CN105287429A - Preparation method of brucea javanica oil solid self-emulsifying capsule - Google Patents
Preparation method of brucea javanica oil solid self-emulsifying capsule Download PDFInfo
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- CN105287429A CN105287429A CN201510804516.6A CN201510804516A CN105287429A CN 105287429 A CN105287429 A CN 105287429A CN 201510804516 A CN201510804516 A CN 201510804516A CN 105287429 A CN105287429 A CN 105287429A
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- self
- fructus bruceae
- oleum fructus
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- emulsifying
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Abstract
The invention discloses a preparation method of a brucea javanica oil solid self-emulsifying capsule. The brucea javanica oil solid self-emulsifying capsule comprises the following components in percentage by weight: 10 to 50% of brucea javanica oil self-emulsifying liquid, 20 to 80% of solid absorbent, 20 to 60% of diluent, and a proper amount of adhesive; wherein the brucea javanica oil self-emulsifying liquid comprises the following components in percentage by weight: 25 to 50% of brucea javanica oil, 40 to 80% of surfactant, and 5 to 20% of co-surfactant. At present, the brucea javanica oil is taken orally, the bioavailability is low, the quality is unstable, transportation and storage are inconvenient, and the provided capsule solves the problem mentioned above. At the same time, the problem that the curing and production cost of self-emulsifying preparation is high is solved.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, specifically the preparation method of Oleum Fructus Bruceae solid self-emulsifying capsule.
Background technology
Oleum Fructus Bruceae is extract the fatty oil obtained in the dry mature fruit of quassia Fructus Bruceae Bruceajavanica (L.) Merr..Oleum Fructus Bruceae is not only used for the treatment of the Several Kinds of Malignancies such as pulmonary carcinoma, lung cancer with brain metastasis, hepatocarcinoma, gastric cancer and breast carcinoma, also can be used for the non-tumor diseases such as treatment chronic gastritis, colitis and condyloma acuminatum, share can improve curative effect with chemotherapeutic, toxicity is few, seldom occurs the toxicity of the conventional chemotherapy medicines such as Nausea and vomiting, anorexia, alopecia, hemogram decline and bone marrow depression.
Oleum Fructus Bruceae is when antitumor, and have the advantages that to improve immunity of organisms and protection marrow hemopoietic stem cells, determined curative effect, toxic and side effects is little, has certain advantage compared with conventional chemotherapeutics.Its dosage form has Oleum Fructus Bruceae vein emulsion, oral emulsion, solid self-emulsifying capsule, capsule and microcapsule etc. at present, wherein with Oleum Fructus Bruceae vein emulsion report at most.But Oleum Fructus Bruceae vein emulsion belongs to the dispersion of heterogeneous Mechanical instability, being heated, in the process of freezing and long storage periods, breast all can be caused to analyse or break; Though can the long period be deposited after Oleum Fructus Bruceae microcapsule vacuum dehydrating at lower temperature, and at room temperature deposit 7 ~ 10d and can break from luggage, illustrate that Oleum Fructus Bruceae needs research further in the exploitation of its novel form.
Self-emulsifying drug delivery system (Self-emulsifyingdrugdeliverysystem, SEDDS) be made up of fat-soluble or poorly water soluble drugs, oil phase, emulsifying agent and co-emulsifier, outward appearance transparent and homogeneous, due to the existence of emulsifying agent, under the condition of gastrointestinal peristalsis or gentle agitation, meet the Emulsion that water self emulsifying becomes oil-in-water (O/W) type.It can by some hydrophobicity, absorb poor medicine and make liquid oral or solid preparation, except the bioavailability that can improve medicine and stability, also can widen the use crowd (as child, being difficult to the patient etc. that swallows) of medicine, being easy to suitability for industrialized production, is a kind of desirable form of administration.
The present invention is carrier with self-emulsifying drug delivery system, is made into capsule, can improve the stripping of Oleum Fructus Bruceae, promotes that it absorbs, and improves oral administration biaavailability.
Summary of the invention
The object of the present invention is to provide a kind of novel form of Oleum Fructus Bruceae.
The object of the present invention is achieved like this:
A kind of Oleum Fructus Bruceae self-emulsifiable liquid, containing Oleum Fructus Bruceae, surfactant, cosurfactant in described Oleum Fructus Bruceae self-emulsifiable liquid component, the content of each component is by weight percentage:
Oleum Fructus Bruceae 25% ~ 50%
Surfactant 40% ~ 80%
Cosurfactant 5% ~ 20%
Described surfactant is lecithin, soybean phospholipid, polyoxyethylene castor oil EL-35, polyoxyethylene hydrogenated Oleum Ricini RH40, tween 80, Arlacel-80, SolutolHS15;
Described cosurfactant is glycerol, 1,2-PD, PEG-400, n-butyl alcohol.
Oleum Fructus Bruceae self-emulsifiable liquid of the present invention, is characterized in that the self-emulsifying systems that Oleum Fructus Bruceae and surfactant, cosurfactant are formed can increasing dissolubility and the dissolution of medicine under certain condition, improves drug oral bioavailability.
