CN101978977A - Self-emulsifying brucea javanica oil oral preparation composition and preparation method thereof - Google Patents
Self-emulsifying brucea javanica oil oral preparation composition and preparation method thereof Download PDFInfo
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- CN101978977A CN101978977A CN 201010533767 CN201010533767A CN101978977A CN 101978977 A CN101978977 A CN 101978977A CN 201010533767 CN201010533767 CN 201010533767 CN 201010533767 A CN201010533767 A CN 201010533767A CN 101978977 A CN101978977 A CN 101978977A
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Abstract
The invention relates to the technical field of medicament preparations, in particular to a self-emulsifying brucea javanica oil oral preparation composition and a preparation method thereof. The composition comprises the following components in percentage by mass: 9 to 35 percent of brucea javanica oil, 45 to 62 percent of emulsifier, 2 to 20 percent of auxiliary emulsifier and 0 to 18 percent of fatty oil. In the method, special equipment is not used, preparation operation is simple, and the obtained composite has a grain size of 10 to 100nm and is easy to store.
Description
Technical field
What the present invention relates to is a kind of mixture and method of field of medicine preparing technology, specifically is Oleum Fructus Bruceae oral preparation composition of a kind of self-microemulsion and preparation method thereof.
Background technology
Fructus Bruceae is the fruit of quassia plant.Cold in nature, bitter in the mouth, slightly poisonous.But heat-clearing and toxic substances removing, preventing the attack (or recurrence) of malaria, dysentery relieving, corrosion wart.Wherein contain alkaloid, glucosides, phenolic constituent and hydroxy carboxylic acid etc.Relevant compositions such as the oleic acid that contains in the Oleum Fructus Bruceae, linoleic acid and tumor cell have special affinity, have stronger active anticancer.This vegetable oil is when antitumor; characteristics with human body immunity improving power and protection marrow hemopoietic stem cells; determined curative effect; toxic and side effects is little; seldom occur to feel sick, vomiting, anorexia, alopecia, hemogram descends and the toxicity of conventional chemotherapy medicine such as bone marrow depression, comparing with chemotherapeutics commonly used has certain advantage.Its dosage form has Oleum Fructus Bruceae vein emulsion, oral liquid and soft capsule etc. at present, wherein uses at most with the Oleum Fructus Bruceae vein emulsion.But the Oleum Fructus Bruceae vein emulsion belongs to the unsettled dispersion of heterogenetic kinetics, is being heated, in the process of freezing and long term store, can causing that all breast analyses or break, and illustrates that Oleum Fructus Bruceae breaks through being still waiting aspect the exploitation of its novel form.
(Self-Microemulsifying Drug Delivery System SMEDDS) is solid or the liquid dosage form that comprises oil phase, surfactant and cosurfactant to the self-emulsifying microemulsion drug delivery system.It is a kind of lipid drug-supplying system.This system basic feature be oral after, spontaneous formation particle diameter is at the capable microemulsion of oil-in-water of 10-100nm under the gastrointestinal gentle agitation.SMEDDS can improve the dissolubility of weak water solublity and fat-soluble medicine, improves the oral absorption of medicine, has become new research focus of pharmaceutics in recent years.In addition, the existing kinds of surface activating agent or the cosurfactant that comprise in the self-microemulsion prescription of studies show that not only has the change cell membrane fluidity, improve the pharmaceutical film permeability, and can suppress on the intestinal epithelial cell film efflux protein to the effect that effluxes of medicine, improve the effect of drug absorption transhipment, as tween 80, PEG400, polyoxyethylene castor oil, Vitamin E TPGS etc.After ciclosporin bacterium A made oral precursor and concentrates microemulsion, bioavailability had reduced individual variation simultaneously by bringing up to 47% less than 10%, has become most popular in the market environmental protection rhzomorph A preparation.
Find that through literature search Zhang Keping etc. are at West China Journal of Pharmaceutical Sciences (2005,20 (31): delivered paper " preparation of Oleum Fructus Bruceae microemulsion and stability study " 199～201) to prior art.This article adopts microemulsion to prepare oral Oleum Fructus Bruceae microemulsion as pharmaceutical carrier.As a kind of novel medicament carrier, microemulsion can reduce first pass effect, and the intensifier target tropism improves bioavailability of medicament.It is compared to Oleum Fructus Bruceae Orally taken emulsion and the injectable emulsion that has gone on the market, and bioavailability improves, and is easy to swallow, and the minimizing patient takes the untoward reaction in the process, and is that thermodynamically stable homodisperse is.But the shortcoming that its system exists is that medicament contg is less, has water in the system, can not further cover the bad smell of medicine, reduces medicine to the gastrointestinal stimulation.
