CN105617133A - Composite peony seed oil self-emulsifying system composition and preparation method thereof - Google Patents
Composite peony seed oil self-emulsifying system composition and preparation method thereof Download PDFInfo
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Abstract
The invention provides a composite peony seed oil self-emulsifying system composition and a preparation method thereof. The self-emulsifying system composition comprises composite peony seed oil, emulsifier and co-emulsifier, can further contain dispersant and/or solid adsorbent and can be prepared into oral formulations like soft capsules, liquid capsules, hard capsules and granules. The self-emulsifying system composition after entering a body can self-microemulsify under action of gastrointestinal liquid to form emulsified liquid, and absorption of the self-emulsifying system composition in a gastrointestinal tract can be promoted, so that bioavailability and efficacy of the composite peony seed oil self-emulsifying system composition are improved. The self-emulsifying system composition is low in cost, high in stability, convenient to store and transport and little in side effect, and compliance of a patient with oral formulation medicine based on the composite peony seed oil self-emulsifying system composition can be improved.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of compound peony seed oil self-emulsifying systems compositions.
Background technology
Peony seed oil is a kind of hydrophobicity golden transparent oily substance extracting from seed of Flos Moutan. Peony seed oil is relatively big in China's yield at present, is a kind of crude vegetal resource recently received much attention. The chemical composition of peony seed oil is mainly fatty acid, containing substantial amounts of unsaturated fatty acid (UFA), its total amount about 80%��92%, hence it is evident that higher than having the olive oil of title of " liquid golden ", soybean oil and Semen arachidis hypogaeae wet goods Vegetable Oils. It is worth noting especially, the UFA in peony seed oil forms based on alpha-linolenic acid, and content, generally 32%��67%, is significantly larger than other Vegetable Oils, close with Semen Lini oil. Except having fairly obvious unsaturated fatty acid and alpha-linolenic acid composition advantage, peony seed oil is easier to the polyunsaturated fatty acid linoleic acid of monounsaturated fatty acid oleic acid and a large amount of needed by human absorbed possibly together with human body. In addition, peony seed oil contains some phytosterin compounds (sitosterol, 24-ethylidenecholest-5-en-3.beta.-ol. etc.), fatsoluble vitamin E and Squalene etc., wherein, plant sterol is the important intermediate of synthesis of vitamin d 3 steroid class medicine such as grade, and has prevention coronary disease atherosclerosis, promotes the medicinal and health value such as cholesterol degradation metabolism; Vitamin E and Squalene are then the important Natural antioxidants, have raising internal superoxide dismutase (SOD) activity, enhancing human body immunity ability, anti-ageing different physiological roles of waiting for a long time. Possibly together with trace elements of Ca, Na, Fe, K, Zn, Mg, Cu etc. in peony seed oil, most important for maintaining normal metabolism and health.
Modern study shows that peony seed oil has higher Nutrition and health function: effect for reducing blood fat, antioxidation, hepatoprotective effect, blood sugar lowering, raising immunity of organisms, sun-proof Bearberry Extract. In March, 2011, Ministry of Public Health assigns " Ministry of Public Health about approval peony seed oil as the bulletin of new resource food " (2011 No. 9), and have approved peony seed oil is new resource food.
Ganoderma spore is the Ganoderma mature period constantly spore of release from cap, is a kind of hydrophobicity oily substance extracted from Ganoderma spore, main fatty acids, sterol, terpenoid, vitamins etc. Semen Coicis is the dry mature kernal of grass CoixlacrymajoibL.var.mayuen (Roman.) Stapf, is a kind of hydrophobicity oily substance extracted from Semen Coicis, mainly contains fatty acid, Coixenolide. Ganoderma spore oil and Semen Coicis oil are researched and developed more at present, also comparative maturity, have greater advantage improving immunity, anti-tumor aspect in vegetable oil.
