CN106692041A - Sinistrorse oxiracetam injection and preparation method thereof - Google Patents
Sinistrorse oxiracetam injection and preparation method thereof Download PDFInfo
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- CN106692041A CN106692041A CN201510510696.7A CN201510510696A CN106692041A CN 106692041 A CN106692041 A CN 106692041A CN 201510510696 A CN201510510696 A CN 201510510696A CN 106692041 A CN106692041 A CN 106692041A
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Abstract
The invention discloses sinistrorse oxiracetam injection. The sinistrorse oxiracetam injection is characterized by being prepared by taking sinistrorse oxiracetam, glycerol, mannitol, vitamin and ethylenediamine tetraacetic acid as raw materials through concentrating, diluting, encapsulating, sterilizing and inspecting-packaging, wherein dosage (in percentage by weight) of the raw materials is as follows: 72%-78% of the sinistrorse oxiracetam, 12%-16% of the glycerol, 7%-13% of glycine, 1%-5% of vitamin C and 2%-7% of the ethylenediamine tetraacetic acid. The sinistrorse oxiracetam injection prepared by the invention is not liable to oxidize in a storage process, and incrementof impurities in a sterilizing process is only 0.02%, stability is good, the valid period is as long as 18 months or longer, product impurities within the valid period are less, content of total impurities is lower than 0.26%, solubility of a product main dug is good, insoluble particles are detected to be smaller than 25 [mu]m; and moreover, the preparation process is simple and feasible, so that the sinistrorse oxiracetam injection is worthy of market promotion.
Description
Technical field
The invention mainly relates to pharmaceutical technology field, and in particular to a kind of levo-oxiracetam injection and preparation method thereof.
Background technology
Cereboactive drug is a kind of new medicine for central nervous system for promoting study, strengthening memory also known as cereboactive drug.Nootropics requirement selection index system is in cerebral cortex, the feature with selection activation, protection and promotion damaged nerve cell functional rehabilitation.Different from other neurologic agents be a little their above-mentioned effect not by network or olfactory bulb, but directly act on cortex.Behavior is neither influenceed, also without calm excitation, therefore such medicine has caused the extensive concern and interest of people, and the demand to such medicine is also growing day by day.
Levo-oxiracetam chemical name is：S- (-) -4- hydroxyl -2- oxo-pyrrolidine-N- acetamides, are white micro-crystals sprills, 135~136 DEG C of fusing point, -36 ° of optical activity (C=1.00in water), and the dissolubility of levo-oxiracetam is substantially better than raceme.Chemical structural formula is shown below：
Existing levo-oxiracetam injection its be primarily present the problems such as product main ingredient dissolubility is bad, the bad oxidizable, sterilization process of product stability easily causes impurity to increase.
The content of the invention
It is an object of the invention to provide the not oxidizable levo-oxiracetam injection of a kind of good stability, product.
Preparation method another object of the present invention is to provide above-mentioned levo-oxiracetam injection.
The purpose of the present invention is realized by following technical measures：
A kind of levo-oxiracetam injection, it is characterised in that it is, with levo-oxiracetam as raw material, to add a certain amount of additives and be obtained；Wherein described additives be glucose, sodium chloride, mannitol, glycerine, Serine, sodium glutamate, alanine, glycine, lecithin, propane diols, phenmethylol, anesin, sodium sulfite, sodium hydrogensulfite, sodium pyrosulfite in, one or more of vitamin C, ethylenediamine tetra-acetic acid.
Inventor has found in research process, select a certain proportion of glycerine with glycine as compound additives in composition described above, add a certain amount of vitamin C and ethylenediamine tetra-acetic acid, coordinate specific sterilization process step, main ingredient dissolubility is good in may be such that the levo-oxiracetam preparation process of above-mentioned injection, and product total impurities increase in sterilization process is smaller, is difficult to be oxidized during product storage, above-mentioned levo-oxiracetam injection, it is characterised in that：It is with levo-oxiracetam, glycerine, mannitol, vitamin, ethylenediamine tetra-acetic acid as supplementary material, by concentrated compounding, it is dilute match somebody with somebody, embedding, sterilizing, test package step be obtained；The levo-oxiracetam 72%~78% that the consumption of wherein described supplementary material is weight percentage, glycerine 12%~16%, glycine 7%~13%, vitamin C 1%~5%, ethylenediamine tetra-acetic acid 2%~7%；Wherein described sterilization steps are that canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, 121 DEG C are risen to, 15min is kept at 121 DEG C；3~5 DEG C/min of compressed air air blast lowers the temperature, and 8~12min is cooled to 70~80 DEG C, and 2~3 DEG C/min of cooling water coolings, 15~18min is cooled to 30 DEG C, and sterilizing is completed.
