CN105125486A - Preparation method for ropivacaine mesylate injection solution - Google Patents
Preparation method for ropivacaine mesylate injection solution Download PDFInfo
- Publication number
- CN105125486A CN105125486A CN201510666012.2A CN201510666012A CN105125486A CN 105125486 A CN105125486 A CN 105125486A CN 201510666012 A CN201510666012 A CN 201510666012A CN 105125486 A CN105125486 A CN 105125486A
- Authority
- CN
- China
- Prior art keywords
- injection
- ropivacaine mesylate
- ropivacaine
- preparation
- mesylate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a preparation method for a ropivacaine mesylate injection solution. The ropivacaine mesylate injection solution is prepared from, by every 1000 pieces, 89.4 g of ropivacaine mesylate, 74.4 g of sodium chloride and 10000 ml of water for injection. According to the ropivacaine mesylate injection solution according to the formula dosage, an ultrafiltration system is used for removing a hot source, no impurities are introduced, and it is ensured that the content of the ropivacaine mesylate in the ropivacaine mesylate injection solution is accurate.
Description
Technical field
The present invention relates to a kind of medical art, especially a kind of preparation method of ropivacaine mesylate injection.
Background technology
Ropivacaine mesylate injection is a kind of small-volume injection that Nanjing Hailing Pharmaceutical Co., Ltd. of Yangtze River Pharmaceutical Group now produces, ropivacaine is local anesthetics of amide derivatives, by raising the threshold value of nerve action potential, delay the expansion cloth of neural impulse, reduce the speed that action potential raises, play the generation of block nerves impulsion and the effect of conduction.The generation of anesthetic action is formed relevant with conduction velocity with the diameter of axle of nerve fiber, myelin.Therefore, ropivacaine mesylate injection is used for: surgical operation anesthesia (1, epidural anesthesia, comprise caesarean operation; 2, field block) and acute pain control (1, Continual epidural infusion or intermittent single medication, as postoperative or labor pains; 2, field block).
Summary of the invention
Object of the present invention provides a kind of and removes the problem that thermal source does not introduce impurity.
The technical scheme realizing the object of the invention is: a kind of preparation method of ropivacaine mesylate injection, and with every 1000 gauge, described ropivacaine mesylate injection is prepared from by following component:
S-ropivacaine mesylate 89.4g,
Sodium chloride 74.4g,
Water for injection adds to 10000ml,
Ropivacaine mesylate injection is prepared: comprise the steps: with described recipe quantity
(1) s-ropivacaine mesylate of recipe quantity, sodium chloride is taken;
(2) measure s-ropivacaine mesylate, the sodium chloride in the pre-molten step (1) of appropriate water for injection, stir;
(3) mixture that step (2) obtains is added in the water for injection of full dose 80% volume, adds water for injection to full dose, be stirred to whole dissolving, and cool,
(4) medicinal liquid step (3) obtained carries out ultrafiltration except thermal source by the ultrafilter membrane in ultrafiltration system, extrudes the dead space capacity in ultrafiltration system, after ultrafiltration terminates, medicinal liquid is circulated with compressed air;
(5) by intermediate products standard detection, pH value is 4.5 ~ 5.8, should be 8.49mg/ml ~ 9.39mg/ml containing s-ropivacaine mesylate;
(6) sterilizing cabinet sterilizing is sent into, sterilising conditions after intermediate products embedding step (5) obtained: 115 DEG C, 30min, F0 >=8.0, obtain ropivacaine mesylate injection.
Preferably, chilling temperature described in step (1) is 25 DEG C ~ 50 DEG C.
Preferably, described in step (4), circulation time is 10 minutes.
Adopt the preparation method of above-mentioned ropivacaine mesylate injection, the present invention has the following advantages:
(1) use ultrafiltration system except thermal source, do not introduce impurity, ensure that in this product, s-ropivacaine mesylate content is accurate.
(2) temperature 115 DEG C, time 30min, sterilizing is carried out in F0 >=8.0, and this sterilization process has good repeatability and reliability, and in production process, aseptic controlling is stricter.
Detailed description of the invention
Set forth the present invention further below by way of specific embodiment, but be not limited to following embodiment.
