CN105616557A - Self-emulsifying soft capsule with peony seed oil and application of self-emulsifying soft capsule to preparing blood fat reducing healthcare products or medicines - Google Patents
Self-emulsifying soft capsule with peony seed oil and application of self-emulsifying soft capsule to preparing blood fat reducing healthcare products or medicines Download PDFInfo
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Abstract
The invention provides a self-emulsifying soft capsule with peony seed oil and application of the self-emulsifying soft capsule to preparing blood fat reducing healthcare products or medicines. The self-emulsifying soft capsule with the peony seed oil contains self-emulsifying compositions with the peony seed oil. The self-emulsifying compositions with the peony seed oil are effective components and comprise, by weight, 40-70%of medicine components with the peony seed oil, 20-55% of emulsifiers and 5-20% of co-emulsifiers. The self-emulsifying soft capsule and the application have the advantages that the self-emulsifying soft capsule with the peony seed oil is high in dispersibility and excellent in storage stability, active components have self-emulsifying characteristics, accordingly, the bioavailability of the self-emulsifying soft capsule can be greatly improved, and blood fat reducing effects of the peony seed oil and the medicines can be improved.
Description
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of peony seed oil self-emulsifying soft capsule and prepare the application of blood fat reducing health products or medicine.
Background technology
Peony seed oil is a kind of hydrophobicity golden transparent oily substance extracting from seed of Flos Moutan. Seed of Flos Moutan is the seed of Ranunculaceae Paeonia machaka Paeonia suffruticosa (PaeoniasuffruticosaAndr.). Paeonia suffruticosa is a kind of multi-purpose type plant, at China's applicating history of existing more than 2000 year, plants very extensive. Peony seed oil is relatively big in China's yield at present, is a kind of crude vegetal resource recently received much attention. Research about Chemical Constituents in Peony Seed Oil and alimentary health-care function is currently goed deep into, the chemical composition of peony seed oil is mainly made up of fatty acid: containing substantial amounts of unsaturated fatty acid (UFA), between its total amount 80%��92%, obviously higher than the olive oil of the title having " 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; Peony seed oil has fairly obvious unsaturated fatty acid and constitutes advantage, contain the monounsaturated fatty acid oleic acid that human body is easier to absorb simultaneously, and the polyunsaturated fatty acid linoleic acid of a large amount of needed by human and alpha-linolenic acid, it is the important substance basis forming its nutrition and health care function. Peony seed oil, except containing substantial amounts of UFA, still 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. Additionally, possibly together with the element such as trace elements of Ca, Na, Fe, K, Zn, Mg, Cu in peony seed oil, all have significant physiological function, 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.
Research shows that in peony seed oil, alpha-linolenic acid may be up to 67%, alpha-linolenic acid in peony seed oil is a kind of ��-3 series polyunsaturated fatty acid, it is described as " hemotrophic nutrition element ", " VF " and " plant NAOHUANGJIN ", it is the healthy indispensable polyunsaturated fatty acid of a kind of human body, is the required nutrient substance of human body health institute. Self can not synthesizing alpha-linolenic acid in human body, the alpha-linolenic acid that human body needs must flow through diet and obtains. In current China eating at home oil, contained alpha-linolenic acid is relatively fewer. Just it is described as in the olive oil of " liquid golden " alpha-linolenic acid content also only 0.3% by west at last. From threpsology's angle, the fatty acid using alpha-linolenic acid as a kind of particular importance, human body can be caused a series of serious consequence by its shortage. Scientist finds through long-term research, human brain 60% is made up of fat, in these fat, at least 30% is omega-fatty acid (Main Ingredients and Appearance is alpha-linolenic acid), metabolite DHA and the EPA of omega-fatty acid is relevant with the many biosiss of human body, and health is played an important role. Omega-fatty acid, once lack, can cause the decline of the multiple disease of health and physical function. Experiment finds: the blood fat of High fat diet rats is had obvious adjustment effect by alpha-linolenic acid, can obviously reduce High fat diet rats plasma triglyceride level (TG) and T-CHOL (TC) level. Experiment also finds, in human fatty tissue, alpha-linolenic acid increases by 1%, shrinks pressure, diastolic pressure and mean arterial pressure can decline 666Pa; Additionally, alpha-linolenic acid has the effects such as blood sugar lowering, prevention cardiovascular and cerebrovascular disease, the minimizing broken dead risk of coronary heart disease, enhancing immunity, antiinflammatory, anticancer, protection vision, raising memory, antioxidation and slow down aging, fat-reducing, suppression calculus. Therefore, the discovery of peony seed oil, it is significant from the angle of supplementary shortage omega-3 polyunsaturated fatty acids.
