CN1602851A - Dripping pills of benactyzine hydrochloride and its preparation - Google Patents
Dripping pills of benactyzine hydrochloride and its preparation Download PDFInfo
- Publication number
- CN1602851A CN1602851A CNA2004100553415A CN200410055341A CN1602851A CN 1602851 A CN1602851 A CN 1602851A CN A2004100553415 A CNA2004100553415 A CN A2004100553415A CN 200410055341 A CN200410055341 A CN 200410055341A CN 1602851 A CN1602851 A CN 1602851A
- Authority
- CN
- China
- Prior art keywords
- benactyzine
- benactyzine hydrochloride
- preparation
- coolant
- 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.)
- Pending
Links
- 239000006187 pill Substances 0.000 title claims abstract description 17
- ZEEXVYNJSAWEML-UHFFFAOYSA-N 3-[4-(4-methylphenyl)sulfanyl-3-nitrophenyl]prop-2-enoic acid Chemical compound C1=CC(C)=CC=C1SC1=CC=C(C=CC(O)=O)C=C1[N+]([O-])=O ZEEXVYNJSAWEML-UHFFFAOYSA-N 0.000 title claims description 28
- 229960001377 benactyzine hydrochloride Drugs 0.000 title claims description 28
- 238000002360 preparation method Methods 0.000 title claims description 13
- 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
- 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
- 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
- 239000002253 acid Substances 0.000 claims description 2
- 230000001476 alcoholic effect Effects 0.000 claims description 2
- 235000010290 biphenyl Nutrition 0.000 claims description 2
- 239000004305 biphenyl Substances 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
- ZUOUZKKEUPVFJK-UHFFFAOYSA-N phenylbenzene Natural products C1=CC=CC=C1C1=CC=CC=C1 ZUOUZKKEUPVFJK-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
- 239000000126 substance 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
- 238000005516 engineering process Methods 0.000 abstract description 4
- 230000000694 effects Effects 0.000 abstract description 2
- DBGIVFWFUFKIQN-UHFFFAOYSA-N (+-)-Fenfluramine Chemical compound CCNC(C)CC1=CC=CC(C(F)(F)F)=C1 DBGIVFWFUFKIQN-UHFFFAOYSA-N 0.000 abstract 1
- IVQOFBKHQCTVQV-UHFFFAOYSA-N 2-hydroxy-2,2-diphenylacetic acid 2-(diethylamino)ethyl ester Chemical compound C=1C=CC=CC=1C(O)(C(=O)OCCN(CC)CC)C1=CC=CC=C1 IVQOFBKHQCTVQV-UHFFFAOYSA-N 0.000 abstract 1
- 229960001498 benactyzine Drugs 0.000 abstract 1
- 230000003247 decreasing effect Effects 0.000 abstract 1
- 230000009748 deglutition Effects 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 229960001582 fenfluramine Drugs 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 230000009747 swallowing Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 description 10
- 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
- 208000019505 Deglutition disease Diseases 0.000 description 2
- 238000004891 communication Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 208000007101 Muscle Cramp Diseases 0.000 description 1
- 208000005392 Spasm Diseases 0.000 description 1
- 208000007107 Stomach Ulcer Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 230000027119 gastric acid secretion Effects 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 230000009278 visceral effect Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention uses super micro shattering and benactyzine drop pills producing the technology to produce fenfluramine drop pills, reaching the purposes such as increasing speed, and dissolution of disintegration, increasing the medicine stability, reducing the dose of auxiliary materials and decreasing cost, with rapid effect and convenient use. It can be buccal as well as deglutition, has remarkable conformity, and is especially suitable for children, older man, sicker in bed or with difficulty of swallowing.
Description
Technical field
The present invention relates to a kind of pharmaceutical product and preparation method thereof, specifically benactyzine hydrochloride drop pill and preparation method thereof.
Background technology
Benactyzine hydrochloride has the visceral smooth muscle of alleviation spasm, reduces gastric acid secretion, the stable effect of maincenter.List marketing at present tablet, clinical gastric and duodenal ulcers, the cramps of gastrointestinal tract etc. of being used for are only arranged.
