CN100528148C - Oil-in-water type nanometer peonol emulsion oral liquid and its preparation process - Google Patents
Oil-in-water type nanometer peonol emulsion oral liquid and its preparation process Download PDFInfo
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- CN100528148C CN100528148C CNB2006101045927A CN200610104592A CN100528148C CN 100528148 C CN100528148 C CN 100528148C CN B2006101045927 A CNB2006101045927 A CN B2006101045927A CN 200610104592 A CN200610104592 A CN 200610104592A CN 100528148 C CN100528148 C CN 100528148C
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Abstract
The oil-in-water type nanometer emulsion oral liquid of peonol consists of surfactant, oil, peonol and distilled water. Its preparation process includes the following steps:weighing surfactant with or without co-surfactant; calculating HLB value and selecting oil for reaching emulsifying HLB value near that of the surfactant phase; changing the ratio between the surfactant phase and the oil phase regularly to dissolve peonol in the surfactant; adding distilled water slowly at 20-25 deg.c to form clear and flowing O/W type stable nanometer emulsion oral liquid. The nanometer emulsion oral liquid has high dissolubility of peonol, raised bioavailability of peonol, delayed the time for the medicine to be metabolized in the body, reduced supplementary material amount, low production cost and wide medicine market foreground.
Description
Technical field
The invention belongs to field of medicaments, relate to a kind of novel form of paeonol medicine, be specifically related to oil-in-water type nanometer peonol emulsion oral liquid of a kind of transparent and stable and preparation method thereof.
Background technology
Paeonol (paeonol, 2-hydroxyl-4-methoxyl group-1-Phenylethanone .) is one of the main active of Cortex Moutan (CortexMoutan) and Radix Cynanchi Paniculati (Radix Cynanhi Paniculati), has pharmacologically active widely, comprise analgesia, analgesic, dispel the wind, anti-inflammation, atherosclerosis, anticoagulant, blood pressure lowering and strengthen many-sided effect such as cellular immune function and antioxidation.The inside and outside antitumor action of paeonol also causes extensive concern gradually in recent years.Paeonol is a fat-soluble medicine, and special stink is arranged, and is little peppery, is dissolved in ethanol, methanol, insoluble in cold water, slightly soluble in the hot water, and instability easily distils.List marketing at present have only ointment and paeonol coated tablet, clinical anaphylactic disease, heating, headache, neuralgia, myalgia, rheumatic arthritis and the rheumatoid arthritis of being used for.The oral disintegrate of paeonol coated tablet is slower, and dissolution and dissolution rate are lower, and bioavailability is low, and child, old people, sickbed patients or dysphagia patients are taken inconvenience, and compliance is relatively poor, has influenced the performance of paeonol curative effect.
Summary of the invention
The objective of the invention is at prior art problems and defective, provide that a kind of dissolubility is good, physical property is stablized, do not have abnormal flavour and irritating paeonol nanometer emulsion oral liquid.
The technical scheme that realizes the foregoing invention purpose is an oil-in-water type nanometer peonol emulsion oral liquid, comprises that mass percent is:
Surfactant 21.19%～40.54%
Oil 3.96%～11.00%
Paeonol 0.1%～10%
Surplus is that distilled water is formed
Above-mentioned total component is 100%.
Described surfactant is any or several mixture in castor oil polyoxyethylene ether, castor oil hydrogenated polyoxyethylene ether, tween 80 and the Arlacel-80.
Described oil is any or several mixture of liquid paraffin, almond oil, Semen Tritici aestivi germ oil, vitamin E oil, ethyl acetate and olive oil.
In the selection of surfactant, the present invention selects the nonionic surfactant of avirulence and good biocompatibility for use.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.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 castor oil polyoxyethylene ether (as EL-40), castor oil hydrogenated polyoxyethylene ether (as RH-40), 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 one or more mixture of liquid paraffin, Semen Tritici aestivi germ oil, almond oil, ethyl acetate, vitamin E oil and olive oil.Be in a liquid state, do not have bad abnormal smells from the patient under these oily room temperature.
