CN105213353B - Compound oral film and preparation method containing sodium azulenesulfonate - Google Patents
Compound oral film and preparation method containing sodium azulenesulfonate Download PDFInfo
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Abstract
Compound oral film and preparation method containing sodium azulenesulfonate, pelliculae pro cavo oris by weight percentage, have：PVA0588 2 4%, PVA1788 1 2%, hyaluronic acid-like chitosan 3 6%, sodium carboxymethylcellulose 2 5%, Tween 80 1 3%, polysorbate60 0.5 2%, glycerine 6 10%, distilled water 55 70%, 10:1 isatis root extract 5 8%, vitamin B2 2 5%, sodium azulenesulfonate 1 4%.The present invention can extend drug treating time, and medication good effect in target portion can play drug effect, can promote the rehabilitation of body and the enhancing of immunity resistance, be conducive to the reparation of canker sore mucous membrane, have good therapeutic effect for canker sore the long period.Material selected by the present invention is also applied in food, and derives from a wealth of sources, relative low price, and product manufacturing cost is low, safe to use, and market application is wider, has very high promotional value.
Description
Technical field
The present invention relates to a kind of compound oral films.Oral cavity caused by treating a variety of causes is used to more particularly to one kind burst
The compound oral film and preparation method containing sodium azulenesulfonate of ulcer.
Background technology
Oral mucosa ulcer is a kind of common disease, is the highest a kind of disease of incidence in the disease of cari oris mucosa, mostly in circle
Shape or ellipse, predilection site is based on the mucosal sites such as tongue cheek lingual margin, followed by gum and hypoglossis mucous membrane, has around ulcer red
It is dizzy to surround.Surface covers yellow pseudomembrane.Patient's self-induction pain, incidence are high.The recurrent oral ulcer cause of disease is still not clear,
It may be related with following factor：1st, disease of digestive system and dysfunction, such as situations such as abdominal distension, diarrhea or constipation.2nd, endocrine
Variation, some female patients often occur in the menstrual period, may be related with internal amount of estrogen decline.3rd, mental element has
Patient falls ill in the case where stress, mood swing, sleep state are bad, may be related with vegetative dystonia.
4th, canker sore is caused by bacterium, virus infection or diet, wound, wearing dentures etc..5th, inherent cause, as parent both sides suffer from
When having recurrent oral ulceration, children are diseased there are about 80%~90%, if one of parents suffer from this disease, children there are about 50%~
60% is diseased.6th, other factors, such as lack trace element zinc, iron or lack folic acid, vitamin, immune function can be reduced, is increased
Add the possibility of recurrence canker sore morbidity.The symptom that mouth disease caused by a variety of causes is shown is roughly the same, ulcer,
Redness, cusalgia etc., ulcer continue one week to two weeks.The drug for the treatment of canker sore includes immunopotentiating agent and amcinonide at present
Object.This kind of drug is wider in foreign applications, can effectively treat that some depths are big, cureless ulcer, and can inhibit ulcer recurrence
Up to 3~6 months.But though immunopotentiating agent can reduce the recurrence of ulcer, such as transfer factor, thymic peptide drug, make for a long time
It is likely to decrease with rear curative effect；And hormone medicine prolonged application can also generate some serious adverse side effects, such as：Fash mistake
Quick reaction and glucocorticoids Systemic reaction.Due to the influence of the factors such as curative effect, adverse reaction, above-mentioned medicine
It can not meet the needs of most of patients, therefore develop treatment canker sore medicine new, that curative effect is high to have larger market.It controls the country
The drug for treating canker sore substantially has three classes：Chinese medicine preparation, patent medicine and compound preparation.Chinese medicine preparation main component is borneol, green grass or young crops
Black pigment used by women in ancient times to paint their eyebrows has effects that clearing heat and detoxicating, promoting blood circulation and removing blood stasis, myogenic pain relieving more.Patent medicine has Sucralfate, nourishing yin shengjisan, xilei san, water melon frost
Spray and compound caoshanhu tablets etc..Compound preparation has ulcer ointment, compound aureomycin etc..But since mucous membrane is more loose in oral cavity
It is soft, frequent along with moving, cause powder that can not locally be fixed in ulcer, therefore it is difficult to ensure that curative effect；Compound preparation curative effect is true
It cuts, but equally exists the shortcomings that respective.
For mouth disease, dosage needed for systemic administration is big and to reach the drug concentration that target site is put low, so local use
Medicine is optimal route of administration.
