Compositions Containing Bioactive Glass or Its Derivatives and Methods for Preparing Their Preparations

Abstract

The present invention discloses a composition containing bioactive glass or its derivatives, a preparation method thereof and its application, belonging to the field of medical technology. The composition includes bioactive glass or its derivatives, a bioadhesive material and a film-forming material. The composition prepared by the present invention can be used for oral care, oral treatment or wound care, and the preparation method is simple and has good effects.

Description

Technical Field

[0001] The present invention belongs to the field of pharmaceutical technology, and particularly relates to a composition containing bioactive glass or its derivatives, a preparation method thereof, and an application thereof. Background Art

[0002] Bioactive glass (abbreviated as BAG) is a silicate glass composed of silicon dioxide, Na2O, calcium oxide, phosphorus pentoxide, etc. After being implanted into the human body, the surface composition and structure of bioactive glass change over time to form a bioactive hydroxyapatite carbonate layer, providing a bonding interface for the restoration and growth of bones and soft tissues.

[0003] Toothpaste containing bioactive glass can be used to treat tooth hypersensitivity and periodontal diseases. When bioactive glass is directly added to water-containing toothpaste, since bioactive glass is prone to react with water, the bioactive glass component in the toothpaste will continuously decrease during the storage period. And water plays an important role in toothpaste. In addition to increasing the stability of toothpaste by combining with hydrophilic colloids, it also has a significant impact on the foaming property, stripability, cleaning value, pH value, rheological properties, taste, etc. of toothpaste. In order to reduce the influence of water on the degradation of active glass, toothpaste containing bioactive glass can adopt a water-free formula, that is, using materials such as glycerol and oligoethylene glycol as the matrix for preparation.

[0004] CN 108125806 A discloses a toothpaste containing bioactive glass. The preparation method is as follows: fully stir medical glycerol and carbomer 940, and let it stand; then sequentially add sorbitol, sodium carboxymethyl cellulose, xylitol, hydrated silica, medical polyethylene glycol - 400, sodium lauryl sulfate, natural essence, micro-nano bioactive glass, nano bioactive glass, nano-hydroxyapatite, purified water, citric acid, and C177891, and fully stir to obtain.

[0005] This kind of toothpaste can reduce the attenuation of the bioactive glass component during storage, but has poor stability. It will heat up due to the absorption of oral saliva in the anhydrous system during use, resulting in a strange taste. Moreover, relying only on saliva to provide moisture, the reaction rate of bioactive glass is relatively low during the limited brushing time, leading to a decrease in utilization rate and toothpaste quality. Effectively solving the coexistence problem of the two can reduce the usage amount of bioactive glass, thereby reducing the toothpaste cost, improving the taste of the toothpaste, and its quality in terms of ulcer healing, enamel remineralization, blocking dental tubules, and reducing gingival bleeding. Summary of the Invention

[0006] The present invention provides a composition containing bioactive glass or its derivatives, a preparation method thereof, and an application thereof, which can be used for oral care, oral treatment, or wound care.

[0007] In order to achieve the above object, the present invention adopts the following technical solutions:

[0008] The first object of the present invention is to provide a composition containing bioactive glass or its derivatives, which comprises the following components by mass:

[0009] Bioactive glass or its derivatives 20 - 80

[0010] Bioadhesive material 5 - 70

[0011] Film-forming material 10 - 75;

[0012] The bioactive glass or its derivatives contain silicon dioxide, calcium oxide and phosphorus pentoxide, and / or contain at least one of K, Na, Zn, Sr;

[0013] The bioadhesive material is selected from acrylic polymers, cellulose derivatives, povidone, copolymers of vinyl methyl ether and maleic anhydride, poloxamer, gums and polysaccharides of natural origin;

[0014] The film-forming material is at least one of acrylic polymers, acrylic resins, polyvinyl butyral esters, polyvinylpyrrolidone, copolymers of vinylpyrrolidone and vinyl acetate, polyvinyl alcohol, polyethylene oxide, thermoplastic elastomeric polyurethanes, graft copolymers of polyvinylcaprolactam - polyvinyl acetate - polyethylene glycol, cellulose and its derivatives, synthetic film-forming materials, natural gums and polysaccharides.

