CN1425385A - Breviscapine infusion preparation and its preparing method - Google Patents
Breviscapine infusion preparation and its preparing method Download PDFInfo
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- CN1425385A CN1425385A CN 02155001 CN02155001A CN1425385A CN 1425385 A CN1425385 A CN 1425385A CN 02155001 CN02155001 CN 02155001 CN 02155001 A CN02155001 A CN 02155001A CN 1425385 A CN1425385 A CN 1425385A
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- breviscapine
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Abstract
The Breviscapine infusion preparation is compounded with Breviscapine as main component, glucose or sodium chloride, propylene glycol, L-arginine, sodium bisulphate, EDTA-2Na and water for injection through certain technological process. The preparation is suitable for great dosage application clinically to avoid cross infection caused by intermediate links. In addition, the present invention is clear and stable.
Description
Technical field
The invention belongs to medical technical field, being specifically related to a kind of is the intravenous transfusion preparation and preparation method thereof of main component with the breviscapine, is erigeron breviscapus glucese injection and Herba Erigerontis sodium chloride injection and preparation method thereof specifically.
Background technology
Breviscapine is the total flavonoids substance that is extracted by the short fluffy plant of Roripa second [Erigron breviscapus (Vaniot) Hand Mazz] Herba Erigerontis of Compositae, is mainly used in the treatment of cardiovascular and cerebrovascular disease.Be widely used at present clinical, determined curative effect, to the diseases such as paralysis due to coronary heart disease, angina pectoris, cerebral thrombosis, the cerebral infarction, total effective rate reaches more than 90%.The clinical practice of breviscapine mainly is a small-volume injection, clinical practice confirms low dose of breviscapine poor effect, has only heavy dose of (20-40ml even bigger) just produce effects of using, clinical practice is poured in normal saline or the glucose injection after many little pins need being cut, and troublesome poeration also pollutes easily.The little pin preparation of also finding breviscapine simultaneously exists stability, the relatively poor problem of clarity.
Summary of the invention
The object of the present invention is to provide a kind of all good breviscapine infusion preparation of heavy dose of use, stability and clarity that is exclusively used in, and preparation method thereof.
The breviscapine infusion preparation that the present invention proposes is a Main Ingredients and Appearance with the breviscapine, and all the other compatibilities are glucose or sodium chloride, propylene glycol, L-arginine, sodium sulfite, EDTA-2Na and water for injection.Using glucose, then is erigeron breviscapus glucese injection, uses sodium chloride, then is the breviscapine sodium chloride injection.
It is bottled that above-mentioned breviscapine infusion preparation is generally 100ml.The dosage of each component is among every 100ml: breviscapine 15-25mg, glucose 4-6g or sodium chloride 0.7-1g, propylene glycol 0.1-0.4ml, L-arginine 30-50mg, sodium sulfite 40-60mg, EDTA-2Na 20-35mg.
The preparation method of the breviscapine infusion preparation that the present invention proposes is as follows: presses the component dosage of infusion preparation, takes by weighing each component,
(1) breviscapine is a mixed solvent with propylene glycol, water, adds the L-arginine, makes it dissolving fully, adds EDTA-2Na again, and (acid for adjusting pH such as available glacial acetic acid is between 4.5～6.5 in case of necessity.) with after the suitable quantity of water dilution, add 0.1% active carbon, 60～80 ℃ were incubated more than 20 minutes, filtering decarbonization, it is standby to be prepared into concentrated solution;
(2) get in the water for injection that glucose or sodium chloride adds to 60～80 ℃, add 0.1% active carbon, insulation was filtered more than 20 minutes, and is for glucose or sodium chloride concentrated solution, standby;
(3) glucose or sodium chloride concentrated solution are joined in the breviscapine concentrated solution, (regulating pH with glacial acetic acid in case of necessity is 4.5～6.5) reuse water standardize solution, fine straining, fill is in the 100ml glass infusion bottle, blooming, jump a queue, roll lid, sterilization promptly gets required breviscapine infusion preparation.
Breviscapine infusion preparation proposed by the invention, solved the heavy dose of problem of using of clinical middle Herba Erigerontis, easy to use, avoided little pin to extract the intermediate link of injecting glucose and sodium chloride infusion solutions, thereby stopped the cross infection of medication process, ensured drug safety.Owing to used propylene glycol and water mixed solvent, overcome the bad shortcoming of breviscapine clarity simultaneously, the dissolubility that the arginic use of L-can increase breviscapine also plays the effect that makes breviscapine infusion stable.
