CN107303269A - A kind of preparation method of levo-oxiracetam parenteral solution - Google Patents
A kind of preparation method of levo-oxiracetam parenteral solution Download PDFInfo
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- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
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- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
The invention discloses a kind of preparation method of levo-oxiracetam parenteral solution；Contain following supplementary material in per mL parenteral solutions：180 ~ 220mg of levo-oxiracetam, 0.01 ~ 0.1mg of natrium adetate, 4 ~ 5mg of methyl hydroxybenzoate, 10 ~ 16mg of meglumine；The sodium hydroxide solution that 0.1 ~ 0.5mol/L is added in preparation process adjusts pH value to 6.5 ~ 7.0, and adds 2 ~ 6 g/L chitosan processing.Levo-oxiracetam parenteral solution prepared by the present invention is non-foaming, does not have decoction adhesion problems, product yield is high, and significantly improves the clarity of parenteral solution, and product stability is good, and the term of validity is long, and product impurity is few, and indices meet production requirement.
Description
Technical field
The invention belongs to pharmaceutical field, and in particular to a kind of preparation method of levo-oxiracetam parenteral solution.
Background technology
Levo-oxiracetam chemical name is：(S)-Esomeprazole, is white micro-crystals shape
Powder, 135~136 DEG C of fusing point, -36 ° of optical activity (C=1.00in water), the dissolubility of levo-oxiracetam is substantially better than
Raceme.Chemical structural formula is shown below：
The medicine is in 1987 in Italy's listing, and the formulation of listing is tablet, 800mg；Capsule, 800mg；Parenteral solution, 1g/
5ml.It is domestic at present there was only oxiracetam capsule and parenteral solution listing, and main active used is racemic modification.Ye Lei
Deng mentioning levo-oxiracetam in the A patents of Publication No. CN 103735545 to the promoting wakening gone into a coma caused by alcoholism
Substantially, and dextrorotation Oxiracetam is not acted on substantially, the above-mentioned rush of levo-oxiracetam wake up that effect is racemization Oxiracetam 2
Times；Levo-oxiracetam is notable to the promoting wakening of stupor caused by wound, anesthesia.Peak etc. is opened in Publication No. CN
Levo-oxiracetam is disclosed in 103599101 A patent to remember the study of traumatic brain injury rat caused by hydraulic pressure and freely falling body
Recall cognition dysfunction to improve significantly, its drug effect is far above dextrorotation Oxiracetam.And the left-handed Auras of 200mg/kg
It is western smooth suitable with the effect of 400mg/kg Oxiracetams.Pharmacokinetic study results are shown：Levo-oxiracetam and dextrorotation are difficult to understand
La Xitan is in beasle dog body without obvious chiral inversion.It is difficult to understand that beasle dog single intravenous injection gives left-handed and 2 multiple doses racemizations
The equal no significant difference of the main pharmacokinetic parameters of levo-oxiracetam in blood plasma after La Xitan.The examinations such as safe pharmacology, anxious malicious, long poison
Test result to show, under isodose level, levo-oxiracetam is with Oxiracetam to the toxicity of animal subject or cell without bright
Significant difference is different.Above-mentioned preclinical result of study shows that levo-oxiracetam is the chief active that drug effect is played in Oxiracetam body
Composition, this product, which is used alone, can reduce Clinical practice dosage, reduce potential toxicity.
But, easily there is foam in pouring process in existing levo-oxiracetam parenteral solution, filling using ampoule bottle,
Decoction will adhere to bottleneck, cause decoction carbonization to make product visible foreign matters unqualified during ampoule bottle heat sealing, reduce product
Yield, while also increasing the unknown security of patient medication；Filling using cillin bottle, solution adheres to bottleneck, easily occurs
The situation of plug jumping, equally reduces product yield.In addition, existing levo-oxiracetam parenteral solution also exist product clarity compared with
During difference, storage easily crystallization, the problems such as product impurity is more, the quality and yield of same influence product.
The content of the invention
In view of this, it is an object of the invention to provide a kind of preparation method of levo-oxiracetam parenteral solution, preparation
Levo-oxiracetam parenteral solution clarity is good, stability is good, and decoction is non-foaming, does not have decoction adhesion problems, improves product yield.
