Traditional Chinese medicine preparation for treating herpes pain and itching as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention discloses a traditional Chinese medicine preparation for treating herpes pain and itch as well as a preparation method and application of the traditional Chinese medicine preparation, and belongs to the technical field of traditional Chinese medicines. 30 to 45 parts of paniculate swallowwort root; 25-35 parts of lithospermum erythrorhizon; 25 to 35 parts of sedum sarmentosum; and 8-12 parts of borneol. The traditional Chinese medicine preparation for treating herpes pain and itching is reasonable in formula, simple in raw material components and low in cost, has the effects of clearing heat, promoting diuresis, detoxifying, cooling blood, relieving itching and pain, and has obvious anti-inflammatory, analgesic and itching-relieving effects; the traditional Chinese medicine is used for treating heat sores caused by excessive lung and stomach heat and liver and gallbladder damp-heat syndromes, can effectively treat pruritus and pain caused by herpes, and is quick in effect and remarkable in curative effect; the traditional Chinese medicine composition can be used for preventing and treating itching and pain caused by herpes zoster and pain and itching of postherpetic nerves, and has a good prevention and treatment effect; the traditional Chinese medicine composition is safe, free of toxic and side effects, free of drug resistance, simple in preparation method and wide in application prospect.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine preparation for treating herpes pain and itching, and a preparation method and application thereof. Background Art

[0002] Herpes refers broadly to diseases caused by viruses in the herpesvirus family. Currently, it is known that there are eight viruses in the herpesvirus family (herpes simplex virus type 1 and 2, varicella-zoster virus, human cytomegalovirus, Epstein-Barr virus and human herpes virus type 6, 7, and 8) that can cause human diseases. These viruses are collectively referred to as human herpes viruses (HHV); they can invade multiple organs of the human body and can occur at any age. Herpes is mainly manifested as localized herpes on the skin or mucous membranes, or accompanied by itching and pain. Clinical manifestations include single or clustered blisters, accompanied by fever, pain, local lymphadenopathy and other symptoms. Common clinical diseases include herpes simplex, herpes zoster, chickenpox, genital herpes, etc.

[0003] Herpes simplex is caused by herpes simplex virus, which often invades the junction of skin and mucosa. The rash is limited clustered small blisters, and the long-term latent and repeated attacks of the virus are its clinical characteristics. It is prone to occur in the skin around the mouth, oral cavity, periocular and genitalia, and symptoms of itching and pain in the affected area often occur. Herpes simplex is one of the most widespread infectious diseases in the world. HSV-1 is common in children under 5 years old, while HSV-2 mainly occurs in adults. Herpes simplex is usually treated with local and systemic antiviral methods, and secondary infection is prevented. Drugs for the treatment of herpes simplex include topical drugs and oral drugs. Oral drugs include chlorpheniramine, loratadine, levocetirizine, acyclovir dispersible tablets, valacyclovir tablets, and topical drugs include mometasone furoate cream, hydrocortisone butyrate cream, tacrolimus ointment, etc.

[0004] Herpes zoster is a viral skin disease caused by the varicella-zoster virus, characterized by erythema and blisters distributed along unilateral peripheral nerves, often accompanied by obvious neuralgia. It is common in the distribution areas of the trigeminal nerve, vertebral nerve, intercostal nerve and lumbosacral nerve. Because it invades the nerves, the patient suffers from unbearable pain and itching, so timely treatment is particularly important. Chinese medicine calls it "snake string sores", "waist-wrapped fire dan" or "fire belt sores". Herpes zoster often occurs in people over 50 years old, with severe symptoms, and the incidence rate in immunosuppressed people is gradually increasing. The varicella-zoster virus is neurotropic, invading the sensory nerve endings of the skin, and transferring along the nerve fibers to the dorsal root ganglia of the spinal cord, lurking there. When the human immune function is low, such as when suffering from a cold, fever or malignant tumor, the virus is revived, causing inflammation and necrosis of the ganglia. At the same time, the virus can move along the nerve fibers to the skin to cause herpes and pain; the older the age, the more severe the neuralgia. If the herpes zoster virus infection is not treated promptly or is treated improperly, persistent neuralgia will occur after recovery, which will have a serious impact on the patient's physical, psychological, daily life and work.

