CN1557302A - Carbazochrome Sodium Sulfonate infusion and its preparation method - Google Patents
Carbazochrome Sodium Sulfonate infusion and its preparation method Download PDFInfo
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- CN1557302A CN1557302A CNA200410023441XA CN200410023441A CN1557302A CN 1557302 A CN1557302 A CN 1557302A CN A200410023441X A CNA200410023441X A CN A200410023441XA CN 200410023441 A CN200410023441 A CN 200410023441A CN 1557302 A CN1557302 A CN 1557302A
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- sodium sulfonate
- carbazochrome
- carbazochrome sodium
- injection
- transfusion
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Abstract
The present invention belongs to the field of medicine technology. The Carbazochrome liquid contains Carbazochrome 0.002-0.5 wt%, antioxidant 0-10 wt%, osmotic pressure regulator 0.8-75 wt%, and injection water 20-99.1 wt%. The preparation process of the Carbazochrome liquid includes dissolving osmotic pressure regulator with partial injection water in a compounding tank; adding injection level active carbon through heating and stirring for adsorption for 30 min; filtering and decarbonizing with titanium rod and adding rest injection water to obtain the solution I; dissolving Carbazochrome and antioxidant in solution I, adding injection level active carbon for adsorption for 30 min, filtering and decarbonizing with titanium rod, regulating pH value, fine filtering, detecting, packing in bottle, disinfecting and other steps. The medicine is used in intravenous transfusion for treating various hemorrhage diseases.
Description
(1) technical field
The present invention relates to carbazochrome sodium sulfonate transfusion and preparation method thereof, belong to medical technical field.
(2) background technology
Carbazochrome sodium sulfonate is a blood vessel hardening agent of new generation, it is the blood vessel hemorrhage of a curative effect brilliance, be to develop jointly at home the earliest by Wuzhong, Jiangsu Suzhou No.6 Pharmaceutical Factory of Industry Co.,Ltd and the expert of Chinese Medical Sciences University, because its determined curative effect, and applied widely be widely used in clinical, its dosage form of going on the market at home is carbazochrome sodium sulfonate sheet and injection carbazochrome sodium sulfonate, the injection carbazochrome sodium sulfonate often needs and normal saline or glucose solution compatibility in clinical practice, be used for intravenous drip (Li Lianhua etc. the carbazochrome sodium sulfonate observation of curative effect. China clinical medical 2002 the 3rd the volume the 24th phase, P39), brought inconvenience for medical personnel's clinical use, also make the injection carbazochrome sodium sulfonate in the compatibility use, easily cause cross-contamination.
(3) summary of the invention
The present invention is directed to the deficiencies in the prior art, a kind of carbazochrome sodium sulfonate transfusion and preparation method thereof is provided.
The present invention is characterized in that for carbazochrome sodium sulfonate transfusion and preparation method thereof, comprises following component, all is weight percentage: carbazochrome sodium sulfonate 0.002%～0.5%, antioxidant 0%～10%, osmotic pressure regulator 0.8%～75%, water for injection 20%～99.1%.
Above-mentioned antioxidant is one or more in sodium sulfite, sodium sulfite, sodium pyrosulfite, ascorbic acid, thioglycerol, thiourea, cysteine hydrochloride, glycine, sorbitol, propyl gallate, disodium edetate, the propylene glycol.
Above-mentioned osmotic pressure regulator is one or more in sodium chloride, glucose, mannitol, xylitol, the potassium chloride.
The preparation method of carbazochrome sodium sulfonate transfusion of the present invention comprises that step is as follows:
(1) infusion bottle, rubber stopper, dacron membrane are handled by the conventional requirement of injection, and be standby.
(2) preparation of medicinal liquid:
A. the osmotic pressure regulator that takes by weighing recipe quantity adds part water for injection stirring and dissolving in Agitation Tank.The needle-use activated carbon that adds conventional amount used, heated and stirred charcoal absorption 30 minutes adds to the full amount of water for injection with mending behind the titanium filter stick filtering decarbonization, stirs evenly.
B. take by weighing the carbazochrome sodium sulfonate of recipe quantity and antioxidant in Agitation Tank, add part a institute obtain solution, stirring and dissolving is added a institute obtain solution to recipe quantity, adds an amount of needle-use activated carbon, and charcoal absorption 30 minutes with titanium filter stick filtering decarbonization, is regulated pH value, fine straining.
(3) product detect in the middle of: the content of taking liquid mensuration pH value and carbazochrome sodium sulfonate, osmotic pressure regulator.
(4) fill: after its content and pH value were qualified, fine straining was qualified to clarity, by the fill of 50～500ml/ infusion bottle, blooming, jump a queue, roll lid.
(5) pressure sterilizing: 105～121 ℃ of pressure sterilizings, the cooling of spray hot water is offerd for sale.
(6) full inspection.
