Formula, preparation method and preparation application of oral ulcer spray

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a formula, a preparation method and application of an oral ulcer spray. The oral ulcer spray is prepared from the following raw materials: rhizoma picrorhizae, cortex phellodendri, alum, mint, borneol, angelica sinensis, pseudo-ginseng powder and lithospermum erythrorhizon. The preparation method comprises the following steps: weighing quantitative mint, and drying for later use; weighing quantitative pseudo-ginseng powder and borneol and packaging the pseudo-ginseng powder and the borneol; the preparation method comprises the following steps: weighing a certain amount of rhizoma picrorhizae, cortex phellodendri, alum, angelica sinensis and lithospermum erythrorhizon, mixing and decocting, adding the dried mint into the mixed and boiled medicinal materials, repeatedly decocting for three times, combining the three filtrates, standing, filtering, taking the filtrate, adding cane sugar, and filling to obtain the oral ulcer spray. The traditional Chinese medicine composition has remarkable anti-inflammatory and healing-promoting functions, has a good effect on treating oral ulcer, is low in cost and free of any toxic and side effects, and can play roles in supporting the healthy energy, clearing heat and treating sores.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparations, and in particular to a formula, a preparation method and preparation application of an oral ulcer spray. Background Art

[0002] Oral ulcers are common oral mucosal diseases, usually occurring in the soft palate, buccal mucosa on both sides, gums and tongue. They are mainly manifested by pain and burning sensation in the local mucosa of the ulcer. They are spontaneous and recurrent, and are more likely to occur in the poorly keratinized part. The ulcer surface is often covered with a light white or grayish yellow pseudomembrane, and the surrounding area is congested and edematous, forming a sunken lesion, which affects the patient's eating and language communication, and brings inconvenience to the patient's life. At present, the cause of oral ulcers is unknown, and the pathological mechanism is still unclear. Abnormal immunity, changes in hormone levels, local trauma in the oral cavity, excessive fatigue and vitamin deficiency can all induce them.

[0003] Western medicine treatment for oral ulcers mainly relies on local medications, such as corticosteroids, immunosuppressants and lidocaine gel, but some Western medicines have significant side effects. Summary of the invention

[0004] The purpose of the present invention is to provide a formula, a preparation method and an application of an oral ulcer spray, so as to solve the problem that the oral ulcer treatment in the prior art mainly relies on local medication, such as glucocorticoids, immunosuppressants and lidocaine gel, but has significant side effects.

[0005] To achieve the above purpose, the present invention provides a formula, preparation method and application of an oral ulcer spray, wherein the formula of the oral ulcer spray comprises the following components: picrorhizon, phellodendron, alum, mint, borneol, angelica, notoginseng powder and lithospermum officinale.

[0006] The specific components of the formula of the oral ulcer spray are: 5-15 parts of picrorhizon, 5-15 parts of phellodendron, 5-15 parts of alum, 4-8 parts of mint, 2-4 parts of borneol, 5-15 parts of angelica, 5-15 parts of notoginseng powder and 5-15 parts of lithospermum.

[0007] The present invention also provides a method for preparing an oral ulcer spray, which is prepared using the oral ulcer spray formulation as described above, comprising the following steps:

[0008] Step 1, weigh a certain amount of mint, dry it and set it aside;

[0009] Step 2, weigh a certain amount of Panax notoginseng powder and borneol and pack them separately;

[0010] Step 3: weigh a certain amount of picrorhizon, phellodendron, alum, angelica and lithospermum officinale, mix and decoct, add the dried mint to the mixed medicinal materials and repeat the decoction three times, combine the three filtrates, let them stand and then filter, take the filtrate, add sucrose, and fill it to obtain the oral ulcer spray.

[0011] Among them, in step three, each decoction is specifically as follows: adding the mixed medicinal materials into water, boiling, and then decocting over low heat.