[0005] There are many drugs for the treatment of herpes zoster on the market, including oral and topical drugs, including aspirin, voltaren painkillers, acyclovir, famciclovir antiviral drugs, Erwei Bodusan, Sanhuang lotion, and calamine topical drugs. Some patients need to be hospitalized for treatment, which is expensive, and generally has problems such as poor efficacy, poor recovery, and easy to cause sequelae such as neuralgia. Postherpetic neuralgia refers to the skin lesions of herpes that have completely subsided, but there is still persistent severe pain in the area of ​​the invaded nerve distribution. The treatment of postherpetic neuralgia includes drug therapy, nerve block, neuromodulation including peripheral nerves and dorsal roots of the spinal cord, nerve damage including physical and chemical nerve damage, spinal cord electrical stimulation, etc., but the treatment effect is poor. At present, the treatment of postherpetic neuralgia is still lacking, and there is no optimal treatment plan that can effectively eliminate pain.

[0006] The itching pain caused by herpes and the pain and itching of postherpetic neuralgia often make patients feel unbearable, seriously affecting their physical and mental health and quality of life. At present, there are many Western medicines on the market for their treatment. Western medicine treatment is mainly antiviral, anti-inflammatory and analgesic, but its medical cost is high, long-term use of Western medicine will produce drug resistance and certain side effects, and the clinical efficacy in preventing and treating postherpetic neuralgia is not obvious.

[0007] Traditional Chinese medicine contains a relatively rich amount of natural antiviral active substances, which is an important resource for the development of antiviral agents. Chinese medicine believes that the pain and itching of postherpetic neuralgia are caused by a variety of reasons, such as the disharmony of qi and blood, stagnation of meridians, and lack of nourishment to the skin. This disease is mostly caused by exogenous wind-heat evil toxins, invading the lungs and stomach, and the heat evil is not resolved, steaming the skin; or because the pathogenic evil invades the liver and gallbladder, causing dampness and heat in the liver and gallbladder, and heat is accumulated inside; or because of repeated attacks of skin lesions, long-term illness, long-term damage to body fluids, yin deficiency and fire, leading to the occurrence of heat sores. Therefore, the occurrence of heat sores can be affected by a variety of factors such as the six exogenous evils, sun and rain, women's pregnancy, and irregular diet, which cause the body to have fever and induce this disease. The most common pathogenic factor of heat sores is exogenous wind-heat, which does not subside and continues to have high fever. Diseases such as colds, scarlet fever, and malaria can induce heat sores. Since wind-heat evil invades the skin, wind-heat evil belongs to Yang evil, which can easily cause pain and itching of the skin. The "Inner Canon of Medicine" says: "Itching spreads to the skin, so it is Yang." Gu Shicheng of the Qing Dynasty said in "The Complete Book of Ulcers": "Heat sores appear all over the body, and the pus and blood are red and rotten like cinnabar, just like burns." Chao Yuanfang of the Sui Dynasty said in "Treatise on the Causes and Symptoms of Various Diseases": "All Yang Qi is on the surface, and when Yang Qi is strong, the surface is hot. Due to exercise and labor, the skin is empty and open, and is invaded by wind evil. When wind and heat fight each other, they stay on the skin and cause sores. At first, it is a sore, and yellow juice comes out. It is itchy when there is too much wind, and it is painful when there is too much heat. When blood and qi take advantage of it, there is a lot of pus and blood, so it is called heat sores." Therefore, after the wind-heat evil invades the lungs and stomach, heat sores occur, and the skin is painful and itchy. If the spleen and stomach are not functioning properly due to external dampness and heat or eating too much fat, sweet meat, or eating in moderation, dampness and turbidity will be generated internally, and will turn into heat, blocking the liver and gallbladder, causing dampness and heat in the liver and gallbladder, and excessive heat in the body. Wind evil will invade and heat evil will interweave, which can cause heat sores. The "Shengji Zonglu" of the Imperial Hospital of the Song Dynasty said: "Heat sores are caused by excessive heat, and wind qi will take advantage of it, so it is called heat sores." If the disease does not heal for a long time, evil heat will damage the body fluid, the kidney will lose its nourishment, and yin deficiency and fire will be strong, which can also lead to heat sores. Zhu Su of the Ming Dynasty said in "Puji Fang": "Husbands with asthenia and yin sores are caused by kidney qi nourishing the yin. Now the kidney is deficient and cannot nourish, so the body fluid and sweat come out of the yin, and the deficiency is taken advantage of by wind evil." Kidney yin is insufficient, kidney essence is deficient, and wind and heat evil take advantage of the weakness to enter, which will induce heat sores.

