CN103110640B - Pharmaceutical composition of injection ceftizoxime sodium and compound amino acid injection - Google Patents
Pharmaceutical composition of injection ceftizoxime sodium and compound amino acid injection Download PDFInfo
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- CN103110640B CN103110640B CN201310044731.1A CN201310044731A CN103110640B CN 103110640 B CN103110640 B CN 103110640B CN 201310044731 A CN201310044731 A CN 201310044731A CN 103110640 B CN103110640 B CN 103110640B
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- acid compound
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Abstract
The invention relates to a pharmaceutical composition of injection ceftizoxime sodium and compound amino acid injection and in particular relates to combined application package. The pharmaceutical composition includes injection ceftizoxime sodium and compound amino acid injection. During a using process, the injeciton ceftizoxime sodium is dropped to the compound amino acid injection for intravenous infusion of 30 minutes to 2 hours. For the compatibility mixing of the injection ceftizoxime sodium and the compound amino acid injection, the combined application package disclosed by the invention is used for simplifying the steps and improving the safety. Moreover, the stability of the ceftizoxime sodium is greatly facilitated, and the clinical application quality and the bioavailability of the medicine are improved.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of ceftiaoxline sodium for injection and Amino Acid Compound Injection, the applied in any combination packing that is specifically related to the formulated sterile solution for injection of a kind of ceftiaoxline sodium for injection and 18 kinds of crystalline amino acids and xylitol, belongs to medical technical field.
Background technology
Ceftizoxime sodium is third generation cephalosporin, has broad-spectrum antibacterial action, stable to the wide spectrum beta lactamase of most gram positive bacterias and gram-negative bacteria generation.Ceftizoxime sodium has good antibacterial action to hemophilus influenza and Neisseria gonorrhoeae.
Ceftiaoxline sodium for injection mechanism of action is for the biosynthesis by anti-bacteria cell wall mucopeptide reaches bactericidal action, is applicable to meningitis and Simple gonorrhea due to lower respiratory infection, urinary tract infection, abdominal cavity infection, pelvic infection, septicemia, skin soft-tissue infection, bone and the infection of joint, streptococcus pneumoniae or the hemophilus influenza due to sensitive organism.
Aminoacid, for human body synthetic protein and other tissue provide nitrogenous source, is the base substance that maintains human life.Aminoacid is except providing nitrogenous source for synthetic protein, part can be used as energy supply material through oxidation Decomposition, another a small amount of aminoacid can also transform and become some biological active substanceies, thereby maintains the function of some tissues and organ, and each seed amino acid can be transported by blood between individual tissue.To guarantee the amino acid metabolism in tissue.Human normal plasma's amino acid concentration is not high, total concentration be about 2 millimoles/liter, children's in cell is lower for the overwhelming majority, may be fast with children growth, aminoacid take in organize more relevant.Therefore, children's should be higher than adult to aminoacid intake.
Amino Acid Compound Injection, the in the situation that of Power supply abundance, can enter histiocyte, participates in the anabolism of protein, obtain positive nitrogen balance, and generate the biological active substanceies such as enzyme, hormone, antibody, structural protein, and promote organization healing, recover normal physiological function.
Amino Acid Compound Injection is hyperfunction for muscle catabolism under the stress state such as large-area burns, wound and severe infections, the patient's of digestive system function obstacle, nutrition deterioration and immunologic function degression nutritional support, also for patients after surgery, improve its nutritional status.For aminoacid such as protein Deficiency of Intake, malabsorptions, can not meet the patient of organism metabolism needs.Also for improving the nutriture of patients after surgery.
In addition, prior art only in operation instructions, mention ceftiaoxline sodium for injection and can use water for injection, sodium chloride injection, 5% glucose injection to dissolve after slow intravenous injection, also can be added in 10% glucose injection, electrolyte injection or amino acid injection iv drip 30 minutes-2 hours.In clinical use, need to buy respectively use in conjunction, ceftiaoxline sodium for injection and Amino Acid Compound Injection assembly packaging do not appear in the Shang He medical institutions of market.
