CN108815132A - Three oxygen activity fat capsules of one kind and the preparation method and application thereof - Google Patents
Three oxygen activity fat capsules of one kind and the preparation method and application thereof Download PDFInfo
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Abstract
The present invention provides a kind of three oxygen activity fat capsules and the preparation method and application thereof.The three oxygen activity fat capsule contents are the three oxygen oil of mass percent 40~61%.The oral administration of three oxygen may be implemented in soft capsule of the invention; mitigate intestinal bacilli illness patient suffering significantly; oral three oxygen is avoided to the irritation of respiratory tract simultaneously; it can be used for adjusting gastrointestinal bacterial flora; promote digestion, defaecation, have assistant protection function to gastric mucosa damage, swelling and aching of gum, canker sore, scytitis etc., it is curative for effect.The present invention also provides the preparation methods of the three oxygen activity fat capsules, and simple production process is easy, are applicable to industrialized production, it is sustainable it is stable produce qualified products, have broad application prospects.
Description
Technical field
The invention belongs to field of medicaments, in particular to a kind of three oxygen activity fat capsules and the preparation method and application thereof.
Background technique
The chemical formula of three oxygen is O3, there is pungent strange taste, also known as ozone.Three oxygen are a kind of native oxidants, high-purity
Spending three oxygen all has killing effect to various bacteriums, virus, fungi etc., has the characteristics that " green " sterilization.At present in Europe, three
Oxygen is mainly used in the treatment of protrusion of lumber intervertebral disc and bone and joint diseases, wound and intractable ulcer (such as diabetes) are controlled
The treatment of the diseases such as treatment, the adjuvant treatment of cancer, free radical resisting be anti-aging, apoplexy and virus hepatitis, clinical efficacy obtain
Abundant affirmation.
Irritable bowel syndrome belongs to one of highest disease type of gastroenterology disease incidence, studies have pointed out that intestines easily swash is comprehensive
Disease is closed with intestinal bacilli illness in the presence of being associated with, has remarkable result for the symptom improvement of patient.The oxidisability of ozone is strong, existing skill
Original intestinal flora can directly be adjusted by bowel lavage in art, enter back into tissue, it can be with life after contact tissue fluid or secretion
Object macromolecular reacts, it is made to be degraded into oxygen molecule or oxygen atom, and single oxygen atom can directly play microorganism aobvious
Bactericidal effect is write, original intestinal flora is adjusted.And oxygen molecule can provide oxygen sources for the aerobic respiration of cell, promote tissue
Self-regeneration.Meanwhile ozone can also react with the unsaturated fatty acid on immunocyte surface, promote protein synthesis,
The cellular immune function for being conducive to improve human body promotes intestinal flora to restore balance from many aspects.But frequent bowel lavage can shadow
Normal defecation reflex is rung, so that natively very fragile normal intestinal flora is made destruction, and irregular bowel lavage may also
Mechanical damage is caused to enteron aisle；The especially weaker people of child old man and constitution, frequent bowel lavage can allow stimulating intestine and stomach instead
Flora imbalance inside enteron aisle.Meanwhile enema operation technical requirements are high, it is necessary to have regular equipment and medical professional that can grasp
Make.
Three oxygen are non-toxic but have strong impulse to respiratory tract, because three oxygen can damage alveolar epithelial cells, three oxygen are all
It is strictly to forbid being directly sucked in intrapulmonary.
Therefore, how to solve three oxygen administration inconvenience and improve patient medication compliance, and solve three oxygen pair of oral administration
The problems such as irritation of respiratory tract, drug effectiveness, it would be highly desirable to research and solve.
Summary of the invention
The primary purpose of the present invention is that the shortcomings that overcoming the prior art and deficiency, provide a kind of three oxygen activity oil flexible glues
Capsule.Soft capsule Orally-administrable of the invention, effectively overcome it is above in the prior art the shortcomings that, significantly mitigation intestinal bacilli illness
Patient suffering.
Another object of the present invention is to provide the preparation method of the three oxygen activity fat capsules.
Another object of the present invention is to provide the applications of the three oxygen activity fat capsules.
