CN112618392A

CN112618392A - Oral care compositions comprising bioactive materials and spherical silica

Info

Publication number: CN112618392A
Application number: CN202110085747.1A
Authority: CN
Inventors: 陈敏珊; 谢晓芳; 郑晓霞; 肖俊芳
Original assignee: Guangzhou Shuke Industrial Co ltd
Current assignee: Guangzhou Shuke Industrial Co ltd
Priority date: 2021-01-22
Filing date: 2021-01-22
Publication date: 2021-04-09

Abstract

The present invention relates to oral care compositions comprising a bioactive material and spherical silica, comprising: a bioactive material, fluoride, and a spherical silica having a D50 median particle size of 3.5 to 4 μm, a D95 particle size of less than 8 μm, an oil absorption value of less than 100cc/100g, and a sphericity coefficient of not less than 0.9. The particle size of the spherical silicon dioxide particles is equivalent to the pipe diameter of the dental tubules, and the particles are in a complete spherical shape, so that the composition can be used for plugging the dental tubules when being used as an oral care product, and the sensitivity of teeth is reduced. In addition, the spherical silicon dioxide can be used as an abrasive, has higher cleaning power, and can reduce the abrasion to enamel due to the spherical particles. The remineralization and the acid erosion resistance of enamel dentin can be effectively promoted by compounding the three substances, and the problems of dental caries and tooth sensitivity can be improved.

Description

Oral care compositions comprising bioactive materials and spherical silica

Technical Field

The invention belongs to the technical field of oral care compositions, and particularly relates to an oral care composition containing a bioactive material and spherical silica.

Background

In recent years, the consumption of acidic beverages is increased and the prevalence rate of erosion and even dental caries is continuously increased as the dietary structure of people changes. Dental hard tissue in the oral environment is constantly demineralised and remineralised, and dental health relies on this balance to produce caries lesions when demineralisation is greater than remineralisation and persists for a period of time. Enamel is the outermost structure of the tooth tissue and is also the first place for caries to occur. The formation of dental enamel caries lesions is mainly a consequence of the breakdown of the dynamic equilibrium between enamel demineralization and remineralization. Remineralization is the process of depositing calcium, phosphorus and other mineral particles in or on the surface of normal or partially demineralized enamel. Toothpaste is the only daily cleanser in widespread contact with teeth, and therefore brushing teeth with a toothpaste containing ingredients that resist acid erosion or promote enamel remineralization is the most common means of caries prevention.

Dentine sensitivity is a common oral problem, and people as many as 1/3 in China suffer from dentine sensitivity pain. Dentine hypersensitivity is a transient, sharp pain of teeth caused by various stimuli in a physiological range, such as mechanical, chemical, temperature, osmotic pressure, etc., and is not an independent disease but a symptom common to various diseases. According to the fluid dynamics theory, the treatment of dentin hypersensitivity mainly depends on two modes of sealing dentinal tubules and blocking nerve conduction in the dentinal tubules, so that the pain is avoided. Sealing dentinal tubules is an effective treatment and is one of the important international research directions for treating dentinal hypersensitivity.

Currently, remineralizing agents and desensitizers commonly used are mainly fluoride, casein phosphopeptide-amorphous calcium phosphate (CPP-ACP), hydroxyapatite, bioactive materials, and the like.

Many studies have shown that fluorine promotes the mineralization process of enamel and dentin, and that fluoride ions can undergo a replacement reaction with crystals on the enamel surface to form fluorapatite and calcium fluoride, which intermediate crystals are more resistant to acids, inhibit acid dissolution of dentin to prevent more dentin tubules from opening and promote remineralization. In addition, fluoride ions can reduce the diameter of dentinal tubules, thereby reducing hydraulic conduction. But still has certain limitation, children are easy to eat by mistake, and the fluorine-resistant streptococcus mutans strain is easy to generate when the streptococcus mutans strain is used in a large amount. Fluoride concentrations remain stable for extended periods of time, require repeated applications, and have limited release areas. Patent CN106511105A discloses an anhydrous toothpaste for repairing demineralized enamel and dentin, which is added with water-soluble phosphate, micron calcium carbonate and fluoride, and is used for remineralizing to repair enamel and block tubules.

