CN104666303B - 一种注射用更昔洛韦的冷冻干燥工艺 - Google Patents
一种注射用更昔洛韦的冷冻干燥工艺 Download PDFInfo
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- CN104666303B CN104666303B CN201510050357.5A CN201510050357A CN104666303B CN 104666303 B CN104666303 B CN 104666303B CN 201510050357 A CN201510050357 A CN 201510050357A CN 104666303 B CN104666303 B CN 104666303B
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- ganciclovir
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- IRSCQMHQWWYFCW-UHFFFAOYSA-N ganciclovir Chemical compound O=C1NC(N)=NC2=C1N=CN2COC(CO)CO IRSCQMHQWWYFCW-UHFFFAOYSA-N 0.000 title claims abstract description 64
- 229960002963 ganciclovir Drugs 0.000 title claims abstract description 64
- 238000004108 freeze drying Methods 0.000 title claims abstract description 40
- 238000000034 method Methods 0.000 title claims abstract description 29
- 238000002347 injection Methods 0.000 title claims abstract description 27
- 239000007924 injection Substances 0.000 title claims abstract description 27
- 230000008569 process Effects 0.000 title claims abstract description 20
- 238000001035 drying Methods 0.000 claims abstract description 92
- 229940077374 ganciclovir injection Drugs 0.000 claims abstract description 39
- 239000000843 powder Substances 0.000 claims abstract description 27
- 229940090044 injection Drugs 0.000 claims abstract description 21
- 238000000859 sublimation Methods 0.000 claims description 64
- 230000008022 sublimation Effects 0.000 claims description 64
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- 239000008215 water for injection Substances 0.000 claims description 19
- 238000007710 freezing Methods 0.000 abstract description 18
- 230000008014 freezing Effects 0.000 abstract description 18
- 239000007788 liquid Substances 0.000 abstract description 13
- 239000003814 drug Substances 0.000 abstract description 7
- 238000003795 desorption Methods 0.000 abstract 2
- 239000000047 product Substances 0.000 description 42
- 238000010438 heat treatment Methods 0.000 description 12
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 10
- 206010003694 Atrophy Diseases 0.000 description 8
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- 230000000052 comparative effect Effects 0.000 description 7
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 6
- 230000001954 sterilising effect Effects 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 5
- 238000004140 cleaning Methods 0.000 description 5
- 150000001875 compounds Chemical class 0.000 description 5
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- 229910052757 nitrogen Inorganic materials 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 241000894006 Bacteria Species 0.000 description 4
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- 206010011831 Cytomegalovirus infection Diseases 0.000 description 3
- 239000006227 byproduct Substances 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 230000002085 persistent effect Effects 0.000 description 3
- 241000701022 Cytomegalovirus Species 0.000 description 2
- 241000700605 Viruses Species 0.000 description 2
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Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510050357.5A CN104666303B (zh) | 2015-01-30 | 2015-01-30 | 一种注射用更昔洛韦的冷冻干燥工艺 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510050357.5A CN104666303B (zh) | 2015-01-30 | 2015-01-30 | 一种注射用更昔洛韦的冷冻干燥工艺 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104666303A CN104666303A (zh) | 2015-06-03 |
| CN104666303B true CN104666303B (zh) | 2017-01-25 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510050357.5A Active CN104666303B (zh) | 2015-01-30 | 2015-01-30 | 一种注射用更昔洛韦的冷冻干燥工艺 |
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| Country | Link |
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| CN (1) | CN104666303B (es) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110585141A (zh) * | 2019-09-19 | 2019-12-20 | 湖北科益药业股份有限公司 | 一种稳定的更昔洛韦冻干粉针剂 |
| CN110613688A (zh) * | 2019-09-26 | 2019-12-27 | 无锡凯夫制药有限公司 | 一种制备更昔洛韦的冻干方法 |
| CN111973564A (zh) * | 2020-09-02 | 2020-11-24 | 海南倍特药业有限公司 | 一种注射用更昔洛韦组合物及其冷冻干燥工艺 |
| CN116763744B (zh) * | 2023-07-20 | 2024-03-08 | 石家庄四药有限公司 | 一种注射用氯诺昔康的冻干工艺 |
| CN117029391A (zh) * | 2023-08-09 | 2023-11-10 | 湖南科伦制药有限公司 | 一种培美曲塞二钠的冻干方法 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101711746A (zh) * | 2009-12-28 | 2010-05-26 | 蚌埠丰原涂山制药有限公司 | 一种注射用更昔洛韦冻干制剂及其制备方法 |
| CN103054819A (zh) * | 2013-01-31 | 2013-04-24 | 南京正宽医药科技有限公司 | 一种注射用更昔洛韦及其制备方法 |
| CN103340830A (zh) * | 2013-07-09 | 2013-10-09 | 上海华源药业（宁夏）沙赛制药有限公司 | 注射用更昔洛韦纳米囊冻干制剂及其制备方法 |
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2015
- 2015-01-30 CN CN201510050357.5A patent/CN104666303B/zh active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101711746A (zh) * | 2009-12-28 | 2010-05-26 | 蚌埠丰原涂山制药有限公司 | 一种注射用更昔洛韦冻干制剂及其制备方法 |
| CN103054819A (zh) * | 2013-01-31 | 2013-04-24 | 南京正宽医药科技有限公司 | 一种注射用更昔洛韦及其制备方法 |
| CN103340830A (zh) * | 2013-07-09 | 2013-10-09 | 上海华源药业（宁夏）沙赛制药有限公司 | 注射用更昔洛韦纳米囊冻干制剂及其制备方法 |
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| CN104666303A (zh) | 2015-06-03 |
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Address after: Yueyang economic and Technological Development Zone Industrial Park Road 414100 Hunan Kanwan chisi city in Yueyang Province Patentee after: Hunan Kelun Pharmaceutical Co., Ltd. Address before: Chengguan town of Yueyang County in Hunan province 414000 Yueyang Rong Road (county eco industrial park No. 3) Patentee before: Hunan Kelun Pharmaceutical Co., Ltd. |