Further, further reduced in order that obtaining impurity in product sterilization process and increasing, above-mentioned levo-oxiracetam injection, it is characterised in that it is obtained by the supplementary material of following significant percentage：Levo-oxiracetam 73%~76%, glycerine 13%~15%, glycine 7%~11%, vitamin C 1%~3%, ethylenediamine tetra-acetic acid 2%~5% takes above-mentioned supplementary material and is placed in material-compound tank, adds sterilized water for injection, and stirring, dissolving obtains concentrated wiring liquid；Concentrated wiring liquid, plus sodium acid carbonate or salt acid for adjusting pH are taken to 6.0~7.0, add the activated carbon that mass fraction is 0.1%~0.3%, adsorption bleaching to be filtered with 0.45 μm of filter membrane, collect filtrate, add sterilized water for injection to prescription, test qualified through middle product examine, you can；Intermediate is filtered with 0.22 μm of filter after the assay was approved, visible foreign matters are checked, after bacterial endotoxin is qualified, upper streamline carries out filling, 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 sealed no more than 0.01% after inflated with nitrogen；Canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, 121 DEG C are risen to, 15min is kept at 121 DEG C；3~5 DEG C/min of compressed air air blast lowers the temperature, and 8~12min is cooled to 70~80 DEG C, and 2~3 DEG C/min of cooling water coolings, 15~18min is cooled to 30 DEG C, and sterilizing is completed, and is hunted leak by rated condition.
A kind of preparation method of levo-oxiracetam injection, it is characterised in that it is obtained as follows：
1. concentrated compounding：To the sterilized water for injection that 1/3 recipe quantity is added in material-compound tank, the supplementary material of recipe quantity is added, stirring, dissolving obtains concentrated wiring liquid；
2. it is dilute to match somebody with somebody：Concentrated wiring liquid, plus sodium acid carbonate or salt acid for adjusting pH are taken to 6.0~7.0, add the activated carbon that mass fraction is 0.1%~0.3%, adsorption bleaching to be filtered with 0.45 μm of filter membrane, collect filtrate, add sterilized water for injection to prescription, test qualified through middle product examine, you can；
3. embedding：Intermediate is filtered with 0.22 μm of filter after the assay was approved, visible foreign matters are checked, after bacterial endotoxin is qualified, upper streamline carries out filling, 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 sealed no more than 0.01% after inflated with nitrogen；
4. sterilize：Canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, 121 DEG C are risen to, 15min is kept at 121 DEG C；3~5 DEG C/min of compressed air air blast lowers the temperature, and 8~12min is cooled to 70~80 DEG C, and 2~3 DEG C/min of cooling water coolings, 15~18min is cooled to 30 DEG C, and sterilizing is completed, and is hunted leak by rated condition；
5. check：Sample checks visible foreign matters after sterilizing, and qualified sample will be checked to be packed, full inspection, storage.The present invention has following beneficial effect：
There is levo-oxiracetam injection of the present invention product during storage to be difficult to be oxidized, impurity incrementss are only 0.02% in sterilization process, good stability, it is valid up to more than 18 months, product impurity is few in the term of validity, its total impurities is less than 0.26%, and product main ingredient dissolubility is good, and particulate matter inspection is respectively less than 25 μm, preparation process is simple is feasible, is worth marketing.
Specific embodiment
The present invention is specifically described below by embodiment; be necessary it is pointed out here that be that following examples are served only for being further described the present invention; it is not intended that limiting the scope of the invention; without departing from the spirit and substance of the case in the present invention; the modification or replacement made to the inventive method, step or condition, belong to the scope of the present invention.
