CN1709398A - Filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion and preparing method - Google Patents
Filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion and preparing method Download PDFInfo
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Abstract
The present invention relates to a Chinese medicine or animal plant volatile oil (fat) emulsion and its preparation method. Said injection composition includes (by wt%) 0.1-10% of Chinese medicine or animal plant volatile oil (fat), 0%-10% of injection oil (including medium and long chain oil), 0.5%-15% of emulsifier, 0%-3% of emulsification adjuvant and 1%-10% of isoosmotic regulating agent. Besides, it also contains pH regulating agent, antioxidant and preservative (bacteria inhibitor). Said emulsion can be filtered and sterilized by adopting micropore filtering membrane with 0.3 micron or less than 0.3 micron or G6 incipient fusion glass funnel.
Description
Technical field:
The present invention relates to medical technical field, exactly is a kind of filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion and preparation method.
Background technology:
The Caulis Gneti volatile oil component is analyzed " biotechnology 2003 "; 112, the experimentation of Herba Schizonepetae, Radix Saposhnikoviae volatile oil antiinflammatory action " Chengdu University of Traditional Chinese Medicine's journal " 2003; 113, the analysis " edible fungi of china " 2003 of wild and cultivating ganoderma volatile oil component; 114, the GC-MS of Fructus cinnamomi camphorae volatile oil analyzes " Chinese Medicine journal " 2003; 115, the research of Herba Kalimeridis volatile oil component " Chinese herbal medicine " 2003; 116, the different medicinal part volatile oil contents of Fructus Alpiniae Oxyphyllae are measured " Nanjing University of Traditional Chinese Medicine's journal " 2003; 117, orthogonal test is inquired into the extraction conditions " CHINA JOURNAL OF CHINESE MATERIA MEDICA 2003 " of Flos Lonicerae volatile oil; 118, chemical composition of volatile oil analysis " CHINA JOURNAL OF CHINESE MATERIA MEDICA " 2003 in the Folium Pini; 119, the FE-CO2 extraction is to the analysis " CHINA JOURNAL OF CHINESE MATERIA MEDICA " 2003 of volatile oil monoterpenes component content influence; 120, several processing methods of traditional medicine volatile oil in preparation " time precious traditional Chinese medical science traditional Chinese medicines " 2003; 121, the experimentation of microwave extraction Fructus Foeniculi Olibanum Herba Schizonepetae volatile oil " Chinese medicine academic periodical " 2003; 122, " new Chinese medicine and clinical pharmacology " 2003 Rhizoma Zingiberis Recens volatile oil composition gas chromatogram finger printing research I); 123, the research of Rhizoma Acori Graminei volatile oil composition " Guiyang Medical College journal " 2003; 124, GC-MS sets up Stone steles Herba Pogostemonis Volatile oil fingerprint spectrum method and learns research " Chinese patent medicine " 2003; 125, Pseudobulbus Cremastrae seu Pleiones chemical composition of volatile oil gas chromatogram-mass spectrometry is analyzed Xu Yurong " time precious traditional Chinese medical science traditional Chinese medicines " 2003; 126, the volatile oil itching-relieving action related mechanism of Fructus Cnidii research " Chinese medicine and clinical " 2003; 127, the volatile oil content testing " health professional education " 2003 in Eucalyptus globulus Labill and the Folium Eucalypti Robustae different parts; 128, the Hydrocotyle sibthorpioides lam.Var.Batvachium (Hand.-Mazz.) et shan. chemical composition of volatile oil is analyzed " Chinese herbal medicine " 2003; 129, Olibanum volatile oil GC-MS Analysis of Chemical " Chinese herbal medicine " 2003; 130, the gas chromatography mass spectrometry analysis of volatile oil " pharmaceutical analysis magazine " 2003 in the Folium Cuculus polioephalus) in field of medicaments, be used widely.As Oleum Curcumae, Oleum Fructus Bruceae, Oleum Bulbus Allii, Oleum Bupleuri, elemene etc.Oleum Curcumae is the volatile material that extracts from zingiberaceous plant Rhizoma Curcumae rhizome, its main component is a sesquiterpene, comprise more than ten kind of compositions such as zederone and zedoarone, wherein the Rhizoma Curcumae sesquiterpene all has similarity with diethylstilbestrol on molecular structure and functional group, therefore, these materials and metabolite thereof may have the effect of steroid hormone sample in vivo or participate in the metabolism adjusting of steroid hormone, thereby show as estrogen-like effects.Oleum Curcumae has promoting flow of QI and blood, removing food stagnancy pain relieving, blood circulation promoting and blood stasis dispelling, removing the necrotic tissue and promoting granulation, enhancing human body immunity function, and can promote the healing of wound surface.In addition, Oleum Curcumae also has antiinflammatory, prevents that adhesion from forming that multiple efficacies such as leukocyte increasing and antitumor have also obtained suitable effect in the treatment of cervical cancer.Discover that Oleum Curcumae also has antivirus action, (RSV) has direct repression to respiratory syncytial virus, and influenza virus A1 and A3 type are had direct deactivation.Also can suppress staphylococcus aureus, escherichia coli, Bacillus typhi etc.Zoopery confirms: to mice acetic acid peritonitis, scald mice ear fat granuloma that mice local edema, Oleum Tiglii cause etc. inhibitory action is all arranged.With Zedoary turmeric oil glucose injection treatment child virus disease, long-term toxicity result shows that this product is harmless to main organs clinically.Oleum Fructus Bruceae extracts from java brucea seed, it has been prepared into Emulsion (comprising injection and oral liquid) now, its main component is an oleic acid, and it can suppress topoisomerase (TOPOII) activity, thereby suppress the synthetic and growth of cell DNA, the propagation of blocking-up cancerous cell.Bruceolic oil emulsion has selectivity to the tumor cancerous cell, and promptly film systems such as selective destruction cancer cell membrane and mitochondrion make the cancerous cell degeneration necrosis, and harmless to normal cell.Bruceolic oil emulsion has targeting to the tumor cancerous cell, and drug level is concentrated after the medication, and has specificity affinity closely with cancerous cell.It all has facilitation to humoral immunization and cellular immunization.It has the hemopoietic function effect that promotes bone marrow stem cell.Oleum Bulbus Allii is the main effective ingredient of Bulbus Allii.A large amount of pharmacological evaluation prove that Oleum Bulbus Allii has stronger antitumaous effect.Use Oleum Bulbus Allii 100mg/kg body weight, the abdominal cavity local injection just can suppress U14 fully and make mitosis with the S180 cancerous cell, makes most of cancerous cell that karyorrhexis, karyopycnosis take place on form, the degeneration variation of tumor cells such as Cytoplasm vacuolation.There is the author to analyze the influence of Oleum Bulbus Allii to the gastric carcinoma cells of In vitro culture from cell and gene level. find, the obviously anticancer growth of 50mg/L Oleum Bulbus Allii, similar Normocellular significant change takes place in the cellular morphology structure, and continues to keep its stable phenotype after stopping using this medicine 1wk.To induce the cell of differentiation to carry out the tumor after being inoculated into nude mice analysis through Oleum Bulbus Allii, the oncogenicity of this cell all disappears as a result.This experiment is significantly increased than matched group through the p53 and the p21 mRNA expression of people's gastric cancer BGC-823 cell that Oleum Bulbus Allii is handled.This results suggest Oleum Bulbus Allii can suppress the cell malignant proliferation by promoting the expression of antioncogene p53 and p21 thereby reach, apoptosis-induced and promotion cell differentiation.This research is proof further, Oleum Bulbus Allii has the obvious suppression effect and induces the differentiation effect the cancerous cell malignant proliferation, its mechanism may be by the adjusting that tumor-related gene in the pair cell is expressed realize (Oleum Bulbus Allii is to the growth inhibited of people's gastric cancer BGC-823 cell and induce the effect Chinese of differentiation to digest magazine on January 15th, 1998; 6 (1): 10-12).