1, prescription
2, preparation method
(1) s-ropivacaine mesylate of recipe quantity, sodium chloride is taken;
(2) measure s-ropivacaine mesylate, the sodium chloride in the pre-molten step (1) of appropriate water for injection, stir;
(3) mixture that step (2) obtains is added in the water for injection of full dose 80% volume, adds water for injection to full dose, be stirred to whole dissolving, and be cooled to 25 DEG C ~ 50 DEG C,
(4) medicinal liquid step (3) obtained carries out ultrafiltration except thermal source by the ultrafilter membrane in ultrafiltration system, extrudes the dead space capacity in ultrafiltration system, after ultrafiltration terminates, medicinal liquid is circulated 10 minutes with compressed air;
(5) by intermediate products standard detection, pH value is 4.5 ~ 5.8, should be 8.49mg/ml ~ 9.39mg/ml containing s-ropivacaine mesylate;
(6) sterilizing cabinet sterilizing is sent into, sterilising conditions after intermediate products embedding step (5) obtained: 115 DEG C, 30min, F0 >=8.0, obtain ropivacaine mesylate injection.
In the present invention, the preparation method of ropivacaine mesylate injection has the following advantages:
(1) use ultrafiltration system except thermal source, do not introduce impurity, ensure that in this product, s-ropivacaine mesylate content is accurate.
(2) temperature 115 DEG C, time 30min, sterilizing is carried out in F0 >=8.0, and this sterilization process has good repeatability and reliability, and in production process, aseptic controlling is stricter.
To one skilled in the art, according to technical scheme described above and design, other various corresponding change and deformation can be made, and all these change and deformation all should belong within the protection domain of the claims in the present invention.
Claims (3)
1. a preparation method for ropivacaine mesylate injection, with every 1000 gauge, described ropivacaine mesylate injection is prepared from by following component:
S-ropivacaine mesylate 89.4g,
Sodium chloride 74.4g,
Water for injection adds to 10000ml,
Prepare ropivacaine mesylate injection with described recipe quantity, it is characterized in that: comprise the steps:
(1) s-ropivacaine mesylate of recipe quantity, sodium chloride is taken;
(2) measure s-ropivacaine mesylate, the sodium chloride in the pre-molten step (1) of appropriate water for injection, stir;
(3) mixture that step (2) obtains is added in the water for injection of full dose 80% volume, adds water for injection to full dose, be stirred to whole dissolving, and cool,
(4) medicinal liquid step (3) obtained carries out ultrafiltration except thermal source by the ultrafilter membrane in ultrafiltration system, extrudes the dead space capacity in ultrafiltration system, after ultrafiltration terminates, medicinal liquid is circulated with compressed air;
(5) by intermediate products standard detection, pH value is 4.5 ~ 5.8, should be 8.49mg/ml ~ 9.39mg/ml containing s-ropivacaine mesylate;
(6) sterilizing cabinet sterilizing is sent into, sterilising conditions after intermediate products embedding step (5) obtained: 115 DEG C, 30min, F0 >=8.0, obtain ropivacaine mesylate injection.
2. the preparation method of ropivacaine mesylate injection according to claim 1, is characterized in that: chilling temperature described in step (3) is 25 DEG C ~ 50 DEG C.