In recent years, the research and development of peony seed oil are all hotter, and the patent of application is more. As publication CN201410307108.5 discloses " a kind of voltage stabilizing fat reducing health product ", and for example Chinese patent CN201310474119.8 discloses " a kind of Peony-seed-oil soft capsule with effect for reducing fat and system thereof ". But, in existing document, find no the report of pass " a kind of peony seed oil self-emulsifying soft capsule that can strengthen effect for reducing blood fat and preparation method thereof ". The main edible blend oil in liquid form of peony seed oil of existing market application provides, as Chinese patent CN201410080184.7 discloses " a kind of mixed oil containing peony seed oil and preparation method thereof ". The soft capsule containing peony seed oil being equipped with medicine direct pressing with peony seed oil is had, as publication CN201510029776.0 discloses " a kind of American ginseng soft capsule containing peony seed oil and preparation method thereof " as what health product were applied. It was verified that existing soft capsule containing peony seed oil and the edible blend oil prepared with peony seed oil all also exist certain defect. Such as, its bioavailability is low, and drug effect is not notable.
Therefore develop the peony seed oil product with higher bioavailability and there is practical significance.
Summary of the invention
It is contemplated that overcome the defect of above-mentioned prior art, it is provided that a kind of peony seed oil self-emulsifying soft capsule. Described peony seed oil self-emulsifying soft capsule, after taking, can automatically form emulsion under the wriggling of stomach, easily be absorbed, and bioavailability is high, has obvious lipid-lowering effect.
Another object of the present invention is to the preparation method that described peony seed oil self-emulsifying soft capsule is provided.
Another object of the present invention is to provide the application of described peony seed oil self-emulsifying soft capsule.
The present invention is achieved through the following technical solutions foregoing invention purpose.
A kind of peony seed oil self-emulsifying soft capsule, the effective ingredient in described peony seed oil emulsifying soft capsule is peony seed oil self-emulsifying composition, and described peony seed oil self-emulsifying composition is made up of following component in percentage by weight:
Comprise the ingredient 40��70% of peony seed oil;
Emulsifying agent 20��55%;
Co-emulsifier 5��20%.
Peony seed oil selected by the present invention and appropriate emulsifying agent, co-emulsifier are mixed to form self-emulsifying composition, and said composition mixes with water, just can be formed oil-in-water Emulsion by gentle agitation, and the particle diameter of emulsion droplet is below 1 ��m. Therefore, this self-emulsifying composition being prepared into soft capsule, human body is after taking this soft capsule, and along with the degraded of capsule, effective ingredient can automatically form emulsion under the wriggling of stomach, is easily absorbed, and reaches to promote the effect of effect for reducing blood fat.
The described ingredient comprising peony seed oil can be pure peony seed oil, or the mixture of peony seed oil and the vegetable oil or medicine with hypolipemic function.
Preferably, the ingredient comprising peony seed oil described in accounts for the 50 ~ 65% of described peony seed oil self-emulsifying composition weight.
Preferably, described emulsifying agent accounts for the 20 ~ 45% of described peony seed oil self-emulsifying composition weight.
Preferably, described emulsifying agent is selected from one or more of following material: fabaceous lecithin, Ovum Gallus domesticus Flavus lecithin, liquid egg phospholipid, 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 or dodecylbenzene sodium sulfonate.
Preferably, described emulsifying agent is selected from one or more of following material: fabaceous lecithin, liquid egg phospholipid, Ovum Gallus domesticus Flavus lecithin, mistake Span.
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 or PEG400.
Preferably, described co-emulsifier is selected from one or more of following combination thing: glycerol, polyoxyethylene fatty acid ester, n-octyl alcohol, PEG400.
The preparation method of described peony seed oil self-emulsifying soft capsule, it is characterised in that comprise the following steps:
S1. will comprise the ingredient of peony seed oil at 10 ~ 50 DEG C, dissolve with emulsifying agent, co-emulsifier, be sufficiently stirred for, filter, obtain peony seed oil self-emulsifying composition;
S2. soft capsule material is prepared;
S3. peony seed oil self-emulsifying composition and soft capsule material are made described peony seed oil self-emulsifying soft capsule.
