CN101396344A - Paeonol microemulsion preparation and preparation method thereof - Google Patents
Paeonol microemulsion preparation and preparation method thereof Download PDFInfo
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- CN101396344A CN101396344A CNA2008102018589A CN200810201858A CN101396344A CN 101396344 A CN101396344 A CN 101396344A CN A2008102018589 A CNA2008102018589 A CN A2008102018589A CN 200810201858 A CN200810201858 A CN 200810201858A CN 101396344 A CN101396344 A CN 101396344A
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Abstract
The invention relates to the medical technical field, in particular to a paeonol micro-emulsion preparation and a preparation method thereof. The paeonol micro-emulsion preparation consists of components with the weight percentage as follows: 0.1 percent to 2 percent of paeonol, 10 percent to 25 percent of surfactant, 5 percent to 30 percent of cosurfactant, 5 percent to 15 percent of oil phase and 40 percent to 70 percent of deionized water. The mouse percutaneous experiment in vitro shows that the paeonol micro-emulsion prepared by the invention has obviously higher capacity of penetrating through the horny layer than the saturated aqueous solution of paeonol (p is less than 0.05), and the paeonol micro-emulsion can penetrate into the skin deeply to take curative effect within a short time and also has certain sustained and controlled release function. At the same time, the paeonol micro-emulsion improves the solubility of the paeonol obviously, increases the drug loading quantity of the preparation and reduces the drug administration times and the dosage. The paeonol micro-emulsion preparation has simple preparation method and uniform grain diameter of the preparation, has the advantages of being safe, stable and efficient and, can be used for preparing dermal medication preparation or cosmetic.
Description
Technical field
The present invention relates to medical technical field, is a kind of paeonol microemulsion preparation and preparation method thereof.
Background technology
Paeonol (Paeonol, Pae) claim paeonol again, be the main active of ranunculaceae peony (Paeonia suffruticosaAndr.) root bark and Asclepiadaceae plant Radix Cynanchi Paniculati Pycnostelma Paniculatum (Bunge) K.Schu herb, have effects such as good antibiotic, antiinflammatory, resistance attitude and analgesic, analgesia and blood pressure lowering.The dosage form of listing mainly contains Paeonal injection agent, paeonol sheet and paeonol unguentum at present.Be mainly used in treatment rheumatalgia, stomachache and other pain, eczema, allergic dermatitis etc. clinically, have better curative effect.The paeonol percutaneous dosing is used for the treatment of eczema, allergic dermatitis etc., has overcome shortcomings such as big, the easy recurrence of traditional hormone medicine side effect, and has advantages such as toxic and side effects is little as Chinese medicine monomer.The dissolubility of paeonol in water is low, and the character instability is volatile, easy oxidation Decomposition, thus had a strong impact on its use and curative effect.The existing dosage form of paeonol percutaneous drug delivery mainly is an ointment simultaneously, is in emulsion, emulsion type gel and the phosphatide complexes etc. in addition of conceptual phase.These dosage forms exist poor stability, and drug loading is low, are difficult for shortcomings such as industrialization.
Microemulsion (microemulsion, ME) be to mix by proper proportion and the spontaneous isotropism that forms, transparent and thermodynamically stable colloidal dispersion system by water, oil phase, surfactant and cosurfactant, size droplet diameter is usually at 10-100nm, lipotropy but also a tool hydrophilic had not only been had, with cuticular iuntercellular lipid bilayer the higher compatibility is arranged, penetrable horny layer enters the body circulation and the effect of performance whole body therapeutic.Microemulsion can significantly increase the dissolubility of insoluble drug as the percutaneous dosing carrier, forms higher Concentraton gradient fast in the skin both sides, thereby improves the percutaneous rate of medicine greatly, shortens time lag.In addition, because the special construction of microemulsion drop has certain slow-releasing and controlled-releasing action behind the medicine percutaneous dosing, prolong release time, and blood drug level is more steady.But do not see the relevant report of paeonol being made microemulsion formulation so far.