[0015] In particular, the acrylic polymer in the film-forming material is a non-crosslinked acrylic polymer with a molecular weight distribution of 100K - 50000K Dalton.

[0016] In particular, the film-forming material is a powder solid, which is soluble / partially soluble in water or Class II and Class III organic solvent systems in the ICH list.

[0017] In particular, the average particle size of the active ingredient ≤ 60μm.

[0018] In particular, the bioactive glass or its derivatives, calculated by mass, comprise the components:

[0019] Silicon dioxide 5 - 60

[0020] Calcium oxide 10 - 60

[0021] Phosphorus pentoxide 30 - 35.

[0022] In particular, the present invention also provides a preparation of a composition containing bioactive glass or its derivatives, which further comprises pharmaceutically acceptable excipients.

[0023] Polymeric substances such as acrylic polymers, cellulose derivatives, natural gums, and polysaccharides, etc., due to the characteristics of their structures, can be used as suspension retention components in the present invention; at the same time, they can also be used as bioadhesive materials.

[0024] The second object of the present invention is to provide a preparation method of a composition containing the above-mentioned bioactive glass or its derivative, and a preparation method of a preparation of a composition containing a bioactive glass or its derivative, which is characterized in that it is prepared by the following method 1 or method 2;

[0025] Method 1:

[0026] (1) Take a bioadhesive material and a film-forming material and place them in a solvent, stir evenly to obtain mixture 1;

[0027] (2) Take the remaining components and add them to mixture 1, mix evenly to obtain mixture 2;

[0028] (3) Mixture 2 is prepared by coating method, electrospinning method or 3D printing.

[0029] Method 2:

[0030] Mix the components of the bioadhesive material, the film-forming material and the bioactive glass or its derivative, and form a film or sheet by hot melt extrusion process, and then cut it to obtain the product;

[0031] Particularly, it is characterized in that

[0032] In step (1), the solvent is selected from water, and class II / III solvents in ICH;

[0033] In step (1), when mixture 1 is a suspension, the sedimentation rate of the suspension is ≤10% after standing at room temperature for 30 min, and it can be redispersed within 10 min after stirring to form a uniform system; the sedimentation rate is the ratio of the volume of the supernatant to the total volume after the solution or suspension is left standing at room temperature for 30 min. According to the convention in the art, the sedimentation rate not exceeding 10% can be understood as that when the preparation is stirred, it can form a uniform system within 10 min.

[0034] In step (1), the viscosity of the obtained mixture 1 is ≤10000 mPa·s (25 °C, Brookfield viscometer 20 RPM).

[0035] Particularly, the environmental temperature during the preparation process is 20 - 35 °C; the environmental humidity RH ≤ 65%;

[0036] The environmental temperature during drying is 35 - 80 °C.

[0037] The present invention also includes the aforementioned composition containing bioactive glass or its derivatives; or a preparation of the composition containing bioactive glass or its derivatives; and its use in the preparation of drugs for oral care, care and repair of mucosal wounds, and care and repair of wounds.

[0038] The aforementioned composition containing bioactive glass or its derivatives; or a preparation of the composition containing bioactive glass or its derivatives; the product form is a film, patch and / or tablet.

[0039] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0040] (1) The composition prepared by the present invention has a good effect of promoting wound healing, can effectively repair oral mucosa, repair periodontal inflammation, and reduce tooth sensitivity;

[0041] (2) The preparation process requires no water or only a small amount of water, which maximally ensures the activity and stability of the product;

[0042] (3) The prepared composition is used under anhydrous conditions, and can achieve adhesion and release for up to 20 s - 8 h depending on oral saliva secretion. Compared with daily brushing behavior: the brushing duration is about 2 - 3 min, and the gargling duration is 30 s - 1 min, it is more persistent; it meets the need for quick use, and also provides the possibility of continuous release and long-lasting effect in the mouth for toothpaste or oral treatment, thus greatly improving the consumer experience.