A kind of Oleum Fructus Bruceae solid self-emulsifying capsule, containing Oleum Fructus Bruceae self-emulsifiable liquid, solid absorbent, diluent, binding agent in described Oleum Fructus Bruceae solid self-emulsifying capsule contents, the content of each component is by weight percentage:
Oleum Fructus Bruceae self-emulsifiable liquid 10% ~ 50%
Solid absorbent 20% ~ 80%
Diluent 20% ~ 60%
Binding agent is appropriate
Described solid absorbent is micropowder silica gel, microcrystalline Cellulose, dextrin, starch, pregelatinized Starch, crospovidone, mannitol, sucrose, lactose, polyethylene glycol 6000, Macrogol 4000.
Diluent of telling is selected from lactose, starch, microcrystalline Cellulose, dextrin, the one of sucrose or mix several.It is 5% ~ 25%(w/w by weight percentage that described binding agent is selected from content) starch slurry.
Oleum Fructus Bruceae solid self-emulsifying capsule of the present invention, it is characterized in that Oleum Fructus Bruceae self-emulsifiable liquid and solid absorbent, diluent, binding agent are prepared into solid solid self-emulsifying capsule under certain condition, dissolubility and the dissolution of medicine can be increased, improve drug oral bioavailability, solve the problem that self-emulsifiable preparation solidification production cost is high.Concrete steps are as follows:
Take Oleum Fructus Bruceae and surfactant, the cosurfactant of recipe quantity, mix homogeneously under magnetic agitation, obtains Oleum Fructus Bruceae self-emulsifiable liquid.
Take the solid absorbent of recipe quantity, and add the stand-by Oleum Fructus Bruceae self-emulsifiable liquid of preparation to it, self-emulsifiable liquid is adsorbed completely, then adds the diluent of recipe quantity, mixing is stirred, then adds appropriate binding agent granulation.Last wet granular is at 50 DEG C of baking oven inner dryings granulate (12 mesh sieve bulky grain) after 4 hours.Again gained granule is pressed in a certain amount of loading hard capsule case, to obtain final product.
Oleum Fructus Bruceae solid self-emulsifying capsule prepared by the present invention, after distilled water emulsifying, particle diameter is (115 ± 5) nm, solve Oleum Fructus Bruceae self poorly water-soluble, oral administration biaavailability is low, to gastrointestinal tract, there is larger zest, the problems such as patient compliance is poor, and self-emulsifiable preparation solidification production cost is high.
Accompanying drawing explanation
Fig. 1 is the rear grain size distribution of Oleum Fructus Bruceae solid self-emulsifying capsule redissolution prepared by the present invention;
Specific implementation method
Below in conjunction with specific embodiment, the invention will be further described.
Embodiment 1
Composition weight (g)
Oleum Fructus Bruceae 30
Polyoxyethylene castor oil EL-3530
Polyoxyethylene hydrogenated Oleum Ricini RH4030
PEG-40010
Specific operation process: by the Oleum Fructus Bruceae of recipe quantity, polyoxyethylene castor oil EL-35, polyoxyethylene hydrogenated Oleum Ricini RH40 and PEG-400 magnetic agitation mix homogeneously, obtain Oleum Fructus Bruceae self-emulsifiable liquid.
Composition weight (g)
Oleum Fructus Bruceae self-emulsifiable liquid 25
Solid absorbent 50
Diluent 25
Binding agent is appropriate
Specific operation process:
Take the solid absorbent of recipe quantity, and add the stand-by self-emulsifiable liquid of preparation to it, self-emulsifiable liquid is adsorbed completely, then adds the diluent of recipe quantity, mixing is stirred, then adds appropriate binding agent granulation.Last wet granular is at 50 DEG C of baking oven inner dryings granulate (12 mesh sieve bulky grain) after 4 hours.Again gained granule is pressed in a certain amount of loading hard capsule case, to obtain final product.
Embodiment 2
Composition weight (g)
Oleum Fructus Bruceae 25
Polyoxyethylene castor oil EL-3555
PEG-40020
Specific operation process: by the Oleum Fructus Bruceae of recipe quantity, polyoxyethylene castor oil EL-35, polyoxyethylene hydrogenated Oleum Ricini RH40 and PEG-400 magnetic agitation mix homogeneously, obtain Oleum Fructus Bruceae self-emulsifiable liquid.
Composition weight (g)
Oleum Fructus Bruceae self-emulsifiable liquid 15
Solid absorbent 65
Diluent 20
Binding agent is appropriate
Specific operation process:
Take the solid absorbent of recipe quantity, and add the stand-by self-emulsifiable liquid of preparation to it, self-emulsifiable liquid is adsorbed completely, then adds the diluent of recipe quantity, mixing is stirred, then adds appropriate binding agent granulation.Last wet granular is at 50 DEG C of baking oven inner dryings granulate (12 mesh sieve bulky grain) after 4 hours.Again gained granule is pressed in a certain amount of loading hard capsule case, to obtain final product.
