CN102824310A - Cefotiam-hydrochloride-containing medicine preparation and preparation method thereof - Google Patents
Cefotiam-hydrochloride-containing medicine preparation and preparation method thereof Download PDFInfo
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- CN102824310A CN102824310A CN201110164999XA CN201110164999A CN102824310A CN 102824310 A CN102824310 A CN 102824310A CN 201110164999X A CN201110164999X A CN 201110164999XA CN 201110164999 A CN201110164999 A CN 201110164999A CN 102824310 A CN102824310 A CN 102824310A
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Abstract
The invention discloses a cefotiam-hydrochloride-containing medicine preparation which is composed of an active component cefotiam hydrochloride, basic amino acid, and anhydrous sodium carbonate. The weight ratio of cefotiam hydrochloride (calculated according to cefotiam) to basic amino acid to anhydrous sodium carbonate is 1:0.4-0.6:0.05-0.15. A preparation method provided by the invention is substantially advantaged in that: (1) vacuum pumping is not needed after product sub-packaging, such that processes are reduced; (2) when the medicine is dissolved, the generation of a large amount of carbon dioxide is prevented, such that the danger for cefotiam medicine liquid to be sprayed from a bottle is avoided; (3) when the cefotiam preparation is diluted into various fluid replacements (including glucose solutions, electrolyte solutions or amino acid preparations), the amount of generated carbon dioxide is extremely low, such that clarity observation of intravenous infusion is not affected; (4) the dosage of anhydrous sodium carbonate is low, such that the possibility of alkalosis is avoided; and (5) the dosage of sodium ions is reduced, such that the preparation is suitable for patients with cardiac or renal insufficiency, edema patients, neonates, pregnant women, and the aged. Therefore, the application scope of the preparation is expended.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation of hydrochloric cefotiam, be used for treatment and infect, belong to field of medicine preparations, also relate to the method for preparing of the pharmaceutical preparation of hydrochloric cefotiam simultaneously.
Background technology
Cephalosporin is claimed cephalosporin again, is one type of wide spectrum semisynthetic antibiotics, and first cephalosporin came out in the sixties in 20th century, kind surplus the kind of going on the market at present 60, and output accounts for more than 60% of antibiotic output in the world.Cephalosporin is compared advantages such as having antimicrobial spectrum is wide, penicillin resistant enzyme, curative effect is high, toxicity is low, anaphylaxis is few with penicillin, in anti-infective therapy, occupy crucial status.
The chemistry of cefotiam hydrochloride (cefotiam hydrochloride) is by name: (6R-is trans)-7-[[(2-amino-4-thiazolyl) acetyl group] amino]-3-[[[1-[(2-(dimethylamino) ethyl]-1H-tetrazolium-5-yl] sulphomethyl]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid dihydrochloride.Its structural formula is:
Molecular formula: C
18H
23N
9O
4S
32HCl
Molecular weight: 598.6
Cefotiam is a second generation cephalosporin class antibiotic.Effect and cefazolin to gram positive bacteria are close; And to gram-negative bacteria; More excellent like effects such as haemophilus, escherichia coli, klebsiella spp, proteus mirabilises, enterobacteria, citrobacter, the positive Bacillus proteus of indole etc. also there are antibacterial action.Its mechanism of action be with bacterial cell membrane on penicillin-binding protein (PBPs) combine, make the transpeptidase acidylate, suppress in the antibacterial synthetic at a distance from cell wall; The intersection that influences the cell wall mucopeptide composition links; Cell division and growth are suppressed, and ne ar is elongated, dissolving at last and dead.
Cefotiam be mainly used in clinically to the responsive staphylococcus of these article, Streptococcus (except the enterococcus), streptococcus pneumoniae, hemophilus influenza, escherichia coli, Kleb, intestinal Pseudomonas, citrobacter belong to, proteus mirabilis, proteus vulgaris, following infection due to the Proteus rettgeri, Morganella etc.: septicemia, postoperative infection; Burn infection, subcutaneous abscess, swelling, furuncle, furuncle and phyma, osteomyelitis, suppurative arthritis, tonsillitis (peritonsillitis, peritonsillar abscess); Bronchitis, concurrent infection of bronchiectasis, pneumonia, pulmonary suppuration disease, empyema; Cholangitis, cholecystitis, peritonitis, pyelonephritis, cystitis; Urethritis, prostatitis, meningitis, endometritis, pelvic inflammatory disease; Parametritis, adnexitis, bartholinitis, otitis media, nasal sinusitis.
