CN101548977B - Composition of cefmetazole acid - Google Patents
Composition of cefmetazole acid Download PDFInfo
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- CN101548977B CN101548977B CN2009100267971A CN200910026797A CN101548977B CN 101548977 B CN101548977 B CN 101548977B CN 2009100267971 A CN2009100267971 A CN 2009100267971A CN 200910026797 A CN200910026797 A CN 200910026797A CN 101548977 B CN101548977 B CN 101548977B
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- cefmetazole acid
- cefmetazole
- aseptic
- acid
- weight ratio
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Abstract
The invention relates to a composition of a cefmetazole acid, which is characterized in that the mix of cefmetazole acid and arginine aseptic powders with the weight ratio of 1: 0.35 to 1:0.70 is dissolved in water. The invention includes the detail steps of weighting 50kg material drug of cefmetazole acid and arginine aseptic powders by the weight percentage of 1: 0.35 to 1:0.70; pouring the material drug in a three-dimensional motion mixer and setting the rotating speed of the three-dimensional motion into 5 rotation per minute; well mixing the material drug for 60 minutes to 90 minutes; discharging the material and sub-packaging the material. The invention has the advantages that the composition improves the quality of products and reduces impurities, the composition markedly improves the stability of product, effectively reduces the content of impurities and solves the problem of water insolvability, and cefmetazole acid is more stable than cefmetazole sodium and can be purified easily; if cefmetazole acid is used to obtain preparation together with arginine proportionally, the all relative material can be stabilized in 2 percent for a long time, thereby reducing the incidence rate of side effects and allergy and achieving actual meaning and value.
Description
Technical field
What the present invention relates to is about a kind of compositions of antibiotics cefmetazole acid, belongs to field of medicine preparing technology.
Background technology
Cefmetazon (Sankyo) (Cefmetazole Sodium) is the novel cephalosporin class antibiotic that three common companies develop alone the earliest.Three altogether companies obtain permission in August, 1978 with the trade name of Cefmetazon, start selling injection from February, 1980.The Cefmetazon (Sankyo) chemistry is by name: sulfur (6R-cis)-7-[[[(cyanogen methyl)] acetyl] amido]-7-methoxy-3-[[(1-methyl isophthalic acid H-5-tetrazole base) sulfur]-methyl]-8-oxo-5-thia-1-azabicyclic [4.2.0] oct-2-ene-2-carboxylic acid sodium salt.
Structural formula is shown below:
Its active component is a cefmetazole acid, but it is water insoluble, and institute thinks convenient the use, makes dosage form with its sodium salt.The employing cefmetazole acid adds sodium carbonate or sodium bicarbonate becomes sodium salt, regulate about pH=6, freeze-dry process is adopted in lyophilizing then, and cefmetazole acid own does not have crystal formation, so less stable, so that its related substances is higher in its quality standard, because increase in freeze-drying process, the Cefmetazon (Sankyo) that adopts lyophilization to make simultaneously is unstable in storage, easily increases related substance, impurity content is than higher, thus in the use secondary reflection and irritated rate than higher.
Summary of the invention
The invention provides the compositions of the high and more stable cefmetazole acid of a kind of large-scale industrial production preferably, product quality.Be intended to overcome the poor stability that prior art is deposited, easily increase related substance, impurity content is than higher, and pair reflects and the more high defective of irritated rate in the use.
Technical scheme of the present invention: a kind of compositions of cefmetazole acid, it is characterized in that the combination of cefmetazole acid and arginine or sodium carbonate or sodium bicarbonate, in water, dissolve; Concrete steps are as follows: in aseptic batch plant, take by weighing cefmetazole acid and arginine or sodium carbonate or the common 50kg of sodium bicarbonate aseptic powder crude drug according to the prescription ratio, pour in the efficient three-dimensional motion mixer, setting the three-dimensional rotating speed that mixes the powder machine is 5 rev/mins, begins to mix the powder operation according to mixed powder packaging standard rule of operation.After being mixed to about 60min～90min mix homogeneously, discharging divides packing.Wherein, the weight ratio of cefmetazole acid aseptic powder and arginine aseptic powder is 1: 0.35～1: 0.70, and optimum weight ratio is 1: 0.40; The weight ratio of cefmetazole acid aseptic powder and sodium carbonate aseptic powder is 1: 0.13～1: 0.20, and optimum weight ratio is 1: 0.14; The weight ratio of cefmetazole acid aseptic powder and sodium bicarbonate aseptic powder is 1: 0.18～1: 0.25, and optimum weight ratio is 1: 0.19.
