CN103751123A - Composite medicine comprising cefazolin - Google Patents
Composite medicine comprising cefazolin Download PDFInfo
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- CN103751123A CN103751123A CN201410027490.4A CN201410027490A CN103751123A CN 103751123 A CN103751123 A CN 103751123A CN 201410027490 A CN201410027490 A CN 201410027490A CN 103751123 A CN103751123 A CN 103751123A
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- cefazolin
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- medicinal liquid
- injection
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Abstract
The invention provides a composite medicine comprising cefazolin, which is prepared from the following active ingredients: cefazolin, vitamin C, propylene glycol and lidocaine at a fraction ratio of (63-130):(6-12):(12-40):(15-36). The invention also provides a preparation method of the composite medicine. The composite medicine provided by the invention is superior to the prior art in safety, stability and therapeutic 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 cefazolin.
Background technology
Cefazolin belongs to injection.Be applicable to treat the grade and moderate infection that responsive aerobe causes.Can be widely used in penicillin resistant class, to the infection of staphylococcus aureus of cefazolin sensitivity with except the infection such as the respiratory tract that causes of Pseudomonas aeruginosa, responsive negative bacillus, urogenital tract, biliary tract, skin soft tissue, and surgical postoperative infects, traumatic infection, diseases of eye, ear, nose and throat section infects and the prophylactic of surgery perioperative.The beta-lactamase that this product produces negative bacillus is unstable, invalid to microbial infection of anaerobism such as drug resistance Enterobacter bacillus, Pseudomonas aeruginosa and bacteroides fragiliss.At present, due to injection cefazolin, under greenhouse, preserve unstablely, 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 cefazolin of best proportioning is provided; oxidation and peroxidating with the combined protection cefazolin of vitamin C, propylene glycol, lignocaine in manufacture, storage, transportation, use, body; untoward reaction is alleviated greatly; and vitamin C, propylene glycol, lignocaine make not superfluous cefazolin 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 cefazolin and preparation method thereof;
Invent a kind of composition of medicine of cefazolin, by effective active ingredient of following parts by weight, made:
Cefazolin 63-130
Vitamin C 6-12
Propylene glycol 12-40
Lignocaine 15-36
The method of described cefazolin 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 cefazolin weight, under stirring, respectively described cefazolin, vitamin C, propylene glycol, lignocaine is dissolved completely, obtains the composition of medicine solution of cefazolin;
(2). with molecular cut off, be the medicinal liquid that 8000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.5-7.4 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 ℃, the sodium hydroxide solution with 8%, is added drop-wise in medicinal liquid under stirring, and the pH value of adjusting medicinal liquid is 6.5-7.4, 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 cefazolin on pharmaceutics;
A. press the dosage of the cefazolin 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 cefazolin composition of medicine;
B. press the dosage of the cefazolin 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 cefazolin content, by well-established law, be mixed with again 0.9% sodium chloride injection of cefazolin or the cefazolin composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form.
The advantage of a kind of cefazolin composition of medicine of the present invention has:
1. the grade and moderate infection that composition of medicine provided by the invention causes treating responsive aerobe.Can be widely used in penicillin resistant class, to the infection of staphylococcus aureus of cefazolin sensitivity with except the grade and moderate infection that causes higher than cefazolin preparation in prior art and other treatment sensitivity aerobe of the therapeutic effect of medicine of infections such as the respiratory tract that causes of Pseudomonas aeruginosa, responsive negative bacillus, urogenital tract, biliary tract, skin soft tissue.Can be widely used in penicillin resistant class, to the infection of staphylococcus aureus of cefazolin sensitivity with except the medicine that infects such as the respiratory tract that causes of Pseudomonas aeruginosa, responsive negative bacillus, urogenital tract, biliary tract, skin soft tissue;
2. the separated thermal source of ultrafilter membrane of the molecular weight 2000D that dams for the present invention, both specific activity charcoal except thermal source technique thorough, also thoroughly more separated than the ultrafilter membrane with the molecular weight 8000D that dams, although heat source substance molecular weight is greater than 8000D, this research also finds that the heat source substance molecule fragment of 8000D also has pyrogen reaction, so the pyrogen sheet segment molecule of necessary separated 8000D molecular weight.So the separated pyrogen of the present invention is thorough, apyrogeneity reaction;
3. medicine of the present invention is eliminated drug anaphylaxis and oxidation by ascorbic effect, and peroxidization, meanwhile, plays 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 than traditional coating, mix and high-speed stirred wet mixing technique high more than 20%.
