CN105982848A - Ropivacaine hydrochloride injection and preparation method thereof - Google Patents
Ropivacaine hydrochloride injection and preparation method thereof Download PDFInfo
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- CN105982848A CN105982848A CN201510100403.8A CN201510100403A CN105982848A CN 105982848 A CN105982848 A CN 105982848A CN 201510100403 A CN201510100403 A CN 201510100403A CN 105982848 A CN105982848 A CN 105982848A
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- water
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- ropivacaine hcl
- parenteral solution
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Abstract
The invention provides a ropivacaine hydrochloride injection and a preparation method thereof. A formula of the ropivacaine hydrochloride injection contains 75 g of ropivacaine hydrochloride, 60 g of sodium chloride and the balance water for injection in 10000 ml injection. The quality of the ropivacaine hydrochloride injection meets the stipulations of 'Notification' issued by State Food and Drug Administration in 2008.
Description
Technical field
The present invention relates to the production method of a kind of Ropivacaine HCL parenteral solution.
Background technology
State Food and Drug Administration evaluates center and has issued state's food medicine prison [2008] No. 7 literary compositions of note in 2008---" with regard to
Issue the notice of chemicals injection and multicomponent Biochemical Drugs injection main technique requirements " (hereinafter referred to as " notifying "),
Its literary composition regulation: small-volume injection should take terminal sterilization technique, it is proposed that first-selected overkill method (F0>=12), as product can not
The condition of tolerance overkill, it is contemplated that use probability of surviving method (8≤F0＜ 12), but all should ensure that the SAL after product sterilizing
(sterilization assurance sterility assurance level) is not more than 10-6.Use other F0Value is less than the work of the terminal sterilization condition of 8
Skill, in principle not accreditation.Terminal sterilization technique can not be used if any sufficient according to proof, and must drug administration by injection for clinic
Kind, it is contemplated that use sterile production technique, but should ensure that SAL is not more than 10-3.Filtration sterilization technique be have employed simultaneously
The kind of flowing steam assisted sterilization, it is proposed that be revised as terminal sterilization technique, to the kind that really cannot use terminal sterilization technique,
Sterile production technique should be revised as.
The preparation process of current Ropivacaine HCL parenteral solution cannot meet the requirement of above-mentioned " notice ", and, current parenteral solution
In formula, sodium chloride content is too high, have impact on the quality of parenteral solution.It would therefore be desirable to a kind of new preparation process, so that salt
The quality of acid Ropivacaine parenteral solution meets the requirement of above-mentioned " notice ".
Content of the invention
First purpose of the present invention is to provide a kind of Ropivacaine HCL parenteral solution.
Second object of the present invention is to provide the preparation process of above-mentioned Ropivacaine HCL parenteral solution.
For realizing above-mentioned first purpose, present invention firstly provides a kind of Ropivacaine HCL parenteral solution, every 100kg includes,
Every 10000ml parenteral solution includes,
Ropivacaine HCL 75g
Sodium chloride 60g
Water for injection adds to 10000ml.
For realizing above-mentioned second purpose, the present invention also provides the preparation method of above-mentioned Ropivacaine HCL parenteral solution, comprises following
Step:
(1) raw material is weighed by formula:
Every 10000ml parenteral solution includes,
Ropivacaine HCL 75g
Sodium chloride 60g
Water for injection adds to 10000ml
(2) in the water for injection of total amount of preparation 50%, add Ropivacaine HCL, sodium chloride, stir；Then note is weighed
Penetrate liquid gross mass 0.1% powdered carbon, add in solution, stand after stirring, carry out filtering to remove powdered carbon, inject use
Water, to about 90%, stirs；
(3), after measuring and regulate solution ph, total amount is injected water to；
(4) by step (3) resulting solution through 0.45 μm and 0.22 μm of filtering with microporous membrane；
(5) filtrate obtaining step (4) carries out embedding, leads to N during embedding2。
In an embodiment of the present invention, described step (3) controls the pH value of solution in the range of 4.8～5.1.
In an embodiment of the present invention, described step (1)～(5) are carried out in closed environment, and all by sterile production technique
Carry out.
In an embodiment of the present invention, after step (5), sterilization steps is farther included:
(6) product obtaining step (5) sterilizes, and sterilising conditions is: 121 DEG C sterilize 10～20 minutes.
It should be noted that the reagent used in the present invention is commercially available reagent.
In the present invention, by adjusting preparation technology, the burnt sulfurous of the antioxidant in Ropivacaine HCL parenteral solution formula is eliminated
Acid sodium, ensures that the quality of Ropivacaine HCL parenteral solution.
