CN105617133B - 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
- Publication number
- CN105617133B CN105617133B CN201610088509.5A CN201610088509A CN105617133B CN 105617133 B CN105617133 B CN 105617133B CN 201610088509 A CN201610088509 A CN 201610088509A CN 105617133 B CN105617133 B CN 105617133B
- Authority
- CN
- China
- Prior art keywords
- seed oil
- peony seed
- composite
- self
- emulsifying system
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/074—Ganoderma
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8994—Coix (Job's tears)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Alternative & Traditional Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Dispersion Chemistry (AREA)
- Medicinal Preparation (AREA)
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, an emulsifier and an auxiliary emulsifier, can also contain a dispersant and/or a solid adsorbent, can be prepared into oral dosage forms such as soft capsules, liquid capsules, hard capsules and granules, can form emulsion by self-microemulsifying under the action of gastrointestinal fluid after entering the body, and can promote the absorption of the emulsion in gastrointestinal tracts, thereby improving the bioavailability and efficacy of the composite peony seed oil self-emulsifying system composition, having low cost, good stability, convenient storage and transportation and small side effect, and improving the treatment compliance of patients on the oral dosage form medicaments based on the composite peony seed oil self-emulsifying system composition.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a composite peony seed oil self-emulsifying system composition.
Background
The peony seed oil mainly contains fatty acids, contains a large amount of Unsaturated Fatty Acids (UFA), the total amount of UFA is about 80-92%, and is obviously higher than common vegetable oil such as olive oil, soybean oil and peanut oil which are called liquid gold, the peony seed oil is particularly worthy of being composed of α -linolenic acid, the content of UFA is generally 32-67%, the UFA is far higher than other common vegetable oil, and the UFA is similar to linseed oil, besides the remarkable advantages of the unsaturated fatty acids and the α -linolenic acid, the peony seed oil also contains monounsaturated fatty acid oleic acid which is easy to absorb by a human body and a large amount of polyunsaturated fatty acid linoleic acid which is necessary for the human body, the peony seed oil also contains certain sterol compounds (sitosterol, fucosterol and the like), fat-soluble vitamin E, squalene and the like, wherein the phytosterol is an important intermediate for synthesizing vitamin D3 and other medicaments, and has the functions of promoting metabolism, enhancing the metabolism of natural vitamin E, vitamin K, vitamin E, vitamin.
Modern researches show that the peony seed oil has higher nutrition and health care functions: reducing blood lipid, resisting oxidation, protecting liver, reducing blood sugar, improving immunity, preventing sunburn, and whitening skin. In 3 months in 2011, the Ministry of health issues a notice that the Ministry of health approves the peony seed oil as a new resource food (No. 9 in 2011), and the peony seed oil is approved as the new resource food.
The ganoderma lucidum spores are spores continuously released from the pileus of the ganoderma lucidum in the mature period, are hydrophobic oil substances extracted from the ganoderma lucidum spores, and mainly contain fatty acid, sterol, terpenes, vitamins and the like. Coix seed is dried mature seed of Coixlacryymajoib L.var.mayuen (Roman.) Stapf of Gramineae, is a hydrophobic oil substance extracted from Coix seed, and mainly contains fatty acid and Coix lacryma-jobi ester. The ganoderma lucidum spore oil and the coix seed oil are researched and developed more and are mature at present, and have great advantages in vegetable oil in the aspects of improving immunity and resisting tumors.
The peony seed oil applied in the current market is mainly provided in the form of liquid edible blend oil, for example, chinese patent CN103859064B discloses "a blend edible oil containing peony seed oil and its preparation method", although there are many patents on the combination of peony seed oil and other vegetable oils, there is no composite peony seed oil combining peony seed oil, ganoderma lucidum spore oil and coix seed oil. According to the composite peony seed oil, the ganoderma spore oil and the coix seed oil are combined into the composite peony seed oil, so that the advantages of the ganoderma spore oil and the coix seed oil in the aspects of improving immunity and resisting tumors can be fully exerted, and the effect of enhancing the immunity of the composite peony seed oil is greatly improved.