Described peony seed oil self-emulsifying soft capsule is as the application in blood fat reducing health products or medicine.
In described S1., it may also be necessary to add the auxiliary agent such as stabilizer, preservative.
Preferably, described S2. comprises the steps:
Gelatin is added in glue pot, add 60 ~ 80 DEG C of water of proportioning, add preservative, 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. 50-70 DEG C of insulation, standby.
The application in preparing blood fat reducing health products or medicine of the described peony seed oil self-emulsifying soft capsule. Zoopery proves, self-emulsifying soft capsule of the present invention, when active ingredient is identical, compared with common soft capsule, has significant hypolipemic function with ratio.
Compared with prior art, there is advantages that
Disclosure one peony seed oil self-emulsifying soft capsule, it has the dispersibility of height, excellent bin stability, variable color and the deterioration of system are suppressed, active component has the feature of self emulsifying, and its bioavailability is greatly improved, and improves the lipid-lowering effect of peony seed oil and medicine.
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
Become to be grouped into as shown in table 1:
Table 1 peony seed oil self-emulsifying soft capsule becomes to be grouped into
S1. press and shown in table 1, fabaceous lecithin, glycerol and PEG-4000 are mixed, 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, stir 3 times, each 2 minutes, make into colostrum, then be transferred to high pressure homogenizer and homogenize 3 times, filter, form homogeneous peony seed oil breast concentrated solution, i.e. the self-emulsifying systems compositions A of 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 systems compositions A of soft capsule material liquid, peony seed oil, adopt pressing to prepare soft capsule, drying, washing, then dry, go-on-go, packaging, obtain finished product.
Self emulsifying effect detection
Take the self-emulsifying systems compositions A0.5ml of this peony seed oil, 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 mean diameter that result is emulsion droplet and be 0.18 ��m.
Embodiment 2
Become to be grouped into as shown in table 2:
Table 2 peony seed oil self-emulsifying soft capsule becomes to be grouped into
S1. press shown in table 2, take peony seed oil, liquid egg phospholipid, polyoxyethylene fatty acid ester are placed in same container ultrasonic agitation mix homogeneously, form the self-emulsifying systems compositions B of homogeneous solution and peony seed oil;
S2. 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 systems compositions B of soft capsule material liquid, peony seed oil, adopt pressing to prepare soft capsule, drying, washing, then dry, go-on-go, packaging, obtain finished product.
Self emulsifying effect detection
Take the self-emulsifying systems compositions B0.5ml of this peony seed oil, 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 mean diameter that result is emulsion droplet and be 0.15 ��m.
Embodiment 3
Become to be grouped into as shown in table 3:
Table 3 peony seed oil self-emulsifying soft capsule becomes to be grouped into
S1. press shown in table 3, take peony seed oil, liquid egg phospholipid, glycerol are placed in same container ultrasonic agitation mix homogeneously, form the self-emulsifying systems compositions C of homogeneous solution and peony seed oil;
S2. 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 systems compositions C of soft capsule material liquid, peony seed oil, adopt pressing to prepare soft capsule, drying, washing, then dry, go-on-go, packaging, obtain finished product.
Self emulsifying effect detection
Take the self-emulsifying systems compositions C0.5ml of this peony seed oil, 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 mean diameter that result is emulsion droplet and be 0.12 ��m.
Embodiment 4
Become to be grouped into as shown in table 4:
Table 4 peony seed oil self-emulsifying soft capsule becomes to be grouped into
S1. press Ovum Gallus domesticus Flavus lecithin, mistake Span and n-octyl alcohol mixing shown in table 4, 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, stir 3 times, each 2 minutes, make into colostrum, then be transferred to high pressure homogenizer and homogenize 3 times, filter, form homogeneous peony seed oil breast concentrated solution, i.e. the self-emulsifying systems compositions D of 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 systems compositions D of soft capsule material liquid, peony seed oil, adopt pressing to prepare soft capsule, drying, washing, then dry, go-on-go, packaging, obtain finished product.
Self emulsifying effect detection
Take the self-emulsifying systems compositions D0.5ml of this peony seed oil, 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 mean diameter that result is emulsion droplet and be 0.15 ��m.