The main edible blend oil in liquid form of peony seed oil of existing market application provides, as Chinese patent CN103859064B discloses " a kind of blending edible oil containing peony seed oil and preparation method thereof ", although peony seed oil is more with the combination patent of other vegetable oil, but yet there are no the compound peony seed oil of peony seed oil and Ganoderma spore oil and Semen Coicis oil combination so far. Peony seed oil and Ganoderma spore oil, Semen Coicis oil are combined into compound peony seed oil by this patent, can give full play to Ganoderma spore oil and Semen Coicis oil in the advantage improving immunity, anti-tumor aspect, be greatly enhanced the effect of compound peony seed oil enhancing immunity.
In recent years, the research and development of peony seed oil are all more popular, and the patent of application is more. As publication CN104106806A discloses " a kind of voltage stabilizing fat reducing health product ", and for example Chinese patent CN103494199A discloses " a kind of Peony-seed-oil soft capsule with effect for reducing fat and preparation thereof ". But, in existing document, do not find the report about peony seed oil self-emulsifying systems composition and method of making the same, it is not related to the report of compound peony seed oil self-emulsifying systems composition and method of making the same, only have the report that peony seed oil is applied as health product, as patent CN104666458A discloses " a kind of American ginseng soft capsule containing peony seed oil and preparation method thereof ", it is equipped with medicine with peony seed oil and is directly compressed into the soft capsule containing peony seed oil. But, there is the defect that bioavailability is low in the existing soft capsule containing peony seed oil. Additionally, peony seed oil is made soft capsule, it is necessary to overcome some difficulties, for instance in storage period, disintegrate becomes defective, capsule is interior occurs material transport and oil components seepage, acid number and oxidation number to raise equistability problem. It is thus desirable to the compound peony seed oil oral Pharmaceutical dosage forms that exploitation makes new advances.
Summary of the invention
It is contemplated that overcome the defect of above-mentioned prior art, a kind of compound peony seed oil self-emulsifying systems compositions is provided, it can automatically form emulsion under the wriggling of stomach, easily absorbed, bioavailability is high, and described compound peony seed oil self-emulsifying systems composition product good stability, degree of safety are high.
Another object of the present invention is to the preparation method that described compound peony seed oil self-emulsifying systems compositions is provided.
Another object of the present invention is to provide the application of described compound peony seed oil self-emulsifying systems compositions.
The present invention is achieved through the following technical solutions foregoing invention purpose.
A kind of compound peony seed oil self-emulsifying systems compositions, including the following component calculated by weight:
Peony seed oil 15��70 parts;
Emulsifying agent 5��55 parts;
Co-emulsifier 5��20 parts;
Wherein, described compound peony seed oil is made up of with Ganoderma spore oil and/or Semen Coicis oil peony seed oil.
Compound peony seed oil selected by the present invention itself is oily substance, it it is crude drug effective ingredient, it it is again oil phase adjuvant, it is alternatively arranged as dispersant or carrier, disperse or dissolve other effective ingredient or medicine to form self-emulsifying drug delivery systems, so relatively adding the ratio of self-emulsifying drug delivery systems medicine when preparing self-emulsifying systems compositions, decreasing the consumption of emulsifying agent, highlighting the effect of autoemulsification. Selected emulsifying agent, co-emulsifier are wide variety of pharmaceutic adjuvant on pharmaceutics, have characteristic nontoxic, non-irritating.
Modern study shows, peony seed oil is mainly containing ��3Unsaturated fatty acid, Semen Coicis oil is mainly containing ��6Unsaturated fatty acid, Ganoderma spore oil is mainly containing ��9Unsaturated fatty acid, compound peony seed oil, by the proportioning of different types of unsaturated fatty acid, can play its health care better.
Preferably, described compound peony seed oil ratio of components by weight is:
Peony seed oil: Ganoderma spore oil=1:0.5��1.5,
Or
Peony seed oil: Semen Coicis oil=1:0.5��2.5,
Or
Peony seed oil: Ganoderma spore oil: Semen Coicis oil=1:0.5��1.5:0.5��2.5.
Preferably, described compound peony seed oil self-emulsifying systems compositions includes dispersant and/or the solid absorbent of 0 ~ 75 part by weight. Described compound peony seed oil self-emulsifying systems compositions can be prepared to different dosage forms, such as soft capsule, liquid capsule, hard capsule or other peroral dosage forms. Described compound peony seed oil self-emulsifying systems compositions can also include some medicines easily dissolved by compound peony seed oil.
