Traditional Chinese medicine composition and medicine for treating and / or assisting in treating children herpes stomatitis and application of traditional Chinese medicine composition and medicine

Abstract

The invention discloses a traditional Chinese medicine composition and medicine for treating and / or assisting in treating children herpes stomatitis and application of the traditional Chinese medicine composition, the traditional Chinese medicine composition comprises radix scrophulariae, radix ophiopogonis, platycodon grandiflorum and raw liquorice, the radix scrophulariae and the radix ophiopogonis are used as main medicines in the traditional Chinese medicine composition, the radix scrophulariae is used for removing stasis and detoxifying, cooling blood and clearing heat, and decreasing internal heat and nourishing yin; radix ophiopogonis can promote salivation, benefit stomach, nourish yin, moisten lung, resist inflammation and relieve pain; the platycodon grandiflorum is used for detoxifying and clearing heat, diminishing swelling and inducing diuresis, relieving exterior syndrome and ventilating lung, and soothing the nerves and stabilizing the mind; all the medicines have a synergistic effect, so that the effects of resisting inflammation, easing pain, dispelling wind, relieving depression, clearing away heat and toxic materials are achieved. Chlortetracycline glycerin has the effects of resisting viruses, diminishing inflammation, sterilizing, relieving pain and the like. According to the medicine, the traditional Chinese medicine composition is combined with aureomycin to assist in treatment of herpetic stomatitis, the traditional Chinese medicine composition is used for internal treatment, aureomycin glycerin is used for external treatment, internal treatment and external treatment are performed at the same time, the disease course of sick children can be remarkably shortened, symptoms are improved, and side effects are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating and / or assisting in treating herpetic stomatitis in children, a medicine and application thereof. Background Art

[0002] Herpetic stomatitis is a type of oral mucosal disease caused by infection with the herpes simplex virus type 1. It often occurs in children under the age of 6 and is highly contagious and spreads rapidly. This disease is an acute attack during its occurrence. Children with this disease will experience fever, clustered herpes on the oral mucosa, general fatigue, poor appetite, and refusal to eat, which will have a serious impact and damage on their growth, development, and health.

[0003] Western medicine believes that this disease is mostly caused by viral infection, and there are also cases where lack of vitamins causes mucosal damage and induces oral ulcers. The treatment is mainly to relieve pain and eliminate local inflammation, or to assist with nutritional medicine support treatment. In recent years, Western medicine has mostly used antiviral treatment, and the drugs include nucleoside antiviral drugs and ribavirin. At present, nucleoside drugs are considered to be the most effective drugs against herpes simplex virus, mainly acyclovir, famciclovir, ganciclovir, etc., but antiviral drugs have more obvious side effects, causing temporary increase in serum creatinine, liver and kidney function damage and leukopenia, etc., and there are safety issues in children's medication. Chlortetracycline glycerol is also used to treat herpetic stomatitis. Chlortetracycline glycerol is an anti-inflammatory drug that can protect the skin while treating the disease, but the efficacy is not stable, which is not conducive to shortening the course of the disease. From the perspective of Western medicine, children with herpetic stomatitis are basically in an embarrassing situation where there is no medicine available. It is undoubtedly a disaster for children, and it is necessary to explore other drugs that can effectively shorten the course of the disease and reduce side effects. Summary of the invention

[0004] Therefore, based on the above background, the present invention provides a traditional Chinese medicine composition, a medicine and its application for treating and / or assisting in treating herpetic stomatitis in children. By combining the traditional Chinese medicine composition with chloramphenicol glycerol to treat herpetic stomatitis in children, the course of herpetic stomatitis in children can be significantly shortened and its side effects can be reduced.

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

[0006] A Chinese medicine composition for treating and / or assisting in treating herpetic stomatitis in children, comprising the following raw materials in parts by weight:

[0007] 2-10 parts of Scrophularia, 2-10 parts of Ophiopogon, 2-10 parts of Platycodon, and 2-10 parts of raw liquorice.

[0008] Preferably, it comprises the following raw materials in parts by weight:

[0009] 3 parts of Scrophularia, 3 parts of Ophiopogon, 3 parts of Platycodon, and 3 parts of raw liquorice.