The benactyzine hydrochloride bitter in the mouth dissolves in water, but its disintegration of tablet time is longer, 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 benactyzine hydrochloride therapeutical effect.
The present invention makes the benactyzine hydrochloride drop pill by using ultramicro communication technique and dropping pill formulation Technology exactly, thereby overcomes the above defective of benactyzine hydrochloride sheet, and the therapeutical effect of benactyzine hydrochloride is given full play to.
Summary of the invention
The benactyzine 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, and is easy to carry and use, and 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 have working condition and production equipment is simple, production cost is low, compare the advantage that supplementary product consumption reduces with tablet, 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 benactyzine hydrochloride fine powder of 1 weight portion through micronizing is added in 5～30 weight portion molten matrix, fully mixing, dropping preparation method is condensed into ball in coolant, remove coolant, drying, promptly.
The chemical name of benactyzine hydrochloride is a 2-diethylamino ethyl diphenyl oxyacetate hydrochlorate among the present invention, and structural formula is
Molecular formula is C
20H
25NO
3Hcl, molecular weight are 363.9.
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 XA of Chinese Pharmacopoeia version in 2000).
Two, commercially available benactyzine hydrochloride sheet disintegration time testing result: 32 minutes
Three, example 1 sample disintegrate (molten loosing) time detecting result: 2 minutes
Four, example 2 sample disintegrates (molten loosing) time detecting result: 2 minutes
Five, example 3 sample disintegrates (molten loosing) time detecting result: 3 minutes
Six, example 4 sample disintegrates (molten loosing) time detecting result: 3 minutes
Seven, example 5 sample disintegrates (molten loosing) time detecting result: 4 minutes
Eight, example 6 sample disintegrates (molten loosing) time detecting result: 5 minutes
The specific embodiment
One, example 1
Prescription:
Benactyzine hydrochloride 1g
Polyethylene glycol 6000 19g
Make 1000
Method for making: the benactyzine 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:
Benactyzine hydrochloride 1g
Macrogol 4000 19g
Make 1000
Method for making: the benactyzine 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:
Benactyzine hydrochloride 1g
Polyethylene glycol 6000 12g
Macrogol 4000 7g
Make 1000
Method for making: the benactyzine 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:
Benactyzine hydrochloride 1g
Glyceryl monostearate 19g
Make 1000
Method for making: the benactyzine 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:
Benactyzine hydrochloride 1g
Polyethylene glycol 6000 12g
Poloxamer 7g
Make 1000
Method for making: the benactyzine 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:
Benactyzine hydrochloride 1g
Glyceryl monostearate 17g
Poloxamer 2g
Make 1000
Method for making: get the mixing fine powders that benactyzine 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. benactyzine hydrochloride drop pill and preparation method thereof is characterized in that: the benactyzine hydrochloride fine powder of 1 weight portion through micronizing is added in 5～30 weight portion molten matrix, fully mixing, dropping preparation method is condensed into ball in coolant, remove coolant, drying, promptly.
2. the chemical name of the described benactyzine hydrochloride of claim 1 is a 2-diethylamino ethyl diphenyl oxyacetate hydrochlorate, and structural formula is
, molecular formula is C
20H
25NO
3Hcl, molecular weight are 363.9.
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 |
|---|---|---|---|
| CNA2004100553415A CN1602851A (en) | 2004-08-23 | 2004-08-23 | Dripping pills of benactyzine hydrochloride and its preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2004100553415A CN1602851A (en) | 2004-08-23 | 2004-08-23 | Dripping pills of benactyzine hydrochloride and its preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1602851A true CN1602851A (en) | 2005-04-06 |
Family
ID=34666173
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2004100553415A Pending CN1602851A (en) | 2004-08-23 | 2004-08-23 | Dripping pills of benactyzine hydrochloride and its preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1602851A (en) |
-
2004
- 2004-08-23 CN CNA2004100553415A patent/CN1602851A/en active Pending
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Legal Events
| 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 |