CN101780044A - Ceftezole sodium powder-needle preparation for injection and preparation method thereof - Google Patents
Ceftezole sodium powder-needle preparation for injection and preparation method thereof Download PDFInfo
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- CN101780044A CN101780044A CN200910005008A CN200910005008A CN101780044A CN 101780044 A CN101780044 A CN 101780044A CN 200910005008 A CN200910005008 A CN 200910005008A CN 200910005008 A CN200910005008 A CN 200910005008A CN 101780044 A CN101780044 A CN 101780044A
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Abstract
The invention provides a ceftezole sodium powder-needle preparation and prescription thereof. Preparations with different specifications can be prepared through directly sub-packaging sterile crude medicine ceftezole sodium. The invention aims to provide the prescription of the ceftezole sodium preparation and the preparation method thereof with the advantages of simple production process and stable and reliable quality.
Description
Technical field
The invention belongs to pharmaceutical preparation, relate to the preparation method of beta-lactam antibiotic, relate in particular to Ceftezole sodium used for injection and preparation method thereof.
Background technology
Ceftezole sodium used for injection (the multiple pin of commodity special sub-society by name) is a first generation wide spectrum cephalosporins, antimicrobial spectrum comprises Grain-positive and gram-negative bacteria, especially gram-positive bacteria such as staphylococcus, streptococcus, streptococcus pneumoniae, gram negative bacilli such as escherichia coli, pneumobacillus, unusual modification bacillus etc. is had stronger antibacterial activity.Be mainly used in various bacterial infections such as secondary infection that septicemia, pneumonia, bronchitis, bronchiectasis (during infection), chronic respiratory system infect, pulmonary abscess, peritonitis, pyelonephritis, cystitis, urethritis clinically, obtain good curative effect.
The purpose of this invention is to provide that a kind of production technology is simple, the prescription of the reliable Ceftezole sodium used for injection preparation of steady quality and preparation method thereof.
Ceftezole sodium used for injection preparation provided by the invention and prescription, its prescription consists of:
The cefobutazine sodium principal agent
Direct packaging is made the preparation of different size
Technical characterstic of the present invention is to select sterile bulk drug cefobutazine sodium direct packaging for use, makes.Its preparation method is simple, and steady quality is fit to suitability for industrialized production.
The specific embodiment:
The invention will be further described with by way of example more below, provides the present invention and get implementation detail, but be not to be intended to limit protection scope of the present invention.
Embodiment 1
Prescription: cefobutazine sodium 100g (in ceftezole)
Make 1000
Preparation method:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefoxitin sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
Embodiment 2
Prescription: cefobutazine sodium 250g (in ceftezole)
Make 1000
Preparation method:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefoxitin sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
Embodiment 3
Prescription: cefobutazine sodium 500g (in ceftezole)
Make 1000
Preparation method:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefoxitin sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
Embodiment 4
Prescription: cefobutazine sodium 750g (in ceftezole)
Make 1000
Preparation method:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefoxitin sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
Embodiment 5
Prescription: cefobutazine sodium 1000g (in ceftezole)
Make 1000
Preparation method:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefoxitin sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
Embodiment 6
Prescription: cefobutazine sodium 1500g (in ceftezole)
Make 1000
Preparation method:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefoxitin sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
Embodiment 7
Prescription: cefobutazine sodium 2000g (in ceftezole)
Make 1000
Preparation method:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefoxitin sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
Embodiment 8
Prescription: cefobutazine sodium 4000g (in ceftezole)
Make 1000
Preparation method:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefoxitin sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
After having read above-mentioned teachings of the present invention, those skilled in the art can make various changes or modification to the present invention, and these equivalent form of values fall within the application's appended claims institute limited range equally.
Claims (2)
1. Ceftezole sodium used for injection preparation and prescription, the dosage form that it is characterized in that said preparation is an injectable powder, its prescription consists of: aseptic raw material cefobutazine sodium direct packaging becomes the preparation of different size.
