Traditional Chinese medicine oral ulcer film and preparation method thereof

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine oral ulcer patch and a preparation method thereof. The application provides a traditional Chinese medicine oral ulcer patch, wherein the patch comprises a drug-containing layer and an isolation layer which are sequentially arranged in layers; according to mass fractions, the drug-containing layer comprises 4-8 parts of bletilla striata polysaccharide, 7-14 parts of bletilla striata powder or 14-28 parts of bletilla striata decoction, 16-32 parts of indigo extract, 8-16 parts of cimicifuga foetida extract, 8-16 parts of mentha extract, 0.5-2 parts of tea polyphenol, 10-15 parts of glycerol and 1-2 parts of sodium carboxymethyl cellulose; and the isolation layer comprises 10-15 parts of glycerol and 20-30 parts of polyvinyl alcohol. The oral ulcer double-layer patch prepared from pure traditional Chinese medicine is mild, safe and reliable, has good healing effect, long-acting effect, simple preparation and low cost, and has a wide application prospect.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine oral ulcer film and a preparation method thereof. BACKGROUND

[0002] Oral ulcer is a common clinical disease, and its onset sites are mostly lips, tongue body, buccal mucosa, soft palate and the like, and the surrounding tissues are accompanied by hyperemia and edema, and the ulcer local burning pain is obvious, which directly affects the daily activities such as eating, swallowing and language communication of patients.

[0003] At present, oral ulcer is mostly treated by using a dispersant, a spray or a gel, but the dosage of the dispersant, the spray or the gel is difficult to control, and the retention of the dispersant, the spray or the gel at the ulcer site is short due to the influence of saliva and swallowing, the taste is bitter, and the ulcer surface has a stimulating feeling. The film is a film-shaped preparation prepared by processing a drug and a suitable film-forming material, and the film can not only persistently give the drug but also reduce the stimulation and protect the ulcer surface.

[0004] Most of the products for treating oral ulcer at present adopt western medicine ingredients, but the western medicine ingredients mostly have a certain stimulation, and long-term repeated use also easily leads to drug resistance of the human body, and the use of traditional Chinese medicinal materials can effectively reduce the strong stimulation effect of western medicine. Chinese patent CN108403870A discloses a chicken gizzard adhesive film for treating oral ulcer, which is composed of chicken gizzard, Diandong Qian, Bengeran, Luoshuanghong, Yiyeqinglan, Chunhuamu, Zhujie Shuoguo, Nantianxianzi, Heiyangshen, Heiguoxibe, Tujiangjie and Haipiaoxie, and does not add any hormone-containing drug, and is high in safety. However, the single-layer design of the spray film is easily affected by the complex environment in the oral cavity, and the effect is not persistent. SUMMARY

[0005] The application aims to provide a traditional Chinese medicine oral ulcer film and a preparation method thereof, and the traditional Chinese medicine oral ulcer film provided by the application is non-irritating, has a persistent effect and has excellent curative effect on aphtha.

[0006] In order to achieve the above-mentioned purpose, the application provides the following technical scheme.

[0007] The application provides a traditional Chinese medicine oral ulcer film, which comprises a drug-containing layer and an isolation layer which are sequentially stacked.

[0008] According to the mass fraction:

[0009] The drug-containing layer comprises 4-8 parts of white pith polysaccharide, 7-14 parts of white pith powder or 14-28 parts of white pith decoction, 16-32 parts of indigo extract, 8-16 parts of rhizoma cimicifugae extract, 8-16 parts of mint extract, 0.5-2 parts of tea polyphenol, 10-15 parts of glycerol and 1-2 parts of sodium carboxymethyl cellulose.

[0010] The isolation layer comprises glycerol 10-15 parts and polyvinyl alcohol 20-30 parts.

[0011] Preferably, the particle size of the bletilla striata powder is 200-300 mesh.