CPP-ACP is a calcium phosphate ion library formed by utilizing the adhesiveness of casein phosphopeptide, adhering to interfaces of tooth surfaces, dental plaques and the like and stabilizing amorphous calcium phosphate under neutral or alkaline conditions. When the acidic environment in the oral cavity is dominant, calcium and phosphorus ions are released, the pH value is increased, demineralization is inhibited, and remineralization is promoted, but compared with fluoride, CPP-ACP has relatively small remineralization effect on early caries surface lesions, and the risk of protein allergy exists in part of people. Patent CN109771319A discloses a bioactive glass (ceramic) material and casein phosphopeptide composition and its application in oral care products, for remineralization repair and anti-sensitivity of sensitive enamel or dentin.

The bioactive glass is made of SiO₂、P₂O₅CaO and Na₂O, and the like, the main active ingredient is calcium sodium phosphosilicate, which is initially used for bone regeneration and is subsequently applied to the field of oral medicine. The bioactive glass can react rapidly with saliva in oral cavity to release calcium and phosphorus ions, and increase pH to form hydroxyl-like groupApatite for treating dentin hypersensitivity by sealing dentinal tubules, deposited on enamel surface to promote remineralization, prevent dental erosion, inhibit demineralization, kill bacteria, diminish inflammation, and promote soft tissue healing. The bioactive glass has good biocompatibility and bioactivity, good biological safety, and long-term use for pregnant women and children. Clinically, bioactive glass materials are widely used in dentistry, bone defect repair and soft tissue injury healing materials worldwide, and have been approved by the U.S. FDA and the Chinese national drug administration in terms of safety and effectiveness.

Silica is a common abrasive in toothpaste, and the RDA (rate of friction) relative to dentin is used as an index for evaluating the degree of tooth abrasion of an oral care product. In addition to the need to keep the teeth clean on a daily basis, it is also desirable to avoid mechanical wear during brushing for patients with caries and sensitive dentin. The spherical silicon dioxide is silicon dioxide particles prepared by a precipitation method, has moderate particle size distribution and spherical shape, and is very suitable for blocking dentinal tubules, so that the invasion of cold and hot liquid is blocked, and the tooth sensitivity is relieved. In addition, the spherical silicon dioxide also has the advantages of low abrasion, high cleaning power and mild mouthfeel. Patent CN111278774A and patent CN111295228A disclose a spherical silica for controlling RDA and tubule occlusion.

The above prior art has the following disadvantages: (1) the deposition and the remineralization rate of calcium ions and phosphorus ions are low, and the remineralization effect is different. (2) The protein structure is complex, and part of people are allergic to the protein. (3) The remineralization mechanism is single, and finally, a hydroxyapatite-like crystal structure is formed on the surface of enamel or dentin. (4) The technical application does not involve tooth demineralization or sensitivity problems in the target population. (5) High consumption, high cost and incapability of meeting daily consumption requirements.

Disclosure of Invention

It is at least one object of the present invention to overcome the technical problems of the background art and to provide an oral care composition comprising a bioactive material and spherical silica, which significantly improves the remineralization and acid erosion resistance of enamel dentin.

In order to achieve the above object, the present invention provides the following technical solutions:

an oral care composition comprising a bioactive material and spherical silica, comprising:

the bioactive material comprises one or more of bioactive glass or ceramic, calcium sodium phosphosilicate, nano calcium oxide-silicon oxide and calcium phosphate;

a fluoride compound; and

spherical silica having a D50 median particle diameter of 3.5 to 4 μm, a D95 particle diameter of less than 8 μm, an oil absorption value of less than 100cc/100g, and a sphericity coefficient of not less than 0.9.

The bioactive material in the present invention refers to a biological material which causes a specific biological or chemical reaction on the surface/interface of the material, promotes or affects the connection between tissues and materials, induces cell activity or regenerates new tissues.