The content of the invention
The technical problem to be solved by the invention is to provide one kind can extend drug treating time, ensure therapeutic effect
The compound oral film and preparation method containing sodium azulenesulfonate.
The technical solution adopted in the present invention is：A kind of compound oral film containing sodium azulenesulfonate, by weight percentage,
Include：
PVA0588 2-4%, PVA1788 1-2%, hyaluronic acid-like chitosan 3-6%, sodium carboxymethylcellulose 2-
5%, Tween-80 1-3%, Tween-60 0.5-2%, glycerine 6-10%, distilled water 55-70%, 10:1 isatis root extract
5-8%, vitamin B2 2-5%, sodium azulenesulfonate 1-4%.
A kind of preparation method of the compound oral film containing sodium azulenesulfonate, includes the following steps：
1) PVA0588 2-4%, PVA1788 1-2%, hyaluronic acid-like chitosan 3-6%, sodium carboxymethylcellulose are selected
2-5%, Tween-80 1-3%, Tween-60 0.5-2%, glycerine 6-10%, 55-70%, isatis root extract 5-8%, dimension life
Plain B2 2-5%, sodium azulenesulfonate 1-4%；
2) PVA0588, PVA1788, hyaluronic acid-like chitosan and the distilled water mixing in step 1) are taken, uses heating water bath
Dissolving obtains lysate；
3) sodium carboxymethylcellulose, Tween-80, Tween-60 and the glycerine mixing in step 1) are taken, and stirs into paste simultaneously
It adds in the lysate that step 1) obtains；
4) isatis root extract, vitamin B2 and sodium azulenesulfonate in step 1) is taken to add in the solution that step 2) obtains,
Stirring is all dissolved to each component, and heat preservation degassing obtains liquid；
5) liquid is poured on the chopping block for scribbling sterile liquid paraffin, liquid is struck off with sterilized scraper plate；
6) be dried in vacuo at a temperature of 35 DEG C -50 DEG C 2-4 it is small when after form a film, then cut film device with special, membrane pressure gone out
The impression of 15mm × 10mm sizes, demoulding sub-dose packaging.
Step 2) the heating temperature is 80 DEG C ± 5 DEG C, time 30min.
Step 5) is described to strike off liquid, is in 0.2~0.25mm by liquid thickness control.
The compound oral film and preparation method containing sodium azulenesulfonate of the present invention, can extend drug treating time, target portion
Medication good effect can promote the rehabilitation of body and the enhancing of immunity resistance, be conducive to the reparation of canker sore mucous membrane, right
There is good therapeutic effect in canker sore.The present invention acts on patient's canker sore affected part part, and drug concentration is concentrated, made
With convenient, energy long period performance drug effect, guarantee therapeutic effect.Material selected by the present invention is also applied in food, and comes
Source is extensive, relative low price, and product manufacturing cost is low, safe to use, and market application is wider, has very high promotional value.
Specific embodiment
The compound oral film containing sodium azulenesulfonate and preparation method of the present invention are made in detail with reference to embodiment
Explanation.
The compound oral film and preparation method containing sodium azulenesulfonate of the present invention, prescription foundation are：Radix Isatidis is in clinic
Upper clearing heat and cooling blood, antiviral antibacterial action are apparent, and dosage is big, can be rated as Chinese patent drug most.It is aobvious that result of study shows that Radix Isatidis has
The effect for removing virus in vivo is write, effect is realized by killing in vivo virus, bacterium etc..Simultaneously, additionally it is possible to promote
Into the rehabilitation of body and the enhancing of immunity resistance.Early stage is applied, while coordinates anti symptom treatment, is greatly improved treatment effect
Fruit.Vitamin B2 plays an important role of to help to eliminate oral inflammation, and shortage can then cause stomatitis.Sodium azulenesulfonate is conducive to oral cavity and bursts
The reparation of ulcer mucous membrane.Shown by many experiments of research and development technology personnel：Only ratio to be applied is appropriate, isatis root extract with
Vitamin B2 and sodium azulenesulfonate combination no not fusion phenomenon from preparation, also without finding to there is any restriction or checking relation in five elements to make from curative effect
With.In order to which this prescription main ingredient is made to play the effect of preferable over the course for the treatment of, preparation type of the invention employs film, because
Film can be bonded with the canker sore surface of a wound well, by the effect of saliva, drug is made slowly to dissolve out the through lesion of release, is beneficial to
Obtain ideal curative effect.Scientific research personnel is from numerous filmogens, final definite different by a series of screening test
Polyvinyl alcohol (PVA), chitosan and the sodium carboxymethylcellulose of the degree of polymerization are as filmogen, according to their water-soluble differences
It is different, appropriate proportioning is carried out, thawing time different medicine film can be made.And these materials are also applied in food, and come
Source is extensive, relative low price, cost-saved, safe to use.It is aided with tween again for emulsifier, each ingredient is promoted preferably to melt
It closes；Increase the moisture retention of film with glycerine again, enhance film suppleness and reflecting feel, promote product appearance value.
