CN104758260A - Cefoxitin sodium powder-injection for injection and preparation method of cefoxitin sodium powder-injection - Google Patents
Cefoxitin sodium powder-injection for injection and preparation method of cefoxitin sodium powder-injection Download PDFInfo
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- CN104758260A CN104758260A CN201510200611.5A CN201510200611A CN104758260A CN 104758260 A CN104758260 A CN 104758260A CN 201510200611 A CN201510200611 A CN 201510200611A CN 104758260 A CN104758260 A CN 104758260A
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Abstract
The invention relates to a cefoxitin sodium powder-injection for injection and a preparation method of the cefoxitin sodium powder-injection. The preparation method comprises the following steps that cefoxitin sodium is synthesized; synthesized cefoxitin sodium is dried and prepared into powder; and a preparation technology of cefoxitin sodium powder comprising the following steps is performed: a reagent bottle for containing the cefoxitin sodium powder is cleaned; the cefoxitin sodium powder is put in the cleaned reagent bottle by specification and quantitatively; nitrogen is charged into the reagent bottle; a rubber plug after pretreatment is put on the reagent bottle; cap bonding treatment is performed with an aluminium cap to seal the product; the reagent bottle after the cap bonding are sequentially pasted with an internal tag, packed and subjected to lamp examination; an external tag is pasted on a packing box; inspection and packaging are performed. The cefoxitin sodium powder-injection for injection and the preparation method of the cefoxitin sodium powder-injection solves the problem that the medicinal effect of cefoxitin sodium for injection is reduced resulting from the existing cefoxitin sodium powder-injection for injection and the preparation method of the existing cefoxitin sodium powder-injection.
Description
Technical field
The present invention relates to medical drugs preparation technology field, particularly, relate to a kind of cefoxitin sodium for injection injectable powder and preparation method thereof.
Background technology
Cefoxitin sodium is semi-synthetic second generation cephalosporin, it is a kind of cephamycin, developed by Merck & Co., Inc., and in Britain, many countries such as Canadian, Italian listing, cefoxitin sodium is head moldin antibiotics, acts on similar to second generation cephalosporin, and its anaerobe resistant effect is better than second generation cephalosporin.Cefoxitin sodium is a safety and all confirmed medicine with bright market prospects of curative effect, has height broad-spectrum antibacterial action to Major Clinical pathogenic bacterium.
Cefoxitin sodium be suitable for symptom: for the pneumonia caused by sensitive bacterial and other lower respiratory infection, urinary tract infection, meningitis, septicemia, abdominal cavity infection, pelvic infection, skin soft-tissue infection, reproductive tract infection, bone and the infection of joint etc.
The effect and the safety that how to improve injecting drug use always are that pharmaceutical producing enterprise wishes the problem solved, the effect of injecting drug use solves from two aspects with safety is main, one is effect and the safety that Formulation guarantees medication, and two is effect and the safety that the process for producing of medicine guarantees medicine.Cefoxitin sodium for injection is a most existing injection agent, and its prescription is single, guarantees that the effect of its medicine and safe main path are exactly by controlling its preparation technology.
The medicinal effects of the cefoxitin sodium for injection that existing cefoxitin sodium for injection injectable powder and preparation method thereof causes reduces.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of cefoxitin sodium for injection injectable powder, the problem reduced with the medicinal effects overcoming the cefoxitin sodium for injection that existing cefoxitin sodium for injection injectable powder and preparation method thereof causes.
The present invention also comprises the preparation method of cefoxitin sodium for injection injectable powder.
The present invention's adopted technical scheme that solves the problem is: cefoxitin sodium for injection injectable powder, is become the preparation of different size by sterile raw material cefoxitin sodium direct packaging, the dosage form of said preparation is injectable powder.