Preparation finishes, and goods are taken out, and seals, and promptly obtains the carbazochrome sodium sulfonate transfusion.
Compared with prior art, excellent results of the present invention is as follows:
(1) selected the transfusion dosage form,, and reduced secondary pollution and guaranteed the injection quality for the clinical worker operation has brought convenience.
(2) instillation of carbazochrome sodium sulfonate transfusion vein is rapid-action, and 1min gets final product onset.
(3) provide a kind of economical and practical novel form for clinical.
The carbazochrome sodium sulfonate transfusion that is made by said method all complies with relevant regulations in the check of items such as content, pyrogen, aseptic, pH, clarity, particulate matter, and no antigen has no side effect.This product can be used for intravenous drip, is used for urinary system, upper digestive tract, respiratory tract and department of obstetrics and gynecology hemorrhagic disease.More remarkable to the urinary system curative effect, also can be used for the prevention and the treatment of operative hemorrhage.
(4) specific embodiment
Embodiment 1: the carbazochrome sodium sulfonate transfusion, and component following (all being weight percentage):
Carbazochrome sodium sulfonate 0.059%
Sodium pyrosulfite 0.005%
Sodium chloride 0.892%
Water for injection 99.044%
Preparation method is as follows:
(1) infusion bottle, rubber stopper, dacron membrane are handled by the conventional requirement of injection, and be standby.
(2) preparation of medicinal liquid:
A. take by weighing 900g sodium chloride in Agitation Tank, add 50000g water for injection stirring and dissolving.Add the 20g needle-use activated carbon, heated and stirred charcoal absorption 30 minutes adds to the full amount of water for injection with mending behind the titanium filter stick filtering decarbonization, stirs evenly.
B. take by weighing 60g carbazochrome sodium sulfonate, 5g sodium pyrosulfite in Agitation Tank, add the 80000g sodium chloride solution, stirring and dissolving, add sodium chloride solution to recipe quantity, add the 5g needle-use activated carbon, charcoal absorption 30 minutes, with titanium filter stick filtering decarbonization, regulating pH value is 5.5, fine straining.
(3) product detect in the middle of: the content of taking liquid mensuration pH value and carbazochrome sodium sulfonate, osmotic pressure regulator.
(4) fill: after its content and pH value were qualified, fine straining was qualified to clarity, fill in the 100ml infusion bottle, blooming, jump a queue, roll lid.
(5) pressure sterilizing: 115 ℃ of pressure sterilizings 30 minutes, the cooling of spray hot water is offerd for sale.
(6) full inspection.
Preparation finishes, and goods are taken out, and seals, and promptly obtains the carbazochrome sodium sulfonate transfusion.
Embodiment 2: the carbazochrome sodium sulfonate transfusion, and component following (being weight):
Carbazochrome sodium sulfonate 0.426%
Glycine 3.551%
Glucose 25%
Water for injection 71.023%
Preparation method is with embodiment 1.
Embodiment 3: the carbazochrome sodium sulfonate transfusion, and component following (all being weight percentage):
Carbazochrome sodium sulfonate 0.12%
Potassium chloride 0.89%
Water for injection 98.99%
Preparation method is with embodiment 1.
Embodiment 4: the carbazochrome sodium sulfonate transfusion, and component following (all being weight percentage):
Carbazochrome sodium sulfonate 0.128%
Sorbitol 0.160%
Disodium edetate 0.008%
Mannitol 20%
Water for injection 79.704%
Preparation method is with embodiment 1.
Claims (4)
1, the present invention is a kind of carbazochrome sodium sulfonate transfusion, it is characterized in that, comprises following component, all is weight percentage: carbazochrome sodium sulfonate 0.002%～0.5%, antioxidant 0%～10%, osmotic pressure regulator 0.8%～75%, water for injection 20%～99.1%.
2, a kind of carbazochrome sodium sulfonate transfusion as claimed in claim 1, it is characterized in that described antioxidant is one or more in sodium sulfite, sodium sulfite, sodium pyrosulfite, ascorbic acid, thioglycerol, thiourea, cysteine hydrochloride, glycine, sorbitol, propyl gallate, disodium edetate, the propylene glycol.
3, a kind of carbazochrome sodium sulfonate transfusion as claimed in claim 1 is characterized in that described osmotic pressure regulator is one or more in sodium chloride, glucose, mannitol, xylitol, the potassium chloride.