[0012] Preferably, the bletilla striata decoction is prepared by water extraction of bletilla striata;

[0013] The temperature for water extraction of bletilla striata is 95-98 ℃, the time is 17-23 min, and the solid-liquid mass ratio is 0.5-1:1-4.

[0014] Preferably, the indigo extract is prepared by ethanol extraction of indigo;

[0015] The temperature for ethanol extraction of indigo is 80-85 ℃, the time is 43-46 min, and the solid-liquid mass ratio is 0.5-1:7-12.

[0016] Preferably, the cimicifuga foetida extract and the mint extract are both prepared by water extraction;

[0017] The temperature for preparing the cimicifuga foetida extract by water extraction is 95-98 ℃, the time is 17-23 min, and the solid-liquid mass ratio is 0.5-1:4-7;

[0018] The temperature for preparing the mint extract by water extraction is 95-98 ℃, the time is 4-9 min, and the solid-liquid mass ratio is 0.5-1:4-7.

[0019] The application also provides a preparation method of the traditional Chinese medicine oral ulcer patch film.

[0020] After the sodium carboxymethyl cellulose is swelled in water, it is mixed with bletilla striata polysaccharide, bletilla striata powder or bletilla striata decoction, cimicifuga foetida extract, indigo extract, mint extract, tea polyphenol and glycerol to obtain a first mixture;

[0021] The first mixture is first dried on the anti-sticking layer to obtain a drug-containing layer;

[0022] After the polyvinyl alcohol is dissolved in an ethanol aqueous solution, it is mixed with glycerol to obtain a second mixture;

[0023] The second mixture is second dried on the surface layer of the drug-containing layer to obtain the traditional Chinese medicine oral ulcer patch film.

[0024] Preferably, the volume percentage of ethanol in the ethanol aqueous solution is 20-30%.

[0025] Preferably, the temperature for the first drying is 30-40 ℃, and the time is 2-2.5 h.

[0026] Preferably, the second drying is performed at a temperature of 25-30℃ for 10-20min.

[0027] Preferably, the dissolving comprises swelling and heating performed in sequence; the swelling is performed for 24-36h; the heating is performed at a temperature of 88-95℃ for 40-60min.

[0028] The application provides a traditional Chinese medicine oral ulcer patch, which comprises a drug-containing layer and an isolation layer arranged in sequence; according to mass fractions, the drug-containing layer comprises 4-8 parts of bletilla striata polysaccharide, 7-14 parts of bletilla striata powder or 14-28 parts of bletilla striata decoction, 16-32 parts of indigo extract, 8-16 parts of radix clematidis extract, 8-16 parts of mint extract, 0.5-2 parts of tea polyphenol, 10-15 parts of glycerol and 1-2 parts of sodium carboxymethyl cellulose; and the isolation layer comprises 10-15 parts of glycerol and 20-30 parts of polyvinyl alcohol. The traditional Chinese medicine oral ulcer patch comprises the drug-containing layer and the isolation layer, wherein the drug-containing layer comprises bletilla striata and excipients, relies on the double properties of film formation and pharmacology of bletilla striata, directly contacts with an ulcer wound, forms a closed, moist and drug delivery environment, slowly releases and stabilizes the embedded medicinal ingredients, and can accelerate wound healing; radix clematidis and indigo can treat aphthous stomatitis, mint can relieve inflammation and pain, improves the medicinal smell, and increases the compliance of patients; tea polyphenol can resist oxidation and prolong the shelf life of the patch; sodium carboxymethyl cellulose serves as an auxiliary film forming material, and various components jointly take effect to accelerate wound healing; the film forming material of the isolation layer is polyvinyl alcohol, which can isolate the complex environment in the oral cavity and provide a good environment for wound recovery. The double-layer structure design can achieve safe drug delivery and avoid external stimulation. The traditional Chinese medicine oral ulcer double-layer patch prepared from pure traditional Chinese medicine is mild, safe and reliable, has good healing effect and long-acting effect, is simple to prepare, low in cost, and has a wide application prospect. BRIEF DESCRIPTION OF DRAWINGS