[0012] Among them, in step three, the amount of water used for each decoction is 3-6 times the total weight of the medicinal materials.

[0013] Wherein, in step three, the decoction time each time is 1-4 hours.

[0014] The present invention also provides a preparation application of an oral ulcer spray. The oral ulcer spray prepared by the preparation method of the oral ulcer spray formulation as described above can be used in drug lozenges, drug gels, drug solutions, drug films and drug films for treating oral ulcers.

[0015] The invention discloses a formula, preparation method and application of oral ulcer spray, wherein 4-8 parts of mint are weighed by weight and dried for standby use; then 5-15 parts of notoginseng powder and 2-4 parts of borneol are weighed by weight and packed separately; finally, 5-15 parts of picrorhizon, 5-15 parts of phellodendron, 5-15 parts of alum, 5-15 parts of angelica and 5-15 parts of lithospermum are weighed by weight and mixed and decocted, mint after drying is added to the mixed and boiled medicinal materials, and the decoction is repeated three times, the three filtrates are combined, and after standing, a 100-mesh filter is used to filter again, the filtrate is taken, sucrose is added, and the oral ulcer spray is obtained by filling, wherein each decoction is specifically as follows: the mixed medicinal materials are added into water of 6 times the total weight of the medicinal materials, and after boiling, the water is decocted over a slow fire for 3 hours. When used, the borneol is taken with water, and the notoginseng powder is taken with water in a separate pack. The prepared oral ulcer spray is used for treating oral ulcers. The oral ulcer spray has significant anti-inflammatory and healing-promoting functions, has a good effect on treating oral ulcers, is low in cost, has no toxic side effects, and can play the role of strengthening the body, clearing away heat and curing ulcers. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0017] Figure 1 It is a step flow chart of Example 1 of the present invention.

[0018] Figure 2 It is a step flow chart of Example 2 of the present invention.

[0019] Figure 3 It is a step flow chart of Example 3 of the present invention. DETAILED DESCRIPTION

[0020] The present invention provides a formula for oral ulcer spray, which is prepared from the following raw materials in parts by weight:

[0021] 5-15 parts of Picrorhizon, 5-15 parts of Phellodendron, 5-15 parts of Alum, 4-8 parts of Menthus, 2-4 parts of Borneolum, 5-15 parts of Angelica, 5-15 parts of Notoginseng Powder and 5-15 parts of Lithospermum officinale.

[0022] In this embodiment, the oral ulcer spray uses picrorhizon to clear dampness and heat, phellodendron enters the upper part of the body, clears heat and removes dampness, and purges fire to treat sores, alum clears heat and dries dampness, mint dispels wind and dissipates heat, relieves sore throat and relieves rashes, borneol clears heat and detoxifies, angelica replenishes blood and promotes blood circulation, Panax notoginseng powder promotes blood circulation and stops bleeding, clears heat and detoxifies, and lithospermum clears heat and detoxifies, stops bleeding and relieves pain. The oral ulcer spray has significant anti-inflammatory and healing-promoting functions, has a good effect on treating oral ulcers, is low in cost, has no toxic side effects, and can play the role of strengthening the body, clearing heat and treating sores.

[0023] Example 1, please refer to Figure 1 The present invention provides a method for preparing an oral ulcer spray, comprising the following steps:

[0024] S101: Weigh 8 parts of mint by weight, dry them and set them aside;

[0025] S102: weigh 15 parts of Panax notoginseng powder and 4 parts of borneol in separate bags;

[0026] S103: According to weight, 15 parts of picrorhizon, 15 parts of phellodendron, 15 parts of alum, 15 parts of angelica and 15 parts of lithospermum are weighed and mixed and decocted; dried mint is added to the mixed and decocted three times; the three filtrates are combined, allowed to stand and then filtered; the filtrate is taken, sucrose is added, and the oral ulcer spray is obtained by filling.

