CN106562937A - Coenzyme Q10 soft capsule and preparation method thereof - Google Patents
Coenzyme Q10 soft capsule and preparation method thereof Download PDFInfo
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- CN106562937A CN106562937A CN201610914971.6A CN201610914971A CN106562937A CN 106562937 A CN106562937 A CN 106562937A CN 201610914971 A CN201610914971 A CN 201610914971A CN 106562937 A CN106562937 A CN 106562937A
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- ubidecarenone
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- ACTIUHUUMQJHFO-UPTCCGCDSA-N coenzyme Q10 Chemical compound COC1=C(OC)C(=O)C(C\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CC\C=C(/C)CCC=C(C)C)=C(C)C1=O ACTIUHUUMQJHFO-UPTCCGCDSA-N 0.000 title claims abstract description 82
- ACTIUHUUMQJHFO-UHFFFAOYSA-N Coenzym Q10 Natural products COC1=C(OC)C(=O)C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)=C(C)C1=O ACTIUHUUMQJHFO-UHFFFAOYSA-N 0.000 title claims abstract description 72
- 235000017471 coenzyme Q10 Nutrition 0.000 title claims abstract description 72
- 239000007901 soft capsule Substances 0.000 title claims abstract description 24
- 238000002360 preparation method Methods 0.000 title claims abstract description 23
- 229940110767 coenzyme Q10 Drugs 0.000 title abstract 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 68
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims abstract description 40
- 235000005979 Citrus limon Nutrition 0.000 claims abstract description 20
- 244000131522 Citrus pyriformis Species 0.000 claims abstract description 20
- 239000003549 soybean oil Substances 0.000 claims abstract description 20
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- 239000004408 titanium dioxide Substances 0.000 claims abstract description 20
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- 235000010215 titanium dioxide Nutrition 0.000 claims description 6
- MIDXCONKKJTLDX-UHFFFAOYSA-N 3,5-dimethylcyclopentane-1,2-dione Chemical compound CC1CC(C)C(=O)C1=O MIDXCONKKJTLDX-UHFFFAOYSA-N 0.000 claims description 5
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- NPCOQXAVBJJZBQ-UHFFFAOYSA-N reduced coenzyme Q9 Natural products COC1=C(O)C(C)=C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)C(O)=C1OC NPCOQXAVBJJZBQ-UHFFFAOYSA-N 0.000 description 2
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Classifications
-
- 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
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
-
- 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
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
-
- 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
-
- 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
- A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Botany (AREA)
- Zoology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention provides a coenzyme Q10 soft capsule and a preparation method thereof. The coenzyme Q10 soft capsule is prepared from a capsule shell and contents. The coenzyme Q10 soft capsule is characterized in that the capsule shell is prepared from the following raw materials in parts by weight: 30-70 parts of gelatin, 10-25 parts of glycerin, 30-60 parts of water, 0.2-1.2 parts of titanium dioxide, 0.2-0.5 parts of caramel color, 0.02-0.3 parts of carmine red, and 0.02-0.3 parts of lemon yellow; and the contents are prepared from the following raw materials in parts by weight: 4-15 parts of coenzyme Q10, 1-30 parts of beewax, and 50-95 parts of soybean oil. The preparation method comprises the steps of performing material selection, pill preparation, pill pressing, shaping, drying, pill selection, sub-packaging, external packaging, checking and warehousing to obtain a qualified product. Therefore, the stability of effect components of the product is effectively ensured.
Description
Technical field
The present invention relates to the field of Chinese medicines, more particularly to a kind of coenzyme Q 10 soft capsule and preparation method thereof.
Background technology
Ubidecarenone also known as coenzyme, ubiquinone and Q10, be liposoluble vitamin class like thing, it is with extremely low content
It is widely present in animal, plant, microorganism etc. intracellular, and can synthesizes in all of body tissue.Ubidecarenone is that have in vivo
One of coenzyme for playing an important role, it be rich in human heart, liver, kidney and pancreas, in human body total content be 0.5～
1.5g.The number of the ubiquinone of separate sources its side chain iso-amylene unit is different, and the mankind and mammal are 10 iso-amylene lists
Position, therefore claim Ubidecarenone.Ubidecarenone has the function of promoting oxidative phosphorylation reaction and protect biological film integrality, and it is biological
The fat-soluble quinoness being widely present in vivo, Ubidecarenone lifting in proton displacement and electron transmission in respiratory chain in vivo
Act on, it is the activator of Cellular respiration and cellular metabolism, be also important antioxidant and nonspecific immunity strengthening agent.
