CN105998286A - Dai-dai flower extract microemulsion preparation and preparation method thereof - Google Patents
Dai-dai flower extract microemulsion preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a dai-dai flower extract microemulsion preparation. On the basis of a formula dosage of 100 g, the dai-dai flower extract microemulsion preparation comprises 2 to 20% of dai-dai flower extract, 2 to 15% of an emulsifier, 2 to 10% of a co-emulsifier, 5 to 10% of an oil phase, 0.5 to 1% of a stabilizing agent and 44 to 88.5% of deionized water. The above-mentioned components are mixed, heated, emulsified and homogenized at a high pressure so as to obtain a clear microemulsion solution with a brown-yellow to pale-yellow color. The invention also discloses a preparation method for the dai-dai flower extract microemulsion preparation. The preparation method comprises the following concrete steps: (1) weighing the dai-dai flower extract, the emulsifier, the co-emulsifier, the oil phase and deionized water in proportion; (2) preparing another oil phase; (3) preparing a water phase; (4) preparing primary microemulsion; and (5) preparing final microemulsion. The dai-dai flower extract microemulsion preparation has the characteristics of long-stem storability at room temperature, stable process, usage of simple equipment and controllable cost. Compared with the prior art, the invention provides a liquid dosage form of the dai-dai flower extract, and the liquid dosage form enables the dai-dai flower extract to be conveniently added into medicines, food, health products and cosmetics.
Description
Technical field
Pharmaceutical technology field of the present invention, a kind of Citrus aurantium L. var. amara Engl. extract microemulsion formulation and preparation method thereof.
Background technology
Turtle turtle (from generation to generation) is Rutaceae Citrus Subgenus, and Citrus aurantium L. var. amara Engl. belongs to the medicinal and edible plant that Ministry of Public Health is announced, can
It is added in medicine, health food, bread and cheese and cosmetics.CitrusaurantiumL.Var.amara Engl. sweet in the mouth, bitter in the mouth, property is flat, has depressed liver-energy dispersing and QI regulating effect,
The traditional Chinese medical science is used for treating the symptoms such as accumulation of food in the stomach and intes tine due to indigestion, phlegm retention, the full vexed distending pain of chest and abdomen.
Citrus aurantium L. var. amara Engl. extract main component is neohesperidin and naringin (neohesperidin and naringin content >=50%), belongs to
In flavones ingredient.Pharmacological evaluation proves that Citrus aurantium L. var. amara Engl. extract has anti-oxidation function, has DPPH free radical with-OH free radical
There is good scavenging action, at aspects such as treatment fat-reducing, blood fat reducing, hepatic injury, skin nursings, there is good antioxidant effect.
Patent CN201110317409 discloses the effect in suppression lipase active of the CitrusaurantiumL.Var.amara Engl. extract, can be developed into appetrol
Thing.In terms of blood fat reducing, Citrus aurantium L. var. amara Engl. extract can effectively treat hyperlipemia, significantly reduces serum total cholesterol, glycerol three
Ester and low density lipoprotein, LDL content, high density lipoprotein increasing content;Atherogenic index can also be reduced.Treatment liver
Damage aspect, Citrus aurantium L. var. amara Engl. extract can effectively remove hyperlipemia patients serum and mda content in liver, increasing serum
With superoxide dismutase from liver content.In terms of skin nursing, patent CN 104434622 A discloses Citrus aurantium L. var. amara Engl. and extracts
Thing can significantly reduce ultraviolet and irradiate the epidermis cell caused, the rise of fibroblastic reactive oxygen species, may additionally facilitate cell
Propagation, expresses with simultaneously facilitating fibroblast IV collagen mRNA, suppression elastoser and matrix metal proteinase activity,
Reduce inflammatory factor secretion, thus skin is played antiallergic, radioprotective, aging-resistant effect.
