CN1640409A - High-purity scutellarin injection agent - Google Patents
High-purity scutellarin injection agent Download PDFInfo
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- CN1640409A CN1640409A CN 200410000002 CN200410000002A CN1640409A CN 1640409 A CN1640409 A CN 1640409A CN 200410000002 CN200410000002 CN 200410000002 CN 200410000002 A CN200410000002 A CN 200410000002A CN 1640409 A CN1640409 A CN 1640409A
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- injection
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- flower acetic
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Abstract
The present invention relates to a high-purity breviscapine injection. Said injection contains breviscapine whose purity is 90.0%-99.5% (containing end point) and physiologically-acceptable salt.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of highly purified breviscapine B injection agent.
Background technology
Breviscapine be from the basis of medication among the people from Herba Erigerontis isolated flavone constituents, mainly contain scutellarin (being 5,6,7,4 '-kaempferol-7-O-glucuronide), breviscapine and other flavones ingredients.Begin from the seventies in 20th century, how tame units such as Yunnan Pharmaceutical Institute, Yunnan bio-pharmaceuticals factory are that raw material is made several formulations with its total flavones, as Breviscapini injection, Herba Erigerontis injection, Herba Erigerontis tablet, injection breviscapine etc., modern pharmacological research shows that breviscapine has following effect:
1. the cerebral blood flow increasing amount reduces vascular resistance, improves blood-brain barrier permeability.
2. resist platelet aggregation and the blood high viscosity syndrome that causes by adenosine diphosphate (ADP), suppress thrombosis.
3. effectively reduce plasma viscosity, packed cell volume, platelet aggregation rate and the Fibrinogen of Cerebral Infarction Patients, the lipoprotein metabolism that suppresses the ischemic cerebrovascular patient is unusual.
4. myocardial nutrition blood volume, microcirculation improvement, coronary artery dilator, decreased heart rate reduces myocardial contraction, reduces Peripheral resistance, reduces myocardial oxygen consumption, resists myocardial ischemia.
Breviscapine is used for the treatment of paralysis, the sequela due to the cerebral hemorrhage and the ischemic cerebrovascular due to the obliterated cerebral vascular disease.As the dizziness due to cerebral thrombosis, cerebral embolism, the cerebral hemorrhage, headache, nose heave, spoken unclear, numb limbs and tense tendons apoplectic hemiplegia, paralysis etc.
The deficiencies in the prior art are that the content of lamp-dish flower acetic in the present employed breviscapine of all preparations has only (HPLC method) about 60%-70%, and the impurity content height causes zest big, and untoward reaction is many, are provided with obstacle for enlarging to use.
Summary of the invention
Innovation of the present invention is to overcome the deficiencies in the prior art, and a kind of purity height, zest is low, untoward reaction is few breviscapine B injection agent are provided.
Breviscapine B injection agent of the present invention by purity be on the lamp-dish flower acetic of 90%-99.5% (containing end points) or its physiology on receivable salt and the pharmacology acceptable injection supplementary material form, the content of every bottle of lamp-dish flower acetic is 5mg-200mg (containing end points), and adjuvant is 0-30g.
The present invention realizes like this, get the lamp-dish flower acetic raw material of recipe quantity, add the injection water, regulating pH with the pH regulator agent is stirring and dissolving behind the 5-8, the adjuvant that adds recipe quantity, standardize solution, the preparation method of injection can be made injection with small volume, injectable powder (containing lyophilized injectable powder), high-capacity injection (transfusion) routinely.
Injection with small volume and high-capacity injection (transfusion) can adopt the method for high temperature sterilize or the method for aseptic filtration to be prepared.
High-capacity injection (transfusion) can also add.
Injectable powder can adopt the method for normal freeze-drying to make freeze-dried powder, also can make sterilized powder earlier and further be distributed into the powder pin again.Perhaps sterilized powder and packing again after other aseptic adjuvants mix.
The adjuvant that can adopt has:
The mixture of any one or more of aminoacid, glucose, lactose, sucrose, trehalose, fructose, maltose, xylitol, sterin, mannitol, dextran, sodium chloride, calcium gluconate or phosphate, phospholipid or derivatives thereof, cyclodextrin or derivatives thereof etc.
The pH regulator agent is potassium carbonate, potassium bicarbonate, sodium carbonate, sodium bicarbonate, sodium hydroxide or its mixture.
Isoosmotic adjusting agent is sodium chloride, glucose, fructose, xylitol, maltose or its mixture.
Injection purity height of the present invention, zest is low, and untoward reaction is few.
Embodiment
Further specify the present invention below by specific embodiment, but be not limited to following examples:
Example 1:
Get lamp-dish flower acetic, add an amount of water for injection, regulate pH to 5-8, stirring and dissolving is made every scutellarin injection that contains 5-200mg by the preparation method of injection with small volume behind the standardize solution.
