CN1626086A - Urapidil powder and injection preparation and preparing method - Google Patents
Urapidil powder and injection preparation and preparing method Download PDFInfo
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- CN1626086A CN1626086A CN 200310117368 CN200310117368A CN1626086A CN 1626086 A CN1626086 A CN 1626086A CN 200310117368 CN200310117368 CN 200310117368 CN 200310117368 A CN200310117368 A CN 200310117368A CN 1626086 A CN1626086 A CN 1626086A
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- urapidil
- injectable powder
- powder
- adjuvant
- injection
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Abstract
A powder injection of urqpidil is prepared from urqpidil or its physiologically acceptable salt, and the pharmacologically acceptable auxiliary for injection. Its advantage is high stability and quality.
Description
Technical field
The invention belongs to medical technical field, relate to medicine of a kind of special form that is used for cardiovascular and cerebrovascular disease and preparation method thereof.
Background technology
Urapidil is a kind of selectivity α 1 receptor blocking agent, has the dual hypotensive effect of periphery and maincenter.The effect of periphery blood vessel dilating mainly by blocking-up postsynaptic α 1 receptor, significantly descends and blood vessel dilating Peripheral resistance.Central action is then by activating 5-hydroxy tryptamine-1A receptor, reduces the sympathetic feedback of medulla oblongata cardio-vascular regulating center and plays the blood pressure lowering effect.This product has the effect of blocking-up postsynaptic α 1 receptor and the effect of blocking-up periphery alpha-2 receptor, but based on the former.This product greater than to arterial vascular effect, and can reduce renal vascular resistance to the diastole effect of vein blood vessel, and the normotensive is not had antihypertensive effect, and heart rate is not had obvious influence, has a good application prospect.We have ratified the listing of urapidil injection at present, but along with output constantly enlarges, quality problems also occur now and then, and aqueous injection freezes in the north winter, and inconvenience is used, intramuscular injection pain, patient is reluctant to use, and these all are to enlarge to use to be provided with obstacle.
Summary of the invention
Innovation of the present invention is to overcome the deficiencies in the prior art, and the urapidil injectable powder of growing a kind of convenient transportation, storage period is provided.
Urapidil injectable powder of the present invention is made up of acceptable injection supplementary material on receivable salt and the pharmacology on urapidil or its physiology, and the content of every bottle of urapidil is 5-100mg (containing end points), and surplus is pharmaceutic adjuvant or water.
Pharmaceutic adjuvant of the present invention is: the mixture of one or more of organic or biochemical adjuvant such as aminoacid, glucose, lactose, phospholipid, cholesterol, cyclodextrin or derivatives thereof, mannitol, polyvinylpyrrolidone, dextran also can be one or more mixture of inorganic salts such as sodium chloride, calcium gluconate or phosphate.
Injectable powder convenient transportation of the present invention, storage period is long, and than the aqueous injection good stability of products, the quality height can be mass-produced, and the gained injection is through check behind the adding water for injection, and every index all meets the requirements.
Embodiment
Further specify preparation process of the present invention below by specific embodiment, but be not limited to following examples:
100 grades to be raw material with urapidil or Urapidil hydrochloride in going to the workshop, add an amount of water, adjusting pH is 4.5-8.5, solution is through aseptic filtration, and aseptic spray drying airtightly promptly gets required injectable powder raw material, be distributed into every bottle and contain urapidil 25mg, roll lid, packing gets product.
At 100 grades being raw material with urapidil or Urapidil hydrochloride in going to the workshop, add an amount of water, adjuvant, adjusting pH is 4.5-8.5, solution is through aseptic filtration, aseptic spray drying airtightly promptly gets required injectable powder raw material, is distributed into every bottle and contains urapidil 25mg, roll lid, packing gets product.
3. separate out urapidil or Urapidil hydrochloride with the menstruum method, sucking filtration, drying promptly gets the powder pin with raw material (also available spray drying method), further is distributed in every bottle of cillin bottle that contains urapidil 25mg, rolls lid, and packing gets product.
4. be raw material and an amount of adjuvant with urapidil or Urapidil hydrochloride, add water for injection, adjusting pH is 4.5-8.5, pass through aseptic filtration at 100 grades with solution in going to the workshop, be distributed into every and contain urapidil 25mg, make lyophilized injectable powder by freeze-drying.
At 100 grades being raw material with urapidil or Urapidil hydrochloride in going to the workshop, add an amount of water and adjuvant, adjusting pH is 4.5-8.5, solution is through aseptic filtration, aseptic spray drying airtightly promptly gets required injectable powder raw material, is distributed into every bottle and contains urapidil 50mg, roll lid, packing gets product.
The urapidil injectable powder that adopts the appeal method to make is checked, all met the requirement of the relevant injectable powder of country.
Claims (5)
1. urapidil injectable powder is characterized by and contains the injection supplementary material that receivable salt and pharmacology allow on urapidil or its physiology and form.
2. according to claim 1 described injectable powder, wherein every bottle contains the 5-100mg urapidil of (containing end points), and all the other are adjuvant or water.
3. according to claim 1,2 described injectable powder, main effective ingredient is a receivable salt on urapidil or its physiology, such as Urapidil hydrochloride, methanesulfonic acid urapidil, lactic acid urapidil etc.
4. according to claim 1,2,3 described injectable powder, described injection supplementary material is one or more a mixture of organic or biochemical adjuvant such as aminoacid, glucose, lactose, phospholipid, cholesterol, cyclodextrin or derivatives thereof, mannitol, polyvinylpyrrolidone, dextran, also can be one or more mixture of inorganic salts such as sodium chloride, calcium gluconate or phosphate.
5. according to claim 1,2,3 described injectable powder, its preparation method is that lyophilization directly obtains finished product, also can adopt the method by lyophilization, spray drying or solvent crystal to obtain aseptic powder, through the aseptic subpackaged finished product that obtains.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN 200310117368 CN1626086A (en) | 2003-12-12 | 2003-12-12 | Urapidil powder and injection preparation and preparing method |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN 200310117368 CN1626086A (en) | 2003-12-12 | 2003-12-12 | Urapidil powder and injection preparation and preparing method |
Publications (1)
Publication Number | Publication Date |
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CN1626086A true CN1626086A (en) | 2005-06-15 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CN 200310117368 Pending CN1626086A (en) | 2003-12-12 | 2003-12-12 | Urapidil powder and injection preparation and preparing method |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101200451B (en) * | 2006-12-15 | 2010-12-15 | 重庆药友制药有限责任公司 | Method for preparing hydrochloride urapidil |
CN104173281A (en) * | 2014-09-05 | 2014-12-03 | 河北一品制药有限公司 | Urapidil hydrochloride injection and preparation method thereof |
CN105193746A (en) * | 2015-09-22 | 2015-12-30 | 青岛华之草医药科技有限公司 | Hypotensive drug urapidil hydrochloride composition freeze-dried powder injection |
-
2003
- 2003-12-12 CN CN 200310117368 patent/CN1626086A/en active Pending
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101200451B (en) * | 2006-12-15 | 2010-12-15 | 重庆药友制药有限责任公司 | Method for preparing hydrochloride urapidil |
CN104173281A (en) * | 2014-09-05 | 2014-12-03 | 河北一品制药有限公司 | Urapidil hydrochloride injection and preparation method thereof |
CN105193746A (en) * | 2015-09-22 | 2015-12-30 | 青岛华之草医药科技有限公司 | Hypotensive drug urapidil hydrochloride composition freeze-dried powder injection |
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C06 | Publication | ||
PB01 | Publication | ||
C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
WD01 | Invention patent application deemed withdrawn after publication |