CN1221261C - Flunarizine hydro chloride high-capacity injecta and preparing process thereof - Google Patents
Flunarizine hydro chloride high-capacity injecta and preparing process thereof Download PDFInfo
- Publication number
- CN1221261C CN1221261C CN 03126391 CN03126391A CN1221261C CN 1221261 C CN1221261 C CN 1221261C CN 03126391 CN03126391 CN 03126391 CN 03126391 A CN03126391 A CN 03126391A CN 1221261 C CN1221261 C CN 1221261C
- Authority
- CN
- China
- Prior art keywords
- injection
- flunarizine
- sodium chloride
- capacity
- flunarizine hydrochloride
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- RXKMOPXNWTYEHI-RDRKJGRWSA-N Flunarizine hydrochloride Chemical compound Cl.Cl.C1=CC(F)=CC=C1C(C=1C=CC(F)=CC=1)N1CCN(C\C=C\C=2C=CC=CC=2)CC1 RXKMOPXNWTYEHI-RDRKJGRWSA-N 0.000 title claims description 62
- 229960002807 flunarizine hydrochloride Drugs 0.000 title claims description 62
- 238000000034 method Methods 0.000 title abstract description 13
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 74
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 38
- 239000011780 sodium chloride Substances 0.000 claims abstract description 35
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 27
- 239000008215 water for injection Substances 0.000 claims abstract description 21
- 239000007924 injection Substances 0.000 claims abstract description 17
- 238000002347 injection Methods 0.000 claims abstract description 17
- 238000002360 preparation method Methods 0.000 claims abstract description 8
- DNIAPMSPPWPWGF-UHFFFAOYSA-N propylene glycol Substances CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 41
- 239000008103 glucose Substances 0.000 claims description 29
- 239000007788 liquid Substances 0.000 claims description 13
- 230000005477 standard model Effects 0.000 claims 1
- 229960000326 flunarizine Drugs 0.000 abstract description 21
- SMANXXCATUTDDT-QPJJXVBHSA-N flunarizine Chemical compound C1=CC(F)=CC=C1C(C=1C=CC(F)=CC=1)N1CCN(C\C=C\C=2C=CC=CC=2)CC1 SMANXXCATUTDDT-QPJJXVBHSA-N 0.000 abstract description 21
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 abstract description 13
- 230000000694 effects Effects 0.000 abstract description 12
- 239000000243 solution Substances 0.000 abstract description 10
- 238000005261 decarburization Methods 0.000 abstract description 7
- 238000010790 dilution Methods 0.000 abstract description 7
- 239000012895 dilution Substances 0.000 abstract description 7
- 239000008121 dextrose Substances 0.000 abstract description 6
- 238000012545 processing Methods 0.000 abstract description 5
- 239000002904 solvent Substances 0.000 abstract description 2
- 229940126673 western medicines Drugs 0.000 abstract description 2
- 239000000463 material Substances 0.000 abstract 4
- 238000004090 dissolution Methods 0.000 abstract 2
- 238000001914 filtration Methods 0.000 abstract 2
- 230000004308 accommodation Effects 0.000 abstract 1
- 229910052799 carbon Inorganic materials 0.000 abstract 1
- 230000001105 regulatory effect Effects 0.000 abstract 1
- 239000000047 product Substances 0.000 description 28
- 238000003756 stirring Methods 0.000 description 20
- 238000007689 inspection Methods 0.000 description 15
- 238000005303 weighing Methods 0.000 description 14
- 229940090044 injection Drugs 0.000 description 11
- 238000010438 heat treatment Methods 0.000 description 10
- 239000012085 test solution Substances 0.000 description 9
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- 238000010521 absorption reaction Methods 0.000 description 6
- 238000003556 assay Methods 0.000 description 6
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 6
- 239000002158 endotoxin Substances 0.000 description 6
- 210000004907 gland Anatomy 0.000 description 6
- 238000012856 packing Methods 0.000 description 6
- 230000010412 perfusion Effects 0.000 description 6
- 239000011265 semifinished product Substances 0.000 description 6
- 238000012546 transfer Methods 0.000 description 6
- 208000026106 cerebrovascular disease Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 238000001990 intravenous administration Methods 0.000 description 5
- KRQUFUKTQHISJB-YYADALCUSA-N 2-[(E)-N-[2-(4-chlorophenoxy)propoxy]-C-propylcarbonimidoyl]-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one Chemical compound CCC\C(=N/OCC(C)OC1=CC=C(Cl)C=C1)C1=C(O)CC(CC1=O)C1CCCSC1 KRQUFUKTQHISJB-YYADALCUSA-N 0.000 description 4
- 206010059245 Angiopathy Diseases 0.000 description 4