As Ubidecarenone is in the extensive application in the fields such as medicine, food additive, the wide market of this product.
In Japan, Ubidecarenone as drug control, and on US and European market, but with food additive name sold by the product.
Estimate according to relevant department, because in recent years U.S. domestic defined real natural health-care products heat, sell in year of the product in the U.S.
Amount reaches more than 3 tons, and growth rate of market is 15%～20%.Nutrient and healthcare products containing Ubidecarenone and other natural health-care products one
Sample, can freely sell in the supermarket in the U.S., feed chain and pharmacy.Due to its definite effect, therefore receive very much western customers
Welcome.Calendar year 2001, consume the most country (area) of Ubidecarenone raw material and be respectively the U.S., Japan, West Europe and Australia, mesh
It is front that in the international market supply falls short of demand.
The application and development of China's Ubidecarenone is enlivened very much, particularly pharmaceuticals industry, the injection of Ubidecarenone, capsule, tablet
There is production, be also widely used as the raw material of all kinds of nutritional health foods in field of health care food, the city of state's coenzyme Q 10
Gesture of the field demand in growth year by year.
According to retrieval with Ubidecarenone as primary raw material made by capsule it is few, the dispensing of addition is also different, obtains
The properties of product for arriving, assimilation effect is also uneven.
The content of the invention
The technical problem to be solved is, there is provided a kind of coenzyme Q 10 soft capsule and preparation method thereof, by capsule
Shell and content are constituted：Characterized in that, softgel shell is made up of following raw material：Gelatin 30-70 parts, glycerol 10-25 parts, water 30-60
Part, titanium dioxide 0.2-1.2 parts, burnt sugar coloring 0.2-0.5 parts, carmine 0.02-0.3 parts, lemon yellow 0.02-0.3 parts；Content
It is made up of following raw materials：Ubidecarenone 4-15 part, Cera Flava 1-30 parts, soybean oil 50-95 parts；By sorting → pill → pelleting →
The step of shape → be dried → selecting ball → subpackage → outer package → inspection → warehouse-in obtains qualified products, and product work(has been effectively ensured
The stability of effect composition.
Preparation method is as follows：
(1). the preparation of supplementary material
Qualified Ubidecarenone, Cera Flava, soybean oil, gelatin, glycerol, titanium dioxide, lemon yellow, carmine, caramel will be checked
Color, in the de- outsourcing in relief area, is carried out after surface sterilization in strict accordance with the program into 100,000 grades of clean areas to inner packing, is sent into clean
Net area is standby；
(2). weighing is got the raw materials ready
Ubidecarenone, Cera Flava, soybean oil, gelatin, glycerol, titanium dioxide, lemon yellow, carmine, Jiao are weighed by formula proportion
Fried sugar, it is standby；
(3) preparation of glue
(3.1) titanium dioxide, the preparation of glycerol mixed liquor：Titanium dioxide is taken by formula proportion and 1/2 glycerol is ground with mortar
Mill is uniform standby；
(3.2) lemon yellow, carmine, the configuration of burnt sugar coloring mixed liquor：Lemon yellow, carmine, caramel are taken by formula proportion
Color is standby after being stirred with appropriate purified water；
(3.3) glue is changed：By formula proportion by remaining 1/2 glycerol, purified water inputization glue tank, 60～80 are heated to
DEG C, standby titanium dioxide, glycerol mixed liquor are added, stir, then gelatin is put into several times, stir and continue to be heated to gelatin
Quan Rong, adds lemon yellow, carmine, burnt sugar coloring mixed liquor, stirs, evacuation (vacuum -0.08MPa) to glue without
Bubble, inspect by random samples glue, it is qualified after the mesh sock filtrations of Jing 100 put glue, be placed in storage glue tank in 50～60 DEG C insulation, it is standby；
(4) preparation of content
Cera Flava is put in 1/2 soybean oil, 70 DEG C are heated to, after Cera Flava is completely dissolved in soybean oil, is added remaining
Soybean oil, mix homogeneously, add Ubidecarenone be sufficiently mixed uniformly, cross colloid mill grind 2 times, mistake 80 mesh sieves, stir,
