CN1562011A - Nicardipine hydrochloride dripping pill and its preparing method - Google Patents
Nicardipine hydrochloride dripping pill and its preparing method Download PDFInfo
- Publication number
- CN1562011A CN1562011A CN 200410030365 CN200410030365A CN1562011A CN 1562011 A CN1562011 A CN 1562011A CN 200410030365 CN200410030365 CN 200410030365 CN 200410030365 A CN200410030365 A CN 200410030365A CN 1562011 A CN1562011 A CN 1562011A
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- CN
- China
- Prior art keywords
- licardipine hydrochloride
- coolant
- licardipine
- hydrochloride
- polyethylene glycol
- 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.)
- Pending
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- 239000006187 pill Substances 0.000 title claims abstract description 17
- 229960002289 nicardipine hydrochloride Drugs 0.000 title abstract 2
- AIKVCUNQWYTVTO-UHFFFAOYSA-N nicardipine hydrochloride Chemical compound Cl.COC(=O)C1=C(C)NC(C)=C(C(=O)OCCN(C)CC=2C=CC=CC=2)C1C1=CC=CC([N+]([O-])=O)=C1 AIKVCUNQWYTVTO-UHFFFAOYSA-N 0.000 title abstract 2
- 238000000034 method Methods 0.000 title description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 45
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 12
- 239000002826 coolant Substances 0.000 claims description 12
- 238000002360 preparation method Methods 0.000 claims description 12
- 238000001035 drying Methods 0.000 claims description 8
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims description 8
- 239000000843 powder Substances 0.000 claims description 8
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 6
- 229940008099 dimethicone Drugs 0.000 claims description 6
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims description 6
- 239000004205 dimethyl polysiloxane Substances 0.000 claims description 6
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 claims description 6
- 229960000502 poloxamer Drugs 0.000 claims description 6
- 229920001983 poloxamer Polymers 0.000 claims description 6
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims description 6
- 239000000758 substrate Substances 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 4
- 239000011159 matrix material Substances 0.000 claims description 4
- 239000002253 acid Substances 0.000 claims description 3
- IQXJCCZJOIKIAD-UHFFFAOYSA-N 1-(2-methoxyethoxy)hexadecane Chemical compound CCCCCCCCCCCCCCCCOCCOC IQXJCCZJOIKIAD-UHFFFAOYSA-N 0.000 claims description 2
- 239000001828 Gelatine Substances 0.000 claims description 2
- 241000238631 Hexapoda Species 0.000 claims description 2
- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- 230000001476 alcoholic effect Effects 0.000 claims description 2
- 229950009789 cetomacrogol 1000 Drugs 0.000 claims description 2
- 229920000159 gelatin Polymers 0.000 claims description 2
- 235000019322 gelatine Nutrition 0.000 claims description 2
- YQEMORVAKMFKLG-UHFFFAOYSA-N glycerine monostearate Natural products CCCCCCCCCCCCCCCCCC(=O)OC(CO)CO YQEMORVAKMFKLG-UHFFFAOYSA-N 0.000 claims description 2
- 235000011187 glycerol Nutrition 0.000 claims description 2
- 229960005150 glycerol Drugs 0.000 claims description 2
- SVUQHVRAGMNPLW-UHFFFAOYSA-N glycerol monostearate Natural products CCCCCCCCCCCCCCCCC(=O)OCC(O)CO SVUQHVRAGMNPLW-UHFFFAOYSA-N 0.000 claims description 2
- 229940057995 liquid paraffin Drugs 0.000 claims description 2
- -1 liquid paraffin Substances 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 2
- 229940093430 polyethylene glycol 1500 Drugs 0.000 claims description 2
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims description 2
- 229940080350 sodium stearate Drugs 0.000 claims description 2
- 239000008117 stearic acid Substances 0.000 claims description 2
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 2
- 239000008158 vegetable oil Substances 0.000 claims description 2
- 239000001993 wax Substances 0.000 claims description 2
- 238000010298 pulverizing process Methods 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 10
- 210000004369 blood Anatomy 0.000 description 7
- 239000008280 blood Substances 0.000 description 7
- 229940079593 drug Drugs 0.000 description 6
- 229940075507 glyceryl monostearate Drugs 0.000 description 4
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 description 4
- 238000003756 stirring Methods 0.000 description 4
- 230000036772 blood pressure Effects 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 210000004185 liver Anatomy 0.000 description 3
- 230000004060 metabolic process Effects 0.000 description 3