[0008] Traditional Chinese medicine has been used to treat viral infections for thousands of years. It has significant antiviral efficacy, a broad antiviral spectrum, and no obvious tissue cytotoxicity, teratogenicity, or mutagenicity when used systemically. It generally does not produce drug resistance. Therefore, it is of great significance to develop a traditional Chinese medicine preparation that is effective, safe, non-toxic, low-cost, and can effectively treat herpes pain and itching. Summary of the invention

[0009] The purpose of the present invention is to provide a Chinese medicine preparation for treating herpes pain and itching, and its preparation method and application in view of the deficiencies of the prior art. The Chinese medicine preparation is designed for heat sores caused by excessive heat in the lung and stomach and damp-heat syndrome in the liver and gallbladder, and is based on the principles of clearing away heat, promoting dampness and detoxifying, cooling blood, relieving itching and relieving pain. The raw material components are simple and the cost is low. It has obvious anti-inflammatory, analgesic and antipruritic effects, has significant efficacy on herpes pain and itching, is safe, has no toxic side effects, and can effectively prevent / treat itching and pain caused by herpes and pain and itching caused by postherpetic neuralgia.

[0010] The technical solution adopted by the present invention is as follows: A traditional Chinese medicine preparation for treating herpes pain and itching comprises the following traditional Chinese medicine raw materials in parts by weight: 80-100 parts of fenugreek; 30-45 parts of cynanchum wilfordii; 25-35 parts of lithospermum officinale; 25-35 parts of scutellaria baicalensis; and 8-12 parts of borneol.

[0011] Preferably, the Chinese medicine preparation for treating herpes pain and itching comprises the following Chinese medicinal materials in parts by weight: 90 parts of Vaccaria segetalis; 40 parts of Cynanchum wilfordii; 30 parts of Lithospermum officinale; 30 parts of Herba Creepersii; and 10 parts of Borneol.

[0012] The Chinese medicinal preparation for treating herpes pain and itching is prepared from the Chinese medicinal materials in the above weight proportions as raw materials into tincture, spray, external water preparation, liniment, film coating, plaster or other pharmaceutically acceptable dosage forms.

[0013] Furthermore, the preparation method of the Chinese medicine preparation and tincture for treating herpes pain and itching is as follows: take Chinese medicinal materials according to weight proportions for use, crush the remaining four medicinal materials except borneol into coarse powder, add 6 to 7 times the amount of 70% ethanol, stir evenly and then soak, stir once every 5 days, soak for 30 days, filter, add borneol to the filtrate and stir to dissolve, add an appropriate amount of 70% ethanol to make up the total amount of the filtrate to the specified amount, stir evenly, and fill.

[0014] Preferably, the preparation method of the tincture is as follows: take the Chinese medicinal materials by weight: 90g of Vaccaria segetalis, 40g of Cynanchum wilfordii, 30g of Lithospermum officinale, 30g of Herba Creepersii, and 10g of Borneol for later use; grind the remaining 4 medicinal materials except Borneol into coarse powder, add 6 to 7 times the amount of 70% ethanol, stir evenly, and then soak, stir once every 5 days, soak for 30 days, filter, add Borneol to the filtrate, stir to dissolve, add an appropriate amount of 70% ethanol to make 1000ml, stir evenly, and fill.

[0015] On the other hand, the present invention also provides the use of the traditional Chinese medicine preparation for treating herpes pain and itching in preventing / treating pain and itching caused by herpes, wherein the herpes includes herpes zoster and herpes simplex.

