CN1493276A - Ferulaic acid sodium drip pill and its preparation method - Google Patents
Ferulaic acid sodium drip pill and its preparation method Download PDFInfo
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- CN1493276A CN1493276A CNA031576664A CN03157666A CN1493276A CN 1493276 A CN1493276 A CN 1493276A CN A031576664 A CNA031576664 A CN A031576664A CN 03157666 A CN03157666 A CN 03157666A CN 1493276 A CN1493276 A CN 1493276A
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- sodium
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- coolant
- sodium ferulate
- acid
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Abstract
A dripping pill of sodium ferulate and its superfine pulverizing process for preparing it are disclosed. Its advantages are high dissolving and disintegrating speed, high stripping percentage, quickly taking its curative 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 sodium ferulic acid and preparation method thereof.
Background technology
Sodium ferulate is non-peptide-like endothelin receptor antagonist, but the vasoconstriction that the antagonism Endothelin causes, boosts and vascular smooth muscle cell proliferation; Increase the synthetic of NO, loose vascular smooth muscle, improves the hemorheology feature at anticoagulant, anticoagulation.Can also suppress the synthetic of cholesterol, blood fat reducing is removed free radical, and the control lipid peroxidation injury influences complement, raise immunity, and have certain analgesia, spasmolysis.
Oral sodium ferulate is eliminated half-life (t
1/2 β) be 11.46min ± 3.2min, plasma protein binding rate is 20.6%, absorption is fast and fully, it is rapid to distribute, and can pass through blood one cerebrospinal fluid barrier, mainly through renal excretion, is difficult in the body accumulating.The sodium ferulate oral formulations of list marketing at present has tablet, is used for coronary heart disease, cerebrovascular and vasculitis etc. clinically.
The disintegration time of sodium ferulate sheet is longer, and dissolution and dissolution rate are lower, the supplementary product consumption large percentage, and child, old people, bed patient and dysphagia patients are taken inconvenience, and compliance is poor, has influenced the performance of sodium ferulate therapeutical effect.
The present invention makes the drop pills of sodium ferulic acid agent by using ultramicro communication technique and dropping pill formulation Technology exactly, thereby overcomes the above defective of sodium ferulate sheet, and the therapeutical effect of sodium ferulate is given full play to.
Summary of the invention
The drop pills of sodium ferulic acid 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, with tablet and compare the advantage that supplementary product consumption reduces, 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 sodium ferulate 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 sodium ferulate is 3-methoxyl group-4-Hydroxycinnamic Acid sodium salt dihydrate among the present invention, and molecular formula is C
10H
9NaO
42H
2O, molecular weight are 252.20, 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: lucifuge operation.Sample thief according to dissolution method (two appendix XC first methods of Chinese Pharmacopoeia version in 2000), is a solvent with water 900ml, rotating speed is that per minute 50 changes, and operation in accordance with the law is in the time of 5,10,20,30 and 45 minutes, get solution 5ml, filter, precision is measured subsequent filtrate 1ml, adds water and makes the solution that contains sodium ferulate 10 μ g among every 1ml approximately, shake up, according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A), measure trap respectively at the wavelength place of 310nm, press C
10H
9NaO
4Absorptance (E
1cm 1%) be 712 calculating, and the result be multiply by 1.1667, promptly get the stripping quantity of every (ball) sample.
Two, commercially available sodium ferulate sheet testing result
1. disintegration time: 46 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 35.2 43.6 61.3 80.2 95.6
Three, example 1 sample detection result
1. the molten diffusing time: 4 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 66.5 82.3 98.4 99.1 99.6
Four, example 2 sample detection results
1. the molten diffusing time: 9 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 69.2 85.3 98.9 99.5 100.6
Five, example 3 sample detection results
1. the molten diffusing time: 10 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 62.3 89.6 95.7 101.2 100.1
Six, example 4 sample detection results
1. the molten diffusing time: 11 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 70.3 90.2 99.6 98.3 99.5
Seven, example 5 sample detection results
1. the molten diffusing time: 8 minutes
2. dissolution rate:
Time (minute) 5 10 20 30 45
Dissolution (%) 65.6 81.2 99.5 98.3 99.9
Eight, example 6 sample detection results
1. the molten diffusing time: 10 minutes
2. dissolution rate
Time (minute) 5 10 20 30 45
Dissolution (%) 53.6 75.3 92.5 98.3 99.1
The specific embodiment
One, example 1
Prescription:
Sodium ferulate 5g
Polyethylene glycol 6000 15g
Make 1000
Method for making: the sodium ferulate 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:
Sodium ferulate 5g
Macrogol 4000 15g
Make 1000
Method for making: the sodium ferulate 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:
Sodium ferulate 5g
Polyethylene glycol 6000 5g
Macrogol 4000 10g
Make 1000
Method for making: the sodium ferulate 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:
Sodium ferulate 5g
Glyceryl monostearate 15g
Make 1000
Method for making: the sodium ferulate 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:
Sodium ferulate 5g
Polyethylene glycol 6000 10g
Poloxamer 5g
Make 1000
Method for making: the sodium ferulate 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:
Sodium ferulate 5g
Glyceryl monostearate 15g
Poloxamer 1g
Make 1000
Method for making: get the mixing fine powders that sodium ferulate 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 sodium ferulic acid and preparation method thereof is characterized in that: the sodium ferulate 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 chemical name of sodium ferulate is 3-methoxyl group-4-Hydroxycinnamic Acid sodium salt dihydrate among the present invention, and molecular formula is C
10H
9NaO
42H
2O, molecular weight are 252.20, 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 |
|---|---|---|---|
| CNA031576664A CN1493276A (en) | 2003-09-06 | 2003-09-06 | Ferulaic acid sodium drip pill and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031576664A CN1493276A (en) | 2003-09-06 | 2003-09-06 | Ferulaic acid sodium drip pill and its preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1493276A true CN1493276A (en) | 2004-05-05 |
Family
ID=34240893
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031576664A Pending CN1493276A (en) | 2003-09-06 | 2003-09-06 | Ferulaic acid sodium drip pill and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1493276A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1872040B (en) * | 2005-06-01 | 2010-09-29 | 天津天士力制药股份有限公司 | Drop pills of sodium ferulic acid, and preparation method |
-
2003
- 2003-09-06 CN CNA031576664A patent/CN1493276A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1872040B (en) * | 2005-06-01 | 2010-09-29 | 天津天士力制药股份有限公司 | Drop pills of sodium ferulic acid, 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 |