The invention has the following advantages:

(1) the particle size of the spherical silicon dioxide particles is equivalent to the pipe diameter of the dental tubules, and the particles are in a complete spherical shape, so that the composition can be used for blocking the dental tubules when being used as an oral care product, and the sensitivity of teeth is reduced. In addition, spherical silica can be used as an abrasive, and since the particles are spherical, abrasion to enamel can be reduced, and cleaning power can be improved.

(2) The composition has the advantages of low relative cost, high universality and mild mouthfeel by compounding the bioactive material, the fluoride and the spherical silicon dioxide, and in addition, the remineralization of enamel dentin, acid erosion resistance and the improvement of the problems of dental caries and tooth sensitivity can be effectively promoted by compounding the three substances.

(3) In the prior art, a bioactive material and protein are generally used to be cooperated to promote tooth remineralization, sterilize and diminish inflammation, but in the invention, the protein is replaced by spherical silicon dioxide to realize the synergistic effect, so that part of users are prevented from being allergic to the protein, and the applicability of the composition is wider.

Preferably, the fluoride comprises one or more of sodium fluoride, sodium monofluorophosphate and stannous fluoride.

Preferably, the weight ratio of the bioactive material to the spherical silica is 10: 1 to 1: 10, preferably 5: 1 to 1: 5. the combination of the bioactive material and the spherical silicon dioxide obviously improves the remineralization repair capability of the enamel, the acid corrosion resistance and the dentin sensitivity resistance.

Preferably, the weight of the bioactive material and the spherical silica is from 0.05% to 20.15% of the total weight of the oral care composition.

The oral care composition of the anhydrous system may be a toothpaste, a dentifrice or a gel. The composition provided by the invention can keep activity and stability in a system by applying the bioactive material and the spherical silicon dioxide to an anhydrous system, can effectively release calcium and phosphorus ions during tooth brushing and promote remineralization of tooth surfaces, and an oral care composition containing the composition has the characteristics of low abrasion, high cleaning power, mild mouthfeel and proper cost.

Preferably, the weight of the bioactive material and the spherical silica is from 5% to 15% of the total weight of the oral care composition.

Preferably, the weight of the bioactive material is from 0.1% to 15%, preferably from 1% to 10%, of the total weight of the oral care composition.

Preferably, the spherical silica is present in an amount of from 0.1% to 10%, preferably from 1% to 8% by weight of the total weight of the oral care composition.

For example, in one embodiment thereof, the weight of the bioactive material is from 1% to 10% of the total weight of the oral care composition and the weight of the spherical silica is from 1% to 8% of the total weight of the oral care composition.

Preferably, the oral care composition further comprises carbomer in an amount of 0.1 to 1% by weight of the total oral care composition and polyvinylpyrrolidone polymer (PVP polymer) in an amount of 0.05 to 0.5% by weight of the total oral care composition. By alternately compounding with carbomer and polyvinylpyrrolidone polymer, the paste is ensured to stand and have stable quality by utilizing the inlaying and crosslinking of an alternate structure.

Preferably, the surfactants sodium lauryl sulfate and cocamidopropyl betaine are also included, in percentages of 1%, 1% respectively, by total weight of the oral care composition.

Drawings

FIG. 1 is a scanning electron microscope image of the non-treated area (left panel) and the treated area (right panel) of the blank control group;

FIG. 2 is a scanning electron microscope photograph of the non-treated area (left image) and the treated area (right image) of comparative example 1;

FIG. 3 is a scanning electron microscope photograph of the non-treated area (left image) and the treated area (right image) of comparative example 2;

FIG. 4 is a scanning electron microscope photograph of the non-treated area (left image) and the treated area (right image) of comparative example 3;

FIG. 5 is a scanning electron microscope photograph of the non-treated area (left image) and the treated area (right image) of example 1;

Detailed Description

The technical solution of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

Comparative example 1

A composition containing common silicon dioxide comprises the following components in percentage by weight:

dispersing carbomer in polyethylene glycol-8, adding glycerol, stirring to obtain gel, adding silicon dioxide, saccharin sodium and titanium dioxide, stirring, adding sodium dodecyl sulfate, cocamidopropyl betaine and essence, stirring, degassing, and making into toothpaste.