Embodiment 5 peony seed oil self-emulsifying soft capsule compares with the hypolipemic function of Peony-seed-oil soft capsule
1 experiment material
1.1 laboratory samples
Peony seed oil: purchased from Shandong multi-form agriculture of a specified duration development in science and technology company limited, lot number 20140928;
Peony seed oil self-emulsifying soft capsule 1 (0.5g/ grain), is prepared from by the prescription of embodiment 1 and method, and tested material is gold oil, lot number 20141019;
Peony seed oil self-emulsifying soft capsule 2 (0.5g/ grain), is prepared from by the prescription of embodiment 2 and method, and tested material is gold oil, lot number 20141018;
Peony-seed-oil soft capsule (0.5g/ grain), directly takes above-mentioned peony seed oil and is prepared from the content of soft capsule (be distinctive in that be all peony seed oil) by the method for embodiment 2, and tested material is gold oil, lot number 20141022.
1.2 laboratory animals
SPF level SD health kind male rat, 60, about body weight 200g, Guangdong Medical Lab Animal Center provides, and animal quality verification of conformity is numbered: No.44411600000901. Laboratory animal occupancy permit number: SYXK(Guangdong) 2013-0002.
Experimental situation condition: temperature 23 DEG C �� 2 DEG C, relative humidity 60% �� 10%, indoor based on natural lighting, well-ventilated, and environment keeps quite, SPF level laboratory animal environmental facility.
1.3 hyperlipidemia model feedstuffs
1.2% cholesterol, 5.0% Adeps Sus domestica, 0.2% sodium cholate is added maintaining in feedstuff, appropriate casein, calcium hydrogen phosphate, stone powder, make model feedstuff (being prepared by Guangdong Prov. Disease Prevention-control Center).
1.4 key instruments
Electronic analytical balance (Beijing Sai Duolisi instrument system company limited); 80-2 type low speed centrifuge (Community of Jin Tan County city Jin Cheng Guo Sheng experimental apparatus factory); 722 type spectrophotometers (Shanghai the 3rd analytical tool factory); HH-6 digital display thermostat water bath (Guo Hua Electrical Appliances Co., Ltd); Epoch type microplate reader (U.S.); KQ-250E type ultrasonic cleaner (Kunshan Ultrasonic Instruments Co., Ltd.) etc.
1.5 reagent are in Table 5
Table 5 uses reagent
1.6 experimental data statistical tool softwares
Experiment the data obtained is numerical variable data. All data all adopt SPSS statistical software (VII .5) that experimental data is analyzed.
2 experimental techniques
2.1 experimental principles
Generally, with high lipid food feeding animal subject, give given the test agent feeding animal subject simultaneously,
After a period of time, TC in detection animal serum, TG, LDL-C, the concentration of HDL-C, by blank group and hyperlipidemia model group, the contrast giving the basic, normal, high dosage group of given the test agent, can determine that given the test agent is on the impact on the absorption of animal subject body lipid, the formation of lipoprotein, the degraded of lipid or excretion of the impact of hyperlipemia animal subject model and given the test agent.
2.2 experimental procedures
Select healthy adult rat, under barrier system with maintains feedstuff feed observe 5 days. By rat body weight with
Machine is divided into blank group (giving normal diet) and model experiment group (feedstuff containing high lipid material). After model experiment group gives model feedstuff 7 days, blank group and model experiment group rat non-fasting, ophthalmic adjoins blood sampling. Separate serum after blood sampling as early as possible, measure serum TC, TG, LDL-C, HDL-C level. According to TC level, model experiment group is randomly divided into model control group, basic, normal, high dosage group totally 4 groups. Blank group compares with model control group, serum TC, TG, LDL-C, HDL-C level there are no significant difference.
The human body recommended intake of given the test agent peony seed oil is everyone every day of 6g, and everyone presses 60kg weighing machine, is 0.1g/kg every day. By 10 times that the are equivalent to human body recommended amounts dosage determining that rat hypolipemic function is tested by given the test agent peony seed oil, i.e. amount respectively 1.00g/kg, 1.67g/kg of Peony-seed-oil soft capsule, peony seed oil self-emulsifying soft capsule group rat edible given the test agent every day, tested material gavage solution is prepared with Semen Maydis oil, gavage gives rat tested material solution once a day, and gavage volume is all by 1ml/100g. Peony-seed-oil soft capsule, peony seed oil self-emulsifying soft capsule dosage group tested material solution concentration respectively 100g/L, 167g/L. Blank group and model control group is given with isopyknic Semen Maydis oil gavage.
