CN1520812A - Troxerutin injection and its preparation method - Google Patents
Troxerutin injection and its preparation method Download PDFInfo
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- CN1520812A CN1520812A CNA031172873A CN03117287A CN1520812A CN 1520812 A CN1520812 A CN 1520812A CN A031172873 A CNA031172873 A CN A031172873A CN 03117287 A CN03117287 A CN 03117287A CN 1520812 A CN1520812 A CN 1520812A
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- troxerutin
- water
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- infusion solutions
- sorbitol
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Abstract
The present invention is one kind of transfused Troxerutin fluid and its preparation process. The transfused Troxerutin fluid includes Troxerutin and non-sodium chloride and non-glucose osmotic pressure regulator of sorbic alcohol, fructose, mannitol or lactose. The transfused Troxerutin fluid preparation accords with the clinical requirement for cerebral vascular disease in limiting sugar and salt intaking amount, and has the osmotic pressure regulating effect the same as that of transfused fluid containing glucose in 5 % or sodium chloride in 0.9 %.
Description
Affiliated technical field:
The present invention relates to a kind of preparation method of medicine, especially a kind of troxerutin intravenous drip infusion solutions and preparation method thereof.
Background technology:
Troxerutin be rutin through hydroxyethylation obtain with 7,3 ', 4 '-troxerutin is the mixture of main hydroxyethyl rutin, the another name troxerutin, soluble in water, be slightly soluble in methanol, the atomic ethanol that is dissolved in is insoluble to chloroform.Be mainly used in diseases such as treatment obliterated cerebral vascular disease, arteriosclerosis, thrombophlebitis, and various optical fundus illness, as retinal illness, retina and vitreous body angiorrbagia due to the diabetes, subconjunctival hemorrhage retinal vessel thromboembolism etc.Domestic existing pharmaceutical factory production troxerutin and tablet thereof, capsule, oral liquid, injection (small-volume injection), troxerutin sodium chloride injection, former recording in domestic local drug standards at different levels, be upgraded to national standard in 2002, and the title unification has been troxerutin.By retrieval, have two parts the invention disclosed patent relate to the preparation of troxerutin raw material, be respectively CN1056850C, CN1331697A; The disclosed Venoruton injecta specially for intravenous of ethyhdroxirutini (infusion solutions) that relates to of portion is CN1336172A, and its osmotic pressure regulator is 5% glucose or 0.9% sodium chloride.
Be used for the cerebrovascular disease patient owing to the troxerutin infusion solutions is clinical, and such disease must limit the intake of sugar, salt, if adopt glucose or sodium chloride as osmotic pressure regulator, contain 12.5g glucose or 2.25g sodium chloride in then every 250ml preparation, obviously unfavorable in patient health.
Summary of the invention:
The purpose of this invention is to provide that a kind of cerebrovascular disease patient is suitable for, do not contain the preparation method of the troxerutin infusion solutions of glucose or sodium chloride, meet the requirement of clinical cerebrovascular disease restriction sugar, salt intake with the preparation of this method preparation.
The object of the present invention is achieved like this:
Troxerutin infusion solutions of the present invention comprises troxerutin, it is characterized in that: also include the osmotic pressure regulator that adopts non-sodium chloride, non-glucose.
Osmotic pressure regulator of the present invention is sorbitol or fructose or mannitol, or lactose.
Sorbitol of the present invention is 5-10% (g/ml) in dry product consumption in infusion solutions.
Fructose of the present invention is 5-10% (g/ml) in dry product consumption in infusion solutions.
Mannitol of the present invention is 5-10% (g/ml) in dry product consumption in infusion solutions.
Lactose of the present invention is 13-20% (g/ml) in dry product consumption in infusion solutions.
The production technology of the preparation method of troxerutin infusion solutions of the present invention can be said this dosage form manufacturing technique on any pharmaceutics.