Evacuation deaerates, and takes off bubble, standby；
(5) pelleting, sizing
Capsule 's content, glue are pressed into into soft capsule by encapsulating machine, 400mg/ grains keep rotating speed to be 1.5～3.0
Rev/min, sprinkler body temperature is kept for 35～50 DEG C, and rubber thickness is 0.65～0.75mm；The soft capsule for pressing is fixed in rotating cage
Type 2.0～3.0 hours, 18～26 DEG C of temperature, relative humidity 30～40%, oil absorbing cloth completes to wipe ball operation used in rotating cage；
(6) it is dried
Jing finalizes the soft gelatin capsule for coming and is placed on basin, in relative humidity 20%～30%, the drying that 20～30 DEG C of temperature
It is dried to rubber moisture 7%～10% in room；
(7) lamp inspection
Dried soft gelatin capsule is placed on and is selected on ball platform, the visual inspection ball under light picks concentric reducer, abnormal shape, oil leak, viscous
The unqualified soft gelatin capsules such as company；Featured soft gelatin capsule is placed in the clean bucket of tool lid, sealing；
(8) pack
The qualified soft gelatin capsule of Jing lamp inspection, by 60/it is bottled enter bottle in, label, loaded in carton, joint sealing；
(9) product warehousing and shelf appeal
(9.1) after the sampled quality inspection of product to be checked is qualified, warehouse-in handss are handled with inspection report, the quality certification, storage bill
It is continuous；
(9.2) product should be stored in ventilation, dry warehouse.In warehouse stack when should from wall, liftoff neat stacking,
Certain distance must be left between heap and heap.
The raw material of this product is Ubidecarenone, and Ubidecarenone is pressed powder, and we design and are made into soft capsule, with Semen sojae atricolor
Oil is substrate, and because Ubidecarenone can not dissolve in substrate, therefore design adds Cera Flava as suspending agent in formula, makes auxiliary
Enzyme Q10 is uniformly dispersed in soybean oil, and in vivo disintegrate makes effective ingredient discharge rapidly after taking, and soft capsule is made in addition
Agent also have it is quantitative accurately, production automation degree it is high, absorb fast, product appearance is exquisite, tempting, takes excellent with easy to carry etc.
Point, further, since the functional component Ubidecarenone of this product is unstable being oxidized easily, being made into soft capsule can also isolate
Air, light, it is to avoid active substance is oxidized, make product stable before the deadline, so as to ensure the performance of effect, therefore this product
Soft capsule is designed as the dosage form of this product.
Specific embodiment：
Embodiment 1, formula：
Softgel shell：Gelatin 30kg, glycerol 10kg, water 30kg, titanium dioxide 0.2kg, burnt sugar coloring 0.2kg, carmine 0.02kg,
Lemon yellow 0.02kg；
Content：Ubidecarenone 4kg, Cera Flava 1kg, soybean oil 50kg；
Preparation method is as follows：
(1). the preparation of supplementary material
Qualified Ubidecarenone, Cera Flava, soybean oil, gelatin, glycerol, titanium dioxide, lemon yellow, carmine, caramel will be checked
Color, in the de- outsourcing in relief area, is carried out after surface sterilization in strict accordance with the program into 100,000 grades of clean areas to inner packing, is sent into clean
Net area is standby；
(2). weighing is got the raw materials ready
Ubidecarenone, Cera Flava, soybean oil, gelatin, glycerol, titanium dioxide, lemon yellow, carmine, Jiao are weighed by formula proportion
Fried sugar, it is standby；
(3) preparation of glue
(3.1) titanium dioxide, the preparation of glycerol mixed liquor：Titanium dioxide is taken by formula proportion and 1/2 glycerol is ground with mortar
Mill is uniform standby；
(3.2) lemon yellow, carmine, the configuration of burnt sugar coloring mixed liquor：Lemon yellow, carmine, caramel are taken by formula proportion
Color is standby after being stirred with appropriate purified water；
(3.3) glue is changed：By formula proportion by remaining 1/2 glycerol, purified water inputization glue tank, 60～80 are heated to
DEG C, standby titanium dioxide, glycerol mixed liquor are added, stir, then gelatin is put into several times, stir and continue to be heated to gelatin
