CN100421719C - Chinese medicine volatoile oil self-mciro emulsifying nano composition and preparing method - Google Patents
Chinese medicine volatoile oil self-mciro emulsifying nano composition and preparing method Download PDFInfo
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Abstract
The present invention discloses a traditional Chinese medicine volatile oil self-microemulsion nanometer composition and a preparation method. The components and the weight percentage contents of the traditional Chinese medicine volatile oil self-microemulsion nanometer composition of the present invention are 0.2 to 40% of traditional Chinese medicine volatile oil, 0.4 to 80% of surface active agent, 0 to 40% of cosurfactant and 0 to 99.40% of water. The present invention combines a self-microemulsion nanometer technology and traditional Chinese medicine volatile oil, medicine can be emulsified into the size of nanometer by itself in bodies, such as oral soft capsules, oral liquid, etc.; or medicine can exist in the form of nanometer preparations outside bodies, such as a sterile solution form and is prepared into injections, suction solutions, etc. The prepared self-microemulsion nanometer composition lowers the stimulation and the toxin of medicine and improves the absorption speed rate and the mucosa penetration capability of medicine simultaneously. Thereby, the biological availability of medicine is improved, the therapeutic effect of medicine is strengthened, and the compliance of patients for medication is improved.
Description
Technical field
The present invention relates to a kind of traditional medicine volatile oil self-mciro emulsifying nano composition and preparation method.
Background technology
The volatile oil that exists in the Chinese medicine is the composition of a class biologically active, also is called quintessence oil.Usually it is with the vapor distillation gained and the general name immiscible volatilization oily composition of water from Chinese medicine.Volatile oil is the oily liquids with special strong abnormal smells from the patient under normal conditions, can wave diffusingly at normal temperatures, can be dissolved in dense ethanol and most of organic solvent, and is water-soluble hardly; Responsive to air, daylight and Temperature Influence, be easy to decompose rotten.And volatile oil and biomembranous affinity are poor, thereby affect the treatment, and its foreign odor causes the patient to be difficult for accepting.Maximum with oral formulations in research and the clinical practice, main employing is made into soft gelatin capsule (Oleum Folium Artemisiae Argyi soft gelatin capsule), microencapsule tablet (Vitex chinensis Mill. leaf volatile oil microencapsule tablet), beta cyclodextrin clathrate, the dried breast of micropowder silica gel etc. and carries out administration.
The notion that proposes nanoparticle and nanocapsule from people such as Birrenbach in 1976 till now, the research of nanotechnology has become one of research focus of pharmaceutical field, has produced the nanocapsule drug-supplying system, comprises nanoparticle (Nanoparticles, NP), nanosphere (Nanoshere, NS), nanocapsule (Nanocapsules, NC), nano-micelle (Nano-liposomes, NL) and nano-emulsion (Nano-emulsion, NE) etc.Nanometer is applied to respectively as carrier in the administration of antineoplastic agent, anti-infective, polypeptide and protein medicaments, has the absorption that increases medicine, the release of control medicine, the interior distribution characteristics of body that changes medicine, the characteristics such as film transporting mechanism of change medicine.
In the numerous nanotechnology research of pharmaceutical field, a good appetite suddenly appearing in a serious disease prescription body have related outside, the research of Chinese medicine compound nanometer formulation is then very few, and the research of volatile oil far lags behind the medicine of other types.
Summary of the invention
The technical issues that need to address of the present invention are to disclose a kind of traditional medicine volatile oil self-mciro emulsifying nano composition and preparation method, to satisfy the needs of clinical practice.
Technical conceive of the present invention is such:
The present invention adopts the self-mciro emulsifying nano technology from volatile oil characteristics and pharmacological action, the oiliness medicine is made the nano-composition of self-microemulsion.After said composition is oral, can in Digestive system, become the breast grain of particle diameter in nanoscale by self-emulsifying microemulsion; Or it is directly mixed with water, make volatile oil be wrapped in the nanocapsule, make and to add microemulsion aqueous medium dilution, low viscosity and low surface tension, breakdown of emulsion when having avoided conventional Emulsion to dilute, and make dispersion increase more than 10 times, when reducing medicine irritation, improve drug absorption speed and saturating mucosa ability, and then improve bioavailability of medicament.