The specific embodiment
Embodiment 1
Invent a kind of composition of medicine of cefazolin, by effective active ingredient of following parts by weight, made:
Cefazolin 63-130
Vitamin C 6-12
Propylene glycol 12-40
Lignocaine 15-36
The method of described cefazolin 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 cefazolin weight, under stirring, respectively described cefazolin, vitamin C, propylene glycol, lignocaine is dissolved completely, obtains the composition of medicine solution of cefazolin;
(2). with molecular cut off, be the medicinal liquid that 8000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.5-7.4 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 ℃, the sodium hydroxide solution with 8%, is added drop-wise in medicinal liquid under stirring, and the pH value of adjusting medicinal liquid is 6.5-7.4, 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 cefazolin on pharmaceutics;
A. press the dosage of the cefazolin 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 cefazolin composition of medicine;
B. press the dosage of the cefazolin 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 cefazolin content, by well-established law, be mixed with again 0.9% sodium chloride injection of cefazolin or the cefazolin composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form.
Embodiment 2
Invent a kind of composition of medicine of cefazolin, by effective active ingredient of following parts by weight, made:
Cefazolin 63-130
Vitamin C 6-12
Propylene glycol 12-40
Lignocaine 15-36
The method of described cefazolin 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 cefazolin weight, under stirring, respectively described cefazolin, vitamin C, propylene glycol, lignocaine is dissolved completely, obtains the composition of medicine solution of cefazolin;
(2). with molecular cut off, be the medicinal liquid that 8000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.5-7.4 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 ℃, the sodium hydroxide solution with 8%, is added drop-wise in medicinal liquid under stirring, and the pH value of adjusting medicinal liquid is 6.5-7.4, 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 cefazolin on pharmaceutics;
A. press the dosage of the cefazolin 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 cefazolin composition of medicine;
B. press the dosage of the cefazolin 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 cefazolin content, by well-established law, be mixed with again 0.9% sodium chloride injection of cefazolin or the cefazolin composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form.
Embodiment 3
Invent a kind of composition of medicine of cefazolin, by effective active ingredient of following parts by weight, made:
Cefazolin 63-130
Vitamin C 6-12
Propylene glycol 12-40
Lignocaine 15-36
The method of described cefazolin 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 cefazolin weight, under stirring, respectively described cefazolin, vitamin C, propylene glycol, lignocaine is dissolved completely, obtains the composition of medicine solution of cefazolin;
(2). with molecular cut off, be the medicinal liquid that 8000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.5-7.4 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 ℃, the sodium hydroxide solution with 8%, is added drop-wise in medicinal liquid under stirring, and the pH value of adjusting medicinal liquid is 6.5-7.4, 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 cefazolin on pharmaceutics;
A. press the dosage of the cefazolin 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 cefazolin composition of medicine;
B. press the dosage of the cefazolin 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 cefazolin content, by well-established law, be mixed with again 0.9% sodium chloride injection of cefazolin or the cefazolin composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form.
Embodiment 4
Invent a kind of composition of medicine of cefazolin, by effective active ingredient of following parts by weight, made:
Cefazolin 63-130
Vitamin C 6-12
Propylene glycol 12-40
Lignocaine 15-36
The method of described cefazolin 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 cefazolin weight, under stirring, respectively described cefazolin, vitamin C, propylene glycol, lignocaine is dissolved completely, obtains the composition of medicine solution of cefazolin;
(2). with molecular cut off, be the medicinal liquid that 8000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.5-7.4 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 ℃, the sodium hydroxide solution with 8%, is added drop-wise in medicinal liquid under stirring, and the pH value of adjusting medicinal liquid is 6.5-7.4, 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 cefazolin on pharmaceutics;
A. press the dosage of the cefazolin 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 cefazolin composition of medicine;
B. press the dosage of the cefazolin 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 cefazolin content, by well-established law, be mixed with again 0.9% sodium chloride injection of cefazolin or the cefazolin composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form.
Embodiment 5
Invent a kind of composition of medicine of cefazolin, by effective active ingredient of following parts by weight, made:
Cefazolin 63-130
Vitamin C 6-12
Propylene glycol 12-40
Lignocaine 15-36
The method of described cefazolin 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 cefazolin weight, under stirring, respectively described cefazolin, vitamin C, propylene glycol, lignocaine is dissolved completely, obtains the composition of medicine solution of cefazolin;
(2). with molecular cut off, be the medicinal liquid that 8000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.5-7.4 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 ℃, the sodium hydroxide solution with 8%, is added drop-wise in medicinal liquid under stirring, and the pH value of adjusting medicinal liquid is 6.5-7.4, 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 cefazolin on pharmaceutics;
A. press the dosage of the cefazolin 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 cefazolin composition of medicine;
B. press the dosage of the cefazolin 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 cefazolin content, by well-established law, be mixed with again 0.9% sodium chloride injection of cefazolin or the cefazolin composition of medicine of 5% glucose injection or 10% glucose injection or oral formulations or spray dosage form.
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;
The mice of the normal saline solution injection experiments model of gram positive coccus and Chlamydia pneumoniae bacterium will be infected.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, the mice to A group, does not add any material and normally raises; To B group mice, the composition of medicine of injection cefazolin; To C group mice, injection cefazolin injection;
(2) above-mentioned three groups are continued to raise with identical food (not containing cefazolin 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 dead.After 1 year, observing, A group mice is substantially dead, and B group mice only has minority dead, 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 cefazolin composition of medicine injection | Build is larger, comparatively flexible, without dead | Mice only has minority dead, and the mice of existence is still healthy | 23 | 16 |
| The C group of injection cefazolin injection | Build is larger, but inflammatory reaction phenomenon appears in part mice, only has minority dead | Mice Mortality, still has the inflammatory phenomena such as respiratory inflammation, lymph enlargement | 0 | 0 |
Visible, cefazolin composition of medicine of the present invention is all better than cefazolin injection prepared by prior art in safety, stability, curative effect comprehensively.
Claims (3)
1. a composition of medicine for cefazolin, is characterized in that, by effective active ingredient of following parts by weight, is made:
Cefazolin 63-130
Vitamin C 6-12
Propylene glycol 12-40
Lignocaine 15-36
The method of described cefazolin 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 cefazolin weight, under stirring, respectively described cefazolin, vitamin C, propylene glycol, lignocaine is dissolved completely, obtains the composition of medicine solution of cefazolin;
(2). with molecular cut off, be the medicinal liquid that 8000D ultrafilter membrane ultrafiltration step (1) obtains, the membrane ultrafiltration that filtrate is 2000D with molecular cut off, filtrate regulates pH value 6.5-7.4 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 ℃, the sodium hydroxide solution with 8%, is added drop-wise in medicinal liquid under stirring, and the pH value of adjusting medicinal liquid is 6.5-7.4, 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 cefazolin on pharmaceutics.
2. the composition of medicine of cefazolin according to claim 1, it is characterized in that, on described pharmaceutics, the dosage form of acceptable cefazolin is lyophilized injection, 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, oral formulations, spray.
3. cefazolin composition of medicine claimed in claim 1, it is characterized in that, for penicillin resistant class, to the infection of staphylococcus aureus of cefazolin sensitivity with except Pseudomonas aeruginosa, the respiratory tract that responsive negative bacillus causes, urogenital tract, gallbladder road, the disease that skin soft tissue etc. is relevant, also protected cefazolin manufacturing, store, transportation, in the process of using, not oxidized and peroxidating, alleviate headache, vomiting, diarrhoea, diarrhoea, abdominal distention, the untoward reaction such as constipation, play and protect the liver simultaneously, the effect of hepatoprotective, improved the safety of composition of medicine, stability and health giving quality.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410027490.4A CN103751123A (en) | 2014-01-22 | 2014-01-22 | Composite medicine comprising cefazolin |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410027490.4A CN103751123A (en) | 2014-01-22 | 2014-01-22 | Composite medicine comprising cefazolin |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4146971A (en) * | 1976-11-24 | 1979-04-03 | Eli Lilly And Company | Method of preparing a rapidly dissolving powder of sterile crystalline cefazolin sodium for parenteral administration |
| CN101822679A (en) * | 2010-02-02 | 2010-09-08 | 邓学峰 | Cefepime hydrochloride combined medicament |
| CN101874808A (en) * | 2010-05-12 | 2010-11-03 | 邓学峰 | Azithromycin compound medicament |
-
2014
- 2014-01-22 CN CN201410027490.4A patent/CN103751123A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4146971A (en) * | 1976-11-24 | 1979-04-03 | Eli Lilly And Company | Method of preparing a rapidly dissolving powder of sterile crystalline cefazolin sodium for parenteral administration |
| CN101822679A (en) * | 2010-02-02 | 2010-09-08 | 邓学峰 | Cefepime hydrochloride combined medicament |
| CN101874808A (en) * | 2010-05-12 | 2010-11-03 | 邓学峰 | Azithromycin compound medicament |
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