[0029] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed in the embodiments. Obviously, the drawings in the following description only some embodiments of the application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0030] Figure 1 The actual picture of the bletilla striata decoction prepared for example 1;

[0031] Figure 2 The actual picture of the indigo extract prepared for example 1;

[0032] Figure 3 The actual picture of the radix clematidis and mint extract prepared for example 1;

[0033] Figure 4 Here is a photograph of the Bletilla striata powder prepared in Example 2;

[0034] Figure 5 A photograph of the oral ulcer double-layer patch prepared in Example 1;

[0035] Figure 6 This is a photograph of the oral ulcer double-layer patch prepared in Example 2;

[0036] Figure 7 A schematic diagram of a double-layer dressing structure for oral ulcers;

[0037] Figure 8 Instructions for using a double-layer oral ulcer dressing;

[0038] Figure 9 This diagram illustrates the healing of oral ulcers in rats from the model control group, propolis oral film group, Bletilla striata decoction film group, and Bletilla striata powder film group.

[0039] Figure 10 This diagram illustrates the effects of the model control group, propolis oral film group, Bletilla striata decoction film group, and Bletilla striata powder film group on the pathological changes of oral ulcer mucosa tissue in rats. Detailed Implementation

[0040] This invention provides a traditional Chinese medicine oral ulcer patch, the patch comprising a medicine-containing layer and an isolation layer stacked sequentially;

[0041] By weight parts:

[0042] The drug-containing layer includes 4-8 parts of Bletilla striata polysaccharide, 7-14 parts of Bletilla striata powder or 14-28 parts of Bletilla striata decoction, 16-32 parts of Indigo naturalis extract, 8-16 parts of Cimicifuga foetida extract, 8-16 parts of Mentha haplocalyx extract, 0.5-2 parts of tea polyphenols, 10-15 parts of glycerin and 1-2 parts of sodium carboxymethyl cellulose.

[0043] The insulating layer comprises 10-15 parts glycerol and 20-30 parts polyvinyl alcohol.

[0044] In this invention, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0045] The drug-containing layer provided by the present invention comprises 4 to 8 parts by weight of Bletilla striata polysaccharide, preferably 4 to 6 parts, and more preferably 4 to 5 parts.

[0046] Based on the mass fraction of the Bletilla striata polysaccharide, the drug-containing layer provided by the present invention comprises 7-14 parts of Bletilla striata powder or 14-28 parts of Bletilla striata decoction; the Bletilla striata powder is preferably 7-12 parts, more preferably 7-9 parts; the Bletilla striata decoction is preferably 14-20 parts, more preferably 14-17 parts.

[0047] In the present application, the particle size of the Bletilla striata powder is preferably 200-300 mesh, more preferably 220-280 mesh, and most preferably 240-260 mesh; the Bletilla striata powder is preferably prepared by grinding Bletilla striata decoction pieces; the grinding is preferably performed using a high-speed multifunctional pulverizer; and the Bletilla striata powder is preferably stored in a sealed and refrigerated manner at 4°C.

[0048] In the present application, the Bletilla striata decoction is preferably prepared by water extraction of Bletilla striata; the Bletilla striata decoction is preferably prepared using Bletilla striata decoction pieces; the temperature for water extraction of Bletilla striata is preferably 95-98°C, more preferably 96-98°C, and most preferably 96-97°C; the time is preferably 17-23 min, more preferably 18-22 min, and most preferably 19-21 min; the solid-liquid mass ratio is preferably 0.5-1:1-4, more preferably 0.5-1:1-3, and most preferably 1:1-3; and the Bletilla striata decoction is preferably stored in a sealed and refrigerated manner at 4°C.

[0049] The drug-containing layer provided by the present application contains 16-32 parts of the Bletilla striata polysaccharide, preferably 16-26 parts, and more preferably 16-20 parts, based on the mass fraction of the Bletilla striata polysaccharide.

