CN102266311B - Compound membrane for treating canker sore and preparation method of compound membrane - Google Patents
Compound membrane for treating canker sore and preparation method of compound membrane Download PDFInfo
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- CN102266311B CN102266311B CN 201110211116 CN201110211116A CN102266311B CN 102266311 B CN102266311 B CN 102266311B CN 201110211116 CN201110211116 CN 201110211116 CN 201110211116 A CN201110211116 A CN 201110211116A CN 102266311 B CN102266311 B CN 102266311B
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
The invention relates to a compound membrane for treating canker sore and a preparation method of the compound membrane, and belongs to the technical field of medicaments for treating oral diseases. The technical scheme comprises the following steps of: dissolving chitosan in a glacial acetic acid aqueous solution with a concentration of 1 percent (v/v, volume ratio) to prepare a chitosan solution with the ratio of the chitosan to solution of 4-8 percent (mg/ml); dripping quercitin into absolute ethanol to be stirred; adding the chitosan solution after the quercitin is dissolved to ensure the ratio of the quercitin to solution is 1-5 percent (mg/ml), and sufficiently stirring to prepare a composite membrane solution; preparing a membrane by the composite membrane solution on a glass sheet by using a casting method, naturally cooling at room temperature, and taking the membrane to obtain the quercitin chitosan membrane. The invention has the advantages of scientific formula, simple preparation process, convenience for application, remarkable effect, and no need of special instrument or equipment, can be popularized and applied, accords with the modern Chinese medicament requirement of 'three-effect, three-smallness and three-convenience', and reflects the path of 'innovation, succession and modernization'.
Description
Technical field
The present invention relates to a kind of composite film-stuck for the treatment of oral ulcer and preparation method thereof, belong to treatment oral disease field of pharmaceutical technology.
Background technology
Oral ulcer (oral ulcer) is the commonly encountered diseases in the disease of cari oris mucosa, and sickness rate and relapse rate are high, and the prevalence of population can reach about 25%, occupy the first place of diseases of oral mucosa, its forming process is complicated, may be the result of many factors comprehensive function, has obvious individual variation.The factors such as the fluctuation of socio-psychological factors, infective agent, trophic factor, hormonal readiness, dysimmunity, inherited genetic factors, activity of SOD decline, microcirculation disturbance all can cause the generation of this disease, and the concrete cause of disease does not still understand.Oral ulcer be mainly manifested in the formation that circumscribed hyperemia, edema and ulcer are arranged on the oral mucosa, patient's main manifestations is inflammation and pain clinically.At present, be to ease the pain for the therapeutic purposes of oral ulcer, prolong the intermission, shorten stage of attack.Its treatment mainly is topical therapeutic and whole body therapeutic, and topical therapeutic mainly is antiinflammatory, and pain relieving also promotes ulcer healing.Whole body therapeutic mainly is to reduce recurrence and promote ulcer healing, and especially etiotropic treatment can also be aided with traditional Chinese medical herbal treatment.On topical therapeutic, acute attack stage promotes ulcer healing as principle take medicines such as antiinflammatory, anticorrosion, pain relieving and immunomodulators, Local treatment and medicine-feeding, or be aided with systemic administration.With regard to therapeutic effect, the result is unsatisfactory.Its main cause is, oral ulcer local application just carries out within the limited time, can not be lasting.And oral ulcer is local chronic inflammatory disease, and oral environment is complicated in addition, and medicine often by dilutions such as saliva, foods, make the use curative effect of medicine limited, and the systemic administration therapeutic effect is also undesirable on the oral ulcer surface.
Summary of the invention
The object of the invention provides a kind of composite film-stuck for the treatment of oral ulcer and preparation method thereof, and curative effect is clear and definite, with low cost, taking convenience, consumption are little, solves the problems referred to above that exist in the background technology.