Comparative example 2

A composition containing fluoride and common silicon dioxide comprises the following components in percentage by weight:

dispersing carbomer and PVP in polyethylene glycol-8, adding glycerol, stirring to form gel, adding silicon dioxide, sodium fluoride, saccharin sodium and titanium dioxide, stirring, adding sodium dodecyl sulfate, cocamidopropyl betaine and essence, stirring, degassing, and making into toothpaste.

Comparative example 3

A composition containing bioactive glass, fluoride and common silicon dioxide comprises the following components in percentage by weight:

dispersing carbomer and PVP in polyethylene glycol-8, adding glycerol, stirring to form gel, adding silicon dioxide, bioactive glass, sodium fluoride, saccharin sodium and titanium dioxide, stirring, adding sodium dodecyl sulfate, cocamidopropyl betaine and essence, stirring, degassing, and making into toothpaste.

Example 1

An oral care composition comprising bioactive glass and spherical silica, comprising the following components in weight percent:

dispersing carbomer and PVP in polyethylene glycol-8, adding glycerol, stirring to form gel, adding spherical silicon dioxide, bioactive glass, sodium fluoride, saccharin sodium and titanium dioxide, stirring, adding sodium dodecyl sulfate, cocamidopropyl betaine and essence, stirring, and degassing to obtain toothpaste containing the composition.

Example 2

Example 3

Testing the stability of the toothpaste:

the anhydrous toothpaste products prepared in comparative examples 1 to 3 and examples 1 to 3 were subjected to accelerated aging at a temperature of 45 ℃ for 3 months, and then various indexes related to the products were examined. The detection result shows that the product is normal, the integral stability of the product is good, and the quality is excellent.

The paste was visually observed for stiffness, with more "+" indicating better stiffness:

as can be seen from the above table, the stiffness of the paste is significantly improved in comparative examples 2, 3 and example 1 compared to comparative example 1, indicating that the polyvinylpyrrolidone PVP component significantly improves the stiffness of the anhydrous toothpaste comprising the composition.

Remineralization repair effect test of enamel:

remineralization repair test for demineralized enamel

Preparing artificial saliva: 2.200g/L gastric MUCIN (MUCIN TYPE II), 0.38g/L NaCl, 0.183g/L CaCl₂、0.528g/L KH₂PO₄1.114g/L KCl. Firstly, stirring MUCIN with hot water of 80 ℃ until the MUCIN is completely dissolved, then sequentially adding other components, stirring for dissolving, fixing the volume, and finally adjusting the pH to 7.0 by using 1mol/L KOH solution.

Preparation of enamel specimens: fresh extracted bovine incisors were selected as experimental specimens. Removing surface pollutants, washing and separating crown roots. Cutting the dental crown into enamel blocks with the size of 5 multiplied by 3mm in length and thickness by adopting a low-speed diamond cutting machine, embedding the enamel blocks into polymethyl methacrylate resin, sequentially grinding lip enamel by a polishing machine and 80#, 600# and 2500# silicon carbide abrasive paper under flowing water, and polishing flannelette and diamond grinding paste with the thickness of 1 mu m to form a mirror surface. Surface Microhardness (SMH) measurements were made on each enamel specimen using a vickers hardness tester with a load of 100g and a loading time of 5 s. Enamel blocks of appropriate hardness size were selected by surface microhardness testing (SMH measurements) and divided into 4 groups of 8 blocks at any time.

Preparation of demineralized enamel specimens: after all enamel samples are kept still and soaked for 2h at 37 ℃ by using artificial saliva, the enamel samples are kept still and soaked for 30min at 37 ℃ by using a 1.0% citric acid solution (pH 3.8), then the enamel samples are taken out, fully washed by using deionized water, and surface moisture is sucked dry by absorbent paper.

