CN106943372A - A kind of auxiliary hyperglycemic soft capsule and its production technology - Google Patents
A kind of auxiliary hyperglycemic soft capsule and its production technology Download PDFInfo
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
- A61K35/644—Beeswax; Propolis; Royal jelly; Honey
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- 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)
- A61K36/42—Cucurbitaceae (Cucumber family)
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- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/488—Pueraria (kudzu)
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- 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
Abstract
The present invention provides a kind of auxiliary hyperglycemic soft capsule, and its prescription component is propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate, linseed oil, beeswax, gelatin, pure water, glycerine, burnt sugar coloring, and the proportioning of above-mentioned each component by weight is：The 60g of propolis 40, the 60g of kudzu root extract 40, the 40g of Bitter Melon P.E 20, the 0.2g of chromium picolinate 0.1, the 370g of linseed oil 350, the 9g of beeswax 6, the 80g of gelatin 60, the 80g of pure water 60, the 19g of glycerine 16, the 1.5g of burnt sugar coloring 0.5.It is an advantage of the current invention that the formula is related to a variety of traditional Chinese medicines, his proportioning saves the activity of various composition to greatest extent, coordination, synthesis and booster action between each composition are played, there is obvious and effective adjustment effect to blood glucose, and processing technology is simple, safe without toxic side effect.
Description
Technical field
The invention belongs to health product technology field, and in particular to a kind of hypoglycemic soft capsule and its production technology.
Background technology
With the development and the change of people's production activity and habits and customs of society, the food of people is more and more finer, battalion
Support and increasingly enrich；The side effect of modern industrialization causes ecological degeneration and environmental pollution, and the health to people is brought not
On chemical substance, pollution by pesticides in profit influence, high-strung work rhythm, air, food, diabetes morbidity are rapid
Rise, as a kind of common disease, frequently-occurring disease.According to the World Health Organization（WHO）And IDF（IDE）Investigation discovery,
At least more than 200,000,000 populations of the whole world in 2003 suffer from diabetes, and diabetes turn into the 3rd after cancer, AIDS
Big persistent ailment.China's diabetes number of patients speedup also quickly, according to investigations, national diabetic account for the ratio of total population from
0.67% in 1980 rises to 3.2% in 1997, rises nearly five times, and whole nation diabetes patient's total population reaches nearly 100,000,000 at present,
Occupy second place of the world.Increase diabetes patient 3000, national epidemiology survey in 2007 ~ 2008 years, more than 20 years old newly daily
Population diabetes prevalence is up to 9.7%, wherein more than 40 years old accounts for the overwhelming majority again.Expect 2015, whole world sugar
Urine patient is up to 400,000,000 people, and American-European diabetic will account for the 5% of population, and Asia diabetic will increase by 3 times,
We may be raised to 14%.From IDF, recent statistics are shown, the whole world just has 1 people to die from every 10 seconds
Diabetes, 2 people are diagnosed as New-Onset Diabetes Mellitus people, and diabetes drastically spread in the world, and its impetus is suddenly, endanger it
Greatly, it has also become " disasters in 21st century ", this severe development trend has caused the whole world and greatly paid close attention to.1989 5
Yue24Jie World Health Assembly is fixed by annual November 14 by a prevention and the agreement of control diabetes
For world's diabetes day, diabetes are paid close attention to arouse people.And the end of the year 2006, the United Nations is further through a resolution：I.e.
From 2007, " world's diabetes day " in annual November 14 are renamed as " the United Nations's diabetes day ", enter one
Step has blowed the bugle of global anti-diabetic.
China's traditional Chinese medicine is a great treasure-house, is that the 2000 Duo Nianlai Chinese nation prevent and cure diseases the preciousness that is abundant without compare
Summary of experience.It is the theoretical system of complete set, early in Yellow Emperor, a legendary ruler《Interior warp》On just have the argumentation of " preventive treatment ", " prevent early
Control " before disease is come, the actually preventive medicine viewpoint and characteristic of the most superb traditional Chinese medical science.In the course of people's life, such as glycosuria
The appearance of the symptoms such as disease, hypertension, cardiovascular and cerebrovascular diseases is common, suitably takes some health food effectives, is carried out early
Preventing and treating, effect that is even more ideal, getting twice the result with half the effort is had than " disease to control it ".
Traditional Chinese medicine is so long lasting, and still highly visible so far, it is to use pure natural, multi-flavor polypharmacy at all,
Multicomponent, multichannel, Mutiple Targets are developed, while effect is played, it is evident in efficacy, with advantageous advantage.Chinese medicine compound prescription is not
Blood glucose, glucose in urine can only be reduced, can also comprehensively regulating whole body reach the purpose treated both principal and secondary aspect of disease.Therefore the whole society especially needs further
Research and develop a class toxicity low, eutherapeutic hypoglycemic health food, the present invention has exactly adapted to this demand.