At present, the preparation that uses clinically of the cefotiam dihydrochloride (CefotiamDihydrochloride) that is cefotiam mixes powder preparation with the buffer agent sodium carbonate.Owing to added a large amount of natrium carbonicum calcinatums in the preparation, therefore, need after packing, carry out evacuation the time marquis of preparation of product, cause technology loaded down with trivial details.
In addition, this a large amount of natrium carbonicum calcinatum is buffer agent there are many unfavorable factors in preparation in clinical practice:
1) in medicine when dissolving,, hydrochloric acid and sodium carbonate react, and can produce a large amount of carbon dioxide, cause the bottle internal pressure excessive, possibly cause the medicinal liquid turnover, pressure of the inside of a bottle even can syringe piston be ejected, thus waste medicine, lessen the curative effect.And existence produces the potential danger property of personal injury to medical personnel.Contemporary Chinese is used pharmacy, rolls up 796 pages of 9 phases and just reports once that a nurse of Quanzhou, Fujian 180 hospitals is in preparation 0.9% sodium chloride 250mL+ cefotiam hydrochloridefor inj 2.0g process in 2010 27; Because of cefotiam hydrochloridefor inj contains the buffer agent natrium carbonicum calcinatum; Can produce a large amount of carbon dioxide during the medicinal liquid dissolving, cause the bottle internal pressure excessive, cause the medicinal liquid turnover to cause this nurse's hand; Hand appears immediately, neck surface is very itched; Pharyngeal obstruction sense, dyspnea, allergic symptom such as uncomfortable in chest, skin rash.
2) in the time of in the cefotiam preparation being diluted to various fluid infusion (containing Glucose Liquid, electrolyte solution or amino acid preparation), the carbon dioxide bubble of generation is difficult for draining, and brings difficulty to the clarity observation of intravenous drip transfusion etc.;
3) natrium carbonicum calcinatum, alkalescence is strong, and preparation stability is reduced, and a large amount of injections are prone to take place alkalosis disease
4) because the existence of sodium ion has certain local irritation.And a large amount of sodium ion, limited clinical application range, the heart, renal insufficiency person, edema patient, neonate, anemia of pregnant woman and old people are to use can increase the weight of physiological load, increase untoward reaction, affect the treatment.
Summary of the invention
Technical problem to be solved by this invention is; The problems that cause because of the carbonate content height to original cefotiam hydrochloride preparation; A kind of pharmaceutical preparation of hydrochloric cefotiam is provided, and carbonate content is lower, makes that it is stable and controllable for quality, untoward reaction is little and technology is easy.
Another technical problem to be solved by this invention is that a kind of method for preparing of pharmaceutical preparation of above-mentioned hydrochloric cefotiam is provided.
A kind of pharmaceutical preparation of hydrochloric cefotiam; Said preparation is made up of cefotiam hydrochloride, basic amino acid and natrium carbonicum calcinatum as active component, and the weight ratio of cefotiam hydrochloride (in cefotiam) and basic amino acid, natrium carbonicum calcinatum is 1: 0.4-0.6: 0.05-0.15.Wherein, basic amino acid can be 0.4,0.42,0.45,0.48,0.5,0.52,0.55,0.58,0.6; Natrium carbonicum calcinatum can be 0.05,0.06,0.07,0.08,0.09,0.10,0.11,0.12,0.13,0.14,0.15.
Described basic amino acid is one or more the compositions in arginine, lysine, the histidine.Basic amino acid effect therein is a pH value of regulating preparation, makes it to meet the requirement of country about preparation pH value scope.
The weight of hydrochloric cefotiam (in cefotiam) is 250mg, 500mg, 750mg, 1000mg, 1500mg and 2000mg in the single-dose preparations of described cefotiam hydrochloride preparation.
Described cefotiam hydrochloride preparation is aseptic subpackaged injection.
A kind of method for preparing of pharmaceutical preparation of hydrochloric cefotiam; According to above-mentioned proportion, described cefotiam hydrochloride and basic amino acid, natrium carbonicum calcinatum three are mixed into mixed powder, will mix powder then and be sub-packed in the aseptic cillin bottle; Capping plug rolls lid.
A kind of method for preparing of pharmaceutical preparation of hydrochloric cefotiam according to above-mentioned proportion, is sub-packed in described cefotiam hydrochloride, basic amino acid, natrium carbonicum calcinatum in the aseptic cillin bottle respectively, and capping plug rolls lid.
A kind of method for preparing of pharmaceutical preparation of hydrochloric cefotiam; According to above-mentioned proportion, basic amino acid and natrium carbonicum calcinatum mix homogeneously are formed mixed powder, will mix powder and cefotiam hydrochloride again and be sub-packed in respectively in the aseptic cillin bottle; Capping plug rolls lid.