Embodiment 1
A kind of levo-oxiracetam injection, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 100g |
| Glycerine | 19g |
| Glycine | 12g |
| Vitamin C | 2g |
| Ethylenediamine tetra-acetic acid | 3g |
| Sterilized water for injection | Add to 1000ml |
It is made 500
Preparation process：
1. concentrated compounding：To the sterilized water for injection that 1/3 recipe quantity is added in material-compound tank, the supplementary material of recipe quantity is added, stirring, dissolving obtains concentrated wiring liquid；
2. it is dilute to match somebody with somebody：Concentrated wiring liquid, plus sodium acid carbonate or salt acid for adjusting pH are taken to 6.0~7.0, add the activated carbon that mass fraction is 0.1%~0.3%, adsorption bleaching to be filtered with 0.45 μm of filter membrane, collect filtrate, add sterilized water for injection to prescription, test qualified through middle product examine, you can；
3. embedding：Intermediate is filtered with 0.22 μm of filter after the assay was approved, visible foreign matters are checked, after bacterial endotoxin is qualified, upper streamline carries out filling, 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 sealed no more than 0.01% after inflated with nitrogen；
4. sterilize：Canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, 121 DEG C are risen to, 15min is kept at 121 DEG C；3~5 DEG C/min of compressed air air blast lowers the temperature, and 8~12min is cooled to 70~80 DEG C, and 2~3 DEG C/min of cooling water coolings, 15~18min is cooled to 30 DEG C, and sterilizing is completed, and is hunted leak by rated condition.
5. check：Sample checks visible foreign matters after sterilizing, and qualified sample will be checked to be packed, full inspection, storage.
In order to be better understood from the present invention, the beneficial effect of invention medicine, rather than limitation of the present invention are expanded on further below by way of stability test of the present invention.
Experiment one：A kind of levo-oxiracetam injection stability experiment of the present invention
Experiment material：
Levo-oxiracetam injection liquid samples：For embodiment 1 is obtained
Acceleration study method：Levo-oxiracetam parenteral solution obtained in embodiment 1 is packed by listing, is put in Acceleration study case, certain hour sampling is tested to investigation project.
Acceleration study temperature：40±2℃
Humidity：RH75% ± 5%
The investigation time：0th, 1,2,3, June
Inspection target：Proterties, visible foreign matters, pH, relevant material, content, sterility test
Accelerated test stability is recorded：
Acceleration study result shows：Accelerate June sample suitable with 0 month sample items Testing index quality, show this product Acceleration study June, quality keeps stabilization, and this product stability is preferable.
Long-term experiment method：Levo-oxiracetam parenteral solution obtained in embodiment 1 is packed by listing, is put in the long-term case that keeps sample, certain hour sampling is tested to investigation project.
Acceleration study temperature：25±2℃
Humidity：RH60% ± 10%
The investigation time：0th, 3,6,9,12,18 months
Inspection target：Proterties, visible foreign matters, pH, relevant material, content, sterility test
Long term test stability is recorded：
Long term test shows：This product long term test 18 months proterties, visible foreign matters, particulate matter, pH value, relevant material, content and sterility test indices meet every relevant regulations of production quality standard draft without significant changes.18 months steady qualities of this product long term test, therefore minimum 18 months of this product term of validity, long term test is still during continuing to investigate.
Experiment two：A kind of levo-oxiracetam parenteral solution sterilization process of the present invention is on the increased influence of impurity
1. experiment material：
Levo-oxiracetam injection liquid samples：Prepared by embodiment 1.
Levo-oxiracetam parenteral solution control sample 1：To lack the sample of vitamin C and ethylenediamine tetra-acetic acid, its preparation technology is with embodiment 1.
Levo-oxiracetam parenteral solution control sample 2：It is the prescription of embodiment 1, sterilising temp is 115 DEG C, and sterilization time is 32 minutes, obtained product.
