CN1830451B - 灯盏花素葡萄糖注射液的制备方法 - Google Patents
灯盏花素葡萄糖注射液的制备方法 Download PDFInfo
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Description
药品名称 | 按照实施例1制备的注射剂 | 常规工艺灯盏花素注射液 |
用法用量 | 肌内注射,一次5mg(实施例1,2ml),一日2次。静脉滴注,一次10~20mg(实施例1,4-8ml),一日1次。 | 肌内注射,一次5mg(灯盏花素),一日2次。静脉滴注,一次10~20mg(灯盏花素),用500ml10%氯化钠注射液稀释后使用,一日1次。 |
临床使用 | 治疗82例冠心病患者 | 治疗90例冠心病患者 |
不良反应观察 | 无全身发痒、胸闷、乏力、皮疹、心悸等现象。 | 有3例心悸现象,1例发痒现象 |
药品名称 | 按照实施例1制备的注射剂 | 常规工艺灯盏花素注射液 |
刺激性观察 | 3例有轻微疼痛现象 | 16例有疼痛现象,3例注射部位有压迫感 |
实施例1 | 常规工艺灯盏花素注射液 | |
标准规定 | 灯盏花素含量95.0%~105.0%澄明度:符合规定有关物质:小于10%pH值:6.3~6.8 | 灯盏花素含量95.0%~105.0%澄明度:符合规定有关物质:小于10%pH值:6.3~6.8 |
0个月 | 灯盏花素含量:100.4%澄明度:符合规定有关物质:8.0%pH值:7.3 | 灯盏花素含量98.2%有关物质:8.1%澄明度:符合规定pH值:6.8 |
1个月 | 灯盏花素含量:98.6%澄明度:符合规定 | 灯盏花素含量97.5%有关物质:8.5% |
有关物质:8.1%pH值:7.3 | 澄明度:符合规定pH值:6.7 | |
2个月 | 灯盏花素含量:98.7%澄明度:符合规定有关物质:8.1%pH值:7.3 | 灯盏花素含量95.3%有关物质:8.7%澄明度:符合规定pH值:6.6 |
3个月 | 灯盏花素含量:97.9%澄明度:符合规定有关物质:8.1%pH值:7.3 | 灯盏花素含量95.0%有关物质:8.9%澄明度:符合规定pH值:6.5 |
6个月 | 灯盏花素含量:98.1%澄明度:符合规定有关物质:8.2%pH值:7.3 | 灯盏花素含量95.0%有关物质:9.0%澄明度:不符合规定pH值:6.3 |
Claims (9)
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CN2005101048776A CN1830451B (zh) | 2005-03-08 | 2005-09-27 | 灯盏花素葡萄糖注射液的制备方法 |
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CN200510051489.6 | 2005-03-08 | ||
CN200510051489 | 2005-03-08 | ||
CN2005101048776A CN1830451B (zh) | 2005-03-08 | 2005-09-27 | 灯盏花素葡萄糖注射液的制备方法 |
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CN1830451A CN1830451A (zh) | 2006-09-13 |
CN1830451B true CN1830451B (zh) | 2010-09-08 |
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Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN108210451B (zh) * | 2018-02-27 | 2020-06-02 | 云南玉药生物制药有限公司 | 一种稳定的灯盏花素注射液及其制备工艺 |
CN108078920B (zh) * | 2018-02-27 | 2020-04-07 | 云南玉药生物制药有限公司 | 一种稳定的灯盏花素注射液制备工艺 |
CN112067708B (zh) * | 2020-06-23 | 2021-06-01 | 云南生物谷药业股份有限公司 | 一种灯盏细辛注射液的一测多评定量检测方法 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1191730A (zh) * | 1997-02-24 | 1998-09-02 | 李春华 | 灯盏花大输液系列制剂 |
CN1425385A (zh) * | 2002-12-19 | 2003-06-25 | 上海博泰医药科技有限公司 | 灯盏花素输液制剂及其制备方法 |
CN1555807A (zh) * | 2004-01-08 | 2004-12-22 | 中国药科大学 | 一种稳定性提高的灯盏花素注射剂及其制备方法 |
CN1565465A (zh) * | 2003-06-26 | 2005-01-19 | 天津药物研究院 | 一种含灯盏乙素活性成分的经注射给药的制剂及其制备方法 |
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- 2005-09-27 CN CN2005101048776A patent/CN1830451B/zh active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1191730A (zh) * | 1997-02-24 | 1998-09-02 | 李春华 | 灯盏花大输液系列制剂 |
CN1425385A (zh) * | 2002-12-19 | 2003-06-25 | 上海博泰医药科技有限公司 | 灯盏花素输液制剂及其制备方法 |
CN1565465A (zh) * | 2003-06-26 | 2005-01-19 | 天津药物研究院 | 一种含灯盏乙素活性成分的经注射给药的制剂及其制备方法 |
CN1555807A (zh) * | 2004-01-08 | 2004-12-22 | 中国药科大学 | 一种稳定性提高的灯盏花素注射剂及其制备方法 |
Non-Patent Citations (2)
Title |
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李俊懿等.提高灯盏花素注射液澄明度的工艺研究.广东药学14 1.2004,14(1),30-31. * |
李勇军等.从灯盏花提取野黄芩苷的工艺研究.中成药26 10.2004,26(10),855-856. * |
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