All volatile oil dissolubility in water is all relatively poor, has part volatile oil also to have poor stability and the big problem of zest.Existing technology is to utilize Tween 80 to carry out solubilising, or adopts phospholipid, soybean oil to prepare Emulsion.All there is certain problem in these two kinds of methods.The former has problems such as haemolysis, allergy, and prolonged application still has mutagenic possibility.A large amount of surfactants that adopt not only increase cost, and more worthless is to lessen the curative effect, and increases toxic and side effects, even reduces the storage period of medicine.The problems that the latter then exists high temperature sterilize to bring, as the physical stability (layering, gathering etc.) of preparation, the chemical stability of supplementary material has many volatile oil easily to decompose under High Temperature High Pressure.
Summary of the invention:
The objective of the invention is to prepare can filtration sterilization Chinese medicine or animal-plant volatile oil (oils and fats) Emulsion, avoid the variety of issue that adopts Tween 80 or high temperature hot pressing sterilization zone.
Because the complicated component in Chinese medicine or the animal-plant volatile oil (oils and fats) contains chemical compound miscellaneous, and alcohols, ketone, esters, phenols, aldehydes etc. are arranged.Wherein phenols, aldehydes, enols used to heat, to light, all unstable to oxygen.When the preparation of this type of medicine of preparation, must consider their existence, adopt measures necessary, prevent or reduce the generation of oxidation.Be prepared into lipomul with existing fat milk technology, because the granularity of Emulsion is big, can not adopt the filter method degerming (if adopt 0.3um or less than the microporous filter membrane of 0.3um could breakdown of emulsion), need through the high temperature pressure sterilizing, can reduce stability equally, increase toxicity.A very practicable method is that existing formulation and technology is reformed, the Emulsion of preparation small grain size, thereby can adopt filter method or low temperature sterilization method to sterilize, the dissolving that can solve medicine is little, the problem of poor stability, can save cost again, improve the safety of medicine, guarantee the curative effect of medicine.
The granularity of Emulsion is also very important for special targeting administration.As the targeting of liver, generally speaking, the sick cell of hepatocarcinoma, hepatitis etc. is a hepatic parenchymal cells, if utilize galactose to carry out targeting drug delivery as part, the granularity of Emulsion is crucial, generally requires less than 100nm, otherwise is difficult to realize.In addition, sometimes need to realize the liver non-parenchymal cell targeting, as for anti-hepatic fibrosis medicines, there is data to show, liver nonparenchymal cell (NPC) plays an important role in the process of hepatic fibrosis as the medium that HSC, kupffer cell and sinusoidal endothelial cell discharge, can realize this purpose by the density that changes part on the Emulsion surface, but its prerequisite remains the granularity of Emulsion less than 100nm.
The problem that exists in view of aspects such as needs solve that drug solubility is little, poor stability, toxicity and curative effects, and the targeting drug delivery requirement of special organ, tissue, cell reduce the granularity of Emulsion, but preparation filtration sterilization Emulsion are particularly important.We find by a large amount of tests, midchain oil (or middle long-chain miscella, midchain oil: the ratio of long-chain oil is 1: 0～1: 5), vitamin E, tocopherol, ethyl oleate etc. are during as oil phase, adopt phospholipid, HS15 (Polyethylene Glycol 12-hydroxy stearic acid ester, polyethylene glycol 660hydroxystearate), vitamin E polyethylene glycol succinic acid ester (TPGS), DSPE-PEG derivant (DSPE-PEG), one or more mixture in the poloxamer (Poloxamer), suitable prescription proportioning and technology, then can prepare particle mean size less than 250nm can filtration sterilization Emulsion, thereby improved stability of drug greatly.For existing Emulsion, key of the present invention is to have adopted the proportioning of more reasonably writing out a prescription, also adopt New-type emulsifier or compound emulsifying agent simultaneously, avoided adopting in the conventional Emulsion single phospholipid to make emulsifying agent, fixedly the problem of oil ratio example (10%, 20%, 30%).Chinese medicine or animal-plant volatile oil (oils and fats) 0.1～10%, oil for injection (long-chain oil in comprising) 0%～10%, emulsifying agent 0.5%～15%, co-emulsifier 0%～3%, isoosmotic adjusting agent 1%～10%, in addition, still contain pH regulator agent, antioxidant, antiseptic (antibacterial).This Emulsion can adopt 0.3um or the following microporous filter membrane of 0.3um, or the G6 sintered glass funnel carries out filtration sterilization.