[0043] (4) The prepared composition can be directly adhered to the surface of hard tissues or soft tissues as needed to achieve precise treatment or care; at the same time, it provides accurate measurement and is convenient to carry.

[0044] (5) The prepared composition shows good efficacy in promoting wound healing and tissue repair. Within the scope of the present invention, it can effectively improve the stability performance of the composition, while increasing the onset speed of the composition, increasing the absorption effect of the drug, increasing the drug utilization rate, and promoting the drug effect. Detailed implementation manners

[0045] To better understand the present invention, the present invention will be further described below in conjunction with specific embodiments. The terms used in the embodiments are for describing specific specific implementation manners and do not constitute a limitation on the protection scope of the present invention.

[0046] In the present invention:

[0047] PVM / MA is a copolymer of vinyl methyl ether and maleic anhydride; PVB is polyvinyl butyral; TPU is thermoplastic elastomeric polyurethane; PVP is vinyl pyrrolidone; PVP / VA is a copolymer of vinyl pyrrolidone and vinyl acetate; EC is ethyl cellulose; NC is nitrocellulose; CA is cellulose acetate; MC is methyl cellulose; HPMC is hydroxypropyl methyl cellulose; HEC is hydroxyethyl cellulose; HPC is hydroxypropyl cellulose; CMC is carboxymethyl cellulose; bag refers to Bioactive Glasses.

[0048] Example 1

[0049] A method for preparing a composition containing bioactive glass or its derivatives, comprising the following steps:

[0050] (1) Weigh the raw materials according to the following parts by mass

[0051]

[0052]

[0053] Among them, the bioactive glass is composed of 5% silica, 60% calcium oxide and 35% phosphorus pentoxide (parts by mass).

[0054] (2) Place PBV, Kollidon SR, trehalose, and carbomer 980 in 400 parts of absolute ethanol, stir well and disperse. After the soluble part is completely dissolved, a homogeneous dispersion system is formed and stirred to obtain mixture 1;

[0055] (3) Take the bioactive glass and add it to mixture 1 to obtain mixture 2, and the viscosity of mixture 2 ≤ 10000 mPa·s.

[0056] (4) Coating mixture 2 on the substrate material by a coating process, drying at a temperature of 40 °C until the water content ≤ 10%, and cutting to obtain a film-like composition of bioactive glass or its derivatives.

[0057] The environmental temperature during the preparation process is 20 - 35 °C; the environmental humidity RH ≤ 65%.

[0058] Example 2

[0059] A method for preparing a composition containing bioactive glass or its derivatives, comprising the following steps:

[0060] (1) Weigh the raw materials according to the following parts by mass

[0061]

[0062] Among them, the bioactive glass is composed of 60% silica, 10% calcium oxide, and 30% phosphorus pentoxide (by mass).

[0063] (2) Place the non-crosslinked acrylic polymer, HPMC E15, and PVP K30 in 400 parts of absolute ethanol, stir well and disperse. After the soluble part is completely dissolved, a uniform dispersion system is formed by stirring to obtain Mixture 1;

[0064] (3) Add the bioactive glass and the remaining components to Mixture 1 to obtain Mixture 2, and the viscosity of Mixture 2 ≤ 10000 mPa·s.

[0065] (4) Coating Mixture 2 on the substrate material by a coating process, drying at a temperature of 60 °C until the water content ≤ 10%, and cutting to obtain the composition of the bioactive glass or its derivative in the form of a film.

[0066] The environmental temperature during the preparation process is 20 - 35 °C; the environmental humidity RH ≤ 65%.

[0067] Example 3

[0068] A preparation method of a composition containing bioactive glass or its derivative, comprising the following steps:

[0069] (1) Weigh the raw materials according to the following mass parts

[0070]

[0071] Among them, the bioactive glass is composed of 20% silica, 60% calcium oxide, and 20% phosphorus pentoxide (by mass).

