CN105616557B - Peony seed oil self-emulsifying soft capsule and application thereof in preparing blood fat-reducing health-care product or medicine - Google Patents
Peony seed oil self-emulsifying soft capsule and application thereof in preparing blood fat-reducing health-care product or medicine Download PDFInfo
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Abstract
The invention provides a peony seed oil self-emulsifying soft capsule and application thereof in preparing a blood fat reducing health product or medicament. The active ingredient in the peony seed oil emulsified soft capsule is a peony seed oil self-emulsifying composition, and the peony seed oil self-emulsifying composition is composed of the following components in percentage by weight: 40-70% of medicinal ingredients containing peony seed oil; 20-55% of an emulsifier; 5-20% of a co-emulsifier. The peony seed oil self-emulsifying soft capsule has high dispersibility and excellent storage stability, the active ingredients have the characteristic of self-emulsification, the bioavailability is greatly improved, and the blood fat reducing effect of the peony seed oil and the medicine is improved.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a peony seed oil self-emulsifying soft capsule and application thereof in preparing a blood fat reducing health product or medicine.
Background
The peony seed oil is a seed of Paeonia suffruticosa Andr in Paeonia of Ranunculaceae, is a multipurpose plant, has more than 2000 years of application history in China, is quite wide in planting, is a relatively high yield in China at present, is a recently focused natural plant oil resource, is deeply researched on chemical components and nutrition and health functions of the peony seed oil, mainly comprises fatty acids, contains a large amount of Unsaturated Fatty Acids (UFA) accounting for 80-92% of the total amount of UFA, is obviously higher than common plant oil such as olive oil, soybean oil and peanut oil called liquid gold, is particularly worthy of paying attention, the UFA in the peony seed oil mainly comprises UFA accounting for α -linolenic acid content which is 32-67% of common linolenic acid, is higher than other common plant oil, has obvious unsaturated fatty acid composition, contains a large amount of fatty acid easily absorbed single 201124-linolenic acid, has important health-care functions of improving lipid-lipid metabolism, improving lipid-soluble cholesterol metabolism, improving lipid-soluble health-protecting health-improving physiological functions of foods, and the like, and the lipid-lipid metabolism of cosmetics, and lipid-reducing health-improving physiological functions of cosmetics, such as vitamin E, vitamin.
The research shows that α -linolenic acid in peony seed oil can reach 67%, α -linolenic acid in peony seed oil is a omega-3 series polyunsaturated fatty acid, which is known as blood nutrient, VF and plant brain gold, and is a polyunsaturated fatty acid indispensable to human health, and is an essential nutrient for human health, α -linolenic acid content in olive oil which is known as liquid gold by Western is only 0.3%, α -linolenic acid cannot be synthesized by human body, α -linolenic acid required by human body must be obtained by diet, α -linolenic acid in domestic edible oil is relatively less, so α -linolenic acid content in olive oil which is known as liquid gold by Western is only 0.3%, from the nutritional point of view, α -linolenic acid is taken as a particularly important fatty acid, the shortage of which can cause a series of serious consequences for human body, scientists discover that 60% of human brain is composed of linolenic acid, at least 30% of the fat is omega-3 fatty acid (the main component is α -linolenic acid), the metabolism of DHA-3 fatty acid and DHA have important functions of reducing, reducing blood pressure, resisting aging, reducing and resisting aging, and preventing and reducing blood fat, and preventing rat blood fat, and reducing blood fat, and blood fat, reducing blood fat, and reducing blood fat, and improving blood fat, and improving blood fat, and blood fat, reducing blood fat, and blood fat, reducing blood fat, and improving blood fat, reducing and blood fat, reducing and improving blood fat, reducing and.