One, zest relatively
Existing elemene emulsion injection is an emulsifying agent owing to adopt phospholipid, and the formed hydrated sheath of phospholipid is thin, is unfavorable for deadening the stimulation of medicine to blood vessel, and this product is very big to the zest of blood vessel, and the phlebitis incidence rate nearly 50% clinically.Requirement in the elemene emulsion injection operation instruction, thoracic cavity injection: with the trocar (enclosed) drain, drain hydrothorax as far as possible after, inject 10ml procaine injection earlier and press 200-300mg/m again
2The dosage of body surface area injects the thoracic cavity.Lumbar injection: as far as possible take out most ascites, first 5-10ml lidocaine injection and the 5-10mg dexamethasone of injecting; after getting the dilution of this product 500～800mg (or following the doctor's advice) usefulness 1500-2000ml normal saline, slowly to intraperitoneal instillation, drip velocity is decided on patient's tolerance.All adopted local anaesthetics in these operations, illustrated the zest of mucous membrane tissue also very big.And adopt the zest of the prepared Emulsion of the present invention to descend greatly.
Irritation test--mouse writhing test:
Experimental animal: kunming mice, 10 every group, male and female half and half.
Test specimen: embodiment five, common Emulsion (0.5% elemene, 10% Oleum Glycines, 1.2% phospholipid) and commercially available injection, formulation concentrations all is diluted to 2mg/ml with 5% glucose.
Dosage and route of administration: the mouse peritoneal injection, preparation 0.5ml/ only
Result of the test: observe in 0.5 hour, the mouse writhing number of times the results are shown in Table 1.
Table 1, mouse writhing result of the test
| Preparation | Embodiment five | Common Emulsion | Commercially available injection |
| Turn round the body number of times | ??1.5±2.1(0～5) | ??2.8±4.6(2～10) | ??12.6±8.5(6～25) |
Hence one can see that, and the zest of preparation of the present invention is far below commercially available injection.
Two, stability and toxicity
Radix Bupleuri volatile oil: employing steam distillation, sodium chloride such as Pu Quan Long are saltoutd, extracted with diethyl ether, activated carbon adsorption, acetone elution process are extracted Radix Bupleuri oil, GC-MS measures, show 15 composition (composition Study chemistry journals 1983,41 (6) of Radix Bupleuri volatile oil such as Pu Quan Long: 559-561) such as containing phenol.88 chemical compounds having determined in the Radix Bupleuri volatile oil of silver-colored state of differentiating with GC-MS-DS talented in literature in addition, (silver-colored state Radix Bupleuri volatile oil The Chemical Constituents Chinese herbal medicine 1997,28 (11): 651) such as cochlear enol, benzaldehyde, valeral, hexanal, decadienal, lauric aldehyde are wherein arranged.Also there is data to show, contains valeric acid, caproic acid, enanthic acid, 2-heptenoic acid, sad, 2-octenoic acid, n-nonanoic acid, dienoic acid, phenol, o-methoxyphenol, eugenol (eugenol), cresols, ethylphenol, thymol (thymol), Ma Suoyi lactone (messoialactone), vanillin acetas etc. in the volatile oil of Radix Bupleuri root.These data show that Radix Bupleuri volatile oil contains the phenols and the aldehyde compound of easy oxidation, if formulation and technology is unreasonable, will produce noxious substance.Given this, we have compared stability and the toxicity that adopts conventional method to prepare the Radix Bupleuri volatile oil lipomul and adopt the Emulsion of the present invention's preparation, when finding for 0 time, the appearance luster of lipomul is deeper than Emulsion of the present invention, place after 3 months for 30 ℃, the fat milk flavescence, even separate out oil.And the Emulsion that adopts the present invention to prepare, its outward appearance still is a milky.The draw the abdomen phenomenon of (may be that zest causes), lassitude of dead and animal appears in mouse peritoneal injection in the former the Emulsion group; Treated animal of the present invention is normal.
Rhizoma Chuanxiong volatile oil Emulsion: get Rhizoma Chuanxiong volatile oil, prepare Emulsion with phospholipid and HS15 respectively, wherein the consumption of emulsifying agent is 1.5%, gained Emulsion places 60 ℃ of baking ovens to carry out accelerated test, the result shows, Emulsion (A) color and luster that phospholipid is done the emulsifying agent preparation is deeper than the Emulsion (B) that the HS15 emulsifying agent prepares far away, and zoopery shows that the toxicity of A is far longer than the toxicity of B).
Three, hemolytic test
The experimental condition room temperature: 22 ℃, relative humidity: 55%.
Test specimen: " embodiment eight " and commercially available injection.
Test method and result
The rabbit ear edge vein exploitating blood, with bamboo let stir defibrinate after, with normal saline washing back centrifugal (2000rpm), remove supernatant, again with the normal saline cyclic washing for several times (all centrifugal supernatant of abandoning) until the supernatant redfree, it is standby to be made into 2% red blood cell suspension with normal saline by volume then.
Get 7 in test tube, press shown in the table 2, each pipe adds the medicinal liquid of different volumes and the red blood cell suspension of equal volume respectively, wherein the 6th manages not dosing, be 5% glucose injection (or 10% glucose injection) blank, the 7th pipe adding distil water is done complete haemolysis contrast (positive control pipe).After each pipe shakes up gently, put in 37 ℃ of water-baths temperature and incubated 4 hours, observe each manages whether haemolysis and erythrocyte aggregation phenomenon are arranged in 0.25 hour to 4.0 hours.
The external hemolytic test application of sample of table 2. table
| Application of sample volume (ml) | Test tube number | ||||||
| ??1 | ??2 | ??3 | ??4 | ??5 | ??6 | ??7 | |
| 2% red blood cell suspension, 5% glucose injection distilled water need testing solution | ??2.5 ??2.0 ??0 ??0.5 | ??2.5 ??2.1 ??0 ??0.4 | ??2.5 ??2.2 ??0 ??0.3 | ??2.5 ??2.3 ??0 ??0.2 | ??2.5 ??2.4 ??0 ??0.1 | ??2.5 ??2.5 ??0 ??0 | ??2.5 ??0 ??2.5 ??0 |
Sample of the present invention does not produce haemolysis, does not have agglutination yet, and commercially available injection has haemolysis.