Nano-emulsion (Nanoemulsion) is meant that the diameter of emulsion droplet is in a kind of special Emulsion of nanoscale.1985, the microemulsion that Shah proposes is defined as: microemulsion was two kinds of mutual exclusive liquid, thermodynamically stable, isotropic, the transparent dispersion that generates under the effect of surfactant molecule interfacial film.
The component of traditional medicine volatile oil self-mciro emulsifying nano composition of the present invention and weight percent content are:
Traditional medicine volatile oil 0.2-40%
Surfactant 0.4-80%
Cosurfactant 0-40%
Water 0-99.40%.
Described traditional medicine volatile oil comprises one or more in Oleum Bupleuri, Oleum Cinnamomi, Oleum Viticis Negundo, oil of Rhizoma Acori Graminei, Oleum Terebinthinae, Oleum Eucalypti, Herba Asari volatile oil, Rhizoma Curcumae volatile oil, Herba Houttuyniae volatile oil, Rhizoma Curcumae Longae volatile oil, ZENAN volatile oil, Radix agastaches volatile oil, Folium Perillae volatile oil, Cortex Magnoliae Officinalis volatile oil, Oleum Caryophylli, Oleum Fructus Bruceae, Bulbus Allii quintessence oil, Oleum Anisi Stellati, Folium Artemisiae Argyi volatile oil and the Semen zanthoxyli volatile oil;
Above-mentioned traditional medicine volatile oil can adopt conventional vapor distillation to extract, also can adopt the method for supercritical extraction to extract (same " Chinese crude drug " 1995,18 (1): 569-572, Ge Fahuan etc. supercritical extraction CO
2The research of volatile component in the extraction Herba Artemisiae annuae; " Chinese crude drug " 1996,27 (1): 15-17, Cui Gang etc. the supercritical fluid extraction of Radix Oenotherae erythrosepalae and quality research).
The surfactant of being addressed is selected a kind of in Polysorbate, poloxamer, Myrij (Mjri), Brij (Brij), lecithin, soybean phospholipid, sodium lauryl sulphate, glyceryl monostearate, sucrose ester, the polyoxyethylene castor oil condensation substance or several for use;
The cosurfactant of being addressed is a kind of in the macromolecular material, ethanol, propylene glycol of gelatin substance, the synthetic of natural extract or several, the gelatin substance of described natural extract is selected alginate, arabic gum, Lac, chitosan, tragakanta, pectin, agar etc. for use, the high score material selection hydroxypropyl emthylcellulose of described synthetic, hydroxypropyl cellulose, carboxymethyl cellulose etc.
The inventor finds that in order to obtain the effect of self-emulsifying microemulsion, the ratio of surfactant and cosurfactant and traditional medicine volatile oil is very crucial.Though a large amount of surfactants and cosurfactant help the self-emulsifying microemulsion effect, they itself have certain toxicity, too much add affiliation and have side effects.Under the prerequisite that does not influence the self-emulsifying microemulsion effect, the addition of preferred surfactant is 1～2 times of volatile oil, according to the characteristics of prescription needs and volatile oil and each surfactant, adds an amount of cosurfactant simultaneously.
The preparation method of traditional medicine volatile oil self-mciro emulsifying nano composition of the present invention comprises as follows:
Traditional medicine volatile oil, surfactant and cosurfactant are stirred after the mixed by prescription, in whipping process, can use the mixing ultrasonic or quickening of high-speed homogenization machine traditional medicine volatile oil, surfactant and cosurfactant, treat to add required water mix homogeneously by the prescription requirement behind these three component mix homogeneously.
Technical characterstic of the present invention is: first self-mciro emulsifying nano technology and traditional medicine volatile oil are combined, medicine self emulsifying in vivo becomes the nanometer size, as oral soft capsule, oral liquid etc.; Or exist as existing with the sterile solution form in external form with nanometer formulation, be prepared into injection, suck solution etc.Prepared self-mciro emulsifying nano composition is reducing medicine irritation and is toxicly improving drug absorption speed and saturating mucosa ability simultaneously, and then improves bioavailability of medicament, strengthens the curative effect of medicine, improves the compliance of patient's medication.