- 206010002383 Angina Pectoris Diseases 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 2
- 208000019505 Deglutition disease Diseases 0.000 description 2
- 206010020772 Hypertension Diseases 0.000 description 2
- 208000001647 Renal Insufficiency Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 229910001424 calcium ion Inorganic materials 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 238000004891 communication Methods 0.000 description 2
- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 201000006370 kidney failure Diseases 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 210000002464 muscle smooth vascular Anatomy 0.000 description 2
- 230000002107 myocardial effect Effects 0.000 description 2
- 210000004165 myocardium Anatomy 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 210000002700 urine Anatomy 0.000 description 2
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 102000004506 Blood Proteins Human genes 0.000 description 1
- 108010017384 Blood Proteins Proteins 0.000 description 1
- 108090000312 Calcium Channels Proteins 0.000 description 1
- 102000003922 Calcium Channels Human genes 0.000 description 1
- 229940127291 Calcium channel antagonist Drugs 0.000 description 1
- 241000282472 Canis lupus familiaris Species 0.000 description 1
- 108091006146 Channels Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 108010052164 Sodium Channels Proteins 0.000 description 1
- 102000018674 Sodium Channels Human genes 0.000 description 1
- 208000007718 Stable Angina Diseases 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 230000008485 antagonism Effects 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 210000000436 anus Anatomy 0.000 description 1
- 230000004872 arterial blood pressure Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 239000002981 blocking agent Substances 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000000480 calcium channel blocker Substances 0.000 description 1
- 230000027288 circadian rhythm Effects 0.000 description 1
- 239000003218 coronary vasodilator agent Substances 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 229940109239 creatinine Drugs 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000035487 diastolic blood pressure Effects 0.000 description 1
- 230000003205 diastolic effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 210000003608 fece Anatomy 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 208000027700 hepatic dysfunction Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000035488 systolic blood pressure Effects 0.000 description 1
- 230000009967 tasteless effect Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
A dripping pill of nicardipine hydrochloride is prepared through superfine pulverizing and conventional steps for preparing dripping pills.
Description
Technical field
The present invention relates to a kind of pharmaceutical product and preparation method thereof, specifically Licardipine Hydrochloride drop pill and preparation method thereof.
Background technology
Licardipine Hydrochloride is calcium channel blocker (slow channel blocking agent or a calcium ion antagonist), can suppress cardiac muscle and not change blood calcium concentration with the striding the film flow of calcium ions of vascular smooth muscle.Licardipine Hydrochloride has the blood vessel selectivity of height, and the calcium antagonism of vascular smooth muscle is better than effect to cardiac muscle.
Licardipine Hydrochloride expansion coronary vasodilator smooth muscle in the zoopery.Licardipine Hydrochloride can increase the motion dosis tolerata of patients with stable angina, reduces the angina pectoris attacks frequency.
Licardipine Hydrochloride reduces human peripheral blood pipe resistance, makes blood pressure drops, can reduce systolic pressure and diastolic pressure light, the moderate hypertension patient, but the circadian rhythm that does not change blood pressure changes.This acts on the hyperpietic greater than normal arterial pressure person, has the reflexive heart rate to accelerate and the myocardial contractility enhancing during blood pressure lowering.
Licardipine Hydrochloride increases cardiac ejection fraction and cardiac output, and left ventricular end diastolic presssure changes few.
Can of short duration increase natruresis.
Licardipine Hydrochloride blocks slow calcium channel and does not influence rapid sodium channels.The experiment of anesthesia Canis familiaris L. shows the Licardipine Hydrochloride coronary artery dilator and increases regional myocardial blood flow, but do not influence the chamber conduction.