Quan Rong, adds lemon yellow, carmine, burnt sugar coloring mixed liquor, stirs, evacuation (vacuum -0.08MPa) to glue without
Bubble, inspect by random samples glue, it is qualified after the mesh sock filtrations of Jing 100 put glue, be placed in storage glue tank in 50～60 DEG C insulation, it is standby；
(4) preparation of content
Cera Flava is put in 1/2 soybean oil, 70 DEG C are heated to, after Cera Flava is completely dissolved in soybean oil, is added remaining
Soybean oil, mix homogeneously, add Ubidecarenone be sufficiently mixed uniformly, cross colloid mill grind 2 times, mistake 80 mesh sieves, stir,
Evacuation deaerates, and takes off bubble, standby；
(5) pelleting, sizing
Capsule 's content, glue are pressed into into soft capsule by encapsulating machine, 400mg/ grains keep rotating speed to be 1.5～3.0
Rev/min, sprinkler body temperature is kept for 35～50 DEG C, and rubber thickness is 0.65～0.75mm；The soft capsule for pressing is fixed in rotating cage
Type 2.0～3.0 hours, 18～26 DEG C of temperature, relative humidity 30～40%, oil absorbing cloth completes to wipe ball operation used in rotating cage；
(6) it is dried
Jing finalizes the soft gelatin capsule for coming and is placed on basin, in relative humidity 20%～30%, the drying that 20～30 DEG C of temperature
It is dried to rubber moisture 7%～10% in room；
(7) lamp inspection
Dried soft gelatin capsule is placed on and is selected on ball platform, the visual inspection ball under light picks concentric reducer, abnormal shape, oil leak, viscous
The unqualified soft gelatin capsules such as company；Featured soft gelatin capsule is placed in the clean bucket of tool lid, sealing；
(8) pack
The qualified soft gelatin capsule of Jing lamp inspection, by 60/it is bottled enter bottle in, label, loaded in carton, joint sealing；
(9) product warehousing and shelf appeal
(9.1) after the sampled quality inspection of product to be checked is qualified, warehouse-in handss are handled with inspection report, the quality certification, storage bill
It is continuous；
(9.2) product should be stored in ventilation, dry warehouse.In warehouse stack when should from wall, liftoff neat stacking,
Certain distance must be left between heap and heap.
The formula of embodiment 2：
Softgel shell：Gelatin 70kg, glycerol 25kg, water 60kg, titanium dioxide 1.2kg, burnt sugar coloring 0.5kg, carmine 0.3kg,
Lemon yellow 0.3kg；Content：Ubidecarenone 15kg, Cera Flava 30kg, soybean oil 95kg；
Preparation method is same as Example 1.
Health care is screened
1st, recipe determination
Ubidecarenone is the vitamin substances being present in organism, and it is primarily involved in the composition of mitochondrial inner membrane respiratory chain,
And the oxidative phosphorylation process of cell is participated in as a class hydrogen carrier, play an important role in ATP synthesis, because it has quinoid
And the construction featuress of isopentenyl side chain, determine that it also has many important physiological functions in organism.In the thin of human body
Ubidecarenone can be found in after birth, is especially enriched in the heart, lung, liver,kidney,spleen, pancreas, adrenal gland, Ubidecarenone is total in human body
Content is only 500～1500mg, and is reduced with age.After research finds that Ubidecarenone is edible, energy active cell is exhaled
Inhale, accelerate to produce the ATP with high-energy, strengthen myocardium metabolic function, improve heartbeat efficiency, mitochondrion can be suppressed
Peroxidating, protect biofilm structure integrity, have special potentiation to immunity.Therefore, my company is from Ubidecarenone
Primary raw material makes soft capsule, the health care with enhancing immunity.
2nd, the impact of the efficacy effect of raw material, consumption and property safe to the human body
The efficacy effect of 2.1 raw materials
Shown according to correlational study and documents and materials, Ubidecarenone has the health care of enhancing immunity, machine can be strengthened
The immunity of body, below just the effect in terms of Ubidecarenone enhancing immunity is discussed with reference to correlational study：
Xu Caiju [1] etc. studies impact of the Ubidecarenone to mouse immune regulatory function, and Primary Study its mechanism of action.