Summary of the invention
The invention provides paeonol microemulsion preparation that a kind of good stability, drug loading are big, pharmaceutical release time is long and preparation method thereof.
The component and the percentage by weight thereof of paeonol microemulsion preparation of the present invention are as follows:
Paeonol 0.1%～2%
Cosurfactant 5%～30%
Oil phase 5%～15%
Deionized water 40%～70%
Said surfactant is selected from one or both in lecithin, alkyl-glucoside (APG), Polysorbate, polyoxyethylene hydrogenated Oleum Ricini (Cremorphor RH40), Cremorphor RH60, the NONIN HS 240 (OP), and wherein Polysorbate is selected from a kind of in tween 20, Tween-40, Tween-60, the tween 80;
Said cosurfactant is selected from glycerol, 1, and 2-propylene glycol, glycerol, n-butyl alcohol, n-octyl alcohol, Polyethylene Glycol-8-glycerol be sad/a kind of in the certain herbaceous plants with big flowers acid esters (Labrasol), TranscutolP;
Said oil phase is selected from a kind of in olive oil, oleic acid, medium chain length fatty acid triglyceride, isopropyl myristate, the ethyl oleate.
The preparation method of paeonol microemulsion preparation of the present invention comprises following three kinds:
(1) manual dripping method: by proportioning the medicine paeonol is dissolved in oil phase, add surfactant and be mixed into the pastille inner phase, at room temperature slowly drip deionized water more while stirring in the pastille inner phase, constant speed stirs, and forms the paeonol microemulsion of clear.
(2) the even method of ultrasonic breast: by proportioning the medicine paeonol is dissolved in oil phase, the adding surfactant is mixed into the pastille inner phase, deionized water is added the pastille inner phase again and mixes, and under the power of 250w, with the even 3-5min of the ultrasonic breast of probe Ultrasound Instrument, gets paeonol microemulsion.
(3) the even method of high pressure homogenize breast: the medicine paeonol is dissolved in oil phase by proportioning, add surfactant and be mixed into the pastille inner phase, again the pastille inner phase is mixed with deionized water, is 60-70bar with high pressure homogenizer at a step valve, secondary valve is under 600-700bar, even 3-5 times of homogenized milk gets paeonol microemulsion.
The paeonol microemulsion of above method preparation is measured particle diameter with Zetasizer Nano ZS90 analyzer, the result as shown in Figure 1, particle size distribution is 30-50nm, size is even, outward appearance is clear and bright, sees Fig. 2.
Selected surfactant, cosurfactant, the oil phase of the present invention is the pharmaceutic adjuvant of extensive use on the pharmaceutics, has nontoxic, non-irritating characteristic.The surfactant that the present invention selects for use is a non-ionic surface active agent, has that toxicity is low, hemolytic is little, the advantage of good biocompatibility.Wherein lecithin is the part of membrane structure, has very high biocompatibility.And alkyl-glucoside (APG) is a kind of novel natural non-ionic surface active agent, has very high biodegradability and good skin toleration.Therefore the microemulsion formulation that adopts these surfactants and preparation method of the present invention to obtain has safe, efficient, stable characteristics.
Show through the stripped transdermal experiment of mice: the prepared paeonol microemulsion of the present invention sees through the saturated aqueous solution (p＜0.05) that cuticular ability is significantly higher than paeonol, can go deep into deep skin performance curative effect at short notice, and have certain slow-releasing and controlled-releasing action, can in 36 hours, continue the release medicine of constant speed.Significantly improved simultaneously the dissolubility of paeonol, increased the preparation drug loading, and reduced administration number of times and dosage.Paeonol microemulsion formulation preparation method of the present invention is simple, and the preparation particle diameter is even, has safety, stable, advantage efficiently, can be used for preparing percutaneous drug administration preparation or cosmetics.
Description of drawings
Fig. 1 is the paeonol microemulsion particle size distribution figure of the embodiment of the invention 1.
