CN101785756A - Celtezole sodium suspension preparation and novel application thereof - Google Patents
Celtezole sodium suspension preparation and novel application thereof Download PDFInfo
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- CN101785756A CN101785756A CN201010100851A CN201010100851A CN101785756A CN 101785756 A CN101785756 A CN 101785756A CN 201010100851 A CN201010100851 A CN 201010100851A CN 201010100851 A CN201010100851 A CN 201010100851A CN 101785756 A CN101785756 A CN 101785756A
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Abstract
The invention relates to a novel celtezole sodium suspension preparation and novel application thereof on treatment of gonococcal conjunctivitis clinically. The celtezole sodium suspension preparation consists of an organic solvent, an emulsifying agent, an auxiliary emulsifying agent, an additive, a biodegradable material and an antioxidant, wherein the weight ratio of celtezole sodium to the biodegradable material is 25:14-52. The celtezole sodium suspension preparation has the advantages of good stability, less impurity content and the like.
Description
Technical field:
The present invention relates to a kind of ceftezole sodium suspension preparation, relate to a kind of preparation method of ceftezole sodium suspension preparation and this mixed suspension preparation particularly clinically to the treatment of gonococcal conjunctivitis.
Technical background:
Along with increasing that gonococcus property genito-urinary system infects, gonococcal conjunctivitis is no longer rare in recent years.Because it is dangerously ill, development is rapid, and infectiousness is strong, and therefore, the clinician should keep vigilance highly to this disease, all need get rid of gonococcus infection for the acute festering type conjunctivitis.Discharge of eye or conjunctiva scraping blade bacteriology checking are seen in epithelial cell and the neutrophilic leukocyte or extracellular G
-Diplococcus is a foundation of making a definite diagnosis this disease, acute stage the antibacterial recall rate reach more than 90%.But one time the bacteriology checking feminine gender can not be got rid of this disease fully, and serious symptom suspects that highly this patient should repeat to do the bacteriology checking of discharge of eye or conjunctiva scraping blade clinically.Because its state of an illness fiendishness, treatment as if the concurrent corneal ulcer of untimely meeting, perforation, cause the visual function forfeiture.How to select effective antibiotic, the development that in time controls inflammation is the key of treatment.
Cefobutazine sodium, have another name called ceftezol sodium, English name, ceftezole sodium, chemical name is: (6R, 7R)-3-[(1,3,4-thiadiazoles-2-yl) sulphomethyl]-8-oxo-7-[2-(1H-tetrazolium-1-yl) acetylamino]-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2 sodium formate, molecular formula: C
13H
11N
8NaO
4S
3, being semisynthetic cephalosporins derivatives, its mechanism of action is by suppressing the synthetic antibacterial activity of bringing into play of bacteria cell wall.It all has inhibitory action to aerobic gram positive bacteria and gram negative bacteria.
CN1823738A and CN101229129 disclose the powder injection formulation of the anhydride raw material direct packaging preparation of cefobutazine sodium.The listing kind of cefobutazine sodium mostly is the powder injection formulation of the anhydride raw material direct packaging preparation of cefobutazine sodium greatly at present.Because cefobutazine sodium has and very strong draws moistly, has very big difficulty in the packing preparation process, and is mobile very poor, and ambient temperature and humidity is required very high, complicated operating process, not easy to operate.And cefobutazine sodium deposits in the process, particularly under the condition of high temperature (＞50 ℃), degraded and polyreaction often takes place, thereby causes active constituents of medicine content to reduce, and color and luster is strengthened, and polymeric impurities content raises.In addition, the cefobutazine sodium of long-term storage also usually makes the medicine active component content reduce, and darkens, and polymer content raises.And in some cases, because controlling of production process is improper, resulting cefobutazine sodium polymer content is high especially.And polymer content easily makes human body produce anaphylaxis when high.
Therefore need provide a kind of quality more excellent cefobutazine sodium injection, the present invention has satisfied this demand.
Summary of the invention:
The inventor provides a kind of new superior in quality ceftezole sodium suspension preparation in order to overcome the shortcoming that above-mentioned powder injection formulation exists, and described ceftezole sodium suspension preparation has good stability, the advantage that impurity content is few.