Description of drawings
Fig. 1 is oil phase, the water of embodiment 1, the three-phase diagram of surfactant phase.
The specific embodiment
Traditional medicine volatile oil among the embodiment all adopts the document disclosed method to be prepared.Can adopt conventional vapor distillation to extract, also can adopt the method for supercritical extraction to extract (same " Chinese crude drug " 1995,18 (1): 569-572, Ge Fahuan etc. supercritical extraction CO
2The research of volatile component in the extraction Herba Artemisiae annuae; " Chinese crude drug " 1996,27 (1): 15-17, Cui Gang etc. the supercritical fluid extraction of Radix Oenotherae erythrosepalae and quality research).
Embodiment 1
Get Oleum Folium Artemisiae Argyi 2g, Oleum Asari 1g mix homogeneously is stand-by.Add polyoxyethylene hydrogenated Oleum Ricini 3g, Polysorbate 1g, after being mixed, add water 200g, the limit edged stirs, and waits to clarify back 0.2um filtering with microporous membrane, promptly obtains suction solution of the present invention by the required dosage branch Brown Glass Brown glass bottles and jars only of packing into.
Fig. 1 is the three-phase diagram of oil phase, water, surfactant phase.1 is microemulsion region, and 2 is the gel district.
As seen from Figure 1, in gel district 2, three-phase mixture is can not free-pouring almost transparent semisolid, this semisolid is put into water, but self emulsifying becomes viscosity and water is proximate, free flowable, slightly with or without the liquid of blue-fluorescence, volatile oil in this liquid with nano-scale disperse (＜200nm); In microemulsion region 1, contain medicine liquid droplet with nanometer size (in the 200nm, more preferably in the 100nm), for viscosity and water is proximate, free flowable, slightly with or without the liquid of blue-fluorescence.
Get Oleum Folium Artemisiae Argyi 2g, zanthoxylum seed oil 10g mix homogeneously is stand-by.Add polyoxyethylene hydrogenated Oleum Ricini 15g, Polysorbate 5g, after being mixed, add water 200g, the limit edged stirs, wait to clarify the back and use the 0.2um filtering with microporous membrane, promptly obtain suction solution of the present invention, have the effect of rapid relieving asthma by the required dosage branch Brown Glass Brown glass bottles and jars only of packing into.
Embodiment 3
Get Herba Pogostemonis oil 5.4g, Folium perillae acutae oil 2.6g, mix homogeneously.Add Polysorbate 4g, polyoxyethylene hydrogenated Oleum Ricini 6g and use high-speed homogenization machine homogenize 10 minutes.The volatile oil mixed liquor that adds entry 300g, joins before pouring into continues homogenate 20 minutes.With promptly obtaining the oral liquid of traditional medicine volatile oil self-mciro emulsifying nano composition of the present invention by the required dosage Brown Glass Brown glass bottles and jars only of packing into behind the 0.45um filtering with microporous membrane.This prescription has been avoided with an organic solvent in preparation process, thereby has reduced the pollution to environment, has reduced production cost.
Embodiment 4
Get Bulbus Allii quintessence oil 30g, Polysorbate 37.5g, Brij 7.5g fully mixes three components, ultrasonic 30 minutes to be mixed evenly uses rotation rolling capsule machine compacting soft capsule automatically by required dosage, promptly obtains Bulbus Allii quintessence oil soft capsule of the present invention.
Oleum Terebinthinae 20g, surfactant lecithin 55g and polyoxyethylene hydrogenated Oleum Ricini 65g are mixed, ultrasonic 10 minutes, add behind the entry 10g mix homogeneously by the required dosage Brown Glass Brown glass bottles and jars only of packing into, roll the Oleum Terebinthinae spray that manual spray valve promptly gets external with sealing machine.
Embodiment 6
Get surfactant polyoxyethylene castor oil hydrogenated 25g, Polysorbate 25g, cosurfactant glycerol 40g, mix homogeneously, stir, add Oleum Viticis Negundo 10g high-speed homogenization machine homogenize 10 minutes, treat to use rotation rolling capsule machine compacting soft capsule automatically by required dosage behind the mixing, promptly obtain Oleum Viticis Negundo soft capsule of the present invention.