The compound oral film containing sodium azulenesulfonate of the present invention, by weight percentage, includes：
PVA0588 2-4%, PVA1788 1-2%, hyaluronic acid-like chitosan 3-6%, sodium carboxymethylcellulose 2-
5%, Tween-80 1-3%, Tween-60 0.5-2%, glycerine 6-10%, distilled water 55-70%, 10:1 isatis root extract
5-8%, vitamin B2 2-5%, sodium azulenesulfonate 1-4%.
The preparation method of the compound oral film containing sodium azulenesulfonate of the present invention, includes the following steps：
1) PVA0588 2-4%, PVA1788 1-2%, hyaluronic acid-like chitosan 3-6%, sodium carboxymethylcellulose are selected
2-5%, Tween-80 1-3%, Tween-60 0.5-2%, glycerine 6-10%, 55-70%, 10:1 isatis root extract 5-
8%, vitamin B2 2-5%, sodium azulenesulfonate 1-4%；
2) PVA0588, PVA1788, hyaluronic acid-like chitosan and the distilled water mixing in step 1) are taken, uses heating water bath
Dissolving obtains lysate, and wherein heating temperature is 80 DEG C ± 5 DEG C, time 30min；
3) sodium carboxymethylcellulose, Tween-80, Tween-60 and the glycerine mixing in step 1) are taken, and stirs into paste simultaneously
It adds in the lysate that step 1) obtains；
4) isatis root extract, vitamin B2 and sodium azulenesulfonate in step 1) is taken to add in the solution that step 2) obtains,
Stirring is all dissolved to each component, and heat preservation degassing obtains liquid；
5) liquid is poured on the chopping block for scribbling sterile liquid paraffin, liquid is struck off with sterilized scraper plate, by liquid
Thickness control is in 0.2~0.25mm；
6) be dried in vacuo at a temperature of 35 DEG C -50 DEG C 2-4 it is small when after form a film, then cut film device with special, membrane pressure gone out
The impression of 15mm × 10mm sizes, demoulding sub-dose packaging.
Embodiment 1 (dosage 250g)
1) choose：
2) PVA0588, PVA1788, hyaluronic acid-like chitosan and the distilled water mixing in step 1) are taken, uses heating water bath
Dissolving obtains lysate, and wherein heating temperature is 80 DEG C ± 5 DEG C, time 30min；
3) sodium carboxymethylcellulose, Tween-80, Tween-60 and the glycerine mixing in step 1) are taken, and stirs into paste simultaneously
It adds in the lysate that step 1) obtains；
4) isatis root extract, vitamin B2 and sodium azulenesulfonate in step 1) is taken to add in the solution that step 2) obtains,
Stirring is all dissolved to each component, and heat preservation degassing obtains liquid；
5) liquid is poured on the chopping block for scribbling sterile liquid paraffin, strikes off liquid with sterilized scraper plate, liquid is thick
It spends for 0.2mm；
6) form a film after when vacuum drying 2.5 is small at 35 DEG C, then film device is cut with special, it is big that membrane pressure is gone out 15mm × 10mm
Small impression, demoulding sub-dose packaging.
Embodiment 2 (dosage 250g)
1) choose：
2) PVA0588, PVA1788, hyaluronic acid-like chitosan and the distilled water mixing in step 1) are taken, uses heating water bath
Dissolving obtains lysate, and wherein heating temperature is 80 DEG C ± 5 DEG C, time 30min；
3) sodium carboxymethylcellulose, Tween-80, Tween-60 and the glycerine mixing in step 1) are taken, and stirs into paste simultaneously
It adds in the lysate that step 1) obtains；
4) isatis root extract, vitamin B2 and sodium azulenesulfonate in step 1) is taken to add in the solution that step 2) obtains,
Stirring is all dissolved to each component, and heat preservation degassing obtains liquid；
5) liquid is poured on the chopping block for scribbling sterile liquid paraffin, strikes off liquid with sterilized scraper plate, liquid is thick
It spends for 0.22mm；
6) form a film after when vacuum drying 2 is small at 35 DEG C, then film device is cut with special, membrane pressure is gone out into 15mm × 10mm sizes
Impression, demoulding sub-dose packaging.