Preferably, described compound peony seed oil self-emulsifying systems compositions, including the following component calculated by mass percentage:
Compound peony seed oil 40%��65%;
Emulsifying agent 15%��30%;
Co-emulsifier 10%��20%;
Dispersant and/or solid absorbent 5%��35%.
Preferably, described emulsifying agent is selected from one or more of following material: fabaceous lecithin, lecithin, cephalin, poloxamer, sucrose laurate, Arlacel-60, tween 85, polyoxyethylene nonyl 2, 2-Oxydiphenol, Palmic acid sucrose ester, stearic acid sucrose ester, fatty acid Pyrusussuriensis is smooth, Polysorbate, Myrj 52, Brij30, Brij35, polyoxyethylene castor oil glycerin ether (ethenoxy unit is 35��40), lose Span, polyoxyethylene, poiyoxypropylene copolymer, castor oil hydrogenated, sodium lauryl sulphate, sodium stearyl sulfate, dodecylbenzene sodium sulfonate.
It is highly preferred that described emulsifying agent is selected from one or more of following material: fabaceous lecithin, lecithin, tween 85, sucrose laurate, polyoxyethylene nonyl 2, 2-Oxydiphenol.
Preferably, described co-emulsifier is selected from one or more of following material: glycerol, isopropanol, l, 2-propylene glycol, diethylene glycol monoethyl ether, n-butyl alcohol, n-octyl alcohol, n-heptanol, ethanol, polyoxyethylene fatty acid ester, PEG400.
It is highly preferred that described co-emulsifier is selected from one or more of following combination thing: glycerol, diethylene glycol monoethyl ether, n-octyl alcohol, PEG400.
Preferably, described dispersant is selected from one or more of following material: Oleum Glycines, Oleum Arachidis hypogaeae semen, Oleum Ricini, olive oil, Ethyl linoleate, ethyl oleate, the triglyceride of medium chain, isopropyl laurate, isopropyl myristate, propyleneglycoles mono-/bis-caprylate, Monooctamoin.
Preferably, described solid adsorption material is selected from one or more of following material: polyethylene glycol 6000, Macrogol 4000, polyvidone, HP-��-CD, oxalic acid, lactose, mannitol, sorbitol, CAP, HP-55, polyacrylic resin, methylcellulose, hydroxypropyl methyl cellulose, ethyl cellulose, chitin, micropowder silica gel or carboxymethyl cellulose.
In described self-emulsifying systems compositions, it is also possible to add a small amount of antioxidant, for instance vitamin E.
The preparation method of described compound peony seed oil self-emulsifying systems compositions, comprises the following steps:
S1. emulsifying agent is mixed homogeneously with co-emulsifier;
S2. add compound peony seed oil, be mixed evenly, form compound peony seed oil breast concentrated solution;
Or directly compound peony seed oil, emulsifying agent, co-emulsifier are mixed evenly, form compound peony seed oil breast concentrated solution.
The mode of mix homogeneously can be stirring for, vibrates, ultrasonic or vortex.
Preferably, the post-processing step of the preparation method of described compound peony seed oil self-emulsifying systems compositions is:
S3-1. the newborn concentrated solution made is obtained soft capsule with soft capsule material pressing or dropping preparation method; Or
S3-2. the newborn concentrated solution made directly is filled in liquid capsule softgel shell and prepares liquid capsule; Or
S3-3. add solid absorbent and do carrier, make granule, be distributed in capsule shells and obtain hard capsule; Or
S3-4. add solid absorbent and do carrier, make granule, be distributed in aluminium plastic bag and obtain granule.
Compound peony seed oil self-emulsifying systems compositions of the present invention is suitably applied oral drugs, such as capsule, electuary etc.
