Double-layer tablet with indication function and preparation method thereof

Abstract

The invention discloses a double-layer tablet with an indication function and a preparation method thereof, and relates to the field of disinfection supplies, the double-layer tablet is provided with a supplement layer and a repair layer which are attached to each other, and the supplement layer takes lactobacillus quintuplet as a main component and is matched with pharmaceutically acceptable auxiliary materials, so that lactic acid bacteria required by vagina can be effectively supplemented, and the balance of vaginal flora can be recovered. The repairing layer contains mussel mucoprotein, pearl powder, a lycium ruthenicum extract, a fructus cnidii extract, a caulis spatholobi extract and the like, and the damaged vaginal mucosa can be effectively repaired. Meanwhile, the lycium ruthenicum extract, the fructus cnidii extract and the suberect spatholobus stem extract can change the color of vaginal secretion along with the pH value, so that the indicating effect is achieved, and the vaginal repair condition is judged in an auxiliary mode. The double-layer tablet is safe and mild in raw material, scientific and reasonable in matching, simple in preparation method and suitable for popularization and large-scale production.

Description

Technical Field

[0001] The invention relates to the field of disinfection products, and in particular to a double-layer tablet with an indication function and a preparation method thereof. Background Art

[0002] Normal vaginal flora is the core of vaginal microecological research. In 1892, Dederlein published the first study on human vaginal microecological flora. It was found that the vaginal flora of healthy women is composed of a variety of anaerobic and aerobic bacteria. In normal vaginal flora, Lactobacillus is dominant, and more than 20 species of Lactobacillus can be isolated from the vagina of healthy women. The normal presence of Lactobacillus in the vagina plays a key role in maintaining normal vaginal flora. Glycogen in vaginal squamous epithelial cells is decomposed into lactic acid by lactobacillus, forming a weakly acidic environment in the local vagina (pH ≤4.5, mostly 3.8~4.4), which can inhibit the excessive growth of other parasitic bacteria. In addition, Lactobacillus prevents pathogenic microorganisms from adhering to vaginal epithelial cells through substitution and competitive exclusion mechanisms. At the same time, it secretes hydrogen peroxide, bacteriocins, bacteriocin-like bacteria and biosurfactants to inhibit the growth of pathogenic microorganisms, thereby maintaining the balance of the vaginal microecological environment.

[0003] In daily life, improper cleaning, drug abuse, changes in hormone levels, and other reasons may lead to a decrease in lactic acid bacteria in the vagina; once lactic acid bacteria decrease, it is easier to cause dysbacteriosis, which in turn induces various diseases, such as bacterial vaginitis, fungal vaginitis, and mixed vaginitis. Therefore, when vaginal lactic acid bacteria decrease, lactic acid bacteria need to be supplemented in time. The more common method is to use vaginal suppositories, capsules, etc., but the related products on the market currently have problems such as single function and poor supplementation effect. Summary of the invention

[0004] The purpose of the present invention is to provide a double-layer tablet with an indicating function, the raw materials of which are safe and reliable, the combination is reasonable, and the damaged mucosa can be repaired while supplementing lactic acid bacteria, and the health of the vagina can be judged by the color of the secretions.

[0005] Another object of the present invention is to provide a method for preparing the above-mentioned double-layer tablet with an indication function, which is simple to operate, has low requirements on equipment, and is suitable for industrial production.

[0006] The embodiment of the present invention is achieved as follows: A double-layer tablet with an indication function, the double-layer tablet comprises a supplementary layer and a repairing layer which are bonded to each other, and the following are measured by weight: Supplementary layers include: 45-60 parts of filler, 5-20 parts of prebiotics, 5-10 parts of binder, 0.5-2 parts of glidant, 2-10 parts of Lactobacillus pentaphyllosus, 0.5-10 parts of sustained-release component; The repair layer includes: 45-60 parts of filler, 0.5-2 parts of moisturizing ingredient, 10-15 parts of adhesive, 0.5-5 parts of pearl powder, 0.5-5 parts of mussel mucin, 0.5-5 parts of black wolfberry extract, 0.5-5 parts of cnidium monnieri extract, 0.5-5 parts of millettia reticulata extract, and 0.5-2 parts of flow aid.