The positive effect of the present invention: the quality of the Ropivacaine HCL parenteral solution of the present invention meets State Food and Drug Administration
The regulation of " notice " issued for 2008.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is described in further detail:
Embodiment 1
A kind of Ropivacaine HCL parenteral solution, every 100kg includes,
Embodiment 2
The preparation method of above-mentioned Ropivacaine HCL parenteral solution, comprises the steps of
(1) in preparation container, add the water for injection of prepare overall accumulated amount 90% less than 30 DEG C, logical CO2, it is allowed to saturated；
(2) sodium chloride is dissolved in the water for injection of appropriate less than 30 DEG C, described accounts for total amount of preparation 5% in right amount；
(3) by natrium adetate, dissolve with the water for injection boiling；
(4) natrium adetate solution and adrenaline that the sodium chloride solution that obtains step (2), step (3) obtain are molten respectively
Solution, in the water for injection that above-mentioned steps (1) obtains, is stirred to dissolve；
(5) survey the pH value that step (4) obtains solution, with 1mol/L hydrochloric acid conditioning solution pH value to 3.6～4.0, add injection
Water stirs evenly to total amount；
(6) solution obtaining with the filter membrane filtration step (5) of 0.45um, 0.22 μm；
(7) solution that step (6) obtains is carried out aseptic embedding by potting operation program, during embedding, in ampoule, lead to N2。
Embodiment 3
The preparation method of above-mentioned Ropivacaine HCL parenteral solution, comprises the steps of
(1) in preparation container, add the water for injection of prepare overall accumulated amount 90% less than 30 DEG C, logical CO2, it is allowed to saturated；
(2) sodium chloride is dissolved in the water for injection of appropriate less than 30 DEG C, described accounts for total amount of preparation 5% in right amount；
(3) by natrium adetate, dissolve with the water for injection boiling；
(4) natrium adetate solution and adrenaline that the sodium chloride solution that obtains step (2), step (3) obtain are molten respectively
Solution, in the water for injection that above-mentioned steps (1) obtains, is stirred to dissolve；
(5) survey the pH value that step (4) obtains solution, with 1mol/L hydrochloric acid conditioning solution pH value to 3.6～4.0, add injection
Water stirs evenly to total amount；
(6) solution obtaining with the filter membrane filtration step (5) of 0.45um, 0.22 μm；
(7) solution that step (6) obtains is carried out aseptic embedding by potting operation program, during embedding, in ampoule, lead to N2；
Sterilize 30 minutes at (8) 100 DEG C.
Comparative example
A kind of Ropivacaine HCL parenteral solution, every 100kg includes,
Detecting the parenteral solution of embodiment 1 and documents respectively, testing result is as shown in table 1.
Table 1.
| Proterties | Indicate content (%) | Sulfonated bodies (%) | |
| Embodiment 1 | Colourless clear liquid | Qualified | Nothing |
| Comparative example | Colourless clear liquid | Qualified | Qualified |
Result above shows, the Ropivacaine HCL parenteral solution of the present invention eliminates sodium pyrosulfite in formula so that finally obtain
Not containing sulfonated bodies in the injection obtaining, this not only increases the quality of parenteral solution, also reduces cost.Simultaneously.The present invention is led to
Cross adjustment preparation technology so that while removing antioxidant sodium pyrosulfite, remain its oxidation resistant effect, can meet
State Food and Drug Administration evaluates state's food medicine prison [2008] No. 7 literary compositions of note issued at center in 2008---" with regard to issue
Chemicals injection and the notice of multicomponent Biochemical Drugs injection main technique requirements " regulation.
Claims (5)
1. a Ropivacaine HCL parenteral solution, it is characterised in that comprise following component:
Every 10000ml parenteral solution includes,
Ropivacaine HCL 75g
Sodium chloride 60g
Water for injection adds to 10000ml.
2. the preparation process of a Ropivacaine HCL parenteral solution as claimed in claim 1, it is characterised in that comprise following step
Rapid:
(1) raw material is weighed by formula:
Every 10000ml parenteral solution includes,
Ropivacaine HCL 75g
Sodium chloride 60g
Water for injection adds to 10000ml
(2) in the water for injection of total amount of preparation 50%, add Ropivacaine HCL, sodium chloride, stir；Then note is weighed
Penetrate liquid gross mass 0.1% powdered carbon, add in solution, stand after stirring, carry out filtering to remove powdered carbon, inject use
Water, to about 90%, stirs；
(3), after measuring and regulate solution ph, total amount is injected water to；
(4) by step (3) resulting solution through 0.45 μm and 0.22 μm of filtering with microporous membrane；
(5) filtrate obtaining step (4) carries out embedding, leads to N during embedding2。
3. preparation process as claimed in claim 2, it is characterised in that in described step (3), the pH value of control solution is 4.8～5.1
In the range of.
4. preparation process as claimed in claim 2, it is characterised in that described step (1)～(5) are entered in closed environment
OK, and all by sterile production technique carry out.
5. preparation process as claimed in claim 2, it is characterised in that after step (5), farther includes sterilization steps:
(6) product obtaining step (5) sterilizes, and sterilising conditions is: 121 DEG C sterilize 10～20 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510100403.8A CN105982848A (en) | 2015-03-06 | 2015-03-06 | Ropivacaine hydrochloride injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510100403.8A CN105982848A (en) | 2015-03-06 | 2015-03-06 | Ropivacaine hydrochloride injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105982848A true CN105982848A (en) | 2016-10-05 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510100403.8A Pending CN105982848A (en) | 2015-03-06 | 2015-03-06 | Ropivacaine hydrochloride injection and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111494310A (en) * | 2020-04-29 | 2020-08-07 | 周晓玲 | Preparation and application method of local anesthetic |
-
2015
- 2015-03-06 CN CN201510100403.8A patent/CN105982848A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111494310A (en) * | 2020-04-29 | 2020-08-07 | 周晓玲 | Preparation and application method of local anesthetic |
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| C06 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20161005 |
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| WD01 | Invention patent application deemed withdrawn after publication |