1. propolis
Prevention And Cure Using Propolis diabetes and its mechanism of action, are reported according to the research of domestic and foreign scholars, propolis reduction blood glucose, are prevented and are controlled
Treating the mechanism of action of diabetes and its intercurrent disease mainly has the following aspects:
The research reports such as the effect Liu Fu seas of 1.1 reduction blood glucose, propolis extract has significant hypoglycemic effect, and its is hypoglycemic
Total effective rate is up to 94.7%.Research shows that some flavonoids, terpenoid substance in propolis, which have, to be promoted to utilize exogenous Portugal
The effect of grape sugar synthesis hepatic glycogen, and the material such as Catalpol, pterostibene in this kind of material has the effect of obvious reduction blood glucose.
For a part of patient, these materials can just play good blood sugar reducing function in the case where content is very low.Study and also found,
Propolis extract does not influence on the blood glucose of normal person, illustrates that propolis extract has the effect of bidirectional modulation blood sugar level.
The 1.2 treatment hypoglycemics for repairing the effect diabetes of impaired pancreas islet are crucial, but the reparation of impaired pancreas islet is only root
This.Research shows that propolis plays the role of promotion organization regeneration, and pancreas islet, promotion pancreatic cell regeneration, raising pancreas are damaged with repairing
Effect of island element secretion quality, is allowed to form benign cycle, so as to effectively adjust blood glucose, is inherently eliminated diabetes disease
Cause.Therefore, adhere to that taking propolis can shield to islet cells, and the islet cells for occurring lesion can be helped to recover just
Chang Gongneng.
The refined China of effect Lee of 1.3 enhancing immunologic functions waits (2001) to study propolis to immunologic hypofunction model mouse cell
The influence of immunologic function, finds the lymphopoiesis that propolis ethanol extract can promote ConA to induce, increase T cell sum is simultaneously
Adjust T cell subgroup disorderly, there is immunostimulation and immunoregulation effect to the mouse cell immunologic function of immunologic hypofunction.
Point out that propolis can strengthen the antibody-producting cell function of immunologic hypofunction mouse in (2001) such as Xiao Hong, improve hemolysin and contain
Amount, strengthens Function of mononuclear phagocyte, illustrates that propolis plays the role of to promote and adjusts humoral immunity of organism function and increase body
The phagocytosis of phagocyte.Immunologic function enhancing be improve body resistance against diseases, improve the overall quality, prevent diabetes and its
The important foundation of complication.
1.4 is anti-oxidant, red plumage Jin of the famous doctor of medicine of effect of scavenging radical bears (1995) report, in vivo it is excessive from
Closely related with diabetes by base and its lipid peroxide, it is that free radical and lipid peroxide cause to have quite a few diabetes
, or it is further deteriorated, and research has shown that, treating diabetes with antioxidant (SOD) has 50% -60% effective percentage.
It is generally acknowledged day with good antioxygenic property containing abundant flavonoids, glucoside, phenols, terpene compound in propolis
Right antioxidant, just there is very strong oxidation resistance in low concentration, and can significantly improve SOD activity, and can be stable
With generation and the deposition for removing free radical, reduction lipid peroxy thing and lipofuscin, protection cell membrane, enhancing cell viability, regulation
Organ-tissue function.Silymarin particularly in propolis can remove free radical, stable biomembrane, play protection to islet damage and make
With reduction MDA (MDA) level, while blood glucose caused by preventing alloxan is persistently raised.Therefore, propolis is used to prevent and treat sugar
Urine disease has good result.
1.5 antibacterial and anti-inflammation functions propolis are precious natural wide spectrum antibiotics, with anti-inflammation, antiviral work
With can simultaneously suppress or kill bacterium, fungi and virus, be the main cause for effectively treating various infection.It facts have proved, sugar
Urine patient adhere to taking propolis in right amount, while smearing bee glue preparation in wound, can effectively treat various infection, make to control long
Infection more is not controlled and rehabilitation.The antibacterial of propolis, antivirus action not only strong excessively any antibiotic, and for a long time
Drug resistance and toxic and side effect will not also be produced by taking.
1.6 reducing blood lipid, improvement blood circulation effect diabetic are mostly with hyperlipidemia, blood vessel aging speed ratio
Normal person is fast, is easy to trigger microcirculation disorder, cerebral thrombus, heart disease, cardio-cerebrovascular complication occurs.Enriched in propolis
Flavonoid substances there is good reducing blood lipid, the permeability of capillary, softening blood vessel, the effect for protecting blood vessel is reduced.
This kind of material antioxygenic property is very strong, is the powerful mean for tackling free radical, blood vessel can be protected prematurely to become fragile,
It is hardened, follows the string.Thus be conducive to improving blood circulation, be conducive to controlling diabetic's visual impairment, prevent blood vascular system
Unite complication.
The research of 1.7 hepatoprotective effects shows that liver has epochmaking effect in the balance of blood glucose, is to maintain blood glucose constant
Vitals, it can adjust the concentration of blood glucose.And propolis extract can protect liver cell from ethanol, carbon tetrachloride, half
Damage (Lin etc., 1997 of the toxic substances such as lactose amine, acrylic ethanol;Merino etc., 1996).Especially propolis water is extracted
Two caffeol quinoline Buddhist nuns acid in thing has very strong hepatoprotective effect (Kadota etc., 1996), thus can make liver in glycometabolism
Preferably play a role, the glucose glycogen biosynthesis entered in human body can be stored, can also be glucose by hepatic glycogenolytic
The concentration of blood glucose is adjusted in input blood with this, blood glucose is maintained normal level.