In recent years, research and development of peony seed oil are more popular, and more patents are applied. For example, the publication patent CN104106806A discloses a health product for stabilizing blood pressure and reducing blood lipid, and for example, the Chinese patent CN 103494199A discloses a peony seed oil soft capsule with blood lipid reducing effect and preparation thereof. However, in the existing literature, no report about a peony seed oil self-emulsifying system composition and a preparation method thereof is found, and no report about a composite peony seed oil self-emulsifying system composition and a preparation method thereof is found, and only the report about the application of peony seed oil as a health care product is reported, for example, patent CN 104666458A discloses "an american ginseng soft capsule containing peony seed oil and a preparation method thereof", and peony seed oil is mixed with a medicine to be directly pressed into a soft capsule containing peony seed oil. However, the existing soft capsule containing peony seed oil has the defect of low bioavailability. In addition, the peony seed oil is prepared into soft capsules, and the problems of unqualified disintegration in storage period, substance migration and leakage of oily components in the capsules, increased acid value and oxidation value and the like which are stability problems need to be overcome. Therefore, a new compound peony seed oil oral pharmaceutical dosage form needs to be developed.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a composite peony seed oil self-emulsifying system composition which can automatically form emulsion under the peristalsis of the stomach, is easy to absorb and has high bioavailability, and the composite peony seed oil self-emulsifying system composition has good product stability and high safety.
The invention also aims to provide a preparation method of the composite peony seed oil self-emulsifying system composition.
The invention also aims to provide application of the composite peony seed oil self-emulsifying system composition.
The invention achieves the above object by the following technical scheme.
The composite peony seed oil self-emulsifying system composition comprises the following components in parts by weight:
15-70 parts of peony seed oil;
5-55 parts of an emulsifier;
5-20 parts of a co-emulsifier;
the composite peony seed oil is composed of peony seed oil and ganoderma lucidum spore oil and/or coix seed oil.
The compound peony seed oil selected by the invention is an oil substance, not only is an active ingredient of a raw material medicine, but also is an oil phase auxiliary material, and can be used as a dispersing agent or a carrier to disperse or dissolve other active ingredients or medicines to form a self-emulsifying system, so that the proportion of the medicines of the self-emulsifying system is relatively increased when the self-emulsifying system composition is prepared, the dosage of an emulsifying agent is reduced, and the effect of self-emulsifying action is highlighted. The selected emulsifier and co-emulsifier are pharmaceutical adjuvants widely used in pharmacy, and have the characteristics of no toxicity and no irritation.
Modern researches show that peony seed oil mainly contains omega3Unsaturated fatty acid and coix seed oil mainly contain omega6Unsaturated fatty acid and Ganoderma spore oil mainly contain omega9Unsaturated fatty acid, compound peony seed oil through the proportion of unsaturated fatty acid of different grade type, can exert its health function better.
Preferably, the composite peony seed oil comprises the following components in parts by weight:
the peony seed oil is ganoderma lucidum spore oil =1: 0.5-1.5,
or
Peony seed oil, coix seed oil =1: 0.5-2.5,
or
The peony seed oil, the ganoderma lucidum spore oil and the coix seed oil are respectively 1: 0.5-1.5: 0.5-2.5.
Preferably, the composite peony seed oil self-emulsifying system composition comprises 0-75 parts by weight of a dispersant and/or a solid adsorbent. The composite peony seed oil self-emulsifying system composition can be prepared into different dosage forms, such as soft capsules, liquid capsules, hard capsules or other oral dosage forms. The composite peony seed oil self-emulsifying system composition can also comprise some medicines which can be easily dissolved by the composite peony seed oil.
Preferably, the composite peony seed oil self-emulsifying system composition comprises the following components in percentage by mass:
40 to 65 percent of composite peony seed oil;
15 to 30 percent of emulsifier;
10 to 20 percent of auxiliary emulsifier;
5 to 35 percent of dispersant and/or solid adsorbent.