Remineralization process: the toothpastes of comparative examples 1 to 3 and examples 1 to 3 were weighed and stirred to prepare toothpaste slurries according to the weight ratio of 1:3 of the toothpaste to deionized water, then the demineralized enamel specimens were soaked in the toothpaste slurries for 5 minutes, then rinsed with deionized water for 3 times, then placed in artificial saliva and soaked in an environment at 37 ℃ for 1 hour, the above steps were repeated for 6 times, and continuously and circularly processed for 2 days, and finally the enamel specimens were taken out for vickers hardness test, and the results are shown in table 1.

TABLE 1 change in Vickers hardness of enamel surface at baseline, after demineralization, after remineralization, and after remineralization

Group of	Baseline/HV	post-demineralization/HV	post-remineralisation/HV	After re-demineralization/HV
					Comparative example 1	320±6.18	195±5.39	214±7.43	93±5.64
Comparative example 2	327±2.56	193±4.70	237±4.64	135±3.68
					Comparative example 3	316±5.28	195±5.39	259±7.66	179±6.61
Example 1	319±9.10	196±5.44	263±4.84	186±6.21
					Example 2	323±4.29	194±6.01	281±6.37	197±4.89
Embodiment 3	320±6.25	195±7.43	239±5.78	131±7.63

Table 1 shows the change in vickers hardness of the surface of enamel after demineralization, remineralization and demineralization. As can be seen from Table 1, the mean Vickers hardnesses of the enamel samples used in the respective groups were 320, 327, 316, 319, 323 and 320HV, respectively, and the hardness levels of the enamel samples used were consistent. The average Vickers hardness values of the enamel surface after acid etching and demineralization treatment are 195, 193, 195, 196, 194 and 195HV respectively, which shows that the hardness of the enamel sample before remineralization is at the same level, and the microhardness values of all groups have no significant difference. After the acid etching treatment, the surface of the enamel is acid etched, so that calcium and phosphorus are lost, and the hardness is reduced. The surface hardness of enamel after remineralization treatment by the toothpastes of comparative example 1, comparative example 2, comparative example 3, example 1, example 2 and example 3 was 214, 237, 259, 263, 281 and 239HV, respectively. Statistical data analysis shows that the groups of the comparative example 3 and the example 1 have significance difference (P <0.05) compared with the groups of the comparative example 2 and the comparative example 1, and the group of the comparative example 2 also has significance difference (P <0.05) compared with the group of the comparative example 1. After the toothpaste of comparative example 1 is treated, the microhardness is not obviously improved, which shows that the remineralization effect is poor. After the toothpaste of comparative example 2, the enamel microhardness is statistically different from that of the group of comparative example 1, which shows that fluorine can improve the enamel hardness. The microhardness of the enamel is further improved after the toothpaste treatment of the comparative example 3 and the toothpaste treatments of the embodiment examples 1 to 3 are added, and compared with the comparative example 2, the microhardness is remarkably different (P <0.05), which shows that the remineralization effect of the toothpaste is remarkably enhanced by adding the bioactive glass. The toothpaste containing the compositions of comparative example 3 and examples 1-3, with saliva or water, released sufficient calcium and phosphorus ions on the enamel surface to promote remineralization of demineralized teeth. However, the remineralization hardness of the composition of example 3 was significantly lower than that of examples 1-2 and comparative example 3, which is related to the lower amount of bioactive glass in the composition of example 3. After each group of remineralized enamel is subjected to acid etching demineralization treatment again, the microhardness of the enamel is respectively 93, 135, 179, 186, 197 and 131HV, the hardness of enamel samples of each group is reduced to different degrees, but the microhardness reduction amplitude of the groups of comparative example 2, comparative example 3 and examples 1-3 is obviously lower than that of comparative example 1, and the microhardness reduction amplitude of the groups of comparative example 3 and examples 1-2 is also obviously lower than that of comparative example 2, which shows that fluoride is beneficial to the acid etching resistance effect of the enamel, and the acid etching resistance effect of the composition is further improved by bioactive glass. Fluoride increases enamel hardness against attack by acidic substances by forming fluorhydroxyapatite on the enamel surface. The bioactive glass forms a substance with a hydroxyapatite-like structure on the surface of enamel, so as to form a tooth protective layer, and the effect of acid corrosion resistance is achieved. Thus, the anhydrous toothpaste comprising the compositions of examples 1-3 had efficacy in promoting remineralization restoration of enamel surfaces and resisting acid erosion.