Water solublity and the oil-soluble of Citrus aurantium L. var. amara Engl. extract are the most relatively low, and bioavailability is low, limit its clinically should
With, should set about from the dissolubility improving Citrus aurantium L. var. amara Engl. extract, develop the formulation products of high bioavailability.Patent
CN105012461A discloses the preparation method of the drop pill of a kind of turtle turtle fruit total flavones, and this technique is by turtle turtle fruit extractive of general flavone
After fine powder and Polyethylene Glycol add heat fusing, move into pill dripping machine drip irrigation.But this dosage form can residual liquid paraffin in preparation process
With dimethicone, after taking, easily cause GI irritation, and this technology does not solve that Citrus aurantium L. var. amara Engl. extract dissolubility is low, inhale
The problem of astigmat.Patent CN201210008449.3 discloses the preparation method of a kind of turtle turtle fruit flavone self-microemulsifying pellet, system
Standby technique is by turtle turtle fruit total flavone valid target, glycol laurate and tween 80 and diethylene glycol monoethyl ether combination, then
Compositions is made micropill with microcrystalline Cellulose and lactose mixing.But the method exists, and drug loading is low, add medicine to uneven etc. lacking
Point;Meanwhile, the microcrystalline Cellulose in composition is the easy moisture absorption during depositing, and promotes drug leakage, causes preparation stability to be deteriorated.
Existing patent provides the novel form of the dispersibility improving turtle turtle extract, improves external molten to a certain extent
Trip is, but the most fundamentally solves the deliquescent problem of extract.It is thus desirable to preparation property is stable, technique is simple,
A kind of novel form that can reach desired raw dissolubility substitutes prior art.
For the problems referred to above, current inventor provides a kind of microemulsion formulation containing Citrus aurantium L. var. amara Engl. extract and preparation side thereof
Method, is made for microemulsion class preparation, it is possible to increase medicine water solublity by extract, improves medicine dissolution in the gastrointestinal tract, improves raw
Thing availability.Provide simultaneously a kind of can conveniently add, the liquid preparation type of the Citrus aurantium L. var. amara Engl. flavone of stable in properties.
Microemulsion is the oil water mixture of transparent or translucent low-viscosity, is the most stable system of thermodynamics and kinetics,
It is made up of emulsifying agent, co-emulsifier, oil phase and aqueous phase.Microemulsion has even particle size distribution, can place not stratified, beneficially suction for a long time
The advantage received, prevailing quality evaluation index is to carry oil (water) amount, particle diameter and the stability of microemulsion.It addition, microemulsion preparation technology is simple
Single, quality controllable, it is suitable for industrialized production, there is good application prospect.
Summary of the invention
Present invention aim at providing one to improve Citrus aurantium L. var. amara Engl. extract dissolubility, it is possible to be conveniently added into medicine, food
Product, health product, the microemulsion formulation and preparation method thereof of cosmetics.When developing microemulsion formulation carrier, should first select emulsifying power
Power is strong, stable in properties, safety are high emulsifying agent and co-emulsifier, and by the condition of triangle Phase Diagram Method research formation of microemulsion,
Reduce the consumption of emulsifying agent and co-emulsifier as far as possible, save production cost.
The present invention is achieved by the following technical solutions:
Citrus aurantium L. var. amara Engl. extract microemulsion formulation involved in the present invention, based on recipe quantity 100g, its component and content is:
Said components is mixed, processes through emulsifying and high pressure homogenize after heating, obtain micro-to the most light yellow, clarification of brown color
Breast solution.
The emulsifying agent of Citrus aurantium L. var. amara Engl. extract microemulsion of the present invention is polyoxyethylene hydrogenated Oleum Ricini, tween, Bo Luosha
The mixing of one or more in nurse, Solutol HS 15.
Currently preferred surfactant be polyoxyethylene hydrogenated Oleum Ricini, Tween 80, the one of PLURONICS F87 or
Several mixing.
The co-emulsifier of Citrus aurantium L. var. amara Engl. extract microemulsion of the present invention be ethanol, propylene glycol, glycerol, Polyethylene Glycol,
The mixture of one or more of diethylene glycol monomethyl ether.Currently preferred co-emulsifier be ethanol, the one of PEG400
Kind or the mixing of the two.
The oil phase of Citrus aurantium L. var. amara Engl. extract microemulsion of the present invention is oleic acid, isopropyl myristate, middle carbochain triglyceride
One or mixture.Currently preferred oil phase is oleic acid and isopropyl myristate.
Stabilizer of the present invention selected from carbomer, arabic gum, sodium carboxymethyl cellulose, sodium alginate, polyvidone,
One or more mixing in hyaluronic acid.Currently preferred stabilizer is carbomer and sodium carboxymethyl cellulose.