Advantage of the present invention: Cefmetazon (Sankyo) must adopt the freeze-dry process method in the past, and freeze-dry process does not have crystallization process, did not have crystal formation, and impurity can not effectively be removed, and must carry out lyophilizing under higher pH value, instability, impurity content height.Said composition need not to adopt the freeze-dry process method to improve product quality, reduces impurity; Obviously improved the stability of product, effectively reduce impurity content, solved water-fast problem, cefmetazole acid is more stable than Cefmetazon (Sankyo), easily purification prepares preparation by a certain percentage with arginine, and total related substance can be steady in a long-term in 2%, effectively reduce secondary reflection and anaphylactoid incidence rate, extremely important practical significance is arranged.
The specific embodiment
Example 1
Adopt the cefmetazole acid aseptic powder, regulating granularity and arginine aseptic powder is to mix in 1: 0.35～1: 0.70 according to weight ratio, and dissolves in water.Concrete steps are as follows: in aseptic batch plant, the ratio of taking by weighing is that 1: 0.35～1: 0.70 cefmetazole acid and arginine sterile bulk drug is total to 50kg, pours in the efficient three-dimensional motion mixer.Setting the three-dimensional rotating speed that mixes the powder machine is 5 rev/mins, begins to mix the powder operation according to existing mixed powder packaging standard rule of operation.After being mixed to about 60min～90min mix homogeneously, discharging divides packing.
Optimum weight ratio is 1: 0.40.Because its mol ratio is about 1: 1, about its pH=7 ± 1,, help injection near neutral.Otherwise pH is too high or too low, and stimulation is played in intravenous injection.
Example 2
Adopt the cefmetazole acid aseptic powder, regulate granularity and the weight ratio of sodium carbonate aseptic powder and be 1: 0.13～1: 0.20 and mix, and in water, dissolve.Concrete steps are as follows: in aseptic batch plant, the ratio of taking by weighing is that 1: 0.13～1: 0.20 cefmetazole acid and sodium carbonate sterile bulk drug is total to 50kg, pours in the efficient three-dimensional motion mixer.Setting the three-dimensional rotating speed that mixes the powder machine is 5 rev/mins, begins to mix the powder operation according to mixed powder packaging standard rule of operation.After being mixed to about 60min～90min mix homogeneously, discharging divides packing.
Optimum weight ratio is 1: 0.14.Because its mol ratio is about 1: 1, about its pH=7 ± 1,, help injection near neutral.Otherwise pH is too high or too low, and stimulation is played in intravenous injection.
Example 3
Adopt the cefmetazole acid aseptic powder, regulate granularity and the weight ratio of sodium bicarbonate aseptic powder and be 1: 0.18～1: 0.25 and mix, and in water, dissolve.Concrete steps are as follows: in aseptic batch plant, the ratio of taking by weighing is that 1: 0.18～1: 0.25 cefmetazole acid and sodium bicarbonate sterile bulk drug is total to 50kg, pours in the efficient three-dimensional motion mixer.Setting the three-dimensional rotating speed that mixes the powder machine is 5 rev/mins, begins to mix the powder operation according to mixed powder packaging standard rule of operation.After being mixed to about 60min～90min mix homogeneously, discharging divides packing.
Optimum weight ratio is 1: 0.19.Because its mol ratio is about 1: 1, about its pH=7 ± 1,, help injection near neutral.Otherwise pH is too high or too low, and stimulation is played in intravenous injection.