Four, peroxide value is measured
There is patent (ZL02139435.0) that vegetable oil is made fat emulsion oral or ejection preparation, in this patent, the emulsifying agent that the inventor adopted is Ovum Gallus domesticus Flavus lecithin, soybean lecithin, hydrogenated yolk lecithin, hydrogenated soy phosphatidyl choline, synthetic lecithin, by embodiment and the process chart given as can be known, the granularity of prepared lipomul is 180nm～300nm, needs 115 ℃ of sterilization 30min simultaneously.Owing to form (existing lipomul is formed like this substantially) by " soybean oil ", " soybean lecithin (or Ovum Gallus domesticus Flavus lecithin) ", all contain unsaturated fatty acid in the molecule of these two kinds of materials, oxidation generates complicated oxidation product and toxigenicity easily.For advance of the present invention is described, we have compared Emulsion (A) that adopts the ZL02139435.0 explained hereafter and the mensuration that Emulsion of the present invention (B, " embodiment three ") carries out peroxide value (POV).(the dynamic (dynamical) experimentation Chinese Journal of Pharmaceuticals 1998 of the oxidation of list of references Liposyn and peroxide breakdown thereof, 29 (5): 205), the POV of A is 2.66meq/L as a result, and the POV of B only is 0.28meq/L, well below the Emulsion of ZL02139435.0 explained hereafter.
For the possible mechanism of the above-mentioned result of the test of the present invention is described, we are list of references (Shimada K, et al.Determination of the thickness of the fixed aqueous layer aroundpolyethyleneglycol-coated liposomes.J Drug Target.1995; 3 (4): 283-9.) emulsifying agent hydrated sheath thickness such as HS15, TPGS are measured with the Zeta potential analyzer.The principle of institute's foundation is the Debye-Huckel principle.The result shows, is 0.38nm with the emulsive Emulsion hydrated sheath of phospholipid thickness, and is 1.22nm with the Emulsion hydrated sheath thickness of HS15, and that TPGS is 1.78nm.Just because of thicker hydrated sheath has been protected medicine, improve stability, reduce zest.
Since adopted in the present invention HS15 as emulsifying agent or with HS15 as one of composition of mixed emulsifier, and HS15 has anti-multidrug resistance effect (JS Coon, et al.Solutol HS 15, nontoxicpolyoxyethylene esters of 12-hydroxystearic acid, reverses multidrug resistanceCancer Research 51 (3): 897-902), prepared Emulsion will have better therapeutic at anti-tumor aspect.
Above-mentioned test explanation adopts that prescription of the present invention, technology prepared preparation have solved that the water-soluble of existing injection is poor, poor stability, zest is big and the hemolytic problem.Owing to adopt filtration sterilization, can guarantee the aseptic of product, can improve stability of drug to greatest extent again.
But the present invention is a kind of Chinese medicine or animal-plant volatile oil (oils and fats) Emulsion prescription of filtration sterilization, it is characterized in that: the percentage by weight of injection is: Chinese medicine or animal-plant volatile oil (oils and fats) 0.1～10%, oil for injection (long-chain oil in comprising) 0%～10%, emulsifying agent 0.5%～15%, co-emulsifier 0%～3%, isoosmotic adjusting agent 1%～10%, in addition, still contain pH regulator agent, antioxidant, antiseptic (antibacterial).This Emulsion can adopt 0.3um or the following microporous filter membrane of 0.3um, or the G6 sintered glass funnel carries out filtration sterilization.Described Chinese medicine or animal-plant volatile oil (oils and fats) are: Rhizoma Chuanxiong oil, Radix Angelicae Sinensis oil, Oleum Curcumae, Oleum Fructus Bruceae, oil of Rhizoma Zingiberis Recens, Fructus Forsythiae oil, Oleum Bulbus Allii, Oleum Bupleuri, elemene, Oleum Folium Artemisiae Argyi, Eucalyptus Globulus oil, eucalyptus oil, cineole, Benzoinum oil, Oleum Tiglii, Flos micheliae Albae oil, Flos micheliae Albae oil, Michelia leap oil, white lemon oil, Lime oil 10X, Lime oil 5X, white camphor oil, thyme oil, Cedar oil, Oleum menthae, Oleum menthae, Mentholum, Rhizoma Atractylodis oil, tea tree oil, petitgrain oil, tea oil, orange blossom oil, linaloe oil, Oleum Citri Reticulatae, Citrus aurantium L. var. amara Engl. Oil, Folium Dai Dai oil, Radix Angelicae Sinensis oil, Oleum Ocimi Gratissimi, Oleum Caryophylli, Flos Caryophylli oil, wintergreen oil, lemon oil, azalea oil, Ledum palustre L. var. dilatatum Wahl.oil, Oleum Bulbus Allii, Lignum cinnamomi camphorae oil, bergamot oil, Radix Et Rhizoma Nardostachyos oil, patchouli oil, Flos Osmanthi Fragrantis quintessence oil, cassia oil, olive oil, caraway oil, Fructus piperis nigrum oil, safflower oil, Oleum Cari, Folium Perillae oil, Fructus Phellodendri oil, Sassafras oil, Oleum Anisi Stellati, anethole, Fructus Dauci Sativae oil, Fructus Zanthoxyli oil, cassie absolute, macadamia nut oil, mentha piperita oil, Herba Schizonepetae oil, turmeric oil, Semen Armeniacae Amarum oil, cananga oil, labdanum absolute, capsicum oil, oil of Rhizoma Zingiberis Recens, Fructus Citri Limoniae oil, citrus seed oil, tangerine oil, Semen Coicis oil, Oleum Menthae Rotundifoliae, Fructus Forsythiae oil, aloe, Roman Herba Cancriniae Discoideae oil, sweet basil oil, estragon oil, Oleum Rosae Rugosae, the wild rose absolute oil, China ink red-face role oil, Oleum Viticis Negundo, Myrrha, oil of rosemary, the spur extrait, eucalyptus citriodora oil, Indian oil of verbena, Fructus Citri Limoniae oil, Herba Origani oil, TIANNIUZHI oil, machilus leaf oil, Oleum Vitis viniferae, seed oil of Herba Apii graveolentis, Herba Artemisiae Annuae oil, Semen Myristicae oil, the shatian pomelo extrait, the shatian pomelo caul-fat, Fructus Litseae foot oil, litsea cubeba oil, mountain autumn oil, oleum Cunninghamiae lanceolatae, Fructus Cnidii oil, oil of Rhizoma Zingiberis Recens, sage oil, the tree orchid absolute oil, Oleum Terebinthinae, Oleum pini koraiensis, pinke needle oil, pinaster seed oil, pine cone oil, cypress oil, Camellia oil, Oleum Santali albi, oleum Citri sinensis, the Fructus Citri sinensis terpene, sinensal, ten times of oleum Citri sinensis, five times of oleum Citri sinensis, Fructus Schisandrae oil, Semen pruni armeniacae oil, vetiver oil, citronella oil, bergamot mint oil, Oleum Pelargonii Graveolentis, Salvia Sclare L.oil, Cardamom oil, cedar oil, fennel oil, jasminum sambac absolute, Flos Magnoliae oil, red cedar wood oil, Oleum lavandula angustifolia, oil of Rhizoma et radix valerianae, the Herba Moslae quintessence oil, Cedrus deoclar (Roxb.) G. Don oil, Oleum Fructus Bruceae, the fireworks absolute oil, the appropriate seed oil of Yuan, Oleum Cocois, wild rose oil, the Flos Chrysanthemi Indici absolute oil, Herba Artemisiae Scopariae grass oil, pomelo oil, Herba Houttuyniae oil, the Rhizoma Iridis Tectori quintessence oil, laurel fat, Oleum Citri grandis, Yi Lan oil, Radix Oenotherae erythrosepalae oil, assorted camphor oil, lavandin oil, gardenia flower oil, fat wingceltis oil, Oleum Perillae, Oleum Camphora.Or the highly finished product of volatile oil, as by the elemene (or elemene of other volatile oil purification) of Oleum Curcumae purification, the ligustilide (or ligustilide of other volatile oil purification) of Rhizoma Chuanxiong oil purification.