The Licardipine Hydrochloride oral absorption is complete, can record this product in 20 minutes bleeding from anus, and the blood drug level peak value comes across 0.5～2 hour (average 1 hour), back of taking medicine, and takes Licardipine Hydrochloride blood drug level after the meal and reduces.Because saturated liver first pass metabolism is Nonlinear Dynamical Characteristics.The peak concentration that reaches during oral 20mg, 30mg and 40mg this product (3 times on the one) stable state is respectively 36ng/ml, 88ng/ml and 133ng/ml, and individual variation is bigger.Administration every day 3 times, blood drug level reaches stable state after 2 to 3 days, and the blood drug level during stable state is high 2 times during than single dose administration, on average eliminates 8.6 hours half-life.Bioavailability during oral 30mg Licardipine Hydrochloride stable state is 35%.The plasma protein binding rate height (＞95%) of Licardipine Hydrochloride is close between the different genera animal.In the extensive metabolism of liver, 60% discharges from urine, and 35% from the feces discharge, and detected prototype medicine is less than 1% in the urine.The medicine total amount that reclaims in 48 hours after the administration is 90%.Licardipine Hydrochloride is not induced self metabolism, does not induce the hepatomicrosome metabolic enzyme yet.Because Licardipine Hydrochloride is in the extensive metabolism of liver, the blood drug level level is subjected to the influence of changes of liver function.Serious hepatic dysfunction patient's vivo medicine concentration is higher than the normal subjects, and the half-life obviously prolongs.
(baseline serum creatinine concentration 1.2～5.5mg/dl) intravital blood drug level are higher than the health volunteer to Licardipine Hydrochloride the renal insufficiency patient.Oral 30mg (3 times on the one) is when Licardipine Hydrochloride reaches stable state, renal insufficiency patient C
MaxHigher 2 times with AUC than the health volunteer.
List marketing at present Licardipine Hydrochloride sheet, clinical hypertension and the exertional angina pectoris of being used for only arranged.
Licardipine Hydrochloride is almost tasteless, and is almost insoluble in water, and its disintegration of tablet time is long, absorption difference, bioavailability is low, and the supplementary product consumption ratio is big, child, old people, bed patient and dysphagia patients are taken inconvenience, and compliance is poor, have influenced the performance of Licardipine Hydrochloride therapeutical effect.
The present invention makes the Licardipine Hydrochloride drop pill by using ultramicro communication technique and dropping pill formulation Technology exactly, thereby overcomes the above defective of Licardipine Hydrochloride sheet, and the therapeutical effect of Licardipine Hydrochloride is given full play to.
Summary of the invention
The Licardipine Hydrochloride drop pill of making by using ultramicro communication technique and dropping pill formulation Technology not only have disintegrate molten loose fast, steady quality, the pill volume is little, both can swallow also can buccal, easy to carry and use, onset is rapid, compliance is good, be particularly suitable for the characteristics that child, old people, bed patient and dysphagia patients are taken, but also has working condition and production equipment is simple, production cost is low, compares the advantage that supplementary product consumption reduces with tablet, has demonstrated fully the new drug research exploitation spirit that people-oriented.
For achieving the above object, the present invention by the following technical solutions: the Licardipine Hydrochloride fine powder of 1 weight portion through micronizing is added in 1～10 weight portion molten matrix, fully mixing, dropping preparation method is condensed into ball in coolant, remove coolant, drying, promptly.
The chemical name of Licardipine Hydrochloride is 2 among the present invention, 6-dimethyl-4-(3-nitrobenzophenone)-1,4-dihydropyridine-3,5-dihydroxy acid, 3-[β-(N-benzyl-N-methylamino)] ethyl ester-5-carbomethoxy hydrochlorate, structural formula is
HCl, molecular formula is C
26H
29N
3O
6HCl, molecular weight are 515.99.
Substrate among the present invention includes but not limited to polyethylene glycol 6000, Macrogol 4000, polyethylene glycol 1500, cetomacrogol 1000, sodium stearate, glycerin gelatine, poloxamer, stearic acid, glycerol monostearate acid, insect wax etc.
Coolant among the present invention includes but not limited to dimethicone, liquid paraffin, vegetable oil, water, alcoholic solution etc.
Below through detecting to beneficial effect of the present invention as directed
One, detects index and method
Disintegrate (molten loosing) time limit: check according to inspection technique disintegration (two appendix X of Chinese Pharmacopoeia version in 2000 A).