In recent years, the research and development of peony seed oil are hot and many patents are applied. For example, the publication patent CN201410307108.5 discloses a health product for stabilizing blood pressure and reducing blood lipid, and for example, the Chinese patent CN 201310474119.8 discloses a peony seed oil soft capsule with blood lipid reducing effect and a preparation method thereof. However, in the existing literature, no report on "a peony seed oil self-emulsifying soft capsule capable of enhancing the effect of reducing blood lipid and a preparation method thereof" is found. The peony seed oil currently applied in the market is mainly provided as edible blend oil in a liquid form, and for example, Chinese patent CN 201410080184.7 discloses 'blend oil containing peony seed oil and a preparation method thereof'. The application of the peony seed oil and medicines directly pressed into the peony seed oil-containing soft capsule as a health-care product is disclosed in the patent publication CN 201510029776.0, for example, American ginseng soft capsule containing peony seed oil and a preparation method thereof are disclosed. The practice proves that the existing soft capsule containing the peony seed oil and the edible blend oil prepared from the peony seed oil have certain defects. For example, it has low bioavailability and insignificant drug effect.
Therefore, the development of the peony seed oil product with higher bioavailability has practical significance.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a peony seed oil self-emulsifying soft capsule. The peony seed oil self-emulsifying soft capsule can automatically form emulsion under the peristalsis of the stomach after being taken, is easy to absorb, has high bioavailability and has obvious effect of reducing blood fat.
The invention also aims to provide a preparation method of the peony seed oil self-emulsifying soft capsule.
The invention also aims to provide application of the peony seed oil self-emulsifying soft capsule.
The invention achieves the above object by the following technical scheme.
The peony seed oil self-emulsifying soft capsule comprises the following effective components in percentage by weight:
40-70% of medicinal ingredients containing peony seed oil;
20-55% of an emulsifier;
5-20% of a co-emulsifier.
The peony seed oil selected by the invention is mixed with a proper amount of emulsifier and co-emulsifier to form a self-emulsifying composition, the composition is mixed with water, and an oil-in-water emulsion can be formed by mild stirring, wherein the particle size of emulsion drops is below 1 mu m. Therefore, the self-emulsifying composition is prepared into the soft capsule, and after a human body takes the soft capsule, along with the degradation of the capsule, the active ingredients can automatically form emulsion under the peristalsis of the stomach, and the emulsion is easy to absorb, thereby achieving the effect of improving the blood fat reducing effect.
The medicine component containing the peony seed oil can be pure peony seed oil or a mixture of the peony seed oil and vegetable oil or medicine with the function of reducing blood fat.
Preferably, the medicinal ingredient containing the peony seed oil accounts for 50-65% of the weight of the peony seed oil self-emulsifying composition.
Preferably, the emulsifier accounts for 20-45% of the weight of the peony seed oil self-emulsifying composition.
Preferably, the emulsifier is selected from one or more of the following: soybean lecithin, egg yolk lecithin, liquid lecithin, cephalin, poloxamer, sucrose laurate, span-60, tween-85, polyoxyethylene nonyl phenol ether, sucrose palmitate, sucrose stearate, sorbitan fatty acid, polysorbate, polyoxyethylene 40 stearate, brij 30, brij 35, polyoxyethylene castor oil glyceryl ether (oxyethylene unit is 35-40), sorbitan fatty acid ester, polyoxyethylene, polyoxypropylene copolymer, hydrogenated castor oil, sodium lauryl sulfate, sodium stearyl sulfate or sodium dodecyl benzene sulfonate.
Preferably, the emulsifier is selected from one or more of the following: soybean lecithin, liquid lecithin, egg yolk lecithin and sorbitan fatty acid ester.
Preferably, the co-emulsifier is selected from one or more of the following: glycerol, isopropanol, l, 2-propanediol, diethylene glycol monoethyl ether, n-butanol, n-octanol, n-heptanol, ethanol, polyoxyethylene fatty acid ester or polyethylene glycol 400.
Preferably, the co-emulsifier is selected from one or more of the following compositions: glycerin, polyoxyethylene fatty acid ester, n-octanol and polyethylene glycol 400.