[0016] The present invention also provides the use of the traditional Chinese medicine preparation for treating herpes pain and itching in preventing / treating pain and itching of postherpetic neuralgia.

[0017] The medicinal properties of the various Chinese medicines used in the Chinese medicine preparation for treating herpes pain and itching of the present invention are as follows: Vaccaria segetalis is the dried mature seed of Vaccaria segetalis (Neck.) Garcke, a plant of the Caryophyllaceae family. [Nature and flavor] Bitter, flat. Enters the liver and stomach meridians. It mainly contains Vaccaria segetalis saponins, Vaccaria segetalis triterpenoid saponins, various cyclic peptides, flavonoid compounds, hydrogenated ferulic acid and other ingredients. It has the effects of promoting blood circulation and menstruation, promoting lactation and reducing swelling, and promoting diuresis and relieving stranguria. It is mainly used to treat irregular menstruation, dysmenorrhea, lack of milk, dystocia, breast abscess, swelling and pain, carbuncle, furuncle and other symptoms. Vaccaria segetalis can clear away heat and detoxify, reduce swelling and heal sores. Sores and furuncle swelling and pain caused by external invasion of heat and toxicity can be treated with Vaccaria segetalis.

[0018] Cynanchum paniculatum (Bunge) Kitag., or the whole plant with roots, is a plant of the Apocynaceae family. It has the effects of dispelling wind and dampness, promoting qi and blood circulation, relieving pain and itching, and detoxifying and reducing swelling. It is mainly used to treat rheumatic pain, low back pain, abdominal pain, toothache, pain from falls, urinary incontinence, diarrhea, dysentery, eczema, urticaria, and snake bites. The whole plant contains peony ol, carnosine aglycone, and deacylated oxalis aglycone; the root contains brass glycosides, sugars, amino acids, peony ol, etc. Cynanchum paniculatum (Bunge) Kitag. is pungent and warm in nature and can treat joint pain caused by rheumatic diseases, as well as low back pain, stomach pain, abdominal pain, toothache, traumatic pain, herpes zoster neuralgia, dysmenorrhea, etc. It also has a certain analgesic effect on tumors and postoperative pain.

[0019] Lithospermum is the dried root of Xinjiang lithospermum Arnebia euchroma (Royle) Johnst., Lithospermum erythrorhizon Sieb. et Zucc. or Inner Mongolia lithospermum Arnebia guttata Bunge. Lithospermum is sweet and salty in taste and cold in nature. It enters the heart and liver meridians. It has the effects of cooling blood and activating blood circulation, clearing away heat and detoxifying, and clearing rashes. It can treat diseases such as warm-heat macules, damp-heat jaundice, hematemesis, maggot blood, hematuria, stranguria, bloody diarrhea, heat-stagnation constipation, burns, eczema, erysipelas, etc. It is often used to treat diseases such as excessive blood heat and toxicity, purple-black macules, measles that do not clear up, sores, eczema and scalds. Lithospermum contains a variety of biologically active compounds such as lithospermum naphthoquinones, monoterpenoid benzoquinones, phenols, alkaloids, phenolic acids, etc., and has anti-tumor, anti-inflammatory, anti-pathogenic microorganism, analgesic and sedative effects.

[0020] Sedum sarmentosum Bunge is the dried whole herb of Sedum sarmentosum Bunge, a plant of the Crassulaceae family. It is sweet, light, slightly sour and cool in nature. It has the effects of promoting dampness and relieving jaundice, clearing away heat and detoxifying, stopping bleeding and nourishing blood. It is often used for damp-heat jaundice, dysuria, carbuncle and ulcer. Sedum sarmentosum Bunge contains alkaloids such as methyl isopungarine, sedoheptose, fructose, sucrose, etc. Sedum sarmentosum Bunge has a liver-protecting effect and has an inhibitory effect on Staphylococcus, Streptococcus, Salmonella typhi, Candida albicans, etc. It is often used in clinical practice to treat burns, snake venom, bites, and jaundice caused by various acute and chronic hepatitis. It can also be used for carbuncle, furuncle, and sore caused by skin diseases.

[0021] Borneol is a processed product of the resin of the evergreen tree plant Dryobalanops aromatica Gaertn. f. of the Dipterocarpaceae family, or a crystal obtained by distilling and cooling the trunk of the Dipterocarpaceae family, called "borneol borneol", also known as "plum slices"; it is also made from the sublimation of the leaves of the perennial herb Blumea balsamifera DC. of the Asteraceae family, which is processed and split, called "mugwort slices"; now it is mostly made of turpentine, camphor, etc., and synthesized by chemical methods, called "mechanical borneol". [Functions and indications] It can open up the mind and refresh the mind, clear away heat and relieve pain. It is used for coma and convulsions caused by fever, phlegm syncope caused by stroke, sudden syncope caused by qi stagnation, coma caused by poisoning, red eyes, mouth sores, sore throat, and pus in the ear canal. Borneol is bitter and cold in nature, and is good at dispersing fire depression. It can reduce swelling and relieve pain when used externally, and can also relieve itching, so it is also an important medicine for external use to treat mouth sores, sore throats and ulcers. Borneol can be used to treat fever due to high fever, coma, phlegm-heat stasis, sudden syncope due to summer heat, infantile convulsions, etc. It can be used to treat coma, phlegm syncope due to stroke, qi syncope, poisoning, sores, mouth sores, sore throat, eye diseases, sore gums, etc.

[0022] The prescription of the Chinese medicine preparation for treating herpes pain and itching of the present invention is designed for heat sores caused by excessive heat in the lung and stomach, and damp-heat syndrome in the liver and gallbladder, and is based on the principles of clearing away heat, promoting dampness and detoxifying, cooling blood, relieving itching and relieving pain. In the prescription, borneol is the main drug, lithospermum officinale is the ministerial drug, and herba scutellariae, radix cynanchifoliae, and herba scutellariae are adjuvants. The borneol in the prescription is pungent and bitter in taste, slightly cold in nature, and enters the heart, spleen, and lung meridians, and has the functions of opening all orifices, dispersing stagnant fire, clearing away heat and detoxifying, and reducing swelling and relieving pain, and is used to treat sores, swelling, and pain, and symptoms that do not heal after ulceration; lithospermum officinale is sweet and salty in taste, cold in nature, and enters the heart and liver meridians, and has the functions of clearing away heat and cooling blood, promoting blood circulation and relieving pain, and removing toxins and clearing rashes, and is used to treat sores and ulcers caused by excessive blood heat evil toxins. Lithospermum officinale is particularly good at clearing away blood heat and toxic evils, and is the ministerial drug in the prescription; herba scutellariae is bitter in taste, flat in nature, and enters the liver and stomach meridians, and has the functions of promoting blood circulation and menstruation, reducing swelling and relieving pain, and is used to treat Treat swelling and pain caused by blood stasis, and it is an adjuvant in the prescription; Cynanchum chinense, pungent in taste, warm in nature, enters the liver and stomach meridians, has the functions of dispelling wind and dampness, promoting qi and blood circulation, relieving pain and itching, detoxifying and reducing swelling, and is used to treat the pain and itching of heat sores, and is an adjuvant in the prescription; Herba Coptidis, sweet, light, slightly sour, slightly cold in nature, enters the heart, liver, and gallbladder meridians, has the functions of promoting dampness, clearing heat, and detoxifying, and is used to treat carbuncle, swelling, and ulcers caused by damp-heat evil, and is compatible with borneol and lithospermum, which can effectively promote stagnation and heat, enhance the function of cooling blood and detoxifying, and is an adjuvant in the prescription. The above medicines are used together to play the functions of clearing heat, promoting dampness, detoxifying, cooling blood, relieving itching, and relieving pain. It is used to treat heat sores caused by excessive heat in the lungs and stomach, and damp-heat syndrome in the liver and gallbladder.