Described injectable emulsion is characterized in that: described oil for injection is midchain oil: hot certain herbaceous plants with big flowers acid glyceride (Delios ) (being called medium chain triglycerides MCT), hot certain herbaceous plants with big flowers acid glyceride; Long-chain oil is: soybean oil, Semen Maydis oil, Oleum Arachidis hypogaeae semen.Midchain oil mixes by 1: 0～1: 5 with vegetable oil; in addition, oil for injection can also be one or more mixture in vitamin E, tocopherol, ethyl oleate, glyceryl linoleate, Polyethylene Glycol glyceryl laurate ester, Ethyl linoleate, oleic acid sorbitol ester, olein, Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, Oleum Cocois C8/C10 propylene glycol dibasic acid esters, Oleum Cocois C8/C10 triglyceride, Oleum Cocois C8/C10 triglyceride, the acetylizad monoglyceride of purification, the purification Oleum helianthi monoglyceride etc.Described Emulsion is characterized in that: described emulsifying agent comprises one or more mixture in phospholipid (egg yolk lecithin or soybean phospholipid), HS15 (Polyethylene Glycol 12-hydroxy stearic acid ester, polyethylene glycol 660 hydroxystearate), vitamin E polyethylene glycol succinic acid ester (TPGS), DSPE-PEG derivant (DSPE-PEG), the poloxamer; Can add co-emulsifier as required, as oleic acid, sad, certain herbaceous plants with big flowers is sour, one or more mixture in the lauric acid, Palmic acid, linoleic acid, linoleic acid, stearic acid, docosahexenoic acid (DHA), cholic acid, deoxycholic acid.Described Emulsion, its isoosmotic adjusting agent are one or more mixture in glycerol, glucose, mannitol, the xylitol.The pH regulator agent is one or more in hydrochloric acid, sodium hydroxide, acetic acid, sodium acetate, phosphoric acid, sodium phosphate, citric acid, the sodium citrate etc., and best pH scope is 3～9; Antioxidant is noble gas, EDTA and its esters, alpha-tocopherol, α-tocopheryl acetate, alpha-lipoic acid, vitamin C and derivant thereof, as one or more mixture in the sodium L-ascorbate-2-phosphate.Antiseptic (antibacterial) is benzyl alcohol, parabens.Described injectable emulsion can adopt the following microporous filter membrane of 0.3um or 0.3um, or the G6 sintered glass funnel carries out filtration sterilization.The particle size range that it is characterized in that institute's antigalactic is 5nm～1000nm, and particle mean size is less than 250nm, and is aseptic in order further to guarantee, also can adopt 100～110 ℃ and sterilize on the basis of filtration sterilization.Prepared Emulsion both can intravenous injection, also can be oral, external (skin, eye drip, collunarium ear), the administration of atomizing respiratory system, can also further be prepared into various dosage forms, as ointment, gel.The preparation technology of Emulsion is as follows:
1) prepare oil phase in preparing tank: in preparing tank, 20～90 ℃ of the temperature of control oil for injection add emulsifying agent (or being added in aqueous phase), and strong agitation adds Chinese medicine or animal-plant volatile oil (oils and fats), the strong agitation mixing to dissolving.
2) in preparing tank, prepare water: water and glycerol (isoosmotic adjusting agent) are stirred 5min down at 20～90 ℃, make it complete miscibility.
3) in the time of 20～80 ℃, oil phase is added water (or water adding oil phase), the strong agitation mixing forms colostrum.
4) regulate pH value to 3～9.
5) cross the homogenizing instrument, the first step is regulated homogenize pressure to 520～600kg/cm
2, second step re-adjustment to 100～140kg/cm
2(or microjet instrument, the first step is regulated homogenize pressure to 4000～8000psi, the second step re-adjustment is to 10000-16000psi) with solution homogenize repeatedly, obtain uniform Emulsion, carry out filtration sterilization with 0.3um or less than the microporous filter membrane (or G6 sintered glass funnel) of 0.3um, encapsulation (in case of necessity can be further under 100～110 ℃ temperature sterilization 30 minutes) promptly gets this product.
The specific embodiment:
Detailed component of the present invention is provided by the following example, but protection scope of the present invention not only is confined to this.
Particle size analyzer: use PSS.NICOMP in this experiment
TM380 as the instrument of measuring particle diameter.
Microjet instrument (Microfluidic company, the U.S.), homogenizer etc.
Specific embodiments:
Embodiment 1: Rhizoma Chuanxiong oil Emulsion
Prescription is formed: Rhizoma Chuanxiong oil 0.1g, and egg yolk lecithin 0.5g, thioctic acid 0.05g, glucose 5g, hydrochloric acid is an amount of, and all the other are water for injection, altogether 100ml.
Manufacture method:
1) preparation oil phase: under nitrogen protection, add Rhizoma Chuanxiong oil and egg yolk lecithin in beaker, strong agitation is cooled to 30 ℃ to homodisperse, adds thioctic acid, strong agitation 5min;
2) preparation water: glucose is added in the water for injection, stir 5min down, make it to dissolve fully (using the active carbon depyrogenation in case of necessity) at 50 ℃;
3) in the time of 30 ℃, water is added oil phase, strong agitation 10min forms colostrum;
4), regulate pH value to 3 with an amount of hydrochloric acid solution;
5) cross the homogenizing instrument, the first step is regulated homogenize pressure to 600kg/cm
2, the second step re-adjustment is to 120kg/cm
2, with solution homogenize repeatedly, obtain uniform Emulsion, cross the degerming of 0.22um microporous filter membrane, packing, inflated with nitrogen seals and promptly gets this product.Can inject with oral.