The preparation method of the peony seed oil self-emulsifying soft capsule is characterized by comprising the following steps:
s1, dissolving medicinal ingredients containing peony seed oil with an emulsifier and an auxiliary emulsifier at 10-50 ℃, fully stirring, and filtering to obtain a peony seed oil self-emulsifying composition;
s2, preparing a soft capsule wall material;
and S3, preparing the peony seed oil self-emulsifying soft capsule from the peony seed oil self-emulsifying composition and a soft capsule wall material.
The peony seed oil self-emulsifying soft capsule is applied to a health product or a medicine for reducing blood fat.
In the S1, auxiliaries such as a stabilizer and a preservative can be added if necessary.
Preferably, said s2. comprises the steps of:
adding gelatin into a gelatin dissolving tank, adding water with the temperature of 60-80 ℃ according to the proportion, adding a preservative, adding an opacifier and a colorant if necessary, sealing and heating simultaneously, stirring until the mixture is completely melted and swelled, adding glycerol, sealing the gelatin preparing tank, closing the stirring, starting a vacuum pump, vacuumizing, and pumping bubbles completely to obtain the soft capsule wall material. Keeping the temperature at 50-70 ℃ for later use.
The application of the peony seed oil self-emulsifying soft capsule in preparing a health product or a medicine for reducing blood fat. Animal experiments prove that the self-emulsifying soft capsule has a remarkable blood fat reducing function compared with the common soft capsule under the condition of the same medicinal ingredients.
Compared with the prior art, the invention has the following beneficial effects:
the invention discloses a peony seed oil self-emulsifying soft capsule, which has high dispersibility, excellent storage stability, inhibited systematic color change and deterioration, self-emulsifying characteristic of active ingredients, greatly improved bioavailability and improved blood fat reducing effect of peony seed oil and medicines.
Detailed Description
The present invention is described below with reference to specific examples, however, the scope of the present invention is not limited to the following examples, and the descriptions of the examples are only used to help understanding the method of the present invention and the core idea thereof. Any modification, equivalent replacement, and improvement made within the spirit and principle of this patent shall be included in the protection scope of the present claims.
Example 1
The composition of the ingredients is shown in table 1:
TABLE 1 peony seed oil self-emulsifying Soft Capsule ingredient composition
S1, mixing the soybean phospholipid, the glycerol and the polyethylene glycol-400 according to the table 1, and stirring twice with a shearing machine (8000 rpm), wherein the first time is 5 minutes, and the second time is 2 minutes, so that the soybean phospholipid, the glycerol and the polyethylene glycol-400 are uniformly dispersed;
s2, adding warm peony seed oil, stirring for 3 times, each time for 2 minutes to obtain primary emulsion, homogenizing for 3 times in a high-pressure homogenizer, and filtering to obtain uniform peony seed oil emulsion concentrate, namely a self-emulsifying system composition A of peony seed oil;
s3, adding gelatin into a gelatin dissolving tank, adding water with the temperature of 80 ℃ according to the proportion, adding a preservative, namely ethyl p-hydroxybenzoate, adding an opacifier and a coloring agent if necessary, sealing and heating simultaneously, stirring until the gelatin is completely melted and swelled, adding glycerol, sealing the gelatin preparing tank, closing the stirring, starting a vacuum pump, vacuumizing, and pumping bubbles completely to obtain a soft capsule material liquid. And keeping the temperature of 50-70 ℃ for later use. And (3) loading the self-emulsifying system composition A of the soft capsule material liquid and the peony seed oil into a soft capsule machine, preparing the soft capsule by adopting a pressing method, drying, washing, drying again, sorting and packaging to obtain a finished product.
Self-emulsification effect detection
0.5ml of the self-emulsifying system composition A of the peony seed oil is taken and added into l0ml artificial gastric juice, and a glass rod is used for gentle stirring, thus an emulsion with blue opalescence can be rapidly formed. The particle size of the emulsion was measured by a TSM ultrafine particle size analyzer, and the average particle size of the emulsion droplets was found to be 0.18. mu.m.
