CN103768069A - Combinatorial drug of ceftazidime - Google Patents
Combinatorial drug of ceftazidime Download PDFInfo
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- CN103768069A CN103768069A CN201410027505.7A CN201410027505A CN103768069A CN 103768069 A CN103768069 A CN 103768069A CN 201410027505 A CN201410027505 A CN 201410027505A CN 103768069 A CN103768069 A CN 103768069A
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Abstract
The invention provides a combinatorial drug of ceftazidime. The combinatorial drug is characterized by being prepared from the pharmacodynamic components: ceftazidime, glutathione, arginine and lysine, of which the ratio in parts by weight is (80-110):(20-60):(8-55):(10-40). A preparation method of the combinatorial drug is provided. The combinatorial drug of the ceftazidime disclosed by the invention is superior to the prior art in safety, stability and curative effect, and the preparation method is energy-saving and environment-friendly.
Description
Technical field
The present invention relates to a kind of composition of medicine and compound method thereof of ceftazidime.
Background technology
Ceftazidime is semisynthetic third generation cephalosporin.Goods are free acid (five hydrates), and are added with a certain amount of natrium carbonicum calcinatum, make injection for.Be applicable to responsive gram negative bacilli septicemia extremely, lower respiratory infection, abdominal cavity gallbladder system infect, complexity urinary tract infection and serious skin soft-tissue infection.At present, under greenhouse, preserve unstablely due to ceftazidime for inj, while meeting the external force such as light, heat, water, oxidation, very easily go to pot, brought greatly inconvenience therefore to storage and transportation, also increased the product cost of storage and cost of transportation.In addition, there is drug allergy person and the untoward reaction such as gastrointestinal tract, liver system and drug fever are reacted;
In order to overcome existing technological deficiency; a kind of composition of medicine of ceftazidime of best proportioning is provided; oxidation and peroxidating with the combined protection ceftazidime of glutathion, arginine, lysine in manufacture, storage, transportation, use, body; untoward reaction is alleviated greatly; and glutathion, arginine, lysine make not superfluous ceftazidime and damaging in body of liver, kidney, play protect the liver, the effect of kidney.
Summary of the invention
In order to overcome the defect of prior art, the invention provides composition of medicine of a kind of ceftazidime and preparation method thereof;
Invent a kind of composition of medicine of ceftazidime, made by effective active ingredient of following parts by weight:
Ceftazidime 80-110
Glutathion 20-60
Arginine 8-55
Lysine 10-40
The method of described ceftazidime composition of medicine, method and step that it is prepared are as follows:
(1). getting weight is the water for injection of 5-15 times of described ceftazidime weight, under stirring, respectively described ceftazidime, glutathion, arginine, lysine is dissolved completely, obtains the composition of medicine solution of ceftazidime;
(2). with molecular cut off be the medicinal liquid that 4000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.3-7.4 with 8% sodium hydroxide solution;
(3). the medicinal liquid that step (2) obtains was 121 ℃ of steam sterilizations 20 minutes;
(4). when the medicinal liquid after sterilizing is cooled to 20-22 ℃, with 8% sodium hydroxide solution, under stirring, be added drop-wise in medicinal liquid, the pH value of adjusting medicinal liquid is 6.3-7.4, then filters through the membrane filtration of 0.22 μ m, obtains composition of medicine solution;
(5). the composition of medicine medicinal liquid that above-mentioned step (4) is made is made the acceptable dosage form of ceftazidime on pharmaceutics;
A. press the dosage of the ceftazidime of pharmaceutics permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in cillin bottle, partly jump a queue, routinely, in the freeze drying box of freezer dryer, lyophilization, makes residual moisture≤2% in composition of medicine solid, tamponade, roll lid, make the lyophilized injection of ceftazidime composition of medicine;
B. press the dosage of the ceftazidime of meterological permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in 316L rustless steel pallet, lyophilization, make moisture≤2% in composition of medicine solid, pulverize composition of medicine solid to 60-80 order, measure ceftazidime content, be mixed with again 0.9% sodium chloride injection of ceftazidime or the ceftazidime composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form by well-established law.
