CN1106845C - 海藻酸钠固态微球血管栓塞剂的生产工艺 - Google Patents
海藻酸钠固态微球血管栓塞剂的生产工艺 Download PDFInfo
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- CN1106845C CN1106845C CN 00123459 CN00123459A CN1106845C CN 1106845 C CN1106845 C CN 1106845C CN 00123459 CN00123459 CN 00123459 CN 00123459 A CN00123459 A CN 00123459A CN 1106845 C CN1106845 C CN 1106845C
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- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 title claims abstract description 15
- 239000000661 sodium alginate Substances 0.000 title claims abstract description 15
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- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims abstract description 7
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Abstract
本发明涉及海藻酸钠固态微球血管栓塞剂的生产工艺，现有技术中没有快速、高效制备海藻酸钠固态微球血管栓塞剂的方法，本发明技术方案是把海藻酸钠制成水溶液，然后加固化剂氯化钙加以交联固化，其优点操作不复杂，产量大，效率高，产品KMG用于人体靶向动脉的栓塞治疗，包括对各种实质性肿瘤，脾功能亢进和甲状腺功能亢进，血管畸形、血管瘤等疾病的栓塞治疗。
Description
本发明涉及药物配制品的生产方法，具体地说是涉及海藻酸钠固态微球血管栓塞剂(简称KMG)的生产工艺。
海带的主要成分之一为海藻酸钠，人们对海藻酸钠研究较多，其中日本专利639542提到：用水溶性的海藻酸分子在制剂中被连结成不溶性的钠盐，固化剂为多价的金属离子，如钙、铁离子等，但未说明海藻酸钠固态微球血管栓塞剂的生产工艺。
本发明的目的提供一种快速、高效制备海藻酸钠固态微球血管栓塞剂的生产工艺。
本发明的技术方案是：把海藻酸钠制成4～8重量％纯水溶液，加热70～90℃，加入交联剂0.5～2重量％氯化钙、冷却到室温，静置12～24小时，以1～3倍大气压强通过20～26G型号注射针头向下方喷淋，注入盛有6～10重量％氯化钙水溶液的容器中，过筛。
本发明KMG生产工艺的优点是操作不复杂、产量大、效率高，当0.1～0.4mm粒径的KMG产品注入血管后，立即溶胀的比率均适于人体小动脉内环境，KMG可起到靶血管永久性栓塞的栓塞疗效，其本身不参与体内化谢，3个月后可以分子脱链的形式降解消失，降解过程中不产生有毒物质，不产生碎屑，且一般固态血管栓塞剂，如明胶海绵、硅橡胶、聚乳酸、乙基纤维素、聚乙烯醇等，在注入血管时和注射后，有可能随倒流的血液冲击或受血管张力的影响而脱离靶组织或靶器官，造成副损伤，而本发明KMG独具有与人体小动脉栓塞部位相适应的溶胀特性，该特性使其注入靶器官后即定位溶胀，不再变更栓塞位置，而且KMG产品有加入各种化疗、放疗靶向药物和示踪剂的开发前景。加入铁粉、可使其具有向磁性，注入血管时在靶器官方位加磁，可使靶向栓塞更准确。
本发明申请专利的同时，又申请了发明专利：发明名称为：海藻酸钠固态微球血管栓塞剂的溶胀压强的检测方法。
下面就一个实施例，对本发明加以进一步说明
实施例：
在带有回流装置的容器中，加入纯水93.5克，海藻酸钠6.5克，制成6.5％的水溶液，边搅拌，边加热至78℃，使溶液成均一的粘稠液体，加入1％氯化钙溶液搅均，冷却至室温，静置18小时，将此溶液加入喷淋器，以2倍大气压强通过22G型号的注射针头向下方喷淋，注入盛有10％氯化钙水溶液的容器中，即可交联固化为微球、过筛、用0.1和0.4mm的网筛，得到0.1～0.4mm粒径的KMG。
所有生产过程均在100级超净环境中进行，KMG分装后，可置高压、高温、灭菌后封装成品。
Claims (1)
1、海藻酸钠固态微球血管栓塞剂的生产工艺，其特征在于：把海藻酸钠制成4～8重量％纯水溶液，加热70～90℃，加入交联剂0.5～2重量％氯化钙、冷却到室温，静置12～24小时，以1～3倍大气压强通过20～26G型号注射针头向下方喷淋，注入盛有6～10重量％氯化钙水溶液的空器中，过筛。
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| CN 00123459 CN1106845C (zh) | 2000-08-17 | 2000-08-17 | 海藻酸钠固态微球血管栓塞剂的生产工艺 |
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| CN 00123459 CN1106845C (zh) | 2000-08-17 | 2000-08-17 | 海藻酸钠固态微球血管栓塞剂的生产工艺 |
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| CN1283463A CN1283463A (zh) | 2001-02-14 |
| CN1106845C true CN1106845C (zh) | 2003-04-30 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1319525C (zh) * | 2004-09-16 | 2007-06-06 | 北京圣医耀科技发展有限责任公司 | 紫杉醇－海藻酸钠微球血管栓塞剂及其制备 |
| CN101077424B (zh) * | 2006-05-25 | 2011-04-06 | 范恒华 | 一种血管粘接吻合密封胶及试剂盒 |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1313156C (zh) * | 2004-02-06 | 2007-05-02 | 北京圣医耀科技发展有限责任公司 | 含妇科药物的海藻酸钠微球血管栓塞剂及其制备方法 |
| EP1870089A4 (en) * | 2005-04-15 | 2012-10-03 | Beijing Shengyiyao Science & Technology Dev Co Ltd | GYNECOLOGIC DRUG-MOISTURIZED MICROBALL VASCULAR SUPPOSITORIUM FROM SODIUM ALGINATE AND ITS MANUFACTURING PROCESS |
| CN1876177B (zh) * | 2005-06-06 | 2011-06-01 | 北京圣医耀科技发展有限责任公司 | 含有脂质体细胞因子的生物降解材料的微球血管栓塞剂及其制备和应用 |
| CN108992431B (zh) * | 2018-09-30 | 2020-10-09 | 重庆医科大学附属永川医院 | 一种多柔比星栓塞微球及其制备方法 |
| CN115245143B (zh) * | 2022-07-06 | 2024-06-28 | 上海市中西医结合医院 | 一种动脉闭塞性疾病动物模型的构建方法 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1319525C (zh) * | 2004-09-16 | 2007-06-06 | 北京圣医耀科技发展有限责任公司 | 紫杉醇－海藻酸钠微球血管栓塞剂及其制备 |
| CN101077424B (zh) * | 2006-05-25 | 2011-04-06 | 范恒华 | 一种血管粘接吻合密封胶及试剂盒 |
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| CN1283463A (zh) | 2001-02-14 |
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