[0010] Preferably, the Chinese medicine composition is added with medically acceptable adjuvants to prepare an oral preparation.

[0011] Based on the same inventive concept, the present invention also provides a use of a traditional Chinese medicine composition for treating and / or assisting in treating herpetic stomatitis in children in the preparation of a medicine for treating and / or assisting in treating herpetic stomatitis in children.

[0012] Based on the same inventive concept, the present invention also provides a medicine for treating herpetic stomatitis in children, which includes an oral preparation and an external preparation, wherein the oral preparation is prepared by adding a medically acceptable adjuvant to the above-mentioned traditional Chinese medicine composition;

[0013] The active ingredient of the raw material for preparing the external preparation is chlortetracycline.

[0014] Preferably, the external preparation is a suspension prepared by adding chlortetracycline to glycerol.

[0015] Preferably, the concentration of chlortetracycline in the suspension is 2.5 (w / v)%.

[0016] Preferably, the oral preparation is a decoction, granules, powder, capsule or honey pill.

[0017] The pharmacology of the present invention is as follows:

[0018] Traditional Chinese medicine believes that herpetic stomatitis belongs to the category of "mouth sores". For the occurrence of herpetic stomatitis, it is mostly believed that it is caused by internal fire, exogenous wind-heat, loss of body fluid, etc., and virtual fire is internally blazing, and inflammation along the meridians, which burns the tongue network, thereby forming mouth sores. Therefore, the treatment of this disease often follows the main principles of dispersing wind and relieving depression, clearing heat and detoxifying. Then, in the Chinese medicine composition of the present invention, Scrophularia and Ophiopogon japonicus are the main drugs, wherein Scrophularia dispersing knots and detoxifying, cooling blood and clearing heat, and reducing fire and nourishing yin; Ophiopogon japonicus promotes body fluid and benefits the stomach, nourishes yin and moistens the lungs, and is anti-inflammatory and analgesic; Platycodon grandiflorum and raw licorice are auxiliary drugs, Platycodon grandiflorum detoxifies and clears heat, reduces swelling and promotes diuresis, relieves the symptoms and promotes lung function, and calms the mind and settles the mind; Raw licorice relieves acute pain, relieves cough and eliminates phlegm, and all drugs work synergistically to achieve anti-inflammatory and analgesic, dispersing wind and relieving depression, and clearing heat and detoxifying. Chlortetracycline glycerol plays the role of antiviral, anti-inflammatory and sterilizing, and analgesic. The medicine of the present invention is used in combination with a Chinese medicine composition to assist in the treatment of herpetic stomatitis. The Chinese medicine composition is used for internal treatment, and chloramphenicol glycerol is used for external treatment. The internal and external treatments can significantly shorten the course of the disease in children, improve symptoms and reduce side effects. DETAILED DESCRIPTION

[0019] 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.

[0020] Example 1: A Chinese medicine composition for treating and / or assisting in treating herpetic stomatitis in children, comprising the following raw materials in parts by weight:

[0021] 3 parts of Scrophularia, 3 parts of Ophiopogon, 3 parts of Platycodon, and 3 parts of raw liquorice.

[0022] When used specifically: The dosage for one dose is:

[0023] Scrophularia 3g, Ophiopogon 3g, Platycodon 3g, and raw licorice 3g.

[0024] Example 2: A medicine for treating herpetic stomatitis in children, comprising an oral preparation and an external preparation, wherein the external preparation is a suspension prepared by adding chlortetracycline to glycerol.

[0025] Specifically, the external preparation is chlortetracycline with a concentration of 2.5 (w / v)%.

[0026] The oral preparation is a granule prepared using the Chinese medicine composition of Example 1.

[0027] Clinical Application:

[0028] 1) Patient source:

[0029] 60 children who received treatment for herpetic stomatitis in Jinhua Maternal and Child Health Hospital from June 2022 to June 2023 were selected and randomly divided into a control group of 30 cases and a treatment group of 30 cases. The general information of the children was compared, as shown in Table 1, and there was no statistical difference (P>0.05), which was comparable.