[0027] In this embodiment, first, 8 parts of mint are weighed by weight, dried and set aside; then, 15 parts of Panax notoginseng powder and 4 parts of borneol are weighed by weight and packed separately; finally, 15 parts of Picrorhizon, 15 parts of Phellodendron, 15 parts of Alum, 15 parts of Angelica and 15 parts of Lithospermum officinale are weighed by weight and mixed and decocted, the dried mint is added to the mixed and boiled medicinal materials, and the decoction is repeated three times, the three filtrates are combined, and after standing, they are filtered again using a 100-mesh filter, the filtrate is taken, sucrose is added, and filling can obtain the oral ulcer spray A, wherein each decoction is specifically as follows: the mixed medicinal materials are added into water of 6 times the total weight of the medicinal materials, boiled, and then decocted on a low heat for 3 hours. When in use, borneol is taken with water, and Panax notoginseng powder is taken with water separately; the prepared oral ulcer spray is used to treat oral ulcers, the oral ulcer spray has significant anti-inflammatory and healing functions, has a good effect on the treatment of oral ulcers, is low in cost, has no toxic side effects, and can play the role of strengthening the body, clearing away heat and treating sores.

[0028] Example 2, please refer to Figure 2 The present invention provides a method for preparing an oral ulcer spray, comprising the following steps:

[0029] S201: Weigh 4 parts of mint by weight, dry them and set them aside;

[0030] S202: weigh 5 parts of Panax notoginseng powder and 2 parts of borneol by weight and pack them separately;

[0031] S203: Weigh 5 parts of picrorhizon, 5 parts of phellodendron, 5 parts of alum, 5 parts of angelica and 5 parts of lithospermum officinale by weight, add dried mint to the mixed medicinal materials, and repeat the decoction three times, combine the three filtrates, let them stand and then filter, take the filtrate, add sucrose, and fill it to obtain the oral ulcer spray.

[0032] In this embodiment, first, 4 parts of mint are weighed by weight, and dried for standby use; then, 5 parts of notoginseng powder and 2 parts of borneol are weighed by weight; finally, 5 parts of picrorhizon, 5 parts of phellodendron, 5 parts of alum, 5 parts of angelica and 5 parts of lithospermum are weighed by weight for mixed decoction, the dried mint is added to the mixed medicinal materials and the decoction is repeated three times, the three filtrates are combined, and the filtrate is filtered again after standing with a 100 mesh filter, the filtrate is taken, sucrose is added, and the oral ulcer spray B can be obtained by filling, wherein each decoction is specifically as follows: the mixed medicinal materials are added to water 5 times the total weight of the medicinal materials, boiled, and simmered for 2 hours. When used, borneol is taken with water, and notoginseng powder is taken with water in another bag; the prepared oral ulcer spray is used to treat oral ulcers, and the oral ulcer spray has significant anti-inflammatory and healing functions, has a good effect on the treatment of oral ulcers, and has low cost, no toxic and side effects, and can play the effect of strengthening the body, clearing away heat and treating sores.

[0033] Example 3, please refer to Figure 3The present invention provides a method for preparing an oral ulcer spray, comprising the following steps:

[0034] S301: Weigh 6 parts of mint by weight, dry them and set them aside;

[0035] S302: weigh 10 parts of Panax notoginseng powder and 3 parts of borneol by weight and pack them separately;

[0036] S303: According to weight, 10 parts of picrorhizon, 10 parts of phellodendron, 10 parts of alum, 10 parts of angelica and 10 parts of lithospermum are weighed and mixed and decocted; dried mint is added to the mixed and decocted three times; the three filtrates are combined, allowed to stand and then filtered; the filtrate is taken, sucrose is added, and the oral ulcer spray is obtained by filling.

