CN1526385A - Ditropan hydrochloride dripping pills and the prepn process - Google Patents
Ditropan hydrochloride dripping pills and the prepn process Download PDFInfo
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- CN1526385A CN1526385A CNA031595545A CN03159554A CN1526385A CN 1526385 A CN1526385 A CN 1526385A CN A031595545 A CNA031595545 A CN A031595545A CN 03159554 A CN03159554 A CN 03159554A CN 1526385 A CN1526385 A CN 1526385A
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- ditropan
- coolant
- polyethylene glycol
- hydrochloride
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Abstract
The present invention is Ditropan hydrochloride dripping pill prepared through superfine crushing and dripping pill producing process. The Ditropan hydrochloride dripping pill has raised disintegrating and dissolving speed, high digestion rate and digestion degree, fast acting, high stability, reduced supplementary material consumption, low production cost and easy carrying about and taking. It may be haven in mouth or swallowed, has excellent conformity and is especially suitable for children, the aged and other patients with dysphagia.
Description
Technical field
The present invention relates to a kind of pharmaceutical product and preparation method thereof, specifically ditropan XL drop pill and preparation method thereof.
Background technology
Ditropan XL (Oxybutynin Hydrochloride) is an anticholinergic agent, odorless, dissolve in water, its disintegration of tablet 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 ditropan XL therapeutical effect.
The present invention makes the ditropan XL drop pill by using ultramicro communication technique and dropping pill formulation Technology exactly, thereby overcomes the above defective of ditropan XL sheet, and the therapeutical effect of ditropan XL is given full play to.
Summary of the invention
The ditropan XL drop 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 ditropan XL 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 ditropan XL is (±)-α-cyclohexyl-Alpha-hydroxy-phenylacetic acid-4-lignocaine-2-butyne ester hydrochloride among the present invention, and molecular formula is C
22H
31NO
3HCl, molecular weight are 393.95, and structural formula is
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 first methods of Chinese Pharmacopoeia version in 2000), is a solvent with water 900ml, Revolution Per Minute 50 changes, and operation in accordance with the law is in the time of 5,10,20,30 and 45 minutes, filter, get subsequent filtrate as need testing solution.It is an amount of that other gets the ditropan XL reference substance, adds water and make the solution product solution in contrast that contains 5.6 μ g among every 1ml approximately; Precision is measured each 20 μ l of above-mentioned two kinds of solution, put in the separatory funnel respectively, respectively add bromocresol green solution and [get bromocresol green 0.2g, add 0.05mol/L sodium hydroxide solution 50ml and make dissolving, add phosphate buffer (pH2.8) 200ml again, regulate pH value to 2.8 with phosphoric acid in case of necessity] 2.0ml and chloroform 10.0ml, jolting 3 minutes, placed 1 hour, get chloroform solution respectively, according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 B), at the wavelength place of 415nm, measure respectively and absorb the calculating stripping quantity.
Two, commercially available ditropan XL sheet testing result
1. disintegration time: 45 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 21.3 35.5 49.6 75.4 82.5
Three, example 1 sample detection result
1. the molten diffusing time: 3 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 61.4 93.5 97.8 99.6 98.1
Four, example 2 sample detection results
1. the molten diffusing time: 4 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 52.4 85.6 98.7 99.6 100.2
Five, example 3 sample detection results
1. the molten diffusing time: 6 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 50.3 79.6 97.5 96.4 98.2
Six, example 4 sample detection results
1. the molten diffusing time: 10 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 45.7 72.5 93.4 98.6 97.2
Seven, example 5 sample detection results
1. the molten diffusing time: 9 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 41.3 74.6 89.5 98.7 97.2
Eight, example 6 sample detection results
1. the molten diffusing time: 15 minutes
2. dissolution rate
Time (minute) 5 10 20 30 45
Dissolution (%) 42.3 71.5 85.4 96.5 97.8
The specific embodiment
One, example 1
Prescription:
Ditropan XL 5g
Polyethylene glycol 6000 15g
Make 1000
Method for making: the ditropan XL 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:
Ditropan XL 5g
Macrogol 4000 15g
Make 1000
Method for making: the ditropan XL 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:
Ditropan XL 5g
Polyethylene glycol 6000 5g
Macrogol 4000 10g
Make 1000
Method for making: the ditropan XL 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:
Ditropan XL 5g
Glyceryl monostearate 15g
Make 1000
Method for making: the ditropan XL fine powder that the micronizing of learning from else's experience is crossed 200 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:
Ditropan XL 5g
Polyethylene glycol 6000 10g
Poloxamer 5g
Make 1000
Method for making: the ditropan XL 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:
Ditropan XL 5g
Glyceryl monostearate 15g
Poloxamer 1g
Make 1000
Method for making: get the mixing fine powders that ditropan XL 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. ditropan XL drop pill and preparation method thereof is characterized in that: the ditropan XL 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 ditropan XL of claim 1 is C
22H
31NO
3HCl, molecular weight are 393.95, and structural formula is
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 |
|---|---|---|---|
| CNA031595545A CN1526385A (en) | 2003-09-23 | 2003-09-23 | Ditropan hydrochloride dripping pills and the prepn process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031595545A CN1526385A (en) | 2003-09-23 | 2003-09-23 | Ditropan hydrochloride dripping pills and the prepn process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1526385A true CN1526385A (en) | 2004-09-08 |
Family
ID=34287329
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031595545A Pending CN1526385A (en) | 2003-09-23 | 2003-09-23 | Ditropan hydrochloride dripping pills and the prepn process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1526385A (en) |
-
2003
- 2003-09-23 CN CNA031595545A patent/CN1526385A/en active Pending
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| WD01 | Invention patent application deemed withdrawn after publication |