Particle size range is 5nm～500nm, and mean diameter is 91nm.
Embodiment 2:
Prescription is formed: Rhizoma Chuanxiong oil 1g, and hot certain herbaceous plants with big flowers acid glyceride 1g, soybean lecithin 0.5g, TPGS 0.5g, injection vitamin E 0.1g, glucose 5g, hydrochloric acid is an amount of, and all the other are water for injection, altogether 100ml.
Manufacture method:
1) preparation oil phase: under nitrogen protection, hot certain herbaceous plants with big flowers acid glyceride, vitamin E are heated to 60 ℃, add soybean lecithin, TPGS, strong agitation is cooled to 20 ℃ to dissolving, adds Rhizoma Chuanxiong oil, strong agitation 1min;
2) preparation water: poloxamer and glucose are added in the water for injection, 40 ℃ of following stirring and dissolving (using the active carbon depyrogenation in case of necessity);
3) in the time of 20 ℃, water is added oil phase, strong agitation 7min forms colostrum;
4), regulate pH value to 4 with an amount of hydrochloric acid solution;
5) cross the homogenizing instrument, the first step is regulated homogenize pressure to 580kg/cm
2, the second step re-adjustment is to 140kg/cm
2, with solution homogenize repeatedly, obtain uniform Emulsion, cross the degerming of 0.22um microporous filter membrane, packing, inflated with nitrogen,
Seal and promptly get this product.Can inject or oral.
Particle size range is 25nm～800nm, and mean diameter is 123nm.
Embodiment 3:
Prescription is formed: Radix Angelicae Sinensis oil 1g, and hot certain herbaceous plants with big flowers acid glyceride 0.5g, soybean oil 0.5g, soybean phospholipid 2.5g, TPGS 0.5g, glycerol 2.2g, hydrochloric acid (sodium hydroxide) is an amount of, and all the other are water for injection, altogether 100ml.
Manufacture method:
1) preparation oil phase: under nitrogen protection, hot certain herbaceous plants with big flowers acid glyceride, soybean oil are heated to 60 ℃, add soybean phospholipid, TPGS, strong agitation is cooled to 40 ℃ to dissolving, adds medicine, strong agitation 2min;
2) preparation water: glycerol is added in the water for injection, 40 ℃ of following stirring and dissolving (using the active carbon depyrogenation in case of necessity);
3) in the time of 40 ℃, water is added oil phase, strong agitation 5min forms colostrum;
4), regulate pH value to 7 with an amount of hydrochloric acid (sodium hydroxide) solution;
5) cross the microjet instrument, the first step is regulated homogenize pressure to 3 circulations of 6000psi homogenize, and the second step re-adjustment is to 14000psi, and 3 circulations of homogenize obtain uniform Emulsion, cross the degerming of 0.3um microporous filter membrane, packing, and inflated with nitrogen seals and promptly gets this product.Can inject or oral.
Particle size range is 50nm～860nm, and mean diameter is 116nm.
Embodiment 4:
Prescription is formed: Oleum Bulbus Allii 0.1g, and hot certain herbaceous plants with big flowers acid glyceride 1g, safflower oil 2g, oleic acid 0.01g, tocopherol 0.1g, soybean phospholipid 2g, poloxamer F68 0.5g, glycerol 10g, sodium hydroxide is an amount of, and all the other are water for injection, altogether 100ml.
Manufacture method:
1) preparation oil phase: under nitrogen protection, hot certain herbaceous plants with big flowers acid glyceride, safflower oil are heated to 50 ℃, add medicine, oleic acid, tocopherol, strong agitation 5min;
2) preparation water: poloxamer and glycerol are added in the water for injection, stir 10min down, make it complete miscibility at 50 ℃;
3) in the time of 50 ℃, water is added oil phase, strong agitation 12min forms colostrum;
4) use proper amount of sodium hydroxide solution, regulate pH value to 9;
5) cross the microjet instrument, the first step is regulated homogenize pressure to 7000psi homogenize 4 times, and the second step re-adjustment obtains uniform Emulsion to 15000psi homogenize 3 times, crosses the degerming of 0.22um microporous filter membrane, packing, and inflated with nitrogen seals and promptly gets this product.Can inject, oral or external.
Particle size range is 35nm～790nm, and mean diameter is 153nm.
Embodiment 5:
Prescription is formed: elemene 0.5g, and soybean phospholipid 1.2g, HS15 1g, TPGS 1g, hot certain herbaceous plants with big flowers acid glyceride 10g, thioctic acid 0.1g, glycerol 2.2g, sodium hydroxide is an amount of, and all the other are water for injection, altogether 100ml.
Manufacture method:
1) preparation oil phase: under nitrogen protection, hot certain herbaceous plants with big flowers acid glyceride is heated to 55 ℃, adds medicine, thioctic acid, soybean phospholipid, HS15, TPGS, strong agitation 10min is uniformly dispersed;
2) preparation water: glycerol is added in the water for injection, stir 1min down, make it complete miscibility at 50 ℃;
3) in the time of 45 ℃, water is added oil phase, strong agitation 10min forms colostrum;
4) use proper amount of sodium hydroxide solution, regulate pH value to 7;
5) cross the homogenizing instrument, the first step is regulated homogenize pressure to 600kg/cm
2, the second step re-adjustment is to 140kg/cm
2,
With solution homogenize repeatedly, obtain uniform Emulsion, cross the degerming of 0.3um microporous filter membrane, packing, inflated with nitrogen seals and promptly gets this product.Can inject, oral or external.
Particle size range is 20nm～760nm, and mean diameter is 186nm.
Embodiment 6:
Prescription is formed: Oleum Fructus Bruceae 10g, and tocopherol 0.2g, soybean phospholipid 10g, TPGS 3g, poloxamer 2g, xylitol 1g, hydrochloric acid is an amount of, and all the other are water for injection, altogether 100ml.