Example 2:
Get lamp-dish flower acetic, add an amount of water for injection, regulate pH to 5-8, stirring and dissolving, add isoosmotic adjusting agent (sodium chloride or glucose or fructose or xylitol or maltose or its mixture), make every bottle of scutellarin high-capacity injection that contains 5-200mg by the preparation method of large capacity transfusion behind the standardize solution.
Example 3:
Get lamp-dish flower acetic, add an amount of water for injection, regulate pH to 5-8, stirring and dissolving, add the lyophilizing adjuvant, standardize solution is made every bottle of scutellarin freeze-dried powder that contains 5-200mg with the packing of lyophilizing bottle by the preparation method of freeze-dried powder, or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Also can not add the lyophilizing adjuvant operates.
Example 4:
An amount of anhydrous alcohol solution of lamp-dish flower acetic, phospholipid and cholesterol is removed dehydrated alcohol, adds water for injection or other buffer solution, dissolving back aseptic filtration, and the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 5:
Get an amount of anhydrous alcohol solution of lamp-dish flower acetic, phospholipid and cholesterol, remove dehydrated alcohol, add water for injection or other buffer solution, mannitol, dissolving back aseptic filtration, the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 6:
Get an amount of anhydrous alcohol solution of lamp-dish flower acetic, other gets phospholipid and an amount of anhydrous alcohol solution of cholesterol, mixes two kinds of solution, remove dehydrated alcohol, add water for injection or other buffer solution, mannitol, lactose, the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, the finished product of further packing system.
Example 7:
Get an amount of anhydrous alcohol solution of lamp-dish flower acetic, other gets an amount of anhydrous alcohol solution of 2-HP-, to make clathrate in the lamp-dish flower acetic solution adding 2-HP-solution, remove dehydrated alcohol, add water for injection or other buffer solution, dissolving is back aseptic filtration fully, and the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 8:
Get an amount of anhydrous alcohol solution of lamp-dish flower acetic, other gets an amount of anhydrous alcohol solution of 2-HP-, to make clathrate in the lamp-dish flower acetic solution adding 2-HP-solution, remove dehydrated alcohol, add water for injection or other buffer solution, mannitol, dissolving is back aseptic filtration fully, and dissolving is back aseptic filtration fully, the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 9:
Get an amount of anhydrous alcohol solution of lamp-dish flower acetic, other gets an amount of anhydrous alcohol solution of 2-HP-, to make clathrate in the lamp-dish flower acetic solution adding 2-HP-solution, remove dehydrated alcohol, add water for injection or other buffer solution, mannitol, lactose, dissolving is back aseptic filtration fully, and dissolving is back aseptic filtration fully, the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 10:
Get an amount of anhydrous alcohol solution of lamp-dish flower acetic, other gets an amount of anhydrous alcohol solution of 2-HP-, phospholipid and cholesterol, to make clathrate in lamp-dish flower acetic solution adding 2-HP-, phospholipid and the cholesterol solution, remove dehydrated alcohol, add water for injection or other buffer solution, dissolving is back aseptic filtration fully, and the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 11:
Get an amount of anhydrous alcohol solution of lamp-dish flower acetic, other gets an amount of anhydrous alcohol solution of 2-HP-, phospholipid and cholesterol, to make clathrate in lamp-dish flower acetic solution adding 2-HP-, phospholipid and the cholesterol solution, remove dehydrated alcohol, add water for injection or other buffer solution, mannitol, dissolving is back aseptic filtration fully, and the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 12:
Get lamp-dish flower acetic, Polyethylene Glycol, tween 80, mannitol, add proper amount of water for injection or other buffer solution, dissolving is back aseptic filtration fully, and the solution branch installs in the cillin bottle, directly makes finished product by freeze-drying.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 13:
Get lamp-dish flower acetic sodium, the preparation method of injection with small volume is made the lamp-dish flower acetic sodium injection routinely.
Example 14:
Get lamp-dish flower acetic sodium and isoosmotic adjusting agent, the preparation method of high-capacity injection is made the transfusion of lamp-dish flower acetic sodium routinely.
Example 15:
Get lamp-dish flower acetic potassium, the preparation method of lyophilized injectable powder is made injection lamp-dish flower acetic sodium routinely.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Example 16:
Get lamp-dish flower acetic potassium, the preparation method of injection with small volume is made the lamp-dish flower acetic sodium injection routinely.
Example 17:
Get lamp-dish flower acetic potassium and isoosmotic adjusting agent, the preparation method of high-capacity injection is made the transfusion of lamp-dish flower acetic sodium routinely.
Example 18:
Get lamp-dish flower acetic potassium, the preparation method of lyophilized injectable powder is made injection lamp-dish flower acetic sodium routinely.Or adopt spray drying method or freeze-drying to make sterilized powder, further packing makes finished product.
Claims (6)
1. highly purified breviscapine B injection agent is characterized by and contains the injection supplementary material that receivable salt and pharmacology allow on lamp-dish flower acetic (claiming scutellarin again) or its physiology and form.
