CN1257709C - 二氯醋酸二异丙胺冻干制剂及其制备方法 - Google Patents
二氯醋酸二异丙胺冻干制剂及其制备方法 Download PDFInfo
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- CN1257709C CN1257709C CN 200410039099 CN200410039099A CN1257709C CN 1257709 C CN1257709 C CN 1257709C CN 200410039099 CN200410039099 CN 200410039099 CN 200410039099 A CN200410039099 A CN 200410039099A CN 1257709 C CN1257709 C CN 1257709C
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Abstract
Description
项目 | 条件 | 时间(天) | ||
0 | 5 | 10 | ||
外观 | 4000Lx92.5%RH60℃ | 白色冻干块状物 | 白色冻干块状物白色冻干块状物白色冻干块状物 | 白色冻干块状物白色冻干块状物白色冻干块状物 |
pH值 | 4000Lx92.5%RH60℃ | 5.72 | 5.745.735.76 | 5.755.735.78 |
干燥失重(%) | 4000Lx92.5%RH60℃ | 0.68 | 0.670.690.66 | 0.680.700.67 |
溶液澄清度与颜色 | 4000Lx92.5%RH60℃ | 澄清无色 | 澄清无色澄清无色澄清无色 | 澄清无色澄清无色澄清无色 |
二氯醋酸二异丙胺含量(%) | 4000Lx92.5%RH60℃ | 101.05 | 101.02101.03100.91 | 101.03101.04100.65 |
葡萄糖酸钠含量(%) | 4000Lx92.5%RH60℃ | 100.54 | 100.51100.53100.41 | 100.48100.58100.35 |
项目 | 制剂 | 时间(月) | ||||
0 | 1 | 2 | 3 | 6 | ||
外观 | BCG | 白色冻干块状物白色冻干块状物白色冻干块状物 | 白色冻干块状物白色冻干块状物白色冻干块状物 | 白色冻干块状物白色冻干块状物白色冻干块状物 | 白色冻干块状物白色冻干块状物白色冻干块状物 | 白色冻干块状物白色冻干块状物白色冻干块状物 |
pH值 | BCG | 5.725.745.75 | 5.735.745.76 | 5.755.765.77 | 5.765.765.78 | 5.775.785.79 |
溶液澄清度与颜色 | BCG | 澄清无色澄清无色澄清无色 | 澄清无色澄清无色澄清无色 | 澄清无色澄清无色澄清无色 | 澄清无色澄清无色澄清无色 | 澄清无色澄清无色澄清无色 |
干燥失重(%) | BCG | 0.680.690.70 | 0.690.710.69 | 0.700.710.72 | 0.710.700.71 | 0.720.710.72 |
二氯醋酸二异丙胺含量(%) | BCG | 101.05101.15101.24 | 101.06101.14101.23 | 101.04101.13101.22 | 101.05101.14101.23 | 101.03101.12101.21 |
葡萄糖酸钠含量(%) | BCG | 100.54100.61100.57 | 100.56100.62100.58 | 100.53100.62100.56 | 100.54100.58100.59 | 100.55100.61100.61 |
项目 | 制剂 | 时间 | ||
0月 | 3月 | 6月 | ||
外观 | BCG | 白色冻干块状物白色冻干块状物白色冻干块状物 | 白色冻干块状物白色冻干块状物白色冻干块状物 | 白色冻干块状物白色冻干块状物白色冻干块状物 |
pH值 | BCG | 5.725.745.75 | 5.735.745.76 | 5.715.735.76 |
溶液澄清度与颜色 | BCG | 澄清无色澄清无色澄清无色 | 澄清无色澄清无色澄清无色 | 澄清无色澄清无色澄清无色 |
干燥失重(%) | BCG | 0.680.690.70 | 0.670.680.68 | 0.660.670.69 |
二氯醋酸二异丙胺含量(%) | BCG | 101.05101.15101.24 | 101.04101.14101.25 | 101.06101.13101.23 |
葡萄糖酸钠含量(%) | BCG | 100.54100.61100.57 | 100.53100.58100.56 | 100.52100.59100.56 |
Claims (4)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 200410039099 CN1257709C (zh) | 2004-02-04 | 2004-02-04 | 二氯醋酸二异丙胺冻干制剂及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 200410039099 CN1257709C (zh) | 2004-02-04 | 2004-02-04 | 二氯醋酸二异丙胺冻干制剂及其制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1557289A CN1557289A (zh) | 2004-12-29 |
CN1257709C true CN1257709C (zh) | 2006-05-31 |
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Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN 200410039099 Expired - Lifetime CN1257709C (zh) | 2004-02-04 | 2004-02-04 | 二氯醋酸二异丙胺冻干制剂及其制备方法 |
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CN (1) | CN1257709C (zh) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN105311010A (zh) * | 2014-06-30 | 2016-02-10 | 南京瑞尔医药有限公司 | 一种复方二氯醋酸二异丙胺冻干粉针剂及其制备方法 |
CN104825431A (zh) * | 2015-03-31 | 2015-08-12 | 山东北大高科华泰制药有限公司 | 注射用复方二氯醋酸二异丙胺冷冻干燥粉针剂药物组合物 |
CN107213120A (zh) * | 2017-06-09 | 2017-09-29 | 安徽赛诺制药有限公司 | 一种二氯醋酸二异丙胺冻干粉针制剂及其制备方法 |
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2004
- 2004-02-04 CN CN 200410039099 patent/CN1257709C/zh not_active Expired - Lifetime
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