CN111000795A - Compound microemulsion gel containing soybean isoflavone nano-microspheres and preparation method thereof - Google Patents
Compound microemulsion gel containing soybean isoflavone nano-microspheres and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a compound microemulsion gel containing soy isoflavone nano-microspheres and a preparation method thereof, wherein the compound microemulsion gel comprises the following raw materials in parts by weight: 10-20 parts of soybean isoflavone nano microspheres, 50-100 parts of a traditional Chinese medicine composition, 5-20 parts of plant essential oil, 20-40 parts of water-soluble chitosan, 1-5 parts of sodium hyaluronate, 20-30 parts of an emulsifier, 80-120 parts of an auxiliary emulsifier, 15-20 parts of a gel matrix, 50-100 parts of a pH regulator, 1-2 parts of a bacteriostatic agent and 900 parts of high-purity water 600-. By adopting the technical scheme of the invention, the prepared microemulsion gel has good physical and chemical stability, obvious antibacterial effect and lasting action time, and is suitable for resisting bacteria and lubricating the female vagina, repairing and nourishing vaginal mucosa cells and improving climacteric symptoms.
Description
Technical Field
The invention relates to the technical field of microemulsion gel preparation, in particular to a compound microemulsion gel containing soy isoflavone nano-microspheres and a preparation method of the compound microemulsion gel containing the soy isoflavone nano-microspheres.
Background
Soy isoflavone is a bioactive substance extracted from natural soybeans and is also called "phytoestrogen" because it is very similar to the molecular structure of estrogen. The functions of soybean isoflavone are summarized as follows:
1. improving the skin: the action of the phytoestrogen can make female skin smooth, fine, soft and smooth and have elasticity;
2. bidirectional regulation function: when the estrogen secretion in the body is insufficient, the estrogen can be supplemented; when the estrogen secretion in the body is excessive, the excessive secretion of the estrogen can be inhibited, and the occurrence of gynecological tumors (such as uterine cancer) can be reduced;
3. can relieve climacteric syndrome symptoms, and soybean isoflavone can be used for relieving climacteric syndrome symptoms of women instead of estrogen;
4. antioxidation and anti-aging: long-term isoflavone supplementation can keep the normal level of estrogen in the body, delay menopause or achieve the aim of improving discomfort in the menopause, thereby playing the role of delaying senility;
5. prevention of osteoporosis: the consequences of bone loss are accelerated by ovarian hormone deficiency leading to dysbolism, an imbalance between bone formation and resorption. The isoflavone can better prevent the bone loss and has the function of preventing osteoporosis;
6. preventing senile dementia: the female patients in the patients are about three times of male patients, particularly, the incidence rate of ovariectomizers, hysterectomizers and postmenopausal patients is higher, the patients are earlier and progress faster, and researches show that the soybean isoflavone supplementation can improve the estrogen level and prevent senile dementia;
7. preventing atherosclerosis and cardiovascular diseases. The gel preparation can be prepared into a gel preparation which can be directly used for special female parts, is convenient and simple and has lasting effect.
The Microemulsion (ME) is a transparent or semitransparent, low-viscosity, isotropic and thermodynamically stable oil-water mixing system formed by mixing a water phase, an oil phase, a surfactant and a cosurfactant according to a certain proportion. The microemulsion has uniform particle size, generally 10-100 nm, and can be divided into oil-in-water (O/W) type, water-in-oil (W/O) type and bicontinuous type structurally; the microemulsion is used as a novel drug delivery carrier, and has the advantages of increasing the solubility of the drug, increasing the transdermal permeation amount of the drug, improving the stability of the drug, prolonging the action time of the drug and the like. The microemulsion is reported to improve the penetrability of the medicine and the retention in the deep layer of the skin when being applied locally, so the microemulsion is a good carrier for local medicines, but the microemulsion has strong flowability and poor adhesiveness as a transdermal drug delivery carrier, and the microemulsion is further prepared into microemulsion gel according to the good adhesiveness of the gel, so the problems of poor adhesiveness, poor skin spreading property, short retention time and the like of the microemulsion as the transdermal drug delivery carrier can be solved.
The gel can be closely adhered to the action part for a long time, has good biocompatibility and biological adhesiveness, and the medicine is adhered to the vaginal mucosa and slowly diffused to the mucosa from the gel. The gel adopts vaginal administration, avoids the first pass effect of liver and the physiological checkpoint effect of gastrointestinal tract, improves the curative effect of the medicine, and reduces the adverse reaction of the medicine.
Disclosure of Invention
Aiming at least one of the problems, the invention provides a compound micro-emulsion gel containing soy isoflavone nano-microspheres and a preparation method thereof, aiming at solving the problems of poor water solubility, insufficient function exertion, low bioavailability, poor adhesion of micro-emulsion administration carriers, short retention time and the like of the existing soy isoflavone.
In order to realize the purpose, the invention provides a compound micro-emulsion gel containing soy isoflavone nano-microspheres, which comprises the following raw materials in parts by weight: 10-20 parts of soybean isoflavone nano microspheres, 50-100 parts of a traditional Chinese medicine composition, 5-20 parts of plant essential oil, 20-40 parts of water-soluble chitosan, 1-5 parts of sodium hyaluronate, 20-30 parts of an emulsifier, 80-120 parts of an auxiliary emulsifier, 15-20 parts of a gel matrix, 50-100 parts of a pH regulator, 1-2 parts of a bacteriostatic agent and 900 parts of high-purity water 600-.
In the above technical scheme, preferably, the Chinese medicinal composition is composed of water-alcohol extracts of phellodendron, sophora flavescens, honeysuckle, salvia miltiorrhiza and fructus cnidii.
In the above technical scheme, preferably, the plant essential oil is tea tree essential oil and eucalyptus oil which are combined according to a ratio of 1: 2.5.
In the above technical scheme, preferably, the emulsifier is one or a combination of more of tween-80, tween 60, span-60, polyoxyethylene castor oil and polyoxyethylene hydrogenated castor oil.
In the above technical solution, preferably, the co-emulsifier is prepared by combining glycerol, ethanol, 1, 2-propylene glycol, and polyethylene glycol 400 in proportion.
In the above technical solution, preferably, the gel matrix is formed by combining carbomer 940 and hypromellose in proportion.
In the above technical solution, preferably, the pH adjusting agent is one or a combination of several of hydrochloric acid, acetic acid, triethanolamine, sodium hydroxide and potassium hydroxide, and the bacteriostatic agent is benzalkonium chloride.
The invention also provides a preparation method of the compound micro-emulsion gel containing the soy isoflavone nano-microspheres, which comprises the following steps: weighing a gel matrix and sodium hyaluronate according to a preset proportion, adding 30-50 times of high-purity water by weight, and standing to completely swell the gel matrix to obtain the gel matrix for later use; adding the compound microemulsion containing the soybean isoflavone nano-microspheres into the gel matrix, adding the rest part by weight of high-purity water in a preset proportion, uniformly stirring, and adjusting the pH value to 5.0-6.0 to obtain the compound microemulsion gel containing the soybean isoflavone nano-microspheres.
In the above technical solution, preferably, the preparation method of the compound microemulsion containing soy isoflavone nano-microspheres comprises: adding soybean isoflavone nanometer microsphere and plant essential oil into ethanol and polyethylene glycol 400, and heating at 60-70 deg.C for 300r min-1—600r·min-1The speed of the stirring is magnetic stirring or mechanical stirring until the mixture is clear and transparent to obtain an oil phase; mixing the Chinese medicinal composition, benzalkonium chloride, water soluble chitosan, glycerol, 1, 2-propylene glycol, and tween-80 under magnetic stirring or mechanical stirring for 300r min-1—600r·min-1Mixing to obtain water phase; and adding the oil phase into the water phase, and uniformly mixing to obtain the compound microemulsion containing the soybean isoflavone nano-microspheres.
In the above technical solution, preferably, the preparation method of the soy isoflavone nano-microsphere comprises: adding soybean isoflavone into water soluble chitosan HCS solution at a preset amount, adjusting pH to 5, and treating at 300 r.min-1—600r·min-1Magnetically stirring and slowly adding the aqueous solution of sodium tripolyphosphate dropwise until the solution appears opalescent.
Compared with the prior art, the invention has the beneficial effects that: the micro-emulsion gel prepared by the invention has good physical and chemical stability, obvious antibacterial effect and no irritation to vaginal mucosa, has certain adhesiveness and lasting action time, and is suitable for resisting bacteria and lubricating female vagina, repairing and nourishing vaginal mucosa cells and improving climacteric symptoms.