Concrete preparation method of the present invention is as follows:
A, by weight ratio with sorbitol or fructose or mannitol, or in the water for injection that boils of lactose input, make into certain density concentrated solution, the active carbon that adds concentrated solution 0.5-2.0% (g/ml), mixing, the about 5-30 of heated and boiled minute, filter while hot and take off charcoal, filtrate for later use;
B, measure troxerutin is dissolved in the water for injection by weight ratio, make into certain density concentrated solution, add the active carbon of concentrated solution 0.5-2.0% (g/ml), mixing the about 5-30 of heated and boiled minute, filters while hot and takes off charcoal, filtrate for later use;
C, sorbitol solution and troxerutin solution are merged, add the injection water to ormal weight, measure PH and content qualified after, filter to clear and bright filling and sealing, 115 ℃, 30 minutes pressure sterilizings repeatedly.
The loading amount of infusion solutions of the present invention can be any capacity of accepting clinically.
Meet the requirement of clinical cerebrovascular disease restriction sugar, salt intake with the preparation of this method preparation, and meet the infusion solutions medicinal standard.
The specific embodiment:
The present invention realizes by the following specific embodiment:
The preparation method of troxerutin infusion solutions adopts non-sodium chloride, non-glucose osmotic pressure regulator.
The preparation method of described troxerutin infusion solutions, the osmotic pressure regulator of employing are sorbitol, fructose, mannitol or lactose.
The preparation method of described troxerutin infusion solutions, sorbitol consumption in infusion solutions is 5-10% (g/ml).
The preparation method of described troxerutin infusion solutions, fructose consumption in infusion solutions is 5-10% (g/ml).
The preparation method of described troxerutin infusion solutions, mannitol consumption in infusion solutions is 5-10% (g/ml).
The preparation method of described troxerutin infusion solutions, lactose consumption in infusion solutions is 13-20% (g/ml).
The preparation method of above-mentioned troxerutin infusion solutions, the production technology of described infusion solutions can be said this dosage form manufacturing techniques on any pharmaceutics.
The preparation method of above-mentioned troxerutin infusion solutions, the loading amount of described infusion solutions can be any capacity of accepting clinically.
Get the troxerutin infusion solutions that 5% sorbitol, 5% fructose, 5% mannitol or 13% lactose are osmotic pressure regulator, with 5% glucose or 0.9% sodium chloride be that the troxerutin infusion solutions of osmotic pressure regulator is made the osmotic pressure contrast test, the result proves all oozes with blood of human body etc.
Above-mentioned troxerutin infusion solutions, two appendix IB check that the result meets every regulation under the injection item according to Chinese Pharmacopoeia version in 2000; Check that according to two appendix VI of Chinese Pharmacopoeia version in 2000 H pH value is 5.5-7.0, meet the injection regulation; Check that according to two appendix IX of Chinese Pharmacopoeia version in 2000 C particulate matter and undue toxicity meet the regulation of intravenous injection administration.Carry out pyrogen test according to two appendix XI of Chinese Pharmacopoeia version in 2000 DJI, check that according to two appendix IX of Chinese Pharmacopoeia version in 2000 B clarity the result is all qualified.
Embodiment 1:
Prescription: sorbitol 50g troxerutin 0.5g
Water for injection adds to 1000ml
Method for making: in the water for injection that the sorbitol input is boiled by recipe quantity, make into certain density concentrated solution, add the active carbon of concentrated solution 0.5% (g/ml), mixing, about 5 minutes of heated and boiled filters while hot and takes off charcoal, filtrate for later use.
By recipe quantity troxerutin is dissolved in the water for injection, makes into certain density concentrated solution, add the active carbon of concentrated solution 0.5% (g/ml), mixing, about 5 minutes of heated and boiled filters while hot and takes off charcoal, filtrate for later use.
Sorbitol solution and troxerutin solution are merged, add the injection water, after mensuration PH and content are qualified, filter to clear and bright filling and sealing, 115 ℃, 30 minutes pressure sterilizings repeatedly to ormal weight.
Embodiment 2:
Prescription: sorbitol 100g troxerutin 10g
Water for injection adds to 1000ml
Method for making: in the water for injection that the sorbitol input is boiled by recipe quantity, make into certain density concentrated solution, add the active carbon of concentrated solution 2.0% (g/ml), mixing, about 30 minutes of heated and boiled filters while hot and takes off charcoal, filtrate for later use.
By recipe quantity troxerutin is dissolved in the water for injection, makes into certain density concentrated solution, add the active carbon of concentrated solution 2.0% (g/ml), mixing, about 30 minutes of heated and boiled filters while hot and takes off charcoal, filtrate for later use.
