CN101069676A - Method for preparing brufen soft capsule - Google Patents
Method for preparing brufen soft capsule Download PDFInfo
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- CN101069676A CN101069676A CNA2006100126819A CN200610012681A CN101069676A CN 101069676 A CN101069676 A CN 101069676A CN A2006100126819 A CNA2006100126819 A CN A2006100126819A CN 200610012681 A CN200610012681 A CN 200610012681A CN 101069676 A CN101069676 A CN 101069676A
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- ibuprofen
- soft capsule
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- liquid soft
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Abstract
The present invention discloses a preparation method of liquid soft capsule containing ibuprofen. Said ibuprofen soft capsule has high bioavailability, its absorption is rapid, its action is quick and its contents matrix is stable. Said method is characterized by that in the solvent an alkaline substance is added, and the produced hydroxide radical can make partial ibuprofen be ionized and existed in the solution in the form of salt and free so as to raise solubility of ibuprofen and greatly reduce irritation of ibuprofen to gastrointestinal tract.
Description
Technical field
The present invention relates to a kind of novel pharmaceutical formulation that contains ibuprofen, particularly a kind of preparation of the liquid content that contains ibuprofen also is prepared into the method for soft capsule.
Background technology
Ibuprofen is one of most widely used nonsteroidal anti-inflammatory drug clinically now, has analgesic significantly, analgesia and antiphlogistic effects.Its mechanism of action is by reducing the synthetic of prostaglandin, alleviate thus the sensitivity of the tissue hyperemia that causes because of prostaglandin, swelling, the reduction peripheral nerve pain sensation to the inhibition of epoxidase.It plays refrigeration function by the hypothalamus center of body temperature regulation.Be mainly used in various rheumatism of treatment and rheumatoid arthritis, be applicable to and remove and the slight extremely moderate multiple pain of alleviation, cause headache, extremities aching pain as flu, other are as toothache, dysmenorrhea, postoperative pain etc.
Ibuprofen is to develop successful nonsteroidal anti-inflammatory drug in the period of 1960～1970.Britain The Boots Co. PLC is an ibuprofen raw materials producers the biggest in the world.There are multiple Motrin listing in Britain, the U.S..Genpril and slow releasing capsule are recorded by Chinese Pharmacopoeia two ones of versions in 2000, become to substitute the most frequently used analgesic, analgesia such as the big dipyrone of toxic and side effects and anti-inflammatory drug.The ibuprofen dosage form of approval comprises tablet, slow releasing capsule, liniment, syrup, suspension, granule, oral liquid etc. now.But above dosage form is with the new development novel form---soft capsule is compared in recent years, and bioavailability is low, absorption is slow, onset is slow, long action time.Do not have as yet at present than soft capsule and discharge dosage form appearance faster.
Summary of the invention
The objective of the invention is to overcome the defective of above-mentioned prior art, a kind of bioavailability height is provided, absorbs the liquid soft capsule that contains ibuprofen fast, that effect is rapid, content substrate is stable.
Technical scheme of the present invention is:
A kind of liquid soft capsule that contains ibuprofen is made up of the content in gelatin and softgel shell and the softgel shell, it is characterized in that:
(a) in the content content of ibuprofen 10～70%;
(b) dicyandiamide solution is the mixture of following substances: Polyethylene Glycol, propylene glycol, Span20, and wherein Polyethylene Glycol is that the mass percent of content is 10～70%; Propylene glycol is that the mass percent of content is 0～5%; Span20 is that the mass percent of content is 0～10%.
The molecular weight of above-mentioned Polyethylene Glycol is 200～10000.
Also contain alkaline matter in the above-mentioned dicyandiamide solution, its OH
-Be 0.01～1.5 times of ibuprofen acid ion.
Above-mentioned alkaline matter is sodium hydroxide or potassium hydroxide.