2. experimental technique：In the preparation process of embodiment 1, sample afterwards before sterilization respectively, detect it about material, investigate sterilizing front and rear to the influence about material.Meanwhile, the prescription for lacking vitamin C and ethylenediamine tetra-acetic acid is taken as control prescription, prepared by the preparation method of embodiment 1, equally sampling detects it about material afterwards before sterilization, investigates sterilization process to the influence about material.Meanwhile, the prescription of Example 1 is changed to 115 DEG C according to sterilising temp, and sterilization time prepared sample for 32 minutes, and sampling detects relevant material afterwards before sterilization respectively, investigated sterilization process to the influence about material.
3. experimental result see the table below：
4. experiment conclusion：The prescription of embodiment 1, coordinates specific sterilization process, and it is only 0.02% that relevant material increases, hence it is evident that better than other two control samples.
Embodiment 2
A kind of levo-oxiracetam injection, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 100g |
| Glycerine | 17g |
| Glycine | 10g |
| Vitamin C | 2g |
| Ethylenediamine tetra-acetic acid | 3g |
| Sterilized water for injection | Add to 1000ml |
It is made 500
Preparation process：Preparation technology according to embodiment 1 is obtained.
By the test method of embodiment 1, the influence experiment increased on impurity of stability test investigation and sterilization process is carried out respectively, stability test result shows to accelerate June sample quality stabilization, long-term 18 months steady qualities, therefore minimum 18 months of this product term of validity.Sterilization process influence result of the test increased on impurity shows the prescription of embodiment 2, coordinates specific sterilization process, and relevant material increase is substantially better than its control sample.
Embodiment 3
A kind of levo-oxiracetam injection, is obtained according to the following steps：
| Composition | Consumption |
| Levo-oxiracetam | 100g |
| Glycerine | 18g |
| Glycine | 10g |
| Vitamin C | 2g |
| Ethylenediamine tetra-acetic acid | 3g |
| Sterilized water for injection | Add to 1000ml |
It is made 500
Preparation process：Preparation technology according to embodiment 1 is obtained.
By the test method of embodiment 1, the influence experiment increased on impurity of stability test investigation and sterilization process is carried out respectively, stability test result shows to accelerate June sample quality stabilization, long-term 18 months steady qualities, therefore minimum 18 months of this product term of validity.Sterilization process influence result of the test increased on impurity shows the prescription of embodiment 3, coordinates specific sterilization process, and relevant material increase is substantially better than its control sample.
Embodiment 4-6：A kind of levo-oxiracetam injection, is prepared by the supplementary material of following weight, and preparation method is with embodiment 1：
| Embodiment | Levo-oxiracetam | Glycerine | Glycine | Vitamin C | Ethylenediamine tetra-acetic acid | Sterilized water for injection |
| 4 | 100g | 18g | 12g | 3g | 3g | Add water to 1000ml |
| 5 | 100g | 20g | 10g | 3g | 3g | Add water to 1000ml |
| 6 | 100g | 17g | 11g | 2g | 3g | Add water to 1000ml |
By the test method of embodiment 1, the influence experiment increased on impurity of stability test investigation and sterilization process is carried out respectively, the sample stability result of the test of embodiment 4,5,6 shows to accelerate June sample quality stabilization, long-term 18 months steady qualities, therefore minimum 18 months of this product term of validity.Sterilization process influence result of the test increased on impurity shows the prescription of embodiment 4,5,6, coordinates specific sterilization process, and relevant material increase is substantially better than its control sample.
Claims (3)
1. a kind of levo-oxiracetam injection, it is characterised in that：It is with levo-oxiracetam, glycerine, mannitol, vitamin, ethylenediamine tetra-acetic acid as supplementary material, by concentrated compounding, it is dilute match somebody with somebody, embedding, sterilizing, test package step be obtained；The levo-oxiracetam 72% ~ 78% that the consumption of wherein described supplementary material is weight percentage, glycerine 12% ~ 16%, glycine 7% ~ 13%, vitamin C 1% ~ 5%, ethylenediamine tetra-acetic acid 2% ~ 7%；Wherein described sterilization steps are that canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, 121 DEG C are risen to, 15min is kept at 121 DEG C；3 ~ 5 DEG C/min of compressed air air blast lowers the temperature, and 8 ~ 12min is cooled to 70 ~ 80 DEG C, and 2 ~ 3 DEG C/min of cooling water coolings, 15 ~ 18min is cooled to 30 DEG C, and sterilizing is completed.