Example 2
The composition of the ingredients is shown in table 2:
TABLE 2 peony seed oil self-emulsifying Soft Capsule ingredient composition
S1, according to the table 2, putting peony seed oil, liquid lecithin and polyoxyethylene fatty acid ester into a same container, and ultrasonically stirring and uniformly mixing to form a uniform solution, namely a self-emulsifying system composition B of the peony seed oil;
s2, adding gelatin into a gelatin dissolving tank, adding water with the temperature of 80 ℃ according to the proportion, adding a preservative, namely ethyl p-hydroxybenzoate, adding an opacifier and a coloring agent if necessary, sealing and heating simultaneously, stirring until the gelatin is completely melted and swelled, adding glycerol, sealing the gelatin preparing tank, closing the stirring, starting a vacuum pump, vacuumizing, and pumping bubbles completely to obtain a soft capsule material liquid. And keeping the temperature of 50-70 ℃ for later use. And (3) putting the self-emulsifying system composition B of the soft capsule material liquid and the peony seed oil into a soft capsule machine, preparing the soft capsule by adopting a pressing method, drying, washing, drying again, sorting and packaging to obtain a finished product.
Self-emulsification effect detection
Adding 0.5ml of the self-emulsifying system composition B of peony seed oil into l0ml artificial gastric juice, and stirring gently with a glass rod to rapidly form an emulsion with blue opalescence. The particle size of the emulsion was measured by a TSM ultrafine particle size analyzer, and the average particle size of the emulsion droplets was 0.15. mu.m.
Example 3
The composition is shown in table 3:
TABLE 3 peony seed oil self-emulsifying Soft Capsule ingredient composition
S1, according to the table 3, putting peony seed oil, liquid lecithin and glycerol into a same container, and ultrasonically stirring and uniformly mixing to form a uniform solution, namely a self-emulsifying system composition C of the peony seed oil;
s2, adding gelatin into a gelatin dissolving tank, adding water with the temperature of 80 ℃ according to the proportion, adding a preservative, namely ethyl p-hydroxybenzoate, adding an opacifier and a coloring agent if necessary, sealing and heating simultaneously, stirring until the gelatin is completely melted and swelled, adding glycerol, sealing the gelatin preparing tank, closing the stirring, starting a vacuum pump, vacuumizing, and pumping bubbles completely to obtain a soft capsule material liquid. And keeping the temperature of 50-70 ℃ for later use. And (3) loading the self-emulsifying system composition C of the soft capsule material liquid and the peony seed oil into a soft capsule machine, preparing the soft capsule by adopting a pressing method, drying, washing, drying again, sorting and packaging to obtain a finished product.
Self-emulsification effect detection
Adding 0.5ml of the self-emulsifying system composition C of the peony seed oil into l0ml artificial gastric juice, and gently stirring with a glass rod to rapidly form an emulsion with blue opalescence. The particle size of the emulsion was measured by a TSM ultrafine particle size analyzer, and the average particle size of the emulsion droplets was found to be 0.12. mu.m.
Example 4
The composition is shown in table 4:
TABLE 4 peony seed oil self-emulsifying Soft Capsule ingredient composition
S1, mixing egg yolk lecithin, sorbitan fatty acid ester and n-octanol according to table 4, and stirring twice with a shearing machine (8000 rpm), wherein the first time is 5 minutes, and the second time is 2 minutes, so that the egg yolk lecithin, the sorbitan fatty acid ester and the n-octanol are uniformly dispersed;
s2, adding warm peony seed oil, stirring for 3 times, each time for 2 minutes to obtain primary emulsion, homogenizing for 3 times in a high-pressure homogenizer, and filtering to obtain uniform peony seed oil emulsion concentrate, namely a peony seed oil self-emulsifying system composition D;
s3, adding gelatin into a gelatin dissolving tank, adding water with the temperature of 80 ℃ according to the proportion, adding a preservative, namely ethyl p-hydroxybenzoate, adding an opacifier and a coloring agent if necessary, sealing and heating simultaneously, stirring until the gelatin is completely melted and swelled, adding glycerol, sealing the gelatin preparing tank, closing the stirring, starting a vacuum pump, vacuumizing, and pumping bubbles completely to obtain a soft capsule material liquid. And keeping the temperature of 50-70 ℃ for later use. And (3) loading the self-emulsifying system composition D of the soft capsule wall material liquid and the peony seed oil into a soft capsule machine, preparing the soft capsule by adopting a pressing method, drying, washing, drying again, sorting and packaging to obtain a finished product.