Another object of the present invention provides the preparation method of oil-in-water type nanometer peonol emulsion oral liquid, and step is as follows:
(1) preparation of surfactant phase takes by weighing surfactant by formula proportion, use separately or with help surface activity composite in proportion, calculate the HLB value of this system, stir.The HLB value of common emulsifying agent can be found in some chemical industry handbooks, as " the chemical products handbook of chemical industry publishing house.Because hydrophile-lipophile balance (HLB) value of surfactant has additive properties, the available quality averaging method is obtained the HLB value of surfactant.For example, after two kinds of surfactant A, B mixed, the hydrophile-lipophile balance HLBAB value of its mixed surfactant was
HLBAB＝(WAHLBA+WBHLBB)/(WA+WB)
WA in the formula, WB---the quality of compound surfactant A, B;
HLBA, the HLB value of HLBB---surfactant A, B.
(2) preparation of oil phase is selected one or more oil according to the HLB value of surfactant phase, transfers its ratio, makes the required HLB value of its emulsifying close with surfactant HLB mutually.
(3) in 9: 1～1: 9 the rule change surfactant phase and the ratio of oil phase, to the paeonol that wherein adds formula proportion, stirring makes it whole dissolvings, fully stir at 20 ℃～25 ℃ slow adding distil waters, until forming clear, viscosity is little and has mobile yellow or water white O/W type nanometer emulsion.
The present invention detects through transmission electron microscope, and droplet diameter distribution is between 10～100nm, and outward appearance is yellow or colourless transparent liquid, has good stability:
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 paeonol 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 paeonol 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 paeonol 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 paeonol 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 nanometer peonol emulsion oral liquid of the present invention have analgesia, analgesic, dispel the wind, anti-inflammation, atherosclerosis, anticoagulant, blood pressure lowering and strengthen many-sided effect such as cellular immune function and antioxidation.Be used for the treatment of various eczematoid dermatitises, skin pruritus, heating, headache, neuralgia, myalgia, rheumatic arthritis and rheumatoid arthritis.Usage: oral, a 4.3g, 3 times on the one.
Oil-in-water type nanometer peonol 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) antiseptic property improves, because decentralized photo liquid is smaller, can prevent the intrusion of antibacterial, increases the dissolubility of some active ingredients simultaneously;
4) have good solubilization, can effectively improve the dissolubility of insoluble drug;
5) can improve the dissolubility of paeonol, delay the regression time of paeonol, thereby improved the bioavailability of paeonol;
6) 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 paeonol nanometer emulsion oral liquid antibacterial activity in vitro
On 8 culture medium, inoculate staphylococcus aureus, escherichia coli, bacillus subtilis and Candida albicans (above strain provides by my school Microbiological Lab) respectively, at 37 ℃, slowly on culture medium, drip 0.1%, 1%, 5%, 10% paeonol nanometer emulsion oral liquid and each 5ml of gentamycin after cultivating 24h, cultivate through 12h, observe antibacterial situation, the results are shown in Table 1.