2. levo-oxiracetam injection as claimed in claim 1, it is characterised in that it is obtained by the supplementary material of following significant percentage：Levo-oxiracetam 73% ~ 76%, glycerine 13% ~ 15%, glycine 7% ~ 11%, vitamin C 1% ~ 3%, ethylenediamine tetra-acetic acid 2% ~ 5% takes above-mentioned supplementary material and is placed in material-compound tank, adds sterilized water for injection, and stirring, dissolving obtains concentrated wiring liquid；Concentrated wiring liquid, plus sodium acid carbonate or salt acid for adjusting pH are taken to 6.0 ~ 7.0, add the activated carbon that mass fraction is 0.1% ~ 0.3%, adsorption bleaching to be filtered with 0.45 μm of filter membrane, collect filtrate, add sterilized water for injection to prescription, test qualified through middle product examine, you can；Intermediate is filtered with 0.22 μm of filter after the assay was approved, visible foreign matters are checked, after bacterial endotoxin is qualified, upper streamline carries out filling, 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 sealed no more than 0.01% after inflated with nitrogen；Canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, 121 DEG C are risen to, 15min is kept at 121 DEG C；3 ~ 5 DEG C/min of compressed air air blast lowers the temperature, and 8 ~ 12min is cooled to 70 ~ 80 DEG C, and 2 ~ 3 DEG C/min of cooling water coolings, 15 ~ 18min is cooled to 30 DEG C, and sterilizing is completed, and is hunted leak by rated condition.
3. a kind of preparation method of levo-oxiracetam injection as claimed in claim 1 or 2, it is characterised in that it is obtained as follows：
A. concentrated compounding：To the sterilized water for injection that 1/3 recipe quantity is added in material-compound tank, the supplementary material of recipe quantity is added, stirring, dissolving obtains concentrated wiring liquid；
B. it is dilute to match somebody with somebody：Concentrated wiring liquid, plus sodium acid carbonate or salt acid for adjusting pH are taken to 6.0 ~ 7.0, add the activated carbon that mass fraction is 0.1% ~ 0.3%, adsorption bleaching to be filtered with 0.45 μm of filter membrane, collect filtrate, add sterilized water for injection to prescription, test qualified through middle product examine, you can；
C. embedding：Intermediate is filtered with 0.22 μm of filter after the assay was approved, visible foreign matters are checked, after bacterial endotoxin is qualified, upper streamline carries out filling, 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 sealed no more than 0.01% after inflated with nitrogen；
D. sterilize：Canned peace is cutd open into semi-finished product feeding steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, 121 DEG C are risen to, 15min is kept at 121 DEG C；3 ~ 5 DEG C/min of compressed air air blast lowers the temperature, and 8 ~ 12min is cooled to 70 ~ 80 DEG C, and 2 ~ 3 DEG C/min of cooling water coolings, 15 ~ 18min is cooled to 30 DEG C, and sterilizing is completed, and is hunted leak by rated condition；
E. check：Sample checks visible foreign matters after sterilizing, and qualified sample will be checked to be packed, full inspection, storage.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510510696.7A CN106692041A (en) | 2015-08-19 | 2015-08-19 | Sinistrorse oxiracetam injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510510696.7A CN106692041A (en) | 2015-08-19 | 2015-08-19 | Sinistrorse oxiracetam injection and preparation method thereof |
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| CN106692041A true CN106692041A (en) | 2017-05-24 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201510510696.7A Pending CN106692041A (en) | 2015-08-19 | 2015-08-19 | Sinistrorse oxiracetam injection and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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- 2015-08-19 CN CN201510510696.7A patent/CN106692041A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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Effective date of registration: 20170825 Address after: 400042 Chongqing city Yubei District Qinye Road No. 9 Applicant after: Chongqing Runze Pharmaceutical Co., Ltd. Address before: 400030 Chongqing city Shapingba District Yubei Road No. 50 of No. 13-15-6A Applicant before: DONGZE PHARMACEUTICAL SCIENCE AND TECHNOLOGY CO., LTD. |
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