The purpose of the invention is achieved by the following technical solution：
A kind of three oxygen activity fat capsules, are made of soft capsule content and capsule material, and the soft capsule content is matter
Measure the three oxygen oil of percentage 40~61%, wherein three oxygen containing 12%~20% mass percent in the three oxygen oil.Institute
The three oxygen activity fat capsule alternatives stated kill anaerobic bacteria.
The oils matrix of the three oxygen oil is preferably vegetable oil, further preferably olive oil, soya-bean oil, sunflower oil,
At least one of tea-seed oil and linseed oil.
The three oxygen activity fat capsules are preferably three oxygen activity oil enteric soft capsules.
The capsule material preferably includes the substance of following mass percent, and the mass percent presses soft capsule gross mass
It calculates：
The thickness of the capsule material is preferably 1.2~1.5mm, and more general soft capsule is thick, can further enhance the anti-of rubber
Oxidability.
It can also include opacifier in the capsule material, prevent oils matrix (especially vegetable oil) light-exposed perishable.
The opacifier is preferably at least one of titanium dioxide, iron oxide, zinc oxide；The use of the opacifier
Amount is preferably mass percent 0.5 ± 0.3%.
It can also include enteric material in the capsule material, for example, being further coated to soft capsule.
The preparation method of the three oxygen activity fat capsules, including following preparation step：
The preparation of (1) three oxygen oil：Three oxygen are passed through in oils matrix according to the ratio, three oxygen oil is made；
(2) change glue：The water of formula ratio, glycerol are mixed and heated, when being heated to 60 DEG C, gelatin is added, continues stirring and adds
Heat when being warming up to 70~80 DEG C, stops heating, obtains glue；If including opacifier in formula, opacifier is added, with glue
Liquid is uniformly mixed；
(3) pelleting：The three oxygen oil that step (1) obtains and the glue that step (2) obtains are made described by pressing
Three oxygen activity fat capsules.
The preparation method of the three oxygen activity fat capsules can also include setting, wipe the post-processings such as ball and drying step
Suddenly.
The concrete operations of the setting are preferably：The three oxygen activity fat capsules are carried out at 25~28 DEG C cold
Wind setting treatment.
The loading amount of the three oxygen activity fat capsules ranges preferably from 0.95~1.05g/, and average loading amount is 1g/.
The three oxygen activity fat capsules can effectively kill bacterium, treat constipation, repairing ulcer, strengthen immunity can
In preparation applied to following any drug：
(1) intestinal flora drug is adjusted；
(2) irritable bowel syndrome drug is treated；
(3) taste-blindness rate drug is treated；
(4) swelling and aching of gum, stomatocace medicine are treated；
(5) inflammatory skin conditions are treated.
The irritable bowel syndrome is preferably constipation-predominant of irritable bowel syndrome.
The drug can also include the effective component that other play compatibility synergistic effect, for example, easy in preparation treatment intestines
When bowel syndrome drug, probiotics can also be used in combination.
The probiotics preferably includes enterococcus faecium, hay bacillus etc..
The present invention has the following advantages and effects with respect to the prior art：
1. three oxygen oil of tradition are creatively prepared into three oxygen activity fat capsules by the present invention, and for adjusting gastrointestinal tract bacterium
Group, alternative kill anaerobic bacteria, promote digestion, defaecation, to gastric mucosa damage, swelling and aching of gum, canker sore, scytitis etc.
There is assistant protection function, be not only conducive to clinical use and administration, while effect in three oxygen oil bodies can be played；It is curative for effect.
2. individually giving three oxygen activity fat capsules of the invention, significant irritable bowels syndrome treatment effect can be realized
Fruit.
3. production technology of the invention is suitble to industrialized production, possibility is high, the simply easily operated production of step.
4. three oxygen oil are prepared into soft capsule by the present invention, it is easy to store and transport.
5. three oxygen fat capsules of the invention can keep three oxygen for stablizing higher concentration in three oxygen oil, effective for product
Property has a significant impact；Composition ratio is suitable, continually and steadily can produce qualified products.
Specific embodiment
Below with reference to embodiment, the present invention is described in further detail, and embodiments of the present invention are not limited thereto.