Self-emulsification effect detection
Adding 0.5ml of the self-emulsifying system composition D of the peony seed oil into l0ml artificial gastric juice, and gently stirring with a glass rod to rapidly form an emulsion with blue opalescence. The particle size of the emulsion was measured by a TSM ultrafine particle size analyzer, and the average particle size of the emulsion droplets was 0.15. mu.m.
Example 5 comparison of blood lipid lowering function of peony seed oil self-emulsifying soft capsule and peony seed oil soft capsule
1 materials of the experiment
1.1 Experimental samples
And (3) peony seed oil: purchased from Shandong Jiu Dai agriculture science and technology development Co., Ltd., lot No. 20140928;
peony seed oil self-emulsifying soft capsule No. 1 (0.5 g/capsule), prepared according to the formulation and method of example 1, the test substance was a golden yellow oil, lot No. 20141019;
peony seed oil self-emulsifying soft capsule No. 2 (0.5 g/capsule), prepared according to the formulation and method of example 2, the test substance was a golden yellow oil, lot No. 20141018;
the peony seed oil soft capsule (0.5 g/capsule) is prepared by directly taking the peony seed oil according to the method of the embodiment 2 (the difference is that the content of the soft capsule is all the peony seed oil), and the tested substance is golden yellow oily substance, and the batch number is 20141022.
1.2 Experimental animals
The male rats of SPF-grade SD healthy species, 60 male rats with the weight of about 200g, provided by Guangdong provincial medical experiment animal center, have the animal quality qualification certification serial number: no. 44411600000901. License number for experimental animals: SYXK (Yue) 2013-.
The experimental environment conditions comprise that the temperature is 23 +/-2 ℃, the relative humidity is 60 +/-10%, the indoor natural light illumination is mainly used, the ventilation is good, the environment is kept quiet, and the environmental facilities of SPF-level experimental animals are provided.
1.3 high fat model feed
1.2% cholesterol, 5.0% lard, 0.2% sodium cholate, and appropriate amount of casein, calcium hydrogen phosphate, and stone powder are added into the maintenance feed to prepare model feed (prepared by Guangdong disease prevention and control center).
1.4 Main Instrument
Electronic analytical balance (beijing sidoris instrument systems ltd); 80-2 type low speed centrifuge (Jincheng Guosheng laboratory plant, Jiangsu Jintan city); type 722 spectrophotometer (shanghai third analytical instrument factory); HH-6 digital display constant temperature water bath (national electric appliance Co., Ltd.); an Epoch type microplate reader (usa); a KQ-250E ultrasonic cleaner (ultrasonic instruments, Inc., Kunshan), etc.
1.5 reagents are shown in Table 5
TABLE 5 use of reagents
1.6 Experimental data statistics tool software
The data obtained by the experiment are numerical variable data. All data were analyzed using SPSS statistical software (VII.5).
2 method of experiment
2.1 principle of the experiment
Generally, the test animals are fed with a high fat diet, and the test samples are administered to the test animals at the same time,
after a period of time, the concentration of TC, TG, LDL-C and HDL-C in the animal serum is measured, and the influence of the test sample on the test animal model with hyperlipidemia and the influence of the test sample on the absorption of lipid, the formation of lipoprotein, the degradation of lipid or the excretion of lipid in the test animal can be judged by comparing the blank control group with the high-lipid model group and the low, medium and high dose groups given with the test sample.