Ceftezole sodium suspension preparation of the present invention is different from the ceftezole sodium suspension preparation of the routine that adopts the routine techniques preparation, because the inventor finds to be had the following disadvantages by the ceftezole sodium suspension preparation of the routine of common process and material preparation in trial test: stability is undesirable, drug safety neither be fine and drug utilization tire limited.The inventor has drawn a kind of complex device that do not relate to by consulting some documents and lots of expriments contrasting, the cheap new preparation method of raw materials used safety.Especially; the ceftezole sodium suspension preparation that the present invention is prepared; adopted the biological degradation polyalcohol material, in emulsification, can well with the principal agent combination; so that the depositing in the process of later stage finished product; can protect the principal agent active component effectively, suppress the generation of ceftezole sodium polymer, solve stability problem; improve drug safety, thereby finished the present invention.
The technical scheme that the present invention realizes is as follows:
A kind of ceftezole sodium suspension preparation, it is at first to prepare the cefobutazine sodium emulsion with organic solvent, emulsifying agent, co-emulsifier, additives, biodegradation material, adds antioxidant then and prepares finished product.
In a preferred embodiment, a kind of ceftezole sodium suspension preparation is provided, it is characterized in that at first preparing the cefobutazine sodium emulsion with organic solvent, emulsifying agent, co-emulsifier, additives, biodegradation material, add antioxidant then and prepare finished product, wherein the part by weight of cefobutazine sodium, biodegradation material is 25: 14～52.
In a preferred embodiment, a kind of ceftezole sodium suspension preparation is provided, it is characterized in that at first preparing the cefobutazine sodium emulsion with organic solvent, emulsifying agent, co-emulsifier, additives, biodegradation material, add antioxidant then and prepare finished product, wherein the part by weight of cefobutazine sodium, biodegradation material, emulsifying agent, co-emulsifier is 25: 14～52: 13.5～18: 8～16.
In one aspect of the invention, biodegradation material can be preferably protein, chitin and chitosan for one or more arbitrary proportions in protein, gelatin, Resina persicae, chitin, chitosan, polyamino acid, polyacrylate, polylactic acid (PLA), polylactic acid/ethanol copolymer (PLGA), polyethylene glycol copolymer, the monomethyl polyethylene glycol copolymer.
In another aspect of the present invention, emulsifying agent can be chosen as that lecithin, soybean phospholipid, cholesterol, fatty acid Pyrusussuriensis are smooth, one or more arbitrary proportions in the Polysorbate, poloxalkol, glyceryl monostearate mix, and is preferably cholesterol, soybean phospholipid and Polysorbate.
In another aspect of the present invention, co-emulsifier can be chosen as one or more in methylcellulose, agar, xanthan gum, the ossein, is preferably methylcellulose and agar.
In another aspect of the present invention, organic solvent is selected from one or more in chloroform, ethanol, methanol, the tert-butyl alcohol, n-butyl alcohol, isopropyl alcohol, acetone, ether, benzyl alcohol, the normal hexane, is preferably ethanol, isopropyl alcohol.
In another aspect of the present invention, additives can be chosen as PVP, mannitol, sodium chloride, lactose, are preferably sodium chloride.
In another aspect of the present invention, antioxidant can be chosen as one or more in vitamin E, sodium sulfite, sodium sulfite, thiourea, the Butylated hydroxyanisole, is preferably sodium sulfite and sodium sulfite.
The present invention also provides a kind of preparation method of ceftezole sodium suspension preparation, and concrete preparation process is as follows:
A. cefobutazine sodium and additives are dissolved in an amount of water for injection, biodegradation material, emulsifying agent, co-emulsifier are dissolved in an amount of organic solvent, these two kinds of solution are mixed being transferred in the dispersing emulsification machine again, obtain emulsion;
B. emulsion is evaporated eluting, remove organic solvent, add the antioxidant of recipe quantity, uniform dissolution obtains mother solution in water for injection;
C. mother solution is carried out packing, in freeze dryer, carry out lyophilizing, obtain finished product.
The present invention also provides the remarkable therapeutical effect of a kind of ceftezole sodium suspension preparation on gonococcal conjunctivitis.