Technical scheme of the present invention is:
A kind of preparation method for the treatment of the composite film-stuck of oral ulcer, processing step is as follows:
1. chitosan solution preparation: it is 1%(v/v that chitosan is dissolved in concentration) glacial acetic acid aqueous solution in, the ratio that obtains chitosan and solution is the chitosan solution of 4-8% (mg/ml), by the centrifugal impurity of removing, is chitosan solution, seals for subsequent use;
2. the preparation of composite solution: Quercetin is dripped absolute ethyl alcohol and stirring, add above-mentioned chitosan solution after the dissolving, making Quercetin and the ratio of solution is 1-5% (mg/ml), fully stirs into composite membrane liquid;
3. the preparation of Quercetin chitosan pad pasting: with casting method above-mentioned composite membrane liquid is made film on glass plate, behind the natural drying at room temperature, skinning obtains Quercetin chitosan pad pasting.
The present invention sterilizes under Burdick lamp after obtaining Quercetin chitosan pad pasting, makes circular film with card punch, package encapsulation.
Said chitosan solution, centrifugal by 3000r/min, lasting 30min removes impurity.
Said Quercetin chitosan pad pasting, the 15min that sterilizes under Burdick lamp makes circular film with diameter 4mm card punch, and the diaphragm quercetin content that makes is the 0.2mg/ sheet, and chitosan content is the 8mg/ sheet.
A kind of composite film-stuck for the treatment of oral ulcer, make by following method, 1. chitosan solution preparation: it is 1%(v/v that chitosan is dissolved in concentration) glacial acetic acid aqueous solution in, the ratio that obtains chitosan and solution is the chitosan solution of 4-8% (mg/ml), by the centrifugal impurity of removing, be chitosan solution, seal for subsequent use; 2. the preparation of composite solution: Quercetin is dripped absolute ethyl alcohol and stirring, add above-mentioned chitosan solution after the dissolving, making Quercetin and the ratio of solution is 1-5% (mg/ml), fully stirs into composite membrane liquid; 3. the preparation of Quercetin chitosan pad pasting: with casting method above-mentioned composite membrane liquid is made film on glass plate, behind the natural drying at room temperature, skinning obtains Quercetin chitosan pad pasting.
After obtaining Quercetin chitosan pad pasting, under Burdick lamp, sterilize, make circular film with card punch, package encapsulation.
Membrane of the present invention forms medicine Quercetin, chitosan.
Quercetin: be a kind of multiple bioactive flavone compound that has, extensively be present in the natural plants, approximately have 100 kinds of Chinese herbal medicine to contain Quercetin.Increasing to its research in recent years, find that it has the multiple pharmacologically actives such as oxidation and removing free radicals, antitumor, analgesia, antiinflammatory, antibiotic, antiviral, enhancing immunity and protection cardiovascular.Because the Quercetin toxic and side effects is little, more and more demonstrates important clinical value.
Chitosan: be to be obtained through deacetylation by the chitin that nature extensively exists, chemical name is Chitosan, has antibiotic, antioxidation, the pharmacological actions such as hemostasis, antiinflammatory and promotion organization healing.Be widely used in the numerous areas such as medicine, food, chemical industry, cosmetics, water treatment and biomedical engineering.Chitosan is again a kind of nontoxic, nonirritant, good biocompatibility and natural material with good filming, pliability and high viscosity.
Effect characteristics according to each medicine among the above-mentioned side show.The present invention is applied to the treatment of oral ulcer animal model, and therapeutical effect is obvious, has obvious advantage at aspects such as antiinflammatory, analgesia, promotion ulcer healings, shows that Quercetin chitosan pad pasting has good preventive and therapeutic effect to oral ulcer.
The invention has the beneficial effects as follows:
Scientific formulation
:As filmogen, the Quercetin that adding aboundresources, economy are easy to get is made composite film-stuck with the natural macromolecule amylose chitosan in the present invention.
Preparation technology is simple: this method technological process is simple, and cost is low.Other composition in the prescription is carried out extracts active ingredients and processing, kept effective ingredient.
It is convenient to use, successful: be applied to the treatment of oral ulcer, show the symptoms such as obvious healing, alleviating pain, ulcer peripheral edema.Show that Quercetin chitosan pad pasting has good preventive and therapeutic effect to oral ulcer.
Preparation process of the present invention is simple, does not need specific apparatus and equipment, can be applicable.Said preparation meets the modern Chinese medicine requirement of " triple effect, three little, three convenience ", has embodied the road of " innovation, succession, modernization ".