- 206010058558 Hypoperfusion Diseases 0.000 description 4
- 206010022562 Intermittent claudication Diseases 0.000 description 4
- 208000026139 Memory disease Diseases 0.000 description 4
- 208000019695 Migraine disease Diseases 0.000 description 4
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 4
- 208000012886 Vertigo Diseases 0.000 description 4
- 230000001154 acute effect Effects 0.000 description 4
- 208000011775 arteriosclerosis disease Diseases 0.000 description 4
- 206010008118 cerebral infarction Diseases 0.000 description 4
- 230000001684 chronic effect Effects 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 4
- 208000002173 dizziness Diseases 0.000 description 4
- 230000002996 emotional effect Effects 0.000 description 4
- 208000021156 intermittent vascular claudication Diseases 0.000 description 4
- 206010027599 migraine Diseases 0.000 description 4
- 238000007254 oxidation reaction Methods 0.000 description 4
- 201000006302 peripheral vertigo Diseases 0.000 description 4
- 229910052700 potassium Inorganic materials 0.000 description 4
- 239000011591 potassium Substances 0.000 description 4
- 238000011160 research Methods 0.000 description 4
- 239000008354 sodium chloride injection Substances 0.000 description 4
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 3
- 208000024780 Urticaria Diseases 0.000 description 3
- 239000012467 final product Substances 0.000 description 3
- 229940093181 glucose injection Drugs 0.000 description 3
- 239000013618 particulate matter Substances 0.000 description 3
- 239000012286 potassium permanganate Substances 0.000 description 3
- 239000008223 sterile water Substances 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- BERDEBHAJNAUOM-UHFFFAOYSA-N copper(I) oxide Inorganic materials [Cu]O[Cu] BERDEBHAJNAUOM-UHFFFAOYSA-N 0.000 description 2
- RSJOBNMOMQFPKQ-ZVGUSBNCSA-L copper;(2r,3r)-2,3-dihydroxybutanedioate Chemical compound [Cu+2].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O RSJOBNMOMQFPKQ-ZVGUSBNCSA-L 0.000 description 2
- LBJNMUFDOHXDFG-UHFFFAOYSA-N copper;hydrate Chemical compound O.[Cu].[Cu] LBJNMUFDOHXDFG-UHFFFAOYSA-N 0.000 description 2
- 238000009413 insulation Methods 0.000 description 2
- 239000002244 precipitate Substances 0.000 description 2
- 159000000000 sodium salts Chemical class 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 241000699670 Mus sp. Species 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- FGCSIJPPCNCQJB-FAOVPRGRSA-M sodium;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanal;chloride Chemical compound [Na+].[Cl-].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O FGCSIJPPCNCQJB-FAOVPRGRSA-M 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention provides a large-capacity flunarizine dihydrochloride injection and a processing technique thereof for the technical field of western medicines. The large-capacity flunarizine dihydrochloride injection has the preparation range (bottle / accommodation) of 2 mg to 50 mg of flunarizine dihydrochloride and 0.1 ml to 10 ml of 1.2-trimethylene glycol, 1g to 50g of dextrose and 0.3g to 10g of sodium chloride are respectively used as solvents, 20 ml of 1.2-trimethylene glycol is measured and put in a material preparing container, and flunarizine dihydrochloride is added to the material preparing container and heated and stirred in the material preparing container for dissolution; water for injection for the dextrose is dissolved and then stirred and added to the material preparing container for dilution and dissolution, the water for injection is nearly added to the full dose, active carbon is added and heated to the temperature of 80 to 90 DEG C, the temperature is kept for 15 minutes, and then, filtration, decarburization and fine filtration are carried out; the flunarizine dihydrochloride and a 1.2-trimethylene glycol solution are uniformly stirred, and a pH value is regulated to 3.5 to 5.0 so as to obtain the large-capacity flunarizine dihydrochloride injection; due to the utilization of the technical scheme, the present invention has the advantages of stable quality, quick and obvious effect, high bioavailability and easy use without the consideration of incompatible preparation.
Description
Technical field:
The invention belongs to technical field of western medicines, is a kind of treatment cardiovascular and cerebrovascular disease intravenous drip medication, relates to flunarizine hydrochloride high-capacity injection and processing technique thereof.