Ceftezole sodium suspension preparation provided by the present invention has the following advantages:
1. to relate to equipment common for preparation technology, and easy operating has reduced to produce and dropped into;
2. the prepared ceftezole sodium suspension preparation of the present invention, owing to introduced the biological degradation polyalcohol material, in emulsification, can well with the principal agent combination, so that the principal agent active component can be effectively protected in depositing in the process of later stage finished product, suppress the generation of ceftezole sodium polymer, can solve this prepared product of prior art so to a certain extent and deposit the problem that occurs in the process, improve drug safety;
3. the prepared ceftezole sodium suspension preparation of the present invention stability has better guaranteed quality before the deadline.
With reference to 2005 editions requirements of Chinese Pharmacopoeia, the prepared ceftezole sodium suspension preparation of the present invention has been carried out acute toxicity test, abnormal toxicity test and bacterial endotoxin inspection, each checks that Xiang Jun meets the requirements.
Simultaneously the prepared ceftezole sodium suspension preparation of the present invention has been carried out stability test (the results are shown in specific embodiment test example one), every inspection index all meets the requirements.
The specific embodiment:
Below all case study on implementation only be to further supplementary notes of the present invention, not should be understood to further restriction of the present invention.
The preparation of case study on implementation one ceftezole sodium suspension preparation
Prescription (specification 0.25g)
Cefobutazine sodium 25g
Chitin 40g
Sodium chloride 12g
Polysorbate 18g
Methylcellulose 20g
Isopropyl alcohol 150ml
Sodium sulfite 9g
Water for injection 600ml
Preparation technology:
A. 25g cefobutazine sodium and 12g sodium chloride are dissolved in the 100ml water for injection, 40g chitin, 18g Polysorbate, 20g methylcellulose are dissolved in the 150ml isopropyl alcohol, again these two kinds of solution are mixed being transferred to the 60min that turns round in the high pressure dispersing emulsification machine, obtained the cefobutazine sodium emulsion;
B. this emulsion is evaporated eluting, remove organic solvent, add the 9g sodium sulfite, uniform dissolution has obtained mother solution in 500ml water for injection;
C. mother solution is sub-packed in the cillin bottle, in freeze dryer, carries out lyophilizing, obtain ceftezole sodium suspension preparation finished product.
The preparation of case study on implementation two ceftezole sodium suspension preparations
Prescription (specification 0.5g)
Cefobutazine sodium 50g
Lactose 34g
Chitosan 28g
Cholesterol 27g
Agar 32g
PVP 7g
Ethanol 250ml
Sodium sulfite 15g
Water for injection 800ml
Preparation technology:
A. 50g cefobutazine sodium, 34g lactose and 7gPVP are dissolved in the 200ml water for injection, 28g chitosan, 27g cholesterol, 32g agar are dissolved in the 250ml alcohol, again these two kinds of solution are mixed being transferred to the 60min that turns round in the high pressure dispersing emulsification machine, obtained the cefobutazine sodium emulsion;
B. this emulsion is evaporated eluting, remove organic solvent, add the 15g sodium bisulfate, uniform dissolution has obtained the mother solution of ceftezole sodium suspension preparation in 600ml water for injection;
C. mother solution is sub-packed in the cillin bottle, in freeze dryer, carries out lyophilizing, obtain ceftezole sodium suspension preparation finished product.
The preparation of case study on implementation three ceftezole sodium suspension preparations
Prescription (specification 0.25g)
Cefobutazine sodium 25g
Protein 52g
Soybean phospholipid 17g
Methylcellulose 8g
Ethanol 150ml
Mannitol 16g
Sodium sulfite 15g
Water for injection 600ml
Preparation technology:
A. 25g cefobutazine sodium, 16g mannitol are dissolved in the 100ml water for injection, 52g protein, 17g soybean phospholipid, 8g methylcellulose are dissolved in the 100ml ethanol, again these two kinds of solution are mixed being transferred to the 40min that turns round in the high pressure dispersing emulsification machine, obtained the cefobutazine sodium emulsion;
B. this emulsion is evaporated eluting, remove organic solvent, add the 15g sodium bisulfate, uniform dissolution has obtained the mother solution of ceftezole sodium suspension preparation in 500ml water for injection;
C. mother solution is sub-packed in the cillin bottle, in freeze dryer, carries out lyophilizing, obtain ceftezole sodium suspension preparation finished product.
