Traditional Chinese medicine composition for treating herpes zoster and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating herpes zoster. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of realgar, 1-3 parts of centipede, 6-10 parts of indigo naturalis and 3-6 parts of dried alum. The invention also discloses a preparation method of the traditional Chinese medicine composition for treating herpes zoster. The method comprises the following steps: pretreating the raw materials; grinding and mixing raw materials; and preparing the traditional Chinese medicine composition. The traditional Chinese medicine composition can effectively treat herpes zoster, reduce postherpetic neuralgia and improve the life quality of a patient through reasonable medicine compatibility according to the symptoms of herpes zoster, materials are convenient to take, and the preparation method is simple and easy to implement; the traditional Chinese medicine belongs to an external treatment method, is prepared into paste by adding table vinegar during use, is externally applied to an affected part, is convenient to use and has high patient compliance.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine prescription, in particular, to a traditional Chinese medicine composition for treating herpes zoster and a preparation method thereof. BACKGROUND

[0002] Herpes zoster is a viral skin disease caused by varicella-zoster virus, which is characterized by severe neuralgia. The skin lesions are clustered vesicles arranged in strips along the nerves, which not only seriously affects the skin health of patients, but also brings great physical and mental suffering and heavy economic burden to patients due to the severe pain and high incidence of postherpetic neuralgia (PHN). From the perspective of Western medicine, herpes zoster and chickenpox are caused by the same virus, i.e. varicella-zoster virus. At the early stage of the disease, red maculopapular rash appears on the skin of patients, most of which are accompanied by obvious local pain, and a few of which are accompanied by itching. Subsequently, millet to soybean size clustered vesicles are formed. The first choice of Western medicine treatment is oral antiviral drugs such as acyclovir and valacyclovir, or external preparations such as acyclovir ointment and penciclovir cream. However, these drugs can only shorten the course of the disease and the time of skin lesion regression to a certain extent, and have obvious limitations: on the one hand, they have large side effects and may cause abnormal liver and kidney function after use; on the other hand, they are completely ineffective for postherpetic neuralgia, and the efficacy of simple external use of Western medicine is even worse. More importantly, under the action of various inducing factors, the latent virus is easily activated, causing inflammation and necrosis of the ganglion, and then producing neuralgia. However, there is no specific Western medicine that can completely kill the virus. In traditional Chinese medicine, herpes zoster is called shesengsuan, and also has other names such as huobangsuan, shedan, zhuanyao huodan and zhuisongsuan. Traditional Chinese medicine believes that the pathogenesis of this disease is related to many factors: or due to emotional internal injury causing liver qi stagnation, which can cause fire over time, and fire toxin of liver meridian accumulating in the skin; or due to spleen deficiency and failure to transport, internal accumulation of damp heat, long-term stagnation of toxic, and re-sensing of toxic; or due to old age, blood deficiency, liver hyperactivity, dampness and heat accumulation, qi stagnation and blood stasis, and pain due to obstruction. Based on this, traditional Chinese medicine divides this disease into heat type, dampness type and qi stagnation and blood stasis type, and the main principles of treatment are clearing heat and removing dampness, promoting qi and relieving pain, and promoting blood circulation to remove blood stasis. Traditional Chinese medicine composition external medicine is an important means for treating herpes zoster. In the prior art, western medicine external medicine such as acyclovir ointment, penciclovir cream and the like has poor clinical curative effect, and patients are prone to have postherpetic neuralgia, and some patients have allergic reactions, causing local itching and other adverse reactions, increasing the psychological obstacles and economic pressure of patients. Traditional Chinese medicine has unique advantages in treating herpes zoster, especially traditional Chinese medicine external treatment method, but at present, some external medicine (such as Chinese patent: CN201210036556.7 A kind of traditional Chinese medicine composition for treating herpes zoster) has problems such as complex prescription, inconvenient material selection, and economic inappropriateness, and it is difficult to meet the clinical needs.

