CN104774211A - Preparation technique of cefuroxime sodium for injection - Google Patents
Preparation technique of cefuroxime sodium for injection Download PDFInfo
- Publication number
- CN104774211A CN104774211A CN201510200597.9A CN201510200597A CN104774211A CN 104774211 A CN104774211 A CN 104774211A CN 201510200597 A CN201510200597 A CN 201510200597A CN 104774211 A CN104774211 A CN 104774211A
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- Prior art keywords
- sodium
- cefuroxime
- cefuroxime sodium
- reagent bottle
- preparation technology
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D501/00—Heterocyclic compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring
- C07D501/14—Compounds having a nitrogen atom directly attached in position 7
- C07D501/16—Compounds having a nitrogen atom directly attached in position 7 with a double bond between positions 2 and 3
- C07D501/20—7-Acylaminocephalosporanic or substituted 7-acylaminocephalosporanic acids in which the acyl radicals are derived from carboxylic acids
- C07D501/24—7-Acylaminocephalosporanic or substituted 7-acylaminocephalosporanic acids in which the acyl radicals are derived from carboxylic acids with hydrocarbon radicals, substituted by hetero atoms or hetero rings, attached in position 3
- C07D501/26—Methylene radicals, substituted by oxygen atoms; Lactones thereof with the 2-carboxyl group
- C07D501/34—Methylene radicals, substituted by oxygen atoms; Lactones thereof with the 2-carboxyl group with the 7-amino radical acylated by carboxylic acids containing hetero rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D501/00—Heterocyclic compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring
- C07D501/02—Preparation
- C07D501/04—Preparation from compounds already containing the ring or condensed ring systems, e.g. by dehydrogenation of the ring, by introduction, elimination or modification of substituents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D501/00—Heterocyclic compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring
- C07D501/02—Preparation
- C07D501/12—Separation; Purification
Abstract
The invention relates to a preparation technique of cefuroxime sodium for injection, which comprises the following steps: synthesizing cefuroxime sodium; drying the synthesized cefuroxime sodium to obtain powder; and preparation technique of cefuroxime sodium: cleaning a reagent bottle for containing the cefuroxime sodium powder, quantitatively filling the cefuroxime sodium powder into the cleaned reagent bottle according to the specifications, charging nitrogen into the reagent bottle filled with the cefuroxime sodium powder, covering a pretreated rubber plug, sealing the product by spinning an aluminum cap, attaching an internal label onto the reagent bottle, packing, carrying out lamp inspection, attaching an external label on the packing box, inspecting, and bagging. The technique solves the problem of lower medicinal effect of the cefuroxime sodium for injection due to the existing preparation technique of the cefuroxime sodium for injection.
Description
Technical field
The present invention relates to medical drugs preparation technology field, particularly, relate to a kind of preparation technology of cefuroxime sodium for injection.
Background technology
Cefuroxime sodium, chemistry (6R, 7R)-7-[2-furyl (methoxyimino) kharophen]-3-carbamoyloxymethyl-8-oxo-5-thia-1-azabicyclic [4.2.0] oct-2-ene-2-formic acid sodium salt by name.
Cefuroxime sodium is second generation cephalosporin class microbiotic, similar to first generation cephalosporin or slightly poor to the anti-microbial activity of gram positive coccus, but to the beta lactamase quite stable that staphylococcus and gram negative bacilli produce.Methicillin-resistant Staphylococcus, enterococcus spp and listeria bacteria number resistance, other this this product of positive cocci is responsive.Can be used for the pneumonia caused by sensitive bacterial and other lower respiratory infection, urinary tract infections, meningitis, septicemia, abdominal cavity infection, pelvic infection, skin soft-tissue infection, genital tract infection, bone and the infection of joint etc.This medicine antibacterial is extensively general, and resistant organism is few, is clinical conventional microbiotic.
The effect and the security that how to improve injecting drug use always are that drug manufacturing 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.Cefuroxime 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 effect of the cefuroxime sodium for injection that the preparation technology of existing cefuroxime sodium for injection causes reduces.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation technology of cefuroxime sodium for injection, the problem of the medicinal effect reduction of the cefuroxime sodium for injection caused with the preparation technology overcoming existing cefuroxime sodium for injection.