The test of table 1 paeonol nanometer emulsion oral liquid antibacterial activity in vitro
The result of table 1 clearlys show except the antibacterial activity along with the increase paeonol 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)
Test example 2 paeonol nanometer emulsion oral liquids and other preparations are separated the thermal effect contrast test
Get the rat of 6 body weight no significant differences, volume is 1,2,3,4,5, No. 6, and test before measurement anus temperature 3 times is surveyed 1 per half an hour, and averaging is basal body temperature, is respectively 37.3 ℃, 37.3 ℃, 37.4 ℃, 37.6 ℃, 37.8 ℃, 37.5 ℃.Water is can't help in the 6h fasting before experiment.To make with extra care escherichia coli endotoxin ET (my school Microbiological Lab provides) and be diluted in physiological saline solution, be made into the solution of 20 μ g/ml, give every rat lumbar injection ET 80 μ g/kg respectively, bring out heating, test heating body temperature is respectively 40.0 ℃, 40.2 ℃, 39.8 ℃, 39.9 ℃, 40.3 ℃, 40.1 ℃.1 body temperature, continuous monitoring 4h are surveyed every 0.5h in the injection back.Use paeonol sheet (the accurate word H45021119 of the traditional Chinese medicines paeonol sheet that Guangxi Yikang Pharmaceutical Industry Co., Ltd. produces for first group, every contains paeonol 36mg) treatment, give No. 1 for examination 1/2 of rat (low dosage) with medicine, No. 2 rats 1 (high dose) grind and drink in drinking-water; Use aspirin tablet (the accurate word H37022276 of the traditional Chinese medicines aspirin tablet that Renhe, Shandong pharmaceutical Co. Ltd produces for second group, every contains aspirin 71.25mg) treatment, give No. 3 for examination 1/4 of rat (low dosage) with medicine, No. 4 1/2 grinding of rat (high dose) and in drinking-water, drinking; The 3rd group with paeonol nanometer emulsion oral liquid of the present invention treatment, oral No. 5 for examination rat 0.35g (containing paeonol 17.5mg, low dosage), No. 6 rat 0.7g (containing paeonol 35mg, high dose) gavage.The results are shown in Table 2.
The contrast test of table 2 paeonol nanometer emulsion oral liquid and other preparation drug effects
The result of table 2 has shown that clearly the drug effect of paeonol nanometer emulsion oral liquid significantly is better than paeonol sheet and aspirin tablet.
Test example 3 paeonol nanometer emulsion oral liquids and other preparation analgesic effect contrast tests
18 patients to headache due to common cold compare treatment with paeonol nanometer emulsion oral liquid, paeonol sheet (the accurate word H45021119 of the traditional Chinese medicines paeonol sheet that Guangxi Yikang Pharmaceutical Industry Co., Ltd. produces) and somedon (the accurate word H15020 of the traditional Chinese medicines somedon that Kang Yi pharmaceutcal corporation, Ltd in Hulun Buir produces) under Isodose, paeonol nanometer emulsion oral liquid total effective rate is 90.91%; Paeonol sheet total effective rate is 89.74%; The somedon total effective rate is 88.65%.Wherein the paeonol nanometer emulsion oral liquid tells on the soonest, and better than other two kinds of medicine mouthfeels, is easy to take.
Below the embodiment that provides by the inventor further set forth the preparation method of paeonol nanometer emulsion oral liquid of the present invention.
Embodiment 1
With determining optimal proportion according to 9: 1～1: 9 rule drafting pseudo-ternary phase diagram by calculating HLB value selected oil and surfactant, cosurfactant.Accurately take by weighing tween 80 3.0g, Arlacel-80 1.0g, liquid paraffin 1.0g, put into beaker, under 20 ℃ of room temperature conditions, manually stir its abundant mix homogeneously, the 0.5g paeonol is directly added, stirring is until whole dissolvings, and to wherein slowly adding distilled water, manually stir on adding distil water limit, limit then, the system viscosity is less during beginning, along with the increase of the distillation water yield, it is sticky that system can become, and this moment, liquid crystal state or water-in-oil type nanoemulsion may appear in system, continue to drip and constantly stir, unexpected when thinning when system, what produced this moment promptly is stable yellow transparent oil-in-water type nanometer peonol emulsion oral liquid, claims that its weight is 10.0g.
Embodiment 2
With determining optimal proportion according to 9: 1～1: 9 rule drafting pseudo-ternary phase diagram by calculating HLB value selected oil and surfactant, cosurfactant.Accurately take by weighing polyoxyethylene hydrogenated Oleum Ricini 3.6g, Semen Tritici aestivi germ oil 0.4g, put into beaker, under 24 ℃ of room temperature conditions, manually stir, the 0.5g paeonol is directly added, stir until whole dissolvings with its abundant mix homogeneously, then to wherein slowly adding distilled water, manually stir on adding distil water limit, limit, and the system viscosity is less during beginning, along with the increase of the distillation water yield, it is sticky that system can become, this moment, liquid crystal state or water-in-oil type nanoemulsion may appear in system, continue to drip and constantly stir, when system unexpected when thinning, what produced this moment promptly is stable water white transparency oil-in-water type nanometer peonol emulsion oral liquid, claims that its gross weight is 10.1g.