Background technology:
Existing flunarizine hydrochloride has peroral dosage form (tablet, capsule), and not only bioavailability is lower, absorbs slowly, uses very difficulty for critical patient and oral mistake disease patient; The little pin of flunarizine hydrochloride is used for intramuscular injection, injection pain, and onset is slow, bioavailability is low, use is inconvenient and need to consider incompatibility.
Summary of the invention:
The purpose of this invention is to provide a kind of rapid-action, bioavailability is high, easy to use and need not consider the flunarizine hydrochloride high-capacity injection and the processing technique thereof of incompatibility.
The technical scheme that the present invention takes is flunarizine hydrochloride high-capacity injection dosage range (bottle/include): flunarizine hydrochloride 2mg-50mg, 1.2-propylene glycol 0.1ml-10ml, solvent is respectively glucose, sodium chloride, glucose sodium chloride, content is respectively glucose 1g-50g, sodium chloride 0.3g-10g;
Its processing technique is respectively (with 1000ml dosing amount):
Measure 1.2-propylene glycol 20ml and put in the proportion container, take by weighing in the flunarizine hydrochloride 50mg adding proportion container and heat 60---80 ℃ of stirring and dissolving; Take by weighing glucose 50g and stir dilution dissolving in the adding proportion container, add to nearly full dose, add activated carbon 3g heating and be incubated 15 minutes for 80-90 ℃, filter decarburization, fine straining with water for injection with water for injection dissolving back; Add flunarizine hydrochloride and 1.2-mixed with propylene glycol liquid, stir, transfer pH3.5-5.0, the inspection of semifinished product is qualified, perfusion, and the tool plug, gland, 115 ℃/45 minutes autoclavings, lamp inspection, packing, that is:
Measuring 1.2-propylene glycol 20ml puts in the proportion container, take by weighing flunarizine hydrochloride 50mg and add 60-80 ℃ of stirring and dissolving of heating in the proportion container, take by weighing sodium chloride 9g and stir dilution dissolving in the adding proportion container with water for injection dissolving back, add to nearly full dose with water for injection, add 80-90 ℃ of insulation of activated carbon 3g heating 15 minutes, filter decarburization, fine straining; Add flunarizine hydrochloride and 1.2-mixed with propylene glycol liquid, stir, transfer pH3.5-5.0, the inspection of semifinished product is qualified, perfusion, and the tool plug, gland, 115 ℃/45 minutes autoclavings, lamp inspection, packing, promptly;
Measure 1.2-propylene glycol 20ml and put in the proportion container, take by weighing flunarizine hydrochloride 50mg and add 60-80 ℃ of stirring and dissolving of heating in the proportion container; Taking by weighing glucose 50g stirs in the adding proportion container with water for injection dissolving back, take by weighing sodium chloride 9g and stir dilution dissolving in the adding proportion container, add to nearly full dose, add activated carbon 3g heating and be incubated 15 minutes minutes for 80-90 ℃ with water for injection with water for injection dissolving back, filter decarburization, fine straining; Add flunarizine hydrochloride and 1.2-mixed with propylene glycol liquid, stir, transfer pH3.5-5.0, the inspection of semifinished product is qualified, perfusion, and the tool plug, gland, 115 ℃/45 minutes autoclavings, lamp inspection, packing, promptly.
Because the present invention has taked technique scheme, these three kinds of preparations (salt phenol flunarizine glucose injection; The flunarizine hydrochloride sodium chloride injection; The flunarizine hydrochloride Dextrose and Sodium Chloride Inj.), through intravenous drip, for property angiopathy on every side, central or peripheral vertigo, and chronic cold type Herba Urticae Cannabinae has been examined better curative effect, be used for the treatment of acute cerebral infarction, cerebrovascular hypoperfusion and periphery extremity vascular sclerosis diseases associated, as typical case (tendency is arranged) or atypia (absence of aura) migraine, dizzy and intermittent claudication; In addition to attention weaken, memory disorder, emotional and balanced capacity obstacle etc. all have certain curative effect, through long-term stable experiment investigation, mice drug effect, pharmacological testing, steady quality, act on rapid-action rapidly, bioavailability is high, easy to use and need not consider incompatibility.
The specific embodiment:
Flunarizine hydrochloride glucose injection dosage range (bottle/include): flunarizine hydrochloride 2mg-50mg, 1.2-propylene glycol 0.1ml-10ml, glucose 1g-50g; That is: the 1. hydrochloric flunarizine 2mg-5mg of 50ml, glucose 1g-5g; 2. 100ml includes flunarizine hydrochloride 2mg-10mg, glucose 5g-10g; 3. 250ml includes flunarizine hydrochloride 5mg-25mg, glucose 12.5g-25g; 4. 500ml includes flunarizine hydrochloride 5mg-50mg, glucose 20g-50g.
With the hydrochloric flunarizine 50mg/ of 1000ml dosing amount glucose 50g specification is example explanation compound method:
Flunarizine hydrochloride 50mg, 1.2-propylene glycol 20mg, glucose 50g, add the injection water be mixed with 1000ml;
Hydrochloric flunarizine (the C of this product
26H
26F
2N
2.2HCI), with C
26H
26F
2N
2Meter should be labelled amount 90-110%: glucose (
6H
12O
6H
2O)---105%: measure 1.2-propylene glycol 20ml and put in the proportion container, take by weighing flunarizine hydrochloride 50mg and add in the proportion container and heat 60---the 80 ℃ of stirring and dissolving that should be 95 of labelled amount; Take by weighing glucose 50g and stir dilution dissolving in the adding proportion container, add to nearly full dose, add activated carbon 3g heating and be incubated 15 minutes for 80-90 ℃, filter decarburization, fine straining with water for injection with water for injection dissolving back; Add flunarizine hydrochloride and 1.2-mixed with propylene glycol liquid, stir, transfer pH3.5-5.0, the inspection of semifinished product is qualified, perfusion, and the tool plug, gland, 115 ℃/45 minutes autoclavings, lamp inspection, packing, promptly;
Preparating liquid is packed as: 1. 50ml, 2. 100ml, 3. 250ml, 4. four specifications of 500ml get final product.
Flunarizine hydrochloride sodium chloride injection dosage range (bottle/include): flunarizine hydrochloride 2mg-50mg, 1.2-propylene glycol 0.1ml-10ml, sodium chloride 0.3g-10g is a specification: the 1. hydrochloric flunarizine 2mg-5mg of 50ml, sodium chloride 0.3g-0.5g; 2. 100ml includes flunarizine hydrochloride 2mg-10mg, sodium chloride 0.5g-1g; 2. 250ml includes flunarizine hydrochloride 5mg-25mg, sodium chloride 2.25g-5g; 4. 500ml includes flunarizine hydrochloride 5mg-50mg, sodium chloride 4.5g-10g.
Flunarizine hydrochloride sodium chloride injection preparation (1000ml)
With the hydrochloric flunarizine 50mg/ of 1000ml dosing amount sodium chloride 9g specification is example explanation compound method:
Flunarizine hydrochloride 50mg, 1.2-propylene glycol 20mg, sodium chloride 9g, add the injection water be mixed with 1000ml:
Hydrochloric flunarizine (the C of this product
26H
26F
2N
2.2HCI) should be labelled amount 90-110%, sodium chloride (NaCL) should be the 95-105% of labelled amount.Method for making; Measuring 1.2-propylene glycol 20ml puts in the proportion container, take by weighing flunarizine hydrochloride 50mg and add 60-80 ℃ of stirring and dissolving of heating in the proportion container, take by weighing sodium chloride 9g and stir dilution dissolving in the adding proportion container with water for injection dissolving back, add to nearly full dose with water for injection, add 80-90 ℃ of insulation of activated carbon 3g heating 15 minutes, filter decarburization, fine straining: add flunarizine hydrochloride and 1.2-mixed with propylene glycol liquid, stir, transfer pH 3.5-5.0, the inspection of semifinished product is qualified, perfusion, the tool plug, gland, 115 ℃/45 minutes autoclavings, lamp inspection, packing, that is:
Preparating liquid is packed as: 1. 50ml, 2. 100ml, 3. 250ml, 4. four specifications of 500ml get final product.
Flunarizine hydrochloride Dextrose and Sodium Chloride Inj. dosage range (bottle/include): flunarizine hydrochloride 2mg-50mg, 1.2-propylene glycol 0.1ml-10ml, glucose 1g-50g, sodium chloride 0.3g-10g: promptly: the 1. hydrochloric flunarizine 2mg-5mg of 50ml, glucose 1g-5g, sodium chloride 03g-0.5g; 2. 100ml includes flunarizine hydrochloride 2mg-20mg, glucose 5g-10g, sodium chloride 0.5g-1g: 3. 250ml includes flunarizine hydrochloride 5mg-25mg, glucose 12.5g-25g, sodium chloride 2.25g-5g; 4. 500ml includes flunarizine hydrochloride 5mg-50mg, glucose 20g-50g, sodium chloride 4.5g-10g.
