CN102920671A - Cefmetazole sodium for injection - Google Patents
Cefmetazole sodium for injection Download PDFInfo
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- CN102920671A CN102920671A CN2012104468026A CN201210446802A CN102920671A CN 102920671 A CN102920671 A CN 102920671A CN 2012104468026 A CN2012104468026 A CN 2012104468026A CN 201210446802 A CN201210446802 A CN 201210446802A CN 102920671 A CN102920671 A CN 102920671A
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- cefmetazole
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Abstract
The invention provides cefmetazole sodium for injection. Cefmetazole sodium sterile packaging preparation is dissolved in water for injection and then mixed with freeze-dried adjuvant, and by means of combination and adoption of a specific ultralow temperature freeze-drying process, the cefmetazole sodium for the injection, which is good in uniformity, high in purity and stability is obtained.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to the cefmetazole for inj injectable powder product of a kind of cefmetazole for inj and preparation method thereof and described method preparation.
Background technology
Cefmetazole chemistry (6R by name, 7S)-and 7-[2-[(cyanogen methyl) sulfo-] acetamido]-7-methoxyl group-3-[[(1-methyl isophthalic acid H-tetrazolium-5-yl) sulfo-] methyl]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid sodium salt, molecular formula is C
15H
16N
7NaO
5S
3, molecular mass is 493.52.
Cefmetazole is a kind of wide spectrum, efficient, low toxicity antibiotic, and its antimicrobial spectrum is similar to cefoxitin, and performance is close with the 2nd generation cephalosporin.It all has antibacterial action to Gram-positive and negative bacterium, anaerobe; Staphylococcus, Hemolytic streptococcus, escherichia coli, pneumobacillus, klebsiella bacillus, indole feminine gender and positive Bacillus proteus etc. there is good antibacterial activity.
Commercially available medicine is generally with the Cefmetazon (Sankyo) sterile packaged preparation or uses the directly aseptic freeze-dried powder of preparation of cryotherapy forming technique at present, that yet freeze-dried powder exists is inhomogeneous, color and luster is relatively poor, pure loading amount is variant, the problem of clarity, the product purity of preparation is lower, the stability problem of material is not solved fully, still is difficult for the problems such as long preservation.Need in this area to address these problems.
Summary of the invention
The invention provides a kind of new cefmetazole for inj, after the Cefmetazon (Sankyo) sterile packaged preparation being dissolved in water for injection, mix with the lyophilizing adjuvant, in conjunction with adopting specific ultralow temperature lyophilizing program, a kind of good uniformity, high-purity and the high cefmetazole for inj of stability have been obtained.
Particularly, the invention provides a kind of cefmetazole for inj, it prepares by the following method:
(1) the Cefmetazon (Sankyo) sterile packaged preparation is dissolved in the water for injection, concentration is controlled at 100-700 g/L;
(2) add mannitol and sodium benzoate, concentration is controlled at respectively 10-60 g/L and 1-15 g/L;
(3) DisodiumHydrogen Citrate of usefulness mol ratio 1:4/trisodium citrate buffer is regulated about pH value to 7.0;
(4) solution that obtains is carried out aseptic filtration;
(5) adopt following lyophilizing parameter to carry out lyophilization:
(i) filtrate after the aseptic filtration is filled in the lyophilizing dish about 10 mm of every dish dress liquid thickness;
When (ii) the flaggy temperature is down to below-30 ℃ the lyophilizing dish is put into freeze drying box;
(iii) continue cooling, product temperature is opened vacuum system after reaching-40 ℃, and vacuum reaches about 50Pa and begins sublimation drying when following in the case;
(iv) under the condition that keeps the following vacuum of 50Pa, slowly heat up;
(v) shelf temperature rises to the highest design temperature (between 45 ~ 50 ℃) below 50 ℃, when products temperature is higher than 40 ℃, is incubated 4 ~ 6 hours, and whole freeze-drying time is 25 ~ 28 hours; And
(6) collect lyophilized products, crushing screening obtains the cefmetazole for inj finished product.
Described DisodiumHydrogen Citrate/trisodium citrate buffer is dissolved in 13 g DisodiumHydrogen Citrates and 60 g trisodium citrates in the 2000 ml waters for injection and obtains.
The present invention also provides a kind of method for preparing cefmetazole for inj, and it may further comprise the steps:
(1) the Cefmetazon (Sankyo) sterile packaged preparation is dissolved in the water for injection, concentration is controlled at 100-700 g/L;
(2) add mannitol and sodium benzoate, concentration is controlled at respectively 10-60 g/L and 1-15 g/L;
(3) DisodiumHydrogen Citrate of usefulness mol ratio 1:4/trisodium citrate buffer is regulated about pH value to 7.0;
(4) solution that obtains is carried out aseptic filtration;
(5) adopt following lyophilizing parameter to carry out lyophilization:
(i) filtrate after the aseptic filtration is filled in the lyophilizing dish about 10 mm of every dish dress liquid thickness;
When (ii) the flaggy temperature is down to below-30 ℃ the lyophilizing dish is put into freeze drying box;
(iii) continue cooling, product temperature is opened vacuum system after reaching-40 ℃, and vacuum reaches about 50Pa and begins sublimation drying when following in the case;
(iv) under the condition that keeps the following vacuum of 50Pa, slowly heat up;
(v) shelf temperature rises to the highest design temperature (between 45 ~ 50 ℃) below 50 ℃, when products temperature is higher than 40 ℃, is incubated 4 ~ 6 hours, and whole freeze-drying time is 25 ~ 28 hours; And
(6) collect lyophilized products, crushing screening obtains the cefmetazole for inj finished product.