The specific embodiment
The invention will be further described by the following examples.
Embodiment one:
Mass volume ratio (mg/ml): Quercetin is 1% with the ratio of solution, and chitosan is 4% with the ratio of solution, every of final products Quercetin 0.2mg/, chitosan 8mg/ sheet.
Embodiment two:
Mass volume ratio (mg/ml): Quercetin is 3% with the ratio of solution, and chitosan is 6% with the ratio of solution, every of final products Quercetin 0.6mg/, chitosan 12mg/ sheet.
Embodiment three:
Mass volume ratio (mg/ml): Quercetin is 5% with the ratio of solution, and chitosan is 8% with the ratio of solution, every of final products Quercetin 1mg/, chitosan 16mg/ sheet.
The present invention has obtained fine therapeutic effect by rat and rabbit experiment research, draws to draw a conclusion:
1. Quercetin chitosan pad pasting can obviously improve rat and rabbit and reduces because of the food-intake that oral ulcer causes.
2. Quercetin chitosan pad pasting can obviously shorten oral ulcer rat and rabbit ulcer surface healing time, improves the healing rate of ulcer surface.
3. Quercetin chitosan pad pasting has obviously improved hyperemia, edema degree and the infection conditions of oral ulcer rat and rabbit ulcer spot.
4. Quercetin chitosan pad pasting can obviously reduce oral ulcer rat and rabbit ulcer place pathological tissues inflammatory cell quantity.
The animal pharmacodynamic experiment:
1. the observation of food-intake is respectively organized the activity of rat and food-intake all than reducing to some extent before the modeling after the ulcer mice modeling success, particularly making film back 3d blank group rats eating amount obviously reduces, each administration group rats eating amount also has minimizing, but blank group increases to some extent, QUCS film group 8d food-intake is substantially replied and is made the front level of film, has compared obvious recovery with administration 1d.See Table 1
The observation of every group of rats eating amount of table .1 (
± s, n=10)
Compare with the blank group
A P＜0.05,
B P＜0.01;
Compare with the chitosan group:
C P＜0.05
D P＜0.01; Compare with Quercetin chitosan group:
E P＜0.05
F P＜0.01 (lower same)
2. the ulcer of the visible diameter 4 * 3.5mm of film 24h (1d) rats with bilateral bicker place mucosa is made in the observation of every group of rat ulcer face the average healing and speed, depression slightly, and surperficial canescence, the periphery congestion and edema is touched a tender spot positive.2d (after the medication 1 day), the matched group ulcer area enlarges to some extent, and congestion and edema is all heavier; Each administration group also has in various degree expansion, but how not obvious, tissue edema is lighter than matched group, and is the lightest with the QUCS group; 3d (after the medication 2 days) blank group ulcer surface is downright bad, has pseudomembrane to generate, and is covered in the ulcer surface, and obviously seriously in each administration group; 4-5d (after the medication 3-4 days), ulcer surface pseudomembrane begins to come off to some extent, and pseudomembrane undertissue wound surface exposes, and the part ulcer surface begins healing, and administration is formed the face healing significantly better than matched group, and QUCS group ulcer area is significantly less than matched group; 6-7d (after the medication 5-6 days), ulcer is clearly better, and ulcer area is obviously dwindled, and each administration group healing state is significantly better than matched group; The most rat ulcers of QUCS group medication 6d heal fully, and BPS group ulcer healing is organized faster than CS; The most rat ulcers of matched group heal fully behind the treatment 10d.QUCS makes healing foreshorten to 6 days by 10 days.Each is organized rat ulcer healing rate, the congested degree of edema and surface infection situation and sees Table 2-5.