Embodiment 3
With determining optimal proportion according to 9: 1～1: 9 rule drafting pseudo-ternary phase diagram by calculating HLB value selected oil and surfactant, cosurfactant.Accurately take by weighing polyoxyethylene hydrogenated Oleum Ricini 3.6g, olive oil 0.4g, put into beaker, under 24 ℃ of room temperature conditions, manually stir, the 0.1g paeonol is directly added, stir until whole dissolvings with its abundant mix homogeneously, then to wherein slowly adding distilled water, manually stir on adding distil water limit, limit, and the system viscosity is less during beginning, along with the increase of the distillation water yield, it is sticky that system can become, this moment, liquid crystal state or water-in-oil type nanoemulsion may appear in system, continue to drip and constantly stir, when system unexpected when thinning, what produced this moment promptly is stable water white transparency oil-in-water type nanometer peonol emulsion oral liquid, claims that its gross weight is 10.0g.
Embodiment 4
With determining optimal proportion according to 9: 1～1: 9 rule drafting pseudo-ternary phase diagram by calculating HLB value selected oil and surfactant, cosurfactant.Accurately take by weighing polyoxyethylene hydrogenated Oleum Ricini 4.0g, ethyl acetate 1.0g, put into beaker, under 25 ℃ of room temperature conditions, manually stir, the 1.0g paeonol is directly added, stir until whole dissolvings with its abundant mix homogeneously, then to wherein slowly adding distilled water, manually stir on adding distil water limit, limit, and the system viscosity is less during beginning, along with the increase of the distillation water yield, it is sticky that system can become, this moment, liquid crystal state or water-in-oil type nanoemulsion may appear in system, continue to drip and constantly stir, when system unexpected when thinning, what produced this moment promptly is stable water white transparency oil-in-water type nanometer peonol emulsion oral liquid, claims that its gross weight is 10.0g.
Embodiment 5
With determining optimal proportion according to 9: 1～1: 9 rule drafting pseudo-ternary phase diagram by calculating HLB value selected oil and surfactant, cosurfactant.Accurately take by weighing tween 80 1.40g, Arlacel-80 0.70g, liquid paraffin 0.90g, put into beaker, under 20 ℃ of room temperature conditions, manually stir its abundant mix homogeneously, the 0.01g paeonol is directly added, stir fully, to wherein slowly adding distilled water, manually stir on adding distil water limit, limit then, the system viscosity is less during beginning, along with the increase of the distillation water yield, it is sticky that system can become, and this moment, liquid crystal state or water-in-oil type nanoemulsion may appear in system, continue to drip and constantly stir, unexpected when thinning when system, what produced this moment promptly is stable yellow transparent oil-in-water type nanometer peonol emulsion oral liquid, claims that its gross weight is 9.91g.
Embodiment 6
With determining optimal proportion according to 9: 1～1: 9 rule drafting pseudo-ternary phase diagram by calculating HLB value selected oil and surfactant, cosurfactant.Accurately take by weighing polyoxyethylene castor oil 4.5g, ethyl acetate 0.5g, vitamin E oil 0.03g, put into beaker, under 25 ℃ of room temperature conditions, manually stir its abundant mix homogeneously, the 0.07g paeonol is directly added, stir fully, to wherein slowly adding distilled water, manually stir on adding distil water limit, limit then, the system viscosity is less during beginning, along with the increase of the distillation water yield, it is sticky that system can become, and this moment, liquid crystal state or water-in-oil type nanoemulsion may appear in system, continue to drip and constantly stir, unexpected when thinning when system, what produced this moment promptly is stable water white transparency oil-in-water type nanometer peonol emulsion oral liquid, claims that its weight is 11.1g.
Embodiment 7
With determining optimal proportion according to 9: 1～1: 9 rule drafting pseudo-ternary phase diagram by calculating HLB value selected oil and surfactant, cosurfactant.Accurately take by weighing polyoxyethylene hydrogenated Oleum Ricini 3.2g, almond oil 0.8g, vitamin E oil 0.3g, put into beaker, under 20 ℃ of room temperature conditions, manually stir its abundant mix homogeneously, the 0.7g paeonol is directly added, stirring is until whole dissolvings, and to wherein slowly adding distilled water, manually stir on adding distil water limit, limit then, the system viscosity is less during beginning, along with the increase of the distillation water yield, it is sticky that system can become, and this moment, liquid crystal state or water-in-oil type nanoemulsion may appear in system, continue to drip and constantly stir, unexpected when thinning when system, what produced this moment promptly is stable water white transparency oil-in-water type nanometer peonol emulsion oral liquid, claims that its gross weight is 10.0g.
Claims (3)
1, a kind of oil-in-water type nanometer peonol emulsion oral liquid comprises that mass percent is: surfactant 21.19%～40.54%, oil 3.96%～11.00%, paeonol 0.1%～10%, surplus are that distilled water is formed, and total component is 100%;
Described surfactant is any or several mixture in castor oil polyoxyethylene ether, castor oil hydrogenated polyoxyethylene ether, tween 80 and the Arlacel-80;
Described oil is any or several mixture in liquid paraffin, Semen Tritici aestivi germ oil, almond oil, ethyl acetate, vitamin E oil, the olive oil.
2, any paeonol nanometer emulsion oral liquid according to claim 1 is characterized in that: described paeonol nanometer emulsion oral liquid particle diameter is 10nm～100nm.
3, the described paeonol nanometer emulsion oral liquid of claim 1 preparation method is characterized in that, may further comprise the steps:
(1) preparation of surfactant phase takes by weighing surfactant by formula proportion, calculates the HLB value of this system, stirs;
(2) preparation of oil phase is selected one or more oil according to the HLB value of surfactant phase, transfers its ratio, makes the required HLB value of its emulsifying close with surfactant HLB mutually;
(3) in 9: 1～1: 9 the rule change surfactant phase and the ratio of oil phase, to the paeonol that wherein adds formula proportion, stirring makes it whole dissolvings, fully stir at 20 ℃～25 ℃ slow adding distil waters, until forming clear, viscosity is little and has mobile yellow or water white O/W type nanometer emulsion.
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Families Citing this family (7)
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| CN101032507B (en) * | 2007-04-06 | 2010-09-29 | 西北农林科技大学 | Bacteria resisting medicine of erythrocin nanometer-emulsion and the preparing method |
| CN101953798A (en) * | 2010-09-21 | 2011-01-26 | 中国药科大学 | Spray drying sustained-release liquid crystal nano particles containing paeonol and preparation thereof |
| CN102166270A (en) * | 2011-04-06 | 2011-08-31 | 西北农林科技大学 | Oil-in-water type dried orange peel oil nano-emulsion and preparation method thereof |
| CN105687136A (en) * | 2014-11-26 | 2016-06-22 | 安徽中医药大学 | PEGylated paeonol nonionic surfactant vesicle and preparation method thereof |
| CN105748436B (en) * | 2014-12-15 | 2020-09-25 | 安徽中医药大学 | Paeonol vesicle cream for external use and preparation method thereof |
| CN109498573A (en) * | 2019-01-23 | 2019-03-22 | 镇江市疾病预防控制中心 | A kind of Paeonol self-micro emulsion formulation and preparation method thereof |
| CN114452316A (en) * | 2022-01-26 | 2022-05-10 | 吉林大学 | Walnut mountain ash flavone component nanoemulsion preparation and preparation method and application thereof |
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Non-Patent Citations (2)
| Title |
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| 丹皮酚复乳的药剂学研究. 汪国华.药学实践杂志，第21卷第6期. 2003 |
| 丹皮酚复乳的药剂学研究. 汪国华.药学实践杂志，第21卷第6期. 2003 * |
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