The present invention also provides the cefmetazole for inj that obtains according to described method.
Embodiment
Embodiment 1: the preparation of cefmetazole for inj
The aseptic Cefmetazon (Sankyo) of 200 g is dissolved in the water for injection, adds 20g mannitol and 2g sodium benzoate and stir, add water for injection to the 1L volume, the DisodiumHydrogen Citrate of usefulness mol ratio 1:4/trisodium citrate buffer is adjusted pH value to 7.0.Carry out aseptic filtration with 0.22 μ m filter.Lyophilization is carried out in the filtrate sabot.Every dish dress liquid thickness is about 10mm.Product sabot inlet when the flaggy temperature is down to below-30 ℃.Continue cooling, (need approximately 1.5 ~ 2h) to open vacuum systems, vacuum reached about 50Pa and begins sublimation drying when following in the case, for the phase I drying (approximately need 11 ~ 13h) after product temperature reached-40 ℃.Second stage is dry, slowly heats up under the condition that keeps the following vacuum of 50Pa, begins adsorption stripping and dry in the time of more than the product temperature to 0 ℃.Shelf temperature when products temperature is higher than 40 ℃, is incubated 4 ~ 6 hours to the highest design temperature (between 45 ~ 50 ℃) below 50 ℃, and the whole time is 25 ~ 28 hours.Lyophilized powder is packed in the stainless steel cask of finished product special use after sterilizing in will coil after lyophilizing finishes.Pouring crushing and pelletizing machine into sieves through 40 orders.Make the cefmetazole for inj injectable powder.
[0010]Embodiment 2
The aseptic Cefmetazon (Sankyo) of 400 g is dissolved in the water for injection, adds 15g mannitol and 1g sodium benzoate and stir, add water for injection to the 1L volume, the DisodiumHydrogen Citrate of usefulness mol ratio 1:4/trisodium citrate buffer is adjusted pH value to 7.0.Carry out aseptic filtration with 0.22 μ m filter.Lyophilization is carried out in the filtrate sabot.Every dish dress liquid thickness is about 10mm.Product sabot inlet when the flaggy temperature is down to below-30 ℃.Continue cooling, (need approximately 1.5 ~ 2h) to open vacuum systems, vacuum reached about 50Pa and begins sublimation drying when following in the case, for the phase I drying (approximately need 11 ~ 13h) after product temperature reached-40 ℃.Second stage is dry, slowly heats up under the condition that keeps the following vacuum of 50Pa, begins adsorption stripping and dry in the time of more than the product temperature to 0 ℃.Shelf temperature when products temperature is higher than 40 ℃, is incubated 4 ~ 6 hours to the highest design temperature (between 45 ~ 50 ℃) below 50 ℃, and the whole time is 25 ~ 28 hours.Lyophilized powder is packed in the stainless steel cask of finished product special use after sterilizing in will coil after lyophilizing finishes.Pouring crushing and pelletizing machine into sieves through 40 orders.Make the cefmetazole for inj injectable powder.
Embodiment 3
The aseptic Cefmetazon (Sankyo) of 250 g is dissolved in the water for injection, adds 25 g mannitol and 2g sodium benzoate and stir, add water for injection to the 1L volume, the DisodiumHydrogen Citrate of usefulness mol ratio 1:4/trisodium citrate buffer is adjusted pH value to 7.0.Carry out aseptic filtration with 0.22 μ m filter.Lyophilization is carried out in the filtrate sabot.Every dish dress liquid thickness is about 10mm.Product sabot inlet when the flaggy temperature is down to below-30 ℃.Continue cooling, (need approximately 1.5 ~ 2h) to open vacuum systems, vacuum reached about 50Pa and begins sublimation drying when following in the case, for the phase I drying (approximately need 11 ~ 13h) after product temperature reached-40 ℃.Second stage is dry, slowly heats up under the condition that keeps the following vacuum of 50Pa, begins adsorption stripping and dry in the time of more than the product temperature to 0 ℃.Shelf temperature when products temperature is higher than 40 ℃, is incubated 4 ~ 6 hours to the highest design temperature (between 45 ~ 50 ℃) below 50 ℃, and the whole time is 25 ~ 28 hours.Lyophilized powder is packed in the stainless steel cask of finished product special use after sterilizing in will coil after lyophilizing finishes.Pouring crushing and pelletizing machine into sieves through 40 orders.Make the cefmetazole for inj injectable powder.