Research shows both at home and abroad for the effect of 1.8 macro- and trace-elements, the chemical element such as calcium, magnesium, potassium, phosphorus, zinc, chromium,
There is special role to the preventing and treating of diabetes.Chromium has hypoglycemic effect, can activate insulin, improves sugar tolerance;Calcium can influence pancreas
The secretion and release of island element;Zinc can maintain the 26S Proteasome Structure and Function of insulin;Magnesium participates in the function point analysis of beta Cell of islet, can change
Kind glycometabolism index, reduces vascular complication incidence;Phosphorus, which lacks, can make insulin combine exception on cell membrane;Nickel is pancreas islet
The coenzyme composition of element;Potassium is the important component in cell liquid, and participates in protein, carbohydrate metabolism, can prevent diabetes
Patient's multiple complications occur;Cobalt can prevent and treat diabetic neuropathy and improve red cell deformability, so as to reduce diabetes
Ischemic blood vessels lesion etc..The macro- and trace-element of rich content is also functioned in diabetes and its prevention and treatment of complication in propolis
Important function.
The materials such as flavonoids, glucoside in 1.9 energy supplies effect propolis, can strengthening ATPase activity, (card is bright
Si Ji etc., 1977), stimulate body to produce more atriphos (ATP).Atriphos is the important next of human body energy
, there is supplying energy in source, regains one's strength.Diabetic is taken after a period of time propolis, and most muscle power are substantially recovered, and
And constitution is progressively improved.
1.10 integrated control Effect studies show, containing more than 30 kinds of the essential trace elements of the human body in propolis, kind more than 20
Amino acid, more than 70 kinds of flavone compound, tens of kinds of aromatic compounds are abundant organic acid, terpenes, vitamin, enzyme, more
The natural bioactive ingredients such as sugar.Even in science highly developed today, the mankind still can not synthesize with equal authenticity
The complicated proportioning of material, exactly propolis, marvellous composition imparts its comprehensive preventive and therapeutic effect extensively:Both it is hypoglycemic, drop again
Blood fat;Both pancreas islet, and dredging vascellum are repaired；Both nerve is repaired, but promotion organization regenerates;Both anti-inflammation, and comprehensive adjustment machine
Body;Both liver is protected, kidney is protected again.Therefore, the preventing and treating of Propolis on Diabetes Mellitus and its complication is many factors collective effect
Result.And, the protective effect of Propolis on Diabetes Mellitus patient is many, and in the complex treatment of diabetes, propolis has
Unique effect and good prospect.
2. balsam pear
The hypoglycemic effect of balsam pear
The blood sugar reducing function of balsam pear is its most important pharmacological action, is constantly subjected to the concern of people.Momordica saponins in recent years by
One of bioactivator being considered in balsam pear.Early in nineteen sixty, just there are some researches show to normal and alloxan type sugar
Urine patient and his family rabbit gavages balsam pear juice, and its blood sugar level is substantially reduced.
Nineteen sixty-five, Sucrow is extracted from the dry fruit of balsam pear isolates Charantin (charantin), and proves
It is the equimolecular mixture of cupreol-β-D-Glucose glucoside and 5,25- beans steroid dienol -3- β-D-Glucose glucoside.
1966, Rao was studied the hypoglycemic effect of balsam pear fruit extract, found intravenous injection extract 5
Blood sugar level can be caused to reduce after mg/kg, 4h, and think that this material is hypoglycemic active ingredient, its hypoglycemic activity is better than
1-butyl-3-tolylsulfonylurea.
1975, Olaniyi, which is experimentally confirmed Charantin, rather stronger blood sugar reducing function than first moral.
1992, Zhang Pingping et al. was experimentally confirmed, with hypoglycemic of the homemade momordica saponins to family's model of rabbit
Effect is obvious.Experimental animal is the big ear rabbit of Japan, with 2.5 mL/kg momordica saponins extract solution gastric infusions, control group medicine
The dosage of glibenclamide is 0.15mg/kg.As a result show, momordica saponins hypoglycemic effect is slow compared with glibenclamide and holds.
Wang Feng et al. carries out clinical verification with momordica saponins, treats type II diabetes people 46, total effective rate reaches
78.3%, continuous use 3 months, patient blood glucose is controlled, and is had no toxic side effect.
Jiang Yi treats patients with NIDDM 100 with momordica saponins, and total effective rate is 82%.
King is first remote et al. to be reported, momordica saponins has hypoglycemic, reducing blood lipid function, and to the hypoglycemic of momordica saponins
Mechanism is explored, and is shown that momordica saponins may be by adjusting sugar skin hormone level, is adjusted enzyme activity, stimulate glycogen
Synthesize to reduce blood glucose.
Modern medicine study shows, momordica saponins also with anti-oxidant, anti-aging and is carried in addition to hypoglycemic effect
The functions such as high immunity.By the developmental research to balsam pear, not only new approach can be provided for the exploitation of balsam pear product, also may be used
New product is provided for the health of people.