[0007] A method for preparing the above-mentioned double-layer tablet with indication function comprises: The raw materials of the repair layer are mixed evenly according to a proportion and then compressed into a pre-compressed tablet; The raw materials of the supplementary layer are mixed evenly according to the proportion and placed on the top of the pre-compressed tablet for secondary tableting.

[0008] The beneficial effects of the embodiments of the present invention are: The embodiment of the present invention provides a double-layer tablet with an indication function and a preparation method thereof. The double-layer tablet has a supplementary layer and a repair layer that are bonded to each other. The supplementary layer uses Lactobacillus quinquefolius as the main component and is combined with pharmaceutically acceptable excipients to effectively supplement the lactic acid bacteria required for the vagina and restore the balance of the vaginal flora. The repair layer contains mussel mucin, pearl powder, black wolfberry extract, cnidium monnieri extract, Millettia reticulata extract and other ingredients, which can effectively repair damaged vaginal mucosa. At the same time, black wolfberry extract, cnidium monnieri extract, and Millettia reticulata extract can change the color of vaginal secretions with pH, ​​thereby playing an indicating role and assisting in judging the condition of vaginal repair. The raw materials of the double-layer tablet are safe and mild, the combination is scientific and reasonable, and the preparation method is simple, which is suitable for promotion and large-scale production. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0010] Figure 1 The results of the color development reaction at different pH values ​​provided in Experimental Example 2 of the present invention. DETAILED DESCRIPTION

[0011] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0012] The following is a detailed description of a double-layer tablet with an indication function and a preparation method thereof according to an embodiment of the present invention.

[0013] A double-layer tablet with an indication function, the double-layer tablet comprises a supplementary layer and a repairing layer which are bonded to each other, and the following are measured by weight: Supplementary layers include: 45-60 parts of filler, 5-20 parts of prebiotics, 5-10 parts of binder, 0.5-2 parts of glidant, 2-10 parts of Lactobacillus pentaphyllosus, 0.5-10 parts of sustained-release component; The repair layer includes: 45-60 parts of filler, 0.5-2 parts of moisturizing ingredient, 10-15 parts of adhesive, 0.5-5 parts of pearl powder, 0.5-5 parts of mussel mucin, 0.5-5 parts of black wolfberry extract, 0.5-5 parts of cnidium monnieri extract, 0.5-5 parts of millettia reticulata extract, and 0.5-2 parts of flow aid.

[0014] Among them, the supplement layer uses pentavalent Lactobacillus as the main ingredient, combined with pharmaceutically acceptable excipients, which can effectively supplement the lactic acid bacteria required by the vagina and restore the balance of vaginal flora.

[0015] The repair layer contains mussel mucin, pearl powder, black wolfberry extract, cnidium monnieri extract, Millettia reticulata extract and other ingredients, which can effectively repair damaged vaginal mucosa.

[0016] Specifically, mussel mucin is extracted from the foot gland of marine mussels and purified by industrial chromatography to obtain a single protein with high purity. It has the functions of promoting cell adhesion and crawling, promoting wound healing, inhibiting itching, broad-spectrum adhesion, and forming a water-resistant protective film.

[0017] External use of pearl powder can promote the healing of various wounds and cuts, reduce pigmentation and scars. At the same time, pearl powder is rich in various amino acids, vitamins, taurine, trace elements, etc., which can supplement nutrition.

[0018] Black wolfberry is sweet and neutral in nature. It is rich in protein, wolfberry sugar, amino acids, vitamins, minerals, trace elements and other nutrients. Black wolfberry also contains rich black fruit pigments - natural proanthocyanidins. A large amount of anthocyanidins can effectively resist oxidation, eliminate free radicals in the human body, and promote vaginal repair.