[0050] In the present application, the Bletilla striata decoction is preferably prepared by water extraction of Bletilla striata; the Bletilla striata decoction is preferably prepared using Bletilla striata decoction pieces; the temperature for water extraction of Bletilla striata is preferably 95-98°C, more preferably 96-98°C, and most preferably 96-97°C; the time is preferably 17-23 min, more preferably 18-22 min, and most preferably 19-21 min; the solid-liquid mass ratio is preferably 0.5-1:1-4, more preferably 0.5-1:1-3, and most preferably 1:1-3; and the Bletilla striata decoction is preferably stored in a sealed and refrigerated manner at 4°C.

[0051] The drug-containing layer provided by the present application contains 8-16 parts of the Cimicifuga foetida extract, preferably 8-13 parts, and more preferably 8-10 parts, based on the mass fraction of the Bletilla striata polysaccharide.

[0052] In the present application, the Cimicifuga foetida extract is preferably prepared by water extraction of Cimicifuga foetida; the Cimicifuga foetida extract is preferably prepared using Cimicifuga foetida decoction pieces; the temperature for water extraction of Cimicifuga foetida is preferably 95-98°C, more preferably 96-98°C, and most preferably 96-97°C; the time is preferably 17-23 min, more preferably 18-22 min, and most preferably 19-21 min; the solid-liquid mass ratio is preferably 0.5-1:4-7, more preferably 0.5-1:4-6, and most preferably 1:4-6; and the Cimicifuga foetida extract is preferably stored in a sealed and refrigerated manner at 4°C.

[0053] The drug-containing layer provided by the present application contains 8-16 parts of mint extract, preferably 8-13 parts, and more preferably 8-10 parts, based on the mass fraction of the bletilla striata polysaccharide.

[0054] In the present application, the mint extract is preferably prepared by water extraction of mint; the mint extract is preferably prepared by mint decoction pieces; the temperature for preparing the mint extract by water extraction is preferably 95-98°C, more preferably 96-98°C, and most preferably 96-97°C; the time is preferably 4-9 min, more preferably 5-8 min, and most preferably 6-7 min; the solid-liquid mass ratio is preferably 0.5-1:4-7, more preferably 0.5-1:4-6, and most preferably 1:4-6; and the mint extract is preferably stored in a sealed container at 4°C.

[0055] The drug-containing layer provided by the present application contains 0.5-2 parts of tea polyphenol, preferably 0.5-1 part, based on the mass fraction of the bletilla striata polysaccharide.

[0056] The drug-containing layer provided by the present application contains 10-15 parts of glycerol, preferably 10-13 parts, and more preferably 10-12 parts, based on the mass fraction of the bletilla striata polysaccharide.

[0057] The drug-containing layer provided by the present application contains 1-2 parts of sodium carboxymethyl cellulose, preferably 1-1.5 parts, based on the mass fraction of the bletilla striata polysaccharide.

[0058] The isolation layer provided by the present application contains 10-15 parts of glycerol, preferably 10-13 parts, and more preferably 10-12 parts, based on the mass fraction of the bletilla striata polysaccharide.

[0059] The isolation layer provided by the present application contains 20-30 parts of polyvinyl alcohol, preferably 20-26 parts, and more preferably 20-23 parts, based on the mass fraction of the bletilla striata polysaccharide.

[0060] The traditional Chinese medicine oral ulcer patch film provided by the application is composed of a drug-containing layer and an isolation layer, wherein the drug-containing layer is composed of bletilla striata components and excipients, relies on the double properties of film formation and pharmacology of bletilla striata to directly contact the ulcer wound, forms a closed and moist drug delivery environment, and slowly releases and stabilizes the embedded medicinal ingredients, so that the wound healing can be accelerated; the cimicifuga and indigo can treat aphthous stomatitis, the mint can relieve inflammation and pain, and improve the drug flavor, so that the patient compliance is increased; the tea polyphenol can resist oxidation and prolong the shelf life of the patch film; the sodium carboxymethyl cellulose is used as an auxiliary film forming material, and various components jointly take effect to accelerate wound healing; the isolation layer is prepared by using polyvinyl alcohol, and the isolation layer can isolate the complex environment in the oral cavity and provide a good environment for the recovery of the wound. The double-layer structure design can achieve safe drug delivery effect and also avoid external stimulation. The traditional Chinese medicine oral ulcer double-layer patch film provided by the application is prepared by using pure traditional Chinese medicine, is mild, safe and reliable, has good healing effect and long-acting effect, is simple to prepare, low in cost, and has a wide application prospect.