Sorbitol solution and troxerutin solution are merged, add the injection water, after mensuration PH and content are qualified, filter to clear and bright filling and sealing, 115 ℃, 30 minutes pressure sterilizings repeatedly to ormal weight.
Embodiment 3:
Prescription: sorbitol 12.5g troxerutin 0.32g
Water for injection adds to 250ml
Method for making: in the water for injection that the sorbitol input is boiled by recipe quantity, make into certain density concentrated solution, add the active carbon of concentrated solution 1.5% (g/ml), mixing, about 15 minutes of heated and boiled filters while hot and takes off charcoal, filtrate for later use.
By recipe quantity troxerutin is dissolved in the water for injection, makes into certain density concentrated solution, add the active carbon of concentrated solution 1.5% (g/ml), mixing, about 15 minutes of heated and boiled filters while hot and takes off charcoal, filtrate for later use.
Sorbitol solution and troxerutin solution are merged, add the injection water, after mensuration PH and content are qualified, filter to clear and bright filling and sealing, 115 ℃, 30 minutes pressure sterilizings repeatedly to ormal weight.
Embodiment 4:
Prescription: fructose 50g troxerutin 0.5g
Water for injection adds to 1000ml
Method for making: with embodiment 1.
Embodiment 5:
Prescription: fructose 100g troxerutin 10g
Water for injection adds to 1000ml
Method for making: with embodiment 2.
Embodiment 6:
Prescription: fructose 12g troxerutin 0.3g
Water for injection adds to 250ml
Method for making: with embodiment 3.
Embodiment 7:
Prescription: mannitol 50g troxerutin 0.5g
Water for injection adds to 1000ml
Method for making: with embodiment 1.
Embodiment 8:
Prescription: mannitol 100g troxerutin 10g
Water for injection adds to 1000ml
Method for making: with embodiment 2.
Embodiment 9:
Prescription: mannitol 15g troxerutin 0.4g
Water for injection adds to 250ml
Method for making: with embodiment 3.
Embodiment 10:
Prescription: lactose 130g troxerutin 0.5g
Water for injection adds to 1000ml
Method for making: with embodiment 1.
Embodiment 11:
Prescription: lactose 200g troxerutin 10g
Water for injection adds to 1000ml
Method for making: with embodiment 2.
Embodiment 12:
Prescription: lactose 18g troxerutin 0.8g
Water for injection adds to 100ml
Method for making: with embodiment 1.
Claims (10)
1, a kind of troxerutin infusion solutions comprises troxerutin, it is characterized in that: also include the osmotic pressure regulator that adopts non-sodium chloride, non-glucose.
2, a kind of troxerutin infusion solutions according to claim 1 is characterized in that: described osmotic pressure regulator is sorbitol or fructose or mannitol, or lactose.
3, a kind of troxerutin infusion solutions according to claim 1 and 2 is characterized in that: described sorbitol is 5-10% (g/ml) in dry product consumption in infusion solutions.
4, a kind of troxerutin infusion solutions according to claim 1 and 2 is characterized in that: described fructose is 5-10% (g/ml) in dry product consumption in infusion solutions.
5, a kind of troxerutin infusion solutions according to claim 1 and 2 is characterized in that: described mannitol is 5-10% (g/ml) in dry product consumption in infusion solutions.
6, a kind of troxerutin infusion solutions according to claim 1 and 2 is characterized in that: described lactose is 13-20% (g/ml) in dry product consumption in infusion solutions.
7, a kind of preparation method of troxerutin infusion solutions is characterized in that: the described technological process of production is said this dosage form manufacturing technique on any pharmaceutics.
8, the preparation method of a kind of troxerutin infusion solutions according to claim 7 is characterized in that: concrete preparation method is as follows:
In A, the water for injection that by weight ratio sorbitol or fructose or mannitol or lactose input boiled, make into certain density concentrated solution, add the active carbon of concentrated solution 0.5-2.0% (g/ml), mixing, the about 5-30 of heated and boiled minute, filter while hot and take off charcoal, filtrate for later use;
B, measure troxerutin is dissolved in the water for injection by weight ratio, make into certain density concentrated solution, add the active carbon of concentrated solution 0.5-2.0% (g/ml), mixing the about 5-30 of heated and boiled minute, filters while hot and takes off charcoal, filtrate for later use;
C, sorbitol solution and troxerutin solution are merged, add the injection water to ormal weight, measure PH and content qualified after, filter to clear and bright filling and sealing, 115 ℃, 30 minutes pressure sterilizings repeatedly.