Fig. 2 is the paeonol microemulsion electromicroscopic photograph of the embodiment of the invention 1, amplifies 100000 times.
Fig. 3 is paeonol microemulsion and paeonol aqueous solution transdermal test in vitro experimental result.
The specific embodiment
Below in conjunction with embodiment the present invention is described in detail.
Embodiment 1. manual dripping methods prepare the paeonol microemulsion preparation, and component and percentage by weight thereof are as follows:
Paeonol 1%
Lecithin (surfactant) 6%
APG (surfactant) 12%
Propylene glycol (cosurfactant) 9%
Isopropyl myristate (oil phase) 12%
Deionized water 60%
Preparation method is as follows:
By proportioning paeonol is dissolved in isopropyl myristate, add lecithin and APG mixing again and fully dissolve and be the pastille inner phase, at room temperature drip deionized water while stirring in the pastille inner phase,, form the paeonol microemulsion of clear with the rotating speed constant speed stirring 2h of 200r/min.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, the results are shown in Figure 1, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright, sees Fig. 2.
The even legal system of embodiment 2. ultrasonic breasts is equipped with the paeonol microemulsion preparation, and component and proportioning are with embodiment 1.
Paeonol is dissolved in isopropyl myristate, add the also abundant dissolving of lecithin and APG mixing again and be the pastille inner phase, the pastille inner phase is mixed with deionized water, with popping one's head in Ultrasound Instrument under the power of 250w, ultrasonic breast is spared 3min, gets paeonol microemulsion at last.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright.
The even legal system of embodiment 3. high pressure homogenize breast is equipped with the paeonol microemulsion preparation, and component and proportioning are with embodiment 1.
Paeonol is dissolved in isopropyl myristate, add the also abundant dissolving of lecithin and APG mixing again and be the pastille inner phase, the pastille inner phase is mixed with deionized water, is 60-70bar with high pressure homogenizer at a step valve, secondary valve is under 600-700bar, and even 3 times of homogenized milk gets paeonol microemulsion.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright.
Paeonol 0.5%
Lecithin (surfactant) 7.5%
OP (cosurfactant) 17.5%
Isopropyl myristate (oil phase) 9%
Deionized water 65.5%
Preparation method is as follows:
By proportioning paeonol is dissolved in isopropyl myristate, add lecithin and OP mixing again and fully dissolve and be the pastille inner phase, at room temperature drip distilled water while stirring in the pastille inner phase,, form the paeonol microemulsion of clear with the rotating speed constant speed stirring 2h of 200r/min.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright.
The even legal system of embodiment 5. ultrasonic breasts is equipped with the paeonol microemulsion preparation, and component and proportioning are with embodiment 4.
Paeonol is dissolved in isopropyl myristate, add the also abundant dissolving of lecithin and OP mixing again and be the pastille inner phase, the pastille inner phase is mixed with deionized water, with popping one's head in Ultrasound Instrument under the power of 250w, ultrasonic breast is spared 4min, gets paeonol microemulsion at last.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright.
The even legal system of embodiment 6. high pressure homogenize breast is equipped with the paeonol microemulsion preparation, and component and proportioning are with embodiment 4.
Paeonol is dissolved in isopropyl myristate, add the also abundant dissolving of lecithin and OP mixing again and be the pastille inner phase, the pastille inner phase is mixed with deionized water, is 60-70bar with high pressure homogenizer at a step valve, secondary valve is under 600-700bar, and even 4 times of homogenized milk gets paeonol microemulsion.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright.Embodiment 7. manual dripping methods prepare the paeonol microemulsion preparation, and component and percentage by weight thereof are as follows:
Paeonol 1%
Cremorphor RH40 (surfactant) 14%
Labrasol (cosurfactant) 28%
Oleic acid (oil phase) 14.6%
Deionized water 42.4%
Preparation method is as follows:
By proportioning paeonol is dissolved in oleic acid, add Cremorphor RH40 and Labrasol mixing again and fully dissolve and be the pastille inner phase, at room temperature drip distilled water while stirring in the pastille inner phase,, form the paeonol microemulsion of clear with the rotating speed constant speed stirring 2h of 200r/min.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright.