To reach above-mentioned purpose, the present invention provides following technical scheme：
Contain following supplementary material in a kind of preparation method of levo-oxiracetam parenteral solution, every mL parenteral solutions：Left-handed Aura
Western smooth 180~220mg, 0.01~0.1mg of natrium adetate, 4~5mg of methyl hydroxybenzoate, 10~16mg of meglumine；
The preparation method of the parenteral solution comprises the following steps：
(1) levo-oxiracetam, natrium adetate, methyl hydroxybenzoate and the meglumine for weighing recipe quantity add water for injection
In, stirring and dissolving obtains concentrated wiring liquid；
(2) concentrated wiring liquid for taking step (1) to obtain, the sodium hydroxide solution for adding 0.1~0.5mol/L adjusts pH value to 6.5
~7.0；
(3) 2~6g/L chitosan is added in the solution obtained to step (2), stirs and evenly mixs, stands after 30~50min
Filtering；
(4) filtered after 1~3g/L activated carbon, adsorption bleaching are added in the solution obtained to step (3)；
(5) the solution water for injection constant volume for obtaining step (4).
Further, following supplementary material is contained in every mL parenteral solutions：Levo-oxiracetam 200mg, natrium adetate 0.05mg,
Methyl hydroxybenzoate 4.5mg, meglumine 13mg.
Further, the preparation method of the parenteral solution is further comprising the steps of：
(6) by the solution after step (5) constant volume, upper streamline carries out filling, buffering fluid reservoir when filling after the assay was approved
Position level height is than the high 10cm~15cm of position level height with liquid nozzle；
(7) canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing.
Further, the concentrated compounding process of the step (1) need to lead to nitrogen processing, and nitrogen flow is 0.03~0.08L/min；It is described
Fluid reservoir is buffered in the pouring process of step (6) needs nitrogen charging to handle, and pouring process need to be filled with the nitrogen of purity 99.99% so that tank
Oxygen content in interior water for injection is no more than 0.01%.
The beneficial effects of the present invention are：
Froth breaking effect and natrium adetate, the hydrotropy stabilization of meglumine of the present invention using methyl hydroxybenzoate, preparation
Levo-oxiracetam parenteral solution is non-foaming, does not have decoction adhesion problems, and product yield is high, and coordinates with specific during liquid
PH adjusting agent and specific pH, then coordinate a certain amount of chitosan to handle, significantly improve the clarity of parenteral solution, prepare
Levo-oxiracetam parenteral solution clarity less than No. 0.5 standard turbidity solution, product stability is good, and the term of validity is long, product impurity
Few, indices meet production requirement.
Embodiment
In order that the purpose of the present invention, technical scheme and beneficial effect are clearer, below by the preferred reality of the present invention
Example is applied to be described in detail.
Embodiment 1
The prescription of the levo-oxiracetam parenteral solution of embodiment 1 is as shown in the table：
The preparation method of the levo-oxiracetam parenteral solution of embodiment 1, comprises the following steps：
(1) levo-oxiracetam, natrium adetate, methyl hydroxybenzoate and the meglumine for weighing recipe quantity add water for injection
In, stirring and dissolving obtains concentrated wiring liquid；Concentrated compounding process need to lead to nitrogen processing, and nitrogen flow is 0.03~0.08L/min；
(2) concentrated wiring liquid for taking step (1) to obtain, the sodium hydroxide solution for adding 0.1mol/L adjusts pH value to 6.5；
(3) 2g/L chitosan is added in the solution obtained to step (2), stirs and evenly mixs, stands after 50min with 0.8 μm
Membrane filtration；
(4) the filter membrane mistake with 0.45 μm after 1g/L activated carbon, adsorption bleaching is added in the solution obtained to step (3)
Filter；
(5) the solution water for injection constant volume for obtaining step (4)；
(6) by the solution after step (5) constant volume, upper streamline carries out filling, buffering fluid reservoir when filling after the assay was approved
Position level height is than the high 10cm~15cm of position level height with liquid nozzle；Fluid reservoir is buffered in pouring process needs nitrogen charging
Processing, pouring process need to be filled with the nitrogen of purity 99.99% so that the oxygen content in tank in water for injection is no more than 0.01%；
(7) canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min produce left-handed Aura
Western smooth parenteral solution.
Comparative example 1
The levo-oxiracetam parenteral solution of comparative example 1 does not add methyl hydroxybenzoate, remaining component and preparation method and implementation
Example 1 is identical.
Embodiment 2
The prescription of the levo-oxiracetam parenteral solution of embodiment 2 is as shown in the table：
The preparation method of the levo-oxiracetam parenteral solution of embodiment 2, comprises the following steps：
(1) levo-oxiracetam, natrium adetate, methyl hydroxybenzoate and the meglumine for weighing recipe quantity add water for injection
In, stirring and dissolving obtains concentrated wiring liquid；Concentrated compounding process need to lead to nitrogen processing, and nitrogen flow is 0.03~0.08L/min；
(2) concentrated wiring liquid for taking step (1) to obtain, the sodium hydroxide solution for adding 0.3mol/L adjusts pH value to 6.8；
(3) 4g/L chitosan is added in the solution obtained to step (2), stirs and evenly mixs, stands after 40min with 0.8 μm
Membrane filtration；
(4) the filter membrane mistake with 0.45 μm after 2g/L activated carbon, adsorption bleaching is added in the solution obtained to step (3)
Filter；
(5) the solution water for injection constant volume for obtaining step (4)；
(6) by the solution after step (5) constant volume, upper streamline carries out filling, buffering fluid reservoir when filling after the assay was approved
Position level height is than the high 10cm~15cm of position level height with liquid nozzle；Fluid reservoir is buffered in pouring process needs nitrogen charging
Processing, pouring process need to be filled with the nitrogen of purity 99.99% so that the oxygen content in tank in water for injection is no more than 0.01%；
(7) canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min produce left-handed Aura
Western smooth parenteral solution.