In order to confirm the ratio of each component in this preparation, we have carried out correlation test, and main its pH value scope should be 5.7-7.2 according to being the national standard of these article, and we have chosen a plurality of proportionings, as follows:
According to above proportioning, we have investigated solution color, clarity and the pH value of each prescription, and the result is following:
Thus; We find; Cefotiam hydrochloride in the cefotiam hydrochloride preparation (in cefotiam) is 1 with the weight ratio of basic amino acid, natrium carbonicum calcinatum: 0.3-0.8: during 0.05-0.25, its pH value drops within the critical field, simultaneously; When its proportion is 1: 0.4-0.6: during 0.05-0.15, its pH value approaches ideal value 6.5.
Simultaneously, because the content of sodium carbonate is to reduce to 1 at 1: 0.2 by the weight ratio of cefotiam hydrochloride in the commercially available prod (in cefotiam) and natrium carbonicum calcinatum: 0.05-0.15, can find out that there is following remarkable advantage in the present invention:
1) after the product packing, needn't carry out evacuation, reduce operation.
When 2) medicine dissolves, can not produce a large amount of carbon dioxide, the danger of having avoided the cefotiam medicinal liquid from bottle, to spray.
3) in the time of in the cefotiam preparation being diluted to various fluid infusion (containing Glucose Liquid, electrolyte solution or amino acid preparation), the amount of carbon dioxide of generation is few, and the clarity that can not influence the intravenous drip transfusion is observed.
4) the natrium carbonicum calcinatum consumption is few, has avoided taking place alkalotic probability.
5) the sodium ion consumption reduces, and to being suitable for per capita in the heart, renal insufficiency person, edema patient, neonate, anemia of pregnant woman and old age, has enlarged the scope of application.
The specific embodiment
Following instance will be done further elaboration to the present invention, but not limit content involved in the present invention in any form.
Embodiment 1 cefotiam hydrochloridefor inj
Prescription:
The preparation process is following:
Wash bottle: vial is used earlier the ultrasound wave wash bottle, dash bottle with purification washing, injection washing, compressed air respectively then, at last baking oven sterilization depyrogenation through the tunnel.
Rubber stopper cleaning-drying sterilization: rubber stopper is washed after steam sterilization and hot air drying are subsequent use with purification washing, injection respectively.
Mix powder: cefotiam hydrochloride, natrium carbonicum calcinatum, the arginine of proportioning behind the mix homogeneously, are taken a sample and carried out the intermediate check in mixer.
Packing: will mix the result of powder according to the intermediate check, aseptic subpackaged in cillin bottle, capping plug rolls lid.
Embodiment 2 cefotiam hydrochloridefor injs
Prescription:
The preparation process is following:
Wash bottle: vial is used earlier the ultrasound wave wash bottle, dash bottle with purification washing, injection washing, compressed air respectively then, at last baking oven sterilization depyrogenation through the tunnel.
Rubber stopper cleaning-drying sterilization: rubber stopper is washed after steam sterilization and hot air drying are subsequent use with purification washing, injection respectively.
Mix powder: cefotiam hydrochloride, natrium carbonicum calcinatum, the arginine of proportioning behind the mix homogeneously, are taken a sample and carried out the intermediate check in mixer.
Packing: will mix the result of powder according to the intermediate check, aseptic subpackaged in cillin bottle, capping plug rolls lid.
Embodiment 3 cefotiam hydrochloridefor injs
Prescription:
The preparation process is following:
Wash bottle: vial is used earlier the ultrasound wave wash bottle, dash bottle with purification washing, injection washing, compressed air respectively then, at last baking oven sterilization depyrogenation through the tunnel.
Rubber stopper cleaning-drying sterilization: rubber stopper is washed after steam sterilization and hot air drying are subsequent use with purification washing, injection respectively.
Packing: cefotiam hydrochloride, natrium carbonicum calcinatum, the arginine of proportioning is aseptic subpackaged respectively in cillin bottle, and capping plug rolls lid.
Embodiment 4 cefotiam hydrochloridefor injs
Prescription:
The preparation process is following:
Wash bottle: vial is used earlier the ultrasound wave wash bottle, dash bottle with purification washing, injection washing, compressed air respectively then, at last baking oven sterilization depyrogenation through the tunnel.
Rubber stopper cleaning-drying sterilization: rubber stopper is washed after steam sterilization and hot air drying are subsequent use with purification washing, injection respectively.
Mix powder: with natrium carbonicum calcinatum, arginine mix homogeneously in mixer of proportioning.