Method:In terms of the attack function four of cellular immunization, humoral immunization, monocytes/macrophages phagocytosiss and natural killer cell
Impact of the observation Ubidecarenone to immune function of mice.As a result:With negative control group (distilled water) and solvent control group (vegetable oil)
Relatively, Ubidecarenone 8.0,12.0 and 24.0mg/kg.BW dosage groups can improve the increasing of the mouse spleen lymphocyte of ConA inductions
Grow ability；4.0th, 8.0 and 12.0mg/kg.BW dosage groups can increase the left back foot plantar thickness difference 24h measured values of mice；12.0
Mice hemolysis plaque number can be improved with 24.0mg/kg.BW dosage groups；4.0th, 8.0,12.0 and 24.0mg/kg.BW dosage groups it is equal
NK cells in mice activity can be improved and Turnover of Mouse Peritoneal Macrophages swallows the phagocytic rate of chicken red blood cell；12.0mg/kg.BW dosage groups
The phagocytic index that Turnover of Mouse Peritoneal Macrophages swallows chicken red blood cell can be improved.Test result indicate that Ubidecarenone has strengthens mice
Immunity.
Peng Liang [2] etc. inquires into impact of the Ubidecarenone to immune function of mice.Method:Respectively with 230.0mg/kg BW,
After 115.0mg/kg BW, the Ubidecarenone of 57.5mg/kg BW dosage are to mice continuous gavage 30d, ConA inductions are determined respectively
Mouse lymphocyte transformation function, the delayed allergy of mice, mouse antibodies are generated and hemolysin level, monokaryon-macrophage
Cell carbonic clearance ability, peritoneal macrophage phagocytosis chicken red blood cell ability and NK cytoactives.As a result:Ubidecarenone can increase
Spleen lymphocyte proliferation, the transformation of strong mice, improves the delayed allergy degree of mice, promotes the antibody life of mice
Into cell propagation, the serum hemolysin of mice is improved, strengthen the monocytes/macrophages carbonic clearance function of mice, improved little
Mus NK cytoactives.As a result show that Ubidecarenone has the effect for strengthening mouse immunity.
Gou big bright [3] etc. to be observed circulate in vitro and add in priming fluid Ubidecarenone to patient during extracorporeal circulation erythrocyte membrane
And the protected effect of immunologic function.The cardiopulmonary bypass time patient of 30 minutes or so 20 is randomly divided into matched group and auxiliary by experiment
Enzyme Q10 groups, 10 per group.Ubidecarenone group circulates in vitro addition Ubidecarenone 2mg/kg in priming fluid.Two groups in favourable turn
Before, favourable turn 15 minutes, 30 minutes and morning next day extracting vein blood survey malonaldehyde (MDA), free hemoglobin (FHb) and erythrocyte
Immune function (R-CIA), erythrocyte membrane immune complex (R-CIC).Test result indicate that Ubidecarenone group is made a connection 15 minutes
Afterwards R-CIA is higher than matched group less than matched group for MDA, FHb.Description of test Ubidecarenone can preferably protect patient during extracorporeal circulation
Erythrocyte membrane and immunologic function.
Immunoloregulation function is disorderly and autoimmune, especially lymphocyte subgroup are extremely dilated cardiomyopathy morbidity
Principal immune mechanism.NK cells work in antiviral, antitumor and immunomodulating, and research finds the NK of cardiomyopathy expansion people
Cytoactive is reduced.Both of the above is relevant with the pathology of cardiomyopathy expansion.Hu Qunying [4] has carried out Ubidecarenone to expanding
The clinical observation of cardiomyopathy immunoregulation effect, test result indicate that, Ubidecarenone treatment group Patient cells' immunologic derangement is obtained
Different degrees of improvement, Ubidecarenone can the immune medicine of two-ways regulation as non-specificity.
Yang Xueyong [5] studies Ubidecarenone and rush of the intravenous nutrition liquid use in conjunction to infant postcardiac surgery immunologic function
Enter effect.Random selection 50 receives the infant of open heart operations, experimental group 25, from preoperative 3 days to 5 days after operation, flesh
Note Ubidecarenone 0.5mg/kg.d and intravenous injection nutritional solution 10ml/kg.d；Matched group 25 is removed and does not receive above-mentioned treatment, remaining
Process consistent.TNF, serum prealbumin, T lymphocyte subtypes are surveyed using immunological method.Test
As a result find that experimental group Postoperative Immunity function lowers to have and change the features such as short little, persistent period and fast recovery, show Ubidecarenone
There is remarkable effect with raising to the recovery as early as possible for promoting Postoperative Immunity function with intravenous nutrition liquid use in conjunction.
In sum, Ubidecarenone has the effect of enhancing immunity, and this product adopts Ubidecarenone for raw material, makes with increasing
The health food of strong immunity function is scientific.Disease prevention and control center of product Jing Hunan Province according to《Health care
Food test and assessment technique specification》(version in 2003) requires to carry out animal functional experiment, as a result proves there is enhancing immunity
Health care.