Applicant offers medical institutions and market by ceftiaoxline sodium for injection of the present invention and Amino Acid Compound Injection with the form of assembly packaging, not only greatly improved ease of use and the drug safety of medical institutions, and the stability of each drug alone has been of great benefit to; More importantly be by add xylitol to obtain unforeseeable clinical practice quality and the bioavailability of using ceftiaoxline sodium for injection and amino acid injection that improved in Amino Acid Compound Injection simultaneously.
Summary of the invention
In order to overcome the series of problems existing in prior art, the inventor has creatively found employing amino acid Xylitol injection and ceftiaoxline sodium for injection compatibility use in conjunction, the ceftiaoxline sodium for injection and the 18 kinds of crystalline amino acid steriles solution for injection dissolvings formulated with xylitol that are about to independent packaging mix in rear input body, not only there is the effect of broad-spectrum antiseptic, but also treat amino acids nutritional supplementation simultaneously.
One of object of the present invention, provides the pharmaceutical composition of a kind of new ceftizoxime sodium and amino acid, and wherein, ceftizoxime sodium is powder ampoule agent for injection, and amino acid is the formulated sterile solution for injection of 18 kinds of crystalline amino acids and xylitol.
One of object of the present invention, the applied in any combination packing of a kind of ceftiaoxline sodium for injection and Amino Acid Compound Injection is provided, wherein, ceftizoxime sodium is powder ampoule agent for injection, and amino acid is the formulated sterile solution for injection of 18 kinds of crystalline amino acids and xylitol.
Applied in any combination packing provided by the invention, usage is for to be added in Amino Acid Compound Injection iv drip 30 minutes-2 hours by ceftiaoxline sodium for injection.
More importantly, the xylitol in Amino Acid Compound Injection contributes to improve the absorption of ceftizoxime sodium medicine also unexpectedly, makes it have the effect that postpones absorption, and curative effect is more obvious, and this is innovative point of the present invention place.
Applied in any combination packing specification provided by the invention is that ceftiaoxline sodium for injection is with C
13h
13n
5o
5s
2meter 0.5-4.0g, Amino Acid Compound Injection 50-1000ml.
As the present invention's one preferred embodiment, packing specification of the present invention is that ceftiaoxline sodium for injection is with C
13h
13n
5o
5s
2meter 0.5-4.0g, Amino Acid Compound Injection 100-500ml.
Ceftiaoxline sodium for injection of the present invention is made by ceftizoxime sodium aseptic powder subpackage, or by ceftizoxime sodium, adds appropriate excipient lyophilization and make.
As one of specific embodiment, concrete component and consumption are as follows:
The present invention also provides a kind of preparation method of ceftiaoxline sodium for injection, and concrete steps are:
Ceftizoxime sodium sterilized powder is sent into (subpackage post ambient temperature is 18 ℃～26 ℃, and relative humidity is below 65%) between subpackage, debugging racking machine, regulate step number to mix up loading amount, make loading amount reach the scope of regulation, be then sub-packed in low Pyrex control injection bottle made, press full plug, roll lid.
Or, by after ceftizoxime sodium and appropriate excipient dissolving, subpackage, lyophilization, tamponade, rolls lid.
Amino Acid Compound Injection of the present invention is the formulated sterile water solution of 18 kinds of crystalline amino acids and xylitol, concrete component comprises arginine hydrochloride 2.89g, histidine monohydrochloride 2.46g, leucine 3.79g, isoleucine 1.70g, lysine hydrochloride 3.33g, phenylalanine 2.83g, threonine 1.97g, valine 1.36g, methionine 1.06g, tryptophan 0.39g, glycine 3.24g, alanine 1.88g, proline 1.00g, tyrosine 0.11g, serine 0.67g, cysteine hydrochloride 0.44g, Aspartic Acid 1.15g, glutamic acid 1.97g, sodium sulfite 0.5g, xylitol 50g, water for injection adds to 1000ml.
