CN100477998C - 一种速溶型注射用吡柔比星冻干粉针及其制备方法 - Google Patents
一种速溶型注射用吡柔比星冻干粉针及其制备方法 Download PDFInfo
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处方 | 5 | 6 | 7 | 8 |
盐酸吡柔比星乳糖注射用水 | 10mg90mg尼泊金甲酯1mg2ml | 10mg90mg尼泊金乙酯1mg2ml | 10mg90mg对羟基苯甲酸1mg2ml | 10mg90mg对氨基苯甲酸1mg2ml |
冻干后外观 | 饱满较好 | 饱满较好 | 饱满较好 | 饱满较好 |
生理盐水复溶性 | 25秒分散,溶液不澄清 | 55秒分散,溶液不澄清 | 45秒分散,溶液不澄清 | 60秒分散,溶液不澄清 |
处方 | 1 | 2 | 3 |
吡柔比星甘露醇注射用水 | 10mg30mg2ml丙酮50ul | 10mg60mg2ml乙醇50ul | 10mg90mg2ml叔丁醇50ul |
冻干后外观 | 外观良好,表面不光滑,颜色较浅 | 外观良好,表面光滑 | 外观良好,表面粗糙,颜色较浅 |
生理盐水复溶性 | 30秒溶解,溶液 | 60秒溶解,溶液 | 45秒溶解,溶液 |
不澄清,溶液中有胶状物存在在。 | 不澄清,溶液中有胶状物存在在。 | 不澄清,溶液中有胶状物存在在。 |
处方 | 5 | 6 | 7 | 8 |
盐酸吡柔比星乳糖注射用水 | 10mg90mg尼泊金甲酯0.05mg2ml | 10mg90mg尼泊金乙酯0.05mg2ml | 10mg90mg对羟基苯甲酸0.05mg2ml | 10mg90mg对氨基苯甲酸0.05mg2ml |
冻干后外观 | 饱满较好 | 饱满较好 | 饱满较好 | 饱满较好 |
生理盐水复溶性 | 25秒溶解,溶液澄清 | 30秒溶解,溶液澄清 | 35秒溶解,溶液澄清 | 40秒溶解,溶液澄清 |
处方 | 1 | 2 | 3 | 4 | 5 |
盐酸吡柔比星乳糖注射用水尼泊金甲酯 | 10mg90mg2ml0.01mg | 10mg90mg2ml0.02mg | 10mg90mg2ml0.05mg | 10mg90mg2ml0.1mg | 10mg90mg2ml0.2mg |
冻干后外观 | 饱满较好 | 饱满较好 | 饱满较好 | 饱满较好 | 饱满较好 |
生理盐水复溶性 | 27秒溶解,溶液澄清 | 26秒溶解,溶液澄清 | 25秒溶解,溶液澄清 | 27秒溶解,溶液澄清 | 30秒溶解,溶液不澄清 |
处方1 | 处方2 | |
盐酸吡柔比星赋形剂 | 10mg乳糖90mg | 10mg甘露醇90mg |
注射用水尼泊金甲酯 | 2ml0.02mg采用上述制备工艺 | 2ml0.02mg采用上述制备工艺 |
0天含量有关物质 | 99.8%0.2% | 99.7%0.3% |
60℃5天含量有关物质 | 99.2%0.8% | 80.5%19.5% |
60℃10天含量有关物质 | 98.1%1.9% | 58.0%42.0% |
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CNB2006101570239A CN100477998C (zh) | 2006-11-24 | 2006-11-24 | 一种速溶型注射用吡柔比星冻干粉针及其制备方法 |
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CNB2006101570239A CN100477998C (zh) | 2006-11-24 | 2006-11-24 | 一种速溶型注射用吡柔比星冻干粉针及其制备方法 |
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CN101028276A CN101028276A (zh) | 2007-09-05 |
CN100477998C true CN100477998C (zh) | 2009-04-15 |
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Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN111675738A (zh) * | 2020-07-10 | 2020-09-18 | 苏州赛分科技有限公司 | 一种吡柔比星的纯化方法 |
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Application publication date: 20070905 Assignee: Shenzhen south intellectual property operation center Co.,Ltd. Assignor: SHENZHEN MAIN LUCK PHARMACEUTICALS Inc. Contract record no.: X2020980008781 Denomination of invention: The invention relates to a quick dissolving pirarubicin injection freeze-dried powder injection and a preparation method thereof Granted publication date: 20090415 License type: Exclusive License Record date: 20201203 |
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Denomination of invention: The invention relates to a quick dissolving pirarubicin injection freeze-dried powder injection and a preparation method thereof Effective date of registration: 20201207 Granted publication date: 20090415 Pledgee: Shenzhen south intellectual property operation center Co.,Ltd. Pledgor: SHENZHEN MAIN LUCK PHARMACEUTICALS Inc. Registration number: Y2020980008885 |
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Date of cancellation: 20220401 Granted publication date: 20090415 Pledgee: Shenzhen south intellectual property operation center Co.,Ltd. Pledgor: SHENZHEN MAIN LUCK PHARMACEUTICALS Inc. Registration number: Y2020980008885 |