[0061] The application further provides a preparation method of the traditional Chinese medicine oral ulcer patch film.

[0062] The sodium carboxymethyl cellulose is swelled in water, and then mixed with bletilla striata polysaccharide, bletilla striata powder or bletilla striata decoction, cimicifuga extract, indigo extract, mint extract, tea polyphenol and glycerol to obtain a first mixture.

[0063] The first mixture is first dried on the anti-sticking layer to obtain the drug-containing layer.

[0064] The polyvinyl alcohol is dissolved in an aqueous ethanol solution, and then mixed with glycerol to obtain a second mixture.

[0065] The second mixture is second dried on the surface layer of the drug-containing layer to obtain the traditional Chinese medicine oral ulcer patch film.

[0066] The sodium carboxymethyl cellulose is swelled in water, and then mixed with bletilla striata polysaccharide, bletilla striata powder or bletilla striata decoction, cimicifuga extract, indigo extract, mint extract, tea polyphenol and glycerol to obtain a first mixture.

[0067] In the application, the mass and volume ratio of the sodium carboxymethyl cellulose and water is preferably 1-4 mg / mL, more preferably 1-3 mg / mL, and most preferably 2-3 mg / mL; and the swelling time is preferably 10-16 h, more preferably 11-15 h, and most preferably 12-14 h.

[0068] In the present application, the mixing is preferably first adding the Cimicifuga foetida extract, the indigo naturalis extract and the mint extract, second adding the tea polyphenol, third adding the Bletilla striata polysaccharide, the Bletilla striata powder or the Bletilla striata decoction, and finally adding the glycerol; the present application does not have any special limitation on the process of the mixing, and the first mixture is mixed uniformly in a manner well known to those skilled in the art.

[0069] After obtaining the first mixture, the present application performs the first drying of the first mixture on the anti-sticking layer to obtain the drug-containing layer.

[0070] In the present application, the anti-sticking layer is preferably a glass plate; the film coating process of the first drying is preferably the uniform paste flow casting method; the temperature of the first drying is preferably 30-40℃, more preferably 31-38℃, and most preferably 32-36℃; the time is preferably 2-2.5h, more preferably 2.1-2.4h, and most preferably 2.2-2.4h; and the first drying is preferably performed by using a drying oven.

[0071] The present application dissolves the polyvinyl alcohol in the aqueous ethanol solution, and then mixes the polyvinyl alcohol with the glycerol to obtain a second mixture.

[0072] In the present application, the polyvinyl alcohol is preferably PVA-1750.

[0073] In the present application, the mass of the polyvinyl alcohol and the volume of the aqueous ethanol solution are preferably 30-80mg / mL, more preferably 40-70mg / mL, and most preferably 40-60g / mL; the volume percentage of ethanol in the aqueous ethanol solution is preferably 20-30%, more preferably 24-26%, and most preferably 25-26%; the dissolving preferably comprises swelling and heating performed in sequence; the time of the swelling is preferably 24-36h, more preferably 26-34h, and most preferably 28-32h; the temperature of the heating is preferably 88-95℃, more preferably 89-94℃, and most preferably 90-93℃; and the time is preferably 40-60min, more preferably 45-58min, and most preferably 50-55min.

[0074] After the dissolving is completed, the present application further preferably comprises sieving the polyvinyl alcohol solution; and the mesh number of the sieve is preferably 24-80 mesh, and more preferably 40-60 mesh.