Drawings
FIG. 1 is a schematic flow chart of a preparation method of a compound microemulsion gel containing soy isoflavone nano-microspheres disclosed in one embodiment of the present invention;
fig. 2 is a flow chart of a preparation method of the compound microemulsion containing the soy isoflavone nano-microspheres disclosed by the embodiment of the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
The invention is described in further detail below with reference to the attached drawing figures:
the compound micro-emulsion gel containing the soy isoflavone nano-microspheres provided by the invention comprises the following raw materials in parts by weight: 10-20 parts of soybean isoflavone nano microspheres, 50-100 parts of a traditional Chinese medicine composition, 5-20 parts of plant essential oil, 20-40 parts of water-soluble chitosan, 1-5 parts of sodium hyaluronate, 20-30 parts of an emulsifier, 80-120 parts of an auxiliary emulsifier, 15-20 parts of a gel matrix, 50-100 parts of a pH regulator, 1-2 parts of a bacteriostatic agent and 900 parts of high-purity water 600-.
In the above embodiments, preferably, the Chinese medicinal composition is composed of water-alcohol extracts of phellodendron, sophora flavescens, honeysuckle, salvia miltiorrhiza and fructus cnidii.
In the above embodiment, preferably, the plant essential oil is tea tree essential oil and eucalyptus oil at a ratio of 1: 2.5.
In the above embodiment, preferably, the emulsifier is one or a combination of several of tween-80, tween 60, span-60, polyoxyethylene castor oil and polyoxyethylene hydrogenated castor oil.
In the above embodiment, preferably, the co-emulsifier is composed of glycerol, ethanol, 1, 2-propylene glycol, and polyethylene glycol 400 in proportion.
In the above embodiment, preferably, the gel matrix is formed by combining carbomer 940 and hypromellose in proportion.
In the above embodiment, preferably, the pH regulator is one or a combination of hydrochloric acid, acetic acid, triethanolamine, sodium hydroxide and potassium hydroxide, and the bacteriostatic agent is benzalkonium chloride.
As shown in fig. 1, the present invention further provides a preparation method of the compound microemulsion gel containing soy isoflavone nano-microspheres of any one of the above embodiments, comprising: weighing a gel matrix and sodium hyaluronate according to a preset proportion, adding 30-50 times of high-purity water by weight, standing overnight to completely swell the gel matrix for later use; adding the compound microemulsion containing the soybean isoflavone nano-microspheres into the gel matrix, adding the rest part by weight of high-purity water in a preset proportion, uniformly stirring, and adjusting the pH value to 5.0-6.0 to obtain the compound microemulsion gel containing the soybean isoflavone nano-microspheres.
As shown in fig. 2, in the above embodiment, preferably, the preparation method of the compound microemulsion containing the soy isoflavone nano-microspheres comprises: adding soybean isoflavone nanometer microsphere and plant essential oil into ethanol and polyethylene glycol 400, and heating at 60-70 deg.C for 300r min-1—600r·min-1The speed of the stirring is magnetic stirring or mechanical stirring until the mixture is clear and transparent to obtain an oil phase; mixing the Chinese medicinal composition, benzalkonium chloride, water soluble chitosan, glycerol, 1, 2-propylene glycol, and tween-80 under magnetic stirring or mechanical stirring for 300r min-1—600r·min-1Mixing to obtain water phase; and adding the oil phase into the water phase, and uniformly mixing to obtain the compound microemulsion containing the soybean isoflavone nano-microspheres.
In the above embodiment, preferably, the preparation method of the soy isoflavone nano-microsphere comprises: adding soybean isoflavone into water soluble chitosan HCS solution at a preset amount, adjusting pH to 5, and treating at 300 r.min-1—600r·min-1Magnetically stirring and slowly adding the aqueous solution of sodium tripolyphosphate dropwise until the solution appears opalescent.
According to the compound microemulsion gel containing soy isoflavone nano-microspheres and the preparation method thereof described in the above examples, the following detailed description is further provided in combination with specific embodiments, and it is obvious that the described examples are only a part of examples of the present invention, but not all examples. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example one
Example 1.1 the raw materials of the compound microemulsion gel containing the soy isoflavone nano-microspheres comprise, by weight:
10 parts of soybean isoflavone nano microspheres, 50 parts of a traditional Chinese medicine composition, 5 parts of plant essential oil, 20 parts of water-soluble chitosan, 5 parts of sodium hyaluronate, 20 parts of an emulsifier, 80 parts of a co-emulsifier, 15 parts of a gel matrix, 50 parts of a pH regulator, 1 part of a bacteriostatic agent and 750 parts of high-purity water.
Example 1.2 on the basis of the above examples, the Chinese medicinal composition is composed of water-alcohol extracts of phellodendron, sophora flavescens, honeysuckle, salvia miltiorrhiza and fructus cnidii; the plant essential oil is tea tree essential oil and eucalyptus oil according to the proportion of 1:2.5 in proportion; the emulsifier is tween-80; the auxiliary emulsifier is formed by combining glycerol, ethanol, 1, 2-propylene glycol and polyethylene glycol 400 according to the proportion of 2:1:4: 3; the gel matrix is formed by combining carbomer 940 and hydroxypropyl methylcellulose in a ratio of 2: 1; the pH regulator is triethanolamine; the bacteriostatic agent is benzalkonium chloride.
Example 1.3 this example provides a method for preparing a compound microemulsion gel containing soy isoflavone nanospheres, comprising the steps of:
s1, weighing a gel matrix and sodium hyaluronate, adding 40 times of high-purity water, standing overnight to enable the gel matrix to be completely swelled, and obtaining the gel matrix for later use;
s2, adding the compound micro emulsion containing the soy isoflavone nano-microspheres into the gel matrix prepared in the step S1, adding the rest parts by weight of high-purity water, uniformly stirring, and adjusting the pH value to 5.0-6.0 to obtain the compound micro emulsion gel containing the soy isoflavone nano-microspheres.
Example 1.4 a compound microemulsion containing soy isoflavone nanospheres was prepared by the following method:
a. weighing the soybean isoflavone nano microspheres and the plant essential oil in the weight parts in example 1.1, adding the soybean isoflavone nano microspheres and the plant essential oil into ethanol and polyethylene glycol 400, and stirring the mixture for 300 r.min at 70 ℃ by adopting magnetic force-1Obtaining an oil phase after the mixture is clear and transparent;
b. weighing the traditional Chinese medicine composition, benzalkonium chloride, water-soluble chitosan, glycerol, 1, 2-propylene glycol and tween 80 in the weight parts in the embodiment 1.1, and uniformly mixing by magnetic stirring or mechanical stirring to obtain a water phase;
c. and (c) adding the oil phase prepared in the step (a) into the water phase prepared in the step (b), and uniformly mixing to obtain the compound microemulsion containing the soybean isoflavone nano-microspheres.
Example 1.5 soy isoflavone nanospheres were prepared by the following method:
adding appropriate amount of soybean isoflavone into water soluble chitosan HCS solution, adjusting pH to 5, magnetically stirring for 300r min-1—600r·min-1Next, an aqueous TPP solution was slowly added dropwise until the solution appeared opalescent.
Example two
Example 2.1 the raw materials of the compound microemulsion gel containing the soy isoflavone nano-microspheres comprise, by weight:
15 parts of soybean isoflavone nano microspheres, 80 parts of a traditional Chinese medicine composition, 5 parts of plant essential oil, 40 parts of water-soluble chitosan, 3 parts of sodium hyaluronate, 25 parts of an emulsifier, 100 parts of a co-emulsifier, 15 parts of a gel matrix, 70 parts of a pH regulator, 1 part of a bacteriostatic agent and 660 parts of high-purity water.
Example 2.2 on the basis of the above example 2.1, the Chinese medicinal composition is composed of water-alcohol extracts of phellodendron, sophora flavescens, honeysuckle, salvia miltiorrhiza and fructus cnidii; the plant essential oil is tea tree essential oil and eucalyptus oil according to the proportion of 1:2.5 in proportion; the emulsifier is tween-80; the auxiliary emulsifier is formed by combining glycerol, ethanol, 1, 2-propylene glycol and polyethylene glycol 400 according to the proportion of 1:1:5: 3; the gel matrix is formed by combining carbomer 940 and hydroxypropyl methylcellulose in a ratio of 2: 1; the pH regulator is triethanolamine; the bacteriostatic agent is benzalkonium chloride.