The specific embodiment
Embodiment:
Embodiment 1: the erigeron breviscapus glucese transfusion
Erigeron breviscapus glucese transfusion prescription is:
Breviscapine 20g (in scutellarin)
Glucose 5kg
Propylene glycol 200ml
L-arginine 40g
Sodium sulfite 50g
EDTA-2Na 26g
Water for injection adds to 100000ml
The method for preparing the erigeron breviscapus glucese transfusion is as follows:
Accurately take by weighing the sodium sulfite and the EDTA-2Na of recipe quantity, add in the suitable quantity of water, make whole dissolvings, the breviscapine that adds recipe quantity stirs and makes into suspension, adds the recipe quantity propylene glycol, stir, add the L-arginine of recipe quantity again, breviscapine is all dissolved, regulate pH to 5.0 with hydrochloric acid, add water to 4000ml, add 0.1% active carbon, 70 ℃ are incubated 20 minutes, filtering decarbonization is prepared into the concentrated solution of 5mg/ml, and is standby; The glucose of getting recipe quantity adds in 10000ml, 70 ℃ the water for injection and makes dissolving, adds 0.1% active carbon, and insulation (70 ℃) 20 minutes is filtered; With the glucose concentrated solution for preparing, be added in the breviscapine concentrated solution, stir while adding, add the injection water and be settled to 100000ml, fine straining, product content (breviscapine and glucose) and pH value in the middle of measuring, after qualified, lid is jumped a queue, rolled to fill blooming, in the 100ml glass infusion bottle, 115 ℃, sterilization 30 minutes are promptly.
Embodiment 2: the transfusion of breviscapine sodium chloride
The transfusion of breviscapine sodium chloride is a raw material with following formulation by weight:
Breviscapine 20g (in scutellarin)
Propylene glycol 200ml
L-arginine 40g
Sodium sulfite 50g
EDTA-2Na 26g
Sodium chloride 0.9kg
Water for injection adds to 100000ml
The method for preparing the transfusion of breviscapine sodium chloride is as follows:
Accurately take by weighing the EDTA-2Na of recipe quantity, add in the suitable quantity of water, make whole dissolvings, the breviscapine that adds recipe quantity stirs and makes into suspension, adds the propylene glycol of recipe quantity, stir, add the L-arginine of recipe quantity again, regulate pH to 9.25, breviscapine is all dissolved, regulate about pH to 5.0, take by weighing the sodium sulfite of recipe quantity with glacial acetic acid, add water to 400ml, add 0.1% active carbon, 70 ℃ of insulation 15min, filter, be prepared into the concentrated solution of 5mg, ml, standby; The sodium chloride of getting recipe quantity adds in 90000ml, 70 ℃ the water for injection and dissolves; The breviscapine concentrated solution for preparing is added and constantly stirring, measure pH, making pH is 5.0, and water for injection adds to capacity; Fine straining, product content and pH in the middle of measuring, qualified after, filter fill in the 100ml glass infusion bottle, gland seal, was sterilized promptly in 30 minutes by 115 ℃.
Embodiment 3:
Erigeron breviscapus glucese transfusion prescription is:
Breviscapine 15g (in scutellarin)
Glucose 5kg
Propylene glycol 300ml
L-arginine 30g
Sodium sulfite 40g
EDTA-2Na 24g
Water for injection adds to 100000ml
The method for preparing the erigeron breviscapus glucese transfusion is as follows:
Accurately take by weighing the sodium sulfite and the EDTA-2Na of recipe quantity, add in the suitable quantity of water, make whole dissolvings, the breviscapine that adds recipe quantity stirs and makes into suspension, adds the recipe quantity propylene glycol, stir, add the L-arginine of recipe quantity again, breviscapine is all dissolved, regulating pH with hydrochloric acid is 4.5, adds water to 4000ml, adds 0.1% active carbon, 80 ℃ are incubated 30 minutes, filtering decarbonization is prepared into the concentrated solution of breviscapine, and is standby; The glucose of getting recipe quantity adds in 10000ml, 80 ℃ the water for injection and makes dissolving, adds 0.1% active carbon, be incubated 30 minutes, filtration; With the glucose concentrated solution for preparing, be added in the breviscapine concentrated solution, stir while adding, add the injection water and be settled to 100000ml, fine straining, product content (breviscapine and glucose) and pH value in the middle of measuring, after qualified, lid is jumped a queue, rolled to fill blooming, in the 100ml glass infusion bottle, 115 ℃, sterilization 30 minutes are promptly.