2. according to claim 1 described injection, the purity that it is characterized in that lamp-dish flower acetic or its pharmaceutical salts is 90.0%-99.5% (containing end points).
3. according to claim 1,2 described injections, every bottle of (propping up) injection contains lamp-dish flower acetic or its pharmaceutical salts of 5-200mg (containing end points), and adjuvant is 0-30g.
4. according to claim 1,2,3 described injections, the pharmaceutical salts of lamp-dish flower acetic refers to lamp-dish flower acetic sodium, lamp-dish flower acetic potassium.
5. according to claim 1,2,3 described injections, refer to injection with small volume, injectable powder (containing lyophilized injectable powder), high-capacity injection (transfusion).
6. according to claim 1,3 described injections, described injection supplementary material is any one or more a mixture of aminoacid, glucose, lactose, sucrose, trehalose, fructose, maltose, xylitol, sterin, mannitol, dextran, sodium chloride, calcium gluconate or phosphate, phospholipid or derivatives thereof, cyclodextrin or derivatives thereof etc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410000002 CN1640409A (en) | 2004-01-02 | 2004-01-02 | High-purity scutellarin injection agent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410000002 CN1640409A (en) | 2004-01-02 | 2004-01-02 | High-purity scutellarin injection agent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1640409A true CN1640409A (en) | 2005-07-20 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410000002 Pending CN1640409A (en) | 2004-01-02 | 2004-01-02 | High-purity scutellarin injection agent |
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| CN (1) | CN1640409A (en) |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1823803B (en) * | 2005-12-31 | 2010-08-18 | 多布瑞菲医药有限公司 | Erigeron breviscapus injection preparation and its preparation method |
| CN1861087B (en) * | 2006-06-15 | 2010-11-24 | 正大青春宝药业有限公司 | High purity wild Radix scutellariae glucoside medicine composition, and application of making medicine to treat diseases of cardiovascular and cerebrovascular |
| CN102247329A (en) * | 2010-05-19 | 2011-11-23 | 昆明制药集团股份有限公司 | 5,6,7,4'-tetrahydroxyflavone powder injection and preparation method thereof |
| CN101683332B (en) * | 2008-09-26 | 2012-04-04 | 昆明龙津药业股份有限公司 | high purity scutellarin salt bulk drug and preparation method thereof |
| CN101966194B (en) * | 2009-07-28 | 2012-05-30 | 成都中医药大学 | New application of scutellarin and derivatives thereof |
| CN109453124A (en) * | 2018-11-23 | 2019-03-12 | 深圳市维琪医药研发有限公司 | A kind of lamp-dish flower acetic lyophilized preparation and preparation method thereof of RGD class peptide modification |
| CN109953996A (en) * | 2019-03-05 | 2019-07-02 | 澳门大学 | Application, drug and regulator of the scutellarin in the drug and regulator for preventing or treating disease |
| CN116059199A (en) * | 2023-03-03 | 2023-05-05 | 中国中医科学院医学实验中心 | Application of scutellarin compound as wild IDH1 agonist |
-
2004
- 2004-01-02 CN CN 200410000002 patent/CN1640409A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1823803B (en) * | 2005-12-31 | 2010-08-18 | 多布瑞菲医药有限公司 | Erigeron breviscapus injection preparation and its preparation method |
| CN1861087B (en) * | 2006-06-15 | 2010-11-24 | 正大青春宝药业有限公司 | High purity wild Radix scutellariae glucoside medicine composition, and application of making medicine to treat diseases of cardiovascular and cerebrovascular |
| CN101683332B (en) * | 2008-09-26 | 2012-04-04 | 昆明龙津药业股份有限公司 | high purity scutellarin salt bulk drug and preparation method thereof |
| CN101966194B (en) * | 2009-07-28 | 2012-05-30 | 成都中医药大学 | New application of scutellarin and derivatives thereof |
| CN102247329A (en) * | 2010-05-19 | 2011-11-23 | 昆明制药集团股份有限公司 | 5,6,7,4'-tetrahydroxyflavone powder injection and preparation method thereof |
| CN102247329B (en) * | 2010-05-19 | 2014-02-05 | 昆明制药集团股份有限公司 | 5,6,7,4'-tetrahydroxyflavone powder injection and preparation method thereof |
| CN109453124A (en) * | 2018-11-23 | 2019-03-12 | 深圳市维琪医药研发有限公司 | A kind of lamp-dish flower acetic lyophilized preparation and preparation method thereof of RGD class peptide modification |
| CN109953996A (en) * | 2019-03-05 | 2019-07-02 | 澳门大学 | Application, drug and regulator of the scutellarin in the drug and regulator for preventing or treating disease |
| CN116059199A (en) * | 2023-03-03 | 2023-05-05 | 中国中医科学院医学实验中心 | Application of scutellarin compound as wild IDH1 agonist |
| CN116059199B (en) * | 2023-03-03 | 2023-07-18 | 中国中医科学院医学实验中心 | Application of scutellarin compound as wild IDH1 agonist |
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