[0072] (2) Place HPMC E50, PVP K90, and POLYOXTM WSR N-10 in 400 parts of absolute ethanol, stir well and disperse. After the soluble part is completely dissolved, a uniform dispersion system is formed by stirring to obtain Mixture 1;

[0073] (3) Add the bioactive glass to Mixture 1 to obtain Mixture 2, and the viscosity of Mixture 2 ≤ 10000 mPa·s.

[0074] (4) Coating Mixture 2 on the substrate material by a coating process, drying at a temperature of 80 °C until the water content ≤ 10%, and cutting to obtain the composition of the bioactive glass or its derivative in the form of a film.

[0075] The environmental temperature during the preparation process is 20 - 35 °C; the environmental humidity RH ≤ 65%.

[0076] Example 4

[0077] A method for preparing a composition containing bioactive glass or its derivatives comprises the following steps:

[0078] (1) Weigh the raw materials according to the following mass parts

[0079]

[0080] The bioactive glass is composed of 5% silicon dioxide, 60% calcium oxide and 35% phosphorus pentoxide (by mass).

[0081] (2) PVB, ethyl cellulose E15, acrylic resin (RS100), and carbomer 980 are placed in 400 parts of anhydrous ethanol, and stirred and dispersed until the soluble part is fully dissolved to form a uniform dispersion system, thereby obtaining a mixture 1;

[0082] (3) Adding bioactive glass to mixture 1 to obtain mixture 2, the viscosity of mixture 2 is ≤10000 mPa.s.

[0083] (4) The mixture 2 is coated on a substrate material by a coating process, dried at a drying temperature of 60° C. until the water content is ≤10%, and then cut to obtain a film-like composition of bioactive glass or its derivatives.

[0084] The ambient temperature during the preparation process is 20-35°C; the ambient humidity RH≤65%.

[0085] Embodiment 5

[0086] A method for preparing a composition containing bioactive glass or its derivatives comprises the following steps:

[0087] (1) Weigh the raw materials according to the following mass parts

[0088]

[0089] The bioactive glass is composed of 5% silicon dioxide, 60% calcium oxide and 35% phosphorus pentoxide (by mass).

[0090] (2) placing non-crosslinked acrylic acid polymer, HPMC E15, CMC-Na and PVB in 400 parts of anhydrous ethanol, stirring and dispersing them sufficiently, and after the soluble part is sufficiently dissolved, forming a uniform dispersion system, and obtaining a mixture 1;

[0091] (3) Adding bioactive glass to mixture 1 to obtain mixture 2, the viscosity of mixture 2 is ≤10000 mPa.s.

[0092] (4) The mixture 2 is printed on the backing layer by 3D printing process and dried at 60° C. to obtain a thin film preparation containing a bioactive glass composition.

[0093] The ambient temperature during the preparation process is 20-35°C; the ambient humidity RH≤65%.

[0094] Embodiment 6

[0095] A method for preparing a composition containing bioactive glass or its derivatives comprises the following steps:

[0096] (1) Weigh the raw materials according to the following mass parts

[0097]

[0098] The bioactive glass is composed of 60% silicon dioxide, 10% calcium oxide and 30% phosphorus pentoxide (by weight).

[0099] (2) placing acrylic acid polymer (non-cross-linked type), HPMC E15, PVP / VA (VA64), PEO (POLYOXTM WSR N-10), and trehalose in 400 parts of anhydrous ethanol, stirring and dispersing them sufficiently, and after the soluble part is fully dissolved, a uniform dispersion system is formed, and a mixture 1 is obtained;

[0100] (3) Add the bioactive glass and other ingredients to mixture 1 to obtain mixture 2, wherein the viscosity of mixture 2 is ≤10000 mPa.s.

[0101] (4) The mixture 2 is coated on a substrate material by an electrospinning process, dried at 50° C., and cut to obtain a film-like bioactive glass composition preparation.

[0102] The ambient temperature during the preparation process is 20-35°C; the ambient humidity RH≤65%.