[0030] Table 1: Comparison of general information between the two groups

[0031]

[0032] Inclusion criteria: ① refer to the diagnostic criteria for herpetic stomatitis in "Children's Dentistry" edited by Ge Lihong et al. and "Oral Medicine" (2nd edition) edited by Zheng Yan et al.; ② meet the diagnostic criteria for pediatric aphthous ulcers in "Guidelines for Clinical Diagnosis and Treatment of Pediatric Chinese Medicine·Aphthous ulcers in Children"; ③ children are 6 months to 3 years old; ④ have a history of contact with herpes patients; ⑤ increased lymphocytes and white blood cell counts; ⑥ clusters of small blisters appear on the skin around the lips and scattered ulcers with signs of clustering are common in the oral mucosa; ⑦ no drug treatment has been used.

[0033] Exclusion criteria: ① patients with cardiovascular and cerebrovascular diseases; ② patients with severe liver and kidney dysfunction; ③ patients with obvious communication disorders; ④ patients with allergic constitution; ⑤ patients with infectious, immune and blood diseases; ⑥ patients with oral ulcers, fever, drooling and other symptoms caused by trauma, hand, foot and mouth disease and other diseases; ⑦ patients with coagulation dysfunction; ⑧ patients with incomplete clinical case data.

[0034] 2) Treatment process:

[0035] Control group: chlortetracycline glycerol was applied to the affected area for treatment.

[0036] Method: Apply 2.5% chlortetracycline glycerol to the affected area (0.25g chlortetracycline hydrochloride powder is placed in 10mL glycerol to prepare a suspension, and place in a cool place), apply once every 2-3 hours. The course of treatment is 6 days.

[0037] Treatment Group:

[0038] The drug of Example 2 was used for treatment. The oral granules were dissolved in warm water, one dose / d; the external medicine was applied every 2-3h / time, and the course of treatment was 6d.

[0039] During the treatment period, the two groups of children need to eat a light diet, avoid irritating and spicy foods, and drink plenty of water. Ensure adequate sleep. When multiple children live together, they need to be isolated to avoid cross infection. During the trial, if the child's temperature exceeds 38.5℃, routine antipyretic treatment should be carried out in time.

[0040] 3) Index detection

[0041] ① TCM syndrome score level

[0042] On the day of enrollment and 3 days after the end of treatment, the TCM syndrome score level was evaluated, which included: oral ulcer, anorexia, drooling, nausea and vomiting. Main symptoms: oral ulcer, anorexia; score: 0, 2, 4, 6 points. Secondary symptoms: drooling, nausea and vomiting; score: 0, 1, 2, 3 points. The higher the score, the more serious the condition.

[0043] ②Clinical characteristics of the patients

[0044] On the day of enrollment and 3 days after the end of treatment, the time for herpes to disappear, body temperature to recover, salivation to disappear, and ulcer to heal were recorded.

[0045] ③CRP level

[0046] On the day of enrollment and the third day after the end of treatment, 2 mL of venous blood was drawn from the children in the fasting state at 8 a.m., centrifuged, and the serum was separated and stored at -25°C for testing. The CRP level was detected using a blood routine tester (manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; model: BC-7500CRP).

[0047] ④Relative expression of HSV-DNA

[0048] The relative expression of HSV-DNA was detected by RT-PCR. RNA in the tissue was extracted using the HSV-DNA extraction and separation kit (Shanghai Zhijiang Biotechnology Co., Ltd.), reverse transcription was performed using the PCR kit, and cDNA was amplified by PCR. The condition parameters were pre-denaturation at 98°C for 9n, cooling to 90°C, denaturation for 4s, rapid cooling to 55°C, annealing for 10s, temperature maintained at 50°C, extension for 42s, 47 cycles, and the experiment was repeated 3 times.

[0049] GAPDH upstream primer:

[0050] 5′-TGACTTCAACAGCGACCCA-3′;

[0051] Downstream primer: 5′-CACCCTGTTGCTGTAGCCAA-3′;

[0052] HSV-DNA upstream primer:

[0053] 5′-GATACAGTACAATTATTTTGGGAC-3′,

[0054] Downstream primer: 5′-ATGCCTCTGAGCCTCATCTC-3′.

[0055] GAPDH was used as the internal reference and 2 -ΔΔ The relative expression of HSV-DNA was calculated by Ct method.