Compared with prior art, there is advantages that
Compound peony seed oil selected by the present invention itself is oily substance, it it is crude drug effective ingredient, it it is again oil phase adjuvant, and it is alternatively arranged as dispersant or carrier, disperse or dissolve other effective ingredient or medicine forms self-emulsifying drug delivery systems, relatively add the ratio of self-emulsifying drug delivery systems medicine, decrease the consumption of self-emulsifier, highlight the effect of autoemulsification; Gained compound peony seed oil self-emulsifying systems compositions has the dispersibility of height, excellent bin stability, variable color and the deterioration of system combination are suppressed, active component speed of dissolution from system combination does not change, and bioavailability is greatly improved, improve the medicinal effects of compound peony seed oil and medicine; Selected emulsifying agent, co-emulsifier, dispersant and solid absorbent are wide variety of pharmaceutic adjuvant on pharmaceutics, there is characteristic nontoxic, non-irritating, both the problem having solved the bioavailability of oil component, do not increase again the toxic and side effects of product, patient's curative compliance to the oral dosage form medicament based on described self-emulsifying drug delivery systems pharmaceutical composition can be improved; Preparation technology flow process is simple, easy to operate, and control of product quality is convenient, has operability, is suitable for industrial safe and reliable preparation method.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention being illustrated, but protection scope of the present invention is not intended to be limited to following example, the explanation of embodiment is only intended to help to understand method and the core concept thereof of the present invention. Any amendment made within all spirit at this patent and principle, equivalent replacement and improvement etc., should be included within the protection domain of application claims.
Embodiment 1
Compound peony seed oil self-emulsifying systems soft capsule prepares one
Compound peony seed oil self-emulsifying systems soft capsule becomes to be grouped into as shown in table 1.
Table 1 compound peony seed oil self-emulsifying systems soft capsule becomes to be grouped into
S1. press fabaceous lecithin, glycerol, sorbitol, vitamin E and PEG-4000 mixing shown in table 1, stir secondary, 5 minutes first times, second time 2 minutes so that it is be uniformly dispersed with cutter (8000 revs/min);
S2. add the peony seed oil of warm, Ganoderma spore oil, stir 3 times, each 2 minutes, make into colostrum, then be transferred to high pressure homogenizer and homogenize 3 times, filter, form homogeneous compound peony seed oil breast concentrated solution, i.e. the self-emulsifying systems compositions A of compound peony seed oil;
S3. gelatin is added in glue pot, add 80 DEG C of water of proportioning, add preservative ethyl hydroxybenzoate, add opacifier and coloring agent if desired, airtight heat simultaneously, stir to melt swelling completely, add glycerol, airtight join glue tank, close stirring, open vacuum pump, evacuation, treat that bubble pumps, obtain soft capsule material liquid. 50��70 DEG C of insulations, standby, take encapsulating machine on the self-emulsifying drug delivery medicinal liquid of soft capsule material liquid, compound peony seed oil, adopt pressing to prepare soft capsule, drying, washing, then dry, go-on-go, packaging, obtain finished product.
Embodiment 2
Compound peony seed oil self-emulsifying systems soft capsule prepares two
Compound peony seed oil self-emulsifying systems soft capsule becomes to be grouped into as shown in table 2.
Table 2 compound peony seed oil self-emulsifying systems soft capsule becomes to be grouped into
S1. press fabaceous lecithin, glycerol, sorbitol, vitamin E and PEG-4000 mixing shown in table 2, stir secondary, 5 minutes first times, second time 2 minutes so that it is be uniformly dispersed with cutter (8000 revs/min);
S2. add the peony seed oil of warm, Ganoderma spore oil, stir 3 times, each 2 minutes, make into colostrum, then be transferred to high pressure homogenizer and homogenize 3 times, filter, form homogeneous compound peony seed oil breast concentrated solution, i.e. the self-emulsifying systems compositions B of compound peony seed oil;
S3. gelatin is added in glue pot, add 80 DEG C of water of proportioning, add preservative ethyl hydroxybenzoate, add opacifier and coloring agent if desired, airtight heat simultaneously, stir to melt swelling completely, add glycerol, airtight join glue tank, close stirring, open vacuum pump, evacuation, treat that bubble pumps, obtain soft capsule material liquid. 50��70 DEG C of insulations, standby, take encapsulating machine on the self-emulsifying drug delivery medicinal liquid of soft capsule material liquid, compound peony seed oil, adopt pressing to prepare soft capsule, drying, washing, then dry, go-on-go, packaging, obtain finished product.
