CN1493293A - Cefathiamidine freeze dried agent and its preparation method - Google Patents
Cefathiamidine freeze dried agent and its preparation method Download PDFInfo
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- CN1493293A CN1493293A CNA031296629A CN03129662A CN1493293A CN 1493293 A CN1493293 A CN 1493293A CN A031296629 A CNA031296629 A CN A031296629A CN 03129662 A CN03129662 A CN 03129662A CN 1493293 A CN1493293 A CN 1493293A
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- cefathiamidine
- lyophilized formulations
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Abstract
A freeze dried powder injection of cefathiamidine is prepared through dissolving scaffold, antioxidizing agent and non-aseptic cefathiamidine in water, and freeze drying. Its advantages are simple preparing process and high quality.
Description
Technical field the present invention relates to water soluble antibiotics cefathiamidine lyophilized formulations and manufacture method thereof.
Technical background cephalosporin-the 18th, the first generation cephalosporin that China develops voluntarily is distributed widely in after the absorption in each organs and tissues, mainly through renal excretion.To G
+The effect of bacterium is better than G
-Bacterium, inhibitory action to golden Portugal bacterium (comprising the penicillin Resistant strain), Streptococcus viridans, streptococcus pneumoniae etc. is stronger, enterococcus there is bacteriostasis preferably, is mainly used in golden Portugal bacterium (comprising the penicillin Resistant strain) clinically, the infection of streptococcus pneumoniae etc.Effect to urinary tract infection is also better.
Cefathiamidine also is cephalosporin-18, pyrrole amidine cephalo, cefathiamidine.
Chemistry is by name: 7-(N, N '-diisopropyl amidino groups sulfur acetyl) Cephalosporanic acid inner salt.
Molecular structural formula is as follows:
The medicine preparation that China has gone on the market at present is the injectable powder of cefathiamidine.General fork-like farm tool used in ancient China says that the quality of cephalo-type product is relatively more responsive to temperature and moisture, when temperature and moisture are higher, and along with the prolongation of time, the easy variation of product quality, even lose medicinal value.So injection cephalo-type product occurs with the form of powder injection formulation mostly on the domestic and international market, the often crystallization from organic solvent of aseptic cephalo-type raw material powder is not moisture substantially.Yet the manufacture process of aseptic raw material powder and powder injection formulation is had relatively high expectations to production equipment and workshop condition, and corresponding workman's amount of labour and fund input are also big.Its production process at first is earlier cefathiamidine to be prepared into aseptic raw material powder after process recrystallization, the drying in the sterile bulk drug workshop, carries out aseptic packaging, and then be distributed into the aseptic powder injection preparation in the sterile preparation workshop.So, need two steps and under aseptic environments, operate, the cleanliness factor of workshop and operation worker's work accountability are required significantly to improve, also improved the probability of producing failure.
For production process is oversimplified, through scrutinizing, we have invented the cefathiamidine lyophilized formulations.Can be in the preparation process of this preparation with the raw material of common cefathiamidine need not aseptic cefathiamidine raw material powder, so just save the construction in sterile bulk drug workshop and higher environment and operation requirement thereof.
The preparation method of summary of the invention cefathiamidine lyophilized formulations is at ambient temperature, elder generation's water dissolves caffolding agent, antioxidant, the former powder of non-sterile cefathiamidine successively, add the proper amount of active carbon decolouring then, be prepared into product by general freeze-dry process through after the aseptic filtration.Because the existence of water is big to the influence of the quality of the pharmaceutical preparations, thereby, in preparing the process of this product, lyophilization notes the control of moisture in the finished product.
It is simpler to the purpose of this invention is to provide a kind of production method, and environment cleanliness and operation require lower, and drug quality is stablized, transported and preserve easily that cefathiamidine freezes lyophilized injectable powder.
Cefathiamidine lyophilized formulations of the present invention mainly contains cefathiamidine, caffolding agent and antioxidant, and wherein the amount of cefathiamidine can make dissolved cefathiamidine reach clinical desired drug level.
The caffolding agent of cefathiamidine lyophilized formulations of the present invention is characterized in that water miscible mannitol, lactose, preferred mannitol.
The antioxidant of cefathiamidine lyophilized formulations of the present invention is characterized in that vitamin C, carbon dioxide, nitrogen.
Cefathiamidine lyophilized formulations of the present invention is characterized in that moisture is wherein controlled, and the content of moisture is that the water yield preferentially is chosen between the 0.5%-2% less than 3%.
Cefathiamidine lyophilized formulations related substance is investigated (room temperature keeps sample)
Cefathiamidine lyophilized formulations of the present invention is to realize by following process: under cleaning condition, caffolding agent, antioxidant is water-soluble, after the stirring and dissolving, add the cefathiamidine dissolving, decolour with proper amount of active carbon, aseptic filtration is sub-packed in this aseptic, pyrogen-free clear and bright filtrate in the aseptic cillin bottle, presses the freeze-dry process lyophilizing and promptly gets product.
The clinical using method of cefathiamidine lyophilized formulations of the present invention is: the cefathiamidine lyophilized formulations is dissolved in water for injection or 5% glucose injection, with the form administration of intramuscular injection, intravenous injection or intravenous drip.