The advantage of a kind of ceftazidime composition of medicine of the present invention has:
Composition of medicine provided by the invention to treat responsive gram negative bacilli septicemia extremely, lower respiratory infection, abdominal cavity gallbladder system infect, the therapeutic effect of the medicine such as complexity urinary tract infection and serious skin soft-tissue infection higher than ceftazidime preparation in prior art and septicemia, lower respiratory infection, abdominal cavity gallbladder system extremely of the responsive gram negative bacilli of other treatment institute infect, complexity urinary tract infection and the serious medicine of skin soft-tissue infection etc.;
2. the present invention separates thermal source with the ultrafilter membrane of the molecular weight 2000D that dams, both specific activity charcoal except thermal source technique thorough, also separate thoroughly than the ultrafilter membrane with the molecular weight 4000D that dams, although heat source substance molecular weight is greater than 4000D, this research also finds that the heat source substance molecule fragment of 4000D also has pyrogen reaction, so must separate the pyrogen sheet segment molecule of 4000D molecular weight.So it is thorough that the present invention separates pyrogen, apyrogeneity reaction;
3. thereby the present invention reduces arginine consumption as cosolvent jointly with arginine and lysine; can strengthen solubilization-aid effect, another medicine is eliminated drug anaphylaxis and oxidation, peroxidization by the effect of glutathion; meanwhile, play the liver protecting tissue and cell.So curative effect of medication of the present invention is stable, quality controllable, use safety;
4. composition of medicine medicinal liquid, the solid after lyophilization is the dispersed system that is molecularity, makes corresponding preparation, the uniformity of dosage units of each composition is higher more than 20% than traditional coating mixing and high-speed stirred wet mixing technique.
The specific embodiment
Embodiment 1
Invent a kind of composition of medicine of ceftazidime, made by effective active ingredient of following parts by weight:
Ceftazidime 80
Glutathion 20
Arginine 8
Lysine 10
The method of described ceftazidime composition of medicine, method and step that it is prepared are as follows:
(1). getting weight is the water for injection of 5-15 times of described ceftazidime weight, under stirring, respectively described ceftazidime, glutathion, arginine, lysine is dissolved completely, obtains the composition of medicine solution of ceftazidime;
(2). with molecular cut off be the medicinal liquid that 4000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.3-7.4 with 8% sodium hydroxide solution;
(3). the medicinal liquid that step (2) obtains was 121 ℃ of steam sterilizations 20 minutes;
(4). when the medicinal liquid after sterilizing is cooled to 20-22 ℃, with 8% sodium hydroxide solution, under stirring, be added drop-wise in medicinal liquid, the pH value of adjusting medicinal liquid is 6.3-7.4, then filters through the membrane filtration of 0.22 μ m, obtains composition of medicine solution;
(5). the composition of medicine medicinal liquid that above-mentioned step (4) is made is made the acceptable dosage form of ceftazidime on pharmaceutics;
A. press the dosage of the ceftazidime of pharmaceutics permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in cillin bottle, partly jump a queue, routinely, in the freeze drying box of freezer dryer, lyophilization, makes residual moisture≤2% in composition of medicine solid, tamponade, roll lid, make the lyophilized injection of ceftazidime composition of medicine;
B. press the dosage of the ceftazidime of meterological permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in 316L rustless steel pallet, lyophilization, make moisture≤2% in composition of medicine solid, pulverize composition of medicine solid to 60-80 order, measure ceftazidime content, be mixed with again 0.9% sodium chloride injection of ceftazidime or the ceftazidime composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form by well-established law.
