CN116158533A - Vitamin D easy to dissolve in water 3 Emulsion and method for producing the same - Google Patents
Vitamin D easy to dissolve in water 3 Emulsion and method for producing the same Download PDFInfo
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Abstract
The invention is disclosed inA readily water-soluble vitamin D is provided 3 Emulsion in the form of an oil-in-water nanoemulsion and/or a sub-micron emulsion, said vitamin D 3 The emulsion comprises an aqueous phase component and an oil phase component, wherein the oil phase component comprises vitamin D 3 The water phase component comprises pure water, glycerol and an emulsifier. Correspondingly, the invention also discloses the vitamin D 3 A method for producing an emulsion. Vitamin D according to the invention 3 The emulsion increases water-insoluble vitamin D 3 Is improved in solubility of vitamin D 3 The in vivo and percutaneous absorption efficiency is improved, and vitamin D is also improved 3 Stability of the emulsion.
Description
Technical Field
The invention relates to a preparation and a manufacturing method thereof, in particular to a vitamin preparation and a manufacturing method thereof.
Background
Vitamin D is a fat-soluble vitamin that is beneficial to human health. However, most foods, except for a few foods, have low vitamin D content, and it is not easy to obtain sufficient vitamin D from the food alone, mainly by synthesis from the skin by sufficient exposure to uv rays B. Most people cannot obtain sufficient vitamin D through skin synthesis due to factors such as season, climate, latitude, lifestyle, etc., and thus, the recommended intake needs to be achieved through vitamin D supplements. Wherein vitamin D 3 Is the highest biological metabolism rate in vitamin D.
Vitamin D 3 Is insoluble in water, slightly soluble in vegetable oil and easily soluble in organic solvent, so common vitamin D 3 Most supplements are soft capsules, drops or prescription injections.
Vitamin D 3 The oil solution in the capsule is slowly absorbed in human body, the absorption rate is not high, and the auxiliary materials such as gelatin, bone glue, leather glue and the like are needed to be used for preparing the capsule, so that the metabolic burden of a user is increased, and meanwhile, the capsule is inconvenient for users such as children, old people and the like who are not easy to swallow the capsule.
Another common vitamin D 3 The supplement is in the form of drops, which are prepared from vitamin D 3 The oil solution is directly dripped into oral cavity to be orally taken, and the use of gelatin auxiliary materials such as gelatin is avoided, but the absorption rate is still low, and the oil solution is usually usedThe food has greasy feel and oily fishy smell, and poor mouthfeel and taste, and increases the difficulty of feeding children; if the flavor is used for flavoring, the taste can be improved to a certain extent, and the greasy feeling in the oral cavity can not be completely avoided.
In addition, due to the water-insoluble nature of the oil solution, even vitamin D is added 3 The oil solution is dripped into the beverage or drinking water, and still can not be dissolved in the aqueous liquid to cause layering, and an oil layer is often adhered to a drinking water container to cause the phenomena of difficult dosage control and waste.
Clinically directed against severe vitamin D 3 Treatment of deficiency is also supplemented by injection. However, the intramuscular injection is adopted for administration, and because of the characteristics of the oil, the oil has higher viscosity, needs to be slowly injected and is slowly absorbed, and uncomfortable feelings such as caking, swelling, pain and the like can occur when the oil is injected too fast. In addition, the injection is insoluble in physiological saline and is used together with intravenous injection, which increases the burden of patients.
Based on this, it is desirable to provide an entirely new form of vitamin D 3 Supplements to overcome the above disadvantages.
Disclosure of Invention
It is an object of the present invention to provide a vitamin D which is readily soluble in water 3 Emulsions which increase water-insoluble vitamin D by forming oil-in-water nanoemulsions or sub-micron emulsions 3 Is improved in solubility of vitamin D 3 The in vivo and percutaneous absorption efficiency of vitamin D is improved 3 Stability of the emulsion.
In order to achieve the above object, the present invention provides a vitamin D which is easily soluble in water 3 Emulsion in the form of an oil-in-water nanoemulsion and/or a sub-micron emulsion, said vitamin D 3 The emulsion comprises an aqueous phase component and an oil phase component, wherein the oil phase component comprises vitamin D 3 The water phase component comprises pure water, glycerol and an emulsifier.
Nanoemulsion means in the art an emulsion having a dispersed particle size of 50-100 nm. Submicron emulsion refers to emulsion with dispersed particle size of 100-600 nm.
The invention is prepared by mixing vitamin D 3 Can be made into nanoemulsion or submicron emulsion for improving vitamin D 3 When the water-soluble compound is mixed with pure water, the water-soluble compound can not be layered or precipitated, so that the water-soluble compound can be conveniently mixed with food, drinking water, beverage, medicines and the like for simultaneous use, and can be further processed into oral liquid, drops, spray, functional beverage, functional food, animal feed and the like as an intermediate.
Further, in the vitamin D of the present invention 3 In the emulsion, the oil phase component accounts for vitamin D 3 The mass percentage of the emulsion is 1-10%.
Further, in the vitamin D of the present invention 3 In the emulsion, the vitamin D 3 Occupying vitamin D 3 The mass percentage of the emulsion is 0.0001-0.1%.
Further, in the vitamin D of the present invention 3 In the emulsion, the oil phase solvent accounts for vitamin D 3 The mass percentage of the emulsion is 0.05-9%.
Further, in the vitamin D of the present invention 3 In the emulsion, the oil-phase auxiliary emulsifier accounts for vitamin D 3 The mass percentage of the emulsion is 0.5-5%.
Further, in the vitamin D of the present invention 3 An emulsion, said antioxidant comprising vitamin D 3 The mass percentage of the emulsion is 0.001-2%.
Further, in the vitamin D of the present invention 3 In the emulsion, the glycerol accounts for vitamin D 3 The mass percentage of the emulsion is 10-20%.
Vitamin D as described in the present invention 3 In the emulsion, glycerol is adopted as the water-phase auxiliary emulsifier, and pure water is matched, so that the use amount of the traditional chemical auxiliary emulsifier can be effectively reduced, the use of the organic amine auxiliary emulsifier is avoided, and the metabolic burden and the adverse reaction risk are reduced. In addition, the glycerol can be used as not only a water-phase auxiliary emulsifier, but also a penetration enhancer of a mucous membrane, so that the efficiency of the active ingredient penetrating the mucous membrane is enhanced.
Further, the method comprises the steps of,vitamin D as described in the present invention 3 In the emulsion, the emulsifier accounts for vitamin D 3 The mass percentage of the emulsion is 0.01 to 0.1 percent.
Further, in the vitamin D of the present invention 3 In the emulsion, the oil phase solvent comprises at least one of the following: medium chain triglycerides, long chain triglycerides, soybean oil, corn oil, olive oil, canola oil, algae oil, tea oil, coconut oil, palm oil.
Further, in the vitamin D of the present invention 3 In the emulsion, the oil-phase co-emulsifier comprises at least one of the following: polyethylene glycol, n-butanol, ethanol, propylene glycol.
Further, in the vitamin D of the present invention 3 An emulsion, the antioxidant comprising at least one of: vitamin E, vitamin C, citric acid, tea polyphenols, butyl Hydroxy Anisole (BHA), dibutyl hydroxy toluene (BHT), tert-butyl hydroquinone (TBHQ).
Further, in the vitamin D of the present invention 3 In the emulsion, the emulsifier comprises at least one of the following: quillaja saponaria extract, lecithin, soybean phospholipid, poloxamer, phospholipid, polysorbate, span, myrj, brij, glyceryl monostearate, sucrose fatty acid ester.
Further, in the vitamin D of the present invention 3 In the emulsion, the water phase component also comprises at least one of a bacteriostatic agent, an acidity regulator, a sweetener and essence.
Still further, when included, the bacteriostatic agent may include at least one of the following: potassium sorbate, sodium benzoate, sodium citrate, citric acid, ascorbic acid; when included, the acidity regulator includes at least one of: citric acid, sodium citrate, malic acid, sodium malate, lactic acid, sodium lactate, tartaric acid, sodium carbonate, sodium bicarbonate, sodium tartrate; when included, the sweetener comprises at least one of the following: xylitol, steviol glycoside, sucralose, sorbitol, erythritol , mannitol, glucose syrup, fructo-oligosaccharides, maltitol, lactose, white sugar.
Further, the viscosity of the vitamin D3 emulsion is less than 11.5 mPa.s at room temperature.
Compared with vitamin D 3 Oil solvent, vitamin D in the present invention 3 The viscosity of the emulsion is lower, and generally at 20deg.C, conventional vitamin D 3 The viscosity of the oil solvent is about 13 mPa.s, whereas the vitamin D in the present invention 3 The emulsion has viscosity below 11.5 mPas, and reduced viscosity to reduce pain during injection, or can be mixed with normal saline and glucose solution for intravenous injection.
Another object of the present invention is to provide a vitamin D which is readily soluble in water 3 The preparation method of the emulsion adopts reasonable preparation process, and can effectively prepare the vitamin D 3 An emulsion.
Based on the above object, the present invention provides vitamin D as described above 3 A method of manufacturing an emulsion comprising the steps of:
uniformly mixing and heating the components of the oil phase component, uniformly mixing and heating the components of the water phase component;
uniformly mixing the oil phase component and the water phase component together, and performing high-speed shearing and emulsification treatment to obtain colostrum;
homogenizing the primary emulsion by adopting an ultrahigh pressure micro-jet homogenizer;
sterilizing to obtain the vitamin D 3 An emulsion.
The preparation method of the invention treats the vitamin D which is insoluble in water through an ultrahigh pressure micro-jet homogenizing process 3 Preparing into nanoemulsion or submicron emulsion, which is easy to dissolve in water, compared with the traditional vitamin D 3 The oil solvent has improved percutaneous, transmembrane and gastrointestinal absorption rate and bioavailability, and can reduce vitamin D 3 Is administered.
The preparation method of the invention obtains nano-emulsion or submicron emulsion through ultra-high pressure micro-jet homogenization treatment, reduces the particle size of emulsion drops, increases the specific surface area of active ingredients, and simultaneously combines the permeation promotion effect of glycerol to further enhance the absorption rate of the active ingredients.
In addition, the easily water-soluble vitamin D obtained by the production method 3 The emulsion is nano emulsion or submicron emulsion, so that the emulsion has good heat stability and dispersibility, is not easy to generate sedimentation and delamination, and can be subjected to high-temperature sterilization treatment in the manufacturing process.
Further, in the manufacturing method of the invention, the components of the oil phase component are uniformly mixed and heated to 40-80 ℃; and/or uniformly mixing the components of the water phase component and heating to 40-80 ℃.
Further, in the manufacturing method of the present invention, the process parameters of the high-speed shearing emulsification treatment satisfy at least one of the following:
the temperature is 40-80 ℃;
the treatment time is 2 min-10 min;
the rotation speed of the high-speed shearing emulsification is 3000 rpm-20000 rpm.
Further, in the manufacturing method according to the present invention, the homogenizing step includes: treating at least 1 time by adopting an ultrahigh pressure micro-jet homogenizer under the pressure of 200-600 bar; at a pressure of 200-800 bar, treating at least 1 time by adopting an ultrahigh pressure micro-jet homogenizer.
Further, in the production method of the present invention, the high-temperature sterilization treatment is performed at 75 to 90℃for 10 to 20 seconds.
Vitamin D according to the invention 3 The emulsion has the following advantages and beneficial effects:
the vitamin D which is easy to dissolve in water 3 The emulsion is easy to dissolve in water, can be conveniently mixed with food, drinking water and beverage, and can also be mixed with water-based intravenous injection such as physiological saline, glucose solution and the like, so that the use difficulty of a user is reduced.
According to the inventionReadily water-soluble vitamin D 3 The emulsion is a nanoemulsion or submicron emulsion, and has high drug loading, which improves the bioavailability of the active ingredient in the human body, so that the dosage of the preparation can be reduced, for example, less than 0.5 milliliter per use.
The vitamin D which is easy to dissolve in water 3 The emulsion is nano-emulsion or submicron emulsion through ultrahigh pressure micro-jet homogenization treatment, so that the particle size of emulsion drops is reduced, the specific surface area of active ingredients is increased, and meanwhile, the absorption rate of the active ingredients is further enhanced by combining the permeation promotion effect of glycerol.
The vitamin D which is easy to dissolve in water 3 The emulsion is nano emulsion or submicron emulsion, has good thermal stability and dispersibility, is not easy to generate sedimentation and delamination, and can be sterilized at high temperature.
The vitamin D which is easy to dissolve in water 3 The emulsion avoids the use of a large amount of auxiliary materials such as capsule skin, filler and adhesive in the traditional capsules or tablets, and further avoids the burden of digestive system and liver and kidney system caused by eating the auxiliary materials, thereby effectively reducing the metabolic burden and adverse reaction risk of human bodies.
The vitamin D which is easy to dissolve in water 3 The emulsion is easily dissolved in water, and can be further made into health food, functional beverage, drop, oral liquid, spray, injection, animal feed, etc., with good economic and social value.
Drawings
FIG. 1 shows the average 25-hydroxy-vitamin D in plasma of two groups of rabbits tested after the administration of example 1 and comparative example, respectively, according to the invention 3 Concentration versus time.
Detailed Description
The water-soluble vitamin D according to the present invention will be described in detail below with reference to specific examples and accompanying drawings 3 The emulsion and the method of manufacturing the same are further explained and illustrated, however, the explanation and illustration do not unduly limit the technical solution of the present invention.
Examples 1 to 6
In the examples of the present invention, the water-soluble vitamin D of examples 1 to 6 was prepared based on the following steps 3 Emulsion:
(1) The components of the oil phase ingredients are uniformly mixed and heated, for example, in certain embodiments, to 40-80 ℃ according to the component designs of tables 1-6 below; the components of the aqueous phase ingredients are mixed together and heated, for example, in some embodiments, to 40-80 ℃.
(2) Uniformly mixing the oil phase component and the water phase component together, and performing high-speed shearing, emulsifying and dispersing treatment to obtain the colostrum, wherein: the temperature is controlled to be 40-80 ℃, the treatment time is controlled to be 2-10 min, and the rotating speed of the high-speed shearing emulsifying dispersing machine is controlled to be 3000-20000 rpm.
(3) Homogenizing the obtained colostrum by using an ultrahigh pressure micro-jet homogenizer, and treating at least 1 time, such as 1 time, by using the ultrahigh pressure micro-jet homogenizer under the pressure of 200-600 bar; at a pressure of 200-800 bar, treating at least 1 time, such as 2 times, with an ultra-high pressure micro-jet homogenizer to obtain nanoemulsion or submicron emulsion.
(4) And (3) performing high-temperature sterilization treatment on the obtained nanoemulsion or submicron emulsion, wherein: controlling the temperature to 75-90 ℃ and the treatment time to 10-20 s, such as 15s, and cooling to obtain the vitamin D which is easy to dissolve in water 3 An emulsion.
In the present invention, vitamin D of examples 1-6 3 The specific composition designs and proportions of the aqueous phase component and the oil phase component of the emulsion are shown in the following tables 1-1 to 1-6.
Table 1-1 (example 1)
Tables 1 to 2 (example 2)
Tables 1 to 3 (example 3)
Tables 1 to 4 (example 4)
Tables 1 to 5 (example 5)
Tables 1 to 6 (example 6)
Although not shown in examples 1 to 6, in other examples, the oil phase solvent may be long chain triglycerides, algae oil, tea oil, coconut oil, palm oil, or a combination of medium chain triglycerides, long chain triglycerides, soybean oil, corn oil, olive oil, rapeseed oil, algae oil, tea oil, coconut oil, palm oil.
In addition, although not listed in examples 1-6 above, in other examples, span, myrj, brij, glyceryl monostearate, sucrose fatty acid ester, or other combinations of quillaja extract, lecithin, soybean phospholipid, poloxamer, phospholipids, polysorbate, span, myrj, brij, glyceryl monostearate, sucrose fatty acid ester may be used as antioxidants.