Summary of the invention
The present invention is directed to the prior art above shortcomings, Oleum Fructus Bruceae oral preparation composition of a kind of self-microemulsion and preparation method thereof is provided, do not need special equipment, preparation manipulation is simple, and the composition particle size distribution that obtains evenly and be easy to preserve.
The present invention is achieved by the following technical solutions:
The present invention relates to a kind of Oleum Fructus Bruceae oral preparation composition of self-microemulsion, its component and mass percentage content are: Oleum Fructus Bruceae 9%-35%, emulsifying agent 45%-62%, co-emulsifier 2%-20% and oils and fats 0%-18%.
Described emulsifying agent is selected from a kind of or its mixture in polyoxyethylene castor oil, polyoxyethylene hydrogenated Oleum Ricini, polyglyceryl fatty acid ester, phospholipid, the tween 80.
Described co-emulsifier is selected from a kind of or its mixture in ethanol, propylene glycol, glycerol or the Polyethylene Glycol.
Described oils and fats is selected from a kind of or its mixture in oleic acid, ethyl oleate, Ethyl linoleate, glyceryl linoleate, hot capric acid polyethyleneglycol glyceride, hot tricaprin, Oleum Ricini, Semen Maydis oil, soybean oil, the isopropyl myristate.
The particle size distribution of described Oleum Fructus Bruceae oral preparation composition is between 10-100nm.
The present invention relates to the preparation method of above-mentioned composition, by emulsifying agent is mixed the water bath with thermostatic control that obtains mixed emulsion and place 37 ± 1 ℃ with co-emulsifier, simultaneously oils and fats and Oleum Fructus Bruceae are mixed when being incorporated in stirring dropping in the mixed emulsion, be added dropwise to complete the back compositions vortex mixing 30 seconds.
Described compositions can place capsule by canning means, obtains soft capsule.
The Oleum Fructus Bruceae oral preparation composition of self-microemulsion of the present invention not only can be applied to treat pulmonary carcinoma, lung cancer with brain metastasis hepatocarcinoma, gastric cancer, breast carcinoma and malignant tumor of digestive tract, also can be used for treating in the aspect medicines such as non-tumor disease such as chronic gastritis, colitis and condyloma acuminatum.
Compared with prior art, the Oleum Fructus Bruceae oral preparation composition of self-emulsifying microemulsion of the present invention, after oral, absorb the interior moisture of gastrointestinal tract and carry out self-emulsifying microemulsion, formed microemulsion is a kind of transparent, low viscosity, each homogeny and thermodynamically stable profit hybrid system, its particle diameter is even, is distributed between the 10-100nm.The preparation of self-emulsifying microemulsion oral administration system does not need special equipment, simple to operate, and be easy to preserve, as a kind of novel medicament carrier, the present invention possesses low viscosity, stable, absorb rapidly, characteristics such as target administration, and improve the oral absorption of medicine, improve bioavailability of medicament, reduce toxic and side effects.
Description of drawings
Fig. 1 is the particle size distribution figure of Oleum Fructus Bruceae microemulsion of the present invention.
The specific embodiment
Below embodiments of the invention are elaborated, present embodiment is being to implement under the prerequisite with the technical solution of the present invention, provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
Embodiment 1
The component of the self-emulsifying composition of present embodiment and percentage by weight thereof are: Oleum Fructus Bruceae 30%, blended emulsifier 62%, co-emulsifier 8%.
Described emulsifying agent is polyoxyethylene hydrogenated Oleum Ricini and polyglyceryl fatty acid ester.
Described co-emulsifier is a glycerol.
The preparation technology of the self-emulsifying composition in the present embodiment is: the polyoxyethylene hydrogenated Oleum Ricini and the polyglyceryl fatty acid ester of measuring recipe quantity add glycerol mixing, vortex mixing; Measure Oleum Fructus Bruceae (37 ± 1) ℃ water bath with thermostatic control 10min.The limit mixes the Emulsion limit and drips medicine, vortex mixing 30 seconds.(37 ± 1) ℃ water bath with thermostatic control 30min.