The present invention also provides a kind of preparation method of Amino Acid Compound Injection, and concrete steps are:
(1) approximately 60% water for injection of getting about full dose boils and adds appropriate xylitol to make to dissolve, then adds about 0.15%(g/ml) active carbon boils 20 minutes, and return filter decolouring and after 20 minutes, filter into rare and join filling.
(2) pass into immediately nitrogen after filtering xylitol liquid in dilute preparing tank, what add other about full dose 40% uses 0.15(g/ml simultaneously again) active carbon boils 20 minutes pretreated water for injection of absorption and the merging of xylitol liquid, and open when cooling water makes amalgamation liquid be cooled to 60 ℃ and start to feed intake.
(3) first antioxidant sodium sulfite is divided into halves, a copy of it antioxidant is dropped in amalgamation liquid, then by above-mentioned formula order, each aminoacid is dropped into one by one and makes to dissolve, during to tryptophan, should control temperature can drop into below approximately 50 ℃, aminoacid feeds intake complete, adds another part of antioxidant and cysteine hydrochloride.
(4) with approximately 10% caustic lye of soda, slowly adding to regulate pH value 5.5-7.0, add and add to the full amount of water for injection, add 0.15%(g/ml) active carbon stirs decolouring 20 minutes, circulating filtration 30 minutes.
(5) filter qualified to visible foreign matters after, fill, sealing, sterilizing, obtains.
The present invention also provides the applied in any combination of a kind of ceftiaoxline sodium for injection and Amino Acid Compound Injection to be packaged in the application in preparation treatment amino acids nutritional supplementation medicine and extensive pedigree antibiotic, there is the human body protein of promotion Metabolism of Normal, correct negative nitrogen balance, supplement protein, accelerating wound, for body provides the effect of energy and essential amino acids.In addition, this product essential amino acids meets Vuj-N formula proportion, and non essential amino acid meets Albumin's pattern.The ratio of essential amino acids and non essential amino acid is 1.04:1, and every seed amino acid is easily effectively used to the synthetic of human body protein, and its bioavailability is high.The contained xylitol of this product can enter the cell interior without insulin, and the formation of tool inhibition ketoboidies, saves protein, improves rate of ultilization of amino acid, and promotes the effect that hepatic glycogen is accumulated, and carbohydrate metabolism is had no adverse effect, and has no and causes metabolic complication.
Accompanying drawing explanation
Accompanying drawing 1 is the four assembly intravenous blood drug level of 5 solution and the graph of relation of time;
The specific embodiment
embodiment 1the preparation of ceftiaoxline sodium for injection
Prescription:
Preparation process:
(1) by ceftizoxime sodium sterilized powder 500g(with C
13h
13n
5o
5s
2meter) send into (subpackage post ambient temperature is 18 ℃～26 ℃, and relative humidity is below 65%) between subpackage, debugging racking machine, regulate step number to mix up loading amount, make loading amount reach the scope of regulation, be then sub-packed in low Pyrex control injection bottle made, press full plug, roll lid.
(2) by ceftizoxime sodium sterilized powder 1000g(with C
13h
13n
5o
5s
2meter) send into (subpackage post ambient temperature is 18 ℃～26 ℃, and relative humidity is below 65%) between subpackage, debugging racking machine, regulate step number to mix up loading amount, make loading amount reach the scope of regulation, be then sub-packed in low Pyrex control injection bottle made, press full plug, roll lid.
embodiment 2the preparation of Amino Acid Compound Injection
Prescription:
(1) get 60L water for injection and boil and add 5000g xylitol to make to dissolve, then add 150g active carbon to boil 20 minutes, return filter decolouring and after 20 minutes, filter into rare and join filling.