2.2 consumptions and safety
This product adds Ubidecarenone 45g per 1000, takes 1 time daily, 1 every time, equivalent to taking Ubidecarenone daily
45mg, Ubidecarenone consumption meet State Food and Drug Administration with regard to Ubidecarenone evaluate regulation " no more than 50mg/
The regulation of day ".
The acute toxicity and genetoxic of coenzyme Q 10 soft capsule, for Ubidecarenone further exploitation provide safety according to
According to.Method:Application mouse acute oral toxicity test, Salmonella reversion test, mice bone marrow micronucleus and mice
Sperm malformation test carries out experimental observation to the toxicity of certain coenzyme Q 10 soft capsule.As a result:The coenzyme Q 10 soft capsule is to male and female
Mice LD50 is all higher than 10000mg/kg.bw, true border innocuous substance；The each dosage group of tested material is returned and becomes clump count in Salmonella reversion test
Become 2 times of clump count not less than beaming back certainly, be as a result feminine gender also without dose-response relationship；PCEMNR
Each dosage group micronuclear rateses in micronucleus test and mouse inbred strain, between rate of teratosperm and negative control group without significance
Difference (P>0.05), there is pole significant difference (P between cyclophosphamide positive controls and negative control group<0.01), it was demonstrated that
Result of the test is feminine gender.Under this experimental condition, the nontoxic level in the true border of the coenzyme Q 10 soft capsule does not show acute toxicity
And Genotoxic Effect.
Inquire into Ubidecarenone toxicological safety.Method is tested using chmice acute Oral toxicity, genetic toxicity test
(Salmonella reversion test, mice bone marrow micronucleus and mouse inbred strain) and rat 30d feeding trials, point
Guan Cha not the acute toxicity of Ubidecarenone, genetoxic and subacute toxicity.As a result maximum tolerated dose of the Ubidecarenone to mice
(MTD) it is more than 30000mg/kg.BW, genetic toxicity test result is feminine gender；(distinguish suitable with 360,540,720mg/kgBW
Recommend 50,75,100 times of consumption in human body), continuously to rat oral gavage 30d, growth of animal is sent out during test for the sample of 3 dosage
Educate good, the body weight of each dosage group rat, gain in weight, food-intake, food utilization, routine blood test and biochemical detection indexes, internal organs
Weight and internal organs/body weight ratio compare with matched group, the not statistically significant (P of difference>0.05)；Histopathological examination, respectively
The tissue such as experimental group rats'liver, kidney, gastrointestinal, spleen, testis and ovary is showed no pathological change.Experiment shows Ubidecarenone to dynamic
Thing is without overt toxicity.
This product Jing acute oral toxicity test shows：The maximum tolerated dose of female, male Kunming mouse is all higher than
18.06g/kgbw, belongs to nontoxic level；Three genetic toxicity test results are feminine gender.30 days feeding trials of Jing：With 0.167,
0.333rd, to SD rat oral gavages 30 days, during experiment, animal growth is good, respectively for 0.667g/kgbw soft capsule contents
Dosage group body weight, weightening, food utilization, routine blood indexes, blood biochemistry index, organ weights and internal organs/body weight ratio with it is right
Compare according to group, there was no significant difference (P>0.05).Gross anatomy and tissue pathology checking have no the abnormal change relevant with sample,
Prompting this product is fed and has no obvious toxic-side effects to rat for 30 days.
Above experimental result prove the safety of this product be it is very high, can long-term taking.
All above-mentioned this intellectual properties of primarily enforcement, setting limits this new product of enforcement of other forms
And/or new method.Those skilled in the art will be using this important information, the above modification, to realize similar execution feelings
Condition.But, all modifications or transformation are based on the right that new product of the present invention belongs to reservation.
The above, is only presently preferred embodiments of the present invention, is not the restriction for making other forms to the present invention, is appointed
What those skilled in the art changed possibly also with the technology contents of the disclosure above or be modified as equivalent variations etc.
Effect embodiment.But it is every without departing from technical solution of the present invention content, according to the technical spirit of the present invention to above example institute
Any simple modification, equivalent variations and the remodeling made, still falls within the protection domain of technical solution of the present invention.