[0103] Embodiment 7

[0104] A method for preparing a composition containing bioactive glass or its derivatives comprises the following steps:

[0105] (1) Weigh the raw materials according to the following mass parts

[0106]

[0107] The bioactive glass is composed of 60% silicon dioxide, 10% calcium oxide and 30% phosphorus pentoxide (by weight).

[0108] (2) acrylic acid polymer (non-crosslinked type), PVP K30 and PVA are placed in 400 parts of anhydrous ethanol, fully stirred and dispersed, and after the soluble part is fully dissolved, a uniform dispersion system is formed to obtain a mixture 1;

[0109] (3) Add bioactive glass to Mixture 1 to obtain Mixture 2, and the viscosity of Mixture 2 ≤ 10,000 mPa·s.

[0110] (4) Coating Mixture 2 onto a substrate material by a coating process, with a drying temperature of 60 °C, and then cutting to obtain a film-like preparation containing the bioactive glass composition.

[0111] The environmental temperature during the preparation process is 20 - 35 °C; the environmental humidity RH ≤ 65%.

[0112] Example VIII

[0113] A bioactive glass composition, comprising the following components: 25 parts of bioactive glass (BAG), 25 parts of a material providing bioadhesion, and 50 parts of a film-forming material.

[0114] Among them, the film-forming material is a mixture of PVP / VA VA64:Soluplus (polyvinylcaprolactam - polyvinyl acetate - polyethylene glycol graft copolymer):TPU with a mass ratio of 1:0.9:0.1; the bioadhesive material is an acrylic polymer (non-crosslinked type) with a mass ratio of 25.

[0115] The bioactive glass is composed of 60% silica, 10% calcium oxide, and 30% phosphorus pentoxide.

[0116] The preparation method of the bioactive glass composition and its preparation is as follows:

[0117] Take 25 parts of acrylic polymer (non-crosslinked type), 50 parts of the mixture of PVP / VA VA64, Soluplus, and TPU, and 25 parts of BAG, stir well and mix evenly, through a hot melt extrusion process, with an extrusion temperature, extrude a film containing BAG, and then cut to obtain a sheet-like product containing the bioactive glass composition.

[0118] Example IX

[0119] A bioactive glass composition, comprising the following components: 20 parts of bioactive glass (BAG), 20 parts of a material providing bioadhesion, and 60 parts of a film-forming material.

[0120] Among them, the film-forming material is a mixture of hydroxypropyl cellulose Klucel ELF, acrylic resin EPO, polyethylene oxide (PEO) N10, chitosan, and pullulan with a mass ratio of 1:1:1:1:1; the bioadhesive material is a mixture of polyvinylpyrrolidone K30, copolyvinylpyrrolidone VA64, PVM / MA S97, poloxamer 407, xanthan gum, and guar gum with a mass ratio of (1:1:1:1:1:1).

[0121] The bioactive glass is composed of 5% silicon dioxide, 60% calcium oxide and 35% phosphorus pentoxide.

[0122] The preparation method of the bioactive glass composition and the preparation thereof:

[0123] (1) 60 parts of the above-mentioned film-forming material and 20 parts of the bioadhesive material are placed in 400 parts of anhydrous ethanol, and stirred and dispersed until the soluble part is fully dissolved to form a uniform dispersion system, thereby obtaining 1;

[0124] (2) Add BAG to 1 and stir thoroughly to obtain a uniform mixture 2, wherein the viscosity of the mixture 2 is ≤10000 mpa.s;

[0125] (3) Mix 2 and apply it to a substrate material by a coating process, dry it at 38° C., and cut it to obtain a film-like bioactive glass composition preparation.

[0126] The compositions of Examples 1 to 9 above were tested.

[0127] 1. Adhesion time limit test

[0128] Test method: Fix the epithelial layer of the pig tongue treated with physiological saline at one end of the "U"-shaped groove with a flat bottom (2cm*5cm*0.3mm is the width*length*thickness of the epithelial layer of the pig tongue, respectively), cut the sample of the embodiment into strips of width*length*thickness=1.5cm*4cm*0.15mm; then place the strips on the injection, ensure that the bottom ends of all strips are at an equal distance from the bottom end of the pig tongue, press for 3s, tilt the "U"-shaped groove by 30° (the angle between the "U"-shaped groove and the ground), and the section with the sample is at the top; turn on the peristaltic pump, and evenly flush the strips with artificial saliva kept at 37±1℃ from the small hole at the top, the flushing speed is 1ml / min, and stop timing when all the strips disappear from the pig tongue. The results are shown in Table 1, and each group was tested 10 times.

