CN1493280A - Mezereum drip pill and its preparation method - Google Patents
Mezereum drip pill and its preparation method Download PDFInfo
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- CN1493280A CN1493280A CNA031591957A CN03159195A CN1493280A CN 1493280 A CN1493280 A CN 1493280A CN A031591957 A CNA031591957 A CN A031591957A CN 03159195 A CN03159195 A CN 03159195A CN 1493280 A CN1493280 A CN 1493280A
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- daphnetin
- preparation
- coolant
- polyethylene glycol
- dissolution
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Abstract
A dripping pill of daphnetin and its superfine pulverizing process for preparing it are disclosed. Its advantages are high dissolving and disintegrating speed, high stripping percentage, quickly taking its effect and low cost.
Description
Technical field
The present invention relates to a kind of pharmaceutical product and preparation method thereof, specifically drop pills of daphnetin and preparation method thereof.
Background technology
Daphnetin has the expansion coronary vasodilator, and coronary blood flow increasing reduces myocardial oxygen consumption, improves myocardial metabolism, promotes cardiac function to recover, and expands peripheral vessel and anti-artery thrombosis and suppresses the platelet aggregation effect; And excited hypophysis---the antiinflammatory action of interrenal system arranged.
Daphnetin is distributed more widely in vivo, wherein the highest with kidney after absorbing, and is lung, spleen, blood plasma secondly, and main excretion pathway is a kidney.The clinical auxiliary treatment that is used for thromboangiitis obliterans and other obliterative vascular diseases and coronary heart disease.
Daphnetin is insoluble in water, odorless, tasteless, list marketing at present have only the daphnetin capsule, not only dosage form is single, and because daphnetin is water insoluble, hydrophobicity is strong, makes capsular dissolution of daphnetin and dissolution rate 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 daphnetin therapeutical effect.
The present invention makes the drop pills of daphnetin agent by using ultramicro communication technique and dropping pill formulation Technology exactly, thereby overcomes the capsular above defective of daphnetin, and the therapeutical effect of daphnetin is given full play to.
Summary of the invention
The drop pills of daphnetin 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 capsule, 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 daphnetin 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 chemical name of daphnetin among the present invention (Daphnelin) is 7, the 8-dihydroxycoumarin, and molecular formula is C
9H
6O
4, molecular weight is 178.4.
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), (9 → 1000ml) 1000ml are solvent with hydrochloric acid solution, rotating speed is that per minute 100 changes, operation in the time of 5,10,20,30 and 45 minutes, is got solution 10ml in accordance with the law, filter, subsequent filtrate is as need testing solution.It is an amount of that other gets the daphnetin reference substance, with above-mentioned dissolve with hydrochloric acid solution and dilution, product solution in contrast.Get above-mentioned two kinds of solution,, measure trap, calculate stripping quantity at the wavelength place of 323nm according to spectrophotography (two IV A of Chinese Pharmacopoeia version in 2000).
Two, commercially available daphnetin capsule testing result
1. disintegration time: 52 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 20.5 34.6 49.8 69.4 80.3
Three, example 1 sample detection result
1. the molten diffusing time: 6 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 62.5 85.6 98.7 98.9 99.2
Four, example 2 sample detection results
1. the molten diffusing time: 5 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 71.3 89.6 99.7 99.2 99.3
Five, example 3 sample detection results
1. the molten diffusing time: 6 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 73.4 91.4 100.0 99.2 99.3
Six, example 4 sample detection results
1. the molten diffusing time: 12 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 49.5 68.9 95.6 99.7 99.1
Seven, example 5 sample detection results
1. the molten diffusing time: 7 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 64.5 82.3 93.4 99.1 99.7
Eight, example 6 sample detection results
1. the molten diffusing time: 13 minutes
2. dissolution rate
Time (minute) 5 10 20 30 45
Dissolution (%) 50.2 65.4 88.6 99.8 98.6
The specific embodiment
One, example 1
Prescription:
Daphnetin 5g
Polyethylene glycol 6000 15g
Make 1000
Make 1000
Method for making: the daphnetin 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:
Daphnetin 5g
Polyethylene glycol 6000 5g
Macrogol 4000 10g
Make 1000
Method for making: the daphnetin 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:
Daphnetin 5g
Glyceryl monostearate 15g
Make 1000
Method for making: the daphnetin 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:
Daphnetin 5g
Polyethylene glycol 6000 10g
Poloxamer 5g
Make 1000
Method for making: the daphnetin 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:
Daphnetin 5g
Glyceryl monostearate 15g
Poloxamer 1g
Make 1000
Method for making: get the mixing fine powders that daphnetin 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. drop pills of daphnetin and preparation method thereof is characterized in that: the daphnetin 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. its chemical name of the described daphnetin of claim 1 is 7, the 8-dihydroxycoumarin, and molecular formula is C
9H
6O
4, molecular weight is 178.4.
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 |
|---|---|---|---|
| CNA031591957A CN1493280A (en) | 2003-09-10 | 2003-09-10 | Mezereum drip pill and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031591957A CN1493280A (en) | 2003-09-10 | 2003-09-10 | Mezereum drip pill and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1493280A true CN1493280A (en) | 2004-05-05 |
Family
ID=34240931
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031591957A Pending CN1493280A (en) | 2003-09-10 | 2003-09-10 | Mezereum drip pill and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1493280A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1872053B (en) * | 2005-06-01 | 2010-11-03 | 天津天士力制药股份有限公司 | Drop pills of daphnetin, and preparation method |
-
2003
- 2003-09-10 CN CNA031591957A patent/CN1493280A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1872053B (en) * | 2005-06-01 | 2010-11-03 | 天津天士力制药股份有限公司 | Drop pills of daphnetin, and preparation method |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |