CN102166233A - Oil-in-water type sea buckthorn oil nano-emulsion oral liquid and preparation method thereof - Google Patents
Oil-in-water type sea buckthorn oil nano-emulsion oral liquid and preparation method thereof Download PDFInfo
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- CN102166233A CN102166233A CN2011100856282A CN201110085628A CN102166233A CN 102166233 A CN102166233 A CN 102166233A CN 2011100856282 A CN2011100856282 A CN 2011100856282A CN 201110085628 A CN201110085628 A CN 201110085628A CN 102166233 A CN102166233 A CN 102166233A
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Abstract
The invention discloses an oil-in-water type sea buckthorn oil nano-emulsion oral liquid. The drop diameter of the oral liquid is 10-100nm. The oral liquid comprises the following components used as raw materials: 23.0-40.0% of surfactant, 0-7.0% of oil, 0.1-7.0% of sea buckthorn oil and the balance of distilled water, wherein the sum of the mass percents of the components is 100%. The oral liquid disclosed by the invention enhances the solubility of the sea buckthorn oil, improves the drug stability, improves the bioavailability of the sea buckthorn oil, delays the drug metabolism time of the sea buckthorn oil in bodies, reduces the dose of assistants, lowers the production cost, and has wide market prospects in the medicine field.
Description
Technical field
The invention belongs to field of medicaments, relate to a kind of can blood fat reducing, vessel softening, promote lipid transfer and removing, prevent and treat atherosclerosis, energy strengthening the spleen and nourishing the stomach, depressed liver-energy dispersing and QI regulating, relieving cough and asthma, sharp lung reduce phlegm, anti-inflammation, energy anti-fatty liver and liver cirrhosis, the Oleum Hippophae novel pharmaceutical formulation of human body immunity improving power.Be particularly related to oil-in-water type Oleum Hippophae nanometer emulsion oral liquid of a kind of clear and preparation method thereof.
Background technology
Oleum Hippophae is the pure natural plant oil that extracts from the seed of Fructus Hippophae, it contains nutritional labelings such as abundant vitamin C and vitamin E, particularly contain a large amount of fatty acids, wherein satisfied fatty acid 11.6%, all the other are unsaturated fatty acid, wherein linoleic acid accounts for 36%, and alpha-linolenic acid accounts for 27.6%, and oleic acid accounts for 32.1%.Oleum Hippophae has antiulcer, blood fat reducing, cholesterol reducing, antithrombotic, anticoagulant and antitumor and immunological enhancement, improves liver function, anti-fatty liver, anti-liver cirrhosis.The infringement of carcinogen such as the bioactive ingredients Aspergillus flavus capable of blocking in the Oleum Hippophae or pathogenic bacteria has the effect of obviously auxiliary anticancer growth.Bioactive ingredients such as Fructus Hippophae total flavones have in various degree regulating power to immune too many levels, and humoral immunization and cellular immunization are had tangible regulating action.Fructus Hippophae just has relieving cough and asthma, the effect of sharp lung expectorant in traditional medical theory, respiratory tract system diseases such as chronic pharyngitis, bronchitis, laryngopharynx swelling and pain, asthma, cough ant phlegm are all had fine effect.
Clinical medicine shows that Fructus Hippophae total flavones can reduce hyperlipidemia, vessel softening.And the reduction low density lipoprotein, LDL, high density lipoprotein increasing is removed the blood vessel wall deposit, and phospholipid can promote lipid transfer and removing, the metabolism of triglyceride in the accelerate blood.Prevent and treat atherosclerotic formation.Owing to contain multiple nutritional components such as a large amount of aminoacid, organic acid in the Fructus Hippophae, can promote the biosynthesis of gastric acid, stimulate gastric secretion.Thereby Fructus Hippophae has the effect of relieving dyspepsia, strengthening the spleen and nourishing the stomach, depressed liver-energy dispersing and QI regulating.For dyspepsia, abdominal distention and pain, gastritis, gastric and duodenal ulcers, enteritis, chronic constipation fabulous effect is arranged all.But, the Oleum Hippophae poor solubility, water insoluble, ethanol, 1, alcohols materials such as 2-propylene glycol, the physicochemical property instability, volatile; And the bioavailability at the Oleum Hippophae oil preparation is low, absorbs soon, eliminates soon, thereby has reduced curative effect.
Summary of the invention
The present invention is just at above-mentioned prior art problems defective, and a kind of dissolubility height, oil-in-water type Oleum Hippophae nanometer emulsion oral liquid that slow-releasing is good are provided.
The technical scheme that realizes the foregoing invention purpose is an oil-in-water type Oleum Hippophae nanometer emulsion oral liquid, and this oral liquid liquid-drop diameter size is made up of the material of following mass percent between 10～100nm:
Surfactant 23.0%～40.0%, oil 0%～7.0%, Oleum Hippophae 0.1%～7.0%, surplus is a distilled water, the mass percent sum of mentioned component is 100%.Total component is 100%.
The optimum ratio of oil-in-water type Oleum Hippophae nanometer emulsion oral liquid of the present invention is:
Surfactant 25.0%～38.0%, oil 0.3%～6.8%, Oleum Hippophae 0.3%～6.5%, surplus are distilled water, and the mass percent sum of mentioned component is 100%.
The further excellent proportioning of oil-in-water type Oleum Hippophae nanometer emulsion oral liquid of the present invention is made up of the raw material of following component:
Surfactant 27.0%～35.0%, oil 1.0%～5.0%, Oleum Hippophae 0.5%～5.5%, surplus are distilled water, and the mass percent sum of mentioned component is 100%.
Oil-in-water type Oleum Hippophae nanometer emulsion oral liquid of the present invention is selected the nonionic surfactant of avirulence and good biocompatibility for use in the selection of surfactant.Nonionic surfactant is more stable in solution, is not subject to the influence of strong electrolyte, inorganic salts, also is not subject to the influence of soda acid, and good with the compatibility of other surfactants, and haemolysis is less.In theory, the preparation of O/W type nanometer emulsion needs the HLB value of surfactant between 8-18, consider preparation technology's simplicity, be the stability of the easy formation of nano-emulsion and the nano-emulsion for preparing, the present invention selects the liquid nonionic surfactant of HLB between 10-15 for use, and is perhaps composite with the non-ionic surface active agent of a kind of HLB＜10.Available surfactant has: one or more mixture in polyoxyethylene (40) castor oil hydrogenated (RH40), tween 80 and the Arlacel-80.
The present invention is according to when the HLB of the required surfactant of emulsifying oil phase is close with surfactant, the principle that formed emulsion is stable, the oils and fats of selecting for use have liquid paraffin, vitamin E oil, Semen Tritici aestivi germ oil, almond oil, glyceryl triacetate, acetic acid second is cruel and one or more mixture of olive oil.Be in a liquid state, do not have bad abnormal smells from the patient under these oily room temperature.
Also can use Oleum Hippophae as unique oil among the present invention, and, also can make oil-in-water type Oleum Hippophae nanometer emulsion oral liquid without other oil.
A further object of the invention provides the preparation method of above-mentioned oil-in-water type Oleum Hippophae nanometer emulsion oral liquid, comprises the following steps:
1) takes by weighing surfactant by prescription, use separately or composite in proportion, calculate the HLB value of this system, stir with other surface activity;
2) take by weighing by prescription that Oleum Hippophae uses separately or with one or more oil, stir;
3) with step 1) gained oil and step 2) mixing of gained surfactant, stir, slowly in mixture, drip distilled water then, the limit edged stirs, add in water and the whipping process this mixture system can occur by rare become sticky thick, last again by the thinning a series of variations of thickness, until forming water oil-packaging type micro-emulsion.
The present invention detects through transmission electron microscope, and droplet diameter distribution is between 10-100nm, and outward appearance is henna transparency liquid, has good stability.
Its stability is in particular in the following aspects:
1, ageing stability
Ageing stability is meant when nanometer emulsion oral liquid is preserved under room temperature nature change condition, and outward appearance prolongs and the degree that changes in time.This Oleum Hippophae nanometer emulsion oral liquid is transparent lastingly, does not find muddy or precipitation, illustrates that then ageing stability is good.This is an important indicator estimating nanometer emulsion oral liquid.
2, heat storage stability
This Oleum Hippophae nanometer emulsion oral liquid is placed test tube, and sealing places 37 ℃ of constant water bath box to store 14 days, this liquid heat storage back appearance transparent.
3, anti-freeze-stable
With this Oleum Hippophae nanometer emulsion oral liquid in refrigerator-4 ℃ preserve a week after.Return to room temperature.If nanometer emulsion oral liquid becomes solids at-4 ℃, return to room temperature, return to transparent, and place one week the back continue transparently, think that then freezing-resistance is good.
4, accelerated stability
This Oleum Hippophae nanometer emulsion oral liquid is placed test tube, and sealing under the rotating speed of 15000r/min centrifugal 20 minutes, does not have layering, still clear.
Oil-in-water type Fructus Hippophae nanometer emulsion oral liquid of the present invention has antiulcer is arranged, blood fat reducing, cholesterol reducing, antithrombotic, anticoagulant and antitumor and immunological enhancement, improves liver function, anti-fatty liver, anti-liver cirrhosis.Can be used for treatment of diseases such as hyperlipidemia, atherosclerosis, cerebral infarction, hyperlipidemia, multiple gastroenteritic ulcer inflammation, hepatopathy, chronic pharyngitis, bronchitis, laryngopharynx swelling and pain, asthma, cough ant phlegm clinically.Usage: oral, every day 0.2g.
Oil-in-water type Oleum Hippophae nanometer emulsion oral liquid of the present invention compared with prior art has the following advantages:
1) thermodynamic stability height.Operation is fairly simple during preparation, not phase-splitting, do not precipitate, and bin stability improves;
2) light transmission is good, and any inhomogeneities or sedimentary existence easily are found, and sensible quality improves;
3) have good solubilization, can effectively improve the dissolubility of insoluble drug;
4) can improve the dissolubility of Oleum Hippophae, delay the regression time of Oleum Hippophae, thereby improved the bioavailability of Oleum Hippophae;
5) method technology is simple, is fit to large-scale production.
The specific embodiment
Below further set forth the beneficial effect of medicine of the present invention by pharmacodynamics test and contrast test.
The test of test example 1 oil-in-water type Oleum Hippophae nanometer emulsion oral liquid antibacterial activity in vitro
On 8 culture medium, inoculate staphylococcus aureus, escherichia coli, bacillus subtilis and Candida albicans respectively, at 37 ℃, slowly on culture medium, drip 0.1% after cultivating 24h, 1%, 5%, 10% oil-in-water type Oleum Hippophae nanometer emulsion oral liquid and each 5ml of penicillin cultivate through 12h, observe antibacterial situation, the results are shown in Table 1.
The test of table 1 oil-in-water type Oleum Hippophae nanometer emulsion oral liquid antibacterial activity in vitro
The result of table 1 clearlys show except the antibacterial activity along with the increase oil-in-water type Oleum Hippophae nanometer emulsion oral liquid of concentration also to be increased, and when dosage is very low drug effect is just arranged, and the same dosage of matched group does not have antibacterial activity.("-" expression is invalid, and "+" expression effectively).