[0075] The present application does not have any special limitation on the process of the mixing, and the second mixture is mixed uniformly in a manner well known to those skilled in the art.

[0076] After obtaining the drug-containing layer and the second mixture, the present application performs the second drying of the second mixture on the surface layer of the drug-containing layer to obtain the traditional Chinese medicine oral ulcer film.

[0077] In the present application, the second drying process is preferably homogenate flow casting method; the second drying temperature is preferably 25-30℃, more preferably 26-29℃, most preferably 27-28℃; the time is preferably 10-20min, more preferably 12-18min, most preferably 14-16min; the second drying is preferably carried out by using drying oven.

[0078] In order to further illustrate the present application, the traditional Chinese medicine oral ulcer film and the preparation method thereof provided by the present application are described in detail below in combination with the drawings and examples, but they should not be understood as limiting the scope of protection of the present application.

[0079] Example 1

[0080] First step, preparation of white Bletilla striata boiled liquid

[0081] 10.8g of white Bletilla striata decoction pieces were extracted by water extraction method, and after heating and distillation water to 96℃ for 20min, filtration was performed. After cooling to room temperature, 21.6g of white Bletilla striata boiled liquid was obtained, which was stored at 4℃ under sealed refrigeration.

[0082] Second step, extraction of auxiliary medicinal materials

[0083] (1) Indigo extract

[0084] 4.8g of indigo powder was extracted by ethanol extraction method, and after heating to 82℃ for 45min, filtration was performed. After cooling to room temperature, 48g of indigo extract was obtained, which was stored at 4℃ under sealed refrigeration.

[0085] (2) Cimicifuga foetida extract and mint extract

[0086] 4.8g of Cimicifuga foetida decoction pieces and 4.8g of mint decoction pieces were extracted by water extraction method, and after heating to 97℃, filtration was performed after 20min and 5min of extraction, respectively. After cooling to room temperature, 24g of Cimicifuga foetida extract and 24g of mint extract were obtained, which were stored at 4℃ under sealed refrigeration.

[0087] Third step, film preparation

[0088] (1) Preparation of drug-containing layer:

[0089] 0.5g of sodium carboxymethyl cellulose was added to 250ml of distilled water and swelled for 12h. 8g of indigo extract, 4g of Cimicifuga foetida extract, 4g of mint extract and 0.4g of tea polyphenol were sequentially added to the swelled sodium carboxymethyl cellulose solution, and then 2g of Bletilla striata polysaccharide and 7.2g of white Bletilla striata boiled liquid were added. Finally, 5g of glycerol was added, and the above ingredients were mixed and dissolved. The homogenate flow casting method was used to spread on a 31.4×21cm glass plate, and the drug-containing layer was prepared by drying in a drying oven at a temperature of 32℃ for 2.4h.

[0090] (2) Isolation layer preparation:

[0091] Put 10g PVA-1750 into 200ml volume percentage of 25% ethanol aqueous solution for 30h, then heated to 92℃ for 52min to dissolve without granular, and passed through No.3 sieve. Add 5g glycerol and mix well. Take 15ml of the mixture and use homogenate flow casting method to lay on the dried drug layer, and put it into the drying oven at 27℃ for 15min, then take off the film, cut, sterilize and package. The traditional Chinese medicine oral ulcer film is obtained.

[0092] Example 2

[0093] Prepare the traditional Chinese medicine oral ulcer film according to the method described in Example 1, except that 7.2g of white peony water decoction is replaced by 3.6g of white peony powder. The preparation process of the white peony powder includes: grinding the white peony decoction pieces into 260 mesh powder using a high-speed multifunctional grinder, and storing at 4℃.

[0094] Test example

[0095] Effect of traditional Chinese medicine oral ulcer double-layer film on oral ulcer wound surface of rats

[0096] (1) Establishment of oral ulcer model in rats:

[0097] This experiment was carried out in the cell biology laboratory of Guizhou Medical University.