3. the root of kudzu vine
The hypoglycemic effect of the root of kudzu vine
Su Yong etc. is with after hyperglycaemia mice lavage 17d of the Dietary Fiber from Pueraria to normal small white mouse and caused by alloxan.Knot
Fruit finds that Dietary Fiber from Pueraria does not make significant difference to normal mouse blood sugar, but can significantly reduce the hyperglycaemia caused by alloxan.
Prompting Dietary Fiber from Pueraria can be used to prevent diabetes.Sun Wei etc. has inquired into Puerarin in Rats diabetic rat pancreas line
The mechanism of plastochondria protective effect, research finds that Puerarin has protective effect to diabetic rat pancreas.Its mechanism may be by
Free radical is removed, the generation of MDA is reduced;Mitochondrial nitric oxide synthase vigor is reduced, so as to mitigate nitric oxide
Caused damage.Sun Wei etc. also detects adipose tissue ADRP gene mRNA levels with RT-PCR methods.Puerarin is observed to II type
The influence of diabetes rat lipid metaboli and IMA-ADF-001 (ADRP) gene mRNA expression.As a result show, by the root of kudzu vine
After extract for treating, rat blood sugar level and insulin resistance level decline, and rat omental adipose tissue ADRP gene mRNAs
Expression substantially reduction, points out Puerarin to may be by suppressing the expression of adipose tissue ADRP genes, reduces insulin resistance water
It is flat, so as to reduce type II diabetes rat blood sugar and improve internal disorders of lipid metabolism, reach the purpose for the treatment of diabetes.
4. chromium picolinate
The hypoglycemic effect of chromium picolinate/Organic Chromium (III)
The relation of 4.1 Organic Chromiums (III) and diabetes
Chromium is one of the essential trace elements of the human body, and chromium exists in human body in trivalent chromium form, and human body total chrome is about 117
Mg, amount is 0.005~0.2 mg the need for human body is daily.The compound formed by trivalent chromium, is referred to as " GTF
", (GTF) this is a kind of compound being made up of chromium, niacin, glutamic acid, glycine, sulfur-containing amino acid etc., there is promotion pancreas islet
The effect of plain activity, can promote insulin to be combined with acceptor.Its mode of action is probably the GTF containing chromium (III)
A stable bridge is formed between the sulfydryl of cell membrane and two disulfide bond of insulin molecule chain, insulin is fully sent out
The effect of waving, and utilization of the succinate dehydrogenase increase to sugar is activated, maintain blood sugar concentration.In addition, chromium also participates in lipid-metabolism, dimension
Hold serum cholesterol level.Type II diabetes is a kind of common metabolic for causing multiple complications (such as cardiovascular disease)
Disease.It can influence the most metabolic process of body, include the metabolism of trace element.
4.2 supplement Organic Chromiums (III) can improve the glucose tolerance of diabetic
The function of pancreas and the bioactivity of insulin, reduction tissue exogenous and endogenous can be influenceed by lacking chromium (III) in human body
The sensitiveness of insulin, influences glucose tolerance, and with vascular lesion, fat occurs and increase with cholesterol level, cause to move
Arteries and veins is hardened.In addition, metabolism of the chromium (III) on protein also has certain influence, so general diabetic is Serum Cr (III)
The ratio increase of chromium (III)/creatinine in reduction, urine chromium (III) increase, urine.Research display, is mending chromium (III) stage, blood glucose-control
There is more significant improvement, while also along with the obvious reduction of Diagnostic Value of Fasting Serum insulin.Supplement chromium (III) can improve II types
The blood glucose-control of diabetic, it, because chromium (III) enhances the activity of insulin, is not to stimulate insulin that this, which is probably,
Secrete and play a role.
The related experiment result carried out with muroid shows, Organic Chromium (III) preparation (Cr-enriched yeast, 2- chromium picolinates
And chromium gluconate etc.) the impaired pancreas islet of tissue of experimental diabetic mice and B cell morphosis tool are improved significantly.
Anderson RA [18] report, in 3 associations have the research of impaired glucose tolerance, the patient for having 18/20,7/8,8/9 respectively is mending
Filling chromium (III), sugar tolerance obtains improving diabetes patient supplement inorganic chromium (III) 500 μ g/ds of the to 12 adult onsets, continuous clothes afterwards
The blood sugar level of these patients is reduced with 60d.The impaired glucose tolerance of the offspring of insulin-dependent diabetes mellitus people, in supplement chromium
(III) after, also return to normal.
5. linseed oil
Linseed oil is the diluent for being used as soft capsule content in edible vegetable oil, this formula.
Diluent is used for increasing the mobility of medicine, it is ensured that preparation loading amount accurate stable, drug safety are effectively and energy is smooth
It is filling, therefore the selection of pharmaceutical diluents is to develop one of key of soft capsule.Vegetable oil is traditional content diluent, is applicable
In water-insoluble drug or fat-soluble medicine.Oils can increase the solubility of steroid drugs, while the oils of low-viscosity can increase
The mobility of content.Selection vegetable oil is in the majority for soft capsule diluent at present, these vegetable oil have soybean oil, corn oil,
Rapeseed oil, grape-kernel oil, attar of rose etc..
6. beeswax
Beeswax is a kind of conventional oiliness suspending agent.Beeswax suspending agent is added to increase the stability of suspension.Beeswax is pharmacopeia
The kind recorded, its stable in properties, safety, therefore selection beeswax makees suspending agent.
When preparing content, the suspended matter that is only made by both extract and diluent suppresses soft capsule, its product
Quality can not meet the requirements.The medicinal extract powder of medicinal substances extract is mixed with oils matrix, and extract powder can be deposited quickly, and be flowed
Dynamic property is poor, is unfavorable for filling, it is necessary to adds a certain amount of suspending agent and to improve the mobility of content, improves the stabilization of decoction
Property and settling ratio.Conventional suspending agent is beeswax, can effectively improve the uniformity of decoction, can also reduce water soluble vitamin pair
The osmosis of capsule wall.
7. gelatin
The capsule skin of current most of soft capsule preparations uses gelatin for main capsule leather material, and water is as solvent, and glycerine is increasing
Solvent simultaneously adds the materials such as opacifier, preservative, pigment and is prepared from.
8. glycerine
Glycerine is to constitute one of composition of soft capsule shell.This product adds glycerine, plays plasticizer.Add and increase in soft softgel shell
Agent is moulded, the plasticity of colloidal materials can be increased, makes softgel shell softness, high resilience.
Glycerine has good compatibility with many colloidal materials, using most extensively, can guarantee that the good stretchability of product,
Long-term holding soft capsule is indeformable, and optimum makees the plasticizer of soft capsule.
9. pure water
Pure water is to constitute one of composition of soft capsule shell, and pure water is added in formula, is served gelatinolytic.
10. burnt sugar coloring
Burnt sugar coloring is colouring agent, is to constitute one of composition of soft capsule shell.
In oral soft capsule kind, some use water white transparency cyst membrane, but to active medicine that is relatively strong, meeting photo-labile
Product, nutrient and healthcare products etc., then need to add suitable colouring agent, opacifier to suppress light transmission in cyst membrane, make content
In stable components.Also sometimes easily recognizable kind or to give the gratified sense of patient mental, added suitably equally in cyst membrane
Pigment.The color of soft capsule cyst membrane is influenceed by content type and color.Generally, transparent glued membrane is usually used in dress
Transparent medicine, the content of opaque soft capsule is generally suspension.Burnt sugar coloring is that the food additives of GB2760-2011 make
With the colouring agent for allowing food to use in standard.
The content of the invention
There is provided a kind of technique is simple, the significant flexible glue of blood sugar decreasing effect aiming at existing defect for the purpose of the present invention
Capsule and production technology.
The present invention is achieved through the following technical solutions, a kind of auxiliary hyperglycemic soft capsule, and its prescription component is honeybee
Glue, kudzu root extract, Bitter Melon P.E, chromium picolinate, linseed oil, beeswax, gelatin, pure water, glycerine, burnt sugar coloring, on
Stating the proportioning of each component by weight is：Propolis 40-60g, kudzu root extract 40-60g, Bitter Melon P.E 20-40g, pyridine first
Sour chromium 0.1-0.2g, linseed oil 350-370g, beeswax 6-9g, gelatin 60-80g, pure water 60-80g, glycerine 16-19g are burnt
Fried sugar 0.5-1.5g.
Preferably, the proportioning of each component by weight is：Propolis 50g, kudzu root extract 50g, Bitter Melon P.E
30g, chromium picolinate 0.15g, linseed oil 362.35g, beeswax 7.5g, gelatin 70g, pure water 70g, glycerine 17.5g, caramel
Color 1g.
A kind of auxiliary hyperglycemic soft capsule production technology, comprises the following steps：
A. the preparation of supplementary material,
1）Electronic scale is checked and approved, propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate, linseed are accurately weighed up by recipe quantity
Oil, beeswax；
2）Kudzu root extract, Bitter Melon P.E, chromium picolinate are crossed into 100 eye mesh screens, it is standby；
B. prepared by capsule filling,
The linseed oil weighed up is added in material-compound tank, 65 DEG C of setting interlayer temperature, 10~15rin/min of mixing speed treat tank
Interior temperature rises to 65 DEG C, starts agitator, adds beeswax, stirs 20min, beeswax is stopped interlayer heating after all dissolving, treats
When temperature is down to 20 DEG C in tank, propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate are slowly separately added into, homogeneous is stirred
1.5~2.0h, is mixed, standby then through 100 mesh sieve net filtrations into feed liquid bucket；
C. capsule leather is standby,
1）The preparation of capsule skin dispensing,
Electronic scale is checked and approved, pure water, gelatin, glycerine, burnt sugar coloring are accurately weighed up by recipe quantity；
2）Change glue
Keep 18 DEG C~26 DEG C of indoor temperature, relative humidity 45%~60%；65 DEG C of settingization glue tank interlayer temperature, speed of agitator
30rin/min；Pure water is added, when being heated to 65 DEG C, will be heated in glycerine, burnt sugar coloring pouring into glue tank, and turn on agitator,
65 DEG C of temperature in tank is kept, 30min is stirred, gelatin is then slowly put into, 65 DEG C of temperature in tank is kept, 0.5h is stirred；Holding is stirred
Mix and be warming up to 75 DEG C of holding 0.5h, be warming up to 80 DEG C and keep 0.5h, it is entirely molten to gelatin；It is evacuated to -0.06~0.08Mpa holdings
0.5h, 2.0~2.5h of exhaust, stand 0.5~1.0h, are then put into by 100 eye mesh screens in glue solution barrel and are incubated 57 DEG C~60
DEG C, it is standby；
D. pill
The heater switch of glue conveying box and glue box is opened, 57 DEG C~60 DEG C of adjustment glue box temperature keeps 21 DEG C~24 DEG C of indoor temperature,
Relative humidity 20%~30%；38 DEG C~45 DEG C of injector temperature of setting, unlatching encapsulating machine, every loading amount 495 of adjustment~
510mg, and adjusting thickness handle makes rubber thickness be 0.78-0.80mm, starts pill；
E. shape
The soft capsule tape transport that pellet press is suppressed makes soft capsule sizing, indoor temperature into rolling cage：26 DEG C~30
DEG C, relative humidity：30%~40%, rotating cage rotating speed：8rin/min, time：More than 2.0h；
F. dry
After soft capsule sizing, low temperature drying in transfer drying plant, temperature control is in 26 DEG C~30 DEG C, relative humidity 30%, time
36h or so；
G. ball is washed
After soft capsule sizing, in the lubricating oil for quickly washing away surface in tank with 95% edible ethanol, finished product is obtained.