Manufacture method:
1) preparation oil phase: under nitrogen protection, Oleum Fructus Bruceae is heated to 60 ℃, adds tocopherol, soybean phospholipid, be stirred to dissolving, be cooled to 20 ℃, stir 5min;
2) preparation water: poloxamer, TPGS, xylitol are added in the water for injection, stir 10min down at 50 ℃,
Make it to dissolve fully;
3) in the time of 20 ℃, water is added oil phase, strong agitation 10min forms colostrum;
4), regulate pH value to 5.5 with an amount of hydrochloric acid solution;
5) cross the microjet instrument, the first step is regulated homogenize pressure to 8000psi, and the second step re-adjustment with solution homogenize repeatedly, obtains uniform Emulsion to 16000psi, crosses the degerming of 0.22um microporous filter membrane, packing, and inflated with nitrogen seals and promptly gets this product.Can inject, oral or external.
Particle size range is 50nm～900nm, and mean diameter is 118nm.
Embodiment 7:
Prescription is formed: Fructus Forsythiae oil 1g, and ethyl oleate 2g, TPGS 1g, soybean phospholipid 0.5g, poloxamer 0.1g, oleic acid 0.01g, tocopherol 0.1g, benzyl alcohol 0.9g, glycerol 2.2g, hydrochloric acid is an amount of, and all the other are water for injection, altogether 100ml.
Manufacture method:
1) preparation oil phase: under nitrogen protection, ethyl oleate is heated to 60 ℃, adds TPGS, soybean phospholipid, oleic acid, tocopherol, the strong agitation dissolving adds medicine, stirs 5min;
2) preparation water: poloxamer, benzyl alcohol and glycerol are added in the water for injection, stir 5min down, make it complete miscibility at 60 ℃;
3) in the time of 45 ℃, water is added oil phase, strong agitation 10min forms colostrum;
4), regulate pH value to 7 with an amount of sodium radio-phosphate,P-32 solution;
5) cross the homogenizing instrument, the first step is regulated homogenize pressure to 600kg/cm
2, the second step re-adjustment is to 140kg/cm
2, with solution homogenize repeatedly, obtain uniform Emulsion, cross the degerming of 0.22um microporous filter membrane, packing, inflated with nitrogen seals and promptly gets this product.
Particle size range is 50nm～1000nm, and mean diameter is 210nm.
Embodiment 8:
Prescription is formed: Oleum Curcumae 1g, and egg yolk lecithin 0.5g, HS15 1g, midchain oil (hot certain herbaceous plants with big flowers acid glyceride) 0.1g, long-chain oil (Oleum Glycines) 0.5g, thioctic acid 0.05g, glucose 5g, hydrochloric acid is an amount of, and all the other are water for injection, altogether 100ml.
Manufacture method:
Preparation method is with " embodiment 7 ".Particle size range is 30nm～700nm, and mean diameter is 166nm.
Embodiment 9:
Prescription is formed: oil of Rhizoma Zingiberis Recens 1g, and TPGS 0.5g, poloxamer 0.05g, soybean lecithin 0.5g, vitamin E 0.1g, glycerol 5g, hydrochloric acid is an amount of, and all the other are water for injection, altogether 100ml.
Preparation method is with " embodiment 6 ", and the G6 sintered glass funnel was sterilized 30 minutes for 100 ℃.Particle size range is 5nm～500nm, and mean diameter is 128nm.Can further be prepared into ointment or gel.
Embodiment 10:
Prescription is formed: Oleum Bupleuri 0.5g, hot certain herbaceous plants with big flowers acid glyceride 2.5g, soybean oil 2.5g, egg yolk lecithin 1.5g, HS15 1g, TPGS 0.5g, linoleic acid 0.1g, thioctic acid 0.1g, glycerol 2.2g, hydrochloric acid (sodium hydroxide) an amount of (adjust pH 7), all the other are water for injection, altogether 100ml.
Preparation method was sterilized 30 minutes for 110 ℃ with " embodiment 5 ".Particle size range is 10nm～760nm, and mean diameter is 212nm.
Claims (7)
1, filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion, it is characterized in that: the percentage by weight of Emulsion is: Chinese medicine or animal-plant volatile oil or oils and fats 0.1～10%, oil for injection 0%～10%, emulsifying agent 0.5%～15%, co-emulsifier 0%～3%, isoosmotic adjusting agent 1%～10%, in addition, still contain pH regulator agent, antioxidant, antiseptic or antibacterial and water for injection.
2, filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion according to claim 1, described Chinese medicine or animal-plant volatile oil or oils and fats are: Rhizoma Chuanxiong oil, Radix Angelicae Sinensis oil, Oleum Curcumae, Oleum Fructus Bruceae, oil of Rhizoma Zingiberis Recens, Fructus Forsythiae oil, Oleum Bulbus Allii, Oleum Bupleuri, elemene, Oleum Folium Artemisiae Argyi, Eucalyptus Globulus oil, eucalyptus oil, cineole, Benzoinum oil, Oleum Tiglii, Flos micheliae Albae oil, Flos micheliae Albae oil, Michelia leap oil, white lemon oil, Lime oil 10X, Lime oil 5X, white camphor oil, thyme oil, Cedar oil, Oleum menthae, Oleum menthae, Mentholum, Rhizoma Atractylodis oil, tea tree oil, petitgrain oil, tea oil, orange blossom oil, linaloe oil, Oleum Citri Reticulatae, Citrus aurantium L. var. amara Engl. Oil, Folium Dai Dai oil, Radix Angelicae Sinensis oil, Oleum Ocimi Gratissimi, Oleum Caryophylli, Flos Caryophylli oil, wintergreen oil, lemon oil, azalea oil, Ledum palustre L. var. dilatatum Wahl.oil, Oleum Bulbus Allii, Lignum cinnamomi camphorae oil, bergamot oil, Radix Et Rhizoma Nardostachyos oil, patchouli oil, Flos Osmanthi Fragrantis quintessence oil, cassia oil, olive oil, caraway oil, Fructus piperis nigrum oil, safflower oil, Oleum Cari, Folium Perillae oil, Fructus Phellodendri oil, Sassafras oil, Oleum Anisi Stellati, anethole, Fructus Dauci Sativae oil, Fructus Zanthoxyli oil, cassie absolute, macadamia nut oil, mentha piperita oil, Herba Schizonepetae oil, turmeric oil, Semen Armeniacae Amarum oil, cananga oil, labdanum absolute, capsicum oil, oil of Rhizoma Zingiberis Recens, Fructus Citri Limoniae oil, citrus seed oil, tangerine oil, Semen Coicis oil, Oleum Menthae Rotundifoliae, Fructus Forsythiae oil, aloe, Roman Herba Cancriniae Discoideae oil, sweet basil oil, estragon oil, Oleum Rosae Rugosae, the wild rose absolute oil, China ink