The preparation method of Citrus aurantium L. var. amara Engl. extract microemulsion formulation involved in the present invention, concrete technology is as follows:
(1) Citrus aurantium L. var. amara Engl. extract, emulsifying agent, co-emulsifier, oil phase and deionized water are weighed in proportion;
(2) prepare oil phase: be dissolved in co-emulsifier by Citrus aurantium L. var. amara Engl. extract, then mix homogeneously with emulsifying agent, oil phase;
(3) aqueous phase is prepared: in aqueous phase, add stabilizer, stir.
(4) preparation just microemulsion: in a heated condition, be slowly added in aqueous phase by oil phase, forms clarification, has the first micro-of opalescence
Emulsion;
(5) preparation breast eventually: above-mentioned just microemulsion is put into high pressure homogenizer, homogenizing, obtains stable Citrus aurantium L. var. amara Engl. extract
Microemulsion.
The preparation method of Citrus aurantium L. var. amara Engl. extract of the present invention just microemulsion can use one or both methods of following method to carry out
Preparation: stirring and emulsifying method, supersound method.The preferred stirring and emulsifying of the present invention sends out method, contributes to microemulsion emulsifying complete, and can subtract
Hypogalactia agent and co-emulsifier consumption.
Stirring and emulsifying method: the Citrus aurantium L. var. amara Engl. extract weighed is dissolved in co-emulsifier, is heated to 30-70 DEG C, treat turtle turtle
After flower extract is completely dissolved, adds emulsifying agent and form mixed phase with oil phase mixing, keep system temperature 30-80 DEG C, will mixing
It is added dropwise to mutually in aqueous phase, high speed shear 5-10 minute, obtains Citrus aurantium L. var. amara Engl. extract just microemulsion.
Supersound method: the Citrus aurantium L. var. amara Engl. extract weighed is dissolved in co-emulsifier, is heated to 30-70 DEG C, treat turtle turtle
After flower extract is completely dissolved, adds emulsifying agent and form mixed phase with oil phase mixing, keep system temperature 30-80 DEG C, will mixing
It is added dropwise to mutually in aqueous phase, under the power of 250W, with ultrasonic emulsification instrument emulsifying 3-8 minute, obtains Citrus aurantium L. var. amara Engl. extract just microemulsion.
By said method prepare microemulsion particle diameter between 10-500nm, uniform particle sizes, solution appearance clarify.
Citrus aurantium L. var. amara Engl. extract microemulsion of the present invention has and can preserve for a long time, process stabilizing, equipment needed thereby
Simply, the feature that cost is controlled.Compared with original patent, the invention provides the liquid dosage form of Citrus aurantium L. var. amara Engl. extract, can facilitate
Be added in medicine, food, health product, cosmetics.
Accompanying drawing explanation
Below according to drawings and Examples, the present invention is described in further detail.
Fig. 1 is Citrus aurantium L. var. amara Engl. extract microemulsion grain-size graph of the present invention.
Fig. 2 is Citrus aurantium L. var. amara Engl. extractive HPLC figure of the present invention.
Detailed description of the invention
Technical scheme uses the mode of form to add up such as following table:
The specific embodiment of the present invention includes:
Embodiment 1
Prescription composition is as follows:
Composition | Weight (g) |
Citrus aurantium L. var. amara Engl. extract (neohesperidin, naringin >=50%) | 5 |
Oleic acid | 3 |
RH40 polyoxyethylene hydrogenated Oleum Ricini | 2 |
Dehydrated alcohol | 25 |
Deionized water | 65.5 |
Sodium carboxymethyl cellulose | 1.5 |
Amount to 100g (Citrus aurantium L. var. amara Engl. extractive content 5%)
Preparation technology:
Weigh each component, RH40 polyoxyethylene hydrogenated Oleum Ricini is mixed homogeneously with oleic acid at 40 DEG C.Citrus aurantium L. var. amara Engl. is carried
Take thing to be dissolved in dehydrated alcohol, add in oil phase, be heated to 40 DEG C and extremely dissolve completely, mixing.By sodium carboxymethyl cellulose with go
Ionized water stirs, at 35 DEG C, oil phase is mixed with water, ultrasonic 5 minutes, forms clarification Citrus aurantium L. var. amara Engl. extract just microemulsion.
By high pressure homogenize 2 times under 500bar pressure of first microemulsion, obtain Citrus aurantium L. var. amara Engl. extract microemulsion.
Embodiment 2
Prescription composition is as follows:
Composition | Weight (g) |
Citrus aurantium L. var. amara Engl. extract (neohesperidin, naringin >=50%) | 10 |
Isopropyl myristate | 5 |
Tween 80 | 2 |
PEG400 | 15 |
Deionized water | 67.5 |
Sodium carboxymethyl cellulose | 0.5 |
Meter 100g (Citrus aurantium L. var. amara Engl. extractive content 10%)
Weigh each component, Tween 80 is mixed homogeneously with isopropyl myristate at 35 DEG C.By molten for Citrus aurantium L. var. amara Engl. extract
In PEG400, mix with oil phase, be heated to 45 DEG C and extremely dissolve completely, mixing.By sodium carboxymethyl cellulose and deionization
Water stirs, at 45 DEG C, oil phase is mixed with water, high speed shear 3 minutes, forms clarification Citrus aurantium L. var. amara Engl. extract just microemulsion.
By high pressure homogenize 3 times under 800bar pressure of first microemulsion, obtain Citrus aurantium L. var. amara Engl. extract microemulsion.
Embodiment 3
Prescription composition is as follows:
Composition | Weight (g) |
Citrus aurantium L. var. amara Engl. extract (neohesperidin, naringin >=50%) | 2 |
Isopropyl myristate | 5 |
RH40 polyoxyethylene hydrogenated Oleum Ricini | 3 |
PEG400 | 5 |
Deionized water | 84 |
Carbomer | 1 |
Amount to 100g (Citrus aurantium L. var. amara Engl. extractive content 2%)
Weigh each component, RH40 polyoxyethylene hydrogenated Oleum Ricini is mixed homogeneously with isopropyl myristate at 50 DEG C.
Citrus aurantium L. var. amara Engl. extract is dissolved in PEG400, mixes with oil phase, be heated to 50 DEG C and extremely dissolve completely, mixing.By carbomer
Mix with deionized water, at 50 DEG C, oil phase is mixed with water, ultrasonic emulsification 8 minutes, formed at the beginning of clarification Citrus aurantium L. var. amara Engl. extract
Microemulsion.First microemulsion is put into high pressure homogenizer, 1200bar homogenizing 2 times, obtains Citrus aurantium L. var. amara Engl. extract microemulsion.
Embodiment 4
Prescription composition is as follows:
Composition | Weight (g) |
Citrus aurantium L. var. amara Engl. extract (neohesperidin, naringin >=50%) | 5 |
Miglyol 812N | 8.5 |
PLURONICS F87 | 3 |
Glycerol | 7 |
Deionized water | 75.5 |
PVP K30 | 1 |
Amount to 100g (Citrus aurantium L. var. amara Engl. extractive content 5%)
Weighing each component, Citrus aurantium L. var. amara Engl. extract is dissolved in glycerol and Miglyol 812N, at 40 DEG C, mixing is all
Even.PLURONICS F87, water are heated to 50 DEG C to mixing with PVP K30.Oil phase is mixed with water, ultrasonic emulsification 10 points
Clock, forms clarification Citrus aurantium L. var. amara Engl. extract just microemulsion.First microemulsion is put into high pressure homogenizer, 800bar homogenizing 3 times, obtains Citrus aurantium L. var. amara Engl.
Extract microemulsion.
Embodiment 5
Amount to 100g (Citrus aurantium L. var. amara Engl. extractive content 10%)
Weigh each component, Citrus aurantium L. var. amara Engl. extract is dissolved in 30% ethanol, Miglyol 812N and Polyethylene Glycol 15 hydroxyl
Base stearate, mix homogeneously at 30 DEG C.Sodium alginate and water are heated to 40 DEG C to mixing.By oil phase with aqueous phase at 40 DEG C
Mixing, high speed shear 5 minutes, form clarification Citrus aurantium L. var. amara Engl. extract just microemulsion.First microemulsion is put into high pressure homogenizer, 1200bar
Homogenizing 2 times, obtains Citrus aurantium L. var. amara Engl. extract microemulsion.
Embodiment 6
As shown in Figure 1-2, physical and chemical index evaluation and stability study
In this invention, physical and chemical index and the physical stability checking of microemulsion formulation are as follows;
1, the physical and chemical index detection of microemulsion formulation
(1) outward appearance detection: microemulsion formulation is yellow to brown color, and clarification, viscosity is low, good fluidity.
(2) emulsion type detection: respectively methylene blue (water-soluble dye) and tonyred (oil-soluble dyes) are added suitable
The Citrus aurantium L. var. amara Engl. extract microemulsion formulation of amount, observes two kinds of solution diffusion velocity in microemulsion.Result shows, methylene blue
Diffusion velocity in microemulsion is significantly faster than that tonyred, experiment prove that Citrus aurantium L. var. amara Engl. extract microemulsion is O/W type Emulsion.
(3) assay
HPLC is used to analyze microemulsion content
Chromatographic column: C18 post, 5 μm, 25 × 0.46cm.
Flowing phase: acetonitrile-water-phosphoric acid (22: 78: 0.78, v/v).
Flow velocity: 1ml/min.
Detection wavelength: 284nm.
Sample size: 20 μ l.
2, dewatering ability detection
Taking appropriate microemulsion and be sealed in centrifuge tube, in 4000r/ minute, lower high speed centrifugation 30 minutes, observed slight Emulsion
Outward appearance.Test result indicate that, microemulsion is layered after being centrifuged, deposited phenomenon.Illustrate that preparation has good physically stable
Property.
3, long-time stability detection
Taking appropriate Citrus aurantium L. var. amara Engl. extract microemulsion, in medicine constant temperature is stably tested, (25 DEG C) are placed 6 months, in 1,2,3,
6 months period sampling measurings, indices has no significant change.Data such as table 1.
Table 1. stability experiment result
The Citrus aurantium L. var. amara Engl. extract microemulsion of above experimental data explanation preparation is placed 6 moonsets at 25 DEG C and is occurred
Layering, emulsion droplet merge, flocculate and demulsifying phenomenon.Outward appearance, particle diameter, content have no significant change.Prove that this microemulsion can
Place through long-term, stable in physicochemical property.
Claims (10)
1. Citrus aurantium L. var. amara Engl. extract microemulsion formulation, based on recipe quantity 100g, its component and content is:
2. Citrus aurantium L. var. amara Engl. extract microemulsion formulation as claimed in claim 1, it is characterised in that said components is mixed, after heating
Process through emulsifying and high pressure homogenize, obtain brown color to light yellow, the microemulsion solution of clarification.
3. Citrus aurantium L. var. amara Engl. extract microemulsion formulation as claimed in claim 1 or 2, it is characterised in that emulsifying agent is polyoxyethylene hydrogen
Change any one or more mixing of Oleum Ricini, tween, poloxamer, Solutol HS 15 apoplexy due to endogenous wind.
4. the Citrus aurantium L. var. amara Engl. extract microemulsion formulation as described in one of claim 1-3, it is characterised in that surfactant is polyoxy
Ethylene hydrogenation Oleum Ricini, Tween 80, any one or more mixing of PLURONICS F87.
5. the Citrus aurantium L. var. amara Engl. extract microemulsion formulation as described in one of claim 1-4, it is characterised in that co-emulsifier be ethanol,
Propylene glycol, glycerol, Polyethylene Glycol, one or more mixing of diethylene glycol monomethyl ether.
6. the Citrus aurantium L. var. amara Engl. extract microemulsion formulation as described in one of claim 1-5, it is characterised in that oil phase is oleic acid, lima bean
Cool isopropyl propionate, any one or more mixing of middle carbochain triglyceride.
7. the Citrus aurantium L. var. amara Engl. extract microemulsion formulation as described in one of claim 1-6, it is characterised in that stabilizer is selected from card ripple
One or more mixing in nurse, arabic gum, sodium carboxymethyl cellulose, sodium alginate, polyvidone, hyaluronic acid.
8. the Citrus aurantium L. var. amara Engl. extract microemulsion formulation as described in one of claim 1-7, it is characterised in that the Citrus aurantium L. var. amara Engl. added carries
Take neohesperidin and naringin content summation >=50% in thing.
9. a preparation method for the Citrus aurantium L. var. amara Engl. extract microemulsion formulation described in any one of claim 1-8, concrete technology is as follows:
(1) Citrus aurantium L. var. amara Engl. extract, emulsifying agent, co-emulsifier, oil phase and deionized water are weighed in proportion;
(2) prepare oil phase: be dissolved in co-emulsifier by Citrus aurantium L. var. amara Engl. extract, then mix homogeneously with emulsifying agent, oil phase;
(3) aqueous phase is prepared: in aqueous phase, add stabilizer, stir;
(4) preparation just microemulsion: in a heated condition, oil phase is slowly added in aqueous phase, forms the first microemulsion clarifying, having opalescence
Liquid;
(5) preparation breast eventually: above-mentioned just microemulsion is put into high pressure homogenizer, homogenizing, obtains stable Citrus aurantium L. var. amara Engl. extract microemulsion
Liquid.
10. Citrus aurantium L. var. amara Engl. extract microemulsion formulation as claimed in claim 9, it is characterised in that step (4) described preparation just microemulsion
Method use following method one or both methods be prepared: stirring and emulsifying method, supersound method;
Preferably, stirring and emulsifying method: the Citrus aurantium L. var. amara Engl. extract weighed is dissolved in co-emulsifier, is heated to 30-70 DEG C, treats turtle
After turtle flower extract is completely dissolved, adds emulsifying agent and form mixed phase with oil phase mixing, keep system temperature 30-80 DEG C, will be mixed
Close and be added dropwise to mutually in aqueous phase, high speed shear 5-10 minute, obtain Citrus aurantium L. var. amara Engl. extract just microemulsion;
Preferably, supersound method: the Citrus aurantium L. var. amara Engl. extract weighed is dissolved in co-emulsifier, is heated to 30-70 DEG C, treats turtle
After turtle flower extract is completely dissolved, adds emulsifying agent and form mixed phase with oil phase mixing, keep system temperature 30-80 DEG C, will be mixed
Close and be added dropwise to mutually in aqueous phase, under the power of 250W, with ultrasonic emulsification instrument emulsifying 3-8 minute, obtain Citrus aurantium L. var. amara Engl. extract the most micro-
Breast.
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Cited By (5)
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CN106974287A (en) * | 2017-05-08 | 2017-07-25 | 中山森谱生物科技有限公司 | A kind of functional food containing Rhizoma Smilacis Glabrae extract and preparation method thereof |
CN107519085A (en) * | 2017-08-28 | 2017-12-29 | 陈霞 | A kind of skin care item and preparation method thereof |
CN109481319A (en) * | 2018-11-22 | 2019-03-19 | 杭州千岛湖天鑫有限公司 | A kind of micro-nano lotion of camellia oil and preparation method thereof |
CN114788524A (en) * | 2022-01-25 | 2022-07-26 | 中国农业科学院烟草研究所(中国烟草总公司青州烟草研究所) | Bacteriostatic microemulsion preparation and preparation method and application thereof |
CN114788524B (en) * | 2022-01-25 | 2024-05-31 | 中国农业科学院烟草研究所(中国烟草总公司青州烟草研究所) | Antibacterial microemulsion preparation and preparation method and application thereof |
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN106974287A (en) * | 2017-05-08 | 2017-07-25 | 中山森谱生物科技有限公司 | A kind of functional food containing Rhizoma Smilacis Glabrae extract and preparation method thereof |
CN107519085A (en) * | 2017-08-28 | 2017-12-29 | 陈霞 | A kind of skin care item and preparation method thereof |
CN109481319A (en) * | 2018-11-22 | 2019-03-19 | 杭州千岛湖天鑫有限公司 | A kind of micro-nano lotion of camellia oil and preparation method thereof |
CN114788524A (en) * | 2022-01-25 | 2022-07-26 | 中国农业科学院烟草研究所(中国烟草总公司青州烟草研究所) | Bacteriostatic microemulsion preparation and preparation method and application thereof |
CN114788524B (en) * | 2022-01-25 | 2024-05-31 | 中国农业科学院烟草研究所(中国烟草总公司青州烟草研究所) | Antibacterial microemulsion preparation and preparation method and application thereof |
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