The beneficial effect of present embodiment is: after (1) diluted 100 times with the self-emulsifying composition for preparing, the mensuration mean diameter was 35.2nm, and particle size distribution is seen accompanying drawing 1.By accompanying drawing 1 as seen, the particle diameter of this microemulsion system is except that the minority granule, and the overwhelming majority meets in the pharmaceutics requirement to microemulsion formulation at 10-100nm.(2) because particle diameter is little, medicine degree of scatter height, thus the degree of absorption of increase medicine improves bioavailability.
Embodiment 2
The component of the self-emulsifying composition of present embodiment and percentage by weight thereof are: Oleum Fructus Bruceae 17.5%, emulsifying agent 45%, co-emulsifier 20%, oils and fats 17.5%.
Described emulsifying agent is a polyoxyethylene castor oil.
Described co-emulsifier is a propylene glycol.
Described oils and fats is an oleic acid.
The preparation technology of the self-emulsifying composition in the present embodiment is: the polyoxyethylene castor oil of measuring recipe quantity adds mixed with propylene glycol, vortex mixing; Measure oleic acid and add Oleum Fructus Bruceae (37 ± 1) ℃ water bath with thermostatic control 10min.The limit mixes the Emulsion limit and drips medicine, vortex mixing 30 seconds.(37 ± 1) ℃ water bath with thermostatic control 30min.
The beneficial effect of present embodiment is: (1) with 100 times of the self-emulsifying composition dilutions of preparation after, the mensuration mean diameter is 50.76nm, particle diameter is less than 100nm, meets in the pharmaceutics requirement to microemulsion formulation.(2) because particle diameter is little, medicine degree of scatter height, thus the degree of absorption of increase medicine improves bioavailability.
Embodiment 3
The component of the self-emulsifying composition of present embodiment and percentage by weight thereof are: Oleum Fructus Bruceae 9%, emulsifying agent 55%, mix co-emulsifier 18%, oils and fats 18%.
Described emulsifying agent is a polyoxyethylene castor oil.
Described co-emulsifier is ethanol and PEG400.
Described oils and fats is an Oleum Ricini.
The preparation technology of the self-emulsifying composition in the present embodiment is: the polyoxyethylene castor oil of measuring recipe quantity adds ethanol and PEG400 mixing, vortex mixing; Measure Oleum Ricini and add Oleum Fructus Bruceae (37 ± 1) ℃ water bath with thermostatic control 10min.The limit mixes the Emulsion limit and drips medicine, vortex mixing 30 seconds.(37 ± 1) ℃ water bath with thermostatic control 30min.
The beneficial effect of present embodiment is: (1) with 100 times of the self-emulsifying composition dilutions of preparation after, the mensuration mean diameter is 40.9nm, particle diameter is less than 100nm, meets in the pharmaceutics requirement to microemulsion formulation.(2) because particle diameter is little, medicine degree of scatter height, thus the degree of absorption of increase medicine improves bioavailability.
Embodiment 4
The component of the self-emulsifying composition of present embodiment and percentage by weight thereof are: Oleum Fructus Bruceae 14.3%, emulsifying agent 60%, co-emulsifier 20%, oils and fats 5.7%.
Described emulsifying agent is a polyoxyethylene hydrogenated Oleum Ricini.
Described co-emulsifier is a PEG400.
Described oils and fats is an Ethyl linoleate.
The preparation technology of the self-emulsifying composition in the present embodiment is: the polyoxyethylene hydrogenated Oleum Ricini of measuring recipe quantity adds PEG400 and mixes the vortex mixing; Measure Ethyl linoleate and add Oleum Fructus Bruceae (37 ± 1) ℃ water bath with thermostatic control 10min.The limit mixes the Emulsion limit and drips medicine, vortex mixing 30 seconds.(37 ± 1) ℃ water bath with thermostatic control 30min.
The beneficial effect of present embodiment is: (1) with 100 times of the self-emulsifying composition dilutions of preparation after, particle diameter is less than 100nm, meets in the pharmaceutics requirement to microemulsion formulation.(2) because particle diameter is little, medicine degree of scatter height, thus the degree of absorption of increase medicine improves bioavailability.