[0098] Select 20 SD rats weighing 200g-250g, half male and half female, and adaptively feed in a well-ventilated room with constant room temperature of 25℃ for one week. After one week, randomly select 4 as the normal group, and the remaining 16 use chemical burning method to construct oral ulcer animal model. After the rats are anesthetized by whole body inhalation of ether, they are fixed on the operation table, then a 2mm×2mm square filter paper piece is placed in anhydrous glacial acetic acid for 5s, then taken out and immediately placed on the labial mucosa of the mandibular alveolar bone of the lower incisor of the rat, and maintained for 30s, then the filter paper piece is taken out and the residual acetic acid is wiped off with a cotton swab.

[0099] (2) Randomly divide the modeled rats into 4 groups, 4 in each group, including the model control group, the white peony water decoction film group, the white peony powder film group, and the propolis oral film group, and feed them in separate cages. The white peony water decoction film group uses the traditional Chinese medicine oral ulcer double-layer film prepared in Example 1; the white peony powder film group uses the traditional Chinese medicine oral ulcer double-layer film prepared in Example 2; and the propolis oral film group uses the commercially available propolis oral film purchased from Huarun Zizhu Pharmaceutical Co., Ltd.

[0100] The model control group was not given any drug, and the other three groups were immediately given drugs after modeling for 24 hours. The area of the film was just enough to cover the affected area, and the drug was given every 3.5 hours, three times a day. The healing of the ulcer wound in each group was recorded during the continuous drug administration for 7 days, and the morphology of the oral ulcer in rats was photographed for morphological observation, and the results are shown in Figure 9 .

[0101] From Figure 9 it can be seen that compared with the model control group, the congestion and edema of the ulcer wound in the Bletilla striata decoction film group, the Bletilla striata powder film group and the propolis oral film group were relieved, and the healing speed was faster. Among them, the Bletilla striata decoction prepared in Example 1 had the best healing effect, and the oral ulcer film group was basically cured within 7 days.

[0102] In the experiment, the modeling rats and normal rats were sacrificed 2 hours after the last administration, and the ulcer tissue was taken for HE staining, and the treatment effect of each group of drugs on the oral ulcer of rats was observed under an optical microscope, as shown in Figure 10 . Among them, the normal group: the structure of the rat oral mucosa tissue layer was complete and clear, and there was no inflammatory cell infiltration; the model control group: the rat oral mucosa was damaged, the squamous epithelium was exfoliated, the cells were arranged in disorder, and a large number of inflammatory cells appeared; the propolis oral film group: the mucosal epithelium was basically healed, there was squamous epithelium hyperplasia, collagen fiber tissue was wrapped in the submucosal layer, and there was a small amount of inflammatory cell infiltration; the Bletilla striata decoction prepared in Example 1 obtained the oral ulcer film group of traditional Chinese medicine: the mucosal epithelium healed well, part of the squamous epithelium thickened and regenerated, the submucosal layer was wrapped with collagen fiber tissue, and there was a small amount of scar tissue and inflammatory cell infiltration; the Bletilla striata powder prepared in Example 2 obtained the oral ulcer film group of traditional Chinese medicine: the mucosal epithelium was healed, part of the tissue was replaced by granulation tissue, part of the cells were arranged in disorder, and there were a large number of inflammatory cells.

[0103] From Figure 10 it can be seen that the ulcer tissue sections on the 7th day were observed, and the propolis oral film group and the traditional Chinese medicine oral ulcer film group both achieved certain healing effect, and the epithelial tissue healing of the Bletilla striata decoction prepared in Example 1 obtained the traditional Chinese medicine oral ulcer film group was better, and the cells were arranged in order, indicating that its healing effect and anti-inflammatory effect were better than those of the other groups.