Claims (1)
1. coenzyme Q 10 soft capsule, is made up of softgel shell and content：Characterized in that, softgel shell is made up of following raw material：Gelatin 30-
70 parts, glycerol 10-25 parts, water 30-60 parts, titanium dioxide 0.2-1.2 parts, burnt sugar coloring 0.2-0.5 parts, carmine 0.02-0.3
Part, lemon yellow 0.02-0.3 parts；Content is made up of following raw materials：Ubidecarenone 4-15 part, Cera Flava 1-30 parts, soybean oil 50-95
Part；
Preparation method is as follows：
(1). the preparation of supplementary material
By checking, qualified Ubidecarenone, Cera Flava, soybean oil, gelatin, glycerol, titanium dioxide, lemon yellow, carmine, burnt sugar coloring are tight
Lattice, in the de- outsourcing in relief area, are carried out after surface sterilization according to the program into 100,000 grades of clean areas to inner packing, send into clean area
It is standby；
(2). weighing is got the raw materials ready
Ubidecarenone, Cera Flava, soybean oil, gelatin, glycerol, titanium dioxide, lemon yellow, carmine, caramel are weighed by formula proportion
Color, it is standby；
(3) preparation of glue
(3.1) titanium dioxide, the preparation of glycerol mixed liquor：Titanium dioxide is taken by formula proportion and 1/2 glycerol mortar grinder is equal
It is even standby；
(3.2) lemon yellow, carmine, the configuration of burnt sugar coloring mixed liquor：Lemon yellow, carmine, burnt sugar coloring are taken by formula proportion to use
Appropriate purified water is standby after stirring；
(3.3) glue is changed：By formula proportion 60～80 DEG C will be heated in remaining 1/2 glycerol, purified water inputization glue tank, plus
Enter standby titanium dioxide, glycerol mixed liquor, stir, then put into gelatin several times, it is entirely molten to stir and continue to be heated to gelatin,
Add lemon yellow, carmine, burnt sugar coloring mixed liquor, stir, evacuation (vacuum -0.08MPa) to glue bubble-free,
Sampling observation glue, it is qualified after the mesh sock filtrations of Jing 100 put glue, be placed in storage glue tank in 50～60 DEG C insulation, it is standby；
(4) preparation of content
Cera Flava is put in 1/2 soybean oil, 70 DEG C are heated to, after Cera Flava is completely dissolved in soybean oil, is added remaining big
Oleum Glycines, mix homogeneously adds Ubidecarenone to be sufficiently mixed uniformly, crosses colloid mill and grinds 2 times, crosses 80 mesh sieves, stirs, and takes out true
Sky degassing, takes off bubble, standby；
(5) pelleting, sizing
Capsule 's content, glue are pressed into into soft capsule by encapsulating machine, 400mg/ grains, keep rotating speed be 1.5～3.0 turns/
Minute, sprinkler body temperature is kept for 35～50 DEG C, and rubber thickness is 0.65～0.75mm；The soft capsule for pressing is shaped in rotating cage
2.0～3.0 hours, 18～26 DEG C of temperature, relative humidity 30～40%, oil absorbing cloth completes to wipe ball operation used in rotating cage；
(6) it is dried
Jing finalizes the soft gelatin capsule for coming and is placed on basin, in relative humidity 20%～30%, the drying shed that 20～30 DEG C of temperature
It is dried to rubber moisture 7%～10%；
(7) lamp inspection
Dried soft gelatin capsule is placed on and is selected on ball platform, ball is visually examined under light, pick concentric reducer, abnormal shape, oil leak, adhesion etc.
Unqualified soft gelatin capsule；Featured soft gelatin capsule is placed in the clean bucket of tool lid, sealing；
(8) pack
The qualified soft gelatin capsule of Jing lamp inspection, by 60/it is bottled enter bottle in, label, loaded in carton, joint sealing；
(9) product warehousing and shelf appeal
(9.1) after the sampled quality inspection of product to be checked is qualified, with inspection report, the quality certification, storage bill warehouse-in formality is handled；
(9.2) product should be stored in ventilation, dry warehouse.When stacking in warehouse should from wall, liftoff neat stacking, heap with
Certain distance must be left between heap.
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|---|---|---|---|---|
| CN107616506A (en) * | 2017-09-12 | 2018-01-23 | 陈胤成 | Brain-invigorating walnut oil capsule based on phosphatidylserine and preparation method thereof |
| CN109394725A (en) * | 2018-12-05 | 2019-03-01 | 天津铸源健康科技集团有限公司 | A kind of ubiquinone10Soft capsule and preparation method thereof |
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Application publication date: 20170419 |