The preparation method of 1 three oxygen fat capsule of embodiment
1. the preparation of three oxygen oil
Olive oil 4000mL (density 0.91g/cm3) be placed in glass container；On have two mouthfuls of screw lid, one is three oxygen
Entrance, another to export for remaining three oxygen, connection Ozone Monitor (IDEAL-2000) uses oxygen-enriched liquid in the environment of 16 DEG C
Preparing instrument (model ZAMT-Y01 type) continuously makes 9 days, and daily 9 hours, i.e., 81 hours altogether, three oxygen concentration of entrance was 100 μ g/
ML, speed are 1L/ minutes；Exporting three oxygen concentrations is 14.5 μ g/mL, and speed is 1L/ minutes；It is detected and is controlled by Ozone Monitor
The conversion efficiency of ozone is 85.5%, and the three oxygen oil containing 12% mass percent, three oxygen is made.
2. mixing
It takes three oxygen oil made from 60.05% step 1 to put into material-compound tank by mass percentage, stirs while adding, stirring is equal
After even, the filtering of 200 mesh is placed spare.
3. changing glue
By in 18.64% (w/w) purified water, 5.46% (w/w) glycerol investmentization glue tank, heats, be heated to while stirring
At 60 DEG C, 15.85% (w/w) gelatin is put into, and open blender and start to stir, be increased to 70~80 DEG C to temperature, stops adding
Heat.
4. pelleting
After glue in tank all dissolution, changes glue tank and vacuumize (0.06~0.08Mpa of pressure), return the bubble of glue
Out.Start to discharge after glue viscosity and the detection of bubble situation are qualified, glue must be stored in heat preservation through 80 mesh sock filtrations by glue
In bucket, kept the temperature at 55 DEG C~65 DEG C, it is spare.It is got from weighing area and examines qualified prepared gelatin soft capsule feed liquid, from mould
Corresponding pelleting mold is got between tool, it is spare.Encapsulating machine and product contact position are cleaned, and disappeared with 75% alcohol
Poison.Feed liquid and glue are carried out to the preparation of capsule, feed liquid weight feed, encapsulated pelletization, loading amount model through soft capsule pellet press
Enclosing is 0.95~1.05g/, and average loading amount is 1g/, and averagely loading amount was checked once every 15 minutes.
5. setting
It produces soft capsule and 25~28 DEG C of cold wind setting treatments in rotating cage is inputted by conveyer belt, should be noted that in type-approval process
Check ball shape it is normal, without adhesion.
6. wiping ball
By it is clean do not fall off fiber, be put into rotating cage drying machine by the dry ball cloth of wiping of disinfection, fix, except the
Outside one section rotating cage and final section rotating cage, every section rotating cage puts one piece, and soft capsule surface paraffin oil is cleaned.
7. dry
Soft capsule after sizing is uniformly dispensed in the clean ball disk that dries in the air, every disc thickness is advisable with 2cm~3cm, when restocking
It is successively put into baking vehicle down from top, prevents foreign matter from falling into soft capsule.Restocking finishes, and closes drying room door and is dried, does
It dry 24 hours, turns over：It turns over for the first time, turns over after continuing drying ten hours second after four hours dry.It is living up to three oxygen oil
Property soft capsule.
The preparation of 2 three oxygen fat capsule of embodiment
In the environment of 16 DEG C, with oxygen-enriched liquid preparing instrument (model ZAMT-Y01 type) continuously production 10 days, daily 11.2
Hour, i.e., 112 hours altogether, three oxygen concentration of entrance was 100 μ g/mL, and speed is 1L/ minutes；Exporting three oxygen concentrations is 14.5 μ g/
ML, speed are 1L/ minutes；The three oxygen oil of three oxygen containing 16% mass percent, three oxygen are made with embodiment 1 in other operations
Conversion efficiency be 85.5%.
Glycerol 8.37%, gelatin 20.92%, purified water 20.91%, three oxygen oil 49.80% are taken by mass percentage, are passed through
The preparation method of embodiment 1 obtains three oxygen fat capsules.