The present invention utilize soft capsule have the bioavailability height, absorb fast, act on characteristics rapidly, ibuprofen is separated with solvent is melt and dissolved, make in the soft capsule shell of packing into behind the suitable solution and make.Because this product is a soft capsule, includes liquid homogeneous phase substrate, can dissolve mutually with water, therefore have high bioavailability, absorb characteristics such as fast, that effect is rapid.In addition, the present invention adds alkaline matter in solvent, and the hydroxyl of its generation can make the ionizing of part ibuprofen and exist in solution with salt and free form, thereby strengthens the dissolubility of ibuprofen, and ibuprofen is reduced greatly to the gastrointestinal zest.
As shown in table 1, the infiltration rate of ibuprofen is apparently higher than the control formulation effervescent tablet in the soft capsule of the present invention's preparation.Wherein between two groups of the Tmax statistical significance is arranged relatively.The infiltration rate of commercially available other dosage forms is farther far above soft capsule dosage form (table 2), and Tmax is all more than 0.79 hour.Advantage of the present invention be mainly reflected in discharge to absorb fast and rapid-action on.
The pharmacokinetic parameter of table 1. brufen soft capsule and effervescent tablet
| Dosage | Adult 400mg | |
| Preparation AUC (μ g.h/ml) Cmax (μ g/ml) Tmax | Soft capsule 135 50 0.48 | Effervescent tablet 140 45 0.68 |
The pharmacokinetic parameter of other dosage form various dose of table 2. ibuprofen
| Dosage | Adult 200mg | |||
| Preparation AUC (μ g.h/ml) Cmax (μ g/ml) Tmax | Suspension 64 19 0.79 | Drop 74 24 1.0 | Capsule 60 20 1.04 | Chewable tablet 66 15 2.0 |
The specific embodiment
Take by weighing ibuprofen 100g, the hydro-oxidation sodium solution is an amount of, stirs, and again PEG400 100g, propylene glycol 5g, Span20 10g is added to heat under 70 ± 2 ℃ of conditions to make fusing, promptly gets the medicinal liquid for preparing; The medicinal liquid for preparing is carried out pelleting, makes 1000 soft capsules, setting, after the drying promptly.
Claims (5)
1. a liquid soft capsule that contains ibuprofen is made up of the content in gelatin and softgel shell and the softgel shell, it is characterized in that content comprises:
(a) in the content content of ibuprofen 10～70%;
(b) dicyandiamide solution.
2. the liquid soft capsule preparation that contains ibuprofen according to claim 1 is characterized in that above-mentioned dicyandiamide solution is the mixture of following substances: Polyethylene Glycol, propylene glycol, Span20, and wherein Polyethylene Glycol is that the mass percent of content is 10～70%; Propylene glycol is that the mass percent of content is 0～5%; Span20 is that the mass percent of content is 0～10%.
3. the liquid soft capsule preparation that contains ibuprofen according to claim 2, the molecular weight that it is characterized in that above-mentioned Polyethylene Glycol is 200～10000.
4. the liquid soft capsule preparation that contains ibuprofen according to claim 1 and 2 is characterized in that also containing in the above-mentioned dicyandiamide solution alkaline matter, its OH
-Be 0.01～1.5 times of ibuprofen acid ion.
5. the liquid soft capsule preparation that contains ibuprofen according to claim 4 is characterized in that above-mentioned alkaline matter is sodium hydroxide or potassium hydroxide.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006100126819A CN101069676A (en) | 2006-05-09 | 2006-05-09 | Method for preparing brufen soft capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006100126819A CN101069676A (en) | 2006-05-09 | 2006-05-09 | Method for preparing brufen soft capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101069676A true CN101069676A (en) | 2007-11-14 |
Family
ID=38897195
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2006100126819A Pending CN101069676A (en) | 2006-05-09 | 2006-05-09 | Method for preparing brufen soft capsule |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101069676A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107951857A (en) * | 2017-11-29 | 2018-04-24 | 浙江安宝药业有限公司 | Brufen soft capsule |
-
2006
- 2006-05-09 CN CNA2006100126819A patent/CN101069676A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107951857A (en) * | 2017-11-29 | 2018-04-24 | 浙江安宝药业有限公司 | Brufen soft capsule |
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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 |