Flunarizine hydrochloride Dextrose and Sodium Chloride Inj. preparation (1000ml)
With the hydrochloric flunarizine 50mg of 1000ml dosing amount glucose 50g sodium chloride 9g specification is example explanation compound method:
Flunarizine hydrochloride 50mg, 1.2-propylene glycol 20mg, glucose 50g, sodium chloride 9g, add the injection water be mixed with 1000ml:
Hydrochloric flunarizine (the C of this product
26H
26F
2N
2.2HCI) with C
26H
26F
2N
2Meter should be labelled amount 90-110%, glucose C
6H
12O
6.H
2O should be labelled amount 95-105%: sodium chloride (NaCL) should be the 95-105% of labelled amount.Method for making: measure 1.2-propylene glycol 20ml and put in the proportion container, take by weighing flunarizine hydrochloride 50mg and add 60-80 ℃ of stirring and dissolving of heating in the proportion container; Taking by weighing glucose 50g stirs in the adding proportion container with water for injection dissolving back, take by weighing sodium chloride 9g and stir dilution dissolving in the adding proportion container, add to nearly full dose, add activated carbon 3g heating and be incubated 15 minutes minutes for 80-90 ℃ with water for injection with water for injection dissolving back, filter decarburization, fine straining; Add flunarizine hydrochloride and 1.2-mixed with propylene glycol liquid, stir, transfer pH3.5-5.0, the inspection of semifinished product is qualified, perfusion, and the tool plug, gland, 115 ℃/45 minutes autoclavings, lamp inspection, packing, promptly.
Preparating liquid is packed as: 1. 50ml, 2. 100ml, 3. 250ml, 4. four specifications of 500ml get final product.
The research of flunarizine hydrochloride infusion solutions quality standard:
(1) flunarizine hydrochloride glucose injection quality standard research:
The sterile water solution of hydrochloric flunarizine of this product and propylene glycol, glucose, hydrochloric flunarizine (C
26H
26F
2N
2.2HCI) with C
26H
26F
2N
2Meter should be labelled amount 90-110%, glucose C
6H
12O
6.H
2O should be labelled amount 95-105%;
(prescription)
Flunarizine hydrochloride 50mg
1.2-propylene glycol 20mg (2%)
Glucose 50g (5%)
Water for injection is an amount of
Be mixed with 1000ml
(character) this product is colourless or almost colourless clear liquid.
(discriminating) 1. gets this product 10ml, puts to be evaporated to driedly in the water-bath, adds ethanol 3ml, and after the jolting dissolving, 2 of hydro-oxidation potassium test solutions shake up, and add 1 of potassium permanganate test solution, and purple promptly takes off.2. get the solution under the assay item, measure, absorption maximum is arranged, minimal absorption is arranged at the wavelength place of 221 ± 2nm and 234 ± 2nm at the wavelength place of 226 ± 2nm according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000).
3. get an amount of (the being equivalent to flunarizine hydrochloride 15mg approximately) evaporate to dryness of this product, get the about 10mg of residue, show the identification (two appendix III of Chinese Pharmacopoeia version in 2000) of organic fluoride
4. get this product, slowly splash in the warm alkaline cupric tartrate test solution, promptly generate the red precipitate of Red copper oxide.
(inspection) pH value should be 3.0-5.0 (two appendix VIH of Chinese Pharmacopoeia version in 2000).
Particulate matter: getting loading amount is 1 bottle of above this product of 100ml or 100ml, checks that in accordance with the law (appendix IXC) should be up to specification.
Bacterial endotoxin: get this product, check that in accordance with the law containing the endotoxin amount among (XIE) every 1ml should be less than 0.5EU.
Other: should meet every regulation relevant under the injection item (two appendix IB of Chinese Pharmacopoeia version in 2000).
(assay) precision is measured this product an amount of (being equivalent to flunarizine hydrochloride 3mg approximately), put in the 250ml volumetric flask, shake up, (24 → 1000ml) are diluted to scale with dilute hydrochloric acid solution, shake up, measure trap according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000) at the wavelength place of 254nm, press C
26H
26F
2N
2.2HCI absorptance (E
1% 1cm) be 439 calculating, promptly.
(indication) for property angiopathy on every side, central or peripheral vertigo, and chronic cold type urticaria had better curative effect.Be used for the treatment of acute cerebral infarction, cerebrovascular hypoperfusion and periphery extremity vascular sclerosis diseases associated, as typical case (tendency is arranged) or atypia (absence of aura) migraine, dizzy and intermittent claudication; In addition to attention weaken, memory disorder, emotional and balanced capacity obstacle etc. all have certain curative effect.
(usage and dosage) intravenous drip, consumption per day 10mg---25mg
(specification) be 50ml/5mg 1.; 2. 100ml/10mg; 3. 250ml/20mg; 4. 500ml/25mg.
(storage) is airtight, and lucifuge is deposited.
(effect duration) tentative 2 years.
(2) flunarizine hydrochloride sodium chloride injection quality standard research;
This product is the sterile water solution of flunarizine hydrochloride and 1.2-propylene glycol, sodium chloride.Hydrochloric flunarizine (C
26H
26F
2N
2.2HCI) with C
26H
26F
2N
2Meter should be labelled amount 90-110%, and sodium chloride (NaCL) should be labelled amount 95-105%;
(prescription)
Flunarizine hydrochloride 50mg
1.2-propylene glycol 20mg (2%)
Sodium chloride 9g (0.9%)
Water for injection is an amount of
Be mixed with 1000ml.
(character) this product is colourless or almost colourless clear liquid.
(discriminating) 1. gets this product 10ml, puts to be evaporated to driedly in the water-bath, adds ethanol 3ml, and after the jolting dissolving, 2 of hydro-oxidation potassium test solutions shake up, and 2 of hydro-oxidation potassium test solutions shake up, and add 1 of potassium permanganate test solution, and purple promptly takes off.2. get the solution under the assay item, measure, have absorption maximum to absorb at the wavelength place of 226 ± 2nm, minimal absorption is arranged at the wavelength place of 221 ± 2nm and 234 ± 2nm according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000).
3. get an amount of (the being equivalent to flunarizine hydrochloride 15mg approximately) evaporate to dryness of this product, get the about 10mg of residue, show the identification (two appendix III of Chinese Pharmacopoeia version in 2000) of organic fluoride
4. this product shows sodium salt and muriatic identification (appendix III).
(inspection) pH value should be 3.0-5.0 (two appendix VIH of Chinese Pharmacopoeia version in 2000).Particulate matter: getting loading amount is 1 bottle of above this product of 100ml or 100ml, checks that in accordance with the law (appendix IXC) should be up to specification.Bacterial endotoxin: get this product, check that in accordance with the law containing the endotoxin amount among (XIE) every 1ml should be less than 0.5EU.
Other: should meet every regulation relevant under the injection item (two appendix 1B of Chinese Pharmacopoeia version in 2000).
(assay) precision is measured this product an amount of (being equivalent to flunarizine hydrochloride 3mg approximately), put in the 250ml volumetric flask, shake up, (24 → 1000ml) are diluted to scale with dilute hydrochloric acid solution, shake up, measure trap according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000) at the wavelength place of 254nm, press C
26H
26F
2N
2.2HCI absorptance (E
1% 1cm) be 439 calculating, promptly.
(indication) for property angiopathy on every side, central or peripheral vertigo, and chronic cold type urticaria had better curative effect.Be used for the treatment of acute cerebral infarction, cerebrovascular hypoperfusion and periphery extremity vascular sclerosis diseases associated, as typical case (tendency is arranged) or atypia (absence of aura) migraine, dizzy and intermittent claudication; In addition to attention weaken, memory disorder, emotional and balanced capacity obstacle etc. all have certain curative effect.
(usage and dosage) intravenous drip, consumption per day 10mg-25mg
(specification) be 50ml/5mg 1.; 2. 100ml/10mg; 3. 250ml/20mg; 4. 500ml/25mg.
(storage) is airtight, and lucifuge is deposited.
(effect duration) tentative 2 years.
(3) flunarizine hydrochloride Dextrose and Sodium Chloride Inj. quality standard research:
This product is the sterile water solution of flunarizine hydrochloride and 1.2-propylene glycol, sodium chloride.Hydrochloric flunarizine (C
26H
26F
2N
2.2HCI) with C
26H
26F
2N
2Meter should be labelled amount 90-110%, glucose C
6H
12O
6.H
20 should be labelled amount 95-105% sodium chloride (NaCL) should be labelled amount 95-105%;
With the hydrochloric flunarizine 20mg/ of 250ml device glucose 5% sodium chloride 0.9% specification is example explanation compound method:
(prescription)
Flunarizine hydrochloride 50mg
1.2-propylene glycol 20mg (2%)
Glucose 50g (5%)
Sodium chloride 9g (0.9%)
Water for injection is an amount of
Be mixed with 1000ml.