2.2 Experimental procedures
Healthy adult rats were selected and kept on feed under a barrier system for 5 days. According to the weight of the rat
The model is divided into a blank control group (fed with common feed) and a model experiment group (feed containing high lipid substances). After the model experiment group is given model feed for 7 days, rats in the blank control group and the model experiment group are not fasted, and blood is collected in eyes. After blood collection, serum was separated as soon as possible and serum TC, TG, LDL-C, HDL-C levels were measured. The model experimental groups were randomly divided into 4 groups of model control group, low, medium and high dose groups according to the TC levels. Compared with the model control group, the blank control group has no significant difference in serum TC, TG, LDL-C and HDL-C water level.
The recommended human body intake of the peony seed oil to be tested is 6g per person per day, and the recommended human body intake is 0.1g/kg per person per day according to the weight of 60 kg per person. Determining the dosage of the peony seed oil to be tested on the rat blood fat reducing function test according to 10 times of the recommended amount of a human body, namely the amount of the peony seed oil soft capsule, the amount of the peony seed oil self-emulsifying soft capsule group and the amount of the edible tested sample of the rat are 1.00g/kg and 1.67 g/kg respectively every day, preparing a tested object gastric lavage solution by using corn oil, feeding the tested object solution to the rat by gavage once every day, and the gavage volume is calculated according to 1ml/100 g. The concentrations of the test substance solutions of the peony seed oil soft capsule and the peony seed oil self-emulsifying soft capsule are respectively 100g/L and 167 g/L. The blank control group and the model control group were gavaged with an equal volume of corn oil.
Grouping experimental animals:
① blank control group comprising common feed and corn oil;
② model control group comprises high fat diet and corn oil;
③ peony seed oil soft capsule group comprises high fat feed and peony seed oil (1000mg/kg, intragastric administration, 10 times of the amount recommended by human body);
④ peony seed oil self-emulsifying soft capsule group, high-fat feed and peony seed oil self-emulsifying system (1670mg/lkg,
the peony seed oil self-emulsifying system contains 60% of peony seed oil, and the amount of the peony seed oil is 10 times of the amount recommended by a human body by intragastric administration).
The test sample 36d was continuously administered by weighing the body weight periodically and calculating the gavage amount based thereon. And (3) collecting blood from abdominal aorta without fasting at the end of the experiment, standing, separating serum as soon as possible, and detecting the TC, TG and HDL-C, LDL-C levels of the serum by a full-automatic biochemical analyzer.
2.3 determination of TC, TG, LDL-C, HDL-C in serum
Measurement of TC: an enzyme colorimetric method (COD-CE-PAP method) is adopted; determination of TG: adopting an enzyme method (GPO-PAP method); measurement of LDL-C: adopting an enzyme-linked immunosorbent assay (ELISA); determination of HDL-C: adopting a magnesium phosphotungstate precipitation method (PTA-Mg2+ precipitation method).
2.4 determination of results
And comparing the change conditions of TC, TG, LDL-C and HDL-C, and if the difference between the experimental group and the normal control group has statistical significance, judging that the results of TC, TG, LDL-C and HDL-C in the serum are positive.
According to the 'evaluation method for assisting in reducing blood fat function', the blood serum TG of the tested animals is reduced and has significant difference by comparing the test group with the control group, the TC and LDL-C of the blood serum are not significantly higher than the control group, the HDL-C of the blood serum is not significantly lower than the control group, the effective rate of the TG of the blood serum of the test group is significantly higher than that of the control group, and the test result of the test sample for assisting in reducing TG function test can be judged to be positive.