(2) pass into immediately nitrogen after filtering xylitol liquid in dilute preparing tank, what add other 40L boils 20 minutes pretreated water for injection of absorption and the merging of xylitol liquid with 150g active carbon simultaneously again, opens when cooling water makes amalgamation liquid be cooled to 60 ℃ and starts to feed intake.
(3) first antioxidant sodium sulfite 50g is divided into halves, a copy of it antioxidant 25g is dropped in amalgamation liquid, then press above-mentioned formula order by arginine hydrochloride 289g, histidine monohydrochloride 246g, leucine 379g, isoleucine 170g, lysine hydrochloride 333g, phenylalanine 283g, threonine 197g, valine 136g, methionine 106g, tryptophan 39g, glycine 324g, alanine 188g, proline 100g, tyrosine 11g, serine 67g, Aspartic Acid 115g, glutamic acid 197g drops into one by one and makes to dissolve, during to tryptophan, should control temperature can drop into below approximately 50 ℃, aminoacid feeds intake complete, add another part of antioxidant 25g and cysteine hydrochloride 44g, .
(4) with approximately 10% caustic lye of soda, slowly add to regulate pH value 6.3, add and add to the full amount of water for injection, add 150g active carbon to stir decolouring 20 minutes, circulating filtration 30 minutes.
(5) filter qualified to visible foreign matters after, fill, 100ml/ bottle or 250ml/ bottle or 500ml bottle, sealing, 121 ℃ of pressure sterilizings 20 minutes, obtain.
embodiment 3the preparation of assembly packaging medicine
Combination 1: ceftiaoxline sodium for injection 0.5g and Amino Acid Compound Injection 100ml.
Combination 2: ceftiaoxline sodium for injection 0.5g and Amino Acid Compound Injection 250ml.
Combination 3: ceftiaoxline sodium for injection 1.0g and Amino Acid Compound Injection 250ml.
Combination 4: ceftiaoxline sodium for injection 1.0g and Amino Acid Compound Injection 500ml.
Combination 5: ceftiaoxline sodium for injection 2.0g and Amino Acid Compound Injection 250ml.
Combination 6: ceftiaoxline sodium for injection 2.0g and Amino Acid Compound Injection 500ml.
Combination 7: ceftiaoxline sodium for injection 1.0g and Amino Acid Compound Injection 100ml.
Combination 8: ceftiaoxline sodium for injection 3.0g and Amino Acid Compound Injection 250ml.
Combination 9: ceftiaoxline sodium for injection 3.0g and Amino Acid Compound Injection 500ml.
Combination 10: ceftiaoxline sodium for injection 4.0g and Amino Acid Compound Injection 500ml.
embodiment 4stability test
In order to verify in assembly packaging process of clinical application of the present invention, the stability of ceftizoxime sodium is of great benefit to, the ceftiaoxline sodium for injection that we choose embodiment 1 preparation carries out compatibility with following injection to be mixed,
(1) sodium chloride injection lot number: 20120801-1 Qingzhou Yaowang Pharmaceutical Co., Ltd.
(2) 5% glucose injection lot numbers: 20121002-5 Qingzhou Yaowang Pharmaceutical Co., Ltd.
(3) Multiple electrolytes injection lot number: 1206003 Kelun Pharm Ind Co., Ltd., Sichuan
(4) the Amino Acid Compound Injection embodiment of the present invention 2 preparations
Then detect mixed liquor in the related substance situation of change of 0,1,2,4,6 hour ceftizoxime sodium, contrast, result is as follows:
Conclusion: can be found out by above result of the test, the Amino Acid Compound Injection compatibility of ceftiaoxline sodium for injection and the embodiment of the present invention 2 preparations mixes, within 6 hours, related substance increases minimum, illustrate that stability of solution is better than other three kinds of injection far away, so assembly packaging of the present invention stability to ceftizoxime sodium in clinical use procedure is of great benefit to, and has ensured product quality.