[0129] Table 1 Adhesion time limit

[0130] Experimental Group Adhesion Time (minutes) Example 1 308±6.5 Example 2 35±1.2 Example 3 3±0.1 Example 4 510±8.3 Example 5 267±4.3 Example 6 195±3.2 Example 7 76±2.4 Example 8 430±5.4 Example 9 326±4.6

[0131] 2. Melting time test

[0132] Test method: Take the finished product of the embodiment and cut it into 1cm 2 Six films of different sizes were clamped with two layers of stainless steel wire with an inner diameter of 2.0 mm, and the disintegration time limit test method for tablets was used for inspection (Chinese Pharmacopoeia 2020 Chinese Pharmacopoeia Part IV General Rules 0921). The time when the sample was completely melted and passed through the sieve was observed and recorded. The results are shown in Table 2, and each group was tested 10 times.

[0133] Table 2 Melting time limit

[0134] Experimental Group Melting Time (minutes) Example 1 59±1.3 Example 2 12±0.3 Example 3 0.3±0.015 Example 4 491±8.5 Example 5 192±4.2 Example 6 126±2.8 Example 7 35±1.0 Example 8 93±2.4 Example 9 67±3.1

[0135] 3. Wound healing test

[0136] Test method: Establish a porcine dorsal defect wound model. Make a square defect of 5 cm×5 cm×4 cm on one side of the porcine spine, reaching the fascia layer. Randomly divide into 9 groups of examples and 1 group of control, with 3 porcine models in each group. In the first three days after surgery, the wound surface is filled with gauze for embedding. After three days, when the wound exudate decreases, the gauze is removed. Take the sample of the example and directly place it on the ulcerated area. After moistening with a little normal saline, keep it; The control group (toothpaste, formula: 8% bioactive glass, 60% glycerol, 22% silicon dioxide, 8% PEG400, 1% essence, 1% sodium lauryl sulfate) and normal saline are mixed according to the mass ratio of 1:1, applied to the ulcerated area for 3 minutes, and debrided with normal saline; The active ingredient used for all wound surfaces is 0.1 g active ingredient / wound surface; Using the same treatment procedure, apply once a day, and treat the porcine dorsal defect for 7 d, 14 d, and 21 d respectively, and track the wound repair situation. The results show that the product of the present invention can grow exactly the same tissue as the original on the 5 cm*5 cm*4 cm wound surface on the 21st day, realizing in-situ tissue regeneration, and new hair follicles and capillaries grow out. The wound healing data are shown in Table 3.

[0137] Table 3 Wound healing test (x±S)

[0138]

[0139]

[0140] 4. Oral mucosa repair test

[0141] Test method: Take SD rats and establish a rat oral ulcer model. After anesthetizing the rats, dip the cotton ball at one end of the glass tube into 900 g / L phenol solution and burn the lower side of the rats' tongues for 60 s, and ulcers with a diameter of 5 mm appear on the lower side of the rats' tongues.

[0142] Sixty successfully modeled SD rats were randomly divided into 10 groups, namely 9 groups of examples and a control group, with 6 rats in each group. For the rats in Examples 1 to 9, the corresponding example samples were used respectively; the dosage and usage method were as follows: use a film / tablet containing 10 mg of the active ingredient and adhere it to the ulcer for 3 minutes; for the control group (the control group is a commercially available product, formula: 8% bioactive glass, 60% glycerol, 22% silicon dioxide, 8% PEG400, 1% essence, 1% sodium lauryl sulfate), take a sample containing 10 mg of the active ingredient and disperse it with physiological saline at a mass ratio of 1:1, apply it to the ulcer for 3 minutes, and treat once a day for 7 consecutive days. The results show that the product of the present invention can rapidly promote the repair and healing of oral mucosal ulcers, and can completely repair an ulcer wound with a diameter of 5 mm in 7 days, realizing the regenerative repair of oral mucosa. The average values of the oral mucosal repair data of each group of rats are shown in Table 4.