Embodiment 3
Composition weight (g)
Oleum Fructus Bruceae 40
Polyoxyethylene hydrogenated Oleum Ricini RH4050
PEG-40010
Specific operation process: by the Oleum Fructus Bruceae of recipe quantity, polyoxyethylene castor oil EL-35, polyoxyethylene hydrogenated Oleum Ricini RH40 and PEG-400 magnetic agitation mix homogeneously, obtain Oleum Fructus Bruceae self-emulsifiable liquid.
Composition weight (g)
Oleum Fructus Bruceae self-emulsifiable liquid 35
Solid absorbent 40
Diluent 25
Binding agent is appropriate
Specific operation process:
Take the solid absorbent of recipe quantity, and add the stand-by self-emulsifiable liquid of preparation to it, self-emulsifiable liquid is adsorbed completely, then adds the diluent of recipe quantity, mixing is stirred, then adds appropriate binding agent granulation.Last wet granular is at 50 DEG C of baking oven inner dryings granulate (12 mesh sieve bulky grain) after 4 hours.Again gained granule is pressed in a certain amount of loading hard capsule case, to obtain final product.
Claims (6)
1. an Oleum Fructus Bruceae solid self-emulsifying capsule, wherein Oleum Fructus Bruceae solid self-emulsifying capsule comprises Oleum Fructus Bruceae self-emulsifiable liquid, solid absorbent, diluent, binding agent.
2. Oleum Fructus Bruceae self-emulsifiable liquid comprises active component Oleum Fructus Bruceae and surfactant, cosurfactant.
3. by Oleum Fructus Bruceae self-emulsifiable liquid according to claim 2, it is characterized in that the self-emulsifying systems that Oleum Fructus Bruceae and surfactant, cosurfactant are formed under certain condition, dissolubility and the dissolution of medicine can be increased, improve drug oral bioavailability.
4. according to preparation method according to claim 3, it is characterized in that described surfactant is selected from lecithin, soybean phospholipid, polyoxyethylene castor oil EL-35, polyoxyethylene hydrogenated Oleum Ricini RH40, tween 80, Arlacel-80, SolutolHS15 wherein one or more, content is more than 25% by weight percentage, preferably 40% ~ 80%; It is characterized in that described cosurfactant is selected from glycerol, 1,2-PD, PEG-400, n-butyl alcohol, content is 5% ~ 25% by weight percentage, preferably 5% ~ 20%; It is characterized in that described Oleum Fructus Bruceae content is 25% ~ 70% by weight percentage, preferably 25% ~ 50%.
5. by Oleum Fructus Bruceae solid self-emulsifying capsule according to claim 1, it is characterized in that Oleum Fructus Bruceae self-emulsifiable liquid, solid absorbent, diluent, the solid solid self-emulsifying capsule that binding agent is formed under certain condition, can solve the problem that self-emulsifiable preparation solidification production cost is high, concrete steps are as follows:
Take the solid absorbent of recipe quantity, and add the stand-by self-emulsifiable liquid of preparation to it, self-emulsifiable liquid is adsorbed completely, then adds the diluent of recipe quantity, mixing is stirred, then adds appropriate binding agent granulation; Last wet granular is at 50 DEG C of baking oven inner dryings granulate (12 mesh sieve bulky grain) after 4 hours; Again gained granule is pressed in a certain amount of loading hard capsule case, to obtain final product.
6., by preparation method according to claim 5, it is characterized in that described solid absorbent is selected from micropowder silica gel, microcrystalline Cellulose, dextrin, starch, pregelatinized Starch, crospovidone, mannitol, sucrose, lactose, polyethylene glycol 6000, Macrogol 4000; Diluent of telling is selected from lactose, starch, microcrystalline Cellulose, dextrin, the one of sucrose or mix several; It is 5% ~ 25%(w/w by mass that described binding agent is selected from content) starch slurry.
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| CN201510804516.6A CN105287429A (en) | 2015-11-20 | 2015-11-20 | Preparation method of brucea javanica oil solid self-emulsifying capsule |
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| CN201510804516.6A CN105287429A (en) | 2015-11-20 | 2015-11-20 | Preparation method of brucea javanica oil solid self-emulsifying capsule |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109924491A (en) * | 2019-04-01 | 2019-06-25 | 东南大学 | A kind of dihydromyricetin solid-state self-emulsifying material and its preparation method and application |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1748777A (en) * | 2004-09-15 | 2006-03-22 | 上海医药工业研究院 | Chinese medicine volatoile oil self-mciro emulsifying nano composition and preparing method |
| CN102631324A (en) * | 2011-02-15 | 2012-08-15 | 南京正科制药有限公司 | Nimesulide self-emulsification particle and preparation method thereof |
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- 2015-11-20 CN CN201510804516.6A patent/CN105287429A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1748777A (en) * | 2004-09-15 | 2006-03-22 | 上海医药工业研究院 | Chinese medicine volatoile oil self-mciro emulsifying nano composition and preparing method |
| CN102631324A (en) * | 2011-02-15 | 2012-08-15 | 南京正科制药有限公司 | Nimesulide self-emulsification particle and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109924491A (en) * | 2019-04-01 | 2019-06-25 | 东南大学 | A kind of dihydromyricetin solid-state self-emulsifying material and its preparation method and application |
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Application publication date: 20160203 |