The even legal system of embodiment 8. ultrasonic breasts is equipped with the paeonol microemulsion preparation, and component and proportioning are with embodiment 7.
Paeonol is dissolved in oleic acid, add the also abundant dissolving of Cremorphor RH40 and Labrasol mixing again and be the pastille inner phase, the pastille inner phase is mixed with deionized water, with popping one's head in Ultrasound Instrument under the power of 250w, ultrasonic breast is spared 5min, gets paeonol microemulsion.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright.
The even legal system of embodiment 9. high pressure homogenize breast is equipped with the paeonol microemulsion preparation, and component and proportioning are with embodiment 7.
Paeonol is dissolved in oleic acid, add Cremorphor RH40 and Labrasol mixing again and fully dissolve and be the pastille inner phase, the pastille inner phase is mixed with deionized water, is 60-70bar with high pressure homogenizer at a step valve, secondary valve is under 600-700bar, even 5 times of homogenized milk gets paeonol microemulsion.Measure the paeonol microemulsion particle diameter with Zetasizer Nano ZS90 analyzer, particle size range is at 30-50nm, and size is even, and outward appearance is clear and bright.
The mice transdermal experiment that exsomatizes: male mice in kunming (available from the The 2nd Army Medical College animal center) 20 ± 2g, with depilatory cream depilation, natural feeding 12h.Disconnected then neck is put to death, and gets mouse part skin, and removes subcutaneous tissue and fat, be embedded in the normal saline, and 4 ℃ of preservations, and in 24h, use.Off-the-shelf mouse part skin is fixed on the Frans diffusion cell accepts (effective radius is 0.85 square centimeter) between pond and the supply pool, acceptable solution is normal saline 5mL, fixes with clip at last.Respectively paeonol saturated aqueous solution and embodiment 1 each 1mL of proportioning microemulsion are put into supply pool, 32 ± 2 ℃, acceptable solution is all taken out from accept the pond respectively at 0.5h, 1h, 2h, 4h, 6h, 8h, 10h, 12h under the rotating speed stirring condition of 300r/min, replenish the synthermal fresh acceptable solution of equal-volume simultaneously, centrifugal (the 10000r/min of sample, 10min), go supernatant to measure paeonol content.
This experiment is adopted the paeonol saturated aqueous solution as a comparison, by the result as can be known, paeonol saturated aqueous solution Transdermal absorption amount behind 8h keeps inconvenience substantially, that paeonol microemulsion then demonstrates is lasting, the transhipment characteristics of time-delay, prolonged the action time of medicine, improved the bioavailability of paeonol, visible paeonol microemulsion is better than the paeonol aqueous solution.Paeonol microemulsion 12h percutaneous steady-state permeation flow is 119.69 μ gcm
-2H
-1, the unit are accumulation infiltration capacity of 12h is 1656.411 μ gcm
-2, result such as Fig. 3.
Claims (6)
1. paeonol microemulsion preparation, component and percentage by weight thereof are as follows:
Paeonol 0.1%～2%
Surfactant 10%～25%
Cosurfactant 5%～30%
Oil phase 5%～15%
Deionized water 40%～70%
Said surfactant is selected from one or both in lecithin, alkyl-glucoside, Polysorbate, Cremorphor RH60 or polyoxyethylene hydrogenated Oleum Ricini, the NONIN HS 240, and wherein Polysorbate is selected from a kind of in tween 20, Tween-40, Tween-60, the tween 80;
Said cosurfactant be selected from glycerol, propylene glycol, glycerol, n-butyl alcohol, n-octyl alcohol, Polyethylene Glycol-8-glycerol sad/a kind of in the certain herbaceous plants with big flowers acid esters, Transcutol P;
Said oil phase is selected from: a kind of in olive oil, oleic acid, medium chain length fatty acid triglyceride, isopropyl myristate, the ethyl oleate.