[0037] In this embodiment, first, 6 parts of mint are weighed by weight, dried and set aside; then, 10 parts of Panax notoginseng powder and 3 parts of borneol are weighed by weight and packed separately; finally, 10 parts of Picrorhizon, 10 parts of Phellodendron, 10 parts of Alum, 10 parts of Angelica and 10 parts of Lithospermum officinale are weighed by weight and mixed and decocted, the dried mint is added to the mixed and boiled medicinal materials, and the decoction is repeated three times, the three filtrates are combined, and after standing, they are filtered again using a 100-mesh filter, the filtrate is taken, sucrose is added, and filling can obtain the oral ulcer spray C, wherein each decoction is specifically as follows: the mixed medicinal materials are added into water 4 times the total weight of the medicinal materials, boiled, and then decocted on low heat for 1 hour. When in use, borneol is taken with water, and Panax notoginseng powder is taken with water separately; the prepared oral ulcer spray is used to treat oral ulcers, the oral ulcer spray has significant anti-inflammatory and healing functions, has a good effect on the treatment of oral ulcers, is low in cost, has no toxic side effects, and can play the role of strengthening the body, clearing away heat and treating sores.

[0038] Example 4, using an oral ulcer model to test the protective effect of the oral ulcer spray prepared in Examples 1 to 3 on oral ulcers:

[0039] 40 SPF Kunming rats were selected, each weighing 20-25 kg. They were randomly divided into 4 groups, marked as dosing group A, dosing group B, dosing group C and blank group. Each group of rats was adaptively fed for one week. In this experiment, the phenol burning method was used to construct an oral ulcer model.

[0040] The method for establishing the oral ulcer model is as follows: rats were fed with tetracycline drinking water (2.5 parts·L-1) for 5 days, and then 250 parts·k parts-1 prednisolone was injected intramuscularly into the rats 1 day before modeling. On the day of modeling, the rats were anesthetized with ether, and a cotton ball was dipped in a 90% phenol solution and placed in a gun head with a 2mm diameter hole at the bottom. The rat tongue was burned for 30 seconds, and the burned part was visibly whitened. Then, the rat mouth was cleaned with normal saline. After an interval of 4 hours, the rats were anesthetized with ether, and a cotton swab was dipped in a Candida albicans cell suspension (2.5×107 cells / ml), and the entire oral cavity of the anesthetized rat was wiped with it for 1 minute to produce oral infection, thereby completing the establishment of the oral ulcer model.

[0041] The rats were deprived of food and water for 2 hours after modeling. 24 hours after modeling, the formation of tongue ulcers in the rats was observed and recorded.

[0042] After the model was established, the rats were randomly divided into 4 groups. The oral ulcer spray A prepared in Example 1 was used for the metering group A, the oral ulcer spray B prepared in Example 2 was used for the metering group B, the oral ulcer spray C prepared in Example 3 was used for the metering group C, and normal saline was used for the blank group. The drugs were administered 3 times a day for 7 consecutive days. The rats were kept in a conventional manner during the period. The oral ulcer area of ​​each group of rats on the 2nd, 4th and 6th day after administration was measured and calculated with a vernier caliper, and the ulcer diameter d was recorded in mm. Because the ulcers are mostly circular, the ulcer area is calculated with reference to the circle area calculation formula, ulcer area = π × (d / 2) 2, in mm2. On the 7th day, each group of rats was fasted for 24 hours but not water, and the eyeballs were removed for blood collection. The rats were then killed. The ulcer area and volume of each dosage group were compared with the blank group, and statistical analysis was performed using the t test. The results are shown in Table 1. Table 1 shows the changes in the size of the ulcer area of ​​each group of oral ulcer sprays prepared in Examples 1-3 ( s, mm2), among which: compared with the blank group, *p<0.05 has significant difference, **p<0.01 has extremely significant difference.

[0043]

[0044] Table 1

[0045] As shown in Table 1, in the oral ulcer model, the oral ulcer spray group A and the oral ulcer spray group B showed significant differences in gastric ulcer area compared with the blank group (p<0.05), and the oral ulcer spray group C showed very significant differences in gastric ulcer area and volume compared with the blank group (p<0.01). This shows that the oral ulcer spray prepared in Examples 1-3 has a protective effect on chronic gastric ulcer.