The preparation of 3 three oxygen fat capsule of embodiment
In the environment of 16 DEG C, continuously made 15 days of oxygen-enriched liquid preparing instrument (model ZAMT-Y01 type), daily 9.8 is small
When, i.e., 147 hours altogether, three oxygen concentration of entrance was 100 μ g/mL, and speed is 1L/ minutes；Exporting three oxygen concentrations is 14.5 μ g/
ML, speed are 1L/ minutes；The three oxygen oil of three oxygen containing 20% mass percent, ozone is made with embodiment 1 in other operations
Conversion efficiency be 85.5%.
Glycerol 20.90%, gelatin 27.50%, purified water 10.65%, three oxygen oil 40.95% are taken by mass percentage,
He operates same as Example 1, obtains three oxygen fat capsules.
The experimental study of 1 three oxygen activity fat capsule of effect example treatment anti-constipation effect
According to clinical statistics we in May, 2017~2018 year May treat 400 many cases of case, obtain good result, always now
It ties as follows：
1. (intelligent with reference to looking into, the diagnosis of Hou Xiao China chronic constipation and its antidiastole [J] of clinical subtype face diagnostic criteria
Bed internal medicine journal, 2003,20 (5)：231-233.)
Have and following 2 or 2 or more symptoms continuously or discontinuously occurred at least 12 weeks 12 middle of the month of past：
①>1/4 time defecation is laborious；
②>1/4 time has excrement in agglomerate or scleroma；
③>1/4 time has defecation to feel not to the utmost；
④>The sense of anus obstruction or anorectal obstruction when there is defecation in 1/4 time；
⑤>1/4 time defecation need to be assisted with gimmick；
⑥>1/4 time has weekly defecation to be less than three times.
2. typical clinical case inclusion criteria：
Inclusion criteria：With typical clinical manifestation, meet diagnostic criteria.
Selected case 456, wherein male 220, women 236.
3. treatment method
Three oxygen activity fat capsules 1 sooner or later, bfore meals made from embodiment 1.
4. curative effect judging standard
It is promulgated referring to State Administration of Traditional Chinese Medicine《Disease of tcm Standardization of diagnosis and curative effect》It formulates.
(1) clinical cure：The soft lubrication of stool, be discharged it is smooth, it is daily or the next day 1 time.
(2) effective：Stool softens, and is easily drained, 1 time/2~3 days.
(3) effectively：Stool interval time shortens, and difficult defecation mitigates.
(4) invalid：Clinical symptoms are without improvement.
(Li Guonian is referred to, Chen Yu root supplementing qi and nourishing yin relaxing bowel treats 48 Jilin [J] traditional Chinese medicines of habitual constipation,
2005,25 (11)：32.)
5. clinical statistics result
Healing the sick is 413, clinical cure rate 90.57%；Effective patient is 7, and clinical obvious effective rate is 1.54%；
Effective patient is 21, clinical effective rate 4.61%；Invalid patient is 15, and clinical inefficiency is 3.28%；To sum up, clinical
Total effective rate is 96.72%.
The experimental study of 2 three oxygen activity fat capsule repairing ulcer of effect example
Canker sore is complicated using traditional treatment method and treatment time is longer, and therapeutic effect is poor, and ozone therapy
Canker sore, one side ozone it is super it is sterilising not only can establish a sterile sanitary condition but also can efficiently repair fester
Soft tissue, promote the healing of mucous membrane tissue, and painless, quick.The mechanism of action of ozone therapy canker sore is by smelly
Oxygen molecule accelerates the red blood cell metabolism of soft tissue surfaces, increase its content of surface oxygen, so as to improve soft tissue surfaces ring
Border and healing acceleration.
1. diagnostic criteria
1. ulcer occurs in lip, cheek, tongue etc., other positions of body are without rotten to the corn and ulcer；
2. previously there is canker sore medical history, medical history is at least at 6 months or more；
3. recurrent exerbation breaks out 1 time at least every 3 months；
4. Clinical symptoms stomatocace recurrent exerbation, delocalization, topical manifestations are pain, ulcer is congested, edge is whole
Together, base portion is not hard；
5. number 1~5, diameter≤5cm；
6. influencing to feed coated with lark or faint yellow cellulosic pseudomembrane in ulcer.