The observation of table .2 every group of rat ulcer face the average healing and speed (
± s, n=20)
| Grouping | The average healing (d) | Average healing rate (mm 2 /d） |
| Blank group | 10.51±1.92 | 1.82±0.35 |
| Chitosan | 8.65±1.72 A | 2.18±0.41 |
| Quercetin chitosan pad pasting | 6.24±1.35 BD | 3.13±0.44 BD |
| BINGPENG SAN | 7.68±1.28 | 2.44±0.37 BF |
The situation of change of every group of rat ulcer face of table .3 (
± s, n=20, mm
2)
Table .4 treatment after 2 days every group of edema degree relatively (
± s, n=20)
| Grouping | Ⅰ° | Ⅱ° | Ⅲ° | Total |  |
| Blank group | 3 | 13 | 4 | 41 | 2.05±0.24 |
| Chitosan | 6 | 11 | 3 | 37 | 1.85±0.27 |
| Quercetin chitosan pad pasting | 16 | 3 | 1 | 25 | 1.25±0.18 A |
| BINGPENG SAN | 14 | 4 | 2 | 28 | 1.40±0.29 |
Table .5 treatment infection conditions around the ulcer after 2 days (
± s, n=20)
| Grouping | Ⅰ° | Ⅱ° | Ⅲ° | Total |  |
| Blank group | 5 | 10 | 5 | 40 | 2.00±0.46 |
| Chitosan | 8 | 10 | 2 | 34 | 1.70±0.33 |
| Quercetin chitosan pad pasting | 15 | 4 | 1 | 26 | 1.30±0.29 A |
| BINGPENG SAN | 15 | 3 | 2 | 27 | 1.35±0.35 |
3. ulcer spot histopathological examination rat is made film 5d in administration 4d() each group gets at random 5 and takes off neck and put to death, cut ulcer place pathological tissues, show under the HE dyeing mirror: matched group covering epithelium cell arrangement is fine and close, degeneration necrosis, and the skin corium tissue necrosis is accompanied a large amount of neutrophil infiltration; QUCS group ulcer superficial necrosis thing is replaced by granulation tissue basically, and cell infiltration is rare; BPS group ulcer superficial necrosis thing is replaced by granulation tissue substantially, accompanies a little cell infiltration; A little inflammatory necrosis thing is seen on CS group ulcer top layer, and deep layer is seen granulation tissue hyperplasia.By the scoring of sxemiquantitative point system, its meansigma methods is asked in 10 visuals field of every sheet Continuous Observation (200 times) under the mirror, and its score value sees the following form 6.Table 6 demonstration, score value the lowest are QUCS group (close with the BPS group), and the soprano is matched group.
Table .6 treatment every group of ulcer surface pathological change after 4 days (
± s, n=25)
| Grouping | 0 | 1 | 2 | 3 | 4 | Sum |  |
| Blank group | 0 | 0 | 18 | 22 | 10 | 142 | 5.68±0.74 |
| Chitosan | 0 | 4 | 24 | 16 | 6 | 130 | 4.96±0.82 B |
| Quercetin chitosan pad pasting | 0 | 10 | 28 | 10 | 2 | 104 | 4.16±0.75 BD |
| BINGPENG SAN | 0 | 8 | 30 | 8 | 4 | 108 | 4.32±0.80 BDF |
The clinical test of pesticide effectiveness:
In January, 2009 to 2011, year December was accepted Blood of Patients with Recurrent Oral 108 examples altogether for medical treatment, was divided at random 2 groups, treatment group, male 16 examples, women 38 examples, 15～54 years old age, 31.5 years old mean age; Matched group, male 17 examples, women 37 examples, 14～53 years old age, 32.6 years old mean age; 2 groups of patients' age, number, the equal no significant difference of the state of an illness have comparability; All meet the diagnostic criteria of recurrent oral ulceration, all get rid of: (1) general disease: anemia, peptic ulcer, crohn, acute infectious diseases, autoimmune disease; (2) heavy RAU, Behcet syndrome; (3) whole body uses 17-hydroxy-11-dehydrocorticosterone in the 24h; (4) malignant tumor.
Matched group: the local ulcer surface place that adopts the BINGPENG SAN spray to be sprayed on the patient, 3 times/d, during the medication without any other medicine.Treatment group: the local Quercetin chitosan pad pasting that adopts is in the affected part, and without any other medicine, treatment is judged curative effect after one week during the treatment.