Embodiment 4: breviscapine sodium chloride transfusion prescription is:
Breviscapine 15g (in scutellarin)
Propylene glycol 300ml
L-arginine 30g
Sodium sulfite 40g
EDTA-2Na 28g
Sodium chloride 0.9kg
Water for injection adds to 100000ml
The method for preparing the transfusion of breviscapine sodium chloride is as follows:
Accurately take by weighing the EDTA-2Na of recipe quantity, add in the suitable quantity of water, make whole dissolvings, the breviscapine that adds recipe quantity stirs and makes into suspension, adds the propylene glycol of recipe quantity, stir, add the L-arginine of recipe quantity again, regulate pH to 9.0, breviscapine is all dissolved, and regulating pH with glacial acetic acid is 4.5, takes by weighing the sodium sulfite of recipe quantity, add water to 400ml, add 0.1% active carbon, 80 ℃ of insulation 15min, filter, be prepared into the concentrated solution of breviscapine, standby; The sodium chloride of getting recipe quantity adds in 90000ml, 80 ℃ the water for injection and dissolves; The breviscapine concentrated solution for preparing is added and constantly stirring, measure pH, making pH is 4.5, and water for injection adds to capacity; Fine straining, product content and pH in the middle of measuring, qualified after, filter fill in the 100ml glass infusion bottle, gland seal, was sterilized promptly in 30 minutes by 115 ℃.
Embodiment 5:
Erigeron breviscapus glucese transfusion prescription is:
Breviscapine 25g (in scutellarin)
Glucose 5kg
Propylene glycol 400ml
L-arginine 50g
Sodium sulfite 60g
EDTA-2Na 34g
Water for injection adds to 100000ml
The method embodiment for preparing the erigeron breviscapus glucese transfusion is as follows:
Accurately take by weighing the sodium sulfite and the EDTA-2Na of recipe quantity, add in the suitable quantity of water, make whole dissolvings, the breviscapine that adds recipe quantity stirs and makes into suspension, adds the recipe quantity propylene glycol, stir, add the L-arginine of recipe quantity again, breviscapine is all dissolved, regulating pH with hydrochloric acid is 5.5, adds water to 4000ml, adds 0.1% active carbon, 80 ℃ are incubated 30 minutes, filtering decarbonization is prepared into the concentrated solution of breviscapine, and is standby; The glucose of getting recipe quantity adds in 10000ml, 80 ℃ the water for injection and makes dissolving, adds 0.1% active carbon, be incubated 30 minutes, filtration; With the glucose concentrated solution for preparing, be added in the breviscapine concentrated solution, stir while adding, add the injection water and be settled to 100000ml, fine straining, product content (breviscapine and glucose) and pH value in the middle of measuring, after qualified, lid is jumped a queue, rolled to fill blooming, in the 100ml glass infusion bottle, 115 ℃, sterilization 30 minutes are promptly.
Embodiment 6:
The transfusion of breviscapine sodium chloride is a raw material with following formulation by weight:
Breviscapine 25g (in scutellarin)
Propylene glycol 500ml
L-arginine 50g
Sodium sulfite 60g
EDTA-2Na 35g
Sodium chloride 0.9kg
Water for injection adds to 100000ml
The method embodiment for preparing the transfusion of breviscapine sodium chloride is as follows:
Accurately take by weighing the EDTA-2Na of recipe quantity, add in the suitable quantity of water, make whole dissolvings, the breviscapine that adds recipe quantity stirs and makes into suspension, adds the propylene glycol of recipe quantity, stir, add the L-arginine of recipe quantity again, regulate pH to 9.35, breviscapine is all dissolved, and regulating pH with glacial acetic acid is 6.5, takes by weighing the sodium sulfite of recipe quantity, add water to 400ml, add 0.1% active carbon, 80 ℃ of insulation 15min, filter, be prepared into the concentrated solution of breviscapine, standby; The sodium chloride of getting recipe quantity adds in 90000ml, 80 ℃ the water for injection and dissolves; The breviscapine concentrated solution for preparing is added and constantly stirring, measure pH, making pH is 6.5, and water for injection adds to capacity; Fine straining, product content and pH in the middle of measuring, qualified after, filter fill in the 100ml glass infusion bottle, gland seal, was sterilized promptly in 30 minutes by 115 ℃.
