CN1660094A - Ropivacaine hydrochloride in use for injection and preparation technique - Google Patents
Ropivacaine hydrochloride in use for injection and preparation technique Download PDFInfo
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- CN1660094A CN1660094A CN 200410077510 CN200410077510A CN1660094A CN 1660094 A CN1660094 A CN 1660094A CN 200410077510 CN200410077510 CN 200410077510 CN 200410077510 A CN200410077510 A CN 200410077510A CN 1660094 A CN1660094 A CN 1660094A
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- ropivacaine
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- aseptic
- hydrochloride
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Abstract
A freeze-dried powder injection of ropivacaine hydrochloride is prepared from ropivacaine hydrochloride and the pharmacologically suporting materials including material, lactose, glucose and dextran. Its preparing process features use of low-temp aseptic vacuum spray drying for shortening time.
Description
(1) technical field
The present invention relates to a kind of ropivacaine hydrochloride in use for injection and preparation technology thereof, belong to anesthesia, analgesic technical field.
(2) background technology
Ropivacaine is a New-type long-acting amide-type local anesthetic, is applicable to regional area anesthesia in 72 hours of surgical operation anesthesia, epidural anesthesia, postoperative analgesia and birth process.This product was at first developed into the Ropivacaine HCL injection by Sweden Aktiebolaget Astra in 1994, nineteen ninety-five obtains the FDA approval and goes on the market in the U.S..Because have optical isomer in the ropivacaine structure, the key of its control of product quality is the control to its enantiomeric purity content, injection is unfavorable for the factor that properties of product are stable owing to its enantiomer under the state of aqueous solution exists wait transition.
(3) summary of the invention
The present invention is directed to the above-mentioned factor that is unfavorable for product quality, on the basis of Ropivacaine HCL injection, be improved to the not ropivacaine hydrochloride in use for injection and the preparation technology thereof of aqueous solution, good stability.
By a kind of ropivacaine hydrochloride in use for injection of this purpose design, it is characterized in that it contains the support substance that Ropivacaine HCL and pharmacology allow; It is powder pin or freeze-dried powder.
Described support substance is mannitol, lactose, glucose, dextran, can be that one or more mix use.The ratio of described Ropivacaine HCL and support substance is: 1: 0.5～5.The quality critical of Ropivacaine HCL is the control to its enantiomeric purity content, requires control R-(+) type Ropivacaine HCL below 2%.
The preparation technology of ropivacaine hydrochloride in use for injection is: under aseptic cleaning condition, the support substance of Ropivacaine HCL and pharmacology permission is added proper amount of water for injection, heated and stirred makes it to dissolve fully, add an amount of activated carbon decolorizing, coarse filtration and take off charcoal, filtering with microporous membrane degerming, get aseptic pyrogen-free clarification medicinal liquid; Adopt the continuous spray dryer drying of vacuum, in the control tank body temperature at 30～50 ℃, vacuum in 0.5KPa～1KPa, material solution preheater temperature 30～50 ℃ of scopes, aseptic, pyrogen-free clarification medicinal liquid is sprayed in the continuous spray dryer of vacuum continuously, get aseptic xeraphium, be sub-packed in the antibiotic bottle of washing and sterilizing, roll lid and promptly get ropivacaine hydrochloride in use for injection powder pin of the present invention.
The another kind of preparation technology of ropivacaine hydrochloride in use for injection is: under aseptic cleaning condition, the support substance of Ropivacaine HCL and pharmacology permission is added proper amount of water for injection, heated and stirred makes it to dissolve fully, add an amount of activated carbon decolorizing, coarse filtration and take off charcoal, filtering with microporous membrane degerming, get aseptic pyrogen-free clarification medicinal liquid, fill is made freeze-dried powder in being placed in the freeze dryer by freeze-drying technology in the antibiotic bottle of washing and sterilizing.
Compared with prior art, ropivacaine hydrochloride in use for injection of the present invention is powder pin or freeze-dried powder, and it constitutes simple, can reduce toxic and side effects, steady quality, determined curative effect.It adopts up-to-date sterile cryogenic vacuum spray drying method preparation technology, both can significantly shorten the production time, reduces the microbiological contamination chance, also can save a large amount of energy; Obviously be better than other injections such as ropivacaine injection at aspects such as product stability and preparation technologies, control stability to its quality critical is good especially, to its control of enantiomeric purity content, than being easier to R-(+) type Ropivacaine HCL is controlled at below 2%, be more suitable for industrialized great production, and be beneficial to transportation and preservation.Though adopt cycle freeze-dried powder production time of conventional freeze-drying preparation long slightly, can guarantee product quality.
(4) specific embodiment
This ropivacaine hydrochloride in use for injection is powder pin or freeze-dried powder, and it contains the support substance of Ropivacaine HCL and pharmacology permission; Support substance be in mannitol, lactose, glucose, the dextran any or appoint several mixing to use.The ratio of its Ropivacaine HCL and support substance is: 1: 0.5～5.
Up-to-date sterile cryogenic vacuum spray drying method preparation technology: under aseptic cleaning condition, the support substance of Ropivacaine HCL and pharmacology permission is added proper amount of water for injection, heated and stirred makes it to dissolve fully, add an amount of activated carbon decolorizing, coarse filtration and take off charcoal, filtering with microporous membrane degerming, get aseptic pyrogen-free clarification medicinal liquid; Adopt the continuous spray dryer drying of vacuum, in the control tank body temperature at 30～50 ℃, vacuum in 0.5KPa～1KPa, material solution preheater temperature 30～50 ℃ of scopes, aseptic, pyrogen-free clarification medicinal liquid is sprayed in the continuous spray dryer of vacuum continuously, get aseptic xeraphium, be sub-packed in the antibiotic bottle of washing and sterilizing, roll lid and promptly get ropivacaine hydrochloride in use for injection powder pin of the present invention.