In addition, although not shown in examples 1-6 above, in other examples, the emulsifier may be butylated hydroxyanisole, dibutylhydroxytoluene, tertiary butylhydroquinone, or other combinations of vitamin E, vitamin C, citric acid, tea polyphenols, butylated hydroxyanisole, dibutylhydroxytoluene, tertiary butylhydroquinone.
Table 2 below lists the vitamin D of examples 1-6 3 Specific process parameters of the emulsion in the above process steps.
TABLE 2
As can be seen from Table 2 above, the vitamin D of examples 1-6 according to the present invention 3 The manufacturing process adopted in the actual preparation of the emulsion meets the design requirements of the invention.
It can be seen that the vitamin D of examples 1-6 can be prepared by the composition design and method of the present invention 3 An emulsion. Vitamin D of examples 1-6 3 The emulsion is oil-in-water nanometer emulsion or submicron emulsion.
For vitamin D of examples 1-6 3 The emulsion is subjected to acceleration stability investigation, the emulsion is specifically selected to be placed for 1, 2 and 3 months respectively in sequence under acceleration conditions (the control temperature is 40+/-5 ℃ and the relative humidity is 75%RH+/-10%RH), the stability of the content of active ingredients of the emulsion is measured and investigated, the corresponding detection item is vitamin D3 (calculated by cholecalciferol), and the detection method is GB 5009.82 fourth method.
In addition, the present invention also relates to the water-soluble vitamin D of examples 1 to 6 3 The microorganism content, sedimentation volume ratio and viscosity at 20℃of the emulsion were measured, and the measurement items and measurement methods are shown in Table 3 below.
TABLE 3 Table 3
| Detecting items | Index (per bottle containing) | Detection method |
| Colony count | ≤100CFU/mL | GB 4789.2 |
| Coliform group bacteria | ≤0.43MPN/mL | GB 4789.3MPN counting method |
| Mould and yeast | ≤50CFU/mL | GB 4789.15 first method |
| Salmonella bacteria | Cannot be detected | GB 4789.4 |
| Staphylococcus aureus | Cannot be detected | GB 4789.10 |
| Sedimentation volume ratio | ≥0.90 | General rules 0123 of four parts of pharmacopoeia of the people's republic of China |
| Viscosity of the mixture | - | GB/T 22235-2008 |
The corresponding test results of examples 1-6 of the above test are shown in tables 4-1 to 4-6, respectively, below.
Table 4-1 (example 1)
Table 4-2 (example 2)
Tables 4-3 (example 3)
Tables 4 to 4 (example 4)
Tables 4 to 5 (example 5)
Tables 4 to 6 (example 6)
The water-soluble vitamin D of examples 1 to 6 prepared according to the present invention 3 The emulsion shows excellent stability and microbial stability after being placed for 1, 2 and 3 months respectively under the acceleration condition (the control temperature is 40+/-5 ℃ and the relative humidity is 75%RH+/-10%RH).
After being placed under the above acceleration conditions for 1, 2 and 3 months, the water-soluble vitamin D of examples 1 to 6 3 The content of active ingredients, the content of microorganisms, the sedimentation volume ratio and the viscosity of the emulsion all meet the requirements of the scheme, and the emulsion has very good application prospect.
To further illustrate the water-soluble vitamin D provided by the present invention 3 Vitamin D in emulsion 3 Can be absorbed well, in the present invention, the water-soluble vitamin D of example 1 is used 3 For example, the emulsion was used for comparative in vivo bioavailability test in rabbits.
In comparison of bioavailability in rabbits, the inventors used a commercially available soft capsule (vitamin D 3 400 IU/grain) as a comparative example and water-soluble vitamin D of example 1 of the present invention 3 The emulsions (1000 IU/0.14 mL) were used separately. 12 New Zealand white rabbits are taken, the weight of the new Zealand white rabbits is 0.25+/-0.2 kg, the male and female rabbits are divided into two groups at random, and 6 rabbits (3 female and 3 male) are taken in each group. In view of the convenience of the test, the comparative soft capsule was punctured and the contents were extruded, and a syringe was used to aspirate the corresponding volume of the drug solution at the time of administration.
At the beginning of the test, blood was collected from the rabbit ear vein for the test and 25-hydroxy-vitamin D was measured in the plasma 3 Initial concentration, then the test group was administered 0.28mL of vitamin D of example 1 of the invention by oral spray 3 Emulsion (equivalent to 2000IU vitamin D) 3 ) Comparative group 1.2mL of the comparative soft capsule content (corresponding to 2000IU-vitamin D 3 ) And measuring 25-hydroxy-vitamin D in plasma from rabbit ear vein blood sampling at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 192, 240, 288 hours post-administration 3 Concentration. The test method refers to the relevant regulations of the drug preparation bioavailability test guidelines in Chinese pharmacopoeia 2020 edition, adopts a random control design method, fully considers the influence of animal sex difference on test results, and meets the relevant regulations of test articles and test animals, and the test scheme is approved by the relevant animal ethics committee of the implementation institution.
FIG. 1 schematically shows 25-hydroxy-vitamin D in rabbit plasma after administration of example 1 and comparative example, respectively, of the present invention 3 Variation of concentration versus test.
As can be seen from a comparison of the changes in the two shown in FIG. 1, the major active metabolite 25-hydroxy-vitamin D after administration of example 1 (Curve II) 3 The peak concentration Cmax of (C) was significantly higher than that of the comparative example commercial product (curve I), and the peak time Tmax was also significantly faster than that of the comparative example commercial product (P<0.01)。
Vitamin D of example 1 compared to the comparative commercially available product 3 The bioavailability of 25-hydroxy-vitamin D3 in rabbits after emulsion administration is about 1.7 times that of the commercial products of the comparative examples, which fully demonstrates the vitamin D of the invention 3 The emulsion has the advantages of rapid drug absorption and high bioavailability.
It should be noted that the combination of the technical features in the present invention is not limited to the combination described in the claims or the combination described in the specific embodiments, and all the technical features described in the present invention may be freely combined or combined in any manner unless contradiction occurs between them.
It should also be noted that the above-recited embodiments are merely specific examples of the present invention. It is apparent that the present invention is not limited to the above embodiments, and similar changes or modifications will be apparent to those skilled in the art from the present disclosure, and it is intended to be within the scope of the present invention.
Claims (19)
1. Vitamin D easy to dissolve in water 3 Emulsion, characterized in that it is an oil-in-water nanoemulsion and/or a sub-micron emulsion, said vitamin D 3 The emulsion comprises an aqueous phase component and an oil phase component, wherein the oil phase component comprises vitamin D 3 The water phase component comprises pure water, glycerol and an emulsifier.
2. Vitamin D according to claim 1 3 An emulsion comprising vitamin D as the oil phase component 3 The mass percentage of the emulsion is 1-10%.
3. Vitamin D according to claim 1 3 An emulsion, characterized in that said vitamin D 3 Occupying vitamin D 3 The mass percentage of the emulsion is 0.0001-0.1%.
4. Vitamin D according to claim 1 3 The emulsion is characterized in that the oil phase solvent occupies vitamin D 3 The mass percentage of the emulsion is 0.05-9%.
5. Vitamin D according to claim 1 3 The emulsion is characterized in that the oil-phase auxiliary emulsifier accounts for vitamin D 3 The mass percentage of the emulsion is 0.5-5%.
6. Vitamin D according to claim 1 3 An emulsion characterized in that the antioxidant comprises vitamin D 3 The mass percentage of the emulsion is 0.001-2%.
7. Vitamin D according to claim 1 3 An emulsion comprising vitamin D and glycerol 3 The mass percentage of the emulsion is 10-20%.
8. Vitamin D according to claim 1 3 An emulsion characterized in thatThe emulsifier is vitamin D 3 The mass percentage of the emulsion is 0.01 to 0.1 percent.
9. Vitamin D according to claim 1 3 Emulsion, characterized in that said oily phase solvent comprises at least one of the following: medium chain triglycerides, long chain triglycerides, soybean oil, corn oil, olive oil, canola oil, algae oil, tea oil, coconut oil, palm oil.