Anti-sensitivity test for occlusion of dental tubule:

preparing artificial saliva: 2.200g/L gastric mucin (gastric mucin) (solubilized with 80 ℃ warm water), 0.38g/L NaCl, 0.213g/L CaCl₂·2H₂O，0.738g/L KH₂PO₄1.114g/L KCl. Finally, the pH was adjusted to 7.0 with 1mol/L KOH solution.

Preparation of dentin samples: selecting fresh extracted bovine incisor as an experimental specimen, cutting a root main body part into a basic block with the width of 5 multiplied by 2mm by a low-speed diamond cutting machine, embedding the pressed root outside upwards into polymethyl methacrylate resin, sequentially grinding by a polishing machine under running water by using 1000# -1500# -2000# silicon carbide abrasive paper, and polishing by adding 1 micron of diamond grinding paste into flannelette to form a mirror surface so as to eliminate surface pollutants and ensure that the surface is smooth and regular.

Preparation of demineralized dentin samples: after the dentin sample is subjected to ultrasonic cleaning, the bovine tooth sample is corroded for 20min by 40% orthophosphoric acid, then is washed by deionized water, is slightly corroded for 5min by 5.0% NaOCl, and finally is subjected to ultrasonic cleaning for 20min by deionized water. And observing the exposure condition of the dental tubules by using a polarizing microscope with the magnification of 500 times, and if the exposure is insufficient, performing demineralization treatment on all the dentin samples again until the dental tubules are fully exposed.

Dentin partition processing: half of the demineralized dentin blocks (5 mm. times.2.5 mm) were taped as non-treated areas for comparison. An additional 5mm by 2.5mm area served as the brushing test treatment area.

Dentin treatment after demineralization: the screened dentin samples were randomly divided into 5 groups of 8 samples each. The toothpastes of comparative examples 1 to 3 and example 7 were weighed and stirred to prepare toothpaste slurries according to the weight ratio of 1:6 of the toothpaste to the deionized water, and then each group of demineralized dentin samples were placed in the corresponding treatment conditions, tooth brushing was simulated for 3 minutes using an electric toothbrush, and then thoroughly washed with deionized water, soaked in artificial saliva and kept at 37 ℃ for 1 hour. The above steps were repeated 6 times, and finally soaked in artificial saliva overnight at 37 ℃. The dentin samples after the cycling treatment were dried in an oven at 25 ℃ for 24 hours before testing.

Observation by a scanning electron microscope: spraying gold on the dried dentin sample, observing under a scanning electron microscope, respectively taking 3 visual field pictures (2000X) of the dried dentin sample and a treatment area and a non-treatment area, using the non-treatment area as a blank control group, counting exposed tubules, and calculating the plugging rate R according to the following formula: (Σnon-processing region c- Σ processing region c)/∑ non-processing region c × 100%. The larger the plugging rate R is, the better the plugging effect of the dental tubules is, and the plugging effect of the dental tubules of each group can be compared by comparing the plugging rates R of different groups.