Embodiment 3
Compound peony seed oil self-emulsifying systems soft capsule prepares three
Compound peony seed oil self-emulsifying systems soft capsule becomes to be grouped into as shown in table 3.
Table 3 compound peony seed oil self-emulsifying systems soft capsule becomes packet
S1. press Brij30, l, 2-propylene glycol, sorbitol, vitamin E and polyoxyethylene fatty acid ester mixing shown in table 3, stir secondary, 5 minutes first times, second time 2 minutes so that it is be uniformly dispersed with cutter (8000 revs/min);
S2. add the peony seed oil of warm, Ganoderma spore oil, stir 3 times, each 2 minutes, make into colostrum, then be transferred to high pressure homogenizer and homogenize 3 times, filter, form homogeneous compound peony seed oil breast concentrated solution, i.e. the self-emulsifying systems compositions C of compound peony seed oil;
S3. gelatin is added in glue pot, add 80 DEG C of water of proportioning, add preservative ethyl hydroxybenzoate, add opacifier and coloring agent if desired, airtight heat simultaneously, stir to melt swelling completely, add glycerol, airtight join glue tank, close stirring, open vacuum pump, evacuation, treat that bubble pumps, obtain soft capsule material liquid. 50��70 DEG C of insulations, standby, take encapsulating machine on the self-emulsifying drug delivery medicinal liquid of soft capsule material liquid, compound peony seed oil, adopt pressing to prepare soft capsule, drying, washing, then dry, go-on-go, packaging, obtain finished product.
Embodiment 4
Compound peony seed oil self-emulsifying systems soft capsule prepares four
Compound peony seed oil self-emulsifying systems soft capsule becomes to be grouped into as shown in table 4.
Table 4 compound peony seed oil self-emulsifying systems soft capsule becomes to be grouped into
S1. press peony seed oil, Ganoderma spore oil, Semen Coicis oil, tween 85, diethylene glycol monoethyl ether mixing shown in table 4, stir three times with cutter (8000 revs/min), each 5 minutes;
S2. it is transferred to high pressure homogenizer to homogenize 3 times, filters, form homogeneous compound peony seed oil breast concentrated solution, i.e. the self-emulsifying systems compositions D of compound peony seed oil;
S3. gelatin is added in glue pot, add 60 DEG C of water of proportioning, add preservative ethyl hydroxybenzoate, add opacifier and coloring agent if desired, airtight heat simultaneously, stir to melt swelling completely, add glycerol, airtight join glue tank, close stirring, open vacuum pump, evacuation, treat that bubble pumps, obtain soft capsule material liquid. 50��70 DEG C of insulations, standby, take encapsulating machine on the self-emulsifying drug delivery medicinal liquid of soft capsule material liquid, compound peony seed oil, adopt pressing to prepare soft capsule, drying, washing, then dry, go-on-go, packaging, obtain finished product.
Embodiment 5
Compound peony seed oil self-emulsifying systems liquid capsule prepares one
Compound peony seed oil self-emulsifying systems becomes to be grouped into as shown in table 5.
Table 5 compound peony seed oil self-emulsifying systems liquid capsule content becomes to be grouped into
S1. press lecithin, polyoxyethylene nonyl 2, 2-Oxydiphenol, glycerol mixing shown in table 5, by the ultrasonic Treatment 5 minutes of 25KHz so that it is be uniformly dispersed;
S2. add the peony seed oil of warm, Semen Coicis oil, by the ultrasonic Treatment 10 points of 25KHz, filter, form homogeneous compound peony seed oil breast concentrated solution, i.e. the self-emulsifying systems compositions E of compound peony seed oil;
S3. the newborn concentrated solution made directly is filled in liquid capsule softgel shell, go-on-go, packaging, obtain finished product.
Embodiment 6
Compound peony seed oil self-emulsifying systems liquid capsule prepares two
Compound peony seed oil self-emulsifying systems becomes to be grouped into as shown in table 6.