Criterion of therapeutical effect: judge after treating for 1 week, the RAU that the oral mucosal disease Professional Committee of understanding according to Chinese stomatology formulates estimates tentative standard.Produce effects: pain disappears, ulcer healing in the 3d after the medication, and own control ulcer recurrence gap prolongs; Effectively: pain relief, medication 5d ulcer healing, own control ulcer recurrence ask that gap prolongs; Invalid: sings and symptoms is without improvement after 1 week of medication.
Total effective rate %=(produce effects+effectively)/patient's sum * 100%.
The result: treatment group 54 routine Blood of Patients with Recurrent Orals, through treatment produce effects 36 examples in 1 week, effective 15 examples, invalid 3 examples, total effective rate is 94.44%; Matched group 54 routine Blood of Patients with Recurrent Orals, through treatment produce effects 29 examples in 1 week, effective 12 examples, invalid 13 examples, total effective rate is 75.93%; 2 groups therapeutic effect is checked through c2, and the c2 value is 7.34, P＜0.01, and significant difference is arranged.
Claims (5)
1. preparation method for the treatment of the composite film-stuck of oral ulcer is characterized in that processing step is as follows:
1. chitosan solution preparation: it is 1%(v/v that chitosan is dissolved in concentration) glacial acetic acid aqueous solution in, the ratio that obtains chitosan and solution is the chitosan solution of 4-8% (mg/ml), by the centrifugal impurity of removing, is chitosan solution, seals for subsequent use;
2. the preparation of composite solution: Quercetin is dripped absolute ethyl alcohol and stirring, add above-mentioned chitosan solution after the dissolving, making Quercetin and the ratio of solution is 1-5% (mg/ml), fully stirs into composite membrane liquid;
3. the preparation of Quercetin chitosan pad pasting: with casting method above-mentioned composite membrane liquid is made film on glass plate, behind the natural drying at room temperature, skinning obtains Quercetin chitosan pad pasting.
2. the preparation method of the composite film-stuck of described treatment oral ulcer according to claim 1, it is characterized in that obtaining Quercetin chitosan pad pasting after, under Burdick lamp, sterilize, make circular film with card punch, package encapsulation.
3. the preparation method of the composite film-stuck of described treatment oral ulcer according to claim 2 is characterized in that said chitosan solution, centrifugal by 3000r/min, and lasting 30min removes impurity; Said Quercetin chitosan pad pasting, the 15min that sterilizes under Burdick lamp makes circular film with diameter 4mm card punch, and the diaphragm quercetin content that makes is the 0.2mg/ sheet, and chitosan content is the 8mg/ sheet.
4. composite film-stuck for the treatment of oral ulcer, it is characterized in that making by following method, 1. chitosan solution preparation: it is 1%(v/v that chitosan is dissolved in concentration) glacial acetic acid aqueous solution in, the ratio that obtains chitosan and solution is the chitosan solution of 4-8% (mg/ml), by the centrifugal impurity of removing, be chitosan solution, seal for subsequent use; 2. the preparation of composite solution: Quercetin is dripped absolute ethyl alcohol and stirring, add above-mentioned chitosan solution after the dissolving, making Quercetin and the ratio of solution is 1-5% (mg/ml), fully stirs into composite membrane liquid; 3. the preparation of Quercetin chitosan pad pasting: with casting method above-mentioned composite membrane liquid is made film on glass plate, behind the natural drying at room temperature, skinning obtains Quercetin chitosan pad pasting.
5. the composite film-stuck of described treatment oral ulcer according to claim 4, it is characterized in that obtaining Quercetin chitosan pad pasting after, under Burdick lamp, sterilize, make circular film with card punch, package encapsulation.
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| CN102688345B (en) * | 2012-05-25 | 2014-12-10 | 泰山医学院 | Composite film for treating oral ulcer, and preparation method thereof |
| CN108851084B (en) * | 2018-06-06 | 2021-06-15 | 福建省农业科学院农业工程技术研究所 | Colon positioning micelle loaded with quercetin and preparation method thereof |
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| CN101444527A (en) * | 2008-12-26 | 2009-06-03 | 昆明创邦医疗器械有限公司 | Medicament for curing oral ulcer |
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| JPH0930987A (en) * | 1995-07-20 | 1997-02-04 | Mikio Ito | Preparation for treating and preventing intractable ulcer, gastritis and dermatitis |
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