Embodiment 7
Get Oleum Fructus Bruceae 12g, surfactant Polysorbate 10g, polyoxyethylene hydrogenated Oleum Ricini 12g, cosurfactant ethanol 0.05g, water 500g, preparation process promptly obtains Oleum Fructus Bruceae oral microemulsion of the present invention with embodiment two.
Embodiment 8
The consumption of each raw material is as follows in the present embodiment:
Volatile oil: Oleum Bupleuri 30g,
Surfactant: soybean phospholipid 20g, glycerol 10g, poloxamer 12g
Cosurfactant: ethanol 1g, propylene glycol 1g,
Normal saline 30g
Preparation method is with soybean phospholipid 20g, glycerol 10g, poloxamer 12g, ethanol 1g and propylene glycol 1g, back adding Oleum Bupleuri oil 30g stirs, high-speed homogenization machine homogenize 15 minutes, add normal saline water 300g, use the 0.2um filtering with microporous membrane behind the mix homogeneously, pack in the ampoule behind the high temperature sterilize by required dosage, promptly obtain the injection of traditional medicine volatile oil self-emulsifying nanometer compositions of the present invention.
Embodiment 9
The consumption of each raw material is as follows in the present embodiment:
Volatile oil: turmeric oil 25g,
Surfactant: sodium lauryl sulphate 20g, glyceryl monostearate 20g, sucrose ester 10g,
Water 500g
Preparation method prepares the turmeric oil oral liquid with embodiment 2.
Embodiment 10
The consumption of each raw material is as follows in the present embodiment:
Volatile oil: Herba Houttuyniae volatile oil 12g,
Surfactant: soybean phospholipid 24g,
Normal saline 6000g
Preparation method prepares Herba Houttuyniae injectio with embodiment 7
Embodiment 11
The consumption of each raw material is as follows in the present embodiment:
Volatile oil: Cortex Magnoliae Officinalis volatile oil 18g,
Surfactant: Myrij 36g,
Cosurfactant: ethanol 25g, propylene glycol 25g,
Water 750g
Preparation method can get Cortex Magnoliae Officinalis oil oral liquid with embodiment 2.
Water, oil phase, surfactant and cosurfactant ratio among each embodiment.
The agent alive of volatilization oil meter helps water
1.45％ 1.93％ 0.00％ 96.62％
5.17％ 8.62％ 0.00％ 86.21％
2.52％ 3.14％ 0.00％ 94.34％
40.00％ 60.00％ 0.00％ 0.00％
13.33％ 80.00％ 0.00％ 6.67％
10.00％ 50.00％ 40.00％ 0.00％
2.25％ 4.12％ 0.01％ 93.62％
28.85％ 40.38％ 1.92％ 28.85％
4.35％ 8.70％ 0.00％ 86.96％
0.20％ 0.40％ 0.00％ 99.40％
2.11％ 4.22％ 5.85％ 87.82％
Embodiment 1 carries out pharmacodynamics test according to the declaration of respiratory medicine new drug about the test direction principle of pharmacodynamics after sample preparation is finished.
(1). antitussive effect
[operating procedure]
White mice is placed in the 500ml glass bell jar, connect the glass fog-spray nozzle by air compressor, with the 400mmHg constant voltage ammonia (25～28% ammonium hydroxide) is sprayed in the bell jar equably, sprayed for 5 seconds, observe and write down the cough latent period of white mice then and the number of times of coughing in 2 minutes.
[experiment grouping]
The mice random packet, 15 every group, matched group and positive drug matched group are all established in each experiment, and (15～25mg/kg) as positive drug to select carbetapentane citrate for use.
[experimental result]
As seen from table, this product can obviously prolong the cough latent period of mice, and significantly reduces the cough number of times in the certain hour, with negative control group comparing difference highly significant (P＜0.01).
(2). antiasthmatic effect
[ultimate principle]
Medicine such as histamine, acetylcholine etc. with bronchoconstriction effect give Cavia porcellus with aeroponics and suck, and can cause Cavia porcellus air flue spasm, thus cause pant, suffocating causes animal to twitch and falls.This drug-induced asthma guinea pig model can be used for observing the antiasthmatic effect (mainly being bronchiectatic activity) of medicine.This law has easy, the characteristics of reliable results.