Normal freeze-drying method preparation technology: under aseptic cleaning condition, the support substance of Ropivacaine HCL and pharmacology permission is added proper amount of water for injection, heated and stirred makes it to dissolve fully, add an amount of activated carbon decolorizing, coarse filtration and take off charcoal, filtering with microporous membrane degerming, get aseptic pyrogen-free clarification medicinal liquid, fill is made freeze-dried powder in being placed in the freeze dryer by freeze-drying technology in the antibiotic bottle of washing and sterilizing.
Be sterile cryogenic vacuum spray drying method preparation technology's specific embodiment below:
1. the aseptic process of Ropivacaine HCL solution: under aseptic cleaning condition, the support substance of Ropivacaine HCL and pharmacology permission is added proper amount of water for injection, heated and stirred makes it to dissolve fully, add an amount of activated carbon decolorizing, coarse filtration is taken off charcoal, the filtering with microporous membrane degerming gets aseptic pyrogen-free clarification medicinal liquid, material moisture 81.2%;
2. the tank body of vacuum spray dehydrator, pipeline are through cleaning, sterilizing;
3. vacuum spray drying:
Temperature in the dry tank body: 35～50 ℃ of vacuum: 40KPa～80KPa
Material preheat temperature: 35～50 ℃
Final " ropivacaine hydrochloride in use for injection " aseptic powder water content: 4%.
With the fill of aseptic " ropivacaine hydrochloride in use for injection " powder in through clean, in the antibiotic bottle of sterilization, roll lid and promptly get ropivacaine hydrochloride in use for injection powder pin of the present invention.
Effect: enhance productivity, 48 hours consuming time of a collection of need of lyophilization, and only need 4.5 hours with the continuous spray drying method of vacuum, enhance productivity 10 times.
Claims (6)
1. ropivacaine hydrochloride in use for injection is characterized in that it contains the support substance that Ropivacaine HCL and pharmacology allow; It is powder pin or freeze-dried powder.
2. ropivacaine hydrochloride in use for injection according to claim 1 is characterized in that described support substance is mannitol, lactose, glucose, dextran, can be that one or more mix use.
3. ropivacaine hydrochloride in use for injection according to claim 1 and 2 is characterized in that the ratio of described Ropivacaine HCL and support substance is: 1: 0.5～5.
4. ropivacaine hydrochloride in use for injection according to claim 1, the quality critical that it is characterized in that Ropivacaine HCL are the control to its enantiomeric purity content, require control R-(+) type Ropivacaine HCL below 2%.
5. the preparation technology of ropivacaine hydrochloride in use for injection according to claim 1, it is characterized in that: under aseptic cleaning condition, the support substance of Ropivacaine HCL and pharmacology permission is added proper amount of water for injection, heated and stirred makes it to dissolve fully, add an amount of activated carbon decolorizing, coarse filtration and take off charcoal, filtering with microporous membrane degerming, get aseptic pyrogen-free clarification medicinal liquid; Adopt the continuous spray dryer drying of vacuum, in the control tank body temperature at 30～50 ℃, vacuum in 0.5KPa～1KPa, material solution preheater temperature 30～50 ℃ of scopes, aseptic, pyrogen-free clarification medicinal liquid is sprayed in the continuous spray dryer of vacuum continuously, get aseptic xeraphium, be sub-packed in the antibiotic bottle of washing and sterilizing, roll lid and promptly get ropivacaine hydrochloride in use for injection powder pin of the present invention.
6. the preparation technology of ropivacaine hydrochloride in use for injection according to claim 1, it is characterized in that: under aseptic cleaning condition, the support substance of Ropivacaine HCL and pharmacology permission is added proper amount of water for injection, heated and stirred makes it to dissolve fully, add an amount of activated carbon decolorizing, coarse filtration and take off charcoal, filtering with microporous membrane degerming, get aseptic pyrogen-free clarification medicinal liquid, fill is made freeze-dried powder in being placed in the freeze dryer by freeze-drying technology in the antibiotic bottle of washing and sterilizing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410077510 CN1660094A (en) | 2004-12-13 | 2004-12-13 | Ropivacaine hydrochloride in use for injection and preparation technique |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410077510 CN1660094A (en) | 2004-12-13 | 2004-12-13 | Ropivacaine hydrochloride in use for injection and preparation technique |
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| CN1660094A true CN1660094A (en) | 2005-08-31 |
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| CN 200410077510 Pending CN1660094A (en) | 2004-12-13 | 2004-12-13 | Ropivacaine hydrochloride in use for injection and preparation technique |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| US10821087B2 (en) | 2015-07-24 | 2020-11-03 | Neon Laboratories Limited | Stabilized injectable emulsion of Propofol and Ketamine |
| US11224593B2 (en) | 2015-07-13 | 2022-01-18 | Neon Laboratories Limited | Hyperbaric injection solution of ropivacaine hydrochloride and process for preparation thereof |
-
2004
- 2004-12-13 CN CN 200410077510 patent/CN1660094A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN102038651B (en) * | 2010-12-25 | 2013-04-03 | 山东新时代药业有限公司 | Ropivacaine mesylate freeze-dried powder injection |
| US11224593B2 (en) | 2015-07-13 | 2022-01-18 | Neon Laboratories Limited | Hyperbaric injection solution of ropivacaine hydrochloride and process for preparation thereof |
| US10821087B2 (en) | 2015-07-24 | 2020-11-03 | Neon Laboratories Limited | Stabilized injectable emulsion of Propofol and Ketamine |
| 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 |
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