Embodiment 2
Invent a kind of composition of medicine of ceftazidime, made by effective active ingredient of following parts by weight:
Ceftazidime 93
Glutathion 31
Arginine 19
Lysine 16
The method of described ceftazidime composition of medicine, method and step that it is prepared are as follows:
(1). getting weight is the water for injection of 5-15 times of described ceftazidime weight, under stirring, respectively described ceftazidime, glutathion, arginine, lysine is dissolved completely, obtains the composition of medicine solution of ceftazidime;
(2). with molecular cut off be the medicinal liquid that 4000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.3-7.4 with 8% sodium hydroxide solution;
(3). the medicinal liquid that step (2) obtains was 121 ℃ of steam sterilizations 20 minutes;
(4). when the medicinal liquid after sterilizing is cooled to 20-22 ℃, with 8% sodium hydroxide solution, under stirring, be added drop-wise in medicinal liquid, the pH value of adjusting medicinal liquid is 6.3-7.4, then filters through the membrane filtration of 0.22 μ m, obtains composition of medicine solution;
(5). the composition of medicine medicinal liquid that above-mentioned step (4) is made is made the acceptable dosage form of ceftazidime on pharmaceutics;
A. press the dosage of the ceftazidime of pharmaceutics permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in cillin bottle, partly jump a queue, routinely, in the freeze drying box of freezer dryer, lyophilization, makes residual moisture≤2% in composition of medicine solid, tamponade, roll lid, make the lyophilized injection of ceftazidime composition of medicine;
B. press the dosage of the ceftazidime of meterological permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in 316L rustless steel pallet, lyophilization, make moisture≤2% in composition of medicine solid, pulverize composition of medicine solid to 60-80 order, measure ceftazidime content, be mixed with again 0.9% sodium chloride injection of ceftazidime or the ceftazidime composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form by well-established law.
Embodiment 3
Invent a kind of composition of medicine of ceftazidime, made by effective active ingredient of following parts by weight:
Ceftazidime 100
Glutathion 40
Arginase 12 9
Lysine 26
The method of described ceftazidime composition of medicine, method and step that it is prepared are as follows:
(1). getting weight is the water for injection of 5-15 times of described ceftazidime weight, under stirring, respectively described ceftazidime, glutathion, arginine, lysine is dissolved completely, obtains the composition of medicine solution of ceftazidime;
(2). with molecular cut off be the medicinal liquid that 4000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.3-7.4 with 8% sodium hydroxide solution;
(3). the medicinal liquid that step (2) obtains was 121 ℃ of steam sterilizations 20 minutes;
(4). when the medicinal liquid after sterilizing is cooled to 20-22 ℃, with 8% sodium hydroxide solution, under stirring, be added drop-wise in medicinal liquid, the pH value of adjusting medicinal liquid is 6.3-7.4, then filters through the membrane filtration of 0.22 μ m, obtains composition of medicine solution;
(5). the composition of medicine medicinal liquid that above-mentioned step (4) is made is made the acceptable dosage form of ceftazidime on pharmaceutics;
A. press the dosage of the ceftazidime of pharmaceutics permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in cillin bottle, partly jump a queue, routinely, in the freeze drying box of freezer dryer, lyophilization, makes residual moisture≤2% in composition of medicine solid, tamponade, roll lid, make the lyophilized injection of ceftazidime composition of medicine;
B. press the dosage of the ceftazidime of meterological permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in 316L rustless steel pallet, lyophilization, make moisture≤2% in composition of medicine solid, pulverize composition of medicine solid to 60-80 order, measure ceftazidime content, be mixed with again 0.9% sodium chloride injection of ceftazidime or the ceftazidime composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form by well-established law.
Embodiment 4
Invent a kind of composition of medicine of ceftazidime, made by effective active ingredient of following parts by weight:
Ceftazidime 104
Glutathion 51
Arginine 39
Lysine 33
The method of described ceftazidime composition of medicine, method and step that it is prepared are as follows:
(1). getting weight is the water for injection of 5-15 times of described ceftazidime weight, under stirring, respectively described ceftazidime, glutathion, arginine, lysine is dissolved completely, obtains the composition of medicine solution of ceftazidime;
(2). with molecular cut off be the medicinal liquid that 4000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.3-7.4 with 8% sodium hydroxide solution;
(3). the medicinal liquid that step (2) obtains was 121 ℃ of steam sterilizations 20 minutes;
(4). when the medicinal liquid after sterilizing is cooled to 20-22 ℃, with 8% sodium hydroxide solution, under stirring, be added drop-wise in medicinal liquid, the pH value of adjusting medicinal liquid is 6.3-7.4, then filters through the membrane filtration of 0.22 μ m, obtains composition of medicine solution;
(5). the composition of medicine medicinal liquid that above-mentioned step (4) is made is made the acceptable dosage form of ceftazidime on pharmaceutics;
A. press the dosage of the ceftazidime of pharmaceutics permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in cillin bottle, partly jump a queue, routinely, in the freeze drying box of freezer dryer, lyophilization, makes residual moisture≤2% in composition of medicine solid, tamponade, roll lid, make the lyophilized injection of ceftazidime composition of medicine;
B. press the dosage of the ceftazidime of meterological permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in 316L rustless steel pallet, lyophilization, make moisture≤2% in composition of medicine solid, pulverize composition of medicine solid to 60-80 order, measure ceftazidime content, be mixed with again 0.9% sodium chloride injection of ceftazidime or the ceftazidime composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form by well-established law.
Embodiment 5
Invent a kind of composition of medicine of ceftazidime, made by effective active ingredient of following parts by weight:
Ceftazidime 110
Glutathion 60
Arginine 55
Lysine 40
The method of described ceftazidime composition of medicine, method and step that it is prepared are as follows:
(1). getting weight is the water for injection of 5-15 times of described ceftazidime weight, under stirring, respectively described ceftazidime, glutathion, arginine, lysine is dissolved completely, obtains the composition of medicine solution of ceftazidime;
(2). with molecular cut off be the medicinal liquid that 4000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.3-7.4 with 8% sodium hydroxide solution;
(3). the medicinal liquid that step (2) obtains was 121 ℃ of steam sterilizations 20 minutes;
(4). when the medicinal liquid after sterilizing is cooled to 20-22 ℃, with 8% sodium hydroxide solution, under stirring, be added drop-wise in medicinal liquid, the pH value of adjusting medicinal liquid is 6.3-7.4, then filters through the membrane filtration of 0.22 μ m, obtains composition of medicine solution;
(5). the composition of medicine medicinal liquid that above-mentioned step (4) is made is made the acceptable dosage form of ceftazidime on pharmaceutics;
A. press the dosage of the ceftazidime of pharmaceutics permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in cillin bottle, partly jump a queue, routinely, in the freeze drying box of freezer dryer, lyophilization, makes residual moisture≤2% in composition of medicine solid, tamponade, roll lid, make the lyophilized injection of ceftazidime composition of medicine;
B. press the dosage of the ceftazidime of meterological permission, composition of medicine medicinal liquid prepared by above-mentioned (4) step is aseptic subpackaged in 316L rustless steel pallet, lyophilization, make moisture≤2% in composition of medicine solid, pulverize composition of medicine solid to 60-80 order, measure ceftazidime content, be mixed with again 0.9% sodium chloride injection of ceftazidime or the ceftazidime composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form by well-established law.
Pharmacodynamics confirmatory experiment:
Animal is selected: 150 of the mices of the experimental model that selection is prepared by Experimental Animal Center, and body weight 18g-22g, male and female half and half, are divided into three groups at random, 50 of every treated animals.Be labeled as tri-groups of A, B, C;
By the mice of the normal saline solution injection experiments model of infection gram positive coccus and Chlamydia pneumoniae bacterium.Three groups of experiment mices are raised with identical food, and observe day by day the physiological conditions of mice, and note down;
(1) cultivate after two days, to the mice of A group, do not add any material and normally raise; To B group mice, the composition of medicine of injection ceftazidime; To C group mice, injection ceftazidime injection;
(2) above-mentioned three groups are continued to raise with identical food (not containing ceftazidime material), and observe day by day the physiological conditions of mice, and note down;
(3) method of experiment: be by observational method day by day, the upgrowth situation of statistics mice, then contrasts;
(4) mice of conclusion: according to observation day by day, after half a year: A group, small, respiratory inflammation, urethra inflammation, lymph inflammation, lymph enlargement, part dead mouse; B organizes mice, and build is larger, comparatively flexible, without dead; C organizes mice, and build is larger, but inflammatory reaction phenomenon appears in part mice, only has minority death.After 1 year, observing, A group mice is substantially dead, and B group mice only has minority death, and the mice of existence is still healthy; C group mice Mortality, still has the inflammatory phenomena such as respiratory inflammation, lymph enlargement;
| Project | Upgrowth situation after half a year | Upgrowth situation after 1 year | Drug fever response rate (%) | Stomach and liver untoward reaction rate (%) |
| The A group of not administration | Type is little, respiratory inflammation, urethra inflammation, lymphatic vessel inflammation, lymph enlargement, part dead mouse | Mice is substantially dead | —— | —— |
| The B group of injection ceftazidime composition of medicine injection | Build is larger, comparatively flexible, without dead | Mice only has minority death, and the mice of existence is still healthy | 23 | 16 |
| The C group of injection ceftazidime injection | Build is larger, but inflammatory reaction phenomenon appears in part mice, only has minority death | Mice Mortality, still has the inflammatory phenomena such as respiratory inflammation, lymph enlargement | 0 | 0 |
Visible, ceftazidime composition of medicine of the present invention is all better than ceftazidime injection prepared by prior art in safety, stability, curative effect comprehensively.