Embodiment 3 (dosage 250g)
1) choose：
2) PVA0588, PVA1788, hyaluronic acid-like chitosan and the distilled water mixing in step 1) are taken, uses heating water bath
Dissolving obtains lysate, and wherein heating temperature is 80 DEG C ± 5 DEG C, time 30min；
3) sodium carboxymethylcellulose, Tween-80, Tween-60 and the glycerine mixing in step 1) are taken, and stirs into paste simultaneously
It adds in the lysate that step 1) obtains；
4) isatis root extract, vitamin B2 and sodium azulenesulfonate in step 1) is taken to add in the solution that step 2) obtains,
Stirring is all dissolved to each component, and heat preservation degassing obtains liquid；
5) liquid is poured on the chopping block for scribbling sterile liquid paraffin, strikes off liquid with sterilized scraper plate, liquid is thick
It spends for 0.25mm；
6) form a film after when vacuum drying 4 is small at 35 DEG C, then film device is cut with special, membrane pressure is gone out into 15mm × 10mm sizes
Impression, demoulding sub-dose packaging.
Embodiment 4 (dosage 250g)
1) choose：
2) PVA0588, PVA1788, hyaluronic acid-like chitosan and the distilled water mixing in step 1) are taken, uses heating water bath
Dissolving obtains lysate, and wherein heating temperature is 80 DEG C ± 5 DEG C, time 30min；
3) sodium carboxymethylcellulose, Tween-80, Tween-60 and the glycerine mixing in step 1) are taken, and stirs into paste simultaneously
It adds in the lysate that step 1) obtains；
4) isatis root extract, vitamin B2 and sodium azulenesulfonate in step 1) is taken to add in the solution that step 2) obtains,
Stirring is all dissolved to each component, and heat preservation degassing obtains liquid；
5) liquid is poured on the chopping block for scribbling sterile liquid paraffin, strikes off liquid with sterilized scraper plate, liquid is thick
It spends for 0.2mm；
6) form a film after when vacuum drying 3 is small at 35 DEG C, then film device is cut with special, membrane pressure is gone out into 15mm × 10mm sizes
Impression, demoulding sub-dose packaging.
Embodiment 5 (dosage 250g)
1) choose：
2) PVA0588, PVA1788, hyaluronic acid-like chitosan and the distilled water mixing in step 1) are taken, uses heating water bath
Dissolving obtains lysate, and wherein heating temperature is 80 DEG C ± 5 DEG C, time 30min；
3) sodium carboxymethylcellulose, Tween-80, Tween-60 and the glycerine mixing in step 1) are taken, and stirs into paste simultaneously
It adds in the lysate that step 1) obtains；
4) isatis root extract, vitamin B2 and sodium azulenesulfonate in step 1) is taken to add in the solution that step 2) obtains,
Stirring is all dissolved to each component, and heat preservation degassing obtains liquid；
5) liquid is poured on the chopping block for scribbling sterile liquid paraffin, strikes off liquid with sterilized scraper plate, liquid is thick
It spends for 0.23mm；
6) form a film after when vacuum drying 3.5 is small at 35 DEG C, then film device is cut with special, it is big that membrane pressure is gone out 15mm × 10mm
Small impression, demoulding sub-dose packaging.
Observation of curative effect
Case is selected to be diagnosed through outpatient clinician without other diseases, only with canker sore, oral mucosa single patient occurs
Diameter 3-5mm ulcer.Patient age 18 more than one full year of life (no other diseases) below 55 one full year of life, is voluntary participation.Participant is total to
300 people divide 3 groups, every group of 100 people.Other drugs are not taken in treatment the last fortnight.Exhort that patient diet is preferably light during treatment
It is nonirritant, avoid pungent food the food that fishes and shrimps meat etc. easily aggravates disease, Diet temperature is unsuitable excessively high, can not be with other oral cavities
Medicine cross-reference.
The compound oral film application method containing sodium azulenesulfonate of the present invention：It is used in conjunction 7 days with 3 times within one day, observation treatment
Effect.The standard of curative effect evaluation is as follows：
1. it cures：Canker sore heals, and malaise symptoms disappear；
2. it improves：Although canker sore does not heal, degree mitigates, and ulcer diameter becomes smaller；
It is 3. invalid：Canker sore symptom is without significant change.
The different embodiment therapeutic effects of table 1 compare
It can see by the tracking test of continuous 7 days, in all embodiments, cure rate reaches more than 60%, effective
Rate is more than 90%.Can be drawn according to result on probation, the compound oral film of the invention containing sodium azulenesulfonate for
Treatment canker sore has good effect.
Claims (4)
1. a kind of compound oral film containing sodium azulenesulfonate, which is characterized in that by weight percentage, have：
PVA0588 2-4%, PVA1788 1-2%, hyaluronic acid-like chitosan 3-6%, sodium carboxymethylcellulose 2-5%, tween-
80 1-3%, Tween-60 0.5-2%, glycerine 6-10%, distilled water 55-70%, 10:1 isatis root extract 5-8%, vitamin
B2 2-5%, sodium azulenesulfonate 1-4%.
2. a kind of preparation method of the compound oral film described in claim 1 containing sodium azulenesulfonate, which is characterized in that including
Following steps：
1）PVA0588 2-4%, PVA1788 1-2%, hyaluronic acid-like chitosan 3-6%, sodium carboxymethylcellulose 2-5% are selected,
Tween-80 1-3%, Tween-60 0.5-2%, glycerine 6-10%, distilled water 55-70%, 10:1 isatis root extract 5-8%, dimension
Raw element B2 2-5%, sodium azulenesulfonate 1-4%；
2）Take step 1）In PVA0588, PVA1788, hyaluronic acid-like chitosan and distilled water mixing, it is molten with heating water bath
Solution obtains lysate；
3）Take step 1）In sodium carboxymethylcellulose, Tween-80, Tween-60 and glycerine mixing, and stir into paste and add in
Step 1）In obtained lysate；
4）Take step 1）In isatis root extract, vitamin B2 and sodium azulenesulfonate add in step 2）In the solution of acquisition, stirring
It is all dissolved to each component, heat preservation degassing obtains liquid；
5）Liquid is poured on the chopping block for scribbling sterile liquid paraffin, liquid is struck off with sterilized scraper plate；
6）Be dried in vacuo at a temperature of 35 DEG C -50 DEG C 2-4 it is small when after form a film, then cut film device with special, by membrane pressure go out 15mm ×
The impression of 10mm sizes, demoulding sub-dose packaging.
3. the preparation method of the compound oral film according to claim 2 containing sodium azulenesulfonate, which is characterized in that step
2）The heating temperature is 80 DEG C ± 5 DEG C, time 30min.
4. the preparation method of the compound oral film according to claim 2 containing sodium azulenesulfonate, which is characterized in that step
5）It is described to strike off liquid, it is in 0.2~0.25mm by liquid thickness control.
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108294967A (en) * | 2017-04-17 | 2018-07-20 | 江苏恩为众心生物医药有限公司 | Compound sodium azulenesulfonate periodontal nurses gel production technology |
| CN107714846A (en) * | 2017-10-18 | 2018-02-23 | 张家港蓝智生物科技有限公司 | A kind of canker sore patch and preparation method containing bioactivity glass |
| CN108310389A (en) * | 2018-01-12 | 2018-07-24 | 佛山科学技术学院 | One kind pro-drug of sodium sulfonate containing Kessazulen and preparation method thereof |
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| CN102000005A (en) * | 2010-11-27 | 2011-04-06 | 天津市顶硕科贸有限公司 | Oral care solution |
| CN102283949A (en) * | 2011-08-31 | 2011-12-21 | 天津市顶硕科贸有限公司 | Spraying agent containing sodium gualenate for treating canker sore |
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| JP2594395B2 (en) * | 1991-11-27 | 1997-03-26 | 吉富製薬株式会社 | Stabilization method and formulation of sodium azulene sulfonate |
| JP2009062285A (en) * | 2007-09-04 | 2009-03-26 | Yuuwa Shoji:Kk | Liquid formulation for oral cavity or throat disease |
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|---|---|---|---|---|
| CN102000005A (en) * | 2010-11-27 | 2011-04-06 | 天津市顶硕科贸有限公司 | Oral care solution |
| CN102283949A (en) * | 2011-08-31 | 2011-12-21 | 天津市顶硕科贸有限公司 | Spraying agent containing sodium gualenate for treating canker sore |
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| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Compound oral film containing sodium azulene sulfonate and its preparation method Effective date of registration: 20210318 Granted publication date: 20180522 Pledgee: Business Department of Bank of Tianjin Co.,Ltd. Pledgor: Tianjin top pharmaceutical Limited by Share Ltd. Registration number: Y2021120000008 |