(character) this product is colourless or almost colourless clear liquid.
(discriminating) 1. gets this product 10ml, puts to be evaporated to driedly in the water-bath, adds ethanol 3ml, and after the jolting dissolving, 2 of hydro-oxidation potassium test solutions shake up, and add 1 of potassium permanganate test solution, and purple promptly takes off.2. get the solution under the assay item, measure, have absorption maximum to absorb at the wavelength place of 226 ± 2nm, minimal absorption is arranged at the wavelength place of 221 ± 2nm and 234 ± 2nm according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000).
3. get an amount of (the being equivalent to flunarizine hydrochloride 15mg approximately) evaporate to dryness of this product, get the about 10mg of residue, show the identification (two appendix III of Chinese Pharmacopoeia version in 2000) of organic fluoride
4. get this product, slowly splash in the warm alkaline cupric tartrate test solution, promptly generate the red precipitate of Red copper oxide.
5. this product shows sodium salt and muriatic identification (appendix III).
(inspection) pH value should be 3.0-5.0 (two appendix VIH of Chinese Pharmacopoeia version in 2000).Particulate matter: getting loading amount is 1 bottle of above this product of 100ml or 100ml, checks that in accordance with the law (appendix IXC) should be up to specification.Bacterial endotoxin: get this product, check that in accordance with the law containing the endotoxin amount among (XIE) every 1ml should be less than 0.5EU.
Other: should meet every regulation relevant under the injection item (two appendix IB of Chinese Pharmacopoeia version in 2000).
(assay) precision is measured this product an amount of (being equivalent to flunarizine hydrochloride 3mg approximately), put in the 250ml volumetric flask, shake up, (24 → 1000ml) are diluted to scale with dilute hydrochloric acid solution, shake up, measure trap according to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000) at the wavelength place of 254nm, press C
26H
26F
2N
2.2HCI absorptance (E
1% 1cm) be 439 calculating, promptly.
(indication) for property angiopathy on every side, central or peripheral vertigo, and chronic cold type urticaria had better curative effect.Be used for the treatment of acute cerebral infarction, cerebrovascular hypoperfusion and periphery extremity vascular sclerosis diseases associated, as typical case (tendency is arranged) or atypia (absence of aura) migraine, dizzy and intermittent claudication; In addition to attention weaken, memory disorder, emotional and balanced capacity obstacle etc. all have certain curative effect.
(usage and dosage) intravenous drip, consumption per day 10mg-25mg
(specification) be 50ml/5mg 1.; 2. 100ml/10mg; 3. 250ml/20mg; 4. 500ml/25mg.
(storage) is airtight, and lucifuge is deposited.
(effect duration) tentative 2 years.
Claims (3)
1, a kind of flunarizine hydrochloride high-capacity injection is pressed the 1000ml preparation, it is characterized in that by flunarizine hydrochloride 50mg, 1, and 2-propylene glycol 20mg, glucose 50g, its surplus are that water for injection is formed.
2, a kind of flunarizine hydrochloride high-capacity injection is pressed the 1000ml preparation, it is characterized in that by flunarizine hydrochloride 50mg, 1, and 2-propylene glycol 20mg, sodium chloride 9g, its surplus are that water for injection is formed.