The contrast test of test example 2 Oleum Hippophae nanometer emulsion oral liquid blood fat reducing drug effects and other preparations
Choose 9 of age, the essentially identical Wistar rats of body weight, use 3% cholesterol, 10% Adeps Sus domestica, 0.2% methylthiouracil, the high lipid food that 86.8% normal feedstuff is made is fed 20d and is set up hyperlipidemia model.Be equally divided into 3 groups, first group with northern continent biological engineering company limited produce super power health Oleum Hippophae soft capsule (every contains the 500mg Oleum Hippophae) treatment, rat is taken 2 times every every day, each 8mg is auxiliary with gag, gives rats gavaged.Second group of peaceful and prosperous treatment of eastern space blood of producing with the Shenyang east fragrant bohr of space Science and Technology Ltd. taken 31 time at rat every every day, grinds and feeds in material.The 3rd group with Oleum Hippophae nanometer emulsion oral liquid of the present invention treatment, every oral 0.3g every day of rat (containing Oleum Hippophae 15mg), after 3 weeks, survey serum glycerol three vinegar (TG), the ratio (LDL-C/HDL-C) of T-CHOL (TC), low-density lipoprotein cholesterol (LDL-C), LDL-C and HDL-C (HDL-C) and the value added of AI (Al) of respectively organizing rat.All in various degree reductions of the above every index that found that three groups of rats, especially the most obvious with the 3rd group.Illustrate that purple Oleum Hippophae nanometer emulsion oral liquid effect aspect blood fat reducing is better than super power health Oleum Hippophae soft capsule and eastern space blood is peaceful and prosperous, and dosage is low.
Below further set forth the composition and the preparation method of medicine of the present invention by specific embodiment.
Embodiment 1
RH4030.0g and Oleum Hippophae 7.0g are mixed and stir, slowly in mixture, drip distilled water 63.0g then, the limit edged stirs, add in water and the whipping process this mixture system can occur by rare become sticky thick, last again by the thinning a series of variations of thickness, until forming water oil-packaging type micro-emulsion.
Embodiment 2
Tween 80 38.0g, ethyl acetate 2.00g, Oleum Hippophae 3.0g, distilled water 57.0g.
Embodiment 3
RH40 23.0g, glyceryl triacetate 7.0g, Oleum Hippophae 0.10g, distilled water 69.9g.
Embodiment 4
RH40 25.0g, IPM 3.7g, Oleum Hippophae 3.7g, distilled water 67.6g.
Embodiment 5
RH40 20.0g, Arlacel-80 5.0g, almond oil 2.0g, Oleum Hippophae 3.0g, distilled water 70.0g.
Embodiment 6
RH40 30.0g, Arlacel-80 10.0g, Semen Tritici aestivi germ oil 1.5g, olive oil 1.2g, Oleum Hippophae 1.3g, distilled water 57.0g.
Embodiment 7
Tween 80 40.0g, ethyl acetate 1.0g, vitamin E 1.0g, Oleum Hippophae 2.0g, distilled water 56.0g.
Embodiment 8
RH40 35.0g, liquid paraffin 2.4g, Oleum Hippophae 1.2g, distilled water 61.4g.
Embodiment 9
Tween 80 32.0g, IPM 0.3g, Oleum Hippophae 0.3g, distilled water 67.4g.
Embodiment 10
Tween 80 36.43g, glyceryl triacetate 0.37g, Oleum Hippophae 0.40g, distilled water 62.80g.
Claims (4)
1. an oil-in-water type Oleum Hippophae nanometer emulsion oral liquid is characterized in that, this oral liquid liquid-drop diameter size is made up of the raw material of following component between 10～100nm:
Surfactant 23.0%～40.0%, oil 0%～7.0%, Oleum Hippophae 0.1%～7.0%, surplus are distilled water, and the mass percent sum of mentioned component is 100%;
Described surfactant is any one or two kinds of mixture of RH40, tween 80 and Arlacel-80;
Described oil is any or several mixture of IPM, vitamin E oil, almond oil, Semen Tritici aestivi germ oil, glyceryl triacetate, acetic acid ethyl ester and olive oil.
2. oil-in-water type Oleum Hippophae nanometer emulsion oral liquid according to claim 1 is characterized in that, is made up of the raw material of following component:
Surfactant 25.0%～38.0%, oil 0.3%～6.8%, Oleum Hippophae 0.3%～6.5%, surplus are distilled water, and the mass percent sum of mentioned component is 100%.
3. oil-in-water type Oleum Hippophae nanometer emulsion oral liquid according to claim 1 is characterized in that, is made up of the raw material of following component:
Surfactant 27.0%～35.0%, oil 1.0%～5.0%, Oleum Hippophae 0.5%～5.5%, surplus are distilled water, and the mass percent sum of mentioned component is 100%.
4. the preparation method of the described oil-in-water type Oleum Hippophae of claim 1 nanometer emulsion oral liquid is characterized in that, comprises the following steps:
1) takes by weighing surfactant by prescription, use separately or composite in proportion, calculate the HLB value of this system, stir with other surface activity;
2) take by weighing by prescription that Oleum Hippophae uses separately or with one or more oil, stir;
3) with step 1) gained oil and step 2) mixing of gained surfactant, stir, slowly in mixture, drip distilled water then, the limit edged stirs, add in water and the whipping process this mixture system can occur by rare become sticky thick, last again by the thinning a series of variations of thickness, until forming water oil-packaging type micro-emulsion.
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Cited By (7)
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| CN102499936A (en) * | 2011-12-01 | 2012-06-20 | 西北农林科技大学 | Compound telithromycin nanoemulsion oral liquid and preparation method thereof |
| CN102499935A (en) * | 2011-11-29 | 2012-06-20 | 西北农林科技大学 | Compound spiramycin nanoemulsion oral liquid and preparation method thereof |
| CN106727310A (en) * | 2016-12-29 | 2017-05-31 | 陕西科技大学 | A kind of vitamin A nano-emulsion and preparation method thereof |
| CN107669717A (en) * | 2017-11-08 | 2018-02-09 | 新疆医科大学 | A kind of oil-in-water type sea-buckthorn oil nanometer emulsion external preparation and preparation method thereof |
| CN108042488A (en) * | 2017-08-24 | 2018-05-18 | 山西医科大学 | A kind of method for reducing micro emulsion dosage of surfactant |
| CN110859258A (en) * | 2019-11-21 | 2020-03-06 | 李晓飞 | Sea-buckthorn oil emulsion and preparation method thereof |
| CN117442654A (en) * | 2023-06-01 | 2024-01-26 | 威海天原生物科技有限公司 | Application of vegetable oil preparation in preparation of hypolipidemic drugs and pharmaceutical preparation for preventing hyperlipidemia |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102499935A (en) * | 2011-11-29 | 2012-06-20 | 西北农林科技大学 | Compound spiramycin nanoemulsion oral liquid and preparation method thereof |
| CN102499935B (en) * | 2011-11-29 | 2013-06-26 | 西北农林科技大学 | Compound spiramycin nanoemulsion oral liquid and preparation method thereof |
| CN102499936A (en) * | 2011-12-01 | 2012-06-20 | 西北农林科技大学 | Compound telithromycin nanoemulsion oral liquid and preparation method thereof |
| CN102499936B (en) * | 2011-12-01 | 2013-06-26 | 西北农林科技大学 | Compound telithromycin nanoemulsion oral liquid and preparation method thereof |
| CN106727310A (en) * | 2016-12-29 | 2017-05-31 | 陕西科技大学 | A kind of vitamin A nano-emulsion and preparation method thereof |
| CN108042488A (en) * | 2017-08-24 | 2018-05-18 | 山西医科大学 | A kind of method for reducing micro emulsion dosage of surfactant |
| CN107669717A (en) * | 2017-11-08 | 2018-02-09 | 新疆医科大学 | A kind of oil-in-water type sea-buckthorn oil nanometer emulsion external preparation and preparation method thereof |
| CN110859258A (en) * | 2019-11-21 | 2020-03-06 | 李晓飞 | Sea-buckthorn oil emulsion and preparation method thereof |
| CN117442654A (en) * | 2023-06-01 | 2024-01-26 | 威海天原生物科技有限公司 | Application of vegetable oil preparation in preparation of hypolipidemic drugs and pharmaceutical preparation for preventing hyperlipidemia |
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Application publication date: 20110831 |