[0019] Cnidium monnieri is the mature fruit of the Umbelliferae plant Cnidium monnieri, which tastes spicy, bitter and warm in nature. Since ancient times, Cnidium monnieri has been used externally to decoct water and wash the genitals, which has the effects of killing insects and removing dampness and heat, and has a better effect on repairing the vaginal microenvironment.

[0020] Millettia reticulata is bitter and slightly cold in nature. It can promote blood circulation, remove blood stasis, dispel wind and cold. When used externally, it can also accelerate local blood circulation and metabolism, help improve the symptoms of local congestion and meridian obstruction, and make blood circulation smoother, improving the repair effect.

[0021] At the same time, black wolfberry extract, cnidium monnieri extract, and millettia reticulata extract can change the color of vaginal secretions, and the color changes with different pH values, thus serving as an indicator to assist in judging the condition of vaginal repair.

[0022] Preferably, the mass ratio of the black wolfberry extract, the cnidium monnieri extract, and the millettia reticulata extract is 1:1.2-1.5:0.8-1.0. The three Chinese medicinal ingredients are mixed in this ratio, not only can the efficacy be better exerted, but also the color presented changes sensitively and clearly with pH, ​​and the indication effect is more obvious.

[0023] Further, the filler includes at least one of lactose, mannitol, xylitol, sorbitol, sucrose powder, and glucose powder. The main function of the filler is to fill the weight or volume of the tablet, thereby facilitating tableting.

[0024] Prebiotics include at least one of isomaltooligosaccharide, fructooligosaccharide, galacto-oligosaccharide, and xylo-oligosaccharide. Prebiotics can promote the growth and reproduction of beneficial bacteria in the vagina, thereby improving the vaginal microenvironment.

[0025] The glidant includes at least one of magnesium stearate, differential silica gel, and PEG 6000. The glidant can reduce the friction between particles and improve the fluidity of the powder, thereby ensuring smooth tableting and reducing damage to lactic acid bacteria.

[0026] The binder includes at least one of hydroxypropyl cellulose, microcrystalline cellulose, and povidone. The binder has the effect of bonding the components together so that the components can be better fused.

[0027] The sustained-release component includes at least one of sodium carboxymethylcellulose and hydroxypropyl methylcellulose. Under the action of the sustained-release component, the drug effect can be slowly released within 3 to 5 hours, providing a long-term repair effect.

[0028] Furthermore, the moisturizing component includes at least one of sodium hyaluronate and trehalose. The moisturizing component can moisturize the skin, thereby improving the repair effect.

[0029] The embodiment of the present invention further provides a method for preparing the above-mentioned double-layer tablet with an indication function, which comprises: S1. The raw materials of the repair layer are mixed uniformly in proportion and then pressed to obtain a pre-compressed tablet; S2. Mix the raw materials of the supplementary layer evenly according to the proportion, and place them on the top of the pre-compressed tablet for secondary tableting.

[0030] The present invention adopts the technology of double tableting, and the repair layer and the supplement layer are separately tableted, which can effectively avoid the influence of the components of the repair layer on the lactic acid bacteria, thereby better maintaining the stability and activity of the lactic acid bacteria. During the double tableting, the repair layer is pressed first, and then the supplement layer is pressed. Thereby reducing the number of times the lactic acid bacteria are pressed, and better protecting the lactic acid bacteria.

[0031] In addition, the raw materials are ground into powders of 60-100 meshes, and then mixed and tableted; the tableting speed is 30-60 thousand tablets / hour, and the pressure is 50-70 kN. Under the above tableting conditions, the double-layer tablet has a better tableting effect and better stability.