Preferably, the emulsifier is selected from one or more of the following: soybean lecithin, cephalin, poloxamer, sucrose laurate, span-60, tween-85, polyoxyethylene nonyl phenol ether, sucrose palmitate, sucrose stearate, sorbitan fatty acid, polysorbate, polyoxyethylene 40 stearate, 30 benzylzee, 35 benzylzee, polyoxyethylene castor oil glycerin ether (the unit of ethylene oxide is 35-40), sorbitan fatty acid ester, polyoxyethylene, polyoxypropylene copolymer, hydrogenated castor oil, sodium dodecyl sulfate, sodium octadecyl sulfate and sodium dodecyl benzene sulfonate.
More preferably, the emulsifier is selected from one or more of the following: soybean lecithin, tween-85, sucrose laurate and polyoxyethylene nonyl phenol ether.
Preferably, the co-emulsifier is selected from one or more of the following: glycerol, isopropanol, l, 2-propylene glycol, diethylene glycol monoethyl ether, n-butanol, n-octanol, n-heptanol, ethanol, polyoxyethylene fatty acid ester and polyethylene glycol 400.
More preferably, the co-emulsifier is selected from one or more of the following compositions: glycerol, diethylene glycol monoethyl ether, n-octanol and polyethylene glycol 400.
Preferably, the dispersant is selected from one or more of the following: soybean oil, peanut oil, castor oil, olive oil, ethyl linoleate, ethyl oleate, medium chain triglycerides, isopropyl laurate, isopropyl myristate, propylene glycol mono/dicaprylate, glycerol monocaprylate.
Preferably, the solid adsorption material is selected from one or more of polyethylene glycol 6000, polyethylene glycol 4000, povidone, hydroxypropyl- β -cyclodextrin, oxalic acid, lactose, mannitol, sorbitol, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, polyacrylic resin, methyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, chitin, aerosil or carboxymethyl cellulose.
To the self-emulsifying system composition, a small amount of an antioxidant, such as vitamin E, may also be added.
The preparation method of the composite peony seed oil self-emulsifying system composition comprises the following steps:
s1, uniformly mixing an emulsifier and a co-emulsifier;
s2, adding the composite peony seed oil, and uniformly mixing to form a composite peony seed oil emulsion concentrate;
or directly mixing the compound peony seed oil, the emulsifier and the co-emulsifier uniformly to form the compound peony seed oil emulsion concentrated solution.
The mode of mixing uniformly can be stirring, shaking, ultrasound or vortexing.
Preferably, the post-treatment steps of the preparation method of the composite peony seed oil self-emulsifying system composition are as follows:
s3-1, pressing the prepared concentrated emulsion and soft capsule wall material to obtain soft capsule; or
S3-2, directly filling the prepared emulsion concentrate into a liquid capsule shell to prepare a liquid capsule; or
S3-3, adding solid adsorbent as carrier, granulating, and packaging into capsule shell to obtain hard capsule; or
S3-4, adding solid adsorbent as carrier, granulating, and packaging in aluminum plastic bags to obtain granule.
The compound peony seed oil self-emulsifying system composition is suitable for being applied to oral medicines, such as capsules, granules and the like.
Compared with the prior art, the invention has the following beneficial effects:
the compound peony seed oil selected by the invention is an oil substance, is not only an active ingredient of a raw material medicine, but also an oil phase auxiliary material, and can also be used as a dispersing agent or a carrier to disperse or dissolve other active ingredients or medicines to form a self-emulsifying system, so that the proportion of the medicines of the self-emulsifying system is relatively increased, the dosage of a self-emulsifying agent is reduced, and the effect of the self-emulsifying effect is highlighted; the obtained compound peony seed oil self-emulsifying system composition has high dispersibility, excellent storage stability, inhibited discoloration and deterioration of the system composition, unchanged dissolution speed of active ingredients from the system composition, greatly improved bioavailability, and improved medicinal effect of compound peony seed oil and medicines; the selected emulsifier, the auxiliary emulsifier, the dispersant and the solid adsorbent are pharmaceutical excipients which are widely applied in pharmaceutics, have the characteristics of no toxicity and no irritation, not only solve the problem of bioavailability of oil components, but also do not increase the toxic or side effect of products, and can improve the treatment compliance of patients to oral dosage form medicines based on the self-emulsifying system medicine composition; the preparation process is simple, convenient to operate, convenient to control the product quality, has operability, and is a safe and reliable preparation method suitable for industrial production.
