CN1568949A - Salbutamol Sulfate drop pills and preparation method thereof - Google Patents
Salbutamol Sulfate drop pills and preparation method thereof Download PDFInfo
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- CN1568949A CN1568949A CN 200410044441 CN200410044441A CN1568949A CN 1568949 A CN1568949 A CN 1568949A CN 200410044441 CN200410044441 CN 200410044441 CN 200410044441 A CN200410044441 A CN 200410044441A CN 1568949 A CN1568949 A CN 1568949A
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- salbutamol sulfate
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- coolant
- polyethylene glycol
- sulfate
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Abstract
The invention discloses a salbutamol sulfate drop pill prepared through ultramicro disintegration and drop pills manufacturing technique, which has the advantages of improving collapse and dissolving speed, quick effect, increased medicament stability, reduced adjuvant consumption, lowered production costs, and easiness in carrying and use. It has good compliance, thus is especially suitable for children, the elderly, bedridden patients and dysphagia patients.
Description
Technical field
The present invention relates to a kind of pharmaceutical product and preparation method thereof, specifically salbutamol sulfate drop pill and preparation method thereof.
Background technology
Salbutamol sulfate acts on the bronchus beta 2 adrenoreceptor, loose smooth muscle, and its mechanism is activated adenyl cyclase, promotes adenosine cyclophosphate to generate.
Oral salbutamol sulfate acts on beginning after 30 minutes, the maximum effect time is 2～3 hours, continues 6 hours, oral back 2.5 hours blood drug level peakings, T
1/2It is 2.7～5 hours.Discharge with urine oral back about 76%, and major part is discharged from one day, and 60% is metabolite.About 4% is discharged by feces.The clinical respiratory tract disease that is used for bronchial asthma or asthmatic bronchitis etc. with bronchospasm.
The salbutamol sulfate bitter in the mouth, easily molten in water, but its disintegration of tablet time is longer, absorption difference, bioavailability is low, and the supplementary product consumption ratio is big, child, old people, bed patient and dysphagia patients are taken inconvenience, and compliance is poor, have influenced the performance of salbutamol sulfate therapeutical effect.
The present invention makes the salbutamol sulfate drop pill by using ultramicro communication technique and dropping pill formulation Technology exactly, thereby overcomes the above defective of salbutamol sulfate sheet, and the therapeutical effect of salbutamol sulfate is given full play to.
Summary of the invention
The salbutamol sulfate drop pill of making by using ultramicro communication technique and dropping pill formulation Technology not only have disintegrate molten loose fast, steady quality, the pill volume is little, and is easy to carry and use, and 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 salbutamol sulfate fine powder of 1 weight portion through micronizing is added in 1～20 weight portion molten matrix, fully mixing, dropping preparation method is condensed into ball in coolant, remove coolant, drying, promptly.
The chemical name of salbutamol sulfate is 1-(4-hydroxyl-3-hydroxymethyl phenyl)-2-(uncle's fourth amino) ethanol sulfate among the present invention, and molecular formula is (C
13H
21NO
3)
2H
2SO
4, molecular weight is 576.71, 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
Disintegrate (molten loosing) time limit: check according to inspection technique disintegration (two appendix XA of Chinese Pharmacopoeia version in 2000).
Two, commercial sulfuric acid albuterol sheet disintegration time testing result: 54 minutes
Three, example 1 sample disintegrate (molten loosing) time detecting result: 2 minutes
Four, example 2 sample disintegrates (molten loosing) time detecting result: 2 minutes
Five, example 3 sample disintegrates (molten loosing) time detecting result: 3 minutes
Six, example 4 sample disintegrates (molten loosing) time detecting result: 5 minutes
Seven, example 5 sample disintegrates (molten loosing) time detecting result: 6 minutes
Eight, example 6 sample disintegrates (molten loosing) time detecting result: 8 minutes
The specific embodiment
One, example 1
Prescription:
Salbutamol sulfate 2.4g
Polyethylene glycol 6000 18g
Make 1000
Method for making: the salbutamol sulfate fine powder that the micronizing of learning from else's experience is crossed 200 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:
Salbutamol sulfate 2.4g
Macrogol 4000 18g
Make 1000
Method for making: the salbutamol sulfate 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:
Salbutamol sulfate 2.4g
Polyethylene glycol 6000 10g
Macrogol 4000 8g
Make 1000
Method for making: the salbutamol sulfate 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:
Salbutamol sulfate 2.4g
Glyceryl monostearate 18g
Make 1000
Method for making: the salbutamol sulfate 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:
Salbutamol sulfate 2.4g
Polyethylene glycol 6000 10g
Poloxamer 8g
Make 1000
Method for making: the salbutamol sulfate 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:
Salbutamol sulfate 2.4g
Glyceryl monostearate 15g
Poloxamer 3g
Make 1000
Method for making: get the mixing fine powders that salbutamol sulfate 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. salbutamol sulfate drop pill and preparation method thereof is characterized in that: the salbutamol sulfate fine powder of 1 weight portion through micronizing is added in 1～20 weight portion molten matrix, fully mixing, dropping preparation method is condensed into ball in coolant, remove coolant, drying, promptly.
2. the chemical name of the described salbutamol sulfate of claim 1 is 1-(4-hydroxyl-3-hydroxymethyl phenyl)-2-(uncle's fourth amino) ethanol sulfate, and molecular formula is (C
13H
21NO
3)
2H
2SO
4, molecular weight is 576.71, 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 |
|---|---|---|---|
| CN 200410044441 CN1568949A (en) | 2004-05-13 | 2004-05-13 | Salbutamol Sulfate drop pills and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410044441 CN1568949A (en) | 2004-05-13 | 2004-05-13 | Salbutamol Sulfate drop pills and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1568949A true CN1568949A (en) | 2005-01-26 |
Family
ID=34481891
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410044441 Pending CN1568949A (en) | 2004-05-13 | 2004-05-13 | Salbutamol Sulfate drop pills and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1568949A (en) |
-
2004
- 2004-05-13 CN CN 200410044441 patent/CN1568949A/en active Pending
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|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |