CN1528286A - Soybean aglycone drop pill and preparing method thereof - Google Patents
Soybean aglycone drop pill and preparing method thereof Download PDFInfo
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- CN1528286A CN1528286A CNA031433383A CN03143338A CN1528286A CN 1528286 A CN1528286 A CN 1528286A CN A031433383 A CNA031433383 A CN A031433383A CN 03143338 A CN03143338 A CN 03143338A CN 1528286 A CN1528286 A CN 1528286A
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- daidzein
- coolant
- polyethylene glycol
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Abstract
The present invention utilizes ultramicropulverization and dripping pill preparation production process to make soybean aglycone 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 drop pills of soybean aglycone and preparation method thereof.
Background technology
Daidzein has coronary artery dilator, femoral artery, cerebral arteries, the cerebral blood flow increasing amount, strengthen the circulation of extremity blood flow, reduce blood viscosity, weaken vascular resistance, reduce myocardial oxygen consumption, improve cardiac function, strengthen microcirculation, increase end blood flow slightly, hemorheology is changed, blood pressure lowering, improve rhythm of the heart effect.List marketing at present tablet and capsule arranged, the clinical auxiliary treatment that is used for hypertension and symptomatic hypertension, coronary heart disease, cerebral thrombosis, vertigo, sudden deafness.Also can be used for menopausal syndrome.
The daidzein odorless, tasteless, almost insoluble in water, its tablet and capsule disintegration time are 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 daidzein therapeutical effect.
The present invention makes the drop pills of soybean aglycone agent by using ultramicro communication technique and dropping pill formulation Technology exactly, thereby overcomes daidzein sheet and capsular above defective, and the therapeutical effect of daidzein is given full play to.
Summary of the invention
The drop pills of soybean aglycone 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 child, the old people, the characteristics that 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 or 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 daidzein 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.
Among the present invention the chemical name of daidzein be 4 ', the 7-dihydroxy isoflavone, molecular formula is C
15H
10O
4, molecular weight is 254.24, 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), be solvent with water 1000ml, rotating speed is that per minute 150 changes, operation in accordance with the law, in the time of 5,10,20,30 and 45 minutes, to get solution and filter in right amount, precision is measured subsequent filtrate 2ml, thin up is to 10ml, shake up,, measure trap at the wavelength place of 249nm according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A); Other gets the about 12mg of daidzein reference substance, accurate claims surely, puts in the 50ml measuring bottle, adds anhydrous alcohol solution, and is diluted to scale, shakes up, and precision is measured 2ml and put in the 100ml measuring bottle, and thin up is measured trap to scale with method, calculates stripping quantity.
Two, commercially available daidzein sheet testing result
1. disintegration time: 57 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 21.2 35.6 51.3 69.4 78.3
Three, example 1 sample detection result
1. the molten diffusing time: 6 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 45.2 62.3 89.4 99.7 101.3
Four, example 2 sample detection results
1. the molten diffusing time: 4 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 41.4 63.5 87.2 98.6 99.7
Five, example 3 sample detection results
1. the molten diffusing time: 6 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 42.3 67.5 90.4 98.6 97.5
Six, example 4 sample detection results
1. the molten diffusing time: 10 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 38.6 61.4 85.3 97.7 98.9
Seven, example 5 sample detection results
1. the molten diffusing time: 11 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 36.4 58.5 82.3 99.7 98.6
Eight, example 6 sample detection results
1. the molten diffusing time: 17 minutes
2. dissolution rate
Time (minute) 5 10 20 30 45
Dissolution (%) 35.4 52.3 81.5 95.6 98.9
The specific embodiment
One, example 1
Prescription:
Daidzein 5g
Polyethylene glycol 6000 15g
Make 1000
Method for making: the daidzein 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:
Daidzein 5g
Macrogol 4000 15g
Make 1000
Method for making: the daidzein 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:
Daidzein 5g
Polyethylene glycol 6000 5g
Macrogol 4000 10g
Make 1000
Method for making: the daidzein 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:
Daidzein 5g
Glyceryl monostearate 15g
Make 1000
Method for making: the daidzein 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:
Daidzein 5g
Polyethylene glycol 6000 10g
Poloxamer 5g
Make 1000
Method for making: the daidzein 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:
Daidzein 5g
Glyceryl monostearate 15g
Poloxamer 1g
Make 1000
Method for making: get the mixing fine powders that daidzein 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 soybean aglycone and preparation method thereof is characterized in that: the daidzein 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.
The chemical name of the described daidzein of claim 1 be 4 ', the 7-dihydroxy isoflavone, molecular formula is C
15H
10O
4, molecular weight is 254.24, 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 |
|---|---|---|---|
| CNA031433383A CN1528286A (en) | 2003-09-27 | 2003-09-27 | Soybean aglycone drop pill and preparing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031433383A CN1528286A (en) | 2003-09-27 | 2003-09-27 | Soybean aglycone drop pill and preparing method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1528286A true CN1528286A (en) | 2004-09-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031433383A Pending CN1528286A (en) | 2003-09-27 | 2003-09-27 | Soybean aglycone drop pill and preparing method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1528286A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100413498C (en) * | 2006-04-25 | 2008-08-27 | 邵爱霞 | Drop pills of soybean aglycone, and preparation method |
-
2003
- 2003-09-27 CN CNA031433383A patent/CN1528286A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100413498C (en) * | 2006-04-25 | 2008-08-27 | 邵爱霞 | Drop pills of soybean aglycone, and preparation method |
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| WD01 | Invention patent application deemed withdrawn after publication |