[0143] Table 4 Oral mucosal repair data

[0144] Experimental Group 0d (mm) 1d (mm) 3d (mm) 5d (mm) 7d (mm) Example 1 5 3.8±0.11 2.3±0.10 0.8±0.03 0 Example 2 5 4.0±0.09 2.9±0.08 1.1±0.02 0 Example 3 5 4.2±0.14 3.4±0.09 1.5±0.04 0 Example 4 5 3.3±0.10 1.8±0.07 0.1±0.05 0 Example 5 5 3.9±0.10 2.5±0.07 0.9±0.03 0 Example 6 5 3.7±0.13 2.2±0.03 0.6±0.01 0 Example 7 5 3.9±0.09 2.7±0.05 0.9±0.02 0 Example 8 5 3.5±0.12 2.0±0.06 0.4±0.03 0 Example 9 5 3.6±0.13 2.1±0.07 0.5±0.02 0 Control Group 5 4.6±0.16 4.1±0.18 3.4±0.12 2.8±0.10

[0145] 5. Periodontal inflammation repair test

[0146] The first mandibular molar was ligated with a silk thread for 3 weeks to establish an experimental periodontitis model in SD rats. Sixty successfully modeled SD rats were randomly divided into 10 groups, namely 9 groups of examples and a control group, with 6 rats in each group. The experiment was carried out for 5 days. For the mice in Examples 1 to 9, the corresponding example samples were used respectively; the dosage and usage method were as follows: use a film / tablet containing 5 mg of the active ingredient and adhere it to the periodontitis site. The control group (8% bioactive glass, 60% glycerol, 22% silicon dioxide, 8% PEG400, 1% essence, 1% sodium lauryl sulfate) was dispersed with physiological saline at a mass ratio of 1:1 and applied to the periodontitis site for 3 minutes. The evaluation index was tissue healing degree: taking the normal tissue state as 100% healing degree and the state of the newly established periodontitis model as 0% healing degree to evaluate the experiment and the recovery speed of the tissue. The results are shown in Table 5. The results show that the product of the present invention can effectively repair periodontitis, and can basically reach a 100% repair effect in 5 days, which is much higher than the control group.

[0147] Table 5 Periodontal inflammation repair data (tissue healing degree )

[0148] Experimental Group 0d 1d 3d 5d Example 1 0 18±0.6 73±1.5 100 Example 2 0 16±0.5 69±1.3 100 Example 3 0 14±0.5 63±1.4 97±0.2 Example 4 0 22±0.4 80±1.6 100 Example 5 0 17±0.7 72±1.2 100 Example 6 0 19±0.6 74±1.1 100 Example 7 0 17±0.2 71±1.8 100 Example 8 0 21±0.6 77±1.4 100 Example 9 0 20±0.7 75±1.8 100 Control Group 0 12±0.3 45±0.9 82±1.2

[0149] The above detailed description is a specific description of one feasible embodiment of the present invention. This embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or change without departing from the present invention should be included within the scope of the technical solution of the present invention.

Claims

1. A composition containing bioactive glass, characterized in that, The preparation method comprises the following steps: (1) Weigh the raw materials according to the following parts by mass Bioactive glass 20 Carbomer 980 20 PVB 6 PVP / VA Kollidon SR 50 Trehalose 4; Among them, the bioactive glass is composed of 5% silica, 60% calcium oxide and 35% phosphorus pentoxide by mass; (2) Put PVB, PVP / VA Kollidon SR, trehalose, and Carbomer 980 into 400 parts of absolute ethanol, stir well and disperse. After the soluble part is completely dissolved, a uniform dispersion system is formed to obtain Mixture 1; (3) Take the bioactive glass and add it to Mixture 1 to obtain Mixture 2, and the viscosity of Mixture 2 ≤ 10000 mPa·s; (4) Coating Mixture 2 on the substrate material by a coating process, drying at a temperature of 40°C until the water content ≤ 10%, and cutting to obtain a film-shaped composition containing bioactive glass; The environmental temperature during the preparation process is 20 - 35°C; the environmental humidity RH ≤ 65%.

2. A composition containing bioactive glass, characterized in that, The preparation method comprises the following steps: (1) Weigh the raw materials according to the following parts by mass Bioactive glass 20 PVB 5 Ethyl cellulose E15 60 Acrylic resin RS100 10 Carbomer 980 5; Among them, the bioactive glass is composed of 5% silica, 60% calcium oxide and 35% phosphorus pentoxide by mass; (2) Put PVB, ethyl cellulose E15, acrylic resin RS100, and Carbomer 980 into 400 parts of absolute ethanol, stir well and disperse. After the soluble part is completely dissolved, a uniform dispersion system is formed to obtain Mixture 1; (3) Take the bioactive glass and add it to Mixture 1 to obtain Mixture 2, and the viscosity of Mixture 2 ≤ 10000 mPa·s; (4) Coating Mixture 2 on the substrate material by a coating process, drying at a temperature of 60°C until the water content ≤ 10%, and cutting to obtain a film-shaped composition containing bioactive glass; The environmental temperature during the preparation process is 20 - 35°C; the environmental humidity RH ≤ 65%.

3. A composition containing bioactive glass, characterized in that, The preparation method comprises the following steps: (1) Weigh the raw materials according to the following parts by mass Bioactive glass 20 Non-crosslinked acrylic polymer 10 HPMC E15 58 CMC-Na 2 PVB 10; Among them, the bioactive glass is composed of 5% silica, 60% calcium oxide and 35% phosphorus pentoxide by mass; (2) Put the non-crosslinked acrylic polymer, HPMC E15, CMC-Na, and PVB into 400 parts of absolute ethanol, stir well and disperse. After the soluble part is completely dissolved, a uniform dispersion system is formed to obtain Mixture 1; (3) Take the bioactive glass and add it to Mixture 1 to obtain Mixture 2, and the viscosity of Mixture 2 ≤ 10000 mPa·s; (4) Printing Mixture 2 on the backing layer by a 3D printing process and drying at 60°C to obtain a film-shaped composition containing bioactive glass; The environmental temperature during the preparation process is 20 - 35°C; the environmental humidity RH ≤ 65%.

4. A composition containing bioactive glass, characterized in that, It includes the following components: 20 parts of bioactive glass, 20 parts of bioadhesive material, 60 parts of film-forming material; The film-forming materials are hydroxypropyl cellulose Klucel ELF, acrylic resin EPO, polyoxyethylene N10, chitosan, and pullulan in a mass ratio of 1:1:1:1:1; the bioadhesive materials are povidone K30, copovidone VA64, PVM / MA S97, poloxamer 407, xanthan gum, and guar gum in a mass ratio of 1:1:1:1:1:1; The bioactive glass is composed of 5% silicon dioxide, 60% calcium oxide and 35% phosphorus pentoxide by mass; The method for preparing the bioactive glass composition comprises the following steps: (1) 60 parts of the above-mentioned film-forming material and 20 parts of the bioadhesive material are placed in 400 parts of anhydrous ethanol, stirred and dispersed sufficiently, and after the soluble part is fully dissolved, a uniform dispersion system is formed to prepare a mixture 1; (2) adding bioactive glass to mixture 1 and stirring thoroughly to obtain a uniform mixture 2, wherein the viscosity of mixture 2 is ≤10000 mPa.s; (3) The mixture 2 is coated on a substrate material by a coating process, dried at 38°C, and cut to obtain a film-like composition containing bioactive glass.

5. Use of the composition containing bioactive glass as claimed in any one of claims 1 to 4 in the preparation of drugs for the care and repair of periodontal inflammation.

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