[0032] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0033] Example 1 This embodiment provides a double-layer tablet with an indication function, wherein the double-layer tablet has a supplementary layer and a repair layer that are bonded to each other, and the following are measured by weight: Supplementary layers include: 45 parts of mannitol, 20 parts of isomaltooligosaccharide, 5 parts of hydroxypropyl cellulose, 2 parts of PEG6000, 2 parts of Lactobacillus pentazyme, 0.5 parts of sodium carboxymethyl cellulose; The repair layer includes: 60 parts of mannitol, 2 parts of sodium hyaluronate, 10 parts of hydroxypropyl cellulose, 5 parts of pearl powder, 0.5 parts of mussel mucin, 5 parts of black wolfberry extract, 5 parts of cnidium monnieri extract, 5 parts of millettia reticulata extract, and 0.5 parts of PEG6000.

[0034] The preparation method is as follows: S1. Grind the raw materials of the repair layer into 60 mesh powder, mix them evenly according to the proportion, and then press them into pre-compressed tablets; wherein the tableting speed is 60 thousand tablets / hour and the pressure is 50 kN.

[0035] S2. Grind the raw materials of the supplementary layer into 60 mesh powder, mix them evenly according to the proportion, and place them on the top of the pre-compressed tablet for secondary tableting; wherein, the tableting speed is 60 thousand tablets / hour and the pressure is 50 kN.

[0036] Example 2 This embodiment provides a double-layer tablet with an indication function, wherein the double-layer tablet has a supplementary layer and a repair layer that are bonded to each other, and the following are measured by weight: Supplementary layers include: 60 parts of lactose, 5 parts of oligofructose, 10 parts of microcrystalline cellulose, 0.5 parts of differential silica, 10 parts of Lactobacillus pentazyme, and 10 parts of hydroxypropyl methylcellulose; The repair layer includes: 45 parts of lactose, 0.5 parts of trehalose, 15 parts of adhesive, 0.5 parts of pearl powder, 5 parts of mussel mucin, 0.5 parts of black wolfberry extract, 0.5 parts of cnidium monnieri extract, 1 part of millettia reticulata extract, and 1 part of differential silica gel.

[0037] The preparation method is as follows: S1. Grind the raw materials of the repair layer into 100 mesh powder, mix them evenly according to the proportion, and then press them into pre-compressed tablets; wherein the tableting speed is 30 thousand tablets / hour and the pressure is 70 kN.

[0038] S2. Grind the raw materials of the supplementary layer into 100 mesh powder, mix them evenly according to the proportion, and place them on the top of the pre-compressed tablet for secondary tableting; wherein, the tableting speed is 30 thousand tablets / hour and the pressure is 70 kN.

[0039] Example 3 This embodiment provides a double-layer tablet with an indication function, wherein the double-layer tablet has a supplementary layer and a repair layer that are bonded to each other, and the following are measured by weight: Supplementary layers include: 50 parts of sorbitol, 5 parts of galacto-oligosaccharides, 5 parts of xylo-oligosaccharides, 8 parts of povidone, 1 part of PEG6000, 8 parts of Lactobacillus pentazyme, and 6 parts of hydroxypropyl cellulose; The repair layer includes: 50 parts of sorbitol, 0.8 parts of sodium hyaluronate, 0.2 parts of trehalose, 12 parts of microcrystalline cellulose, 3 parts of pearl powder, 2 parts of mussel mucin, 2 parts of black wolfberry extract, 3 parts of cnidium monnieri extract, 2 parts of millettia reticulata extract, and 1 part of magnesium stearate.

[0040] The preparation method is as follows: S1. Grind the raw materials of the repair layer into 80 mesh powder, mix them evenly according to the proportion, and then press them into pre-compressed tablets; wherein the tableting speed is 50 thousand tablets / hour and the pressure is 60 kN.

[0041] S2. Grind the raw materials of the supplementary layer into 60 mesh powder, mix them evenly according to the proportion, and place them on the top of the pre-compressed tablet for secondary tableting; wherein, the tableting speed is 50 thousand tablets / hour and the pressure is 70 kN.