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
Preparation of composite peony seed oil self-emulsifying system soft capsule
The composition of the compound peony seed oil self-emulsifying system soft capsule is shown in table 1.
TABLE 1 composition of the composite peony seed oil self-emulsifying system soft capsule ingredients
S1, mixing soybean phospholipid, glycerol, sorbitol, vitamin E and polyethylene glycol-400 according to the table 1, stirring twice with a shearing machine (8000 rpm), and uniformly dispersing for 5 minutes for the first time and 2 minutes for the second time;
s2, adding warm peony seed oil and ganoderma spore 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 a uniform composite peony seed oil emulsion concentrated solution, namely a self-emulsifying system composition A of the composite 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. Keeping the temperature at 50-70 ℃ for later use, putting the soft capsule material liquid and the self-emulsifying drug-releasing liquid medicine of the composite 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.
Example 2
Preparation of composite peony seed oil self-emulsifying system soft capsule
The composition of the compound peony seed oil self-emulsifying system soft capsule is shown in table 2.
TABLE 2 composition of the composite peony seed oil self-emulsifying system soft capsule ingredients
S1, mixing soybean phospholipid, glycerol, sorbitol, vitamin E and polyethylene glycol-400 according to the table 2, stirring twice with a shearing machine (8000 rpm), and uniformly dispersing for 5 minutes for the first time and 2 minutes for the second time;
s2, adding warm peony seed oil and ganoderma spore 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 a uniform composite peony seed oil emulsion concentrated solution, namely a self-emulsifying system composition B of the composite 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. Keeping the temperature at 50-70 ℃ for later use, putting the soft capsule material liquid and the self-emulsifying drug-releasing liquid medicine of the composite 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.
Example 3
Preparation of composite peony seed oil self-emulsifying system soft capsule
The composition of the compound peony seed oil self-emulsifying system soft capsule is shown in table 3.
TABLE 3 composite peony seed oil self-emulsifying system soft capsule component group
S1, mixing 30 portions of benzyl, l, 2-propylene glycol, sorbitol, vitamin E and polyoxyethylene fatty acid ester according to the table 3, stirring twice with a shearing machine (8000 rpm), and uniformly dispersing for 5 minutes for the first time and 2 minutes for the second time;
s2, adding warm peony seed oil and ganoderma spore 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 a uniform composite peony seed oil emulsion concentrate, namely a self-emulsifying system composition C of the composite 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. Keeping the temperature at 50-70 ℃ for later use, putting the soft capsule material liquid and the self-emulsifying drug-releasing liquid medicine of the composite 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.
Example 4
Preparation of composite peony seed oil self-emulsifying system soft capsule
The composition of the compound peony seed oil self-emulsifying system soft capsule is shown in table 4.
TABLE 4 composition of the composite peony seed oil self-emulsifying system soft capsule ingredients
S1, mixing peony seed oil, ganoderma spore oil, coix seed oil, tween-85 and diethylene glycol monoethyl ether according to the table 4, and stirring for three times and 5 minutes each time by using a shearing machine (8000 rpm);
s2, homogenizing for 3 times in a high-pressure homogenizer, and filtering to form a uniform composite peony seed oil emulsion concentrated solution, namely a self-emulsifying system composition D of the composite peony seed oil;
s3, adding gelatin into a gelatin dissolving tank, adding water with the temperature of 60 ℃, 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 mixing tank, closing the stirring, starting a vacuum pump, vacuumizing, and pumping bubbles to obtain the soft capsule material liquid. Keeping the temperature at 50-70 ℃ for later use, putting the soft capsule material liquid and the self-emulsifying drug-releasing liquid medicine of the composite 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.
Example 5
Preparation of composite peony seed oil self-emulsifying system liquid capsule
The composition of the components of the compound peony seed oil self-emulsifying system is shown in table 5.