Claims (3)
1. the compositions of a cefmetazole acid, the weight ratio that it is characterized in that cefmetazole acid aseptic powder and arginine aseptic powder is 1: 0.40, can in water, dissolve, and make as follows: in aseptic batch plant, take by weighing weight ratio and be 1: 0.40 cefmetazole acid aseptic powder and arginine aseptic powder crude drug 50kg altogether, pour in the efficient three-dimensional motion mixer, the rotating speed of setting efficient three-dimensional motion mixer is 5 rev/mins, after mixing 60min～90min mix homogeneously, discharging divides packing.
2. the compositions of a cefmetazole acid, the weight ratio that it is characterized in that cefmetazole acid aseptic powder and sodium carbonate aseptic powder is 1: 0.14, can in water, dissolve, and make as follows: in aseptic batch plant, take by weighing weight ratio and be 1: 0.14 cefmetazole acid aseptic powder and sodium carbonate aseptic powder crude drug 50kg altogether, pour in the efficient three-dimensional motion mixer, the rotating speed of setting efficient three-dimensional motion mixer is 5 rev/mins, after mixing 60min～90min mix homogeneously, discharging divides packing.
3. the compositions of a cefmetazole acid, the weight ratio that it is characterized in that cefmetazole acid aseptic powder and sodium bicarbonate aseptic powder is 1: 0.19, can in water, dissolve, and make as follows: in aseptic batch plant, take by weighing weight ratio and be 1: 0.19 cefmetazole acid aseptic powder and sodium bicarbonate aseptic powder crude drug 50kg altogether, pour in the efficient three-dimensional motion mixer, the rotating speed of setting efficient three-dimensional motion mixer is 5 rev/mins, after mixing 60min～90min mix homogeneously, discharging divides packing.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100267971A CN101548977B (en) | 2009-05-06 | 2009-05-06 | Composition of cefmetazole acid |
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| CN2009100267971A CN101548977B (en) | 2009-05-06 | 2009-05-06 | Composition of cefmetazole acid |
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| CN101548977A CN101548977A (en) | 2009-10-07 |
| CN101548977B true CN101548977B (en) | 2011-04-20 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862296B (en) * | 2010-07-09 | 2011-06-22 | 山东罗欣药业股份有限公司 | Cefmetazole sodium composition powder injection for injection |
| CN102526741A (en) * | 2010-12-09 | 2012-07-04 | 单爱莲 | Composition of arginine and series of cephalosporin acids |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1526396A (en) * | 2003-03-03 | 2004-09-08 | 中国医药集团总公司四川抗菌素工业研 | New prepn form of cefmenoxime hydrochloride for injection |
| CN1706387A (en) * | 2004-06-09 | 2005-12-14 | 北京盛世伟唐科技有限公司 | Stable cephalosporin powder injection |
| CN101036657A (en) * | 2006-03-15 | 2007-09-19 | 广州白云山天心制药股份有限公司 | Stable cefoperazone medicine prparation |
-
2009
- 2009-05-06 CN CN2009100267971A patent/CN101548977B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1526396A (en) * | 2003-03-03 | 2004-09-08 | 中国医药集团总公司四川抗菌素工业研 | New prepn form of cefmenoxime hydrochloride for injection |
| CN1706387A (en) * | 2004-06-09 | 2005-12-14 | 北京盛世伟唐科技有限公司 | Stable cephalosporin powder injection |
| CN101036657A (en) * | 2006-03-15 | 2007-09-19 | 广州白云山天心制药股份有限公司 | Stable cefoperazone medicine prparation |
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Owner name: SINOPHARM GROUP ZHIJUN (SUZHOU) PHARMACEUTICAL CO. Free format text: FORMER NAME: SUZHOU ZHIJUN WANQING PHARMACEUTICAL CO., LTD. |
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Address after: 215415 Taicang Regal Economic Development Zone, Jiangsu Patentee after: Sinopharm (Suzhou) Pharmaceutical Co., Ltd. Address before: 215415 Taicang Regal Economic Development Zone, Jiangsu Patentee before: Suzhou Zhijun Wanqing Pharmaceutical Co., Ltd. |
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Granted publication date: 20110420 Termination date: 20160506 |