[0042] Example 4 This embodiment provides a double-layer tablet with an indication function, wherein the double-layer tablet has a supplementary layer and a repair layer that are bonded to each other, and the following are measured by weight: Supplementary layers include: 35 parts of sucrose powder, 20 parts of glucose powder, 10 parts of isomaltooligosaccharide, 5 parts of fructooligosaccharide, 6 parts of microcrystalline cellulose, 1.5 parts of magnesium stearate, 4 parts of Lactobacillus pentazyme, and 4 parts of sodium carboxymethyl cellulose; The repair layer includes: 53 parts of galacto-oligosaccharide, 0.8 parts of moisturizing ingredients, 14 parts of hydroxypropyl cellulose, 1.5 parts of pearl powder, 2 parts of mussel mucin, 2 parts of black wolfberry extract, 2.5 parts of cnidium monnieri extract, 1.8 parts of millettia reticulata extract, and 1.2 parts of magnesium stearate.

[0043] The preparation method is as follows: S1. Grind the raw materials of the repair layer into 60 mesh powder, mix them evenly according to the proportion, and then press them into pre-compressed tablets; wherein the tableting speed is 40 thousand tablets / hour and the pressure is 50 kN.

[0044] S2. Grind the raw materials of the supplementary layer into 60 mesh powder, mix them evenly according to the proportion, and place them on the top of the pre-compressed tablet for secondary tableting; wherein, the tableting speed is 40 thousand tablets / hour and the pressure is 60 kN.

[0045] Comparative Example 1 This comparative example provides a lactic acid bacteria supplement tablet. Compared with Example 3, the lactic acid bacteria supplement tablet is a single-piece structure and does not contain a repair layer.

[0046] Comparative Example 2 This comparative example provides a lactic acid bacteria supplement tablet. Compared with Example 3, the lactic acid bacteria supplement tablet has a single-piece structure, and the raw materials of the repair layer and the supplement layer are completely mixed and then tableted.

[0047] Test Example 1 This test example uses the double-layer tablets with indicating functions provided in Examples 1 to 4, and the supplementary tablets provided in Comparative Examples 1 to 2 to conduct mouse experiments. A total of 80 experimental mice were randomly divided into 8 groups, with 10 mice in each group. One group of mice was used as a blank case, and normal feeding was not intervened. The remaining 7 groups of mice were stimulated to form vaginal inflammatory reactions by continuous vaginal injection of Escherichia coli suspension for 5 days. Six groups of inflammatory mice were randomly selected from the 7 groups and the tablets of Examples 1 to 4 and Comparative Examples 1 to 2 were respectively administered vaginally (the tablets were cut into appropriate sizes of the same size, administered once in the morning and evening each day, and administered continuously for 3 days), and the remaining 1 group was used as a control example, and the changes in the average vaginal pH of each group of mice were recorded. The recorded results are shown in Table 1.

[0048] Table 1. Changes in vaginal pH in mice As can be seen from Table 1, the vaginal pH of normal mice is stable at about 6.15 (blank example). After the inflammatory reaction is formed, the vaginal pH of mice will increase significantly (control example), and the pH will continue to increase over time. After one day of using the double-layer tablets provided in Examples 1 to 4 of the present invention, the pH of the vagina can be effectively reduced, indicating that the supplementation of lactic acid bacteria has a significant effect on regulating the vaginal microenvironment. After 3 days of continuous medication, the vaginal pH of the mice has basically returned to normal, and after 2 days of discontinuation, the pH can be basically stable. In contrast, the lactic acid bacteria supplement tablets provided in Comparative Example 1 are also effective in regulating the vaginal pH, but the effect is significantly worse than that of the embodiments of the present invention, and after discontinuation of the drug, the pH value also rises to a certain extent. Comparative Example 2 does not use layered tableting, and it can also be seen that the medication effect is affected to a certain extent, indicating that after the repair layer and the supplement layer are mixed, the raw materials of the repair layer have a negative impact on the lactic acid bacteria.

[0049] Test Example 2 The double-layer tablet with indicator function of Example 3 was used to collect vaginal secretions from mice, and the pH was adjusted to 4, 6 and 8 respectively. The double-layer tablet was added and dissolved at 38°C for 3 hours. The color changes of the solutions were compared. The comparison results are shown in FIG. Figure 1 shown.