Packing: with cefotiam hydrochloride, mixing powder (natrium carbonicum calcinatum and arginine), to mix powder aseptic subpackaged respectively in cillin bottle, capping plug rolls lid.
Embodiment 5 cefotiam hydrochloridefor injs
Prescription:
The preparation process is following:
Wash bottle: vial is used earlier the ultrasound wave wash bottle, dash bottle with purification washing, injection washing, compressed air respectively then, at last baking oven sterilization depyrogenation through the tunnel.
Rubber stopper cleaning-drying sterilization: rubber stopper is washed after steam sterilization and hot air drying are subsequent use with purification washing, injection respectively.
Mix powder: cefotiam hydrochloride, natrium carbonicum calcinatum, the lysine of proportioning behind the mix homogeneously, are taken a sample and carried out the intermediate check in mixer.
Packing: will mix the result of powder according to the intermediate check, aseptic subpackaged in cillin bottle, capping plug rolls lid.
Embodiment 6 cefotiam hydrochloridefor injs
Prescription:
The preparation process is following:
Wash bottle: vial is used earlier the ultrasound wave wash bottle, dash bottle with purification washing, injection washing, compressed air respectively then, at last baking oven sterilization depyrogenation through the tunnel.
Rubber stopper cleaning-drying sterilization: rubber stopper is washed after steam sterilization and hot air drying are subsequent use with purification washing, injection respectively.
Mix powder: with natrium carbonicum calcinatum, arginine mix homogeneously in mixer of proportioning.
Packing: with cefotiam hydrochloride, mixing powder (natrium carbonicum calcinatum and histidine), to mix powder aseptic subpackaged respectively in cillin bottle, capping plug rolls lid.
Embodiment 1-embodiment 3 detects contrast test with the correlated performance of general commercially available article
One, sample and reference substance source
Sample is embodiment 1, embodiment 2,3 products that obtain respectively of embodiment.
Reference substance is the cefotiam hydrochloridefor inj of selling on the market (carbonated sodium).
Two, assay
Assay by the prepared cefotiam hydrochloridefor inj of the embodiment of the invention is as shown in the table:
The result indicates that the cefotiam hydrochloridefor inj prepared by the embodiment of the invention is being consistent with the listing article qualitatively.
Three, stability study
In order further to study the product quality that this embodiment obtains, we have carried out the stability study of product, comprise accelerated stability research and Journal of Sex Research steady in a long-term.
The investigation project and the method for inspection are following:
Character: estimating is extremely little yellow crystalline powder of white.
PH: the pH meter algoscopy is measured.
Clarity: turbidity standard counter point.
Clarity: according to the regulation inspection of " clarity test detailed rules and regulations and criterion ", should be up to specification.
The color of solution: standard color solution counter point.
Loss on drying: 60 ℃ of hypobaric drying method (P
2O
5Be desiccant).
Related substance: 1% Self-control method.
Assay: HPLC external standard method.
1. accelerated stability test
Condition: the packing of will going on the market sample places in the climatic chamber, keeps temperature 40 ℃ ± 2; Humidity 75% ± 5, regularly pick test.Result of the test is as shown in the table:
The result shows that through 6 months study on the stability of acceleration, each item indexs such as its content, color and luster, sign content all meet quality standard.
2. long-term stable experiment
Condition: the sample of embodiment is placed in the climatic chamber, keep temperature 25 ℃ ± 2; Humidity 60% ± 5, regularly pick test.Result of the test is as shown in the table:
The result shows that through long-term 24 months study on the stability, each item indexs such as its content, color and luster, sign content all meet quality standard.
Four, compatibility research
These article are aseptic subpackaged goods, in clinical use, need with suitable injection solvent dissolving back injection.For investigating these article stability in use, we have carried out compatibility stability research to these article, and contrast with the listing sample.
Sample and the commercially available article of getting embodiment 1 add to respectively in 0.9% sodium chloride solution and 5% glucose injection, shake up; Respectively under the room temperature, 40 ℃ placed 4 hours down and in the refrigerator, observe solution appearance, calculate the cefotiam relative amount of each time point respectively and investigate the variation of its related substance, result of the test is following:
Investigate the result with 0.9% sodium chloride injection compatibility stability
Investigate the result with 5% glucose injection compatibility stability
This shows that according to the cefotiam hydrochloridefor inj of the present invention's preparation, its stability in 0.9% sodium chloride injection and 5% glucose injection all is superior to the product that goes on the market.