Table 6 compound peony seed oil self-emulsifying systems liquid capsule content becomes to be grouped into
S1. shown in table 4, sucrose laurate and glycerol are uniformly mixed;
S2. by peony seed oil, Ganoderma spore oil, Semen Coicis oil, Oleum Arachidis hypogaeae semen mix homogeneously, join in the mixed liquor of sucrose laurate and glycerol, stir 30 minutes with the high speed agitator that mixing speed is 8000 revs/min, it is mixed evenly, form compound peony seed oil breast concentrated solution, i.e. the self-emulsifying systems composition F of compound peony seed oil;
S3. compound peony seed oil self emulsifying concentrated solution is directly filled in liquid capsule softgel shell, go-on-go, packaging, obtain finished product.
Embodiment 7
Compound peony seed oil self-emulsifying systems hard capsule prepares one
Compound peony seed oil self-emulsifying systems becomes to be grouped into as shown in table 7.
Table 7 compound peony seed oil self emulsifying (hard capsule content) becomes to be grouped into
S1. shown in table 7, fabaceous lecithin, n-octyl alcohol are uniformly mixed;
S2. add peony seed oil, Ganoderma spore oil, within 30 minutes, be mixed evenly by the high speed agitator high-speed stirred that mixing speed is 10000 revs/min, form compound peony seed oil breast concentrated solution;
S3. taking polyethylene glycol 6000, ethyl cellulose, after mixing homogeneously with above-mentioned concentrated solution, cross 18 mesh sieves, prepare granule, load and capsule shells obtains hard capsule, i.e. the self-emulsifying systems compositions G of compound peony seed oil, go-on-go, packaging, obtain finished product.
Embodiment 8
Compound peony seed oil self-emulsifying systems hard capsule prepares two
Compound peony seed oil self-emulsifying systems becomes to be grouped into as shown in table 8.
Table 8 compound peony seed oil self-emulsifying systems (hard capsule content) becomes to be grouped into
S1. shown in table 8, polyoxyethylene nonyl 2, 2-Oxydiphenol and glycerol are uniformly mixed;
S2. add peony seed oil, Ganoderma spore oil, within 30 minutes, be mixed evenly by the high speed agitator high-speed stirred that mixing speed is 10000 revs/min, form compound peony seed oil breast concentrated solution;
S3. taking polyethylene glycol 6000, polyvidone, after mixing homogeneously with above-mentioned concentrated solution, cross 18 mesh sieves, prepare granule, i.e. the self-emulsifying systems compositions H of compound peony seed oil, load in capsule shells to obtain hard capsule, go-on-go, packaging, obtain finished product.
Embodiment 9
Compound peony seed oil self-emulsifying systems granule prepares one
Compound peony seed oil self-emulsifying systems becomes to be grouped into as shown in table 9.
Table 9 compound peony seed oil self-emulsifying systems (particulate matter) becomes to be grouped into
S1. press and shown in table 9, tween 85 is mixed homogeneously with glycerol;
S2. add peony seed oil, Semen Coicis oil, within 30 minutes, be mixed evenly by the high speed agitator high-speed stirred that mixing speed is 10000 revs/min, form compound peony seed oil breast concentrated solution;
S3. polyethylene glycol 6000, micropowder silica gel, Macrogol 4000 being crossed 100 mesh sieves, after mixing homogeneously with above-mentioned concentrated solution, cross 18 mesh sieves, prepare granule, i.e. the self-emulsifying systems composition I of compound peony seed oil, after inspection, granule is distributed in aluminium plastic bag and obtains finished product.
Embodiment 10
Compound peony seed oil self-emulsifying systems granule prepares two
Compound peony seed oil self-emulsifying systems particulate matter component composition is as shown in table 10.
Table 10 compound peony seed oil self-emulsifying systems becomes to be grouped into
S1. press and shown in table 7, tween 85 mixed homogeneously with glycerol,
S2. add peony seed oil, Semen Coicis oil, within 30 minutes, be mixed evenly by the high speed agitator high-speed stirred that mixing speed is 10000 revs/min, form compound peony seed oil breast concentrated solution;
S3. polyethylene glycol 6000, micropowder silica gel, Macrogol 4000 being crossed 100 mesh sieves, after mixing homogeneously with above-mentioned concentrated solution, cross 18 mesh sieves, prepare granule, i.e. the self-emulsifying systems compositions J of compound peony seed oil, after inspection, granule is distributed in aluminium plastic bag and obtains finished product.