Further, propolis is also included in the preparation of described step A supplementary materials to crush, comprises the following steps that, open powder
Broken machine, makes its 0.5min that dallies, holding rotating speed is 25000r/min, and temperature control is below 5 DEG C；Confirm that machine is normal, will
600g or so propolis pours into pulverizer, crushes 1.5min or so, is sieved for subsequent use through 100 eye mesh screens.
The advantage of the present invention：The formula is related to a variety of traditional Chinese medicines, and his proportioning saves various to greatest extent
The activity of composition, has played coordination, synthesis and booster action between each composition, has had obvious and effective adjustment effect to blood glucose,
And processing technology is simple, safe without toxic side effect.
Brief description of the drawings
Fig. 1 is the flow chart of the present invention.
Embodiment
In order that technical scheme can more clearly show, the present invention is made into one with reference to embodiment
Walk explanation.
Propolis 40-60g, kudzu root extract 40-60g, Bitter Melon P.E 20-40g, chromium picolinate 0.1-0.2g, flax
Seed oil 350-370g, beeswax 6-9g, gelatin 60-80g, pure water 60-80g, glycerine 16-19g, burnt sugar coloring 0.5-1.5g.
Embodiment 1
A kind of auxiliary hyperglycemic soft capsule, its prescription component is propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate, Asia
Flaxseed oil, beeswax, gelatin, pure water, glycerine, burnt sugar coloring, the proportioning of above-mentioned each component by weight is：Propolis 50g, the root of kudzu vine
Extract 50g, Bitter Melon P.E 30g, chromium picolinate 0.15g, linseed oil 362.35g, beeswax 7.5g, gelatin 70g are pure
Water 70g, glycerine 17.5g, burnt sugar coloring 1g.
Embodiment 2
A kind of auxiliary hyperglycemic soft capsule, its prescription component is propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate, Asia
Flaxseed oil, beeswax, gelatin, pure water, glycerine, burnt sugar coloring, the proportioning of above-mentioned each component by weight is：Propolis 40g, the root of kudzu vine
Extract 50g, Bitter Melon P.E 20g, chromium picolinate 0.1g, linseed oil 360g, beeswax 7g, gelatin 80g, pure water 80g,
Glycerine 16g, burnt sugar coloring 0.5g.
Embodiment 3
A kind of auxiliary hyperglycemic soft capsule, its prescription component is propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate, Asia
Flaxseed oil, beeswax, gelatin, pure water, glycerine, burnt sugar coloring, the proportioning of above-mentioned each component by weight is：Propolis 40g, the root of kudzu vine
Extract 40g, Bitter Melon P.E 20g, chromium picolinate 0.1g, linseed oil 350g, beeswax 6g, gelatin 60g, pure water 60g,
Glycerine 16g, burnt sugar coloring 0.5g.
Embodiment 4
A kind of auxiliary hyperglycemic soft capsule, its prescription component is propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate, Asia
Flaxseed oil, beeswax, gelatin, pure water, glycerine, burnt sugar coloring, the proportioning of above-mentioned each component by weight is：Propolis 60g, the root of kudzu vine
Extract 60g, Bitter Melon P.E 40g, chromium picolinate 0.2g, linseed oil 370g, beeswax 9g, gelatin 80g, pure water 80g,
Glycerine 19g, burnt sugar coloring 1.5g.
Embodiment 5
A kind of auxiliary hyperglycemic soft capsule, its prescription component is propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate, Asia
Flaxseed oil, beeswax, gelatin, pure water, glycerine, burnt sugar coloring, the proportioning of above-mentioned each component by weight is：Propolis 55g, the root of kudzu vine
Extract 55g, Bitter Melon P.E 35g, chromium picolinate 0.16g, linseed oil 365g, beeswax 8.5g, gelatin 72g, pure water
72g, glycerine 18g, burnt sugar coloring 1.2g.