The mensuration of embodiment 5 blood drug level
40 rats are divided into 4 groups at random, wherein the ceftiaoxline sodium for injection of first group of intravenous injection embodiment 1 preparation and the compatibility mixed liquor of commercially available product sodium chloride injection (lot number: 20120801-1, Qingzhou Yaowang Pharmaceutical Co., Ltd.); The ceftiaoxline sodium for injection of second group of intravenous injection embodiment 1 preparation and the compatibility mixed liquor of commercially available product 5% glucose injection (lot number: 20121002-5, Qingzhou Yaowang Pharmaceutical Co., Ltd.); The compatibility mixed liquor of the ceftiaoxline sodium for injection of the 3rd group of intravenous injection embodiment 1 preparation and commercially available product Multiple electrolytes injection (lot number: 1206003, Kelun Pharm Ind Co., Ltd., Sichuan); The compatibility mixed liquor of the Amino Acid Compound Injection of the ceftiaoxline sodium for injection of the 4th group of intravenous injection embodiment 1 preparation and embodiment 2 preparations.By 1.0g ceftizoxime sodium and 250ml injection compatibility, injected dose is 8ml/kg body weight.After administration, respectively at 0.5h, 1h, 1.5h, 2h, 3h, 6h, 8h, 12h, take a blood sample, blood sample after treatment, is measured the blood drug level of ceftizoxime sodium with HPLC-MS method.Draw the four assembly intravenous blood drug level of 5 solution and the relation curves of time, be shown in accompanying drawing 1.
As shown in Figure 1, in four assembly 5 solution, the 4th group of solution intravenous injection has the following advantages: the blood drug level peak value of ceftizoxime sodium is high, release rate in vivo slows down, in body circulation, distribution time extends, and has reached improved delayed release effect, and bioavailability increases.
The mensuration of test example 6 bioavailability
Get 24 rats, body weight (205 ± 10) g, be divided at random 4 groups, wherein the ceftiaoxline sodium for injection of first group of intravenous injection embodiment 1 preparation and the compatibility mixed liquor of commercially available product sodium chloride injection (lot number: 20120801-1, Qingzhou Yaowang Pharmaceutical Co., Ltd.); The ceftiaoxline sodium for injection of second group of intravenous injection embodiment 1 preparation and the compatibility mixed liquor of commercially available product 5% glucose injection (lot number: 20121002-5, Qingzhou Yaowang Pharmaceutical Co., Ltd.); The compatibility mixed liquor of the ceftiaoxline sodium for injection of the 3rd group of intravenous injection embodiment 1 preparation and commercially available product Multiple electrolytes injection (lot number: 1206003, Kelun Pharm Ind Co., Ltd., Sichuan); The compatibility mixed liquor of the Amino Acid Compound Injection of the ceftiaoxline sodium for injection of the 4th group of intravenous injection embodiment 1 preparation and embodiment 2 preparations.Dosage is ceftiaoxline sodium for injection 1.0g and injects liquid 250ml.After administration, 2h takes a blood sample 48 hours.Adopt high performance liquid chromatography to detect the blood drug level of ceftizoxime sodium, be specially: with octadecylsilane chemically bonded silica, be filler; With pH3.6 buffer (get citric acid 1.42g, sodium hydrogen phosphate 2.31g, is dissolved in water and is diluted to 1000ml)-acetonitrile (9:1), be mobile phase; Detection wavelength is 254nm.Take ceftizoxime reference substance 5mg, put in 10ml bottle, add 0.1mol/L sodium hydroxide solution 1ml, place 30 minutes, with pH7.0 phosphate buffer, be diluted to scale, shake up, must get 20 μ l injection liquid chromatographies containing the mixed solution of approximately 4% ceftizoxime alkaline degradation thing (its relative retention time approximately 0.8), record chromatogram, ceftizoxime peak retention time is about 8 minutes, and the ceftizoxime peak corresponding thereto separating degree at retention time approximately 0.8 alkaline degradation thing peak, place should be not less than 3.0.Sample thief adds pH7.0 phosphate buffer and is diluted to scale, shakes up, and precision measures 20 μ l injection liquid chromatographies, records chromatogram; Content by external standard method with ceftizoxime in calculated by peak area test sample.Use software 3p87 and WT1.4 to carry out data analysis, relevant pharmacokinetic parameters result is as following table.