Embodiment 11
Compound peony seed oil self-emulsifying systems granule prepares three
Compound peony seed oil self-emulsifying systems particulate matter component composition is as shown in table 11.
Table 11 compound peony seed oil self-emulsifying systems becomes to be grouped into
S1. press and shown in table 11, sodium lauryl sulphate mixed homogeneously with glycerol,
S2. add peony seed oil, Semen Coicis oil, within 30 minutes, be mixed evenly by the high speed agitator high-speed stirred that mixing speed is 10000 revs/min, form compound peony seed oil breast concentrated solution;
S3. polyethylene glycol 6000, micropowder silica gel, Macrogol 4000 being crossed 100 mesh sieves, after mixing homogeneously with above-mentioned concentrated solution, cross 18 mesh sieves, prepare granule, i.e. the self-emulsifying systems compositions K of compound peony seed oil, after inspection, granule is distributed in aluminium plastic bag and obtains finished product.
Embodiment 12
Compound peony seed oil self-emulsifying systems granule prepares four
Compound peony seed oil self-emulsifying systems becomes to be grouped into as shown in table 12.
Table 12 compound peony seed oil self-emulsifying systems particulate matter component forms
S1. press and shown in table 12, soybean phosphatide mixed homogeneously with glycerol,
S2. add peony seed oil, Ganoderma spore oil, Semen Coicis oil, within 20 minutes, be mixed evenly by the high speed agitator high-speed stirred that mixing speed is 12000 revs/min, form compound peony seed oil breast concentrated solution;
S3. polyethylene glycol 6000, HP-��-CD, lactose being crossed 100 mesh sieves, after mixing homogeneously with above-mentioned concentrated solution, cross 18 mesh sieves, prepare granule, i.e. the self-emulsifying systems compositions L of compound peony seed oil, after inspection, granule is distributed in aluminium plastic bag and obtains finished product.
Self emulsifying effect monitoring: take the self-emulsifying systems compositions A ~ L(of compound peony seed oil as taken 0.5mL for concentrated solution, if granule, take 0.5g), add in l0ml simulated gastric fluid, relax stirring with Glass rod, the Emulsion with blue-opalescent can be quickly formed. The particle diameter TSM Ultra-fine-particle Size analyser of Emulsion is measured, records the result of mean diameter of emulsion droplet in Table 13.
Particle diameter after each embodiment self-emulsifying systems compositions decomposition of table 13
Claims (10)
1. a compound peony seed oil self-emulsifying systems compositions, it is characterised in that include the following component calculated by weight:
Compound peony seed oil 15��70 parts;
Emulsifying agent 5��55 parts;
Co-emulsifier 5��20 parts;
Wherein, described compound peony seed oil is made up of with Ganoderma spore oil and/or Semen Coicis oil peony seed oil.
2. compound peony seed oil self-emulsifying systems compositions according to claim 1, it is characterised in that described compound peony seed oil ratio of components by weight is:
Peony seed oil: Ganoderma spore oil=1:0.5��1.5,
Or
Peony seed oil: Semen Coicis oil=1:0.5��2.5,
Or
Peony seed oil: Ganoderma spore oil: Semen Coicis oil=1:0.5��1.5:0.5��2.5.
3. compound peony seed oil self-emulsifying systems compositions according to claim 1, it is characterised in that also include dispersant and/or the solid absorbent of 0��75 part.
4. compound peony seed oil self-emulsifying systems compositions according to claims 1 to 3 any one claim, it is characterised in that include the following component calculated by mass percentage:
Compound peony seed oil 40%��65%;
Emulsifying agent 15%��30%;
Co-emulsifier 10%��15%;
Dispersant and/or solid absorbent 5%��35%.
5. compound peony seed oil self-emulsifying systems compositions according to claims 1 to 3 any one claim, it is characterized in that, described emulsifying agent is selected from one or more of following material: fabaceous lecithin, lecithin, cephalin, poloxamer, sucrose laurate, Arlacel-60, tween 85, polyoxyethylene nonyl 2, 2-Oxydiphenol, Palmic acid sucrose ester, stearic acid sucrose ester, fatty acid Pyrusussuriensis is smooth, Polysorbate, Myrj 52, Brij30, Brij35, polyoxyethylene castor oil glycerin ether, lose Span, polyoxyethylene, poiyoxypropylene copolymer, castor oil hydrogenated, sodium lauryl sulphate, sodium stearyl sulfate, dodecylbenzene sodium sulfonate.