red-face role oil, Oleum Viticis Negundo, Myrrha, oil of rosemary, the spur extrait, eucalyptus citriodora oil, Indian oil of verbena, Fructus Citri Limoniae oil, Herba Origani oil, TIANNIUZHI oil, machilus leaf oil, Oleum Vitis viniferae, seed oil of Herba Apii graveolentis, Herba Artemisiae Annuae oil, Semen Myristicae oil, the shatian pomelo extrait, the shatian pomelo caul-fat, Fructus Litseae foot oil, litsea cubeba oil, mountain autumn oil, oleum Cunninghamiae lanceolatae, Fructus Cnidii oil, oil of Rhizoma Zingiberis Recens, sage oil, the tree orchid absolute oil, Oleum Terebinthinae, Oleum pini koraiensis, pinke needle oil, pinaster seed oil, pine cone oil, cypress oil, Camellia oil, Oleum Santali albi, oleum Citri sinensis, the Fructus Citri sinensis terpene, sinensal, ten times of oleum Citri sinensis, five times of oleum Citri sinensis, Fructus Schisandrae oil, Semen pruni armeniacae oil, vetiver oil, citronella oil, bergamot mint oil, Oleum Pelargonii Graveolentis, Salvia Sclare L.oil, Cardamom oil, cedar oil, fennel oil, jasminum sambac absolute, Flos Magnoliae oil, red cedar wood oil, Oleum lavandula angustifolia, oil of Rhizoma et radix valerianae, the Herba Moslae quintessence oil, Cedrus deoclar (Roxb.) G. Don oil, Oleum Fructus Bruceae, the fireworks absolute oil, the appropriate seed oil of Yuan, Oleum Cocois, wild rose oil, the Flos Chrysanthemi Indici absolute oil, Herba Artemisiae Scopariae grass oil, pomelo oil, Herba Houttuyniae oil, the Rhizoma Iridis Tectori quintessence oil, laurel fat, Oleum Citri grandis, Yi Lan oil, Radix Oenotherae erythrosepalae oil, assorted camphor oil, lavandin oil, gardenia flower oil, fat wingceltis oil, Oleum Perillae, Oleum Camphora, or the highly finished product of volatile oil.
3; filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion according to claim 1; it is characterized in that: described oil for injection is midchain oil or long-chain oil; or its mixture; midchain oil is oily by 1 with long-chain: 0-1: 5 mix; in addition, the injection oil phase can also be a vitamin E; tocopherol; ethyl oleate; glyceryl linoleate; the Polyethylene Glycol glyceryl laurate ester; Ethyl linoleate; the oleic acid sorbitol ester; olein; Oleum Cocois C8/C10 monoglyceride or dibasic acid esters; Oleum Cocois C8/C10 propylene glycol dibasic acid esters; Oleum Cocois C8/C10 triglyceride; Oleum Cocois C8/C10 triglyceride; one or more mixture in the acetylizad monoglyceride purification of the purification Oleum helianthi monoglyceride etc.
4, filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion according to claim 1 is characterized in that: described emulsifying agent comprises one or more mixture that adopt in phospholipid, HS15, vitamin E polyethylene glycol succinic acid ester, DSPE-PEG derivant, the poloxamer; Can add co-emulsifier as required.
5, filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion according to claim 1, it is characterized in that: its isoosmotic adjusting agent is one or more mixture in glycerol, glucose, mannitol, the xylitol, the pH regulator agent is one or more in hydrochloric acid, sodium hydroxide, acetic acid, sodium acetate, phosphoric acid, sodium phosphate, citric acid, the sodium citrate etc., and the pH scope is 3～9; Antioxidant is noble gas, EDTA and its esters, alpha-tocopherol, α-tocopheryl acetate, alpha-lipoic acid, vitamin C and derivant thereof, as one or more mixture in the sodium L-ascorbate-2-phosphate, antiseptic or antibacterial are benzyl alcohol, parabens.
6, filtering-degerming Chinese medicine or animal-plant volatile oil or fat emulsion according to claim 1, it is characterized in that: Emulsion can adopt 0.3um or the following microporous filter membrane of 0.3um, or the G6 sintered glass funnel carries out filtration sterilization, the particle size range of institute's antigalactic is 5nm～1000nm, particle mean size is less than 250nm, aseptic in order further to guarantee, also can be on the basis of filtration sterilization, adopt 100 110 ℃ to sterilize, prepared Emulsion both can intravenous injection, also can be oral, external, the administration of atomizing respiratory system can also further be prepared into various dosage forms.
But 7, the preparation method of a kind of Chinese medicine of filtration sterilization or animal-plant volatile oil Emulsion, it is characterized in that: preparation process is as follows:
1) prepare oil phase in preparing tank: in preparing tank, 20～90 ℃ of the temperature of control oil for injection add emulsifying agent (or being added in aqueous phase), and strong agitation adds Chinese medicine or animal-plant volatile oil, the strong agitation mixing to dissolving;
2) in preparing tank, prepare water: water and glycerol (isoosmotic adjusting agent) are stirred 5min down at 20～90 ℃, make it complete miscibility;
3) in the time of 20～80 ℃, oil phase is added water (or water adding oil phase), the strong agitation mixing forms colostrum;
4) regulate pH value to 3～9;
5) cross the homogenizing instrument, the first step is regulated homogenize pressure to 520～600kg/cm
2, second step re-adjustment to 100～140kg/cm
2, or the microjet instrument, the first step is regulated homogenize pressure to 4000～8000psi, second step re-adjustment to 10000～16000psi; With solution homogenize repeatedly, obtain uniform Emulsion, carry out filtration sterilization with 0.3um or less than microporous filter membrane or the G6 sintered glass funnel of 0.3um, encapsulation promptly gets this product.
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| CN109260151B (en) * | 2018-10-30 | 2021-03-19 | 成都中医药大学 | Forsythia volatile oil self-microemulsion and preparation method thereof |
| CN110755591A (en) * | 2019-11-26 | 2020-02-07 | 健民药业集团股份有限公司 | Pain-relieving aerosol |
| CN117224489A (en) * | 2022-06-08 | 2023-12-15 | 威海天原生物科技有限公司 | Plant volatile oil composition and preparation method thereof |
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