TABLE 5 composition of content of composite peony seed oil self-emulsifying system liquid capsule
S1, mixing lecithin, polyoxyethylene nonyl phenol ether and glycerol as shown in Table 5, and treating for 5 minutes by using 25KHz ultrasonic waves to uniformly disperse the mixture;
s2, adding warm peony seed oil and coix seed oil, treating for 10 minutes by using 25KHz ultrasonic waves, and filtering to form uniform composite peony seed oil emulsion concentrated solution, namely a self-emulsifying system composition E of the composite peony seed oil;
s3, directly filling the prepared emulsion concentrate into a capsule shell of the liquid capsule, sorting and packaging to obtain a finished product.
Example 6
Preparation of composite peony seed oil self-emulsifying system liquid capsule II
The composition of the components of the compound peony seed oil self-emulsifying system is shown in table 6.
TABLE 6 composition of the content of the composite peony seed oil self-emulsifying system liquid capsule
S1, uniformly stirring and mixing sucrose laurate and glycerol as shown in Table 4;
s2, uniformly mixing the peony seed oil, the ganoderma spore oil, the coix seed oil and the peanut oil, adding the mixture into a mixed solution of sucrose laurate and glycerol, stirring the mixture for 30 minutes by using a high-speed stirrer with the stirring speed of 8000 revolutions per minute, and uniformly mixing the mixture to form a composite peony seed oil emulsion concentrated solution, namely a self-emulsifying system composition F of the composite peony seed oil;
s3, directly filling the self-emulsifying concentrated solution of the compound peony seed oil into a capsule shell of the liquid capsule, and performing sorting and packaging to obtain a finished product.
Example 7
Preparation of composite peony seed oil self-emulsifying system hard capsule
The composition of the components of the compound peony seed oil self-emulsifying system is shown in table 7.
TABLE 7 composition of the components of the composite peony seed oil self-emulsifying (hard capsule content)
S1, uniformly stirring and mixing bean lecithin and n-octanol according to the table 7;
s2, adding peony seed oil and ganoderma spore oil, and uniformly mixing the peony seed oil and the ganoderma spore oil for 30 minutes by using a high-speed stirrer with the stirring speed of 10000 revolutions per minute to form a composite peony seed oil emulsion concentrated solution;
s3, uniformly mixing polyethylene glycol 6000 and ethyl cellulose with the concentrated solution, sieving with a 18-mesh sieve to obtain granules, filling the granules into a capsule shell to obtain a hard capsule, namely the self-emulsifying system composition G of the compound peony seed oil, sorting and packaging to obtain a finished product.
Example 8
Preparation of composite peony seed oil self-emulsifying system hard capsule II
The composition of the components of the compound peony seed oil self-emulsifying system is shown in table 8.
TABLE 8 composition of the ingredients of the composite peony seed oil self-emulsifying system (hard capsule content)
S1, stirring and uniformly mixing polyoxyethylene nonyl phenol ether and glycerol according to the table 8;
s2, adding peony seed oil and ganoderma spore oil, and uniformly mixing the peony seed oil and the ganoderma spore oil for 30 minutes by using a high-speed stirrer with the stirring speed of 10000 revolutions per minute to form a composite peony seed oil emulsion concentrated solution;
s3, uniformly mixing polyethylene glycol 6000 and povidone with the concentrated solution, sieving with a 18-mesh sieve to obtain granules, namely the self-emulsifying system composition H of the composite peony seed oil, filling the granules into capsule shells to obtain hard capsules, and performing sorting and packaging to obtain finished products.
Example 9
Preparation of composite peony seed oil self-emulsifying system granules
The composition of the components of the compound peony seed oil self-emulsifying system is shown in table 9.
TABLE 9 composition of the components of the composite peony seed oil self-emulsifying system (particulate matter)
S1, uniformly mixing Tween-85 and glycerol as shown in Table 9;
s2, adding peony seed oil and coix seed oil, and uniformly mixing the peony seed oil and the coix seed oil by using a high-speed stirrer with the stirring speed of 10000 rpm for 30 minutes to form a composite peony seed oil emulsion concentrated solution;
s3, sieving polyethylene glycol 6000, superfine silica gel powder and polyethylene glycol 4000 with a 100-mesh sieve, uniformly mixing with the concentrated solution, sieving with a 18-mesh sieve to obtain particles, namely the self-emulsifying system composition I of the compound peony seed oil, and after inspection, filling the particles into aluminum plastic bags to obtain finished products.