Embodiment 5
The component of the self-emulsifying composition of present embodiment and percentage by weight thereof are: Oleum Fructus Bruceae 30%, emulsifying agent 50%, co-emulsifier 2%, oils and fats 18%.
Described emulsifying agent is a polyoxyethylene hydrogenated Oleum Ricini; Described co-emulsifier is a propylene glycol; Described oils and fats is a glyceryl linoleate.
The preparation technology of the self-emulsifying composition in the present embodiment is: the polyoxyethylene hydrogenated Oleum Ricini of measuring recipe quantity adds mixed with propylene glycol, vortex mixing; Measure glyceryl linoleate and add Oleum Fructus Bruceae (37 ± 1) ℃ water bath with thermostatic control 10min.The limit mixes the Emulsion limit and drips medicine, vortex mixing 30 seconds.(37 ± 1) ℃ water bath with thermostatic control 30min.
The beneficial effect of present embodiment is: (1) with 100 times of the self-emulsifying composition dilutions of preparation after, particle diameter is less than 100nm, meets in the pharmaceutics requirement to microemulsion formulation.(2) because particle diameter is little, medicine degree of scatter height, thus the degree of absorption of increase medicine improves bioavailability.
Embodiment 6
The Oleum Fructus Bruceae self-emulsification soft capsules of inventing in order to check has been studied the influence that Oleum Fructus Bruceae self-emulsification soft capsules, fluorouracil (5-Fu), bruceolic oil emulsion oral liquid are bred two kinds of human tumor cell lines of In vitro culture to the inhibitory action of tumor cell in vitro.
Oleum Fructus Bruceae self-emulsification soft capsules of the present invention sees the following form to the human hepatoma cell strain SMMG-7721 of In vitro culture and the influence of human stomach cancer cell line BGC-823 propagation.Shown in table 1 and table 2, YDZ and KFY all have inhibitory action in various degree to the propagation of 2 kinds of human tumor cell lines such as SMMC-7721, its suppression ratio is along with the increase of drug level is obviously risen, be the dose-effect dependence, wherein to YDZ tumor-inhibiting action reaction the most responsive be human hepatoma cell strain SMMC-7721.And by to the analysis of YDZ and KFY tumor control rate and half amount of suppression (IC50) as can be seen, the tumor-inhibiting action of Oleum Fructus Bruceae self-microemulsion is better than oral liquid.
Table 1 Oleum Fructus Bruceae self-microemulsion is to the influence of the human hepatoma cell strain SMMG-7721 propagation of In vitro culture
Compare with the feminine gender group: * P＜0.05
Table 2 Oleum Fructus Bruceae self-microemulsion is to the influence of the human stomach cancer cell line BGC-823 propagation of In vitro culture
Compare with the feminine gender group: * P＜0.05
Claims (8)
1. the Oleum Fructus Bruceae oral preparation composition of a self-microemulsion is characterized in that, its component and mass percentage content are: Oleum Fructus Bruceae 9%-35%, emulsifying agent 45%-62%, co-emulsifier 2%-20% and oils and fats 0%-18%.
2. the Oleum Fructus Bruceae oral preparation composition of self-microemulsion according to claim 1, it is characterized in that described emulsifying agent is selected from a kind of or its mixture in polyoxyethylene castor oil, polyoxyethylene hydrogenated Oleum Ricini, polyglyceryl fatty acid ester, phospholipid or the tween 80.
3. the Oleum Fructus Bruceae oral preparation composition of self-microemulsion according to claim 1 is characterized in that, described co-emulsifier is selected from a kind of or its mixture in ethanol, propylene glycol, glycerol or the Polyethylene Glycol.
4. the Oleum Fructus Bruceae oral preparation composition of self-microemulsion according to claim 1, it is characterized in that described oils and fats is selected from a kind of or its mixture in oleic acid, ethyl oleate, Ethyl linoleate, glyceryl linoleate, hot capric acid polyethyleneglycol glyceride, hot tricaprin, Oleum Ricini, Semen Maydis oil, soybean oil or the isopropyl myristate.
5. the Oleum Fructus Bruceae oral preparation composition of self-microemulsion according to claim 1 is characterized in that, the particle size distribution of described Oleum Fructus Bruceae oral preparation composition is between 10-100nm.