[operating procedure]
Draw and breathe heavily device: the glass bell jar by air compressor, ultrasound atomizer, hydrargyrum manometer, base and 4L constitutes the fog chamber.
Childhood Cavia porcellus (body weight＜200g), male and female all can, respectively seemingly in the glass bell jar, spray into 2% acecoline and 15 seconds of 0.1% histamine phosphate's isometric(al) mixed liquor with the pressure of 400mmHg.After spraying stops, observing Cavia porcellus draw and breathe heavily incubation period (promptly from spraying begin to asthma attack, breathe be the devil, until time that tic is fallen), with the number of animals that takes place to twitch.Cavia porcellus should select in advance, draws to breathe heavily incubation period＞120 a second person and do not select.Learn from else's experience to measure to draw and breathe heavily qualified Cavia porcellus incubation period, be subjected to reagent thing drawing to suck earlier before breathing heavily next day, observes after the medication to draw and breathe heavily incubation period and the number of animals that tic takes place.The relatively variation before and after the medication.
[experiment grouping]
Cavia porcellus is divided matched group and medication group at random, 8 every group.3 groups of medication groups, 1 group of matched group, 1 group of negative control group.Adopt the inhalation administration.
[experimental result]
As seen from table, the heavy dose of administration group of Chinese medicine ultrasonic atomizatio agent significantly prolonged guinea pig cause the time of breathing heavily, illustrate to have significant antiasthmatic effect.
Embodiment 8 carries out pharmacodynamics test according to the declaration of nervous system medication new drug about the test direction principle of pharmacodynamics after sample preparation is finished.
[operating procedure]
18 of rats are divided 3 groups at random, intravenous drug or water, 1 hour subcutaneous injection 10% sterilised yeast suspension 10ml/kg behind the medicine, each survey in the 3rd, 4,5,10,24 hour once, represent drug potency with the body temperature of different time and the temperature difference of basal body temperature, the results are shown in following table.
[experimental result]
The result shows that preparation of the present invention has tangible refrigeration function to rat owing to the caused fervescence of yeast, and is rapid-action, still effective in cure to 24 hours.
Claims (1)
1. a traditional medicine volatile oil self-mciro emulsifying nano composition is characterized in that, component and weight percent content are:
Traditional medicine volatile oil 0.2-40%
Surfactant 0.4-80%
Cosurfactant 0-40%
Water 0-99.40%
Described traditional medicine volatile oil comprises one or more in Oleum Bupleuri, Oleum Cinnamomi, Oleum Viticis Negundo-Herba Asari volatile oil, Rhizoma Curcumae volatile oil, Herba Houttuyniae volatile oil, Rhizoma Curcumae Longae volatile oil, Radix agastaches volatile oil, Folium Perillae volatile oil, Oleum Caryophylli, Oleum Fructus Bruceae, Bulbus Allii quintessence oil, Oleum Anisi Stellati, Folium Artemisiae Argyi volatile oil and the Semen zanthoxyli volatile oil;
The surfactant of being addressed is selected a kind of in Polysorbate, poloxamer, Myrij, Brij, lecithin, soybean phospholipid, sodium lauryl sulphate, glyceryl monostearate, sucrose ester, the polyoxyethylene castor oil condensation substance or several for use;
The cosurfactant of being addressed is selected from a kind of or its mixture in ethanol or the propylene glycol;
The preparation method of above-mentioned traditional medicine volatile oil self-mciro emulsifying nano composition comprises the steps: traditional medicine volatile oil, surfactant and cosurfactant are stirred after the mixed by prescription, adds the entry mix homogeneously then.
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| CN1486684A (en) * | 2003-08-08 | 2004-04-07 | 中国科学院新疆理化技术研究所 | Herbal acne-eliminating cream |
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| CN1486684A (en) * | 2003-08-08 | 2004-04-07 | 中国科学院新疆理化技术研究所 | Herbal acne-eliminating cream |
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Granted publication date: 20081001 Termination date: 20150915 |
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