9, a kind of troxerutin infusion solutions according to claim 1, it is characterized in that: constituent and weight proportion are:
A, sorbitol 50g, troxerutin 0.5g, water for injection adds to 1000m1;
Or B, sorbitol 100g, troxerutin 10g, water for injection adds to 1000ml;
Or C, sorbitol 12.5g, troxerutin 0.32g, water for injection adds to 250ml;
Or D, fructose 50g, troxerutin 0.5g, water for injection adds to 1000ml;
Or E, fructose 100g, troxerutin 10g, water for injection adds to 1000ml;
Or F, fructose 12g, troxerutin 0.3g, water for injection adds to 250ml;
Or G, mannitol 50g, troxerutin 0.5g, water for injection adds to 1000ml;
Or H, mannitol 100g, troxerutin 10g, water for injection adds to 1000ml;
Or I, mannitol 15g, troxerutin 0.4g, water for injection adds to 250ml;
Or J, lactose 130g, troxerutin 0.5g, water for injection adds to 1000ml;
Or K, lactose 200g, troxerutin 10g, water for injection adds to 1000ml;
Or L, lactose 18g, troxerutin 0.8g, water for injection adds to 100ml.
10, according to the preparation method of claim 7 or 8 described a kind of troxerutin infusion solutionses, it is characterized in that: in the water for injection that the sorbitol input is boiled by recipe quantity, make into certain density concentrated solution, the active carbon that adds concentrated solution 0.5% (g/ml), mixing, about 5 minutes of heated and boiled filters while hot and takes off charcoal, filtrate for later use; By recipe quantity troxerutin is dissolved in the water for injection, makes into certain density concentrated solution, add the active carbon of concentrated solution 0.5% (g/ml), mixing, about 5 minutes of heated and boiled filters while hot and takes off charcoal, filtrate for later use; Sorbitol solution and troxerutin solution are merged, add the injection water, after mensuration PH and content are qualified, filter to clear and bright filling and sealing, 115 ℃, 30 minutes pressure sterilizings repeatedly to ormal weight.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031172873A CN1520812A (en) | 2003-02-11 | 2003-02-11 | Troxerutin injection and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031172873A CN1520812A (en) | 2003-02-11 | 2003-02-11 | Troxerutin injection and its preparation method |
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| Publication Number | Publication Date |
|---|---|
| CN1520812A true CN1520812A (en) | 2004-08-18 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031172873A Pending CN1520812A (en) | 2003-02-11 | 2003-02-11 | Troxerutin injection and its preparation method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100574805C (en) * | 2004-10-25 | 2009-12-30 | 蚌埠丰原医药科技发展有限公司 | Therapeutic Infusions Containing Fructose |
| CN101953783A (en) * | 2010-09-15 | 2011-01-26 | 河南辅仁怀庆堂制药有限公司 | Preparation process of troxerutin injection |
| WO2024008987A1 (en) * | 2022-07-05 | 2024-01-11 | Consejo Superior De Investigaciones Científicas (Csic) | Peritoneal dialysis solutions containing a natural flavonoid as an osmotic agent |
-
2003
- 2003-02-11 CN CNA031172873A patent/CN1520812A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100574805C (en) * | 2004-10-25 | 2009-12-30 | 蚌埠丰原医药科技发展有限公司 | Therapeutic Infusions Containing Fructose |
| CN101953783A (en) * | 2010-09-15 | 2011-01-26 | 河南辅仁怀庆堂制药有限公司 | Preparation process of troxerutin injection |
| WO2024008987A1 (en) * | 2022-07-05 | 2024-01-11 | Consejo Superior De Investigaciones Científicas (Csic) | Peritoneal dialysis solutions containing a natural flavonoid as an osmotic agent |
| ES2958165A1 (en) * | 2022-07-05 | 2024-02-02 | Consejo Superior Investigacion | Peritoneal dialysis solutions containing a natural flavonoid as an osmotic agent |
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