Laboratory animal is grouped:
1. blank group: normal diet+Semen Maydis oil;
2. model control group: high lipid food+Semen Maydis oil;
3. Peony-seed-oil soft capsule group: high lipid food+peony seed oil (1000mg/kg, gavage are equivalent to 10 times of human body recommended amounts);
4. peony seed oil self-emulsifying soft capsule group: high lipid food+peony seed oil self-emulsifying drug delivery systems (1670mg/lkg,
Peony seed oil self-emulsifying drug delivery systems, containing peony seed oil 60%, gavage, is equivalent to 10 times of human body recommended amounts).
Regularly weigh and calculate gavage amount accordingly, giving given the test agent 36d continuously. Non-fasting ventral aorta blood sampling when experiment terminates, stands, separates serum as early as possible, automatic clinical chemistry analyzer detection serum TC, TG, HDL-C, LDL-C level.
The mensuration of TC, TG, LDL-C, HDL-C in 2.3 serum
The mensuration of TC: adopt enzymic colorimetric (COD-CE-PAP method); The mensuration of TG: adopt enzyme process (GPO-PAP method); The mensuration of LDL-C: adopt euzymelinked immunosorbent assay (ELISA) (ELISA); The mensuration of HDL-C: adopt phosphotungstic acid magnesium precipitate method (the PTA-Mg2+ sedimentation method).
2.4 results judge
Relatively TC, TG, LDL-C, HDL-C situation of change, if experimental group is statistically significant with Normal group comparing difference, can determine that serum TC, TG, LDL-C, and HDL-C result is positive.
According to " auxiliary lipid-lowering function evaluation methodology ", test-meal group self compares and compares between test-meal group with matched group group, animal subject serum TG reduces, difference has significance, serum TC and LDL-C are not significantly higher than matched group simultaneously, Serum HDL-C is not significantly lower than matched group, and test group serum TG effective percentage is significantly higher than matched group, can determine that this given the test agent auxiliary reduces TG function test-meal result of the test positive.
Auxiliary reduces cholesterol function result and judges: model control group and blank group compare, and serum TC or LDL-C raise, and difference has significance, serum TG no significant difference, it is determined that model is set up. Each dosage group compares with model control group, arbitrary dosage group serum TC or LDL-C reduce, difference has significance, and each dosage group Serum HDL-C is not significantly lower than model control group, serum TG is not significantly higher than model control group, can determine that this given the test agent auxiliary reduces cholesterol function results of animal positive.
2.5 experimental data statistics
Experiment the data obtained is numerical variable data, adopts SPSS data processing software to carry out one factor analysis of variance and t checks, experimental data employing average scholar's standard deviation (), if P < 0.01, represent that difference has significant, namely this group is positive through comparing result.
3 experimental results
3.1 Peony-seed-oil soft capsule on the impact of rat body weight in Table 6. From table 6, the weight of animals of each dosage group of tested material compares with model control group, difference there are no significant meaning (P > 0.05), namely Peony-seed-oil soft capsule on laboratory animal body weight without impact.
Table 6 Peony-seed-oil soft capsule on the impact of rat body weight (, n=12)
The impact on rat fat contents level of 3.2 Peony-seed-oil soft capsule
3.2.1 rat fat content before experiment
Before experiment, rat fat content is in Table 7. Analysis of variance, before experiment, blank group compares Serum TC, TG, LDL-C, HDL-C content difference statistically significant (P<0.05) with other each group, illustrates that hyperlipidemia model is set up; Model control group compares Serum TC, TG, LDL-C, the equal not statistically significant of HDL-C content difference (P>0.05) with each dosage group.
Serum TC respectively organized by table 7 before testing, TG, LDL-C, HDL-C comparision contents (, n=12)
3.2.2 rat fat contents level after experiment
After experiment, rat fat content is in Table 8. Comparing with blank group, TC, TG, the LDL-C content of model control group all significantly raises, difference statistically significant (P < 0.01), illustrates that hyperlipidemia model is set up. Comparing with model control group, peony seed oil self-emulsifying soft capsule group TC, TG, LDL-C content is all remarkably decreased, difference statistically significant (P < 0.05); The HDL-C content of peony seed oil self-emulsifying soft capsule group significantly raises, difference statistically significant (P < 0.01).
