KIISf2hsHdQVaicovFMgWZ29pbe"},{"id":41,"type":"block","recordId":"SLZafacpxdEHMUc0fhrktBEEyOT"}],"pasteFlag":"b489d837-53b3-45e8-a907-e1479b97cb0f","copyAllInfo":{"sourceFileId":"PiG0dF0IToBhWHxGt0zcixDXn6s","sourceFileType":"docx","isFromDoubao":true,"wordNum":2006,"contentType":"text,heading2,table"}}" data-lark-record-format="docx/record" class="lark-record-clipboard">