TABLE 2 tubule occlusion Rate R (%)

Group of	Plugging Rate R (%)
		Blank control group (treated with deionized water)	3.25
Comparative example 1	6.23
		Comparative example 2	8.15
Comparative example 3	70.41
		Example 1	87.25

The plugging rates of comparative examples 1 and 2 were not significantly different from those of the blank control group. Compared with a blank control group and a comparative example 1/2, the plugging rate of the comparative example 3 is obviously higher than that of the blank control group, and the plugging rate of the blank control group and the comparative example 1/2 has significant difference, which shows that the bioactive glass has significant effect of plugging the dentinal tubules, compared with the comparative example 3, the plugging rate of the bioactive glass and the plugging rate of the comparative example 1 also have significant difference statistically, which shows that the spherical silicon dioxide further improves the plugging effect of the dentinal tubules of the composition.

From the scanning electron micrographs, it is clear that the dentin after the acid etching demineralization treatment had the surface tubules fully exposed. The dentinal tubules of the dentin surfaces treated in the blank control group and comparative examples 1 and 2 had substantially no occlusion effect. Most of the dentinal tubules on the surface of the dentin treated by the comparative example 3 were blocked, and compared with other groups, the blocking rate of the dentinal tubules was greatly improved after the treatment of the embodiment 1, and it can be seen that the addition of the spherical silica significantly improves the blocking ability of the dentin effect. The composition can release calcium and phosphorus ions on the surface of dentin after demineralization to promote remineralization and restoration of the surface of dentin, and can also perform physical plugging through spherical silicon dioxide with special particle size to further enhance the plugging effect of dental tubules in a synergic manner, so that the tooth desensitization effect of the composition is improved.

The tooth whitening effect test:

and evaluating the whitening effect of the toothpaste product on removing the exogenous color spots by a PCR (polymerase chain reaction) method of a biological film cleaning rate experimental model. Stained bovine enamel was brushed in a toothpaste slurry using a standard toothbrush, the enamel color before and after brushing was tested using an X-rite SP64 colorimeter, and the whitening effect of the toothpaste samples was evaluated by comparing the enamel whiteness difference Δ L before and after brushing. The larger Δ L represents the better whitening and stain removing effects.

From the data, the tooth whiteness Δ L values of the embodiment examples 1 and 3 are remarkably improved compared with the comparative examples 1-3 and the embodiment example 2, which shows that the whitening and stain removing effects of the two embodiment examples are best, and the spherical silicon dioxide has excellent tooth whitening effect.

Variations and modifications to the above-described embodiments may occur to those skilled in the art, which fall within the scope and spirit of the above description. Therefore, the present invention is not limited to the specific embodiments disclosed and described above, and some modifications and variations of the present invention should fall within the scope of the claims of the present invention. Furthermore, although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. An oral care composition comprising a bioactive material and spherical silica, characterized by comprising:

a fluoride compound; and

2. The oral care composition of claim 1, wherein the fluoride comprises one or more of sodium fluoride, sodium monofluorophosphate, stannous fluoride.

3. The oral care composition of claim 1, wherein the weight ratio of bioactive material to spherical silica is from 10: 1 to 1: 10.

4. the oral care composition of any one of claims 1 to 3, wherein the weight of the bioactive material and the spherical silica is from 0.05% to 20.15% of the total weight of the oral care composition.

5. The oral care composition of claim 4, wherein the weight of the bioactive material and the spherical silica is from 5% to 15% of the total weight of the oral care composition.

6. The oral care composition of claim 4, wherein the bioactive material is present in an amount from 0.1% to 15% by weight of the total weight of the oral care composition.

7. The oral care composition of claim 4, wherein the spherical silica is present in an amount of from 0.1% to 10% by weight of the total weight of the oral care composition.

8. The oral care composition of claim 4, further comprising carbomer in an amount from 0.1% to 1% by weight of the total oral care composition and a polyvinylpyrrolidone polymer in an amount from 0.05% to 0.5% by weight of the total oral care composition.

9. The oral care composition of claim 4, wherein the weight of the bioactive material is from 1% to 10% of the total weight of the oral care composition; the spherical silica is present in an amount of 1% to 8% by weight of the total weight of the oral care composition.

10. The oral care composition of claim 4, further comprising the surfactants sodium lauryl sulfate and cocamidopropyl betaine, in respective percentages of 1%, 1% by total weight of the oral care composition.