Two, commercially available Licardipine Hydrochloride sheet disintegration time testing result: 60 minutes
Three, example 1 sample disintegrate (molten loosing) time detecting result: 3 minutes
Four, example 2 sample disintegrates (molten loosing) time detecting result: 2 minutes
Five, example 3 sample disintegrates (molten loosing) time detecting result: 4 minutes
Six, example 4 sample disintegrates (molten loosing) time detecting result: 6 minutes
Seven, example 5 sample disintegrates (molten loosing) time detecting result: 5 minutes
Eight, example 6 sample disintegrates (molten loosing) time detecting result: 9 minutes
The specific embodiment
One, example 1
Prescription:
Licardipine Hydrochloride 5g
Polyethylene glycol 6000 15g
Make 1000
Method for making: the Licardipine Hydrochloride fine powder that the micronizing of learning from else's experience is crossed 200 mesh sieves is added in the fused polyethylene glycol 6000 substrate, stirs evenly, and with the dimethicone coolant, the dropping preparation method pill, drying, promptly.
Two, example 2
Prescription:
Licardipine Hydrochloride 5g
Macrogol 4000 15g
Make 1000
Method for making: the Licardipine Hydrochloride fine powder that the micronizing of learning from else's experience is crossed 200 mesh sieves is added in the fused Macrogol 4000 substrate, stirs evenly, and with the dimethicone coolant, the dropping preparation method pill, drying, promptly.
Three, example 3
Prescription:
Licardipine Hydrochloride 5g
Polyethylene glycol 6000 5g
Macrogol 4000 10g
Make 1000
Method for making: the Licardipine Hydrochloride fine powder that the micronizing of learning from else's experience is crossed 200 mesh sieves is added in fused Macrogol 4000 and the polyethylene glycol 6000 mixed-matrix, stirs evenly, and with the dimethicone coolant, the dropping preparation method pill, drying, promptly.
Four, example 4
Prescription:
Licardipine Hydrochloride 5g
Glyceryl monostearate 15g
Make 1000
Method for making: the Licardipine Hydrochloride fine powder that the micronizing of learning from else's experience is crossed 200 mesh sieves is added in the fused glyceryl monostearate substrate, and mixing is a coolant with the frozen water, the dropping preparation method pill, and drying, promptly.
Five, example 5
Prescription:
Licardipine Hydrochloride 5g
Polyethylene glycol 6000 10g
Poloxamer 5g
Make 1000
Method for making: the Licardipine Hydrochloride fine powder that the micronizing of learning from else's experience is crossed 200 mesh sieves is added in fused polyethylene glycol 6000 and the poloxamer mixed-matrix, stirs evenly, and with the dimethicone coolant, the dropping preparation method pill, drying, promptly.
Six, example 6
Prescription:
Licardipine Hydrochloride 5g
Glyceryl monostearate 15g
Poloxamer 1g
Make 1000
Method for making: get the mixing fine powders that Licardipine Hydrochloride and poloxamer cross 200 mesh sieves through micronizing and be added in the fused glyceryl monostearate substrate, mixing is a coolant with the frozen water, the dropping preparation method pill, and drying, promptly.
Claims (4)
1. Licardipine Hydrochloride drop pill and preparation method thereof is characterized in that: the Licardipine Hydrochloride fine powder of 1 weight portion through micronizing is added in 1～10 weight portion molten matrix, fully mixing, dropping preparation method is condensed into ball in coolant, remove coolant, drying, promptly.
2. the molecular formula of the described Licardipine Hydrochloride of claim 1 is C
26H
29N
3O
6HCl, molecular weight are 515.99, and structural formula is
HCl.
3. the described substrate of claim 1 includes but not limited to polyethylene glycol 6000, Macrogol 4000, polyethylene glycol 1500, cetomacrogol 1000, sodium stearate, glycerin gelatine, poloxamer, stearic acid, glycerol monostearate acid, insect wax etc.
4. the described coolant of claim 1 includes but not limited to dimethicone, liquid paraffin, vegetable oil, water, alcoholic solution etc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410030365 CN1562011A (en) | 2004-03-29 | 2004-03-29 | Nicardipine hydrochloride dripping pill and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410030365 CN1562011A (en) | 2004-03-29 | 2004-03-29 | Nicardipine hydrochloride dripping pill and its preparing method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1562011A true CN1562011A (en) | 2005-01-12 |
Family
ID=34481092
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410030365 Pending CN1562011A (en) | 2004-03-29 | 2004-03-29 | Nicardipine hydrochloride dripping pill and its preparing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1562011A (en) |
-
2004
- 2004-03-29 CN CN 200410030365 patent/CN1562011A/en active Pending
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |