CN105998286B - Daidaidai flower extract microemulsion preparation and preparation method thereof - Google Patents
Daidaidai flower extract microemulsion preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a daidaidai flower extract microemulsion preparation, which comprises the following components in 100g of formula: 2% -20% of citrus aurantium extract; 2% -15% of emulsifier; 2% -10% of auxiliary emulsifier; 5% -10% of oil phase; 0.5 to 1 percent of stabilizer; 44-88.5 percent of deionized water. Mixing the above components, heating, emulsifying, and homogenizing under high pressure to obtain brown yellow to light yellow clear microemulsion solution. The invention also discloses a preparation method of the daidaidai flower extract microemulsion preparation, which comprises the following specific processes: (1) weighing bitter orange extract, an emulsifier, an auxiliary emulsifier, an oil phase and deionized water in proportion; (2) preparing an oil phase; (3) preparing an aqueous phase; (4) preparing a primary microemulsion; (5) and (4) preparing the final milk. The daidaidai flower extract microemulsion has the characteristics of long-term storage at room temperature, stable process, simple required equipment and controllable cost. Compared with the original patent, the invention provides a liquid preparation of the bitter orange extract, which can be conveniently added into medicines, foods, health-care products and cosmetics.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a daidaidai flower extract microemulsion preparation and a preparation method thereof.
Background
The bitter orange (bitter orange) is a plant of the citrus subgenus of the Rutaceae, and the bitter orange belongs to a medicinal and edible plant published by the Ministry of health, and can be added into medicines, health-care foods, common foods and cosmetics. The bitter citrus immature flower is sweet in taste, bitter in taste and neutral in nature, has the effect of soothing the liver and regulating the flow of qi, and is used for treating symptoms such as indigestion, phlegm and fluid retention, fullness and stuffiness and distending pain in chest and abdomen and the like in traditional Chinese medicine.
The citrus aurantium extract mainly contains neohesperidin and naringin (the content of the neohesperidin and the naringin is more than or equal to 50 percent), and belongs to flavonoid components. Pharmacological experiments prove that the bitter orange extract has an antioxidant function, has a good scavenging effect on DPPH free radicals and-OH free radicals, and has a good antioxidant effect in the aspects of treating weight loss, reducing blood fat, liver injury, skin care and the like. Patent CN201110317409 discloses the effect of seville orange flower extract in inhibiting lipase activity, and can be developed into weight-reducing medicines. In the aspect of reducing blood fat, the citrus aurantium extract can effectively treat hyperlipidemia, remarkably reduce the content of serum total cholesterol, triglyceride and low-density lipoprotein, and increase the content of high-density lipoprotein; it can also reduce the atherosclerotic index. In the aspect of treating liver injury, the citrus aurantium extract can effectively eliminate the malondialdehyde content in serum and liver of a patient with hyperlipidemia and increase the superoxide dismutase content in the serum and the liver. In the aspect of skin care, patent CN 104434622 a discloses that citrus aurantium extract can significantly reduce the level of active oxygen in epidermal cells and fibroblasts caused by ultraviolet irradiation, and also can promote cell proliferation, promote the expression of fibroblast type IV collagen mRNA, inhibit the activities of elastase and matrix metalloproteinase, and reduce the secretion of inflammatory factors, thereby having the effects of anti-allergy, anti-radiation, and anti-aging on skin.
The bitter orange extract has low water solubility and oil solubility and low bioavailability, limits the clinical application of the bitter orange extract, and develops a preparation product with high bioavailability by starting from improving the solubility of the bitter orange extract. The patent CN105012461A discloses a method for preparing dropping pills of dai-dai fruit total flavonoids, which comprises the steps of heating and melting dai-dai fruit total flavonoid extract fine powder and polyethylene glycol, and then transferring the dai-dai fruit total flavonoid extract fine powder into a dropping pill machine for dropping. However, liquid paraffin and simethicone are remained in the preparation process of the preparation, gastrointestinal stimulation is easily caused after the preparation is taken, and the problems of low solubility and poor absorption of the bitter orange extract are not solved by the technology. Patent CN201210008449.3 discloses a method for preparing self-microemulsifying pellets of daidai-dai-fruit flavone, which comprises the steps of combining dai-fruit total flavone effective parts, propylene glycol laurate, tween-80 and diethylene glycol monoethyl ether, and uniformly mixing the composition, microcrystalline cellulose and lactose to prepare pellets. But the method has the defects of low drug loading, uneven drug application and the like; meanwhile, microcrystalline cellulose in the components is easy to absorb moisture in the storage process, so that the drug leakage is promoted, and the stability of the preparation is poor.
The prior patent provides a new formulation for improving the dispersibility of the daidaidai extract, improves the in vitro dissolution behavior to a certain extent, but does not fundamentally solve the problem of the solubility of the extract. There is therefore a need to replace the prior art by a new formulation which has stable properties and a simple process and which achieves the desired raw solubility.
Aiming at the problems, the inventor provides a micro-emulsion preparation containing the bitter orange extract and a preparation method thereof, and the extract is prepared into the micro-emulsion preparation, so that the water solubility of the medicament can be increased, the dissolution of the medicament in the gastrointestinal tract can be improved, and the bioavailability can be improved. Simultaneously provides a liquid preparation type of the daidai flower flavone which can be conveniently added and has stable property.
The microemulsion is a transparent or semitransparent oil-water mixture with low viscosity, is a system with stable thermodynamics and kinetics, and consists of an emulsifier, an auxiliary emulsifier, an oil phase and a water phase. The microemulsion has the advantages of uniform particle size distribution, no layering after long-term storage and favorable absorption, and the main quality evaluation indexes are oil (water) carrying amount, particle size and microemulsion stability. In addition, the microemulsion preparation process is simple, the quality is controllable, and the microemulsion preparation method is suitable for industrial production and has a good application prospect.
Disclosure of Invention
The invention aims to provide a micro-emulsion preparation which can improve the solubility of a bitter orange extract and can be conveniently added into medicines, foods, health-care products and cosmetics, and a preparation method thereof. When a microemulsion preparation carrier is developed, an emulsifier and a co-emulsifier with strong emulsifying capacity, stable property and high safety are selected firstly, and the forming condition of the microemulsion is researched by a triangular phase diagram method, so that the dosage of the emulsifier and the co-emulsifier is reduced as much as possible, and the production cost is saved.
The invention is realized by the following technical scheme:
the daidaidai flower extract microemulsion preparation comprises the following components by 100g of formula:
mixing the above components, heating, emulsifying, and homogenizing under high pressure to obtain brown yellow to light yellow clear microemulsion solution.
The emulsifier of the daidaidai flower extract microemulsion is one or a mixture of more of polyoxyethylene hydrogenated castor oil, tween, poloxamer and polyethylene glycol 15 hydroxystearate.
The preferable surfactant in the invention is one or a mixture of more of polyoxyethylene hydrogenated castor oil, tween 80 and poloxamer 188.
The coemulsifier of the daidaidai flower extract micro emulsion is one or a mixture of more of ethanol, propylene glycol, glycerol, polyethylene glycol and diethylene glycol monomethyl ether. The preferred coemulsifier of the invention is one or the mixture of ethanol and polyethylene glycol 400.
The oil phase of the daidaidai flower extract microemulsion is one or a mixture of oleic acid, isopropyl myristate and medium-chain triglyceride. Preferred oil phases of the present invention are oleic acid and isopropyl myristate.
The stabilizer is one or a mixture of more of carbomer, Arabic gum, sodium carboxymethylcellulose, sodium alginate, povidone and hyaluronic acid. Preferred stabilizers of the present invention are carbomer and sodium carboxymethylcellulose.
The invention relates to a preparation method of a daidaidai flower extract microemulsion preparation, which comprises the following specific processes:
(1) weighing bitter orange extract, an emulsifier, an auxiliary emulsifier, an oil phase and deionized water in proportion;
(2) preparing an oil phase: dissolving the bitter orange extract in a co-emulsifier, and then uniformly mixing the bitter orange extract with an emulsifier and an oil phase;
(3) preparing an aqueous phase: adding a stabilizer into the water phase, and uniformly stirring.
(4) Preparing a primary microemulsion: under the heating condition, slowly adding the oil phase into the water phase to form clear and opalescent primary microemulsion;
(5) preparing final milk: and (3) placing the primary microemulsion into a high-pressure homogenizer for homogenization to obtain the stable daidaidai flower extract microemulsion.
The preparation method of the bitter orange extract primary microemulsion can adopt one or two methods of the following methods for preparation: stirring emulsification method and ultrasonic emulsification method. The invention prefers the stirring emulsification method, which is helpful for the complete emulsification of the microemulsion and can reduce the dosage of the emulsifier and the auxiliary emulsifier.
Stirring and emulsifying: dissolving the weighed bitter orange extract in an auxiliary emulsifier, heating to 30-70 ℃, adding the emulsifier and an oil phase after the bitter orange extract is completely dissolved, uniformly mixing to form a mixed phase, keeping the system temperature at 30-80 ℃, dripping the mixed phase into a water phase, and shearing at a high speed for 5-10 minutes to obtain the bitter orange extract primary microemulsion.
An ultrasonic emulsification method: dissolving the weighed bitter orange extract in an auxiliary emulsifier, heating to 30-70 ℃, adding the emulsifier and an oil phase after the bitter orange extract is completely dissolved, uniformly mixing to form a mixed phase, keeping the system temperature at 30-80 ℃, dropwise adding the mixed phase into a water phase, and emulsifying for 3-8 minutes by using an ultrasonic emulsifier under the power of 250W to obtain the bitter orange extract primary microemulsion.
The microemulsion prepared by the method has the advantages of uniform particle size of 10-500nm and clear solution appearance.
The daidaidai flower extract microemulsion has the characteristics of long-term storage at room temperature, stable process, simple required equipment and controllable cost. Compared with the original patent, the invention provides a liquid preparation of the bitter orange extract, which can be conveniently added into medicines, foods, health-care products and cosmetics.
Drawings
The invention is explained in more detail below with reference to the figures and examples.
FIG. 1 is a particle size diagram of a citrus aurantium extract microemulsion of the present invention.
FIG. 2 is an HPLC chart of the bitter orange extract of the present invention.
Detailed Description
The technical scheme of the invention adopts a table mode to count as follows:
the specific embodiment of the invention comprises the following steps:
example 1
The prescription composition is as follows:
| composition (I) | Weight (g) |
| Daidaidai flower extract (neohesperidin and naringin more than or equal to 50%) | 5 |
| Oleic acid | 3 |
| RH40 polyoxyethylene hydrogenated castor oil | 2 |
| Anhydrous ethanol | 25 |
| Deionized water | 65.5 |
| Sodium carboxymethylcellulose | 1.5 |
The total amount of the bitter citrus immature flower extract is 100g (the content of the bitter citrus immature flower extract is 5%)
The preparation process comprises the following steps:
weighing the components, and uniformly mixing RH40 polyoxyethylene hydrogenated castor oil and oleic acid at 40 ℃. Dissolving bitter orange extract in anhydrous ethanol, adding into oil phase, heating to 40 deg.C until completely dissolved, and mixing. Uniformly stirring sodium carboxymethylcellulose and deionized water, mixing an oil phase and a water phase at 35 ℃, and performing ultrasonic treatment for 5 minutes to form a clear bitter orange extract primary microemulsion. And (3) homogenizing the primary microemulsion for 2 times under the pressure of 500bar to obtain the citrus aurantium extract microemulsion.
Example 2
The prescription composition is as follows:
| composition (I) | Weight (g) |
| Daidaidai flower extract (neohesperidin and naringin more than or equal to 50%) | 10 |
| Myristic acid isopropyl ester | 5 |
| Tween 80 | 2 |
| Polyethylene glycol 400 | 15 |
| Deionized water | 67.5 |
| Sodium carboxymethylcellulose | 0.5 |
100g (bitter orange extract content 10%)
Weighing the components, and uniformly mixing tween 80 and isopropyl myristate at 35 ℃. Dissolving bitter orange extract in polyethylene glycol 400, mixing with oil phase, heating to 45 deg.C until completely dissolved, and mixing. Uniformly stirring sodium carboxymethylcellulose and deionized water, mixing an oil phase and a water phase at 45 ℃, and shearing at a high speed for 3 minutes to form the clear bitter orange extract primary microemulsion. And (3) homogenizing the primary microemulsion under the pressure of 800bar for 3 times to obtain the daidaidaidai flower extract microemulsion.
Example 3
The prescription composition is as follows:
| composition (I) | Weight (g) |
| Daidaidai flower extract (neohesperidin and naringin more than or equal to 50%) | 2 |
| Myristic acid isopropyl ester | 5 |
| RH40 polyoxyethylene hydrogenated castor oil | 3 |
| Polyethylene glycol400 | 5 |
| Deionized water | 84 |
| |
1 |
The total amount of the bitter orange is 100g (the content of the bitter orange flower extract is 2 percent)
The components are weighed and the RH40 polyoxyethylene hydrogenated castor oil and isopropyl myristate are mixed evenly at 50 ℃. Dissolving bitter orange extract in polyethylene glycol 400, mixing with oil phase, heating to 50 deg.C until completely dissolved, and mixing. Mixing carbomer and deionized water, mixing oil phase and water phase at 50 deg.C, and ultrasonic emulsifying for 8 min to obtain clear Dai dai flower extract primary microemulsion. And (3) placing the primary microemulsion into a high-pressure homogenizer, and homogenizing for 2 times at 1200bar to obtain the daidaidai flower extract microemulsion.
Example 4
The prescription composition is as follows:
| composition (I) | Weight (g) |
| Daidaidai flower extract (neohesperidin and naringin more than or equal to 50%) | 5 |
| Caprylic capric acid triglyceride | 8.5 |
| Poloxamer 188 | 3 |
| Glycerol | 7 |
| Deionized water | 75.5 |
| |
1 |
The total amount of the bitter citrus immature flower extract is 100g (the content of the bitter citrus immature flower extract is 5%)
Weighing the components, dissolving the bitter orange flower extract in glycerol and caprylic/capric triglyceride, and uniformly mixing at 40 ℃. Poloxamer 188, water and povidone K30 were heated to 50 ℃ to mix well. And mixing the oil phase and the water phase, and performing ultrasonic emulsification for 10 minutes to form a clear bitter orange extract primary microemulsion. And (3) placing the primary microemulsion into a high-pressure homogenizer, and homogenizing for 3 times at 800bar to obtain the daidaidai flower extract microemulsion.
Example 5
The total amount of the bitter orange is 100g (the content of the bitter orange flower extract is 10 percent)
Weighing the components, dissolving the bitter orange extract in 30% ethanol, caprylic capric triglyceride and polyethylene glycol 15 hydroxystearate, and uniformly mixing at 30 ℃. Heating sodium alginate and water to 40 deg.C, and mixing. And mixing the oil phase and the water phase at 40 ℃, and shearing at high speed for 5 minutes to form the clear bitter orange extract primary microemulsion. And (3) placing the primary microemulsion into a high-pressure homogenizer, and homogenizing for 2 times at 1200bar to obtain the daidaidai flower extract microemulsion.
Example 6
As shown in FIGS. 1-2, evaluation of physical and chemical indexes and stability study
The physical and chemical indexes and physical stability of the microemulsion preparation are verified as follows;
1. detection of physical and chemical indexes of microemulsion preparation
(1) And (3) appearance detection: the microemulsion preparation is yellow to brown yellow, clear, low in viscosity and good in fluidity.
(2) And (3) emulsion type detection: methylene blue (water-soluble dye) and Sudan red (oil-soluble fuel) are respectively added into a proper amount of daidaidai flower extract microemulsion preparation, and the diffusion speed of the two solutions in the microemulsion is observed. The result shows that the diffusion speed of methylene blue in the microemulsion is obviously faster than that of Sudan red, and the experiment proves that the daidaidai flower extract microemulsion is O/W type emulsion.
(3) Determination of content
Content of microemulsion was analyzed by HPLC
A chromatographic column: c18 column, 5 μm, 25X 0.46 cm.
Mobile phase: acetonitrile-water-phosphoric acid (22: 78: 0.78, v/v).
Flow rate: 1 ml/min.
Detection wavelength: 284 nm.
Sample introduction amount: 20 μ l.
2. Centrifugal stability testing
Taking a proper amount of microemulsion, sealing the microemulsion in a centrifugal tube, centrifuging the microemulsion for 30 minutes at a high speed of 4000 r/min, and observing the appearance of the microemulsion. The experimental result shows that the phenomenon of layering and precipitation does not occur after the microemulsion is centrifuged. Indicating that the formulation has good physical stability.
3. Long term stability testing
A proper amount of daidaidai flower extract microemulsion is taken and placed in a constant temperature stable experiment (25 ℃) for 6 months, and samples are regularly taken for measurement in 1, 2, 3 and 6 months, and all indexes have no obvious change. The data are shown in Table 1.
TABLE 1 stability test results
The above experimental data show that the prepared daidaidaidai flower extract microemulsion does not appear after being placed at 25 ℃ for 6 months
Demixing, emulsion drop merging, flocculation and emulsion breaking phenomena. The appearance, the grain diameter and the content are not obviously changed. The microemulsion is proved to be capable of being placed for a long time and has stable physicochemical property.
Claims (6)
1. The daidaidai flower extract microemulsion preparation comprises the following components in 100g of formula:
5% of bitter orange extract;
2% of an emulsifier;
25% of auxiliary emulsifier;
3% of an oil phase;
1.5% of a stabilizer;
the balance of deionized water;
the content sum of neohesperidin and naringin in the citrus aurantium extract is more than or equal to 50 percent;
the emulsifier is polyoxyethylene hydrogenated castor oil;
the auxiliary emulsifier is ethanol;
the oil phase is oleic acid;
the stabilizer is sodium carboxymethyl cellulose;
the daidaidai flower extract microemulsion preparation is prepared by the preparation method comprising the following steps:
(1) weighing bitter orange extract, an emulsifier, an auxiliary emulsifier, an oil phase and deionized water in proportion;
(2) preparing an oil phase: dissolving the bitter orange extract in a co-emulsifier, and then uniformly mixing the bitter orange extract with an emulsifier and an oil phase;
(3) preparing an aqueous phase: adding a stabilizer into the water phase, and uniformly stirring;
(4) preparing a primary microemulsion: under the heating condition, slowly adding the oil phase into the water phase to form clear and opalescent primary microemulsion;
(5) preparing final milk: and (3) placing the primary microemulsion into a high-pressure homogenizer for homogenization to obtain the stable daidaidai flower extract microemulsion.
2. The daidaidai flower extract microemulsion preparation as claimed in claim 1, wherein the components are mixed, emulsified after heating and homogenized under high pressure to obtain a yellowish to yellowish clear microemulsion solution.
3. The preparation method of the daidaidai flower extract microemulsion preparation of claim 1 or 2 comprises the following specific processes:
(1) weighing bitter orange extract, an emulsifier, an auxiliary emulsifier, an oil phase and deionized water in proportion;
(2) preparing an oil phase: dissolving the bitter orange extract in a co-emulsifier, and then uniformly mixing the bitter orange extract with an emulsifier and an oil phase;
(3) preparing an aqueous phase: adding a stabilizer into the water phase, and uniformly stirring;
(4) preparing a primary microemulsion: under the heating condition, slowly adding the oil phase into the water phase to form clear and opalescent primary microemulsion;
(5) preparing final milk: and (3) placing the primary microemulsion into a high-pressure homogenizer for homogenization to obtain the stable daidaidai flower extract microemulsion.
4. The method for preparing a daidai flower extract microemulsion preparation according to claim 3, wherein the method for preparing the primary microemulsion in the step (4) is prepared by one or two methods of the following methods: stirring emulsification method and ultrasonic emulsification method.
5. The method for preparing the micro-emulsion preparation of bitter orange extract according to claim 4, wherein the stirring emulsification method comprises the following steps: dissolving the weighed bitter orange extract in an auxiliary emulsifier, heating to 30-70 ℃, adding the emulsifier and an oil phase after the bitter orange extract is completely dissolved, uniformly mixing to form a mixed phase, keeping the system temperature at 30-80 ℃, dripping the mixed phase into a water phase, and shearing at a high speed for 5-10 minutes to obtain the bitter orange extract primary microemulsion.
6. The method for preparing a micro-emulsion preparation of citrus aurantium extract according to claim 4, wherein the ultrasonic emulsification comprises: dissolving the weighed bitter orange extract in an auxiliary emulsifier, heating to 30-70 ℃, adding the emulsifier and an oil phase after the bitter orange extract is completely dissolved, uniformly mixing to form a mixed phase, keeping the system temperature at 30-80 ℃, dropwise adding the mixed phase into a water phase, and emulsifying for 3-8 minutes by using an ultrasonic emulsifier under the power of 250W to obtain the bitter orange extract primary microemulsion.
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| CN102552491A (en) * | 2012-01-11 | 2012-07-11 | 福建中医药大学 | Dai-dai fruit total flavonoid self-microemulsion micro pill and preparation method thereof |
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| CN102552491A (en) * | 2012-01-11 | 2012-07-11 | 福建中医药大学 | Dai-dai fruit total flavonoid self-microemulsion micro pill and preparation method thereof |
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