Comparative example 2
The levo-oxiracetam parenteral solution of comparative example 2 does not add methyl hydroxybenzoate, remaining component and preparation method and implementation
Example 2 is identical.
Embodiment 3
The prescription of the levo-oxiracetam parenteral solution of embodiment 3 is as shown in the table：
The preparation method of the levo-oxiracetam parenteral solution of embodiment 3, comprises the following steps：
(1) levo-oxiracetam, natrium adetate, methyl hydroxybenzoate and the meglumine for weighing recipe quantity add water for injection
In, stirring and dissolving obtains concentrated wiring liquid；Concentrated compounding process need to lead to nitrogen processing, and nitrogen flow is 0.03-0.08L/min；
(2) concentrated wiring liquid for taking step (1) to obtain, the sodium hydroxide solution for adding 0.5mol/L adjusts pH value to 7.0；
(3) 6g/L chitosan is added in the solution obtained to step (2), stirs and evenly mixs, stands after 30min with 0.8 μm
Membrane filtration；
(4) the filter membrane mistake with 0.45 μm after 3g/L activated carbon, adsorption bleaching is added in the solution obtained to step (3)
Filter；
(5) the solution water for injection constant volume for obtaining step (4)；
(6) by the solution after step (5) constant volume, upper streamline carries out filling, buffering fluid reservoir when filling after the assay was approved
Position level height is than the high 10cm-15cm of position level height with liquid nozzle；Fluid reservoir is buffered in pouring process needs nitrogen charging
Processing, pouring process need to be filled with the nitrogen of purity 99.99% so that the oxygen content in tank in water for injection is no more than 0.01%；
(7) canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min produce left-handed Aura
Western smooth parenteral solution.
Comparative example 3
The levo-oxiracetam parenteral solution of comparative example 3 does not add methyl hydroxybenzoate, remaining component and preparation method and implementation
Example 3 is identical.
Comparative example 4
The step of comparative example 4 (2), adjusts pH value, remaining component and preparation method and reality using sodium acid carbonate as pH adjusting agent
Apply example 1 identical.
Comparative example 5
The step of comparative example 5 (2), adjusts pH value to 6.0, and remaining component and preparation method are same as Example 1.
Comparative example 6
The step of comparative example 6 (2), adjusts pH value to 7.5, and remaining component and preparation method are same as Example 1.
Comparative example 7
Comparative example 7 is without step (3) addition chitosan processing, and remaining component and preparation method are same as Example 1.
First, long term test is investigated：
Levo-oxiracetam parenteral solution made from embodiment 1-3 is packed by listing, put in the long-term case that keeps sample, certain time
Sampling, tests to investigation project.
Long term test temperature：20 ± 2 DEG C, humidity：RH60% ± 10%, investigates the time：0th, 12,24 months, inspection target：Outside
See character, visible foreign matters, pH, relevant material, content.
Long term test stability is recorded：
Result is investigated from long term test, levo-oxiracetam injection products stability is good made from embodiment 1-3,
The term of validity is long, and product impurity is few, and indices meet production requirement.
2nd, yield is calculated：
Embodiment 1-3 and comparative example 1-3 product yield is calculated, it is as a result as follows：
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 | |
| Theoretical yield (bottle) | 200 | 200 | 200 | 200 | 200 | 200 |
| Actual production (bottle) | 175 | 168 | 166 | 130 | 130 | 132 |
| Yield (%) | 87.5 | 84 | 83 | 65 | 65 | 66 |
From yield result of calculation, because comparative example 1-3 in pouring process has decoction to stick in ampoule bottleneck, cause peace
When small jar bottle height temperature is sealed, stick in the decoction carbonization of bottleneck and make parenteral solution visible foreign matters unqualified, reduce product yield；And
Embodiment 1-3 is non-foaming due to decoction, and in the absence of the situation of adhesion ampoule bottleneck, its yield is greatly improved.