Claims (3)
1. a composition of medicine for ceftazidime, is characterized in that, is made up of effective active ingredient of following parts by weight:
Ceftazidime 80-110
Glutathion 20-60
Arginine 8-55
Lysine 10-40
The method of described ceftazidime composition of medicine, method and step that it is prepared are as follows:
(1). getting weight is the water for injection of 5-15 times of described ceftazidime weight, under stirring, respectively described ceftazidime, glutathion, arginine, lysine is dissolved completely, obtains the composition of medicine solution of ceftazidime;
(2). with molecular cut off be the medicinal liquid that 4000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.3-7.4 with 8% sodium hydroxide solution;
(3). the medicinal liquid that step (2) obtains was 121 ℃ of steam sterilizations 20 minutes;
(4). when the medicinal liquid after sterilizing is cooled to 20-22 ℃, with 8% sodium hydroxide solution, under stirring, be added drop-wise in medicinal liquid, the pH value of adjusting medicinal liquid is 6.3-7.4, then filters through the membrane filtration of 0.22 μ m, obtains composition of medicine solution;
(5). the composition of medicine medicinal liquid that above-mentioned step (4) is made is made the acceptable dosage form of ceftazidime on pharmaceutics.
2. the composition of medicine of ceftazidime according to claim 1, it is characterized in that, on described pharmaceutics, the dosage form of acceptable ceftazidime is lyophilized injection, 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, oral formulations, spray.
3. ceftazidime composition of medicine claimed in claim 1; it is characterized in that; for septicemia, lower respiratory infection, abdominal cavity gallbladder system extremely of responsive gram negative bacilli institute infect, complexity urinary tract infection and the serious relevant disease such as skin soft-tissue infection; also protect ceftazidime in the process of manufacturing, store, transport, using; not oxidized and peroxidating; alleviate the untoward reaction such as headache, vomiting, diarrhoea, diarrhoea, abdominal distention, constipation; play simultaneously protect the liver, the effect of hepatoprotective, improved safety, stability and the health giving quality of composition of medicine.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110396104A (en) * | 2018-07-26 | 2019-11-01 | 赛法洛抗生素有限公司 | The new indication of Tai Siting cefotaxime pharmaceutical preparation treatment gynecological infection |
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| CN101850105A (en) * | 2010-04-06 | 2010-10-06 | 邓学峰 | Cefuroxime sodium composite medicine |
| CN103027894A (en) * | 2012-11-05 | 2013-04-10 | 海南卫康制药(潜山)有限公司 | Ceftazidime composition for injection and preparation method for ceftazidime composition |
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2014
- 2014-01-22 CN CN201410027505.7A patent/CN103768069A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101822679A (en) * | 2010-02-02 | 2010-09-08 | 邓学峰 | Cefepime hydrochloride combined medicament |
| CN101850105A (en) * | 2010-04-06 | 2010-10-06 | 邓学峰 | Cefuroxime sodium composite medicine |
| CN103027894A (en) * | 2012-11-05 | 2013-04-10 | 海南卫康制药(潜山)有限公司 | Ceftazidime composition for injection and preparation method for ceftazidime composition |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110396104A (en) * | 2018-07-26 | 2019-11-01 | 赛法洛抗生素有限公司 | The new indication of Tai Siting cefotaxime pharmaceutical preparation treatment gynecological infection |
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Application publication date: 20140507 |