2. the criterion of severity
It is divided into 0~IV grade according to the difference of coincident with severity degree of condition, 0 degree normal for mucous membrane of mouth, no headache；IV grade is ulcer
Sharp ache, is fused into big sheet, and patient cannot feed.Degree is higher, and the state of an illness is more serious.
3. typical clinical case inclusion criteria
Inclusion criteria：With typical clinical manifestation, meet diagnostic criteria.
Selected case 320, wherein male 178, women 142.
4. treatment method
According to clinical statistics, we are multiple using three oxygen activity soft capsules treatment case 320 in May, 2017~2018 year May
Hair property canker sore patient is randomly divided into observation group and control group, and every group 160.
(1) control group：It is treated using conventional western medicine, dexamethasone acetate mouth paster, 1 times/day.
(2) observation group：It is treated using three oxygen activity fat capsules, 1~2 (can be adjusted according to surface of a wound quantity, size), 2
It~3 times/day, punctures capsule and smears affected part.
Compare the variation of two groups of therapeutic effect, healing and symptom scores.
5. curative effect judging standard
It cures：Canker sore heals in 3 days, and clinical symptoms disappear, no sense of discomfort；
Effectively：Canker sore heals 2/3 or more in 3~5 days, and clinical symptoms are clearly better, and slightly there is sense of discomfort in part；
In vain：Canker sore area and clinical symptoms are without significant change.
6. clinical statistics result
According to clinical observation, the therapeutic effect of observation group is higher than control group, and the patient of control group generally requires 7~10 days and creates
Face can heal completely, and observation group can heal for 3~5 days completely, and healing is shorter than control group, the statistically significant (P of difference
<0.05).Canker sores, number, size after observation group's treatment, hyperemia, burn feeling scoring are below control group, and difference has system
Meter learns meaning (P<0.05).
Typical case
Clinical case 1：Yang, women, 90 years old, outpatient service number：0000945238, diagnosis：Reflux exophagitis.Give implementation
Three oxygen activity fat capsules 1,2 times/day made from example 1.Sour regurgitation, belch remission after 1 week.
Clinical case 2：Liu, women, 85 years old, outpatient service number：00001787965, diagnosis：Constipation.Give three oxygen activities oil
Soft capsule 1,2 times/day.Defecation after 1 day.
Clinical case 3：Slowly certain, male, 80 years old, outpatient service number：0000945836, diagnosis：Habitual constipation.Give three oxygen activities
Fat capsule 1,2 times/day.Free movement of the bowels two days later is defecated normal after 1 week.
Clinical case 4：Yuan so-and-so, women, 47 years old, outpatient service number：00001744780 diagnosis：Allergic dermatitis.It is living to give three oxygen
Property fat capsule 1 it is oral, red swelling of the skin, pruritis subside after 2 times/day, 1 week.
Clinical case 5:Shao so-and-so, women, 56 years old, outpatient service number：0000295141 diagnosis：Psoriasis.Give three oxygen activities oil
Soft capsule 1,2 times/day, affected part is smeared after puncturing soft capsule, skin lesion is substantially reduced after 10 days.
Clinical case 6:Huang, women, 37 years old, outpatient service number：00001388114 diagnosis：Stomach CA is postoperative.Give three oxygen activities
Abdominal distension symptom improves after fat capsule 1,2 times/day, 2 days.
Clinical case 7:Chen, male, 7 years old, outpatient service number：00001436973 diagnosis：Canker sore.Give three oxygen activities
Fat capsule 1,2 times/day, oral cavity chewing.Ulcer healing after 2 days.
The above embodiment is a preferred embodiment of the present invention, but embodiments of the present invention are not by above-described embodiment
Limitation, other any changes, modifications, substitutions, combinations, simplifications made without departing from the spirit and principles of the present invention,
It should be equivalent substitute mode, be included within the scope of the present invention.
Claims (10)
1. a kind of three oxygen activity fat capsules, are made of soft capsule content and capsule material, it is characterised in that：
The soft capsule content is the three oxygen oil of mass percent 40~61%, wherein is contained in the three oxygen oil
Three oxygen of 12%~20% mass percent.