4, the preparation method of the described carbazochrome sodium sulfonate transfusion of claim 1, step is as follows:
(1) infusion bottle, rubber stopper, dacron membrane are handled by the conventional requirement of injection, and be standby;
(2) preparation of medicinal liquid:
A. the osmotic pressure regulator that takes by weighing recipe quantity adds part water for injection stirring and dissolving in Agitation Tank.The needle-use activated carbon that adds conventional amount used, heated and stirred charcoal absorption 30 minutes adds to the full amount of water for injection with mending behind the titanium filter stick filtering decarbonization, stirs evenly;
B. take by weighing the carbazochrome sodium sulfonate of recipe quantity and antioxidant in Agitation Tank, add part a institute obtain solution, stirring and dissolving is added a institute obtain solution to recipe quantity, adds an amount of needle-use activated carbon, and charcoal absorption 30 minutes with titanium filter stick filtering decarbonization, is regulated pH value, fine straining;
(3) product detect in the middle of: the content of taking liquid mensuration pH value and carbazochrome sodium sulfonate, osmotic pressure regulator;
(4) fill: after its content and pH value were qualified, fine straining was qualified to clarity, by the fill of 50～500ml/ infusion bottle, blooming, jump a queue, roll lid;
(5) ripe pressure sterilization: 105～121 ℃ of pressure sterilizings, the cooling of spray hot water is offerd for sale;
(6) full inspection, packing, warehouse-in.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA200410023441XA CN1557302A (en) | 2004-01-15 | 2004-01-15 | Carbazochrome Sodium Sulfonate infusion and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA200410023441XA CN1557302A (en) | 2004-01-15 | 2004-01-15 | Carbazochrome Sodium Sulfonate infusion and its preparation method |
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| CN1557302A true CN1557302A (en) | 2004-12-29 |
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| CNA200410023441XA Pending CN1557302A (en) | 2004-01-15 | 2004-01-15 | Carbazochrome Sodium Sulfonate infusion and its preparation method |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101554377B (en) * | 2008-04-09 | 2011-04-13 | 鲁南制药集团股份有限公司 | Pharmaceutical composition containing prasugrel and carbazochrome sodium sulfonate |
| CN102210656A (en) * | 2011-04-12 | 2011-10-12 | 罗诚 | Medicinal composition containing carbazochrome sodium sulfonate compound and preparation method thereof |
| CN102757378A (en) * | 2012-07-06 | 2012-10-31 | 江苏汉斯通药业有限公司 | Preparation method of carbazochrome sodium sulfonate |
| CN103961310A (en) * | 2014-05-23 | 2014-08-06 | 华仁药业（日照）有限公司 | Carbazochrome sodium sulfonate sodium chloride injection and preparation method thereof |
| CN110478313A (en) * | 2019-05-17 | 2019-11-22 | 四川联成迅康医药股份有限公司 | A kind of carbazochrome sodium sulfonate for injection |
| CN110613681A (en) * | 2019-09-19 | 2019-12-27 | 湖北科益药业股份有限公司 | Ganciclovir injection and preparation process thereof |
| CN111265477A (en) * | 2020-04-15 | 2020-06-12 | 合肥智汇医药科技有限公司 | Carbazochrome sodium sulfonate and sodium chloride injection and preparation method thereof |
| CN113476399A (en) * | 2021-07-30 | 2021-10-08 | 康普药业股份有限公司 | Sodium carbazochrome injection and preparation method thereof |
-
2004
- 2004-01-15 CN CNA200410023441XA patent/CN1557302A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101554377B (en) * | 2008-04-09 | 2011-04-13 | 鲁南制药集团股份有限公司 | Pharmaceutical composition containing prasugrel and carbazochrome sodium sulfonate |
| CN102210656A (en) * | 2011-04-12 | 2011-10-12 | 罗诚 | Medicinal composition containing carbazochrome sodium sulfonate compound and preparation method thereof |
| CN102210656B (en) * | 2011-04-12 | 2013-07-17 | 罗诚 | Medicinal composition containing carbazochrome sodium sulfonate compound and preparation method thereof |
| CN102757378A (en) * | 2012-07-06 | 2012-10-31 | 江苏汉斯通药业有限公司 | Preparation method of carbazochrome sodium sulfonate |
| CN103961310A (en) * | 2014-05-23 | 2014-08-06 | 华仁药业（日照）有限公司 | Carbazochrome sodium sulfonate sodium chloride injection and preparation method thereof |
| CN110478313A (en) * | 2019-05-17 | 2019-11-22 | 四川联成迅康医药股份有限公司 | A kind of carbazochrome sodium sulfonate for injection |
| CN110478313B (en) * | 2019-05-17 | 2020-06-16 | 四川联成迅康医药股份有限公司 | Sodium carbazochrome injection |
| CN110613681A (en) * | 2019-09-19 | 2019-12-27 | 湖北科益药业股份有限公司 | Ganciclovir injection and preparation process thereof |
| CN111265477A (en) * | 2020-04-15 | 2020-06-12 | 合肥智汇医药科技有限公司 | Carbazochrome sodium sulfonate and sodium chloride injection and preparation method thereof |
| CN113476399A (en) * | 2021-07-30 | 2021-10-08 | 康普药业股份有限公司 | Sodium carbazochrome injection and preparation method thereof |
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