Composition for toothache and application thereof

Abstract

The invention discloses a composition for toothache and application thereof.The composition is prepared from 2-6 parts of anisodamine, 4-12 parts of dexamethasone, 200-600 parts of naproxen and 200-500 parts of metronidazole. Through reasonable raw material matching, the composition can treat toothache caused by pulpitis, apical apitis, periodontal abscess, tooth oscillation trauma or periodontal disease and the like; rapid pain relieving can be achieved within 10-20 min for the first time, the pain relieving effect is rapid, and toothache can be treated fundamentally and efficiently; in addition, the traditional Chinese medicine composition is also beneficial to restoring the activity of dental pulp and has an effective treatment effect on tooth renaturation pulpitis; in addition, the root canal can be assisted in treating non-recupable pulpitis or apicitis, and the root canal treatment effect is improved.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a composition for toothache and application thereof. Background Art

[0002] Toothache is one of the common symptoms of oral diseases. It refers to pain caused by various reasons in teeth or surrounding tissues. It is caused by many reasons, such as pulpitis, apical periodontitis, periodontal abscess, dental concussion trauma or periodontal disease, which are common diseases that cause toothache. Pulpitis refers to oral inflammation caused by bacteria or toxins invading the pulp in the center of the tooth. It is divided into reversible pulpitis and irreversible pulpitis. Acute reversible pulpitis is its common type. It means that during the inflammation process, only the pulp is congested. When the stimulation disappears, the pain is quickly relieved or disappears (usually occurs in wedge-shaped defects. When the wedge-shaped defect is large and close to the pulp, eating cold or hot food will stimulate the pulp and cause it to become congested). In treatment, reversible pulpitis does not require inactivation of the dental nerve.

[0003] As we all know, "toothache is not a disease, but it is really painful when it happens." Therefore, toothache generally needs to be treated with rapid pain relief, but conventional painkillers, such as ibuprofen, take effect slowly and cannot quickly relieve pain. In addition, the current drugs for toothache only have an analgesic effect, but cannot treat the underlying disease that causes the pain, such as reversible pulpitis. Summary of the invention

[0004] Therefore, based on the above background, the present invention provides a composition for toothache and application thereof.

[0005] The technical solution provided by the present invention is:

[0006] A composition for toothache, which consists of the following raw materials:

[0007] 2-6 parts of anisodamine, 4-12 parts of dexamethasone, 200-600 parts of naproxen, and 200-500 parts of metronidazole.

[0008] Further, it is composed of the following raw materials:

[0009] 5 parts of anisodamine, 10 parts of dexamethasone, 500 parts of naproxen, and 400 parts of metronidazole.

[0010] Based on the same inventive concept, the present invention also applies the above-mentioned composition to the preparation of a drug for toothache caused by at least one of pulpitis, apical periodontitis, dry socket syndrome, periodontal abscess, tooth concussion trauma or periodontal disease.

[0011] Furthermore, the medicine is an oral dosage form, and its active ingredient is the composition.

[0012] Based on the same inventive concept, the present invention also applies the above-mentioned composition to the preparation of a drug for improving the treatment of pulpitis.

[0013] Furthermore, the pulpitis is reversible pulpitis.

[0014] Furthermore, the medicine is an oral dosage form, and its active ingredient is the composition.

[0015] Based on the same inventive concept, the present invention also applies the above-mentioned composition to the preparation of drugs for auxiliary root canal treatment of irreversible pulpitis or apical periodontitis.

[0016] Furthermore, the drug is in oral dosage form.

[0017] The above technical solution has the following beneficial effects:

[0018] The invention can treat toothache caused by pulpitis, apical periodontitis, periodontal abscess, tooth concussion trauma or periodontal disease through reasonable raw material combination, and can achieve rapid pain relief within 10-20 minutes for the first time, and the pain relief effect is fast, and the toothache can be fundamentally and efficiently treated;

[0019] The common point of pulpitis, apical periodontitis, periodontal abscess, tooth concussion trauma, periodontal disease and other diseases that cause toothache is that after bacterial infection, acute or chronic inflammatory reaction of the pulp or apex or periodontal is caused, resulting in edema compression, blood circulation disorder, local high pressure, compression and stimulation of the dental nerve and alveolar nerve, causing severe pain. According to the applicant's long-term clinical practice, the reasonable combination of metronidazole, naproxen, scopolamine and dexamethasone has been found. The combination can target the causes of toothache caused by the above diseases, fundamentally treat toothache, and has a precise effect and quick analgesic effect.