3. the preparation method of ropivacaine mesylate injection according to claim 1, is characterized in that: described in step (4), circulation time is 10 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510666012.2A CN105125486A (en) | 2015-10-15 | 2015-10-15 | Preparation method for ropivacaine mesylate injection solution |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510666012.2A CN105125486A (en) | 2015-10-15 | 2015-10-15 | Preparation method for ropivacaine mesylate injection solution |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105125486A true CN105125486A (en) | 2015-12-09 |
Family
ID=54711318
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510666012.2A Pending CN105125486A (en) | 2015-10-15 | 2015-10-15 | Preparation method for ropivacaine mesylate injection solution |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105125486A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106177970A (en) * | 2016-07-12 | 2016-12-07 | 扬子江药业集团有限公司 | Ropivacaine injection preparation and its preparation method and application |
| CN109568259A (en) * | 2018-12-31 | 2019-04-05 | 辰欣药业股份有限公司 | A kind of liquid drugs injection and preparation method thereof containing s-ropivacaine mesylate |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101658490A (en) * | 2008-08-25 | 2010-03-03 | 西安博森生物制药有限责任公司 | Preparation method of ropivacaine mesylate injection packed by soda-lime glass bottle |
| CN102038651A (en) * | 2010-12-25 | 2011-05-04 | 山东新时代药业有限公司 | Ropivacaine mesylate freeze-dried powder injection |
| CN103304471A (en) * | 2013-07-12 | 2013-09-18 | 四川省惠达药业有限公司 | Ropivacaine mesylate compound, preparation process thereof and pharmaceutical composition thereof |
-
2015
- 2015-10-15 CN CN201510666012.2A patent/CN105125486A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101658490A (en) * | 2008-08-25 | 2010-03-03 | 西安博森生物制药有限责任公司 | Preparation method of ropivacaine mesylate injection packed by soda-lime glass bottle |
| CN102038651A (en) * | 2010-12-25 | 2011-05-04 | 山东新时代药业有限公司 | Ropivacaine mesylate freeze-dried powder injection |
| CN103304471A (en) * | 2013-07-12 | 2013-09-18 | 四川省惠达药业有限公司 | Ropivacaine mesylate compound, preparation process thereof and pharmaceutical composition thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106177970A (en) * | 2016-07-12 | 2016-12-07 | 扬子江药业集团有限公司 | Ropivacaine injection preparation and its preparation method and application |
| CN106177970B (en) * | 2016-07-12 | 2019-09-17 | 扬子江药业集团有限公司 | Ropivacaine injection preparation and its preparation method and application |
| CN109568259A (en) * | 2018-12-31 | 2019-04-05 | 辰欣药业股份有限公司 | A kind of liquid drugs injection and preparation method thereof containing s-ropivacaine mesylate |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103768091B (en) | Sodium bicarbonate injection and its preparation method | |
| CN103550143A (en) | Preparation method of levetiracetam injection | |
| CN103126978A (en) | Preparing method for ambroxol hydrochloride injection | |
| CN103284945A (en) | Preparation method of pre-filled dexmedetomidine hydrochloride injection | |
| CN105125486A (en) | Preparation method for ropivacaine mesylate injection solution | |
| CN103239684A (en) | Zedoary oil injection and preparation method thereof | |
| CN104127410A (en) | Ornidazole injection liquid | |
| CN102038651B (en) | Ropivacaine mesylate freeze-dried powder injection | |
| CN103989630A (en) | Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof | |
| CN102670489A (en) | Ropivacaine hydrochloride sodium chloride injection and preparation method thereof | |
| CN104188902B (en) | A kind of production technology of high stability Dalteparin Sodium Injection | |
| CN102697708A (en) | Ropivacaine hydrochloride injection and preparation process thereof | |
| CN104721132A (en) | Zoledronic acid injection and preparation method thereof | |
| CN114126583A (en) | Ornidazole injection and S-ornidazole injection | |
| CN110898208A (en) | Preparation method of carbetocin injection | |
| CN103951679B (en) | A kind of cefoperazone sodium compound and pharmaceutical composition thereof | |
| CN102144963A (en) | Citicoline sodium glucose injecta and preparation process thereof | |
| CN102144966B (en) | Preparation method of clindamycin phosphate injection | |
| CN101336903A (en) | Preparation method of (s)-ornidazole disodium phosphate intravenous preparation for injection | |
| CN103239392B (en) | Ornidazole injection preparation and preparation method thereof | |
| CN105982852A (en) | Dopamine hydrochloride injection and preparation method thereof | |
| CN104478899A (en) | Preparation methods for azlocillin sodium and azlocillin sodium freeze-dried powder for injection | |
| CN111249227A (en) | Preparation method of fondaparinux sodium injection | |
| CN103751104A (en) | Edaravone injection and preparation method thereof | |
| CN110693822A (en) | Ibuprofen injection and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20151209 |
|
| RJ01 | Rejection of invention patent application after publication |