[0104] From the above examples, the traditional Chinese medicine oral ulcer film provided by the application is composed of a drug-containing layer and an isolation layer, wherein the drug-containing layer is composed of bletilla striata components and excipients, relies on the double properties of film formation and pharmacology of bletilla striata itself, directly contacts with the ulcer wound, forms a closed and moist drug delivery environment, and slowly releases and stabilizes the embedded medicinal ingredients, so that the wound healing can be accelerated; the radix clematidis and indigo can treat aphthous stomatitis, the mentha can relieve inflammation and pain, and improve the drug flavor, so that the patient compliance is increased; the tea polyphenol can resist oxidation and prolong the shelf life of the film; the sodium carboxymethyl cellulose is used as an auxiliary film forming material, and multiple components jointly take effect to accelerate wound healing; the isolation layer is prepared by using polyvinyl alcohol, and plays a role in isolating the complex environment in the oral cavity, so that a good environment can be provided for the recovery of the wound. The double-layer structure design can achieve safe drug delivery effect, and also can avoid external stimulation. The traditional Chinese medicine oral ulcer double-layer film provided by the application is made of pure traditional Chinese medicine, is mild, safe and reliable, has good healing effect and long-acting effect, is simple to prepare, low in cost, and has a broad application prospect.

[0105] Although the above examples make a detailed description of the application, it is only a part of the embodiments of the application, but not all the embodiments, and other embodiments can be obtained according to the present embodiments without creativity, and these embodiments all belong to the protection scope of the application.

Claims

1. A traditional Chinese medicine oral ulcer patch, characterized in that, The film consists of a drug-containing layer and a release layer stacked sequentially. By weight parts: The drug-containing layer is composed of 4-8 parts of Bletilla striata polysaccharide, 14-28 parts of Bletilla striata decoction, 16-32 parts of Indigo naturalis extract, 8-16 parts of Cimicifuga foetida extract, 8-16 parts of Mentha haplocalyx extract, 0.5-2 parts of tea polyphenols, 10-15 parts of glycerin, and 1-2 parts of sodium carboxymethyl cellulose. The isolation layer comprises 10-15 parts of glycerol and 20-30 parts of polyvinyl alcohol; The decoction of Bletilla striata was prepared by water extraction of Bletilla striata slices; the temperature for water extraction of Bletilla striata slices was 95~98℃, the time was 17~23min, and the solid-liquid mass ratio was 0.5~1:1~4. The indigo extract was prepared by ethanol extraction of indigo; the temperature of ethanol extraction of indigo was 80~85℃, the time was 43~46min, and the solid-liquid mass ratio was 0.5~1:7~12. Both the cimicifuga extract and the peppermint extract were prepared by water extraction. The temperature for preparing Cimicifuga extract by water extraction was 95-98℃, the time was 17-23 min, and the solid-liquid mass ratio was 0.5-1:4-7. The water extraction method for preparing peppermint extract uses a temperature of 95-98℃, a time of 4-9 min, and a solid-liquid mass ratio of 0.5-1:4-7.

2. The preparation method of the traditional Chinese medicine oral ulcer patch according to claim 1, characterized in that, Includes the following steps: Sodium carboxymethyl cellulose was swollen in water and then mixed with Bletilla striata polysaccharide, Bletilla striata decoction, Cimicifuga foetida extract, Indigo naturalis extract, peppermint extract, tea polyphenols and glycerin to obtain the first mixture; The first mixture is dried on the non-stick layer to obtain a drug-containing layer; Polyvinyl alcohol was dissolved in an aqueous ethanol solution and then mixed with glycerol to obtain a second mixture; The second mixture is subjected to a second drying process on the surface of the drug-containing layer to obtain the traditional Chinese medicine oral ulcer patch.

3. The preparation method according to claim 2, characterized in that, The volume percentage of ethanol in the ethanol-water solution is 20-30%.

4. The preparation method according to claim 2, characterized in that, The first drying temperature is 30~40℃, and the time is 2~2.5h.

5. The preparation method according to claim 2, characterized in that, The second drying temperature is 25~30℃, and the time is 10~20min.

6. The preparation method according to claim 2, characterized in that, The dissolution process includes sequential swelling and heating; the swelling time is 24-36 hours; the heating temperature is 88-95°C and the heating time is 40-60 minutes.

Images