1 operating process and process conditions：
1.1 supplementary materials are checked and accepted
The title for leading material, specification, lot number, quantity are checked by production ordering, and it is checked and accepted by supplementary material relevant criterion.
The confirmation and inspection of 1.2 supplementary materials
Check species, the presentation quality, the incoming clear production area of eligible of supplementary material.
1.3 propolis are crushed
Pulverizer is opened, makes its 0.5min that dallies, holding rotating speed is 25000r/min, and temperature control is below 5 DEG C.Confirmation machine
Device is normal, and 600g or so propolis is poured into pulverizer, crushes 1.5min or so, is sieved for subsequent use through 100 eye mesh screens.
Kudzu root extract, Bitter Melon P.E, chromium picolinate are crossed 100 eye mesh screens by 1.4, standby.
1.5 weigh dispensing
Electronic scale is checked and approved, each raw material is accurately weighed up by recipe quantity, electronic scale and weighing operate double check.
It is prepared by 1.6 capsule fillings
The linseed oil weighed up is added in material-compound tank, 65 DEG C of setting interlayer temperature, 10~15rin/min of mixing speed treat tank
Interior temperature rises to 65 DEG C, starts agitator, adds beeswax, stirs 20min, beeswax is stopped interlayer heating after all dissolving, treats
When temperature is down to 20 DEG C in tank, bee glue powder, kudzu root extract, Bitter Melon P.E, chromium picolinate are slowly separately added into, stirring is equal
1.5~2.0h of matter, is mixed, standby then through 100 mesh sieve net filtrations into feed liquid bucket.
1.7 capsule skin preparation technologies
1.7.1 capsule skin dispensing
Electronic scale is checked and approved, pure water, gelatin, glycerine, burnt sugar coloring are accurately weighed up by recipe quantity
1.7.2 glue is changed
Keep 18 DEG C~26 DEG C of indoor temperature, relative humidity 45%~60%；65 DEG C of settingization glue tank interlayer temperature, speed of agitator
30rin/min；Pure water is added, heating during to 65 DEG C, will be heated, and open stirring in glycerine, burnt sugar coloring pouring into glue tank
Device, keeps 65 DEG C of temperature in tank, stirs 30min, then slowly puts into gelatin, keeps 65 DEG C of temperature in tank, stirs 0.5h；Keep
Stirring is warming up to 75 DEG C of holding 0.5h, is warming up to 80 DEG C and keeps 0.5h, entirely molten to gelatin；It is evacuated to -0.06~0.08Mpa guarantors
Hold 0.5h, 2.0~2.5h of exhaust, stand 0.5~1.0h, be then put into by 100 eye mesh screens in glue solution barrel be incubated 57 DEG C~
It is 60 DEG C, standby.
1.8 pills
The heater switch of glue conveying box and glue box is opened, 57 DEG C~60 DEG C of adjustment glue box temperature keeps 21 DEG C~24 DEG C of indoor temperature,
Relative humidity 20%~30%.38 DEG C~45 DEG C of injector temperature of setting, unlatching encapsulating machine, every loading amount 495 of adjustment~
510mg, and adjusting thickness handle makes rubber thickness be 0.78-0.80mm, starts pill.Specification is 500mg/.
1.9 sizings
The soft capsule suppressed through pellet press, certain temperature because having, body is softer, needs cooling and shaping.Method is by pellet press
The soft capsule tape transport suppressed makes soft capsule sizing, indoor temperature into rolling cage：26 DEG C~30 DEG C, relative humidity：
30%~40%, rotating cage rotating speed：8rin/min, time：More than 2.0h.
1.10 dry
After soft capsule sizing, low temperature drying in transfer drying plant, temperature control is in 26 DEG C~30 DEG C, relative humidity 30%, time
36h or so.In drying process, ventilation of room is kept to dehumidify, drying is neither too hard, nor too soft to rubber.
1.11 wash ball
After soft capsule sizing, in the lubricating oil for quickly washing away surface in tank with 95% edible ethanol.Ethanol specification, volume fraction
>=95%, by GB 10343-2002《Edible alcohol》Regulation is performed.
1.12 select ball
Sort out underproof soft capsule.
1.13 inner packings
Operating personnel in carrying out artificial quantitative separating on operating desk on request, and bottle cap are tightened after both hands and the sterilizing of small spoon
Sealing.
1.14 external packings
By the production time, date of manufacture or lot number are printed on Product labelling and packing case, and labels, fill on request
Case.
1.15 products are inspected by random samples
Laboratory is to packaged production sampling test, eligible storage.
1.16 storages
Stored in shady and cool, dry, ventilative storehouse.
Claims (4)
1. a kind of auxiliary hyperglycemic soft capsule, it is characterised in that its prescription component be propolis, kudzu root extract, Bitter Melon P.E,
Chromium picolinate, linseed oil, beeswax, gelatin, pure water, glycerine, burnt sugar coloring, the proportioning of above-mentioned each component by weight is：
Propolis 40-60g, kudzu root extract 40-60g, Bitter Melon P.E 20-40g, chromium picolinate 0.1-0.2g, linseed oil 350-
370g, beeswax 6-9g, gelatin 60-80g, pure water 60-80g, glycerine 16-19g, burnt sugar coloring 0.5-1.5g.