The preparation method of cefoxitin sodium for injection injectable powder, comprises the following steps:
(1), the experiment synthesis of cefoxitin sodium: taking 35g acetyl group cephalothin acid, to add temperature be in the tetrahydrofuran solution 380mL of 50 DEG C, stir 30min, keep temperature, slowly add CSI27g, add rear maintenance said temperature and continue reaction 60min, liquid phase test sample reactant purity is less than 2%, add water 150mL, temperature is raised 10 DEG C, keep thermotonus 90min, add ethyl acetate 750mL, 10% sodium-chloride water solution 750mL layering, ethyl acetate layer 20% sodium chloride solution 2000mL washes twice, add purified water 200mL, regulate pH to 7.2 with sodium bicarbonate, isolate water layer, be 1.8 with hcl acidifying to pH, leach crystallization, obtain cefoxitin acid wet product, wet product is dissolved in 230mL methanol, temperature is kept to be 25 DEG C, the acetone soln 100mL containing Sodium isooctanoate. 20g that slow dropping is solvent in advance, add after rear maintenance temperature stirs 1h and filter, vacuum drying white solid is cefoxitin sodium, the ratio row that commercial production is empirically synthesized are multiplied,
(2), the cefoxitin sodium of synthesis dried and be prepared into Powdered;
(3), the preparation technology of cefoxitin sodium: first cleaning is used for the reagent bottle of splendid attire cefoxitin sodium powder, then cefoxitin sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and be filled with nitrogen, then pretreated plug is covered, Zha Gai process is carried out again with aluminium lid, product is sealed, interior label, packaging, lamp inspection are pasted successively to the reagent bottle after Zha Gai, then label outer on packing box, then test, lid of packing.The medicinal effects of the cefoxitin sodium for injection that the preparation technology of existing cefoxitin sodium for injection causes reduces.The present invention strictly carries out handle control to each operation in the preparation technology of cefoxitin sodium, from wash bottle, subpackage, Zha Gai to outer package, all sterilization treatment is carried out to working environment from use equipment, the problem that its result of use avoiding the performance impairment of the cefoxitin sodium caused in son preparation process to cause reduces, so, the problem of the medicinal effects reduction of the cefoxitin sodium for injection that the preparation technology that instant invention overcomes existing cefoxitin sodium for injection causes.
Further, the cleaning process of reagent bottle is followed successively by supersound washing, Shui Chong, air oven dry, oven for drying, sterilizing.Guarantee the thoroughly clean of reagent bottle and gnotobasis, avoid reagent bottle to have influence on the quality of cefoxitin sodium.
Further, the temperature of oven for drying is set to 180 DEG C ~ 230 DEG C.High temperature sterilization, if the too high meeting flying temperature setting causes having influence on the use of reagent bottle.
Further, sterilizing adopts dry heat sterilization.The sterilization effect of dry heat sterilization is good and can not cause the humidity in reagent bottle.
Further, the plug of reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilization treatment.Plug is avoided to have influence on the use of reagent bottle.
Further, aluminium lid need pass through and process, and pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
To sum up, the invention has the beneficial effects as follows:
1, the present invention strictly carries out handle control to each operation in the preparation technology of cefoxitin sodium, from wash bottle, subpackage, Zha Gai to outer package, all sterilization treatment is carried out to working environment, the problem that its result of use avoiding the performance impairment of the cefoxitin sodium caused in son preparation process to cause reduces from use equipment.
2, the present invention is by all carrying out sterilization treatment to the plug of reagent bottle, Zha Gai and aluminium lid, avoids the problem of the performance impairment of the cefoxitin sodium caused because of reagent bottle.
Detailed description of the invention
Below in conjunction with embodiment, to the detailed description further of invention do, but embodiments of the present invention are not limited thereto.
Embodiment:
Cefoxitin sodium for injection injectable powder, is become the preparation of different size by sterile raw material cefoxitin sodium direct packaging, the dosage form of said preparation is injectable powder.
The preparation method of cefoxitin sodium for injection injectable powder, comprises the following steps:
(1), the experiment synthesis of cefoxitin sodium: taking 35g acetyl group cephalothin acid, to add temperature be in the tetrahydrofuran solution 380mL of 50 DEG C, stir 30min, keep temperature, slowly add CSI27g, add rear maintenance said temperature and continue reaction 60min, liquid phase test sample reactant purity is less than 2%, add water 150mL, temperature is raised 10 DEG C, keep thermotonus 90min, add ethyl acetate 750mL, 10% sodium-chloride water solution 750mL layering, ethyl acetate layer 20% sodium chloride solution 2000mL washes twice, add purified water 200mL, regulate pH to 7.2 with sodium bicarbonate, isolate water layer, be 1.8 with hcl acidifying to pH, leach crystallization, obtain cefoxitin acid wet product, wet product is dissolved in 230mL methanol, temperature is kept to be 25 DEG C, the acetone soln 100mL containing Sodium isooctanoate. 20g that slow dropping is solvent in advance, add after rear maintenance temperature stirs 1h and filter, vacuum drying white solid is cefoxitin sodium, the ratio row that commercial production is empirically synthesized are multiplied,
(2), the cefoxitin sodium of synthesis dried and be prepared into Powdered;
(3), the preparation technology of cefoxitin sodium: first cleaning is used for the reagent bottle of splendid attire cefoxitin sodium powder, the cleaning process of reagent bottle is followed successively by supersound washing, water rushes, air is dried, oven for drying, dry heat sterilization, the temperature of oven for drying is set to 180 DEG C, then cefoxitin sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and be filled with nitrogen, then pretreated plug is covered, Zha Gai process is carried out again with aluminium lid, product is sealed, successively interior label is pasted to the reagent bottle after Zha Gai, packaging, lamp inspection, then label outer on packing box, test again, packing, the plug of described reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilization treatment, described aluminium lid need pass through and process, pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
As mentioned above, the present invention can be realized preferably.
Claims (7)
1. cefoxitin sodium for injection injectable powder, is characterized in that, is become the preparation of different size by sterile raw material cefoxitin sodium direct packaging, and the dosage form of said preparation is injectable powder.
2. the preparation method of cefoxitin sodium for injection injectable powder, is characterized in that, comprises the following steps:
(1), the experiment synthesis of cefoxitin sodium: taking 35g acetyl group cephalothin acid, to add temperature be in the tetrahydrofuran solution 380mL of 50 DEG C, stir 30min, keep temperature, slowly add CSI27g, add rear maintenance said temperature and continue reaction 60min, liquid phase test sample reactant purity is less than 2%, add water 150mL, temperature is raised 10 DEG C, keep thermotonus 90min, add ethyl acetate 750mL, 10% sodium-chloride water solution 750mL layering, ethyl acetate layer 20% sodium chloride solution 2000mL washes twice, add purified water 200mL, regulate pH to 7.2 with sodium bicarbonate, isolate water layer, be 1.8 with hcl acidifying to pH, leach crystallization, obtain cefoxitin acid wet product, wet product is dissolved in 230mL methanol, temperature is kept to be 25 DEG C, the acetone soln 100mL containing Sodium isooctanoate. 20g that slow dropping is solvent in advance, add after rear maintenance temperature stirs 1h and filter, vacuum drying white solid is cefoxitin sodium, the ratio row that commercial production is empirically synthesized are multiplied,
(2), the cefoxitin sodium of synthesis dried and be prepared into Powdered;
(3), the preparation technology of cefoxitin sodium: first cleaning is used for the reagent bottle of splendid attire cefoxitin sodium powder, then cefoxitin sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and be filled with nitrogen, then pretreated plug is covered, Zha Gai process is carried out again with aluminium lid, product is sealed, interior label, packaging, lamp inspection are pasted successively to the reagent bottle after Zha Gai, then labels outer on packing box, then test, pack.
3. the preparation method of cefoxitin sodium for injection injectable powder according to claim 2, is characterized in that, the cleaning process of described reagent bottle is followed successively by supersound washing, Shui Chong, air oven dry, oven for drying, sterilizing.
4. the preparation method of cefoxitin sodium for injection injectable powder according to claim 3, is characterized in that, the temperature of described oven for drying is set to 180 DEG C ~ 230 DEG C.
5. the preparation method of cefoxitin sodium for injection injectable powder according to claim 3, is characterized in that, described sterilizing adopts dry heat sterilization.
6. the preparation method of cefoxitin sodium for injection injectable powder according to claim 2, is characterized in that, the plug of described reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilization treatment.
7. the preparation method of the cefoxitin sodium for injection injectable powder according to claim 2 or 6, it is characterized in that, described aluminium lid need pass through and process, pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510200611.5A CN104758260A (en) | 2015-04-27 | 2015-04-27 | Cefoxitin sodium powder-injection for injection and preparation method of cefoxitin sodium powder-injection |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050031544A1 (en) * | 2003-08-07 | 2005-02-10 | Njemanze Philip Chidi | Receptor mediated nanoscale copolymer assemblies for diagnostic imaging and therapeutic management of hyperlipidemia and infectious diseases |
| CN101780045A (en) * | 2009-01-16 | 2010-07-21 | 海南中化联合制药工业有限公司 | Cefoxitin sodium powder-needle preparation for injection and preparation method thereof |
| CN102895182A (en) * | 2012-10-22 | 2013-01-30 | 四川制药制剂有限公司 | Method for preparing cefoxitin sodium for injection |
| CN103271877A (en) * | 2012-12-18 | 2013-09-04 | 张宏民 | Cefoxitin sodium agent and preparation method thereof |
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2015
- 2015-04-27 CN CN201510200611.5A patent/CN104758260A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050031544A1 (en) * | 2003-08-07 | 2005-02-10 | Njemanze Philip Chidi | Receptor mediated nanoscale copolymer assemblies for diagnostic imaging and therapeutic management of hyperlipidemia and infectious diseases |
| CN101780045A (en) * | 2009-01-16 | 2010-07-21 | 海南中化联合制药工业有限公司 | Cefoxitin sodium powder-needle preparation for injection and preparation method thereof |
| CN102895182A (en) * | 2012-10-22 | 2013-01-30 | 四川制药制剂有限公司 | Method for preparing cefoxitin sodium for injection |
| CN103271877A (en) * | 2012-12-18 | 2013-09-04 | 张宏民 | Cefoxitin sodium agent and preparation method thereof |
Non-Patent Citations (2)
| Title |
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| 刘倩，张军立: "头孢西丁的合成研究进展", 《煤炭与化工》 * |
| 王英杰，等: "头孢西丁钠的合成", 《药学与临床》 * |
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Application publication date: 20150708 |