6. preparation method according to the described Oleum Fructus Bruceae oral preparation composition of above-mentioned arbitrary claim, it is characterized in that, by emulsifying agent is mixed the water bath with thermostatic control that obtains mixed emulsion and place 37 ± 1 ℃ with co-emulsifier, simultaneously oils and fats and Oleum Fructus Bruceae are mixed when being incorporated in stirring dropping in the mixed emulsion, be added dropwise to complete the back compositions vortex mixing 30 seconds.
7. the preparation method of the soft capsule of an Oleum Fructus Bruceae oral preparation composition according to claim 6 is characterized in that, places capsule by the compositions that described preparation method is obtained by canning means, obtains soft capsule.
8. a soft capsule is characterized in that, contains arbitrary described Oleum Fructus Bruceae oral preparation composition in the aforesaid right requirement 1 to 5.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102274274A (en) * | 2011-08-05 | 2011-12-14 | 上海交通大学 | Self-microemulsifiable kudzu root flavone oral micro-pill composition and preparation method thereof |
| CN103536632A (en) * | 2012-07-17 | 2014-01-29 | 陕西省中医药研究院 | Self-microemulsifying brucea javanica oil oral granules and preparation method thereof |
| CN103610711A (en) * | 2013-11-21 | 2014-03-05 | 浙江中医药大学 | Borneol and oleum fructus bruceae nanoemulsion and preparation method thereof |
| CN104706689A (en) * | 2013-12-16 | 2015-06-17 | 天津迈迪瑞康生物医药科技有限公司 | Oleum fructus bruceae fat emulsion concentrated solution, preparation method and application thereof |
| CN105582029A (en) * | 2014-10-21 | 2016-05-18 | 上海中医药大学 | Brucea javanica oil floating type gastric retention microsphere and preparation method thereof |
| CN106309515A (en) * | 2015-07-08 | 2017-01-11 | 上海中医药大学附属龙华医院 | Brucea javanica oil lyotropic liquid crystal nanoparticle dispersion body, raw material composition and preparation method |
| CN111228319A (en) * | 2020-03-30 | 2020-06-05 | 广东省微生物研究所（广东省微生物分析检测中心） | Brucea javanica extract, preparation method thereof and application thereof in preventing and treating breast cancer |
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Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102274274A (en) * | 2011-08-05 | 2011-12-14 | 上海交通大学 | Self-microemulsifiable kudzu root flavone oral micro-pill composition and preparation method thereof |
| CN102274274B (en) * | 2011-08-05 | 2013-11-20 | 上海交通大学 | Self-microemulsifiable kudzu root flavone oral micro-pill composition and preparation method thereof |
| CN103536632A (en) * | 2012-07-17 | 2014-01-29 | 陕西省中医药研究院 | Self-microemulsifying brucea javanica oil oral granules and preparation method thereof |
| CN103536632B (en) * | 2012-07-17 | 2018-05-08 | 陕西省中医药研究院 | A kind of brucea fruit oil oral granular formulation of self-microemulsion and preparation method thereof |
| CN103610711A (en) * | 2013-11-21 | 2014-03-05 | 浙江中医药大学 | Borneol and oleum fructus bruceae nanoemulsion and preparation method thereof |
| CN103610711B (en) * | 2013-11-21 | 2016-03-09 | 浙江中医药大学 | A kind of Borneolum Syntheticum brucea fruit oil nanometer emulsion and preparation method thereof |
| CN104706689A (en) * | 2013-12-16 | 2015-06-17 | 天津迈迪瑞康生物医药科技有限公司 | Oleum fructus bruceae fat emulsion concentrated solution, preparation method and application thereof |
| CN105582029A (en) * | 2014-10-21 | 2016-05-18 | 上海中医药大学 | Brucea javanica oil floating type gastric retention microsphere and preparation method thereof |
| CN105582029B (en) * | 2014-10-21 | 2019-12-24 | 上海中医药大学 | Brucea javanica oil floating type gastric stasis microspheres and preparation method thereof |
| CN106309515A (en) * | 2015-07-08 | 2017-01-11 | 上海中医药大学附属龙华医院 | Brucea javanica oil lyotropic liquid crystal nanoparticle dispersion body, raw material composition and preparation method |
| CN111228319A (en) * | 2020-03-30 | 2020-06-05 | 广东省微生物研究所（广东省微生物分析检测中心） | Brucea javanica extract, preparation method thereof and application thereof in preventing and treating breast cancer |
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Application publication date: 20110223 |