2. a kind of auxiliary hyperglycemic soft capsule according to claim 1, it is characterised in that the proportioning of each component by weight
For：Propolis 50g, kudzu root extract 50g, Bitter Melon P.E 30g, chromium picolinate 0.15g, linseed oil 362.35g, beeswax
7.5g, gelatin 70g, pure water 70g, glycerine 17.5g, burnt sugar coloring 1g.
3. a kind of auxiliary hyperglycemic soft capsule production technology, it is characterised in that comprise the following steps：
A. the preparation of supplementary material,
1）Electronic scale is checked and approved, propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate, linseed are accurately weighed up by recipe quantity
Oil, beeswax；
2）Kudzu root extract, Bitter Melon P.E, chromium picolinate are crossed into 100 eye mesh screens, it is standby；
B. prepared by capsule filling,
The linseed oil weighed up is added in material-compound tank, 65 DEG C of setting interlayer temperature, 10~15rin/min of mixing speed treat tank
Interior temperature rises to 65 DEG C, starts agitator, adds beeswax, stirs 20min, beeswax is stopped interlayer heating after all dissolving, treats
When temperature is down to 20 DEG C in tank, propolis, kudzu root extract, Bitter Melon P.E, chromium picolinate are slowly separately added into, homogeneous is stirred
1.5~2.0h, is mixed, standby then through 100 mesh sieve net filtrations into feed liquid bucket；
C. capsule leather is standby,
The preparation of capsule skin dispensing,
Electronic scale is checked and approved, pure water, gelatin, glycerine, burnt sugar coloring are accurately weighed up by recipe quantity；
2）Change glue
Keep 18 DEG C~26 DEG C of indoor temperature, relative humidity 45%~60%；65 DEG C of settingization glue tank interlayer temperature, speed of agitator
30rin/min；Pure water is added, when being heated to 65 DEG C, will be heated in glycerine, burnt sugar coloring pouring into glue tank, and turn on agitator,
65 DEG C of temperature in tank is kept, 30min is stirred, gelatin is then slowly put into, 65 DEG C of temperature in tank is kept, 0.5h is stirred；Holding is stirred
Mix and be warming up to 75 DEG C of holding 0.5h, be warming up to 80 DEG C and keep 0.5h, it is entirely molten to gelatin；It is evacuated to -0.06~0.08Mpa holdings
0.5h, 2.0~2.5h of exhaust, stand 0.5~1.0h, are then put into by 100 eye mesh screens in glue solution barrel and are incubated 57 DEG C~60
DEG C, it is standby；
D. pill
The heater switch of glue conveying box and glue box is opened, 57 DEG C~60 DEG C of adjustment glue box temperature keeps 21 DEG C~24 DEG C of indoor temperature,
Relative humidity 20%~30%；38 DEG C~45 DEG C of injector temperature of setting, unlatching encapsulating machine, every loading amount 495 of adjustment~
510mg, and adjusting thickness handle makes rubber thickness be 0.78-0.80mm, starts pill；
E. shape
The soft capsule tape transport that pellet press is suppressed makes soft capsule sizing, indoor temperature into rolling cage：26 DEG C~30
DEG C, relative humidity：30%~40%, rotating cage rotating speed：8rin/min, time：More than 2.0h；
F. dry
After soft capsule sizing, low temperature drying in transfer drying plant, temperature control is in 26 DEG C~30 DEG C, relative humidity 30%, time
36h or so；
G. ball is washed
After soft capsule sizing, in the lubricating oil for quickly washing away surface in tank with 95% edible ethanol, finished product is obtained.
4. a kind of auxiliary hyperglycemic soft capsule production technology according to claim 3, it is characterised in that described step A
Also include propolis in the preparation of supplementary material to crush, comprise the following steps that, open pulverizer, make its 0.5min that dallies, keep rotating speed
For 25000r/min, temperature control is below 5 DEG C；Confirm that machine is normal, 600g or so propolis is poured into pulverizer, crush
1.5min or so, sieves for subsequent use through 100 eye mesh screens.
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| CN108743744A (en) * | 2018-08-03 | 2018-11-06 | 东营广元生物科技股份有限公司 | A kind of bluish dogbane bee glue soft capsule and preparation method thereof |
| CN109222029A (en) * | 2018-09-10 | 2019-01-18 | 福建省神六保健食品有限公司 | A kind of bee glue bitter gourd mulberry leaf soft capsule and preparation method thereof |
| CN113521124A (en) * | 2021-08-05 | 2021-10-22 | 江西汪氏蜜蜂园有限公司 | Preparation and process of propolis and kudzu root soft capsule |
| CN114425041A (en) * | 2020-10-14 | 2022-05-03 | 江西奇鹤堂健康产业有限公司 | Preparation method of DHA algae oil for improving postpartum depression and promoting fetal intelligence development |
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Application publication date: 20170714 |