10. Vitamin D according to claim 1 3 An emulsion, wherein the oil-assisted emulsifier comprises at least one of: polyethylene glycol, n-butanol, ethanol, propylene glycol.
11. Vitamin D according to claim 1 3 Emulsion, characterized in that said antioxidant comprises at least one of the following: vitamin E, vitamin C, citric acid, tea polyphenols, butyl hydroxy anisole, dibutyl hydroxy toluene, and tertiary butyl hydroquinone.
12. Vitamin D according to claim 1 3 Emulsion, characterized in that the emulsifier comprises at least one of the following: quillaja saponaria extract, lecithin, soybean phospholipid, poloxamer, phospholipid, polysorbate, span, myrj, brij, glyceryl monostearate, sucrose fatty acid ester.
13. Vitamin D according to claim 1 3 The emulsion is characterized in that the aqueous phase component also comprises at least one of a bacteriostat, an acidity regulator, a sweetener and essence.
14. Vitamin D according to claim 1 3 An emulsion, characterized in that it has a viscosity at room temperature of less than 11.5 mPa-s.
15. Vitamin D according to any of claims 1-14 3 A method for producing an emulsion comprising the steps of:
uniformly mixing and heating the components of the oil phase component, uniformly mixing and heating the components of the water phase component;
uniformly mixing the oil phase component and the water phase component together, and performing high-speed shearing and emulsification treatment to obtain colostrum;
homogenizing the colostrum by an ultrahigh-pressure micro-jet homogenizer to obtain nano-emulsion and/or submicron emulsion;
sterilizing at high temperature to obtain vitamin D 3 An emulsion.
16. The method of claim 15, wherein the components of the oil phase component are mixed uniformly and heated to 40-80 ℃; and/or uniformly mixing the components of the water phase component and heating to 40-80 ℃.
17. The method of manufacturing of claim 15, wherein the process parameters of the high shear emulsification process satisfy at least one of:
the temperature is 40-80 ℃;
the treatment time is 2 min-10 min;
the rotation speed of the high-speed shearing emulsification is 3000 rpm-20000 rpm.
18. The method of manufacturing of claim 15, wherein the homogenizing step comprises: treating at least 1 time by adopting an ultrahigh pressure micro-jet homogenizer under the pressure of 200-600 bar; at a pressure of 200-800 bar, treating at least 1 time by adopting an ultrahigh pressure micro-jet homogenizer.
19. The method according to claim 15, wherein the high-temperature sterilization treatment is performed at a temperature of 75 to 90 ℃.
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| CN202310269631.2A CN116158533A (en) | 2023-03-20 | 2023-03-20 | Vitamin D easy to dissolve in water 3 Emulsion and method for producing the same |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117503708A (en) * | 2023-09-27 | 2024-02-06 | 济南维瑞医药科技开发有限公司 | A special calcium supplement for children with rickets and its preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105746730A (en) * | 2016-02-22 | 2016-07-13 | 李宏 | Nano-emulsion containing vitamin D and linseed oil as well as preparation method and application of nano-emulsion |
| CN107296152A (en) * | 2017-08-25 | 2017-10-27 | 山东静远药业有限公司 | Emulsion compositions containing 25 hydroxycholecalciferols and preparation method thereof |
| CN115105472A (en) * | 2022-07-15 | 2022-09-27 | 上海迦蓝海纳米技术集团有限公司 | Nano suspension for oral mucosa administration and preparation method thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105746730A (en) * | 2016-02-22 | 2016-07-13 | 李宏 | Nano-emulsion containing vitamin D and linseed oil as well as preparation method and application of nano-emulsion |
| CN107296152A (en) * | 2017-08-25 | 2017-10-27 | 山东静远药业有限公司 | Emulsion compositions containing 25 hydroxycholecalciferols and preparation method thereof |
| CN115105472A (en) * | 2022-07-15 | 2022-09-27 | 上海迦蓝海纳米技术集团有限公司 | Nano suspension for oral mucosa administration and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN117503708A (en) * | 2023-09-27 | 2024-02-06 | 济南维瑞医药科技开发有限公司 | A special calcium supplement for children with rickets and its preparation method |
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