Test through the injectable powder that embodiment 1-3 is made, we have prepared uniform particles, highly purified cefmetazole for inj injectable powder, and it has, and impurity content is low, stability is high and dissolve rapidly characteristics.
Claims (4)
1. cefmetazole for inj, it prepares by the following method:
(1) the Cefmetazon (Sankyo) sterile packaged preparation is dissolved in the water for injection, concentration is controlled at 100-700 g/L;
(2) add mannitol and sodium benzoate, concentration is controlled at respectively 10-60 g/L and 1-15 g/L;
(3) DisodiumHydrogen Citrate of usefulness mol ratio 1:4/trisodium citrate buffer is regulated about pH value to 7.0;
(4) solution that obtains is carried out aseptic filtration;
(5) adopt following lyophilizing parameter to carry out lyophilization:
(i) filtrate after the aseptic filtration is filled in the lyophilizing dish about 10 mm of every dish dress liquid thickness;
When (ii) the flaggy temperature is down to below-30 ℃ the lyophilizing dish is put into freeze drying box;
(iii) continue cooling, product temperature is opened vacuum system after reaching-40 ℃, and vacuum reaches about 50Pa and begins sublimation drying when following in the case;
(iv) under the condition that keeps the following vacuum of 50Pa, slowly heat up;
(v) shelf temperature rises to the highest design temperature (between 45 ~ 50 ℃) below 50 ℃, when products temperature is higher than 40 ℃, is incubated 4 ~ 6 hours, and whole freeze-drying time is 25 ~ 28 hours; And
(6) collect lyophilized products, crushing screening obtains the cefmetazole for inj finished product.
2. according to claim 1 cefmetazole for inj, wherein said DisodiumHydrogen Citrate/trisodium citrate buffer are dissolved in 13 g DisodiumHydrogen Citrates and 60 g trisodium citrates in the 2000 ml waters for injection and obtain.
3. method for preparing cefmetazole for inj may further comprise the steps:
(1) the Cefmetazon (Sankyo) sterile packaged preparation is dissolved in the water for injection, concentration is controlled at 100-700 g/L;
(2) add mannitol and sodium benzoate, concentration is controlled at respectively 10-60 g/L and 1-15 g/L;
(3) DisodiumHydrogen Citrate of usefulness mol ratio 1:4/trisodium citrate buffer is regulated about pH value to 7.0;
(4) solution that obtains is carried out aseptic filtration;
(5) adopt following lyophilizing parameter to carry out lyophilization:
(i) filtrate after the aseptic filtration is filled in the lyophilizing dish about 10 mm of every dish dress liquid thickness;
When (ii) the flaggy temperature is down to below-30 ℃ the lyophilizing dish is put into freeze drying box;
(iii) continue cooling, product temperature is opened vacuum system after reaching-40 ℃, and vacuum reaches about 50Pa and begins sublimation drying when following in the case;
(iv) under the condition that keeps the following vacuum of 50Pa, slowly heat up;
(v) shelf temperature rises to the highest design temperature (between 45 ~ 50 ℃) below 50 ℃, when products temperature is higher than 40 ℃, is incubated 4 ~ 6 hours, and whole freeze-drying time is 25 ~ 28 hours; And
(6) collect lyophilized products, crushing screening obtains the cefmetazole for inj finished product.
4. according to claim 3 method, described DisodiumHydrogen Citrate/trisodium citrate buffer are dissolved in 13 g DisodiumHydrogen Citrates and 60 g trisodium citrates in the 2000 ml waters for injection and obtain.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104468026A CN102920671A (en) | 2012-11-11 | 2012-11-11 | Cefmetazole sodium for injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104468026A CN102920671A (en) | 2012-11-11 | 2012-11-11 | Cefmetazole sodium for injection |
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| CN102920671A true CN102920671A (en) | 2013-02-13 |
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| CN2012104468026A Pending CN102920671A (en) | 2012-11-11 | 2012-11-11 | Cefmetazole sodium for injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105343017A (en) * | 2015-12-01 | 2016-02-24 | 李正梅 | Freeze-dried powder of antibacterial cefmetazole sodium for injection |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862296A (en) * | 2010-07-09 | 2010-10-20 | 山东罗欣药业股份有限公司 | Cefmetazole sodium composition powder injection for injection |
| CN102204916A (en) * | 2011-04-07 | 2011-10-05 | 罗诚 | Pharmaceutical composition containing cefmetazole sodium compound, and preparation method thereof |
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2012
- 2012-11-11 CN CN2012104468026A patent/CN102920671A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862296A (en) * | 2010-07-09 | 2010-10-20 | 山东罗欣药业股份有限公司 | Cefmetazole sodium composition powder injection for injection |
| CN102204916A (en) * | 2011-04-07 | 2011-10-05 | 罗诚 | Pharmaceutical composition containing cefmetazole sodium compound, and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105343017A (en) * | 2015-12-01 | 2016-02-24 | 李正梅 | Freeze-dried powder of antibacterial cefmetazole sodium for injection |
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Application publication date: 20130213 |