[0046] Example 5, using an oral ulcer model to test the protective effect of the oral ulcer spray prepared in Examples 1 to 3 on oral ulcers:

[0047] 40 SPF SD rats were selected, each weighing 20-25 kg. They were randomly divided into 4 groups, marked as dosing group A, dosing group B, dosing group C and blank group. Each group of rats was adaptively fed for one week. In this experiment, the phenol burning method was used to construct an oral ulcer model.

[0048] The method for establishing the oral ulcer model is as follows: rats were fed with tetracycline drinking water (2.5 parts·L-1) for 5 days, and then 250 parts·k parts-1 prednisolone was injected intramuscularly into the rats 1 day before modeling. On the day of modeling, the rats were anesthetized with ether, and a cotton ball was dipped in a 90% phenol solution and placed in a gun tip with a 2mm diameter hole at the bottom. The rat tongue was burned for 30 seconds, and the burned part was visibly whitened. Then, the rat mouth was cleaned with normal saline. After an interval of 4 hours, the rats were anesthetized with ether, and a cotton swab was dipped in a Candida albicans cell suspension (2.5×107 cells / ml). The entire oral cavity of the anesthetized rat was wiped with it for 1 minute to produce oral infection and complete the establishment of the oral ulcer model.

[0049] The rats were deprived of food and water for 2 hours after modeling. 24 hours after modeling, the formation of tongue ulcers in the rats was observed and recorded.

[0050] After the model was established, the rats were randomly divided into 4 groups. The oral ulcer spray A prepared in Example 1 was used for the metered group A, the oral ulcer spray B prepared in Example 2 was used for the metered group B, the oral ulcer spray C prepared in Example 3 was used for the metered group C, and normal saline was used for the blank group. The drugs were administered 3 times a day for 7 consecutive days. On the 7th day, the rats in each group were fasted but not watered for 24 hours, and their eyeballs were removed for blood collection. The rats were then killed, and blood was collected from the abdominal aorta of the rats. The supernatant was centrifuged and determined by radioimmunoassay according to the instructions of the kit for TNF-α, IL-1β, IL-6, INF-Y, and IL-4. The results are shown in Table 2. Table 2 shows the changes in the levels of serum inflammatory factors in the rats in each group of Examples 1-3 ( p portions / mL-1), where: compared with the blank group, *p<0.05 had significant differences, **p<0.01 had extremely significant differences.

[0051]

[0052] Table 2

[0053] As shown in Table 2, compared with the blank, the levels of TNFα, IL-1β, IL-6 and INF-Y in the dosage groups A, B and C were reduced. It has a protective effect on oral ulcers. The spray in the present invention has the effect of clearing heat and treating ulcers, and can be used for treatment.

[0054] Example 6, the oral ulcer spray prepared in Examples 1 to 3 was tested for its in vitro antibacterial effect:

[0055] Take the ATCC standard strain with a bacterial age of 16-24 hours and dilute it to 1*10^6 CFU / ml with casein beef broth.

[0056] Take a 96-well sterile culture plate, set 12*3 wells for each strain, the first well is a negative control well (original concentration of Example 1, Example 2, Example 3 oral ulcer spray, no bacteria), the 12th well is a positive control well (no drug), use a pipette to add 50 μl of bacteria-containing casein beef broth medium to each well from the 2nd to the 12th well, and make 3 rows for each strain to reduce experimental errors.

[0057] Add 50 μl of the original concentration of each example oral ulcer spray to the 1st and 2nd wells, mix the 2nd well, then pipette 50 μl of the mixture from the 2nd well to the 3rd well, mix it and then pipette 50 μl to the 4th well, and so on, dilute it continuously to the 11th well, and pipette 50 μl of the mixture from the 11th well and discard it. At this time, the dilution multiples of each example oral ulcer spray in each well from the 1st to the 12th wells are 1 times, 2 times, 4 times, 8 times, ..., 1024 times, and 0 times, respectively.

[0058] After covering, the plates were placed in a 37°C constant temperature incubator for 24 h and then taken out for preliminary evaluation of bacterial growth in each well using turbidimetry.

[0059] In a biological safety cabinet, Haemophilus chocolate agar selective medium was used to culture each well of Haemophilus influenzae and Moraxella catarrhalis, and Columbia blood agar medium was used to culture each well of the other 9 bacteria. After incubation in a 37°C constant temperature incubator for 24h-48h, the medium was taken out and observed for bacterial growth, so as to determine the in vitro inhibitory concentration of the oral ulcer spray in each example against common pathogens.

[0060] The lowest drug concentration at which no bacteria grow in the small wells and on the corresponding culture medium is the minimum inhibitory concentration. The experiment is meaningful only when bacteria grow significantly in the positive control well (well 12). The results of the minimum inhibitory concentration test of oral ulcer spray are shown in Table 3, where * indicates that the oral ulcer spray has no antibacterial effect on the bacteria:

[0061]

[0062] Table 3

[0063] It can be seen from Table 3 that the oral ulcer sprays prepared in Examples 1 to 3 have good inhibitory effects on most bacteria.

[0064] The present invention also provides a preparation application of an oral ulcer spray. The oral ulcer spray prepared by the preparation method of the oral ulcer spray formulation as described above can be used in drug lozenges, drug gels, drug solutions, drug films and drug films for treating oral ulcers.

[0065] What is disclosed above is only a preferred embodiment of the present invention, and it certainly cannot be used to limit the scope of rights of the present invention. Ordinary technicians in this field can understand that all or part of the processes of the above embodiment and equivalent changes made according to the claims of the present invention still fall within the scope of the invention.

Claims

1. A formula for oral ulcer spray, characterized in that: The formula of the oral ulcer spray comprises the following components: picrorhizon, phellodendron, alum, mint, borneol, angelica, notoginseng powder and lithospermum officinale.

2. The formulation of the oral ulcer spray according to claim 1, characterized in that: The specific components of the formula of the oral ulcer spray are: 5-15 parts of picrorhizon, 5-15 parts of phellodendron, 5-15 parts of alum, 4-8 parts of mint, 2-4 parts of borneol, 5-15 parts of angelica, 5-15 parts of notoginseng powder and 5-15 parts of lithospermum.

3. A method for preparing an oral ulcer spray, prepared from the formula of the oral ulcer spray according to claim 2, characterized in that: The steps include: Step 1, weigh a certain amount of mint, dry it and set it aside; Step 2, weigh a certain amount of Panax notoginseng powder and borneol and pack them separately; Step 3: weigh a certain amount of picrorhizon, phellodendron, alum, angelica and lithospermum officinale, mix and decoct, add the dried mint to the mixed medicinal materials and repeat the decoction three times, combine the three filtrates, let them stand and then filter, take the filtrate, add sucrose, and fill it to obtain the oral ulcer spray.

4. The method for preparing the formula of the oral ulcer spray according to claim 3, characterized in that: In step three: The specific steps of each decoction are: add the mixed medicinal materials into water, boil it, and then simmer it over low heat.

5. The method for preparing the formula of the oral ulcer spray according to claim 4, characterized in that: In step three: The amount of water used for each decoction is 3-6 times the total weight of the medicinal materials.

6. The method for preparing the formula of the oral ulcer spray according to claim 5, characterized in that: In step three: The decoction time for each time is 1-4 hours.

7. An application of an oral ulcer spray preparation, wherein the oral ulcer spray prepared by the preparation method of the oral ulcer spray formulation as claimed in claim 3 can be used in drug lozenges, drug gels, drug solutions, drug films and drug films for treating oral ulcers.

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