3rd, clarity contrast test：
According to version pharmacopeia annex IXB clarity inspection techniques in 2010, embodiment 1 and comparative example 4-7 clarity, knot are examined
Fruit is as follows：
| Sample survey | As a result |
| Embodiment 1 | The standard turbidity solutions of ＜ 0.5 |
| Comparative example 4 | The standard turbidity solutions of 0.5 standard turbidity solution ＜ clarity ＜ 1.0 |
| Comparative example 5 | The standard turbidity solutions of 0.5 standard turbidity solution ＜ clarity ＜ 1.0 |
| Comparative example 6 | The standard turbidity solutions of 0.5 standard turbidity solution ＜ clarity ＜ 1.0 |
| Comparative example 7 | The standard turbidity solutions of ＞ 1.0 |
From clarity comparative test result, embodiment 1 matches somebody with somebody specific pH adjusting agent and specific pH during liquid
Value, then coordinate a certain amount of chitosan to handle, significantly improve the clarity of parenteral solution, the levo-oxiracetam parenteral solution of preparation
Less than No. 0.5 standard turbidity solution of clarity.
Finally illustrate, preferred embodiment above is merely illustrative of the technical solution of the present invention and unrestricted, although logical
Cross above preferred embodiment the present invention is described in detail, it is to be understood by those skilled in the art that can be
Various changes are made to it in form and in details, without departing from claims of the present invention limited range.
Claims (4)
1. a kind of preparation method of levo-oxiracetam parenteral solution, it is characterised in that：Contain following supplementary material in per mL parenteral solutions：
180 ~ 220mg of levo-oxiracetam, 0.01 ~ 0.1mg of natrium adetate, 4 ~ 5mg of methyl hydroxybenzoate, 10 ~ 16mg of meglumine；
The preparation method of the parenteral solution comprises the following steps：
（1）Levo-oxiracetam, natrium adetate, methyl hydroxybenzoate and the meglumine for weighing recipe quantity are added in water for injection, are stirred
Dissolving is mixed, concentrated wiring liquid is obtained；
（2）Take step（1）Obtained concentrated wiring liquid, the sodium hydroxide solution for adding 0.1 ~ 0.5mol/L adjusts pH value to 6.5 ~ 7.0；
（3）To step（2）2 ~ 6 g/L chitosan is added in obtained solution, is stirred and evenly mixed, stands and is filtered after 30 ~ 50min；
（4）To step（3）Filtered after 1 ~ 3 g/L activated carbon, adsorption bleaching are added in obtained solution；
（5）By step（4）Obtained solution water for injection constant volume.
2. the preparation method of levo-oxiracetam parenteral solution according to claim 1, it is characterised in that：Per in mL parenteral solutions
Contain following supplementary material：Levo-oxiracetam 200mg, natrium adetate 0.05mg, methyl hydroxybenzoate 4.5mg, meglumine 13mg.
3. the preparation method of levo-oxiracetam parenteral solution according to claim 1 or 2, it is characterised in that：The injection
The preparation method of liquid is further comprising the steps of：
（6）By step（5）Upper streamline carries out filling, the position of buffering fluid reservoir when filling to solution after constant volume after the assay was approved
Level height is than the high 10cm ~ 15cm of position level height with liquid nozzle；
（7）Canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing.
4. the preparation method of the levo-oxiracetam parenteral solution according to claims 1 to 3 any one, it is characterised in that：
The step（1）Concentrated compounding process need to lead to nitrogen processing, nitrogen flow be 0.03 ~ 0.08L/min；The step（6）Filling mistake
Fluid reservoir is buffered in journey needs nitrogen charging to handle, and pouring process need to be filled with the nitrogen of purity 99.99% so that containing in water for injection in tank
Oxygen amount is no more than 0.01%.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009039460A2 (en) * | 2007-09-21 | 2009-03-26 | Acadia Pharmaceuticals, Inc. | Co-administration of pimavanserin with other agents |
| CN101766597A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Injection preparation with levo-oxiracetam as active component |
| CN102670527A (en) * | 2012-05-28 | 2012-09-19 | 南京优科生物医药研究有限公司 | Freeze-dried powder injection of L-oxiracetam and process for preparing freeze-dried powder injection |
-
2016
- 2016-04-18 CN CN201610240677.1A patent/CN107303269A/en not_active Withdrawn
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009039460A2 (en) * | 2007-09-21 | 2009-03-26 | Acadia Pharmaceuticals, Inc. | Co-administration of pimavanserin with other agents |
| CN101766597A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Injection preparation with levo-oxiracetam as active component |
| CN102670527A (en) * | 2012-05-28 | 2012-09-19 | 南京优科生物医药研究有限公司 | Freeze-dried powder injection of L-oxiracetam and process for preparing freeze-dried powder injection |
Non-Patent Citations (1)
| Title |
|---|
| 颜素华等: "奥拉西坦注射液的研制", 《中国现代医学杂志》 * |
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Application publication date: 20171031 |