Test example one ceftezole sodium suspension preparation study on the stability
Reference standard: 2005 editions appendix X of Chinese Pharmacopoeia IX
The test specimen source: embodiment one, embodiment two, embodiment three, listing sample Ceftezole sodium used for injection are the sample of the lot number 20080304 of Xinfeng Pharmaceutical Co., Ltd., Tianjin's production.
Experimental condition:
1. influence factor's test: under 60 ℃ of high temperature, illumination 4500Lx condition, placed 10 days respectively:
2. accelerated test: under 40 ℃ of high temperature, relative humidity 75% ± 5% condition, placed 6 months;
3. long term test: under 25 ℃ of high temperature, relative humidity 60% ± 10% condition, place and investigated in 24 months.
Result of the test such as following table:
Table 1 influence factor result
Table 2 accelerated test result
Table 3 long-term test results
By above test data as can be seen, through behind the study on the stability, listing sample acidity descends bigger, and related substance obviously increases, and clarity is against regulation, and content obviously descends; And the every detection index of ceftezole sodium suspension preparation of embodiment of the invention preparation does not all have significant change; particularly related substance ceftezole sodium polymer does not obviously increase; proved absolutely the protective effect of biodegradation material, had unexpected effect cefobutazine sodium.
Two clinical trials of test example
1. object man 25 examples, women 19 examples, 4 days～57 years old age, neonate 4 examples wherein, child's 3 examples.Make a definite diagnosis time gap morbidity 3 days～26 days.4 routine neonates and 3 routine children all were eyes morbidities when the patient went to a doctor, and 9 examples are simple eye morbidity in the adult patient, and all the other are the eyes morbidity.The patient shows as eyelid swelled, and the severe patient fissura palpebrae can not be opened, and palpebral conjunctiva and fornical conjunctiva are congested red and swollen, and chemosis is obvious, but the swelling protuberance exceeds limbus of corneae.A large amount of purulent secretions spill from palpebral fissure.Diagnostic criteria: discharge of eye or conjunctiva scraping blade bacteriology checking are seen in epithelial cell and the neutrophilic leukocyte or extracellular G-(Gram-negative) diplococcus.
2. give the cefobutazine sodium suspensoid intravenous drip of the embodiment of the invention 1 preparation after method is made a definite diagnosis, every day 2 times, continuous 5 days.Adult's dosage is 3g/ time, and child, infant are the 40mg/kg body weight.The part begins per 10 minutes 1 time with 0.9% normal saline cleaning down conjunctival sac, is kept to flushing in per 15,30 minutes 1 time after secretions reduces gradually.Ofloxacin collyrium and 15% sulphacetamide collyrium replace eye drip, begin every 5min once, prolong gradually after the state of an illness is alleviated to drip medicine blanking time.2 weeks of continuous use.Erythromycin eye ointment is coated with into conjunctival sac, every day 2 times.
3. result
The cefobutazine sodium suspensoid treatment of the embodiment of the invention 1 preparation is after 1 day, and patient's symptom all is clearly better, and conjunctival sac secretions disappears substantially after 3 days, treats that conjunctiva scraping blade bacteriology checking G-diplococcus all transfers feminine gender to after 5 days.Syndromes such as no cornea ulcer, perforation.
By the clinical research of this group data, we think that the cefobutazine sodium suspensoid intravenous drip treatment gonococcal conjunctivitis that the present invention prepares is safe and effective, can be used as the first-selected medication of treatment gonococcal conjunctivitis.
Claims (10)
1. a ceftezole sodium suspension preparation is characterized in that preparing the cefobutazine sodium emulsion with organic solvent, emulsifying agent, co-emulsifier, additives, biodegradation material, adds antioxidant then and prepares finished product.