[0020] Specifically, dexamethasone has a strong anti-inflammatory effect, which can relieve inflammation, remove edema, reduce high pressure and protect nerves; secondly, scopolamine can treat acute microcirculatory disorders and neuralgia, improve local blood circulation, make dental blood vessels unobstructed, reduce edema and high pressure, and allow antibacterial and analgesic drugs such as metronidazole and naproxen to directly reach the lesion and exert their effects. The combination of these drugs can be antibacterial and anti-inflammatory, quickly reduce the high pressure reaction of local inflammation of the teeth, and quickly relieve pain and protect the pulp tissue. It can also help restore the activity of the dental pulp and have an effective therapeutic effect on reversible pulpitis of the teeth; it can also assist in the root canal treatment of irreversible pulpitis or apical periodontitis, and improve the effect of root canal treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Attached Figure 1 These are the results of pulp activity testing of patients with reversible pulpitis before and after treatment in the embodiment. DETAILED DESCRIPTION

[0022] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] Embodiment 1: A composition for toothache, which is composed of the following raw materials:

[0024] Scopolamine 5mg, dexamethasone 10mg, naproxen 500mg, metronidazole 400mg.

[0025] In specific applications, the above-mentioned drugs can be crushed and mixed, and then filled into capsules for oral administration.

[0026] The specific drug amount in this embodiment is a single oral dose for adults.

[0027] Children under 12 years old need to take half the dose, that is, the one-time dose for children is:

[0028] Scopolamine 2.5mg, dexamethasone 5mg, naproxen 250mg, metronidazole 200mg.

[0029] Contraindications: Not suitable for pregnant women, should be used with caution by those who are allergic.

[0030] Toxicity test:

[0031] Thirty adult Kunming mice were randomly divided into two groups, 15 mice in each group, namely a control group and an experimental group. Both groups were fed normally. The control group was gavaged with 25 ml of normal saline three times a day on the basis of normal feeding, and the experimental group was gavaged with 25 ml of the aqueous solution of Example 1 three times a day;

[0032] Specifically, the effective drug dose in the aqueous solution administered to the experimental group was 5.8 mg / g (this was obtained based on the formula for converting the clinical dose of humans into the dose of experimental animals, specifically, the mouse dose = the clinical dose of humans mg / Kg × 70 kg × 0.018 / 200 g);

[0033] The mice were gavaged for 7 consecutive days, and the mice were observed every day. The activities and diet of the mice in the control group and the experimental group were normal. After 7 days, the mice in the experimental group were randomly selected for dissection, and no abnormalities were found in their organs.

[0034] Clinical data:

[0035] From January 2023 to February 2024, 254 patients with toothache were enrolled, aged between 11 and 58 years old, including 56 patients with toothache caused by apical periodontitis, 42 patients with toothache caused by pulpitis (23 of which were reversible pulpitis and 19 were irreversible pulpitis), 67 patients with toothache caused by periodontitis, and 89 patients with dry socket syndrome after tooth extraction. All of the above patients were unable to tolerate toothache and came to our clinic for treatment of toothache first.

[0036] The above patient was treated orally with Example 1, three times a day, the dosage for adults each time was the dosage shown in Example 1, children under 12 years old took half the dosage, and adults weighing less than 40 kg also took half the dosage. After taking it for three consecutive days, the efficacy was statistically analyzed after continuing to observe for three days.

[0037] Efficacy criteria:

[0038] Quick effect: toothache symptoms disappear within 15-20 minutes after the first oral administration, and pain does not recur within 3 days after stopping taking the medicine.

[0039] Marked effect: toothache was significantly relieved 15-20 minutes after the first oral administration. The pain symptoms disappeared after 3 days of taking the medicine. There was no recurrence of pain within 3 days of stopping the medicine.

[0040] Effective: After the first dose, the pain is relieved within 15-20 minutes. After 3 days of use, the pain symptoms disappear. The pain recurs within 3 days of stopping the medication.

[0041] Ineffective: The pain did not ease after 15-20 minutes of taking the medicine for the first time.

[0042] Effectiveness = (rapid effect + marked effect + effective) * 100% / total number of people

[0043] The pain in the above efficacy was measured by visual analog pain scale (VAS), ranging from 0 to 10 points, and the higher the score, the stronger the pain the patient felt. And the significant pain relief in the above marked effect was reflected in the reduction of VAS value by more than 40%.

[0044] The efficacy results are shown in Table 1 below:

[0045] Table 1: Efficacy statistics

[0046]

[0047] The pulp vitality of patients with reversible pulpitis was tested before and after taking the medicine. The test results are shown in Figure 1 .