Serum TC is respectively organized after table 8 experiment, TG, LDL-C, HDL-C comparision contents (, n=12)
Note: compare with blank group:##P < 0.01; Compare with model control group:*P<0.05,**P < 0.01; Compare with Peony-seed-oil soft capsule group:��P<0.05,����P < 0.01;
4 conclusions
Originally test result indicate that, per os gives the Peony-seed-oil soft capsule sample of rat various dose, compares with blank group, and TC, TG and the LDL-C of model control group significantly raise, and difference is all statistically significant, illustrates that hyperlipidemia model is set up. Comparing with model control group, the serum TC of peony seed oil self-emulsifying soft capsule group, TG and LDL-C significantly reduces, and difference is all statistically significant; The Serum HDL-C of peony seed oil self-emulsifying soft capsule group significantly raises, and difference is statistically significant. Comparing with Peony-seed-oil soft capsule group, the serum TC of peony seed oil self-emulsifying soft capsule group, TG and LDL-C also significantly reduces, and difference is all statistically significant; The Serum HDL-C of peony seed oil self-emulsifying soft capsule group also work raises, and difference is statistically significant. Can be determined that peony seed oil self-emulsifying soft capsule has hypolipemic function according to experimental data and result, and its hypolipemic function is substantially better than Peony-seed-oil soft capsule.
Claims (10)
1. a peony seed oil self-emulsifying soft capsule, it is characterised in that the effective ingredient in described peony seed oil emulsifying soft capsule is peony seed oil self-emulsifying composition, described peony seed oil self-emulsifying composition is made up of following component in percentage by weight:
Comprise the ingredient 40��70% of peony seed oil;
Emulsifying agent 20��55%;
Co-emulsifier 5��20%.
2. peony seed oil self-emulsifying soft capsule according to claim 1, it is characterised in that described in comprise peony seed oil ingredient be pure peony seed oil, or the mixture of peony seed oil and the vegetable oil or medicine with hypolipemic function.
3. peony seed oil self-emulsifying soft capsule according to claim 1, it is characterised in that described in comprise peony seed oil ingredient account for the 50 ~ 65% of described peony seed oil self-emulsifying composition weight.
4. peony seed oil self-emulsifying soft capsule according to claim 1, it is characterised in that described emulsifying agent accounts for the 20 ~ 45% of described peony seed oil self-emulsifying composition weight.
5. peony seed oil self-emulsifying soft capsule according to Claims 1-4 any one claim, it is characterized in that, described emulsifying agent is selected from one or more of following material: fabaceous lecithin, Ovum Gallus domesticus Flavus lecithin, liquid egg phospholipid, 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 or dodecylbenzene sodium sulfonate.
6. peony seed oil self-emulsifying soft capsule according to claim 5, it is characterised in that described emulsifying agent is selected from one or more of following material: fabaceous lecithin, liquid egg phospholipid, Ovum Gallus domesticus Flavus lecithin, mistake Span.
7. peony seed oil self-emulsifying soft capsule according to Claims 1-4 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 or PEG400.
8. peony seed oil self-emulsifying soft capsule according to claim 7, it is characterised in that described co-emulsifier is selected from one or more of following combination thing: glycerol, polyoxyethylene fatty acid ester, n-octyl alcohol, PEG400.
9. the preparation method of peony seed oil self-emulsifying soft capsule described in claim l to 8 any one claim, it is characterised in that comprise the following steps:
S1. will comprise the ingredient of peony seed oil at 10 ~ 50 DEG C, dissolve with emulsifying agent, co-emulsifier, be sufficiently stirred for, filter, obtain peony seed oil self-emulsifying composition;
S2. soft capsule material is prepared;
S3. peony seed oil self-emulsifying composition and soft capsule material are made described peony seed oil self-emulsifying soft capsule.
10. peony seed oil self-emulsifying soft capsule application in preparing blood fat reducing health products or medicine described in claim l to 8 any one claim.
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| CN108703949A (en) * | 2018-06-07 | 2018-10-26 | 重庆市中药研究院 | A kind of indigo red solid self-emulsifying drug delivery system preparation and preparation method |
| CN109893513A (en) * | 2019-03-29 | 2019-06-18 | 广东现代汉方科技有限公司 | Compound Astaxanthin In Haematococcus Pluvialis self-emulsifying soft capsule and the preparation method and application thereof |
| CN110038090A (en) * | 2019-04-02 | 2019-07-23 | 江苏圣典医药科技有限公司 | A kind of compound celery oil self-emulsifying soft capsule and preparation method thereof with antigout effect |
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