[0050] It can be seen that the double-layer tablet is lavender at pH 4, and gradually turns to red as the pH increases. Therefore, the pH value in the vagina can be intuitively understood through the color change of vaginal secretions, which indirectly reflects the health status of the vaginal microenvironment.

[0051] In summary, the embodiments of the present invention provide a double-layer tablet with an indication function and a preparation method thereof. The double-layer tablet has a supplementary layer and a repair layer that fit each other. The supplementary layer uses Lactobacillus quinquefolius as the main component and is combined with pharmaceutically acceptable excipients to effectively supplement the lactic acid bacteria required for the vagina and restore the balance of the vaginal flora. The repair layer contains mussel mucin, pearl powder, black wolfberry extract, cnidium monnieri extract, Millettia reticulata extract and other ingredients, which can effectively repair damaged vaginal mucosa. At the same time, black wolfberry extract, cnidium monnieri extract, and Millettia reticulata extract can change the color of vaginal secretions with pH, ​​thereby playing an indicating role and assisting in judging the condition of vaginal repair. The raw materials of the double-layer tablet are safe and mild, the combination is scientific and reasonable, and the preparation method is simple, which is suitable for promotion and large-scale production.

[0052] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A double-layer tablet with an indication function, characterized in that: The double-layer sheet has a supplementary layer and a repair layer that are bonded to each other, and according to weight percentage, The supplementary layer comprises: 45-60 parts of filler, 5-20 parts of prebiotics, 5-10 parts of binder, 0.5-2 parts of glidant, 2-10 parts of Lactobacillus pentaphyllosus, 0.5-10 parts of sustained-release component; The repair layer comprises: 45-60 parts of filler, 0.5-2 parts of moisturizing ingredient, 10-15 parts of adhesive, 0.5-5 parts of pearl powder, 0.5-5 parts of mussel mucin, 0.5-5 parts of black wolfberry extract, 0.5-5 parts of cnidium monnieri extract, 0.5-5 parts of millettia reticulata extract, and 0.5-2 parts of flow aid.

2. The double-layer tablet with indication function according to claim 1, characterized in that: The mass ratio of the black wolfberry extract, the cnidium monnieri extract, and the millettia reticulata extract is 1:1.2-1.5:0.8-1.

0.

3. The double-layer tablet with indication function according to claim 1, characterized in that: The filler includes at least one of lactose, mannitol, xylitol, sorbitol, sucrose powder, and glucose powder.

4. The double-layer tablet with indication function according to claim 1, characterized in that: The prebiotics include at least one of isomaltooligosaccharide, fructooligosaccharide, galacto-oligosaccharide, and xylo-oligosaccharide.

5. The double-layer tablet with indication function according to claim 1, characterized in that: The glidant includes at least one of magnesium stearate, differential silica gel, and PEG6000.

6. The double-layer tablet with indication function according to claim 3, characterized in that: The binder includes at least one of hydroxypropyl cellulose, microcrystalline cellulose, and povidone.

7. The double-layer tablet with indication function according to claim 4 or 5, characterized in that: The sustained-release component includes at least one of sodium carboxymethylcellulose and hydroxypropyl methylcellulose.

8. The double-layer tablet with indication function according to claim 6, characterized in that: The moisturizing component includes at least one of sodium hyaluronate and trehalose.

9. A method for preparing a double-layer tablet with an indication function according to any one of claims 1 to 8, characterized in that: include: The raw materials of the repair layer are mixed evenly according to a certain proportion and then pressed into tablets to obtain pre-pressed tablets; The raw materials of the supplementary layer are mixed evenly according to the proportion, and placed on the top of the pre-compressed tablet for secondary tableting.

10. The preparation method according to claim 9, characterized in that: The raw materials are ground into powders of 60-100 mesh, mixed and tableted; the tableting speed is 30-60 thousand tablets / hour, and the pressure is 50-70 kN.

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