Example 10
Preparation of composite peony seed oil self-emulsifying system granules
The composition of the particulate matter components of the composite peony seed oil self-emulsifying system is shown in table 10.
TABLE 10 composition of the components of the compound peony seed oil self-emulsifying system
S1, uniformly mixing Tween-85 and glycerol as shown in Table 7,
s2, adding peony seed oil and coix seed oil, and uniformly mixing the peony seed oil and the coix seed oil by using a high-speed stirrer with the stirring speed of 10000 rpm for 30 minutes to form a composite peony seed oil emulsion concentrated solution;
s3, sieving polyethylene glycol 6000, superfine silica gel powder and polyethylene glycol 4000 with a 100-mesh sieve, uniformly mixing with the concentrated solution, sieving with a 18-mesh sieve to obtain particles, namely the self-emulsifying system composition J of the compound peony seed oil, and after inspection, filling the particles into aluminum plastic bags to obtain finished products.
Example 11
Preparation of composite peony seed oil self-emulsifying system granules
The composition of the particulate matter components of the composite peony seed oil self-emulsifying system is shown in table 11.
TABLE 11 composition of the components of the composite peony seed oil self-emulsifying system
S1, uniformly mixing sodium dodecyl sulfate and glycerol as shown in Table 11,
s2, adding peony seed oil and coix seed oil, and uniformly mixing the peony seed oil and the coix seed oil by using a high-speed stirrer with the stirring speed of 10000 rpm for 30 minutes to form a composite peony seed oil emulsion concentrated solution;
s3, sieving polyethylene glycol 6000, superfine silica gel powder and polyethylene glycol 4000 with a 100-mesh sieve, uniformly mixing with the concentrated solution, sieving with a 18-mesh sieve to obtain particles, namely the self-emulsifying system composition K of the compound peony seed oil, and after inspection, filling the particles into aluminum plastic bags to obtain finished products.
Example 12
Preparation of compound peony seed oil self-emulsifying system granules
The composition of the components of the compound peony seed oil self-emulsifying system is shown in table 12.
TABLE 12 particulate component composition of composite peony seed oil self-emulsifying system
S1, uniformly mixing the soybean phospholipids and glycerol as shown in Table 12,
s2, adding peony seed oil, ganoderma lucidum spore oil and coix seed oil, and uniformly mixing the materials by high-speed stirring for 20 minutes by using a high-speed stirrer with the stirring speed of 12000 r/min to form a composite peony seed oil emulsion concentrated solution;
s3, sieving polyethylene glycol 6000, hydroxypropyl- β -cyclodextrin and lactose with a 100-mesh sieve, uniformly mixing with the concentrated solution, sieving with a 18-mesh sieve to obtain granules, namely the self-emulsifying system composition L of the compound peony seed oil, and after inspection, filling the granules into aluminum plastic bags to obtain finished products.
Monitoring self-emulsifying effect: adding the self-emulsifying system composition A-L (such as 0.5mL for concentrated solution and 0.5g for granule) of the composite peony seed oil into L0mL artificial gastric juice, and stirring with glass rod to rapidly form 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 measured, and the results are shown in Table 13.