[0003] Therefore, it is of great significance to develop a traditional Chinese medicine composition with reasonable prescription, convenient material selection, economic applicability and significant curative effect for effectively treating herpes zoster, reducing postherpetic neuralgia and improving the quality of life of patients. SUMMARY

[0004] In order to solve the technical problems existing in the prior art, the present application provides a traditional Chinese medicine composition for treating herpes zoster and a preparation method thereof. The traditional Chinese medicine composition can effectively treat herpes zoster, reduce postherpetic neuralgia and improve the quality of life of patients, and has reasonable prescription, convenient material selection and simple and easy-to-operate preparation method.

[0005] The present application provides a traditional Chinese medicine composition for treating herpes zoster, which is composed of the following raw materials in parts by weight: realgar 10-20 parts, centipede 1.5-3 parts, indigo 6-10 parts and vitriol 3-6 parts.

[0006] In a preferred embodiment of the traditional Chinese medicine composition for treating herpes zoster provided by the present application, the weight parts of the raw materials are: realgar 12 parts, centipede 2 parts, indigo 8 parts and vitriol 5 parts.

[0007] In a preferred embodiment of the traditional Chinese medicine composition for treating herpes zoster provided by the present application, the traditional Chinese medicine composition is a traditional Chinese medicine external medicine, which is used by adding vinegar to form a paste.

[0008] The present application also provides a preparation method of the traditional Chinese medicine composition for treating herpes zoster, which comprises the following steps: (selecting, drying, crushing, mixing and processing the medicine) Step one, raw material selection: realgar, centipede, indigo and vitriol meeting the standards of pharmacopoeia are selected respectively, wherein the centipede needs to remove the head and foot impurities, and it is ensured that each raw material is free of mildew, insect damage and peculiar smell; Step two, drying treatment: the selected realgar, indigo and vitriol are placed in a constant temperature drying oven and dried at 60-80℃ for 2-3 hours until the water content is ≤5%; the centipede is dried at 40-50℃ for 4-6 hours by low temperature drying method to avoid damage to its effective components by high temperature, and then cooled to room temperature after drying; Step three, crushing treatment: the dried realgar, indigo, and vitriol are respectively put into a traditional Chinese medicine crusher and crushed to 120-150 mesh fine powder; the centipede is separately crushed, first cut into 1-2 cm small pieces, and then put into the crusher and crushed to 80-100 mesh fine powder, and sieved and reserved; Step four, mixing treatment: the crushed realgar powder, centipede powder, indigo powder, and vitriol powder are placed in a three-dimensional mixer according to the weight ratio of claim 1 or 2, mixed for 15-20 minutes, and uniformly mixed to obtain mixed medicine powder; Step five, processing: when used, the mixed medicine powder is taken according to the proportion, food vinegar is added according to the weight ratio of 1:1.5-2, stirred to form a uniform paste, and a traditional Chinese medicine preparation directly used externally is obtained.

[0009] In the preferred embodiment of the preparation method of the traditional Chinese medicine composition for treating herpes zoster provided by the application, the realgar in the crushing process in step three needs to be treated with explosion-proof equipment to avoid safety hazards caused by its intense friction with metal.

[0010] In the preferred embodiment of the preparation method of the traditional Chinese medicine composition for treating herpes zoster provided by the application, the raw materials in step four need to be accurately weighed to ensure the exertion of the drug efficacy, i.e., the weight parts of the raw materials are as follows: realgar 12 parts, centipede 2 parts, indigo 8 parts, and vitriol 5 parts.

[0011] In the preferred embodiment of the preparation method of the traditional Chinese medicine composition for treating herpes zoster provided by the application, the mixed medicine powder in step four should be sealed and stored in a cool and dry place.

[0012] In the preferred embodiment of the preparation method of the traditional Chinese medicine composition for treating herpes zoster provided by the application, the food vinegar in step five is food-grade brewed food vinegar with a total acid content of ≥3.5 g / 100 mL.

[0013] Compared with the prior art, the application has the following beneficial effects: (1) Significant efficacy and strong targeting: The traditional Chinese medicine composition in the application is based on the understanding of the etiology and pathogenesis of herpes zoster (snake string sores) in traditional Chinese medicine, and realgar is used for detoxification and insect killing, indigo is used for clearing heat and detoxification, centipede is used for dredging collaterals and relieving pain, and vitriol is used for drying dampness and astringency. The four drugs are precisely matched, and the effects of clearing heat and removing dampness, detoxification and pain relief, and astringency and skin regeneration are achieved together. The traditional Chinese medicine composition can effectively relieve symptoms such as redness, blisters, and pain caused by herpes zoster, and is particularly outstanding in reducing neuralgia and reducing the incidence of postherpetic neuralgia, thereby significantly improving the quality of life of patients.

[0014] (2) The composition is reasonable and has high safety: the composition of the application is simple and only consists of four traditional Chinese medicines, the raw materials of which are widely available and convenient to obtain. The medicine is administered externally, avoiding potential damage to liver and kidney functions and reducing the risk of systemic adverse reactions. In addition, the medicine is reasonably matched in the prescription, reducing the influence of irritating components while ensuring efficacy, and improving patient tolerance.

[0015] (3) The preparation method is simple and easy to promote: the preparation method of the application has clear steps and does not require complex equipment or special processes. The method can be completed by conventional Chinese medicine processing methods such as screening, drying, crushing and mixing, and is suitable for large-scale production and use in primary medical institutions and at home. In addition, the mixed powder is convenient to store and transport, and only needs to be mixed with vinegar before use, which is simple to operate and has good patient compliance.

[0016] (4) Economical and practical, wide applicability: the raw materials used in the application have low cost, and the preparation and use cost is significantly lower than that of some existing western medicine preparations and complex traditional Chinese medicine prescriptions, which can reduce the economic burden of patients. In addition, the composition is suitable for a wide range of people and has high clinical application value and promotion prospect. DETAILED DESCRIPTION

[0017] The technical solutions in the embodiments of the application will be described below in a clear and complete manner. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of the application.

[0018] Example 1: Preparation of the traditional Chinese medicine composition 1) Action principle of the traditional Chinese medicine composition: 1 / Analysis of medicinal ingredients: compatibility based on the nature and taste of herpes zoster pathogenesis The composition is aimed at the core pathogenesis of herpes zoster (snake string sores) "dampness-heat and toxin accumulation, qi stagnation and blood stasis", and the four medicinal ingredients achieve precise targeted treatment through complementary nature and taste: The compatibility of the four medicinal ingredients not only clears heat and dries dampness to eliminate evil, but also unblocks collaterals and relieves pain to treat symptoms, and takes into account detoxification and astringency, which is in line with the pathogenesis characteristics of herpes zoster "heat, dampness, toxin and stasis". Realgar: pungent, warm, toxic, belongs to liver and large intestine channels, has the effects of detoxifying and killing insects, drying dampness and eliminating phlegm, and its "toxic attack on toxin" feature can directly attack the symptoms of virus accumulation, and target redness and blisters caused by excessive heat and toxin; Indigo: salty, cold, belongs to liver and lung channels, can clear heat and detoxify, cool blood and remove spots, can clear liver fire toxin, and relieve skin burning pain caused by blood heat running wildly, and take into account dampness and toxin stagnation; Centipede: pungent, warm, toxic, liver meridian, good for dredging collaterals and relieving pain, attacking toxins and resolving masses, its wandering nature can dredge the blocked meridians, and is especially suitable for severe pain caused by qi stagnation and blood stasis. Glauber's salt: sour, astringent, cold, lungs, spleen, liver, large intestine meridian, can dry dampness, astringe, stop bleeding and detoxify, can astringe exudate, promote blister dryness and scabbing, prevent the spread of dampness and toxins, and take into account the basis of spleen deficiency and dampness.

[0019] 2 / Group structure: hierarchical division based on the principle of "monarch-minister-assistant-minor" a. Monarch: realgar, indigo Realgar is the core of detoxification and insect killing, directly attacking the root of virus accumulation; indigo is the key to clearing heat and cooling blood, clearing liver fire toxins, both of which target the core pathogenesis of "heat and toxin accumulation in the skin", and together play the role of clearing heat and resolving toxins, attacking toxins and resolving masses.

[0020] b. Minister: centipede Centipede is pungent and warm, and can dredge collaterals and relieve pain, assisting the monarch in dredging qi and blood stagnation, enhancing the analgesic effect, and targeting the symptoms of neuralgia of herpes zoster, solving the key pathological link of "qi stagnation and blood stasis".

[0021] c. Assistant: Glauber's salt Glauber's salt has the nature of astringing and astringing, which can dry dampness and astringe sores, astringe blister exudate, prevent the spread of dampness and toxins, and at the same time moderate the harshness of the monarch and minister, avoiding excessive attack and damage to the skin.

[0022] d. Minor: vinegar Vinegar, as a harmonizing agent (external use of the medium), is sour and bitter, warm, can lead the medicine into the meridian, enhance the penetration of the medicine, and help the medicine reach the diseased area, while adjusting the nature of the medicine, making the paste easy to adhere to the skin.

[0023] 3 / Compatibility characteristics and innovation points a. Precise targeting of pathogenesis, multi-target synergistic effect This traditional Chinese medicine composition closely follows the core pathogenesis of herpes zoster "dampness and heat toxin accumulation, qi stagnation and blood stasis", achieving multi-level, multi-target treatment synergy. The monarch realgar and indigo are combined, the former directly attacks the virus accumulation with "toxin attacking toxin", and the latter clears heat and cools blood to calm liver fire toxins, together to curb the core pathological link of "heat and toxin"; the minister centipede dredges collaterals and relieves pain, precisely solving the neuralgia caused by "qi stagnation and blood stasis"; the assistant Glauber's salt dries dampness and astringes, targeting the blister exudate caused by "dampness and toxin", the four drugs have clear division of labor and mutual cooperation, forming a complete treatment system of "clearing, resolving, dredging, and astringing", covering the key pathogenesis of disease development.

[0024] b. Mutual complementation of nature and taste, both reducing toxicity and increasing efficacy The medicinal properties and flavors of the formula combine cold and hot properties, combining both firmness and softness, ensuring efficacy while minimizing toxic side effects. Realgar is pungent, warm, and toxic, while Indigo is salty, cold, and heat-clearing. The two counterbalance each other, preventing the overpowering properties of either herb. Scolopendra is pungent and warm, dispersing, while Alum is sour, astringent, and cold. This dispersing and astringent combination enhances the effects of dredging meridians, alleviating pain, and drying dampness and healing sores, while also mitigating the harshness of Scolopendra and the toxicity of Realgar. This complementary combination of properties and flavors enhances the heat-clearing, detoxifying, analgesic, and astringent properties while reducing skin irritation and improving safety.

[0025] c. External targeted drug delivery, directly reaching the diseased area to take effect This Chinese medicine composition is administered externally by applying a vinegar paste to the affected skin, allowing the medicinal ingredients to directly act on the affected skin and surrounding meridians. This prevents the burden on liver and kidney function associated with oral medication absorption through the gastrointestinal tract. Furthermore, the vinegar's guiding effect promotes drug penetration through the skin barrier, allowing it to quickly reach the virus-infected ganglia and diseased tissue, increasing local drug concentration and achieving targeted treatment, delivering a more direct and rapid onset of action.

[0026] Innovation: (1) The formula is streamlined and efficient, breaking through the limitations of traditional complex prescriptions: Compared to some existing traditional Chinese medicine external-use prescriptions for treating herpes zoster, which are complex in formulation and require a wide variety of medicinal ingredients, this combination uses only four herbs, yet achieves comprehensive efficacy. By precisely selecting the four core herbs—realgar, centipede, indigo, and alum—and eliminating redundant ingredients, this combination not only ensures the synergistic effects of each herb, but also simplifies the preparation process, reduces the cost of medicinal materials, and facilitates standardized production and clinical application, resolving the pain points of traditional traditional Chinese medicine external-use prescriptions: complex formulations, inconvenient material sourcing, and poor economic efficiency. (2) Based on classical theory, innovate and optimize the compatibility structure: Based on the classic TCM theory of "monarch-minister-assistant-envoy" compatibility, this combination innovatively optimizes the traditional formula. Breaking away from the single monarch-dominant model, it employs both realgar and indigo as monarchs, creating a dual core of "detoxification and heat-clearing," more in line with the pathogenesis of herpes zoster, characterized by both heat and toxicity. Vinegar, an external medium, is explicitly included as an "envoy," not only harmonizing the medicinal properties and enhancing adhesion, but also leveraging its sour and bitter properties to guide the drug into the meridians and improve its penetration efficiency. This fusion of traditional compatibility theory with modern topical drug delivery requirements enhances the scientific and practical nature of the prescription. (3) Taking into account both rapid and long-term effects to reduce the risk of postherpetic neuralgia: The existing western medicine and some traditional Chinese medicine prescriptions for external use are mostly focused on relieving the symptoms of skin lesions, and the improvement effect on neuralgia and residual neuralgia is limited. The composition innovatively includes "analgesia" and "prevention of residual" into the core treatment goal, quickly relieves acute neuralgia through the collateral-dredging analgesic effect of centipede, at the same time, inhibits virus replication with the sustained detoxification effect of realgar and indigo, promotes skin lesion healing with the astringent effect of mirabilite, reduces the risk of residual neuralgia from the source by reducing the inflammatory necrosis of the ganglion. (4) Safety design innovation, balance efficacy and risk: In view of the toxicity of realgar and centipede, the composition realizes safety control through multi-dimensional design. First, the dosage of medicinal materials is strictly controlled, and the best ratio is determined within the effective range of clinical verification to avoid excessive toxic components; second, the external administration is adopted to reduce the dose of systemic absorption of drugs and reduce the risk of systemic toxicity; third, the toxicity and irritability of monarch and ministerial drugs are alleviated through the auxiliary effect of mirabilite, and the processing technology is standardized in the preparation process (such as low-temperature drying of centipede and explosion-proof crushing of realgar) to ensure the stability of drug components. Only one case of mild local itching occurred in clinical application, without serious adverse reactions, which embodies the innovative design concept of "efficacy priority and safety control".

[0027] 2) Preparation process of traditional Chinese medicine composition: Step one, raw material selection: realgar, centipede, indigo and mirabilite meeting the standards of Chinese Pharmacopoeia are selected, among which the head and foot impurities of centipede are removed to ensure that each raw material is free of mildew, insect damage and peculiar smell; Specifically, the medicinal materials meeting the standards of Chinese Pharmacopoeia are selected, realgar is selected from natural sulfide mineral realgar family realgar, mainly containing arsenic disulfide; the dry body of Eremocentrus is selected for centipede, and the head, foot and impurities are removed; indigo is selected from the leaves or stems and leaves of the plants of the genus Indigofera, the family Polygonaceae or the family Cruciferae, which are processed into dry powder; mirabilite is selected from the dry product of alum after calcination. All medicinal materials are free of mildew, insect damage and peculiar smell.

[0028] Step two, drying treatment: realgar, indigo and mirabilite after screening are placed in a constant temperature drying oven, dried at 60-80℃ for 2-3 hours until the water content is ≤5%; centipede is dried at 40-50℃ for 4-6 hours by low-temperature drying method to avoid damage to its effective components, and then cooled to room temperature; Specifically, realgar, indigo and mirabilite are placed in a constant temperature drying oven, the temperature is set to 70℃, and they are dried for 2.5 hours. The water content is detected to be 4.2% (≤5%); Centipede is dried by low-temperature drying method, the temperature is set to 45℃, and it is dried for 5 hours. After cooling to room temperature, it is ready for use.

[0029] Step three, crushing treatment: the dried realgar, indigo, and vitriol are respectively put into a traditional Chinese medicine crusher, and are crushed to 120-150 mesh fine powder; the centipede is separately crushed, is cut into 1-2cm small pieces first, and then is put into a crusher and is crushed to 80-100 mesh fine powder, and is reserved after sieving; Specifically, the realgar is crushed by using an explosion-proof crusher, and is passed through a 150 mesh sieve to obtain realgar fine powder; the indigo and the vitriol are respectively crushed by using a traditional Chinese medicine crusher, and are passed through a 120 mesh sieve to obtain indigo powder and vitriol powder; the centipede is cut into 1.5cm small pieces, and is separately crushed by using a crusher, and is passed through a 100 mesh sieve to obtain centipede powder.

[0030] Step four, mixing treatment: the crushed realgar powder, the crushed centipede powder, the crushed indigo powder and the crushed vitriol powder are placed in a three-dimensional mixer according to the weight ratio of claim 1 or 2, and are mixed for 15-20 minutes to uniformly mix the components, so as to obtain mixed medicine powder. Specifically, the medicine powders are weighed according to the above weight ratio, are placed in a three-dimensional mixer, a rotating speed of 30r / min is set, and the mixed medicine powder is obtained after mixing for 18 minutes, and is sealed and stored in a cool and dry place (relative humidity ≤60%, temperature 15-25℃).

[0031] The raw materials are accurately weighed to ensure the play of the medicine effect, that is, the weight of the raw materials is: realgar 10-20g, centipede 1.5-3g, indigo 6-10g, and vitriol 3-6g.

[0032] The weight ratio of the three raw materials is preferably as follows: (1) realgar 10g, centipede 1.5g, indigo 6g, and vitriol 3g.

[0033] (2) realgar 12g, centipede 2g, indigo 8g, and vitriol 5g; the ratio is a preferable embodiment.

[0034] (3) realgar 20g, centipede 3g, indigo 10g, and vitriol 6g.

[0035] Step five, processing: when used, the mixed medicine powder is taken according to the proportion, food vinegar is added according to the weight ratio of 1:1.5-2, and is stirred until a uniform paste is formed, so as to obtain a traditional Chinese medicine preparation which can be directly used externally.

[0036] 3) The use method and matters needing attention of the traditional Chinese medicine composition: 1 / Use method: Take 27g of mixed medicinal powder and add 40.5mL of food-grade brewing vinegar with a total acid content of 4.0g / 100mL (weight ratio of medicinal powder to vinegar 1:1.5). Stir until a uniform paste is formed, and then use after standing for 5 minutes. After cleaning the affected skin, use a sterile cotton swab to apply the medicinal paste evenly to the skin lesions (including erythema, blisters, and painful areas) with a thickness of about 0.2cm. Apply 3 times a day, and remove any remaining medicinal paste before each application. A course of treatment is 7 days.

[0037] 2 / Precautions: a / This product is for external use only and must not be taken orally. It is contraindicated for pregnant women, infants, and individuals who are allergic to the ingredients of this product (realgar, centipede, vinegar, etc.). b / Before use, apply a small amount of the medicinal paste to the inside of the forearm and observe for 24 hours. If there is no redness, swelling, itching, or other allergic reactions, the product can be used. c / If there is a break in the skin lesions, stop using the product immediately and clean the affected area if severe pain occurs after applying the medicinal paste. d / Avoid eating spicy and greasy foods and scratching the affected area during the treatment period. e / Realgar contains arsenic, so the continuous use of the product should not exceed 2 courses of treatment. It must be used strictly according to the doctor's instructions. f / The product must be stored in a sealed container away from children and metal containers.

[0038] Example 2: Clinical effect of the traditional Chinese medicine composition 1) Clinical data Case selection: 80 patients diagnosed with herpes zoster from January 2024 to January 2025 were selected, all of whom met the "snake string sore" diagnostic criteria in "Diagnosis and Treatment Criteria for Traditional Chinese Medicine Syndromes", manifested as clustered blisters along the nerve distribution with obvious neuralgia, and the disease duration was ≤7 days without anti-viral treatment. Patients with severe liver and kidney dysfunction, pregnant women, those allergic to the test drug, and those with other serious skin diseases were excluded. Grouping method: Using the random number table method, the patients were divided into a treatment group and a control group, with 40 patients in each group. In the treatment group, there were 22 males and 18 females, aged 35-70 years, with an average age of (52.3±8.5) years, and a disease duration of (3.2±1.1) days. In the control group, there were 21 males and 19 females, aged 36-69 years, with an average age of (51.8±7.9) years, and a disease duration of (3.1±1.2) days. There was no statistically significant difference in the baseline data such as gender, age, and disease duration between the two groups (P>0.05), and they were comparable.

[0039] 2) Treatment method Treatment group: The traditional Chinese medicine composition of the present application was used according to the usage method of Example 1 to apply to the affected area, 3 times a day, and a course of treatment was 7 days. Two courses of continuous treatment were performed. Control group: external use of acyclovir ointment (specification 10g:0.3g), 4 times a day to apply to the affected area, 7 days for a course of treatment, continuous treatment for 2 courses.

[0040] 3) Therapeutic efficacy criteria Cure: complete regression of skin lesions, pain disappeared, no residual neuropathic pain; Marked effect: skin lesions regression ≥70%, pain significantly reduced (visual analog scale VAS score decreased ≥60%); Effective: skin lesions regression 30%-69%, pain reduced (VAS score decreased 30%-59%); Ineffective: skin lesions regression <30%, pain without significant improvement (VAS score decreased <30%) or aggravated, residual neuropathic pain. Observation index: record the time of stopping blister (water blister stopped new time), scabbing time (50% skin lesions scabbing time), pain relief time (VAS score decreased to 3 points or less time) and incidence of residual neuropathic pain (1 month follow-up after treatment).

[0041] 4) Clinical results Efficacy comparison: 28 cases were cured, 7 cases were markedly effective, 4 cases were effective, and 1 case was ineffective in the treatment group, with a total effective rate of 97.5%; 15 cases were cured, 9 cases were markedly effective, 8 cases were effective, and 8 cases were ineffective in the control group, with a total effective rate of 80.0%.

[0042] Symptom improvement time: the treatment group's blister stopping time was (2.1±0.5) days, scabbing time was (4.3±0.8) days, and pain relief time was (3.5±0.7) days; the control group's were (3.8±0.7) days, (6.5±1.1) days, and (5.9±1.0) days, respectively.

[0043]

[0044] Incidence of residual neuropathic pain: the treatment group was followed up for 1 month, and the incidence of residual neuropathic pain was 2.5% (1 / 40); the control group was 20.0% (8 / 40).

[0045]

[0046] 5) Safety evaluation There was 1 patient in the treatment group who had mild local itching, which was relieved after stopping the drug and did not affect treatment; 3 cases in the control group had local erythema and burning sensation, and the incidence of adverse reactions was slightly higher than that in the treatment group. Both groups had no abnormal liver and kidney function and no systemic adverse reactions.

[0047] 6) Clinical conclusion The clinical trial is carried out through the clinical control study of 80 herpes zoster patients, and the results show that the total effective rate of the traditional Chinese medicine composition (realgar 12g, centipede 2g, indigo 8g, and vitriol 5g) for treating herpes zoster reaches 97.5%, which is significantly higher than 80.0% of the control group of acyclovir ointment (P<0.05), and fully embodies the significant advantages of the traditional Chinese medicine composition in improving the clinical symptoms of herpes zoster. From the improvement speed of symptoms, the blister stopping time, scabbing time and pain stopping time of the treatment group are (2.1±0.5) days, (4.3±0.8) days and (3.5±0.7) days respectively, which are significantly shorter than (3.8±0.7) days, (6.5±1.1) days and (5.9±1.0) days of the control group (P<0.01), which shows that the traditional Chinese medicine composition can quickly inhibit the new blister, promote the healing of skin lesions, effectively relieve pain and shorten the course of disease. In the aspect of preventing postherpetic neuralgia, the incidence of postherpetic neuralgia of the treatment group followed up for 1 month is only 2.5%, which is far lower than 20.0% of the control group (P<0.05), which shows that the composition can not only improve the symptoms in the acute stage, but also reduce the risk of postherpetic neuralgia of herpes zoster, which has important significance for improving the long-term quality of life of patients. In the aspect of safety, only one case in the treatment group has local mild itching, the incidence of adverse reactions is low and the symptoms are mild, and the symptoms can be relieved after stopping the drug, and there is no systemic adverse reactions such as liver and kidney function abnormalities; although three cases in the control group have local discomfort, there is no serious safety problem in the whole. It can be seen that the traditional Chinese medicine composition of the application has high safety while ensuring significant efficacy. In summary, the traditional Chinese medicine composition for treating herpes zoster of the application can effectively play the roles of clearing heat and removing dampness, detoxifying and relieving pain, and astringing and promoting skin regeneration through scientific formula matching and standard preparation process, and has significant effects in rapidly improving the skin lesions and pain symptoms of herpes zoster and reducing the incidence of postherpetic neuralgia, and has good safety, simple preparation, convenient use, high clinical application value and promotion prospect.

[0048] Finally, it should be pointed out that: the above only describes the preferred embodiments of the application and is not used to limit the application, although the application has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions recorded in the foregoing embodiments or make equivalent replacement of some technical features, any modification, equivalent replacement, improvement, etc. within the spirit and principles of the application shall be included in the protection scope of the application.

Claims

1. A Chinese medicine composition for treating herpes zoster, characterized in that: The invention is composed of the following raw materials in parts by weight: 10-20 parts of realgar, 1.5-3 parts of centipede, 6-10 parts of indigo and 3-6 parts of alum.

2. The Chinese medicine composition for treating herpes zoster according to claim 1, wherein The weight parts of the raw materials are: 12 parts of realgar, 2 parts of centipede, 8 parts of indigo, and 5 parts of alum.

3. The Chinese medicine composition for treating herpes zoster according to claim 1, wherein The Chinese medicine composition is a Chinese medicine for external use, and vinegar is added to form a paste when used.

4. A method for preparing a traditional Chinese medicine composition for treating herpes zoster, characterized in that: The following steps are involved: (The drugs are screened, dried, crushed, mixed and processed) Step 1: Raw material screening: Select realgar, centipede, indigo, and alum that meet the pharmacopoeia standards. Remove impurities from the head and feet of the centipede to ensure that the raw materials are free of mold, insect damage, and odor. Step 2: Drying: Place the screened realgar, indigo, and alum in a constant temperature drying oven and dry them at 60-80°C for 2-3 hours until the moisture content is ≤5%. Use low-temperature drying for centipede, drying at 40-50°C for 4-6 hours to avoid high temperature damage to its active ingredients, and then cool to room temperature after drying. Step 3, grinding treatment: put the dried realgar, indigo, and alum into a traditional Chinese medicine grinder respectively, and grind them into 120-150 mesh fine powder; grind the centipede separately, cut it into 1-2 cm small pieces, and then put it into the grinder and grind it into 80-100 mesh fine powder, sieve it and set aside; Step 4, mixing: according to the weight ratio of claim 1 or 2, the crushed realgar powder, centipede powder, indigo powder, and alum powder are placed in a three-dimensional mixer and mixed for 15-20 minutes to uniformly mix the components to obtain a mixed powder; Step 5, preparation and processing: when using, take the above mixed powder according to the proportion, add vinegar according to the weight ratio of powder to vinegar 1:1.5-2, stir until a uniform paste is formed, and the traditional Chinese medicine preparation that can be directly used externally is obtained.

5. The method for preparing the Chinese medicine composition for treating herpes zoster according to claim 5, wherein: During the crushing process in step three, explosion-proof equipment must be used to handle the realgar to avoid potential safety hazards caused by severe friction between it and metal.

6. The method for preparing the Chinese medicine composition for treating herpes zoster according to claim 5, wherein: The raw material formula in the step 4 needs to be accurately weighed to ensure the efficacy of the medicine, that is, the weight parts of the raw materials are: 12 parts of realgar, 2 parts of centipede, 8 parts of indigo, and 5 parts of alum.

7. The method for preparing the Chinese medicine composition for treating herpes zoster according to claim 5, wherein: The mixed powder in step 4 should be sealed and stored in a cool and dry place.

8. The method for preparing the Chinese medicine composition for treating herpes zoster according to claim 5, wherein: The vinegar in the step 5 is edible-grade brewed vinegar with a total acid content of ≥3.5g / 100mL.

Images