The present invention's adopted technical scheme that solves the problem is: the preparation technology of cefuroxime sodium for injection, comprises the following steps:
(1), the synthesis of Cefuroxime sodium: add dehydrated alcohol or methyl alcohol, breast in a reservoir
Acid sodium aqueous solution and Sodium isooctanoate, be stirred to Sodium isooctanoate all to dissolve, obtain sodium liquid, wherein, in described sodium liquid, it is 2:43 ~ 43:2 that Sodium isooctanoate and Sodium.alpha.-hydroxypropionate obtain mol ratio, acetone, water and cefuroxime acid is added in another container, stirring makes cefuroxime acid dissolve completely, adds gac, stirs decolouring, filter, obtain cefuroxime acid filtrate, cefuroxime acid filtrate joined in sodium liquid, sodium liquid measure is greater than the amount of cefuroxime acid filtrate, stir, produce precipitation, filter, obtain Cefuroxime sodium wet product;
(2), by the Cefuroxime sodium wet product of synthesis respectively with after the mixed solution washing of methanol/acetone, then with acetone soln washing, dry and be prepared into Powdered;
(3), the preparation technology of head Cefuroxime sodium: first cleaning is used for the reagent bottle of splendid attire Cefuroxime sodium powder, then Cefuroxime sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification, again the reagent bottle that Cefuroxime sodium powder is housed is 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, pack.The medicinal effect of the cefuroxime sodium for injection that the preparation technology of existing cefuroxime sodium for injection causes reduces.The present invention strictly carries out handle control to each operation in the preparation technology of Cefuroxime sodium, from wash bottle, packing, Zha Gai to outer packaging, all sterilising treatment is carried out to Working environment from use equipment, the problem that its result of use avoiding the performance impairment of the Cefuroxime sodium caused in son preparation process to cause reduces, so, the problem of the medicinal effect reduction of the cefuroxime sodium for injection that the preparation technology that instant invention overcomes existing cefuroxime sodium for injection causes.
Further, Sodium isooctanoate and Sodium.alpha.-hydroxypropionate obtain mol ratio is 2:7 ~ 7:2.Sodium isooctanoate and Sodium.alpha.-hydroxypropionate are obtained mol ratio to be set to, into 2:7 ~ 7:2, solution rapid solution can be made.
Further, the solvent temperature of cefuroxime acid is 30 DEG C ~ 35 DEG C.Cefuroxime acid is 30 DEG C ~ 35 DEG C in temperature and has good dissolution rate.
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 Cefuroxime 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, the plug of reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilising 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 Cefuroxime sodium, from wash bottle, packing, Zha Gai to outer packaging, all sterilising treatment is carried out to Working environment, the problem that its result of use avoiding the performance impairment of the Cefuroxime sodium caused in son preparation process to cause reduces from use equipment.
2, the present invention is by all carrying out sterilising treatment to the plug of reagent bottle, Zha Gai and aluminium lid, avoids the problem of the performance impairment of the Cefuroxime sodium caused because of reagent bottle.
Embodiment
Below in conjunction with embodiment, to the detailed description further of invention do, but embodiments of the present invention are not limited thereto.
Embodiment:
The preparation technology of cefuroxime sodium for injection, comprises the following steps:
(1), the synthesis of Cefuroxime sodium: add dehydrated alcohol or methyl alcohol, breast in a reservoir
Acid sodium aqueous solution and Sodium isooctanoate, be stirred to Sodium isooctanoate all to dissolve, solvent temperature is set to 30 DEG C, obtains sodium liquid, wherein, in described sodium liquid, it is 2:7 that Sodium isooctanoate and Sodium.alpha.-hydroxypropionate obtain mol ratio, in another container, add acetone, water and cefuroxime acid, stirs and cefuroxime acid is dissolved completely, add gac, stir decolouring, filter, obtain cefuroxime acid filtrate, cefuroxime acid filtrate is joined in sodium liquid, sodium liquid measure is greater than the amount of cefuroxime acid filtrate, stirs, and produces precipitation, filter, obtain Cefuroxime sodium wet product;
(2), by the Cefuroxime sodium wet product of synthesis respectively with after the mixed solution washing of methanol/acetone, then with acetone soln washing, dry and be prepared into Powdered;
(3), the preparation technology of Cefuroxime sodium: first cleaning is used for the reagent bottle of splendid attire Cefuroxime sodium powder, the cleaning process of reagent bottle is followed successively by supersound washing, water rushes, air is dried, oven for drying, sterilizing, then Cefuroxime sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification, again the reagent bottle that Cefuroxime sodium powder is housed is 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 is examined, then label outer on packing box, test again, packing, described plug adopts rubber plug cleaning machine cleaning and sterilising 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. the preparation technology of cefuroxime sodium for injection, is characterized in that, comprises the following steps: the synthesis of (1), Cefuroxime sodium: add dehydrated alcohol or methyl alcohol, breast in a reservoir
Acid sodium aqueous solution and Sodium isooctanoate, be stirred to Sodium isooctanoate all to dissolve, obtain sodium liquid, wherein, in described sodium liquid, it is 2:43 ~ 43:2 that Sodium isooctanoate and Sodium.alpha.-hydroxypropionate obtain mol ratio, acetone, water and cefuroxime acid is added in another container, stirring makes cefuroxime acid dissolve completely, adds gac, stirs decolouring, filter, obtain cefuroxime acid filtrate, cefuroxime acid filtrate joined in sodium liquid, sodium liquid measure is greater than the amount of cefuroxime acid filtrate, stir, produce precipitation, filter, obtain Cefuroxime sodium wet product;
(2), by the Cefuroxime sodium wet product of synthesis respectively with after the mixed solution washing of methanol/acetone, then with acetone soln washing, dry and be prepared into Powdered;
(3), the preparation technology of Cefuroxime sodium: first cleaning is used for the reagent bottle of splendid attire Cefuroxime sodium powder, then Cefuroxime sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification, again the reagent bottle that Cefuroxime sodium powder is housed is 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, pack.