And (4) judging the functional result of assisting in reducing cholesterol, namely comparing the model control group with a blank control group, wherein the TC or LDL-C in the serum is increased, the difference is significant, the difference of the TG in the serum is not significant, and the judgment model is established. Compared with the model control group, the serum TC or LDL-C of any dose group is reduced, the difference is significant, the serum HDL-C of each dose group is not significantly lower than that of the model control group, the serum TG is not significantly higher than that of the model control group, and the positive experimental result of the functional animal with the function of assisting in reducing cholesterol of the test sample can be judged.
2.5 statistics of Experimental data
The data obtained by the experiment are numerical variable data, SPSS data processing software is adopted to carry out single-factor variance analysis and t test, and the experimental data adopts mean standard deviation (
) If P is<0.01, indicating that the difference has significant meaning, namely the group is positive through comparison results.
3 results of the experiment
3.1 the effect of the peony seed oil soft capsules on the body weight of rats is shown in Table 6. As can be seen from Table 6, the differences of the animal weights of the test substance dose groups and the model control group have no significance (P > 0.05), namely the peony seed oil soft capsules have no influence on the animal weights of the experiments.
TABLE 6 influence of peony seed oil softgel on rat body weight: (
，n=12）
3.2 Effect of peony seed oil Soft Capsule on rat blood lipid level
3.2.1 rat blood lipid content before experiment
The blood lipid content of the rats before the experiment is shown in Table 7. Through analysis of variance, the blank control group before the experiment has statistical significance in comparing the differences of the TC, TG, LDL-C and HDL-C contents in the serum of rats with other groups (P<0.05), which indicates that a high fat model is established; the differences of the TC, TG, LDL-C and HDL-C contents in the serum of rats compared with the model control group and the dosage groups have no statistical significance: (P>0.05).
TABLE 7 comparison of serum TC, TG, LDL-C, HDL-C levels in rats of the groups before the experiment: (
，n=12）
3.2.2 post-experiment rat blood lipid levels
The blood lipid content of the rats after the experiment is shown in Table 8. Compared with the blank control group, the TC, TG and LDL-C contents of the model control group are all obviously increased, and the difference has statistical significance (P<0.01), indicating that a high fat model is established. Compared with the model control group, the TC, TG and LDL-C contents of the peony seed oil self-emulsifying soft capsule group are all obviously reduced, and the difference has statistical significance: (P<0.05); the HDL-C content of the peony seed oil self-emulsifying soft capsule group is obviously increased, and the difference has statistical significance (P)<0.01)。
TABLE 8 comparison of the serum TC, TG, LDL-C, HDL-C levels in rats of each group after the experiment: (
, n=12）
Note:## P<0.01; comparison with model control group:* P<0.05,** P<0.01; compared with the peony seed oil soft capsule group:▲ P<0.05,▲▲ P<0.01；
4 conclusion
The experimental result shows that when the peony seed oil soft capsule samples with different doses are orally administered to rats, compared with a blank control group, TC, TG and LDL-C of the model control group are obviously increased, and the differences have statistical significance, so that a high-fat model is established. Compared with a model control group, the serum TC, TG and LDL-C of the peony seed oil self-emulsifying soft capsule group are obviously reduced, and the differences have statistical significance; the serum HDL-C of the peony seed oil self-emulsifying soft capsule group is obviously increased, and the difference has statistical significance. Compared with the peony seed oil soft capsule group, the serum TC, TG and LDL-C of the peony seed oil self-emulsifying soft capsule group are also obviously reduced, and the differences have statistical significance; the serum HDL-C of the peony seed oil self-emulsifying soft capsule group is also obviously increased, and the difference has statistical significance. According to experimental data and results, the peony seed oil self-emulsifying soft capsule can be judged to have the function of reducing blood fat, and the function of reducing blood fat is obviously superior to that of the peony seed oil soft capsule.