TABLE 13 particle size of self-emulsifying system composition after decomposition for each example
Claims (1)
1. A preparation method of a compound peony seed oil self-emulsifying system soft capsule is characterized by comprising the following steps:
s1, mixing 200g of peony seed oil, 200g of ganoderma spore oil, 240g of coix seed oil, 85300 g of tween-and 60g of diethylene glycol monoethyl ether, and stirring three times at 8000 rpm by using a shearing machine, wherein each time is 5 minutes;
s2, homogenizing for 3 times in a high-pressure homogenizer, and filtering to form a uniform composite peony seed oil emulsion concentrated solution, namely a self-emulsifying system composition D of the composite peony seed oil;
s3, adding gelatin into a gelatin dissolving tank, adding water with the temperature of 60 ℃ 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 to obtain a soft capsule material liquid; keeping the temperature at 50-70 ℃ for later use, putting the soft capsule material liquid and the self-emulsifying drug-releasing liquid medicine of the composite 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610088509.5A CN105617133B (en) | 2016-02-17 | 2016-02-17 | Composite peony seed oil self-emulsifying system composition and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610088509.5A CN105617133B (en) | 2016-02-17 | 2016-02-17 | Composite peony seed oil self-emulsifying system composition and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105617133A CN105617133A (en) | 2016-06-01 |
| CN105617133B true CN105617133B (en) | 2020-04-28 |
Family
ID=56032739
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610088509.5A Active CN105617133B (en) | 2016-02-17 | 2016-02-17 | Composite peony seed oil self-emulsifying system composition and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105617133B (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107669495B (en) * | 2017-09-29 | 2020-08-18 | 成都大学 | Simple self-nano emulsified preparation for skin 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 |
| 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 |
| 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 |
| CN114711411A (en) * | 2022-03-31 | 2022-07-08 | 重庆小丸生物科技股份有限公司 | Self-dispersed oil microcapsule in water and preparation method thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5110606A (en) * | 1990-11-13 | 1992-05-05 | Affinity Biotech, Inc. | Non-aqueous microemulsions for drug delivery |
| CN100577146C (en) * | 2006-07-03 | 2010-01-06 | 李颖 | Self-emulsion preparation of glossy ganoderma spore oil and preparation method thereof |
| CN101028461B (en) * | 2007-03-30 | 2010-05-19 | 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 |
-
2016
- 2016-02-17 CN CN201610088509.5A patent/CN105617133B/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN105617133A (en) | 2016-06-01 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN105617133B (en) | Composite peony seed oil self-emulsifying system composition and preparation method thereof | |
| CN102088978B (en) | Ameliorating or therapeutic agent for dyslipidemia | |
| CA2236023C (en) | Method for enhancing dissolution properties of relatively insoluble dietary supplements and product incorporating same | |
| CN100577146C (en) | Self-emulsion preparation of glossy ganoderma spore oil and preparation method thereof | |
| CN101028461B (en) | Job's tears nut oil self-emusifying preparation and its making method | |
| JP2003238396A (en) | Coenzyme q10-containing emulsified composition | |
| JPS6410494B2 (en) | ||
| CN107073127A (en) | The solid oral dosage form of lipophilic compound | |
| JP2022549729A (en) | Pharmaceutical composition containing abiraterone acetate, and method for production and use thereof | |
| JP5820256B2 (en) | Self-emulsifying formulation | |
| JPS5813508A (en) | Drug containing polyglycerol ester of fatty acid | |
| JP2016512828A (en) | Racecadotril lipid composition | |
| US20220202768A1 (en) | Dihydromyricetin nanoemulsion formulations and methods for forming them | |
| JP2015522031A (en) | Racecadotril lipid composition | |
| KR20160149398A (en) | A Vitamin C delivery system and liposomal composition thereof | |
| JPS5877810A (en) | Oral drug composition containing polyglycerol unsaturated fatty acid ester | |
| CN107921017A (en) | The method treated using cadotril composition | |
| Raviadaran et al. | Simple and multiple emulsions emphasizing on industrial applications and stability assessment | |
| CN105708911A (en) | Peony seed oil self-emulsifying system composition and preparation method thereof | |
| CN112353845A (en) | Hot-melt extrusion composition containing traditional Chinese medicine volatile oil, preparation method thereof and pharmaceutical preparation | |
| CN111567805A (en) | Water-soluble haematococcus pluvialis astaxanthin soft capsule and preparation method thereof | |
| CN101874817B (en) | Brucea javanica oil enteric-coated microcapsule and preparation method | |
| JP2014047189A (en) | Superfine powder-containing capsule agent | |
| AU2015294993A1 (en) | Oral pharmaceutical composition of isotretinoin | |
| JP7335256B2 (en) | Pharmaceutical formulation of emulsion of simethicone and loperamide |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |