A traditional Chinese medicine composition for herpes zoster oticus and its application

Abstract

The present invention provides a traditional Chinese medicine composition for herpes zoster oticus and its application, which relates to the technical field of traditional Chinese medicine pharmacy. The traditional Chinese medicine composition is obtained by reasonable compatibility in accordance with the principle of syndrome differentiation and treatment of traditional Chinese medicine, and is composed of Scorzonera austriaca, Cimicifuga foetida, Cortex Fraxini, Arisaema heterophyllum, Abutilon theophrasti, Aucklandia lappa, Chrysanthemum indicum, Houttuynia cordata, Cynanchum atratum, and Ginger Peel. The compatibility of various herbs is reasonable, and it has the effects of clearing heat and detoxifying, promoting qi circulation to relieve pain, detumescing and treating sores, and promoting diuresis to reduce swelling. It has good curative effect, short course of treatment, and no toxic and side effects. The traditional Chinese medicine composition of the present invention has a significant improvement effect on the spontaneous pain behavior of rats with postherpetic neuralgia model and aspects such as the levels of serum IL-2, IL-6, and TNF-α, achieving the simultaneous treatment of the symptoms and root causes of herpes zoster oticus. The traditional Chinese medicine composition of the present invention has a significant therapeutic effect on herpes zoster oticus, has a high effective rate, can quickly relieve the clinical symptoms of patients, shorten the recovery time of patients, and relieve the pain of patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmacy, and particularly relates to a traditional Chinese medicine composition for Ramsay-Hunt syndrome and its application. Background Art

[0002] Ramsay-Hunt syndrome is a common clinical condition in current otolaryngology. It is caused by the varicella-zoster virus invading the facial nerve and the auditory nerve. When the virus invades the facial nerve in the temporal bone segment and invades the geniculate ganglion, Ramsay-Hunt syndrome may occur. The specific clinical manifestations are the triad of severe pain of herpes, herpes in the external auditory canal, and peripheral facial paralysis. Clinically, due to the different order of appearance of the three major symptoms, it is easy to be misdiagnosed and missed diagnosed in the early stage. Compared with herpes zoster in the hypochondrium, Ramsay-Hunt syndrome has a severe condition, a long course of disease, a rapid progression of the disease, and a poor prognosis. Some patients have sequelae such as persistent neuralgia, hearing impairment, and facial paralysis after the skin lesions subside, which seriously affect the quality of life of the patients.

[0003] Currently, the western medicine treatment of herpes zoster mainly focuses on symptomatic treatment such as pain relief, anti-virus, nerve nutrition, and glucocorticoids to relieve the ear pain in the acute stage. However, since the virus lurks in the ganglion cells of the spinal nerves or cranial nerves for a long time, the effect of simply using western medicine treatment is not ideal.

[0004] Ramsay-Hunt syndrome belongs to the category of "snake blisters and facial paralysis" in traditional Chinese medicine. It is mostly caused by insufficient vital qi, external contraction of wind-heat pathogen toxin or excessive heat toxin leading to the stagnation of dampness-heat in the liver and gallbladder, which transforms into fire and ascends along the meridian to steam and burn the ear canal. According to its pathogenesis, prescriptions for clearing the liver and discharging the gallbladder, detoxifying and resolving dampness, dispersing wind and clearing heat, and activating blood circulation and dredging collaterals are given. In the field of traditional Chinese medicine research, relevant traditional Chinese medicine prescriptions for the treatment and prevention of herpes zoster have been disclosed and certain curative effects have been achieved. However, the existing traditional Chinese medicine prescriptions for herpes zoster have problems such as inaccurate curative effects, complex drug components, and easy recurrence. Therefore, there is an urgent need to provide a new medication plan for the prevention and treatment of Ramsay-Hunt syndrome. Summary of the Invention

[0005] (1) Technical Problems to be Solved

[0006] In view of the deficiencies of the prior art, the present invention provides a traditional Chinese medicine composition for Ramsay-Hunt syndrome and its application.

[0007] (2) Technical Solutions

[0008] To achieve the above object, the present invention is realized through the following technical solutions:

[0009] First, the present invention provides a traditional Chinese medicine composition for herpes zoster oticus. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 9-15 parts of Scorzonera austriaca, 3-15 parts of Cimicifuga foetida, 5-15 parts of Cortex Fraxini, 4-5 parts of Arisaema heterophyllum, 3-9 parts of Abutilon theophrasti, 5-10 parts of Aucklandia lappa, 9-15 parts of Chrysanthemum indicum, 10-20 parts of Houttuynia cordata, 5-9 parts of Cynanchum atratum, and 5-10 parts of Ginger Peel.

[0010] Further, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Scorzonera austriaca, 8 parts of Cimicifuga foetida, 10 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 6 parts of Abutilon theophrasti, 7 parts of Aucklandia lappa, 10 parts of Chrysanthemum indicum, 14 parts of Houttuynia cordata, 7 parts of Cynanchum atratum, and 7 parts of Ginger Peel.

[0011] Secondly, the traditional Chinese medicine composition provided by the present invention is used for preparing a drug for preventing and treating herpes zoster oticus. The traditional Chinese medicine composition can be prepared into an oral dosage form and / or an external dosage form.

[0012] When the traditional Chinese medicine composition is prepared into an oral dosage form, it is mainly a decoction. One dose is taken daily, orally in two divided doses, and 14 days is a course of treatment.

[0013] When the traditional Chinese medicine composition is prepared into an external dosage form, it is mainly an ointment. The ointment is externally applied to the affected area of the auricular skin, about 0.1 mm thick, removed after covering with a sterile gauze for 4-6 hours, once a day, and 7 days is a course of treatment.

[0014] The pharmacological effects of the Chinese medicinal materials involved in the traditional Chinese medicine composition of the present invention are as follows:

[0015] Scorzonera austriaca: Bitter, pungent, cold in nature, and belongs to the heart meridian; has the effects of expelling wind and dampness, regulating qi and activating blood circulation, clearing heat and detoxifying, and promoting lactation; commonly used for treating furuncles, carbuncles, breast abscesses, traumatic injuries, snake bites, mosquito bites and other symptoms.

[0016] Cimicifuga foetida: Pungent, sweet, slightly cold in nature, and belongs to the lung, spleen, large intestine, and stomach meridians; has the effects of inducing sweating and rash, clearing heat and detoxifying, and ascending yang to lift the sinking; used for headache, aversion to cold and fever, carbuncles and sores, epidemic febrile diseases, and failure of macules to come out.

[0017] Cortex Fraxini: Bitter, astringent, cold in nature, and belongs to the liver, gallbladder, and large intestine meridians; has the effects of clearing heat and detoxifying, astringing to stop dysentery, stopping leukorrhea, and improving eyesight; used for damp-heat dysentery, leukorrhea with red and white discharge, red and swollen eyes, and nebula in the eyes.

[0018] Arisaema heterophyllum: Bitter, pungent, warm in nature, toxic, and belongs to the lung, liver, and spleen meridians; has the functions of drying dampness and resolving phlegm, expelling wind and stopping convulsions, and resolving phlegm and dissipating nodules; used for stubborn phlegm cough, wind-phlegm dizziness, wind-phlegm congestion in stroke, deviation of the mouth and eyes, hemiplegia, epilepsy, infantile convulsions, and tetanus. When used raw, it is externally applied for treating carbuncles and snake and insect bites.

[0019] Abutilon theophrasti: Bitter, neutral in nature, and belongs to the large intestine, small intestine, and bladder meridians; has the effects of clearing heat and promoting diuresis, detoxifying, and removing nebula; commonly used for dysentery with red and white discharge, gonorrhea with painful urination, carbuncles and nebula in the eyes.

[0020] Costus Root: Pungent and bitter in taste, warm in nature, attributive to the spleen, stomach, large intestine, triple energizer and gallbladder meridians; having the effects of promoting qi flow to relieve pain and strengthening the spleen to promote digestion; used for chest and hypochondrium distending pain, abdominal distending pain, tenesmus after diarrhea, indigestion, anorexia.

[0021] Wild Chrysanthemum: Bitter and pungent in taste, slightly cold in nature, attributive to the liver and heart meridians; having the effects of clearing heat and detoxifying, purging fire and soothing the liver; used for furuncles and carbuncles, red and swollen eyes, headache and dizziness, etc.

[0022] Houttuynia Cordata: Pungent in taste, cold in nature, attributive to the lung meridian; clearing heat and detoxifying, detumescing and treating sores, inducing diuresis for removing dampness, clearing heat and stopping diarrhea, strengthening the spleen to promote digestion, used for lung abscess, sores and carbuncles, hemorrhoids with blood in stool, accumulation of heat in the spleen and stomach caused by pathogenic heat, dampness, etc.; modern pharmacological experiments show that this product has the effects of antibacterial, antiviral, enhancing the body's immunity, diuresis, etc.

[0023] Cynanchum atratum: Bitter and salty in taste, cold in nature, attributive to the lung, stomach and kidney meridians; having the effects of clearing heat and cooling blood, inducing diuresis for treating stranguria, detoxifying and treating sores; used for fever caused by pathogenic warm factor injuring nutrient qi, yin deficiency fever, hectic fever, carbuncles and sores, etc.

[0024] Ginger Peel: Pungent in taste, cool in nature, attributive to the spleen and lung meridians; having the effect of promoting diuresis to alleviate edema; used for initial edema, dysuria, etc.

[0025] (III) Beneficial Effects

[0026] The present invention provides a traditional Chinese medicine composition for treating herpes zoster oticus. The traditional Chinese medicine composition is obtained by reasonable compatibility according to the principle of treatment based on syndrome differentiation in traditional Chinese medicine. In the formula, Scorzonera austriaca is used as the monarch drug to dispel wind and remove dampness, regulate qi and activate blood circulation; Rhizoma Cimicifugae and Cortex Fraxini are used as the ministerial drugs to induce eruption and clear heat and detoxify; Arisaema heterophyllum, Abutilon theophrasti Medic. and Costus Root are used as the assistant drugs to dry dampness and resolve phlegm, expel wind and stop convulsions, clear heat and promote diuresis, promote qi flow to relieve pain; Wild Chrysanthemum, Houttuynia Cordata, Cynanchum atratum and Ginger Peel are used as the messenger drugs to detumesce and treat sores, strengthen the spleen to promote digestion, clear heat and cool blood, promote diuresis to alleviate edema. The compatibility of various drugs is reasonable, having the effects of clearing heat and detoxifying, promoting qi flow to relieve pain, detumescing and treating sores, promoting diuresis to alleviate edema, with good curative effect, short course of treatment and no toxic and side effects. The traditional Chinese medicine composition of the present invention has a significant improvement effect on the spontaneous pain behavior and serum IL-2, IL-6, TNF-α levels of rats with postherpetic neuralgia model, realizing the simultaneous treatment of the symptoms and root cause of herpes zoster oticus. The traditional Chinese medicine composition of the present invention has a significant therapeutic effect on herpes zoster oticus, with a high effective rate, can quickly relieve the clinical symptoms of patients, shorten the recovery time of patients and relieve the pain of patients. Description of the Drawings

[0027] Figure 1 Results of mechanical pain threshold of rats in each group at 1d, 7d and 14d after drug administration; compared with the model group, *p < 0.05, **p < 0.01.

[0028] Figure 2 Values of serum IL-2 in each group of rats; compared with the model group, *p < 0.05, **p < 0.01.

[0029] Figure 3 Values of serum IL-6 in each group of rats; compared with the model group, *p < 0.05, **p < 0.01.

[0030] Figure 4 Values of serum TNF-α in each group of rats; compared with the model group, *p < 0.05, **p < 0.01. Detailed implementation manners

[0031] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are some, rather than all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0032] Example 1

[0033] A traditional Chinese medicine composition for herpes zoster oticus, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Scorzonera austriaca, 8 parts of Cimicifuga foetida, 10 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 6 parts of Abutilon theophrasti, 7 parts of Aucklandia lappa, 10 parts of Chrysanthemum indicum, 14 parts of Houttuynia cordata, 7 parts of Cynanchum atratum, 7 parts of Ginger Peel.

[0034] The traditional Chinese medicine composition is prepared into a decoction, one dose per day, taken orally in two divided doses, and 14 days is a course of treatment.

[0035] The traditional Chinese medicine composition is prepared into an external plaster, and the plaster is externally applied to the affected area of the auricular skin, about 0.1 mm thick, covered with a sterile gauze for 4 - 6 hours and then removed, once a day, and 7 days is a course of treatment.

[0036] Example 2

[0037] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 9 parts of Scorzonera austriaca, 3 parts of Cimicifuga foetida, 5 parts of Cortex Fraxini, 4 parts of Arisaema heterophyllum, 3 parts of Abutilon theophrasti, 5 parts of Aucklandia lappa, 9 parts of Chrysanthemum indicum, 10 parts of Houttuynia cordata, 5 parts of Cynanchum atratum, 5 parts of Ginger Peel.

[0038] Example 3

[0039] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Scorzonera austriaca, 15 parts of Cimicifuga foetida, 15 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 9 parts of Abutilon theophrasti, 10 parts of Aucklandia lappa, 15 parts of Chrysanthemum indicum, 20 parts of Houttuynia cordata, 9 parts of Cynanchum atratum, 10 parts of Ginger Peel.

[0040] Example 4

[0041] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Scorzonera austriaca, 6 parts of Cimicifuga foetida, 7 parts of Cortex Fraxini, 4 parts of Arisaema heterophyllum, 4 parts of Abutilon theophrasti, 6 parts of Aucklandia lappa, 12 parts of Chrysanthemum indicum, 16 parts of Houttuynia cordata, 6 parts of Cynanchum atratum, and 6 parts of Ginger Peel.

[0042] Example 5

[0043] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 14 parts of Scorzonera austriaca, 10 parts of Cimicifuga foetida, 6 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 5 parts of Abutilon theophrasti, 8 parts of Aucklandia lappa, 11 parts of Chrysanthemum indicum, 18 parts of Houttuynia cordata, 8 parts of Cynanchum atratum, and 9 parts of Ginger Peel.

[0044] Example 6

[0045] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 11 parts of Scorzonera austriaca, 5 parts of Cimicifuga foetida, 11 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 6 parts of Abutilon theophrasti, 9 parts of Aucklandia lappa, 14 parts of Chrysanthemum indicum, 14 parts of Houttuynia cordata, 5 parts of Cynanchum atratum, and 8 parts of Ginger Peel.

[0046] Example 7

[0047] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 13 parts of Scorzonera austriaca, 11 parts of Cimicifuga foetida, 8 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 3 - 9 parts of Abutilon theophrasti, 7 parts of Aucklandia lappa, 13 parts of Chrysanthemum indicum, 12 parts of Houttuynia cordata, 7 parts of Cynanchum atratum, and 6 parts of Ginger Peel.

[0048] Test Example 1

[0049] 1 Materials and Methods

[0050] 1.1 Test Animals

[0051] SPF (Specific Pathogen Free) - level male SD (Sprague Dawley) rats, 7 - week - old, with a body weight of 250 - 300 g, were purchased from the Experimental Animal Center of the Basic Medical College of Zhengzhou University, license number: SYXK(Yu)2021 - 0011. The rats were housed in a room with a temperature of 22°C, a humidity of 50%, and an environmental noise less than 40 dB.

[0052] 1.2 Test Drugs

[0053] Traditional Chinese Medicine Stock Solution 1: 12 parts of Scorzonera austriaca, 8 parts of Cimicifuga foetida, 10 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 6 parts of Abutilon theophrasti, 7 parts of Aucklandia lappa, 10 parts of Chrysanthemum indicum, 14 parts of Houttuynia cordata, 7 parts of Cynanchum atratum, and 7 parts of Ginger Peel.

[0054] Chinese medicine stock solution 2: 8 parts of Cimicifuga foetida, 10 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 7 parts of Aucklandia lappa, 10 parts of Chrysanthemum indicum, 14 parts of Houttuynia cordata, 7 parts of ginger peel.

[0055] Chinese medicine stock solution 3: 12 parts of Scorzonera austriaca, 10 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 6 parts of Abutilon theophrasti, 14 parts of Houttuynia cordata, 7 parts of Cynanchum atratum, 7 parts of ginger peel.

[0056] Chinese medicine stock solution 4: 12 parts of Scorzonera austriaca, 8 parts of Cimicifuga foetida, 5 parts of Arisaema heterophyllum, 6 parts of Abutilon theophrasti, 7 parts of Aucklandia lappa, 10 parts of Chrysanthemum indicum, 14 parts of Houttuynia cordata, 7 parts of Cynanchum atratum.

[0057] Chinese medicine stock solution 5: 12 parts of Scorzonera austriaca, 8 parts of Cimicifuga foetida, 10 parts of Cortex Fraxini, 6 parts of Abutilon theophrasti, 7 parts of Aucklandia lappa, 10 parts of Chrysanthemum indicum, 7 parts of Cynanchum atratum, 7 parts of ginger peel.

[0058] Positive control drug: Pregabalin capsules

[0059] For Chinese medicine stock solutions 1 - 5, weigh each raw material according to the above weight parts, wash, dry, add 10 times (m / V) of distilled water, soak for 30 min, decoct for 1 h to obtain a filtrate, add 8 times the amount of distilled water again and decoct for 1 h, combine the filtrates, concentrate the filtrates to 1 g of the original drug per milliliter of solution to obtain Chinese medicine stock solutions with different formulations, sterilize, and store at 4 °C for later use.

[0060] 1.3 Animal model establishment and grouped drug administration

[0061] 1.3.1 Preparation of virus inoculum

[0062] Prepare African green monkey kidney fibroblasts (CV - 1), count and inoculate into culture flasks (concentration: 5×10 4 cells / cm 2 ), then infect with varicella - zoster virus (VZV). When 80% of CV - 1 cells are infected, wash with PBS, resuspend, and finally the concentration is about 12×10 6 cells / 100 μL to obtain the virus inoculum.

[0063] 1.3.2 Preparation of animal model

[0064] Inject the virus inoculum prepared in 1.3.1 into the left toe web of rats at a dose of 50 μL per rat. An abnormal mechanical pain sensitivity threshold 3 days later indicates successful model establishment. Inject 50 μL of normal saline into the left toe web of non - modeled rats.

[0065] 1.3.3 Animal grouping and drug administration

[0066] Ten non-modeled rats were selected as the blank control group; seventy successfully modeled rats were randomly divided into seven groups of ten rats each, namely the model group, experimental groups 1 - 6, and the positive control group. The administration methods and dosages for each group are shown in Table 1.

[0067] Table 1 Administration methods and dosages for each group

[0068]

[0069] 1.4 Detection indicators

[0070] 1.4.1 Detection of mechanical pain threshold (PWT)

[0071] One day, seven days, and fourteen days after administration, the PWT of the right hind limb of rats was measured using a Von Frey Filament tactile analgesimeter. Record the stimulation intensity when the rats showed foot lifting, foot licking, or avoidance behaviors. Each rat was measured 5 times, and the average value of the 3 measurements after removing the maximum and minimum values was taken as the PWT.

[0072] 1.4.2 Determination of serum IL-2, IL-6, and TNF-α

[0073] After the last administration and measurement of PWT, the rats were decapitated to collect blood, centrifuged at 3000 r / min for 15 min, and the contents of IL-2, IL-6, and TNF-α were measured using ELISA according to the kit instructions.

[0074] 1.5 Statistical analysis

[0075] SPSS 17.0 software was used for statistical analysis, and the results were expressed as mean ± standard deviation (Mean ± SD). Graphpad Prism 8.0 software was used for data statistical analysis and graphing. One-way ANOVA was used for comparison of differences between groups, and p < 0.05 was considered statistically significant.

[0076] 2 Results

[0077] 2.1 Comparison of mechanical pain thresholds of rats in each group

[0078] The results of the mechanical pain thresholds of rats in each group are as Figure 1 shown. Compared with the blank control group, the PWT in the model group was significantly decreased during the experiment (p < 0.01); compared with the model group, there were no significant differences in the PWT values of each group in the positive control group and experimental groups 1 - 5 on the 1st day after administration (p > 0.05); on the 7th and 14th days after administration, the PWT values of the positive control group and experimental groups 1 - 5 were significantly higher than those in the model group (p < 0.05 or p < 0.01); among them, the increase in the PWT value of experimental group 1 was the largest, significantly higher than that of experimental groups 2 - 5, and slightly higher than that of the positive control group.

[0079] 2.2 Serum IL-2, IL-6, and TNF-α levels in each group of rats

[0080] The results of serum IL-2, IL-6, and TNF-α levels in each group of rats are as Figures 2 - 4 shown.

[0081] As Figure 2 can be seen, the serum IL-2 level in the model group was significantly lower than that in the blank group (p < 0.01); the serum IL-2 levels in the positive control group and experimental groups 1-5 were significantly higher than that in the model group (p < 0.05 or p < 0.01); among them, the increase in serum IL-2 level in experimental group 1 was the largest, significantly higher than that in experimental groups 2-5, and slightly higher than that in the positive control group.

[0082] As Figure 3 can be seen, the serum IL-6 level in the model group was significantly higher than that in the blank group (p < 0.01); the serum IL-2 levels in the positive control group and experimental group 1 were significantly lower than that in the model group (p < 0.05); the serum IL-6 values in experimental groups 2-5 were lower than that in the model group, but the difference was not significant (p > 0.05).

[0083] As Figure 4 can be seen, the serum TNF-α level in the model group was significantly higher than that in the blank group (p < 0.01); the serum TNF-α levels in the positive control group and experimental groups 1-5 were significantly lower than that in the model group (p < 0.05 or p < 0.01); among them, the decrease in serum TNF-α level in experimental group 1 was the largest, significantly lower than that in experimental groups 2-5, and slightly lower than that in the positive control group.

[0084] 3 Conclusion

[0085] According to the above experimental results, it can be seen that rats with postherpetic neuralgia model have severe hyperalgesia. After different drug treatments, the PWT values of each group of model rats increased significantly to varying degrees. Among them, the increase in PWT value in experimental group 1 (the traditional Chinese medicine composition of the present invention, traditional Chinese medicine stock solution 1) was the largest, significantly higher than that of other traditional Chinese medicine compositions (lacking some herbs in the traditional Chinese medicine composition of the present invention, traditional Chinese medicine stock solutions 2-5), and slightly higher than that in the positive control group (pregabalin). This result indicates that the traditional Chinese medicine composition of the present invention has more advantages in improving the spontaneous pain behavior of rats with postherpetic neuralgia model.

[0086] Clinical studies have shown that the serum IL-2 level in patients with postherpetic neuralgia is lower than that in healthy people, while the serum IL-6 and TNF-α levels are significantly increased. The decrease in IL-2 reduces the body's immunity and antiviral ability, accelerating the replication of the virus in the ganglia of the posterior roots of the spinal cord, thus leading to postherpetic neuralgia. High levels of IL-6 and TNF-α may cause nervous system damage and stimulate inflammatory cells to produce inflammatory mediators, resulting in pain. According to the above test results, the traditional Chinese medicine composition of the present invention can significantly increase the serum IL-2 level and decrease the serum IL-6 and TNF-α levels in rats with postherpetic neuralgia model compared with other traditional Chinese medicine compositions, and has a significant therapeutic effect on postherpetic neuralgia. The components in the traditional Chinese medicine composition of the present invention interact with each other and have a synergistic effect. The traditional Chinese medicine composition lacking some of these medicinal materials cannot achieve a good effect in improving the spontaneous pain behavior of rats with postherpetic neuralgia model and in improving the levels of serum IL-2, IL-6, and TNF-α. The traditional Chinese medicine composition of the present invention is obtained by applying the principle of dialectical treatment of traditional Chinese medicine and reasonable compatibility, and each medicinal material is indispensable.

[0087] Experimental Example 2

[0088] 1 Materials and Methods

[0089] 1.1 General Information

[0090] A total of 76 patients with Ramsay Hunt syndrome admitted to the 988th Hospital of the Joint Logistics Support Force from January 2021 to June 2023 were selected as the research objects and randomly divided into a control group and an observation group, with 38 cases in each group. Among them, there were 20 males and 18 females in the control group, aged 35 - 65 years, with an average age of (49.79 ± 14.77) years; there were 22 males and 16 females in the observation group, aged 32 - 65 years, with an average age of (47.62 ± 11.64) years; there was no significant difference in the general information between the two groups (p > 0.05).

[0091] 1.2 Treatment Methods

[0092] Control Group: Acyclovir ointment [Jiangsu Yongda Pharmaceutical Co., Ltd., National Medicine Approval No. H19993851, Specification: 10 g, 300 mg (3%)] was externally applied to the affected area of the control group, applied to the affected area with a thickness of about 0.1 mm, 5 times a day. The treatment was continued for 10 days.

[0093] Observation Group: The decoction of the traditional Chinese medicine composition described in Example 1 was taken orally, one dose per day, divided into two oral administrations; the external ointment of the traditional Chinese medicine composition described in Example 1 was externally applied to the affected area of the auricular skin, the ointment was applied with a thickness of about 0.1 mm, removed after being covered with sterile gauze for 4 - 6 h, once a day; the administration was continued for 14 days.

[0094] 1.3 Efficacy Judgment Criteria

[0095] Recovery: All the scabs of herpes zoster oticus have fallen off, the pain symptoms have completely disappeared, the tinnitus symptoms have basically disappeared, the patient's hearing has increased by more than 15 decibels, the vertigo has been effectively controlled, and there has been no recurrence. Within one month after treatment, the facial nerve function of the patient has basically returned to normal, and the score reaches Grade 1-2;

[0096] Effective: The scabs of herpes zoster oticus have significantly fallen off, and the improvement of scab shedding has reached more than 30.0%. The pain symptoms have been significantly relieved, the tinnitus symptoms have been significantly relieved, the patient's hearing has increased by more than 10 decibels, the vertigo has been improved and controlled to a certain extent, and recurrence is less likely to occur. Within one month after treatment, the facial nerve function of the patient has improved significantly, and the score reaches Grade 3;

[0097] Ineffective: The scabs of herpes zoster oticus have not fallen off, the pain symptoms have not improved, the tinnitus symptoms have not improved, the patient's hearing has increased by less than 10 decibels, the vertigo has not been improved and effectively controlled, recurrence often occurs, and there is no sign of improvement in the facial nerve function of the patient within 1 month after treatment.

[0098] 1.4 Data statistics and processing

[0099] SPSS 17.0 software was used for statistical analysis. Measurement data were expressed as mean ± standard deviation (Mean ± SD), and count data were expressed as percentages (%). Graphpad Prism 8.0 software was used for data statistical analysis and graphing. The x 2 test was used, and p < 0.05 was considered statistically significant.

[0100] 2 Results

[0101] 2.1 Comparison of the curative effects of the two groups

[0102] The curative effects of the two groups are shown in Table 2. The total effective rate of the treatment group was 92.11%, and the total effective rate of the control group was 78.95%.

[0103] Table 2 Curative effects of the two groups [n(%)]

[0104] Group Quantity Cured Effective Ineffective Total effective rate Treatment group 38 29 6 3 92.11 Control group 38 20 10 8 78.95

[0105] 2.2 Comparison of the disappearance time of clinical symptoms between the two groups

[0106] The results are shown in Table 3. The disappearance time of clinical symptoms such as herpes, pain, mild facial paralysis, and combined tinnitus in the treatment group was significantly lower than that in the control group, with a significant or extremely significant difference (*p < 0.05 or **p < 0.01).

[0107] Table 3 Disappearance time of clinical symptoms in the two groups (d)

[0108] Group Time for herpes disappearance Time for pain disappearance Time for mild facial paralysis disappearance Time for associated tinnitus disappearance Treatment group 8.13±3.17** 3.26±1.67* 27.10±5.01** 9.12±4.45* Control group 13.02±4.98 4.87±2.45 33.56±7.37 11.28±4.37

[0109] Note: Compared with the control group, *p < 0.05, **p < 0.01.

[0110] 3 Conclusions

[0111] Compared with Western medicine, the traditional Chinese medicine composition of the present invention has a significant therapeutic effect on herpes zoster oticus, significantly improves the total effective rate, can quickly relieve the clinical symptoms of patients, shorten the recovery time of patients, and relieve the pain of patients.

[0112] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for herpes zoster oticus, characterized in that, The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 9-15 parts of Scorzonera austriaca, 3-15 parts of Cimicifuga foetida, 5-15 parts of Cortex Fraxini, 4-5 parts of Arisaema heterophyllum, 3-9 parts of Abutilon theophrasti, 5-10 parts of Aucklandia lappa, 9-15 parts of Chrysanthemum indicum, 10-20 parts of Houttuynia cordata, 5-9 parts of Cynanchum atratum, 5-10 parts of Ginger Peel.

2. The traditional Chinese medicine composition for herpes zoster oticus according to claim 1, wherein The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Scorzonera austriaca, 8 parts of Cimicifuga foetida, 10 parts of Cortex Fraxini, 5 parts of Arisaema heterophyllum, 6 parts of Abutilon theophrasti, 7 parts of Aucklandia lappa, 10 parts of Chrysanthemum indicum, 14 parts of Houttuynia cordata, 7 parts of Cynanchum atratum, 7 parts of Ginger Peel.

3. The traditional Chinese medicine composition according to any one of claims 1-2 is used for preparing a drug for preventing and treating Ramsay Hunt syndrome, and the traditional Chinese medicine composition is prepared into an orally acceptable dosage form and / or an external dosage form for human body.

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