Claims (1)
1. The application of the peony seed oil self-emulsifying soft capsule in preparing the hypolipidemic drug is characterized in that the peony seed oil self-emulsifying soft capsule is prepared by the following method:
s1, mixing 200g of soybean lecithin, 50g of glycerol and 150g of polyethylene glycol-400150 g, and stirring twice with a shearing machine at 8000 rpm, wherein the first time is 5 minutes, and the second time is 2 minutes, so that the soybean lecithin is uniformly dispersed;
s2, adding 600g of warm peony seed oil, stirring for 3 times, each time for 2 minutes, so as to obtain primary emulsion, then transferring the primary emulsion into a high-pressure homogenizer for homogenizing for 3 times, and filtering to form uniform peony seed oil emulsion concentrated solution, namely a self-emulsifying system composition A of peony seed oil;
s3, adding 200g of gelatin into a gelatin dissolving tank, adding 240g of water at 80 ℃, adding 0.2g of preservative ethylparaben, adding an opacifier and a coloring agent, sealing and heating at the same time, stirring until the gelatin is completely melted and swelled, adding 100g of glycerol, sealing the gelatin preparing tank, closing the stirring, starting a vacuum pump, vacuumizing until bubbles are completely pumped out, and obtaining a soft capsule material liquid; preserving heat at 50-70 ℃ for later use; loading the self-emulsifying system composition A of the soft capsule wall material liquid and the peony seed oil into a soft capsule machine, preparing soft capsules by adopting a pressing method, drying, washing, drying again, sorting and packaging to obtain a finished product;
or
S1, placing 600g of peony seed oil, 250g of liquid lecithin and 150g of polyoxyethylene fatty acid ester in a same container, and ultrasonically stirring and uniformly mixing to form a uniform solution, namely a self-emulsifying system composition B of the peony seed oil;
s2, adding 200g of gelatin into a gelatin dissolving tank, adding 240g of water at 80 ℃, adding 0.2g of preservative ethylparaben, adding an opacifier and a colorant, sealing and heating, stirring until the gelatin is completely melted and swelled, adding 100g of glycerol, sealing the gelatin mixing tank, closing the stirring, starting a vacuum pump, vacuumizing until bubbles are completely pumped out to obtain soft capsule material liquid, keeping the temperature at 50-70 ℃ for later use, putting the self-emulsifying system composition B of the soft capsule material liquid and the peony seed oil into a soft capsule machine, preparing soft capsules by adopting a pressing method, drying, washing, drying again, sorting and packaging to obtain a finished product.
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| CN107319008B (en) * | 2017-07-03 | 2020-07-24 | 中国林业科学研究院林产化学工业研究所 | Preparation method of cornus wilsoniana oil microcapsule |
| 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 |
| CN109893513B (en) * | 2019-03-29 | 2021-08-10 | 广东现代汉方科技有限公司 | Composite haematococcus pluvialis astaxanthin self-emulsifying soft capsule and 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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| CN1366877A (en) * | 2002-02-06 | 2002-09-04 | 中国人民解放军第二军医大学 | Chinese medicine volatile self-emulsification medicine-releasing system |
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| CN101190182A (en) * | 2006-12-01 | 2008-06-04 | 北京大学 | Self-emulsifying composition |
| CN103844270A (en) * | 2012-12-04 | 2014-06-11 | 洛阳花瓣舞生物技术有限公司 | Hypolipidemic compound peony seed oil soft capsule |
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| CN1366877A (en) * | 2002-02-06 | 2002-09-04 | 中国人民解放军第二军医大学 | Chinese medicine volatile self-emulsification medicine-releasing system |
| CN1903228A (en) * | 2006-07-03 | 2007-01-31 | 李颖 | Prepn. of self-emulsion of glossy ganoderma spore oil, and its prepn. method |
| CN101190182A (en) * | 2006-12-01 | 2008-06-04 | 北京大学 | Self-emulsifying composition |
| CN101028461A (en) * | 2007-03-30 | 2007-09-05 | 吴敏 | Job's tears nut oil self-emusifying preparation and its making method |
| CN103844270A (en) * | 2012-12-04 | 2014-06-11 | 洛阳花瓣舞生物技术有限公司 | Hypolipidemic compound peony seed oil soft capsule |
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