2. the preparation technology of cefuroxime sodium for injection according to claim 1, is characterized in that, it is 2:7 ~ 7:2 that described Sodium isooctanoate and Sodium.alpha.-hydroxypropionate obtain mol ratio.
3. the preparation technology of cefuroxime sodium for injection according to claim 1 and 2, is characterized in that, the solvent temperature of described cefuroxime acid is 30 DEG C ~ 35 DEG C.
4. the preparation technology of cefuroxime sodium for injection according to claim 1, 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.
5. the preparation technology of cefuroxime sodium for injection according to claim 4, is characterized in that, the temperature of described oven for drying is set to 180 DEG C ~ 230 DEG C.
6. the preparation technology of cefuroxime sodium for injection according to claim 1, is characterized in that, the plug of described reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilising treatment.
7. the preparation technology of the cefuroxime sodium for injection according to claim 1 or 6, it is characterized in that, described 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510200597.9A CN104774211A (en) | 2015-04-27 | 2015-04-27 | Preparation technique of cefuroxime sodium for injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510200597.9A CN104774211A (en) | 2015-04-27 | 2015-04-27 | Preparation technique of cefuroxime sodium for injection |
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| Publication Number | Publication Date |
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| CN104774211A true CN104774211A (en) | 2015-07-15 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201510200597.9A Pending CN104774211A (en) | 2015-04-27 | 2015-04-27 | Preparation technique of cefuroxime sodium for injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108066338A (en) * | 2017-12-26 | 2018-05-25 | 金华智济药物科技合伙企业（有限合伙） | New antibiotic composition when prevention and treatment aerobic bacteria and anaerobic bacteria mixed infection and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4277601A (en) * | 1979-02-15 | 1981-07-07 | Glaxo Group Limited | Preparation of sodium cefuroxime |
| CN101054386A (en) * | 2006-11-12 | 2007-10-17 | 西南合成制药股份有限公司 | Method of synthesizing cefuroxime |
| CN101613359A (en) * | 2009-08-07 | 2009-12-30 | 哈药集团制药总厂 | Method for synthesizing cefuroxime sodium |
| CN101812076A (en) * | 2009-02-24 | 2010-08-25 | 丽珠医药集团股份有限公司 | Cefuroxime sodium and preparation method thereof |
| CN101955492A (en) * | 2009-07-15 | 2011-01-26 | 上海新先锋药业有限公司 | Preparation method of cefuroxime sodium |
-
2015
- 2015-04-27 CN CN201510200597.9A patent/CN104774211A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4277601A (en) * | 1979-02-15 | 1981-07-07 | Glaxo Group Limited | Preparation of sodium cefuroxime |
| CN101054386A (en) * | 2006-11-12 | 2007-10-17 | 西南合成制药股份有限公司 | Method of synthesizing cefuroxime |
| CN101812076A (en) * | 2009-02-24 | 2010-08-25 | 丽珠医药集团股份有限公司 | Cefuroxime sodium and preparation method thereof |
| CN101955492A (en) * | 2009-07-15 | 2011-01-26 | 上海新先锋药业有限公司 | Preparation method of cefuroxime sodium |
| CN101613359A (en) * | 2009-08-07 | 2009-12-30 | 哈药集团制药总厂 | Method for synthesizing cefuroxime sodium |
Non-Patent Citations (2)
| Title |
|---|
| 游莉，等: "头孢呋辛钠合成工艺的改进", 《中国抗生素杂志》 * |
| 郑玉林，等: "头孢呋辛钠产业化工艺研究", 《中兽医医药杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108066338A (en) * | 2017-12-26 | 2018-05-25 | 金华智济药物科技合伙企业（有限合伙） | New antibiotic composition when prevention and treatment aerobic bacteria and anaerobic bacteria mixed infection and preparation method thereof |
| CN108066338B (en) * | 2017-12-26 | 2020-04-24 | 磐安县道地磐药中药研究所 | Antibiotic composition and preparation method thereof |
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Application publication date: 20150715 |
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