6. compound peony seed oil self-emulsifying systems compositions according to claim 5, it is characterised in that described emulsifying agent is selected from one or more of following material: fabaceous lecithin, lecithin, tween 85, sucrose laurate, polyoxyethylene nonyl 2, 2-Oxydiphenol.
7. compound peony seed oil self-emulsifying systems compositions according to claims 1 to 3 any one claim, it is characterized in that, described co-emulsifier is selected from one or more of following material: glycerol, isopropanol, l, 2-propylene glycol, diethylene glycol monoethyl ether, n-butyl alcohol, n-octyl alcohol, n-heptanol, ethanol, polyoxyethylene fatty acid ester, PEG400.
8. the preparation method of compound peony seed oil self-emulsifying systems compositions as described in claim l to 7 any one claim, it is characterised in that comprise the following steps:
S1. emulsifying agent is mixed homogeneously with co-emulsifier;
S2. add compound peony seed oil, be mixed evenly, form compound peony seed oil breast concentrated solution;
Or directly compound peony seed oil, emulsifying agent, co-emulsifier are mixed evenly, form compound peony seed oil breast concentrated solution.
9. the preparation method of compound peony seed oil self-emulsifying systems compositions according to claim 8, it is characterised in that also including the step that compound peony seed oil breast concentrated solution carries out post processing, described post processing includes:
S3-1. the newborn concentrated solution made is obtained soft capsule with soft capsule material pressing or dropping preparation method; Or
S3-2. the newborn concentrated solution made directly is filled in liquid capsule softgel shell and prepares liquid capsule; Or
S3-3. add solid absorbent and do carrier, make granule, be distributed in capsule shells and obtain hard capsule; Or
S3-4. add solid absorbent and do carrier, make granule, be distributed in aluminium plastic bag and obtain granule.
10. compound peony seed oil self-emulsifying systems compositions application in oral drugs as described in claim l to 7 any one claim.
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| CN107669495A (en) * | 2017-09-29 | 2018-02-09 | 成都大学 | A kind of easy skin is with from nanometer emulsified preparation and preparation method thereof |
| CN109430659A (en) * | 2018-12-25 | 2019-03-08 | 哈尔滨氧态健康科技股份有限公司 | A kind of peony seed oil cream and preparation method thereof |
| CN109820884A (en) * | 2019-03-29 | 2019-05-31 | 广东现代汉方科技有限公司 | Compound inulol self-emulsifying soft capsule and preparation method and application with digestion promoting function |
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| CN112076224A (en) * | 2020-08-19 | 2020-12-15 | 江苏圣典医药科技有限公司 | Method for preparing whole ganoderma lucidum spore oil self-emulsifying soft capsule rich in ganoderic acid |
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| CN107669495A (en) * | 2017-09-29 | 2018-02-09 | 成都大学 | A kind of easy skin is with from nanometer emulsified preparation and preparation method thereof |
| CN109430659A (en) * | 2018-12-25 | 2019-03-08 | 哈尔滨氧态健康科技股份有限公司 | A kind of peony seed oil cream and preparation method thereof |
| CN109820884A (en) * | 2019-03-29 | 2019-05-31 | 广东现代汉方科技有限公司 | Compound inulol self-emulsifying soft capsule and preparation method and application with digestion promoting function |
| CN109820884B (en) * | 2019-03-29 | 2022-02-18 | 广东现代汉方科技有限公司 | Composite aucklandia root oil self-emulsifying soft capsule with stomach invigorating function and preparation method and application thereof |
| CN111905067A (en) * | 2020-07-10 | 2020-11-10 | 南昌大学 | Coix seed oil self-emulsifying system and preparation method thereof |
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| WO2023184621A1 (en) * | 2022-03-31 | 2023-10-05 | 重庆小丸生物科技股份有限公司 | Oil microcapsule capable of self-dispersing in water and preparation method therefor |
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