Claims (7)
1. the pharmaceutical preparation of a hydrochloric cefotiam; It is characterized in that: cefotiam hydrochloride, basic amino acid and natrium carbonicum calcinatum by as active component are formed, and cefotiam hydrochloride is 1 in the weight ratio of cefotiam and basic amino acid, natrium carbonicum calcinatum: 0.4-0.6: 0.05-0.15.
2. pharmaceutical preparation according to claim 1 is characterized in that, described basic amino acid is one or more the compositions in arginine, lysine, the histidine.
3. pharmaceutical preparation according to claim 1 is characterized in that, hydrochloric cefotiam in the single-dose preparations of described cefotiam hydrochloride preparation is 250mg, 500mg, 750mg, 1000mg, 1500mg and 2000mg in the weight of cefotiam.
4. pharmaceutical preparation according to claim 1 is characterized in that, described cefotiam hydrochloride preparation is aseptic subpackaged injection.
5. according to the method for preparing of the pharmaceutical preparation of the described hydrochloric cefotiam of one of claim 1 to 4; It is characterized in that; Cefotiam hydrochloride and basic amino acid, the natrium carbonicum calcinatum three of said proportioning are mixed into mixed powder; To mix powder then and be sub-packed in the aseptic cillin bottle, capping plug rolls lid.
6. according to the method for preparing of the pharmaceutical preparation of the described hydrochloric cefotiam of one of claim 1 to 4; It is characterized in that; Cefotiam hydrochloride, basic amino acid, natrium carbonicum calcinatum with said proportioning is sub-packed in the aseptic cillin bottle respectively, and capping plug rolls lid.
7. according to the method for preparing of the pharmaceutical preparation of the described hydrochloric cefotiam of one of claim 1 to 4; It is characterized in that; Said basic amino acid and natrium carbonicum calcinatum are formed mixed powder by the proportioning mix homogeneously; To mix powder and cefotiam hydrochloride again and be sub-packed in respectively in the aseptic cillin bottle, capping plug rolls lid.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103446159A (en) * | 2013-09-09 | 2013-12-18 | 海南美兰史克制药有限公司 | Pharmaceutical composition containing pediatric compound amino acid injection and cefotiam hydrochloride |
| CN105769770A (en) * | 2016-05-12 | 2016-07-20 | 浙江永宁药业股份有限公司 | Cefotiam hydrochloride powder injection preparation for injection |
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| EP1618894A1 (en) * | 2003-04-28 | 2006-01-25 | Takeda Pharmaceutical Company Limited | Composition for injection |
| JP2007238491A (en) * | 2006-03-08 | 2007-09-20 | Nipro Corp | Medical preparation |
| CN101544662A (en) * | 2009-05-12 | 2009-09-30 | 海南数尔药物研究有限公司 | Cefotiam salt compound and pharmaceutical composition made therefrom |
| CN101559040A (en) * | 2008-04-18 | 2009-10-21 | 汪娟 | Medicament composition of cefotiam hydrochloride and preparation thereof |
| CN101584665A (en) * | 2009-07-17 | 2009-11-25 | 山东罗欣药业股份有限公司 | Cefotiam hydrochloride medicament composition sterile powder injection and preparation method thereof |
-
2011
- 2011-06-17 CN CN201110164999XA patent/CN102824310A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1618894A1 (en) * | 2003-04-28 | 2006-01-25 | Takeda Pharmaceutical Company Limited | Composition for injection |
| JP2007238491A (en) * | 2006-03-08 | 2007-09-20 | Nipro Corp | Medical preparation |
| CN101559040A (en) * | 2008-04-18 | 2009-10-21 | 汪娟 | Medicament composition of cefotiam hydrochloride and preparation thereof |
| CN101544662A (en) * | 2009-05-12 | 2009-09-30 | 海南数尔药物研究有限公司 | Cefotiam salt compound and pharmaceutical composition made therefrom |
| CN101584665A (en) * | 2009-07-17 | 2009-11-25 | 山东罗欣药业股份有限公司 | Cefotiam hydrochloride medicament composition sterile powder injection and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103446159A (en) * | 2013-09-09 | 2013-12-18 | 海南美兰史克制药有限公司 | Pharmaceutical composition containing pediatric compound amino acid injection and cefotiam hydrochloride |
| CN103446159B (en) * | 2013-09-09 | 2014-07-02 | 海南美兰史克制药有限公司 | Pharmaceutical composition containing pediatric compound amino acid injection and cefotiam hydrochloride |
| CN105769770A (en) * | 2016-05-12 | 2016-07-20 | 浙江永宁药业股份有限公司 | Cefotiam hydrochloride powder injection preparation for injection |
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