CN1528302A - Domperidone drop pill and preparing method thereof - Google Patents
Domperidone drop pill and preparing method thereof Download PDFInfo
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- CN1528302A CN1528302A CNA2003101009096A CN200310100909A CN1528302A CN 1528302 A CN1528302 A CN 1528302A CN A2003101009096 A CNA2003101009096 A CN A2003101009096A CN 200310100909 A CN200310100909 A CN 200310100909A CN 1528302 A CN1528302 A CN 1528302A
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- domperidone
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- polyethylene glycol
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Abstract
The present invention utilizes ultramicropulverization and dripping pill preparation production process to make domperiodine dripping pills, and can attain the goal of raising disintegration and dissolution speed, quickly obtaining therapeutic effect, raising stability of medicine, reducing dose of auxiliary material, reducing production cost and convenient administration. Said pill not only can be sucked, but also can be swallowed, and its compliance property is good.
Description
Technical field
The present invention relates to a kind of pharmaceutical product and preparation method thereof, specifically domperidone drip pill and preparation method thereof.
Background technology
Domperidone is a periphery dopamine receptor blocade, directly act on gastrointestinal wall, can increase esophagus bottom sphincter tone, prevent stomach-esophageal reflux, strengthen gastric peristalsis, promote gastric emptying, coordinate the motion of stomach and duodenum, suppress to feel sick, vomit, and can prevent bile reflux effectively, do not influence gastric secretion.Domperidone is difficult for by blood-cerebrospinal fluid barrier, and to dopamine receptor unrestraint effect in the brain, therefore, no extrapyramidal system etc. are neural, spiritual untoward reaction.
The oral post-absorption of domperidone is rapid, but 15～30 minutes peaking blood drug level.Distribution is the highest with the gastrointestinal local drug concentration, and blood plasma takes second place, and does not almost have in the brain.Domperidone is almost all at intrahepatic metabolism, half-life (t
1/2) be 7 hours, be 31.23% by the urine excretion total amount, the original shape medicine accounts for 0.4%; Defecate total amount 65.7%, the original shape medicine accounts for 10%.
Clinical being used for: 1. alleviate by gastric emptying delays, gastrointestinal tract instead flows, esophagitis causes indigestion symptom as: epigastrium feeling of distension and oppression sense, abdominal distention, Upper abdominal pain, belch, flatulence, mouthful have or do not have the stomach burn feeling of anti-stream gastric content.
2. treat that functional, organic, infectious, diet, radiation treatment or chemotherapy are causedly felt sick, vomiting.
The domperidone tablet disintegration time is long, and dissolution and dissolution rate are low, absorption difference, bioavailability is low, and the supplementary product consumption ratio is big, and child, old people, bed patient and dysphagia patients are taken inconvenience, compliance is poor, has influenced the performance of domperidone therapeutical effect.
The present invention makes the domperidone drip pill agent by using ultramicro communication technique and dropping pill formulation Technology exactly, thereby overcomes the above defective of domperidone tablet, and the therapeutical effect of domperidone is given full play to.
Summary of the invention
The domperidone drip pill of making by using ultramicro communication technique and dropping pill formulation Technology not only have disintegrate molten loose fast, dissolution and dissolution rate improve, 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 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 domperidone fine powder of 1 weight portion through micronizing is added in 1～10 weight portion molten matrix, abundant mixing, dropping preparation method is condensed into ball in coolant, remove coolant, drying, promptly.
The molecular formula of domperidone among the present invention (Duopanlitong) is C
22H
24ClN
5O
2
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
1. disintegrate (molten loosing) time limit: check according to inspection technique disintegration (two appendix XA of Chinese Pharmacopoeia version in 2000).
2. dissolution rate: sample thief, according to dissolution method (two appendix XC second methods of Chinese Pharmacopoeia version in 2000), with sodium chloride 2g, add water and make dissolving in right amount, add hydrochloric acid 7ml, thin up is to 1000ml again, shake up, getting 500ml is solvent, and rotating speed is that per minute 100 changes, operation in accordance with the law, in the time of 10,20,30,40,50 minutes, it is an amount of to get solution, filters, and filtrate is as need testing solution.It is an amount of that other gets the domperidone reference substance, adds methanol and make the solution that contains 1mg among every 1ml, and precision is measured 1ml, puts in the 50ml measuring bottle, adds above-mentioned solvent dilution to scale, shakes up, in contrast product solution.According to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A), measure trap respectively at the wavelength place of 284nm, calculate stripping quantity.
Two, commercially available domperidone tablet testing result
1. disintegration time: 53 minutes
2. dissolution rate:
Time (minute) 10 20 30 40 50
Dissolution (%) 26.4 57.2 73.6 85.3 94.1
Three, example 1 sample detection result
1. the molten diffusing time: 3 minutes
2. dissolution rate:
Time (minute) 10 20 30 40 50
Dissolution (%) 41.4 73.6 96.7 98.3 99.2
Four, example 2 sample detection results
1. the molten diffusing time: 3 minutes
2. dissolution rate:
Time (minute) 10 20 30 40 50
Dissolution (%) 45.6 78.4 95.2 97.3 98.1
Five, example 3 sample detection results
1. the molten diffusing time: 3 minutes
2. dissolution rate:
Time (minute) 10 20 30 40 50
Dissolution (%) 49.5 74.6 96.7 99.8 101.2
Six, example 4 sample detection results
1. the molten diffusing time: 5 minutes
2. dissolution rate:
Time (minute) 10 20 30 40 50
Dissolution (%) 41.2 69.4 92.3 99.6 98.9
Seven, example 5 sample detection results
1. the molten diffusing time: 7 minutes
2. dissolution rate:
Time (minute) 10 20 30 40 50
Dissolution (%) 37.4 65.3 88.2 96.4 99.1
Eight, example 6 sample detection results
1. the molten diffusing time: 10 minutes
2. dissolution rate
Time (minute) 10 20 30 40 50
Dissolution (%) 33.1 57.6 84.2 96.4 98.9
The specific embodiment
One, example 1
Prescription:
Domperidone 5g
Polyethylene glycol 6000 15g
Make 1000
Method for making: the domperidone 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:
Domperidone 5g
Macrogol 4000 15g
Make 1000
Method for making: the domperidone 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:
Domperidone 5g
Polyethylene glycol 6000 5g
Macrogol 4000 10g
Make 1000
Method for making: the domperidone 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:
Domperidone 5g
Glyceryl monostearate 15g
Make 1000
Method for making: the domperidone 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:
Domperidone 5g
Polyethylene glycol 6000 10g
Poloxamer 5g
Make 1000
Method for making: the domperidone 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:
Domperidone 5g
Glyceryl monostearate 15g
Poloxamer 1g
Make 1000
Method for making: get the mixing fine powders that domperidone 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. domperidone drip pill and preparation method thereof is characterized in that: the domperidone fine powder of 1 weight portion through micronizing is added in 1～10 weight portion molten matrix, and abundant mixing, dropping preparation method is condensed into ball in coolant, remove coolant, drying, promptly.
2. the molecular formula of the described domperidone Duopanlitong of claim 1 is C
22H
24ClN
5O
2
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 |
|---|---|---|---|
| CNA2003101009096A CN1528302A (en) | 2003-10-08 | 2003-10-08 | Domperidone drop pill and preparing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2003101009096A CN1528302A (en) | 2003-10-08 | 2003-10-08 | Domperidone drop pill and preparing method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1528302A true CN1528302A (en) | 2004-09-15 |
Family
ID=34304102
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2003101009096A Pending CN1528302A (en) | 2003-10-08 | 2003-10-08 | Domperidone drop pill and preparing method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1528302A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100435795C (en) * | 2006-02-27 | 2008-11-26 | 南京长澳医药科技有限公司 | Micro-powder dom peridone maleate medicinal composition and its preparing method |
-
2003
- 2003-10-08 CN CNA2003101009096A patent/CN1528302A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100435795C (en) * | 2006-02-27 | 2008-11-26 | 南京长澳医药科技有限公司 | Micro-powder dom peridone maleate medicinal composition and its preparing method |
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