[0048] Pulp vitality was tested using cold and hot treatments, specifically, using small popsicles and hot gutta-percha to test the pulp response of the affected teeth, compared with a reference tooth. Pulp vitality was graded from 1 to 5, with the higher the grade, the worse the patient's pulp vitality.

[0049] After the above patients were treated with the present invention, some of them continued to receive targeted treatment, for example, some patients with apical periodontitis subsequently received root canal treatment.

[0050] Typical cases:

[0051] Case 1: Zhang, female, 17 years old, had acute apical periodontitis of the left lower sixth molar. She took roxithromycin, metronidazole, and ibuprofen on her own, but still had unbearable toothache. She went to the dental clinic and received root canal treatment, but still had unbearable pain. She was advised to take the composition of the embodiment, which was effective after the first dose. After taking it three times, the pain symptoms disappeared. Then continued to complete the root canal treatment.

[0052] Case 2: Fang, male, 56 years old, right upper sixth molar, deep caries caused pulpitis complicated with apical periodontitis, severe pain for one day, unable to sleep at night, took painkillers, roxithromycin, acetaminophen, but no obvious relief. After taking the drug of the present invention, the pain disappeared after the first dose, continued to take it for three times, could chew normally, and then completely repaired the tooth caries, repaired the primary tooth disease, and preserved the tooth.

[0053] Case 3: Ms. Ding, female, 51 years old, suffered from dry socket and severe pain after the extraction of eight wisdom teeth on the upper left side. She received infusions of metronidazole, clindamycin and other drugs in the hospital for four days, but the pain was still not relieved. She took the drug of the present invention and it was effective on the first day, and the pain symptoms disappeared after three days.

[0054] Case 4: Wu, female, 47 years old, periodontal abscess, upper left 5.7.3 periodontal swelling and pain, obvious biting pain, infusion of cefoperazone and metronidazole for three days, no significant effect, oral administration of acetaminophen and codeine tablets, no pain relief, then took the medicine of the present invention, effective at one time, no pain after taking it for three consecutive days (three times a day).

[0055] Case 5: Mr. Huo, male, 50 years old, had chronic apical periodontitis in the lower left groin. He underwent root canal treatment and experienced aggravated acute pain. After taking the medicine of the present invention, the pain disappeared in 20 minutes. He took the medicine three times in a row and there was no recurrence until the end of root canal treatment.

[0056] Case 6: Huo Mouwei, male, 38 years old, had abscess on the left lower fifth root apex. Examination showed that the left lower fifth buccal gingiva was severely red and swollen, forming an abscess the size of a peanut. He underwent root canal treatment at the dentistry, but the symptoms did not improve significantly. Root canal treatment was temporarily decided. He then took the medicine of the present invention, and the pain stopped in about 20 minutes. The abscess disappeared after 10 hours. He took the medicine for a total of three days (three times a day) without any adverse reactions during the medication period. He then completed the root canal treatment.

[0057] Case 7: Yang, 75 years old, right lower seven, residual root, apical periodontitis, pain, severe pain at night, self-administered painkiller tablets, roxithromycin capsules, no relief, then switched to the drug of the present invention twice, the pain disappeared, continued to take two days (three times a day), the residual root was removed. No adverse reactions during the period of taking.

[0058] Case 8: Bao, male, 46. Upper right six, occlusal pain, apical periodontitis for eight days, took anti-inflammatory and analgesic drugs on his own, but the pain did not improve significantly. He took the drug of the present invention twice and it was effective. After taking it for three days (three times a day), he no longer felt toothache.

[0059] Case 9: Ms. Li, 34 years old, complained of severe toothache, which was worse at night for three days. After taking the medicine of the present invention once, the pain disappeared, and she took it for three days in total (three times a day).

[0060] Case 10: Liu, female, 58 years old, had seven caries on the lower right side, pain from hot and cold stimulation, pain from biting, and spontaneous pain. She was diagnosed with pulpitis complicated with apical periodontitis. She took metronidazole fenbufen, roxithromycin, and acetaminophen for four days, but no obvious effect was seen. She took the medicine of the present invention, and the effect was obvious at the first time, and the pain disappeared after the second time. She went to the dentist to repair the bad teeth. No adverse reactions were seen during the medication period.

[0061] Case 11: Zhang, male, 49 years old, had severe pain in upper left wisdom tooth. Examination showed that the upper left wisdom tooth was misaligned, not carious, not loose, painful when cold or hot, and no pain when biting. He was diagnosed with pulpitis. After taking the drug of the present invention for three days (three times a day), he no longer felt pain. The affected tooth was then extracted. There were no adverse reactions during the period of taking the drug.