Embodiment 2.3 this embodiment provides a method for preparing a compound microemulsion gel containing soy isoflavone nano-microspheres, comprising the following steps:
s1, weighing a gel matrix and sodium hyaluronate, adding 40 times of high-purity water, standing overnight to enable the gel matrix to be completely swelled, and obtaining the gel matrix for later use;
s2, adding the compound micro emulsion containing the soybean isoflavone nano-microspheres into the gel matrix prepared in the step S1, adding the rest parts by weight of high-purity water, uniformly stirring, and adjusting the pH value to 5.0-6.0 to obtain the compound micro emulsion gel containing the soybean isoflavone nano-microspheres.
Example 2.4 a compound microemulsion containing soy isoflavone nanospheres was prepared by the following method:
a. weighing the soybean isoflavone nano microspheres and the plant essential oil in the weight parts in the embodiment 2.1, adding the soybean isoflavone nano microspheres and the plant essential oil into ethanol and polyethylene glycol 400, and stirring the mixture for 300 r.min at 70 ℃ by adopting magnetic force-1Obtaining an oil phase after the mixture is clear and transparent;
b. weighing the traditional Chinese medicine composition, benzalkonium chloride, water-soluble chitosan, glycerol, 1, 2-propylene glycol and tween 80 in parts by weight in the embodiment 2.1, and uniformly mixing by magnetic stirring or mechanical stirring to obtain a water phase;
c. and (c) adding the oil phase prepared in the step (a) into the water phase obtained in the step (b), and uniformly mixing to obtain the compound microemulsion containing the soybean isoflavone nano-microspheres.
Example 2.5 soy isoflavone nanospheres were prepared by the following method:
adding appropriate amount of soybean isoflavone into water soluble chitosan HCS solution, adjusting pH to 5, magnetically stirring for 300r min-1—600r·min-1Next, an aqueous TPP solution was slowly added dropwise until the solution appeared opalescent.
EXAMPLE III
Example 3.1 the raw materials of the compound microemulsion gel containing the soy isoflavone nano-microspheres comprise, by weight:
20 parts of soybean isoflavone nano microspheres, 100 parts of a traditional Chinese medicine composition, 20 parts of plant essential oil, 20 parts of water-soluble chitosan, 5 parts of sodium hyaluronate, 30 parts of an emulsifier, 120 parts of a co-emulsifier, 15 parts of a gel matrix, 100 parts of a pH regulator, 2 parts of a bacteriostatic agent and 570 parts of high-purity water.
Example 3.2 on the basis of the above example 3.1, the Chinese medicinal composition is composed of water-alcohol extracts of phellodendron, sophora flavescens, honeysuckle, salvia miltiorrhiza and fructus cnidii; the plant essential oil is tea tree essential oil and eucalyptus oil according to the proportion of 1:2.5 in proportion; the emulsifier is tween-80; the auxiliary emulsifier is formed by combining glycerol, ethanol, 1, 2-propylene glycol and polyethylene glycol 400 according to the proportion of 2:1:5: 2; the gel matrix is formed by combining carbomer 940 and hydroxypropyl methylcellulose in a ratio of 2: 1; the pH regulator is triethanolamine; the bacteriostatic agent is benzalkonium chloride.
Embodiment 3.3 this embodiment provides a method for preparing a compound microemulsion gel containing soy isoflavone nano-microspheres, comprising the following steps:
s1, weighing a gel matrix and sodium hyaluronate, adding 30 times of high-purity water, standing overnight to enable the gel matrix to be completely swelled, and obtaining the gel matrix for later use;
s2, adding the compound micro emulsion containing the soybean isoflavone nano-microspheres into the gel matrix prepared in the step S1, adding the rest parts by weight of high-purity water, uniformly stirring, and adjusting the pH value to 5.0-6.0 to obtain the compound micro emulsion gel containing the soybean isoflavone nano-microspheres.
Example 3.4 a compound microemulsion containing soy isoflavone nanospheres was prepared by the following method:
a. weighing the soybean isoflavone nano microspheres and the plant essential oil in the weight parts in the embodiment 3.1, adding the soybean isoflavone nano microspheres and the plant essential oil into ethanol and polyethylene glycol 400, and stirring the mixture for 300 r.min at 70 ℃ by adopting magnetic force-1Obtaining an oil phase after the mixture is clear and transparent;
b. weighing the traditional Chinese medicine composition, benzalkonium chloride, water-soluble chitosan, glycerol, 1, 2-propylene glycol and tween 80 in parts by weight in the embodiment 3.1, and uniformly mixing by magnetic stirring or mechanical stirring to obtain a water phase;
c. and (c) adding the oil phase prepared in the step (a) into the water phase obtained in the step (b), and uniformly mixing to obtain the compound microemulsion containing the soybean isoflavone nano-microspheres.
Example 3.5 soy isoflavone nanospheres were prepared by the following method:
adding appropriate amount of soybean isoflavone into water soluble chitosan HCS solution, adjusting pH to 5, magnetically stirring for 300r min-1—600r·min-1Next, an aqueous TPP solution was slowly added dropwise until the solution appeared opalescent.
The pH value of the compound microemulsion gel prepared according to the embodiment is 4.5-7.5, and the compound microemulsion gel meets the physiological requirements of female vaginas. The prepared compound microemulsion gel is subjected to heat-resistant and cold-resistant stability tests, the result is kept for 24 hours at 40 +/-1 ℃ and-8 +/-2 ℃, no obvious shape difference exists after the room temperature is recovered and the compound microemulsion gel is not subjected to the tests, and the stable quality is shown. The prepared compound microemulsion gel has stronger antibacterial action on escherichia coli, staphylococcus aureus and candida albicans through in vitro bacteriostasis tests, meets the requirements of GB 15979-:
TABLE 1 results of in vitro antibacterial test of compound microemulsion gel
Note: test bacterial suspension range: 1X 104cfu/g-9×104cfu/g
The compound microemulsion gel prepared according to the embodiment has no irritation to the vaginal mucosa through a vaginal mucosa irritation test, and the vaginal mucosa irritation response scoring condition is shown in the following table 2:
TABLE 2 stimulation test results of compound microemulsion gel on vaginal mucosa
Note: 1) the average integral is the sum of the stimulation response integrals of 3 sites of 3 animals/total number of observations (number of animals × 3);
2) stimulation index is the mean integral of the infected group-the mean integral of the negative control group.
The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes will occur to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The compound microemulsion gel containing the soybean isoflavone nano-microspheres is characterized by comprising the following raw materials in parts by weight:
10-20 parts of soybean isoflavone nano microspheres, 50-100 parts of a traditional Chinese medicine composition, 5-20 parts of plant essential oil, 20-40 parts of water-soluble chitosan, 1-5 parts of sodium hyaluronate, 20-30 parts of an emulsifier, 80-120 parts of an auxiliary emulsifier, 15-20 parts of a gel matrix, 50-100 parts of a pH regulator, 1-2 parts of a bacteriostatic agent and 900 parts of high-purity water 600-.
2. The compound microemulsion gel containing the soy isoflavone nano-microspheres as claimed in claim 1, wherein the traditional Chinese medicine composition consists of water-alcohol extracts of phellodendron, radix sophorae flavescentis, honeysuckle, salvia miltiorrhiza and fructus cnidii.
3. The compound microemulsion gel containing the soybean isoflavone nano-microspheres as claimed in claim 1, wherein the plant essential oil is tea tree essential oil and eucalyptus oil which are combined according to a ratio of 1: 2.5.
4. The compound microemulsion gel containing the soybean isoflavone nano-microspheres of claim 1, wherein the emulsifier is one or a combination of more of tween-80, tween 60, span-60, polyoxyethylene castor oil and polyoxyethylene hydrogenated castor oil.
5. The compound microemulsion gel containing the soybean isoflavone nano-microspheres of claim 1, wherein the co-emulsifier is prepared by proportionally combining glycerol, ethanol, 1, 2-propylene glycol and polyethylene glycol 400.
6. The compound microemulsion gel containing the soy isoflavone nano-microspheres as claimed in claim 1, wherein the gel matrix is formed by combining carbomer 940 and hypromellose in proportion.
7. The compound microemulsion gel containing the soybean isoflavone nano-microspheres according to claim 1, wherein the pH regulator is one or more of hydrochloric acid, acetic acid, triethanolamine, sodium hydroxide and potassium hydroxide, and the bacteriostatic agent is benzalkonium chloride.
8. A method for preparing the compound microemulsion gel containing the soy isoflavone nano-microspheres as set forth in any one of claims 1 to 7, which comprises the following steps:
weighing a gel matrix and sodium hyaluronate according to a preset proportion, adding 30-50 times of high-purity water by weight, and standing to completely swell the gel matrix to obtain the gel matrix for later use;
adding the compound microemulsion containing the soybean isoflavone nano-microspheres into the gel matrix, adding the rest part by weight of high-purity water in a preset proportion, uniformly stirring, and adjusting the pH value to 5.0-6.0 to obtain the compound microemulsion gel containing the soybean isoflavone nano-microspheres.
9. The method for preparing the compound microemulsion gel containing the soy isoflavone nano-microspheres as claimed in claim 8, wherein the method for preparing the compound microemulsion gel containing the soy isoflavone nano-microspheres comprises the following steps:
adding soybean isoflavone nanometer microsphere and plant essential oil into ethanol and polyethylene glycol 400, and heating at 60-70 deg.C for 300r min-1—600r·min-1The speed of the stirring is magnetic stirring or mechanical stirring until the mixture is clear and transparent to obtain an oil phase;
mixing the Chinese medicinal composition, benzalkonium chloride, water soluble chitosan, glycerol, 1, 2-propylene glycol, and tween-80 under magnetic stirring or mechanical stirring for 300r min-1—600r·min-1Mixing to obtain water phase;
and adding the oil phase into the water phase, and uniformly mixing to obtain the compound microemulsion containing the soybean isoflavone nano-microspheres.
10. The method for preparing the compound microemulsion gel containing the soy isoflavone nano-microspheres as claimed in claim 8, wherein the method for preparing the soy isoflavone nano-microspheres comprises the following steps:
adding soybean isoflavone into water soluble chitosan HCS solution at a predetermined amount, adjusting pH to 5, and adding water to obtain a solution of 300 r.min-1—600r·min-1Magnetically stirring and slowly adding the aqueous solution of sodium tripolyphosphate dropwise until the solution appears opalescent.
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1348439A1 (en) * | 2002-03-29 | 2003-10-01 | Marfarma S.R.L. | Compositions for vaginal use |
| CN1813684A (en) * | 2005-11-15 | 2006-08-09 | 暨南大学 | Method for preparing 5-fluorouracil/chitosan nano drug-carrying microsphere |
| CN101797304A (en) * | 2010-03-23 | 2010-08-11 | 杨霞 | Gel for adjusting microecology in vaginas of women |
| CN102652736A (en) * | 2012-04-16 | 2012-09-05 | 河南科技大学第一附属医院 | Method for preparing soybean isoflavone sustained-release microspheres |
| CN104644553A (en) * | 2015-02-11 | 2015-05-27 | 山西中医学院 | Tanshinone IIA micro-emulsion preparation, tanshinone IIA micro-emulsion gel preparation and preparation methods of preparations |
| CN105496809A (en) * | 2016-01-16 | 2016-04-20 | 杨建华 | Cistanche phenethyl alcohol total-glycosides micro-emulsion gel and preparation method thereof |
| CN108158993A (en) * | 2018-01-12 | 2018-06-15 | 连云港本草美汇医药科技有限公司 | A kind of removing acnes and controlling oil micro emulsion gels and preparation method and application |
-
2019
- 2019-12-26 CN CN201911370481.4A patent/CN111000795A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1348439A1 (en) * | 2002-03-29 | 2003-10-01 | Marfarma S.R.L. | Compositions for vaginal use |
| CN1813684A (en) * | 2005-11-15 | 2006-08-09 | 暨南大学 | Method for preparing 5-fluorouracil/chitosan nano drug-carrying microsphere |
| CN101797304A (en) * | 2010-03-23 | 2010-08-11 | 杨霞 | Gel for adjusting microecology in vaginas of women |
| CN102652736A (en) * | 2012-04-16 | 2012-09-05 | 河南科技大学第一附属医院 | Method for preparing soybean isoflavone sustained-release microspheres |
| CN104644553A (en) * | 2015-02-11 | 2015-05-27 | 山西中医学院 | Tanshinone IIA micro-emulsion preparation, tanshinone IIA micro-emulsion gel preparation and preparation methods of preparations |
| CN105496809A (en) * | 2016-01-16 | 2016-04-20 | 杨建华 | Cistanche phenethyl alcohol total-glycosides micro-emulsion gel and preparation method thereof |
| CN108158993A (en) * | 2018-01-12 | 2018-06-15 | 连云港本草美汇医药科技有限公司 | A kind of removing acnes and controlling oil micro emulsion gels and preparation method and application |
Non-Patent Citations (1)
| Title |
|---|
| 林彦等: "烷基化壳聚糖――TPP纳米微球的制备及性能研究", 《科技创新导报》 * |
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