Claims (4)
1, a kind of breviscapine infusion preparation is characterized in that main component is a breviscapine, and other composition has glucose or sodium chloride, propylene glycol, L-arginine, sodium sulfite, EDTA-2Na, water for injection.
2, breviscapine infusion preparation according to claim 1 is characterized in that containing in every 100ml transfusion breviscapine 15-25mg, glucose 4-6g or sodium chloride 0.7-1g, propylene glycol 0.1-0.4ml, L-arginine 30-50mg, sodium sulfite 40-60mg, EDTA-2Na 20-35mg.
3, a kind of preparation method of breviscapine infusion preparation according to claim 1 is characterized in that concrete steps are as follows: the component dosage by infusion preparation takes by weighing each component,
(1) breviscapine is a mixed solvent with propylene glycol, water, adds the L-arginine, makes it dissolving fully, adds EDTA-2Na again, after the suitable quantity of water dilution, adds 0.1% active carbon, and 70～80 ℃ were incubated more than 20 minutes, filtering decarbonization, and it is standby to be prepared into concentrated solution;
(2) get in the water for injection that glucose or sodium chloride adds to 70～80 ℃, add 0.1% active carbon, insulation was filtered more than 20 minutes, and is for glucose or sodium chloride concentrated solution, standby;
(3) glucose or sodium chloride concentrated solution are joined in the breviscapine concentrated solution, reuse water standardize solution, fine straining, lid is jumped a queue, rolled to fill blooming, in the 100ml glass infusion bottle, sterilization, promptly.
4, preparation method according to claim 3, when it is characterized in that preparing the breviscapine concentrated solution, regulating pH value with glacial acetic acid is 4.5-6.5.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02155001 CN1231223C (en) | 2002-12-19 | 2002-12-19 | Breviscapine infusion preparation and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02155001 CN1231223C (en) | 2002-12-19 | 2002-12-19 | Breviscapine infusion preparation and its preparing method |
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| CN1425385A true CN1425385A (en) | 2003-06-25 |
| CN1231223C CN1231223C (en) | 2005-12-14 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 02155001 Expired - Fee Related CN1231223C (en) | 2002-12-19 | 2002-12-19 | Breviscapine infusion preparation and its preparing method |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1297280C (en) * | 2003-11-15 | 2007-01-31 | 昆明紫健生物技术有限公司 | Breviscapine amino acid transfusion liquid and its producing method |
| CN100406021C (en) * | 2006-05-26 | 2008-07-30 | 昆明龙津药业有限公司 | Breviscapine B injection preparation and its preparing method |
| CN1830451B (en) * | 2005-03-08 | 2010-09-08 | 万生联合制药有限公司 | Preparation method of erigeron breviscapus glucese injection |
| CN1839866B (en) * | 2005-08-13 | 2011-04-20 | 杭州民生药业有限公司 | Medicinal composition containing breviscapine |
| CN108210451A (en) * | 2018-02-27 | 2018-06-29 | 云南玉药生物制药有限公司 | The Breviscapini injection and its preparation process of a kind of stabilization |
-
2002
- 2002-12-19 CN CN 02155001 patent/CN1231223C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1297280C (en) * | 2003-11-15 | 2007-01-31 | 昆明紫健生物技术有限公司 | Breviscapine amino acid transfusion liquid and its producing method |
| CN1830451B (en) * | 2005-03-08 | 2010-09-08 | 万生联合制药有限公司 | Preparation method of erigeron breviscapus glucese injection |
| CN1839866B (en) * | 2005-08-13 | 2011-04-20 | 杭州民生药业有限公司 | Medicinal composition containing breviscapine |
| CN100406021C (en) * | 2006-05-26 | 2008-07-30 | 昆明龙津药业有限公司 | Breviscapine B injection preparation and its preparing method |
| CN108210451A (en) * | 2018-02-27 | 2018-06-29 | 云南玉药生物制药有限公司 | The Breviscapini injection and its preparation process of a kind of stabilization |
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| Publication number | Publication date |
|---|---|
| CN1231223C (en) | 2005-12-14 |
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Granted publication date: 20051214 Termination date: 20111219 |