[0062] Case 12: Ma, male, 70 years old, pulpitis of the lower left fifth tooth, severe pain, especially at night, unable to sleep for two days, self-administered acetaminophen, tramadol, bezoar metronidazole, all ineffective, took the drug of the present invention, the pain was significantly relieved after the first dose, the pain disappeared after three doses. Follow-up for one month later, no recurrence. No adverse reactions were observed after taking the drug of the present invention.

[0063] Case 13: Gao, male, 66 years old, spontaneous pain in the right upper six, pain with cold and hot stimulation, no damage, moderate periodontal disease, no loose teeth, self-administered bezoar metronidazole and ibuprofen, effective, but stopped taking the medicine, took the medicine of the present invention, the pain was relieved after the first dose, took it for three days (three times a day), and followed up for three months without recurrence. No adverse reactions were observed after taking the medicine of this prescription.

[0064] Case 14: Zhang, male, 64 years old. Left upper quadrant periapical inflammation, moderate caries, severe pain, taking the drug of the present invention immediately relieved the pain, and the pain disappeared after taking it for three days (three times a day). There was no adverse reaction during the period of taking it. Later, he went to the dentist to repair the carious tooth.

[0065] Case 15: Wei, male, 57 years old, pulpitis of right upper six teeth, severe pain at night, walking around the house in pain. After taking the medicine of the present invention, the pain was relieved immediately after the first dose, and the pain disappeared after taking it for two days (three times a day). No adverse reactions were observed after taking the medicine of this formula.

[0066] Case 16: Mr. Liu, male, 47 years old, had caries on his lower left wisdom tooth, which caused pulpitis and severe pain. He took multiple drugs on his own but the pain did not improve. The drug of the present invention showed obvious effect after the first use. After taking it for three days (three times a day), the pain disappeared. No recurrence was found during the one-month follow-up, and the affected tooth was extracted. There was no adverse reaction during the period of taking the drug.

[0067] Case 17: Wei, female, 37 years old, had wisdom tooth caries, pericoronitis, pulpitis, which caused severe pain. She took cefixime, bezoar metronidazole, and ibuprofen tablets but the pain was not relieved. She took the drug of the present invention once and it was effective. The pain disappeared after two times. She took it for three days (three times a day) and there was no recurrence after one month of follow-up. The combined tooth was extracted later. No adverse reactions were observed after taking the drug.

[0068] Case 18: Wei, female, 33 years old. Wisdom tooth pericoronitis, limited mouth opening, redness, swelling and severe pain around the crown, unable to eat, taking multiple drugs, and infusion with no obvious effect. After taking the drug of the present invention twice, the limited mouth opening was significantly relieved, the redness and swelling subsided, and liquid food could be eaten. After taking it for four days (three times a day), the pain and symptoms disappeared, and no recurrence was observed during the three-month follow-up. There was no adverse reaction during the period of taking it.

[0069] The present invention and its implementation methods have been described, but such description is not restrictive and the actual methods are not limited thereto. In short, if ordinary technicians in the field are inspired by it and design implementation methods and embodiments similar to the technical solution without creative design without departing from the purpose of the invention, they should all fall within the protection scope of the present invention.

Claims

1. A composition for toothache, characterized in that: It is composed of the following raw materials: 2-6 parts of anisodamine, 4-12 parts of dexamethasone, 200-600 parts of naproxen, and 200-500 parts of metronidazole.

2. A composition for toothache according to claim 1, characterized in that: It is composed of the following raw materials: 5 parts of anisodamine, 10 parts of dexamethasone, 500 parts of naproxen, and 400 parts of metronidazole.

3. Use of the composition according to claim 1 or 2 in the preparation of a medicament for toothache caused by at least one of pulpitis, apical periodontitis, dry socket syndrome, periodontal abscess, tooth concussion trauma or periodontal disease.

4. The use according to claim 3, characterized in that: The medicine is in oral dosage form, and its active ingredient is the composition.

5. Use of the composition according to claim 1 or 2 in the preparation of a drug for improving the treatment of pulpitis.

6. The use according to claim 5, characterized in that: The pulpitis is reversible pulpitis.

7. The use according to claim 5, characterized in that: The medicine is in oral dosage form, and its active ingredient is the composition.

8. Use of the composition according to claim 1 or 2 in the preparation of a drug for assisting root canal treatment of irreversible pulpitis or apical periodontitis.

9. The use according to claim 7, characterized in that: The drug is in oral dosage form.

Images