[0056] The HSV viral load was detected by RT-PCR, as follows: 50 μL of the frozen blister fluid was thawed and placed in a new EP tube, an equal volume of nucleic acid extract was added and mixed in a boiling water bath for 10 min, the supernatant was collected after centrifugation, and the HSV viral DNA load in the blister fluid was measured using the HSV virus detection kit produced by Daan Gene Co., Ltd. The 7500 type fluorescence quantitative detector was purchased from ABI, USA, and the reaction system was: 17 μL of reaction solution A, 3 μL of reaction solution B, and 5 μL of DNA; the PCR reaction program was: the detection channel was set to FAM, and the reaction conditions were 50°C for 2 min, 95°C for 15 min, (94°C for 15 s, 55°C for 45 s) for 40 cycles. The Ct value of each monitoring sample was brought in according to the standard curve of the kit sample determination to obtain the DNA copy number of the HSV virus in the blister fluid of each sample.

[0057] ⑤Evaluation of clinical effectiveness

[0058] Markedly effective: Markedly effective: oral herpes or ulcers healed, systemic symptoms significantly relieved, appetite normal, bowel movements normal; effective: oral herpes or ulcers reduced or lightened in color or pain relieved, systemic symptoms relieved, appetite increased, bowel movement symptoms improved; ineffective: symptoms did not improve or even worsened. Total effective rate = (markedly effective + effective) / total number of cases × 100%.

[0059] ⑥ Assessment of adverse reactions

[0060] The adverse reactions of the two groups of children after the treatment were statistically analyzed, including gastrointestinal discomfort, vomiting, mild diarrhea, and rash.

[0061] Statistical treatment:

[0062] The statistical software SPSS 26.0 was used for analysis. The independent sample t test was used for inter-group comparison, and the paired t test was used for intra-group comparison; the count data were expressed as percentages, and the x 2 Test, P<0.05 was statistically significant.

[0063] 4) Results

[0064] ① Comparison of TCM syndrome score levels between the two groups

[0065] As shown in Table 2, there was no statistical difference in the TCM syndrome score levels between the two groups before treatment (P>0.05). After treatment, compared with the control group, the scores of oral ulcers, anorexia, salivation, nausea and vomiting in the treatment group decreased, with statistical significance (P<0.05).

[0066] Table 2: Comparison of TCM syndrome score levels between the two groups

[0067]

[0068] ②Comparison of improvement in clinical characteristics between the two groups

[0069] As shown in Table 3, after treatment, compared with the control group, the herpes disappearance time, body temperature recovery time, salivation disappearance time, and ulcer healing time in the treatment group were reduced, with statistically significant differences (P<0.05).

[0070] Table 3: Comparison of improvement in clinical characteristics between the two groups of patients

[0071]

[0072] ③Comparison of CRP levels between the two groups

[0073] As shown in Table 4, there was no statistical difference in the levels of inflammatory mediators between the two groups before treatment (P>0.05). After treatment, the CRP level in the treatment group decreased compared with that in the control group, with a statistically significant difference (P<0.05).

[0074] Table 4: Comparison of CRP levels between the two groups

[0075]

[0076] ④Comparison of relative expression of HSV-DNA between the two groups

[0077] As shown in Table 5, before treatment, there was no statistical difference in the relative expression of HSV-DNA and HSV viral load between the two groups (P>0.05). After treatment, compared with the control group, the relative expression of HSV-DNA and HSV viral load in the treatment group decreased, with statistical difference (P<0.05).

[0078] Table 5: Comparison of relative expression of HSV-DNA between the two groups

[0079]

[0080] ⑤Comparison of clinical efficacy between the two groups

[0081] As shown in Table 6, after treatment, the total effective rate of the treatment group increased compared with that of the control group, with a statistically significant difference (P<0.05).

[0082] Table 6: Comparison of clinical efficacy between the two groups [n (%)]

[0083]

[0084] ⑥ Comparison of adverse reactions between the two groups

[0085] As shown in Table 7, after treatment, the incidence of total adverse reactions in the treatment group decreased compared with that in the control group, with no statistically significant difference (P>0.05).