Some following concrete examples further describe the preparation process of cefathiamidine lyophilized formulations of the present invention, but are not limited to following examples.
The specific embodiment
Embodiment one:
Accurately take by weighing 40 gram mannitol, under mechanical agitation, be dissolved in 600 milliliters of waters for injection, after the non-sterile cefathiamidine dissolving of adding 100 grams, restrain activated carbon decolorizing 20 minutes with 0.4, aseptic filtration, the gained liquid subpackage is prepared into product by the freeze-dry process condition in 200 aseptic cillin bottles.
Embodiment two:
Accurately take by weighing 40 gram mannitol, 0.4 gram vitamin C, under mechanical agitation, be dissolved in 600 milliliters of waters for injection, after adding the non-sterile cefathiamidine dissolving of 100 grams, restrain activated carbon decolorizing 20 minutes with 0.4, aseptic filtration, the gained liquid subpackage is prepared into product by the freeze-dry process condition in 200 aseptic cillin bottles.
Embodiment three:
Accurately take by weighing 40 gram mannitol, under mechanical agitation, be dissolved in 600 milliliters in the saturated water for injection of carbon dioxide, after adding the non-sterile cefathiamidine dissolving of 100 grams, restrain activated carbon decolorizing 20 minutes with 0.4, aseptic filtration, the gained liquid subpackage is prepared into product by the freeze-dry process condition in 200 aseptic cillin bottles.
Embodiment four:
Accurately take by weighing 35 gram lactose; under mechanical agitation and nitrogen protection; be dissolved in 600 milliliters of waters for injection; after adding the non-sterile cefathiamidine dissolving of 100 grams; restrain activated carbon decolorizing 20 minutes with 0.4; aseptic filtration, the gained liquid subpackage is prepared into product by the freeze-dry process condition in 200 aseptic cillin bottles.
Claims (6)
1, a kind of is the pharmaceutical preparation of active substance with the cefathiamidine, it is characterized by said preparation and comprises cefathiamidine and the last water solublity caffolding agent that allows of pharmacology, and wherein the meltage of cefathiamidine reaches clinical desired drug level.
2, cefathiamidine lyophilized formulations according to claim 1 is characterized in that the water solublity caffolding agent is mannitol, lactose.
3, cefathiamidine lyophilized formulations according to claim 1 is characterized in that also containing antioxidant.
4, cefathiamidine lyophilized formulations according to claim 3, its antioxidant is vitamin C, carbon dioxide, nitrogen.
5, cefathiamidine lyophilized formulations according to claim 1, its water content is less than 3%.
6, cefathiamidine lyophilized formulations according to claim 5, its water content is preferentially selected between the 0.5%-2%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031296629A CN1493293A (en) | 2003-07-03 | 2003-07-03 | Cefathiamidine freeze dried agent and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031296629A CN1493293A (en) | 2003-07-03 | 2003-07-03 | Cefathiamidine freeze dried agent and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1493293A true CN1493293A (en) | 2004-05-05 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031296629A Pending CN1493293A (en) | 2003-07-03 | 2003-07-03 | Cefathiamidine freeze dried agent and its preparation method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780034A (en) * | 2010-03-05 | 2010-07-21 | 陶灵刚 | Cefathiamidine suspension and novel application thereof |
| CN102716075A (en) * | 2012-07-03 | 2012-10-10 | 哈药集团制药总厂 | Ceftizoxime sodium-containing pharmaceutical composition |
| CN102727451A (en) * | 2012-07-03 | 2012-10-17 | 哈药集团制药总厂 | Cefmetazole-containing pharmaceutical composition |
| CN104524585A (en) * | 2014-12-08 | 2015-04-22 | 悦康药业集团有限公司 | Cefathiamidine composition |
-
2003
- 2003-07-03 CN CNA031296629A patent/CN1493293A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780034A (en) * | 2010-03-05 | 2010-07-21 | 陶灵刚 | Cefathiamidine suspension and novel application thereof |
| CN101780034B (en) * | 2010-03-05 | 2011-05-18 | 陶灵刚 | Cefathiamidine suspension and novel application thereof |
| CN102716075A (en) * | 2012-07-03 | 2012-10-10 | 哈药集团制药总厂 | Ceftizoxime sodium-containing pharmaceutical composition |
| CN102727451A (en) * | 2012-07-03 | 2012-10-17 | 哈药集团制药总厂 | Cefmetazole-containing pharmaceutical composition |
| CN102727451B (en) * | 2012-07-03 | 2013-07-03 | 哈药集团制药总厂 | Cefmetazole-containing pharmaceutical composition |
| CN102716075B (en) * | 2012-07-03 | 2013-08-21 | 哈药集团制药总厂 | Ceftizoxime sodium-containing pharmaceutical composition |
| CN104524585A (en) * | 2014-12-08 | 2015-04-22 | 悦康药业集团有限公司 | Cefathiamidine composition |
| CN104524585B (en) * | 2014-12-08 | 2018-11-09 | 悦康药业集团有限公司 | Cefathiamidine composition |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
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