2. ceftezole sodium suspension preparation according to claim 1, the part by weight that it is characterized in that cefobutazine sodium and biodegradation material is 25: 14～52.
3. according to the described ceftezole sodium suspension preparation of claim 1～2, it is characterized in that biodegradation material can be the blended biodegradation material of one or more arbitrary proportions in protein, gelatin, Resina persicae, chitin, chitosan, polyamino acid, polyacrylate, polylactic acid (PLA), polylactic acid/ethanol copolymer (PLGA), polyethylene glycol copolymer, the monomethyl polyethylene glycol copolymer.
4. according to the described ceftezole sodium suspension preparation of claim 1～3, it is characterized in that emulsifying agent can be chosen as that lecithin, soybean phospholipid, cholesterol, fatty acid Pyrusussuriensis are smooth, the blended emulsifying agent of one or more arbitrary proportions in the Polysorbate, poloxalkol, glyceryl monostearate.
5. according to the described ceftezole sodium suspension preparation of claim 1～4, it is characterized in that co-emulsifier can be chosen as one or more in methylcellulose, agar, xanthan gum, the ossein.
6. according to the described ceftezole sodium suspension preparation of claim 1～5, it is characterized in that organic solvent is selected from one or more in chloroform, ethanol, methanol, the tert-butyl alcohol, n-butyl alcohol, isopropyl alcohol, acetone, ether, benzyl alcohol, the normal hexane.
7. according to the described ceftezole sodium suspension preparation of claim 1～6, it is characterized in that additives can be chosen as PVP, mannitol, sodium chloride, lactose.
8. according to the described ceftezole sodium suspension preparation of claim 1～7, it is characterized in that antioxidant is selected from one or more in vitamin E, sodium sulfite, sodium sulfite, thiourea, the Butylated hydroxyanisole.
9. according to the arbitrary described ceftezole sodium suspension preparation of claim 1～8, it is characterized in that concrete preparation process is:
A. cefobutazine sodium and additives are dissolved in an amount of water for injection, biodegradation material, emulsifying agent, co-emulsifier are dissolved in an amount of organic solvent, again these two kinds of solution are mixed to be transferred in the dispersing emulsification machine and rotate, obtain emulsion;
B. emulsion is evaporated eluting, remove organic solvent, add the antioxidant of recipe quantity, uniform dissolution obtains mother solution in water for injection;
C. mother solution is carried out packing, in freeze dryer, carry out lyophilizing, obtain finished product.
10. according to the arbitrary described ceftezole sodium suspension preparation of claim 1～9, its feature also is the remarkable therapeutical effect of this product on gonococcal conjunctivitis.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2010101008515A CN101785756B (en) | 2010-01-26 | 2010-01-26 | Celtezole sodium suspension preparation |
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| CN2010101008515A CN101785756B (en) | 2010-01-26 | 2010-01-26 | Celtezole sodium suspension preparation |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101912361A (en) * | 2010-07-29 | 2010-12-15 | 陶灵刚 | Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof |
| CN106361704A (en) * | 2016-08-30 | 2017-02-01 | 甘肃新天马制药股份有限公司 | Ceftiofur sodium drug sustained-release colloid powder injection for injection and preparation method thereof |
-
2010
- 2010-01-26 CN CN2010101008515A patent/CN101785756B/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101912361A (en) * | 2010-07-29 | 2010-12-15 | 陶灵刚 | Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof |
| CN101912361B (en) * | 2010-07-29 | 2012-03-07 | 陶灵刚 | Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof |
| CN106361704A (en) * | 2016-08-30 | 2017-02-01 | 甘肃新天马制药股份有限公司 | Ceftiofur sodium drug sustained-release colloid powder injection for injection and preparation method thereof |
| CN106361704B (en) * | 2016-08-30 | 2019-02-12 | 甘肃新天马制药股份有限公司 | A kind of injection ceftiofur sodium medicament slow release colloid powder-injection and preparation method thereof |
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| CN101785756B (en) | 2011-09-14 |
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