3,, it is characterized in that the medicinal liquid of preparation is set to the standard model of 50ml, 100ml, 250ml, 500ml according to a kind of flunarizine hydrochloride high-capacity injection of claim 1 or 2.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03126391 CN1221261C (en) | 2003-09-27 | 2003-09-27 | Flunarizine hydro chloride high-capacity injecta and preparing process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03126391 CN1221261C (en) | 2003-09-27 | 2003-09-27 | Flunarizine hydro chloride high-capacity injecta and preparing process thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1528308A CN1528308A (en) | 2004-09-15 |
| CN1221261C true CN1221261C (en) | 2005-10-05 |
Family
ID=34285968
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03126391 Expired - Lifetime CN1221261C (en) | 2003-09-27 | 2003-09-27 | Flunarizine hydro chloride high-capacity injecta and preparing process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1221261C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100340240C (en) * | 2006-05-26 | 2007-10-03 | 南京虹桥医药技术研究所 | Flunarizine hydrochloride lyophilized agent for injection and its preparing method |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108324685A (en) * | 2018-04-28 | 2018-07-27 | 武汉田田药业有限公司 | A kind of production technology of flunarizine hydrochloride oral administration solution |
-
2003
- 2003-09-27 CN CN 03126391 patent/CN1221261C/en not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100340240C (en) * | 2006-05-26 | 2007-10-03 | 南京虹桥医药技术研究所 | Flunarizine hydrochloride lyophilized agent for injection and its preparing method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1528308A (en) | 2004-09-15 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1887882A (en) | Dextro lipoic amidate and its prepn | |
| CN1221261C (en) | Flunarizine hydro chloride high-capacity injecta and preparing process thereof | |
| CN1775215A (en) | Azasetron hydrochloride glucose injection formulation, and its preparing method and quality control technology | |
| CN101053587A (en) | Medicinal composition for treating tumor and preparation method and quality control method thereof | |
| CN1903846A (en) | Ornidazole derivative used for therapy, its preparation method and use | |
| CN1686127A (en) | Injection use-powder ampoule for inhibiting thrombocyte agglutination and its preparation method | |
| CN1887859A (en) | Tiopronin amidate and its prepn | |
| CN1887874A (en) | Ornidazole derivative and its prepn and use | |
| CN104940941A (en) | Montmorillonite compound slow-release preparation, metformin hydrochloride sustained release tablet and preparation method and application thereof | |
| CN1541669A (en) | Prepared traditional Chinese drug Liangfu drop pills for treating epigastric pain | |
| CN1255102C (en) | Dripping pills of compound allantoin | |
| CN100341511C (en) | Itraconazole dripping pill and its prepn | |
| CN1224386C (en) | Fumagucin injection against cancers and its preparing method | |
| CN1526379A (en) | Sibutramine hydrochloride dripping pill and its prepn | |
| CN1562001A (en) | Carbazochrome sodium sulfoate dripping pill and its preparing method | |
| CN1528302A (en) | Domperidone drop pill and preparing method thereof | |
| CN1528300A (en) | Bulleyaconitne drop pill and preparing method thereof | |
| CN1682818A (en) | Fleabane and earthworm dripping pill and its preparing method | |
| CN1868482A (en) | Aspirin slow-release tablet and its prepn. method | |
| CN1493276A (en) | Ferulaic acid sodium drip pill and its preparation method | |
| CN1568987A (en) | Dripping pills of paroxetine hydrochloride and its preparation method | |
| CN1528298A (en) | Isocarboxazid drop pill and preparing method thereof | |
| CN1528287A (en) | Herba lysionoti extract drop pill and preparing method thereof | |
| CN1582908A (en) | Tramadol hydrochloride drops and their preparation | |
| CN1526393A (en) | Hydralazine hydrochloride guttate pills and the prepn |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| ASS | Succession or assignment of patent right |
Owner name: HENAN FUSEN PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: XICHUAN PHARMACEUTICAL GROUP CO., LTD., HENAN Effective date: 20041022 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20041022 Address after: Jinhe industrial zone of Xichuan County of Henan province Fussen Pharmaceutical Co. Ltd. Applicant after: HENAN FUSEN PHARMACEUTICAL Co.,Ltd. Address before: Xichuan Henan Jinhe industrial area Henan Xichuan Pharmaceutical Group Co., Ltd. Applicant before: XICHUAN PHARMACEUTICAL GROUP Co.,Ltd. HENAN |
|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: CAO ZHANGCHENG Free format text: FORMER OWNER: HE'NAN FUSEN PHARMACEUTICAL CO., LTD. Effective date: 20110909 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20110909 Address after: Jinhe industrial zone of Xichuan County in Henan province 474450 Henan Fussen Pharmaceutical Co. Ltd. Patentee after: Cao Changcheng Address before: Jinhe industrial zone of Xichuan County in Henan province 474450 Fussen Pharmaceutical Co. Ltd. Patentee before: HENAN FUSEN PHARMACEUTICAL Co.,Ltd. |
|
| ASS | Succession or assignment of patent right |
Owner name: HE'NAN FUSEN PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: CAO CHANGCHENG Effective date: 20120329 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20120329 Address after: Jinhe industrial zone of Xichuan County in Henan province 474450 Henan Fussen Pharmaceutical Co. Ltd. Patentee after: HENAN FUSEN PHARMACEUTICAL Co.,Ltd. Address before: Jinhe industrial zone of Xichuan County in Henan province 474450 Henan Fussen Pharmaceutical Co. Ltd. Patentee before: Cao Changcheng |
|
| CX01 | Expiry of patent term |
Granted publication date: 20051005 |
|
| CX01 | Expiry of patent term |