As can be seen from the above experimental data, in four assembly 5 solution, the 4th group of solution be the ceftiaoxline sodium for injection of the embodiment of the present invention 1 preparation with the compatibility mixed liquor intravenous injection of the Amino Acid Compound Injection of embodiment 2 preparations than other three assembly, 5 mixed liquor intravenous injections, bioavailability improves greatly, absolutely proved that the present invention is by the intravenous benefit of the assembly packaging of ceftiaoxline sodium for injection and Amino Acid Compound Injection, the delayed release of xylitol, embodying of sorbefacient successful, make injection improve widely bioavailability, obtained unexpected technical effect.
industrial applicibility
Below through the specific embodiment and the embodiment the present invention is had been described in detail; but should understand; these explanations do not form any restriction to scope of the present invention; in the case of without departing from the spirit and scope of protection of the present invention; can carry out multiple modification, improvement and replacement to technical solutions and their implementation methods of the present invention, these are all because falling within the scope of protection of the present invention.
Each list of references of mentioning in the application or quoting, which is hereby incorporated by reference.
Claims (1)
1. an applied in any combination packing that comprises ceftiaoxline sodium for injection and Amino Acid Compound Injection, is characterized in that ceftizoxime sodium is powder ampoule agent for injection, and Amino Acid Compound Injection is the formulated sterile solution for injection of 18 kinds of crystalline amino acids and xylitol; Wherein, ceftiaoxline sodium for injection is made in C13H13N5O5S2 0.5-4.0g by ceftizoxime sodium; Amino Acid Compound Injection is by arginine hydrochloride 2.89g, histidine monohydrochloride 2.46g, leucine 3.79g, isoleucine 1.70g, lysine hydrochloride 3.33g, phenylalanine 2.83g, threonine 1.97g, valine 1.36g, methionine 1.06g, tryptophan 0.39g, glycine 3.24g, alanine 1.88g, proline 1.00g, tyrosine 0.11g, serine 0.67g, cysteine hydrochloride 0.44g, Aspartic Acid 1.15g, glutamic acid 1.97g, sodium sulfite 0.5g, xylitol 50g, water for injection adds to 1000ml and makes.
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| CN103393689B (en) * | 2013-08-02 | 2014-09-10 | 海南灵康制药有限公司 | Pharmaceutical composition of cefotiam hydrochloride for injection and compound amino acid injection |
| CN103463094B (en) * | 2013-09-04 | 2015-01-21 | 海南美大制药有限公司 | Medicine composition of cefpiramide sodium and infant compound amino acid injection (19AA-I) |
| CN103446056B (en) * | 2013-09-05 | 2014-07-02 | 海南美大制药有限公司 | Pharmaceutical composition containing ceftizoxime sodium and pediatric compound amino acid injection (19AA-I) |
| CN103446158B (en) * | 2013-09-06 | 2015-01-07 | 海南美兰史克制药有限公司 | Pharmaceutical composition of cefmenoxime hydrochloride and pediatric compound amino acid injection |
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| CN101439036B (en) * | 2008-12-22 | 2010-10-27 | 郑飞雄 | Pharmaceutical composition containing 18 kinds of amino acid |
| CN101606910B (en) * | 2009-07-20 | 2010-12-22 | 山东罗欣药业股份有限公司 | Ceftizoxime sodium drug injection powder and preparation method thereof, as well as synthetic method of bulk drug ceftizoxime sodium |
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