2. the preparation method of Ceftezole sodium used for injection injectable powder as claimed in claim 1 is characterized in that, described preparation method is:
Vial is removed through outer package, and cleaning machine cleans, and clean compressed air dries up, after 350 ℃ of dry heat sterilizations 5 minutes, and cooling, standby.Butyl rubber bung is removed through outer package, washes the plug machine and cleans, and is in 121 ℃ of dry heat sterilizations 120 minutes, cooling, standby.Aluminium-plastic cap is removed through outer package, and baking is 120 minutes in 110 ℃ of baking ovens, and cooling is standby.Aseptic raw material cefobutazine sodium is through outer package dismounting, surface sterilization, imports 10000 grades of clean areas, local 100 grades of clean areas into, carry out with the control antibiotic glass bottle aseptic subpackaged, tamponade.Lid is rolled in packing and the intact sample of tamponade.The intact sample of lid be will roll and lamp inspection, labeling and packing carried out.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910005008A CN101780044A (en) | 2009-01-16 | 2009-01-16 | Ceftezole sodium powder-needle preparation for injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910005008A CN101780044A (en) | 2009-01-16 | 2009-01-16 | Ceftezole sodium powder-needle preparation for injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101780044A true CN101780044A (en) | 2010-07-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910005008A Pending CN101780044A (en) | 2009-01-16 | 2009-01-16 | Ceftezole sodium powder-needle preparation for injection and preparation method thereof |
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| CN (1) | CN101780044A (en) |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102824309A (en) * | 2011-06-15 | 2012-12-19 | 悦康药业集团有限公司 | Cefmetazole sodium powder for injection and preparation method thereof |
| CN102872021A (en) * | 2012-09-25 | 2013-01-16 | 罗诚 | Medicinal composition containing ceftezole sodium compound and preparation method for medicinal composition |
| CN103271878A (en) * | 2012-12-18 | 2013-09-04 | 张宏民 | Ceftezole sodium agent and preparation method thereof |
| CN104161730A (en) * | 2014-08-18 | 2014-11-26 | 四川制药制剂有限公司 | Preparation method of cefodizime sodium for injection |
| CN104188915A (en) * | 2014-08-22 | 2014-12-10 | 四川制药制剂有限公司 | Method for preparing ceftezole sodium for injection |
| CN104224793A (en) * | 2014-08-22 | 2014-12-24 | 四川制药制剂有限公司 | Method for controlling related substances in ceftezole sodium |
| CN104784102A (en) * | 2015-03-20 | 2015-07-22 | 成都汇智远景科技有限公司 | Ceftezole sodium ointment |
| CN107095851A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The preparation technology of Ceftezole sodium used for injection sterile powder injection |
-
2009
- 2009-01-16 CN CN200910005008A patent/CN101780044A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102824309A (en) * | 2011-06-15 | 2012-12-19 | 悦康药业集团有限公司 | Cefmetazole sodium powder for injection and preparation method thereof |
| CN102872021A (en) * | 2012-09-25 | 2013-01-16 | 罗诚 | Medicinal composition containing ceftezole sodium compound and preparation method for medicinal composition |
| CN103271878A (en) * | 2012-12-18 | 2013-09-04 | 张宏民 | Ceftezole sodium agent and preparation method thereof |
| CN104161730A (en) * | 2014-08-18 | 2014-11-26 | 四川制药制剂有限公司 | Preparation method of cefodizime sodium for injection |
| CN104188915A (en) * | 2014-08-22 | 2014-12-10 | 四川制药制剂有限公司 | Method for preparing ceftezole sodium for injection |
| CN104224793A (en) * | 2014-08-22 | 2014-12-24 | 四川制药制剂有限公司 | Method for controlling related substances in ceftezole sodium |
| CN104784102A (en) * | 2015-03-20 | 2015-07-22 | 成都汇智远景科技有限公司 | Ceftezole sodium ointment |
| CN104784102B (en) * | 2015-03-20 | 2018-01-02 | 宋益兴 | Cefobutazine sodium ointment |
| CN107095851A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The preparation technology of Ceftezole sodium used for injection sterile powder injection |
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Open date: 20100721 |