2. three oxygen activities fat capsule according to claim 1, it is characterised in that：
The three oxygen activity fat capsules are three oxygen activity oil enteric soft capsules.
3. three oxygen activities fat capsule according to claim 1, it is characterised in that：
The oils matrix of the three oxygen oil is vegetable oil.
4. three oxygen activities fat capsule according to claim 1, it is characterised in that：
The capsule material includes the substance of following mass percent, and the mass percent is calculated by soft capsule gross mass：
。
5. three oxygen activities fat capsule according to claim 1, it is characterised in that：
It further include opacifier in the capsule material；
It further include enteric material in the capsule material；
The capsule material with a thickness of 1.2~1.5mm.
6. three oxygen activities fat capsule according to claim 5, it is characterised in that：
The opacifier is at least one of titanium dioxide, iron oxide, zinc oxide；
The dosage of the opacifier is mass percent 0.5 ± 0.3%；
The oils matrix of the three oxygen oil is at least one of olive oil, soya-bean oil, sunflower oil, tea-seed oil, linseed oil.
The preparation method of three oxygen activity fat capsules described in 7., which is characterized in that including following preparation step：
The preparation of (1) three oxygen oil：Three oxygen are passed through in oils matrix according to the ratio, obtain three oxygen oil；
(2) change glue：The water of formula ratio, glycerol are mixed and heated, when being heated to 60 DEG C, gelatin is added, continues agitating and heating, rises
When temperature is to 70~80 DEG C, stops heating, obtain glue；If including opacifier in formula, opacifier is added, is mixed with glue
Uniformly；
(3) pelleting：Three oxygen are made by pressing in the three oxygen oil that step (1) obtains and the glue that step (2) obtains
Active fat capsule.
8. the preparation method of three oxygen activities fat capsule according to claim 7, it is characterised in that：
The preparation method of the three oxygen activity fat capsules further includes setting, wipes ball and dry post-processing step；
The loading amount range of the three oxygen activity fat capsules is 0.95~1.05g/.
9. the application of the described in any item three oxygen activities fat capsules of claim 1~6, which is characterized in that can be applied to following
In the preparation of any drug：
(1) intestinal flora drug is adjusted；
(2) irritable bowel syndrome drug is treated；
(3) taste-blindness rate drug is treated；
(4) swelling and aching of gum, stomatocace medicine are treated；
(5) inflammatory skin conditions are treated.
10. the application of the three oxygen activity fat capsules according to claim 9, it is characterised in that：
The irritable bowel syndrome is constipation-predominant of irritable bowel syndrome；
The drug further includes the effective component that other play compatibility synergistic effect.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114796262A (en) * | 2022-05-23 | 2022-07-29 | 广东怡康生物科技有限公司 | Method for preparing three-atom oxidized oil capsule |
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| WO2003085072A1 (en) * | 2002-04-08 | 2003-10-16 | Centro Nacional De Investigaciones Cientificas (Cnic) | Method for obtaining ozonized oils and vegetable fats and use of said products for pharmaceutical and cosmetic purposes |
| CN101049380A (en) * | 2007-05-11 | 2007-10-10 | 张冰文 | Enteric solubility soft capsule containing camellia oil, and preparation method |
| CN106389463A (en) * | 2016-11-01 | 2017-02-15 | 侯建生 | Application of ozonized oil in prevention and treatment of autoimmune disease and irritable bowel syndrome |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003085072A1 (en) * | 2002-04-08 | 2003-10-16 | Centro Nacional De Investigaciones Cientificas (Cnic) | Method for obtaining ozonized oils and vegetable fats and use of said products for pharmaceutical and cosmetic purposes |
| CN101049380A (en) * | 2007-05-11 | 2007-10-10 | 张冰文 | Enteric solubility soft capsule containing camellia oil, and preparation method |
| CN106389463A (en) * | 2016-11-01 | 2017-02-15 | 侯建生 | Application of ozonized oil in prevention and treatment of autoimmune disease and irritable bowel syndrome |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114796262A (en) * | 2022-05-23 | 2022-07-29 | 广东怡康生物科技有限公司 | Method for preparing three-atom oxidized oil capsule |
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