[0086] Table 7: Comparison of adverse reactions between the two groups [n (%)]

[0087]

[0088] From the above clinical application results, it is obvious that the medicine for treating herpetic stomatitis in children of the present invention can significantly shorten the course of the disease, alleviate symptoms, and reduce adverse reactions by combining the traditional Chinese medicine composition with chloramphenicol glycerol; specifically, compared with single external treatment with chloramphenicol glycerol, the medicine for treating both internal and external diseases of the present invention can significantly reduce the score levels of oral ulcers, anorexia, drooling, nausea and vomiting in children, and reduce the clinical characteristics of children such as herpes regression time, body temperature recovery time, salivation disappearance time, ulcer healing time, further alleviate the condition and improve the overall symptoms.

[0089] CRP is a clinical inflammatory cytokine that can reflect the inflammatory response in the body. Herpetic stomatitis is caused by viral infection, which can cause abnormal release of related inflammatory cytokines, cause damage to the oral mucosa, and aggravate the inflammatory response in the body. The above clinical application results show that after the children with herpetic stomatitis were treated with the drug of the present invention, the CRP level in the treatment group was reduced and was significantly lower than that in the control group. It shows that the drug of the present invention can significantly reduce the inflammatory response in the children's body.

[0090] The viral load in the blister fluid of children with herpetic stomatitis is correlated with the severity of the disease, the course of the disease and age. In the above clinical application, the viral load of the blister fluid of children with herpetic stomatitis was tested and the results also showed that it was positively correlated with the severity of the disease. The HSV-DNA virus concentration in the body of children with herpetic stomatitis was detected by PCR technology. The results showed that compared with the control group, the relative expression of HSV-DNA and the decrease of HSV viral load in the treatment group were more significant. The reason for speculation is that the medicine of the present invention can significantly improve the clinical symptoms of children, reduce the inflammatory response in the body of children, thereby significantly killing the HSV-DNA virus, thereby improving the condition of children.

[0091] In summary, by using the drug of the present invention to treat children with herpetic stomatitis, the TCM syndrome score level can be reduced, the clinical characteristics can be improved, the inflammatory response can be alleviated, the immune function can be enhanced, the condition can be significantly alleviated, and the clinical promotion value is high.

[0092] The present invention and its embodiments are described above, and such description is not restrictive. What is shown in the embodiment is only one of the embodiments of the present invention, and the actual structure is not limited thereto. In short, if ordinary technicians in the field are inspired by it, without departing from the purpose of the invention, they can design a structure and embodiment similar to the technical solution without creativity, which should belong to the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating and / or assisting in treating herpetic stomatitis in children, characterized in that: It is composed of the following raw materials in parts by weight: 2-10 parts of Scrophularia, 2-10 parts of Ophiopogon, 2-10 parts of Platycodon, and 2-10 parts of raw liquorice.

2. A Chinese medicine composition for treating and / or assisting in treating herpetic stomatitis in children according to claim 1, characterized in that: It is composed of the following raw materials in parts by weight: 3 parts of Scrophularia, 3 parts of Ophiopogon, 3 parts of Platycodon, and 3 parts of raw liquorice.

3. A Chinese medicine composition for treating and / or assisting in treating herpetic stomatitis in children according to claim 1 or 2, characterized in that: The Chinese medicine composition is added with medically acceptable adjuvants to prepare an oral preparation.

4. Use of a Chinese medicine composition for treating and / or assisting the treatment of herpetic stomatitis in children as claimed in any one of claims 1 to 3 in the preparation of a medicine for treating and / or assisting the treatment of herpetic stomatitis in children.

5. A medicine for treating herpetic stomatitis in children, characterized in that: It includes oral preparations and external preparations, wherein the oral preparation is prepared by adding a medically acceptable adjuvant to the traditional Chinese medicine composition according to any one of claims 1 or 2; The active ingredient of the raw material for preparing the external preparation is chlortetracycline.

6. A medicine for treating herpetic stomatitis in children according to claim 5, characterized in that: The external preparation is a suspension prepared by adding chlortetracycline into glycerol.

7. A medicine for treating herpetic stomatitis in children according to claim 6, characterized in that: The concentration of chlortetracycline in the suspension is 2.5 (w / v)%.

8. A medicine for treating herpetic stomatitis in children according to claim 5, characterized in that: The oral preparation is a decoction, granules, powder, capsule or honey pill.

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