2. by the described paeonol microemulsion preparation of claim 1, it is characterized in that component and percentage by weight thereof are as follows:
Paeonol 1%
Lecithin 6%
Alkyl-glucoside 12%
Propylene glycol 9%
Isopropyl myristate 12%
Deionized water 60%.
3. by the described paeonol microemulsion preparation of claim 1, it is characterized in that component and percentage by weight thereof are as follows:
Paeonol 0.5%
Lecithin 7.5%
NONIN HS 240 17.5%
Isopropyl myristate 9%
Deionized water 65.5%.
4. by the described paeonol microemulsion preparation of claim 1, it is characterized in that component and percentage by weight thereof are as follows:
Paeonol 1%
Polyoxyethylene hydrogenated Oleum Ricini 14%
Polyethylene Glycol-8-glycerol is sad/certain herbaceous plants with big flowers acid esters 28%
Oleic acid 14.6%
Deionized water 42.4%.
5. the preparation method of claim 1,2,3 or 4 described paeonol microemulsion preparations comprises following three kinds:
(1) manual dripping method: by proportioning medicine is dissolved in oil phase, add surfactant and be mixed into the pastille inner phase, at room temperature slowly drip deionized water more while stirring in the pastille inner phase, constant speed stirs, and forms the paeonol microemulsion of clear;
(2) the even method of ultrasonic breast: by proportioning medicine is dissolved in oil phase, the adding surfactant is mixed into the pastille inner phase, deionized water is added the pastille inner phase again and mixes, and under the power of 250w, with the even 3-5min of the ultrasonic breast of probe Ultrasound Instrument, gets paeonol microemulsion;
(3) the even method of high pressure homogenize breast: by proportioning medicine is dissolved in oil phase, add surfactant and be mixed into the pastille inner phase, again the pastille inner phase is mixed with deionized water, is 60-70bar with high pressure homogenizer at a step valve, secondary valve is under 600-700bar, and even 3-5 times of homogenized milk gets paeonol microemulsion.
6. the application in claim 1,2,3 or 4 described paeonol microemulsions, antiinflammatory antibiotic, resistance attitude or analgesic, analgesia, the antihypertensive drugs in preparation.
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| CN105687136A (en) * | 2014-11-26 | 2016-06-22 | 安徽中医药大学 | PEGylated paeonol nonionic surfactant vesicle and preparation method thereof |
| CN105748436A (en) * | 2014-12-15 | 2016-07-13 | 安徽中医药大学 | Paeonol niosome emulsifiable paste for external use and preparation method thereof |
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| CN102335131A (en) * | 2011-10-10 | 2012-02-01 | 山西仁源堂药业有限公司 | Osthole micro emulsion, osthole micro emulsion sustained-release patch 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 |
| CN105748436A (en) * | 2014-12-15 | 2016-07-13 | 安徽中医药大学 | Paeonol niosome emulsifiable paste for external use 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 |
| CN106924177A (en) * | 2017-03-21 | 2017-07-07 | 西安培华学院 | A kind of external application Paeonol nano controlled-release thermosensitive in situ gel and preparation method thereof |
| CN108969424A (en) * | 2018-09-29 | 2018-12-11 | 花安堂生物科技集团有限公司 | A kind of moderately removing dandruff anti-pruritic compositions and its preparation method and application |
| CN108969424B (en) * | 2018-09-29 | 2021-03-02 | 花安堂生物科技集团有限公司 | Mild anti-dandruff itching-relieving composition and preparation method and application 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 |
| CN111870543A (en) * | 2020-08-24 | 2020-11-03 | 汕头市奇伟实业有限公司 | Antioxidant lycopene microemulsion and preparation method thereof |
| CN112353704A (en) * | 2020-11-20 | 2021-02-12 | 苏州纳康生物科技有限公司 | Preparation method of paeonol nano lipid particle |
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