[0023] The present invention observes the pharmacodynamics of the local skin administration of the Chinese medicine preparation for treating herpes pain and itching (herpes pain and itching tincture) of the present invention through mouse auricle swelling test, mouse cotton ball granuloma test, glacial acetic acid-induced mouse writhing test, mouse hot plate test, and histamine phosphate tolerance test on the local skin of guinea pigs. Pharmacological experiments prove that the Chinese medicine preparation for treating herpes pain and itching (herpes pain and itching tincture) of the present invention has a significant analgesic effect on the pain of mice caused by glacial acetic acid and hot plate, has a significant inhibitory effect on the ear swelling of mice caused by xylene, can significantly increase the itch threshold of histamine phosphate on the local skin itch reaction of guinea pigs, and has anti-inflammatory, analgesic and antipruritic effects.

[0024] The beneficial effects of the present invention are: The Chinese medicine preparation for treating herpes pain and itching of the present invention has a reasonable formula, simple raw material ingredients, wide drug sources, and low cost. The Chinese medicine preparation has the effects of clearing away heat, promoting dampness and detoxifying, cooling blood, relieving itching and relieving pain, and has obvious anti-inflammatory, analgesic and antipruritic effects. It is used to treat heat sores caused by lung and stomach heat and liver and gallbladder damp-heat syndrome, can effectively treat itching and pain caused by herpes, has a fast onset, can quickly relieve and eliminate pain and itching symptoms, and has a significant effect. It can be used to prevent and treat itching and pain caused by herpes and pain and itching of postherpetic neuralgia, with good prevention and treatment effects; it is safe, has no toxic side effects, has no drug resistance, is simple in preparation method, is easy to use, and has broad application prospects. DETAILED DESCRIPTION Example 1

[0025] A Chinese medicine preparation for treating herpes pain and itching, wherein the preparation method of the tincture is as follows: weigh Chinese medicinal materials: 90g of fenugreek, 40g of cynanchum, 30g of lithospermum, 30g of scutellaria baicalensis, and 10g of borneol, and set aside; crush the remaining four medicinal materials except the borneol into coarse powder, add 7 times the amount of 70% ethanol, stir evenly, and then soak, stir once every 5 days, soak for 30 days, filter, add borneol to the filtrate, stir to dissolve, add an appropriate amount of 70% ethanol to make 1000ml, stir evenly, and fill to obtain the tincture. Example 2

[0026] A Chinese medicine preparation for treating herpes pain and itching, the preparation method of the tincture is as follows: weigh the Chinese medicinal materials according to weight: 100g of fenugreek, 45g of cynanchum, 35g of lithospermum, 35g of scutellaria baicalensis, and 12g of borneol for standby use; grind the remaining four medicinal materials except borneol into coarse powder, add 70% ethanol in an amount of 6 times the weight of the ethanol, stir evenly, and then soak, stir once every 5 days, soak for 30 days, filter, add borneol to the filtrate, stir to dissolve, add appropriate amount of 70% ethanol to make 1000ml, stir evenly, and fill to obtain the tincture. Example 3

[0027] A traditional Chinese medicine preparation for treating herpes pain and itching, and the preparation method thereof is as follows: weigh the following Chinese medicinal materials by weight: 95 parts of fenugreek; 41 parts of Cynanchum chinense; 32 parts of Lithospermum officinale; 31 parts of Herba Creepersii; and 11 parts of borneol; set aside; grind the remaining four medicinal materials except borneol into coarse powder, add 7 times the amount of 70% ethanol to perform reflux extraction for 3 times, combine the extracts, add borneol to the extracts, stir to dissolve, obtain extract components, and add appropriate amounts of auxiliary materials to the obtained extract components according to conventional pharmaceutical processes in pharmacy to prepare a spray. Example 4

[0028] A Chinese medicine preparation for treating herpes pain and itching, and the preparation method thereof is as follows: weigh the Chinese medicinal materials by weight: 80 parts of fenugreek, 30 parts of cynanchum wilfordii, 25 parts of lithospermum officinale, 25 parts of scutellaria baicalensis, and 8 parts of borneol; set aside; use the Chinese medicinal materials by weight as raw materials, follow conventional pharmaceutical processes in pharmacy, add conventional pharmaceutical excipients, and prepare tinctures, sprays, external water preparations, liniments, film coatings, plasters or other pharmaceutically acceptable dosage forms.

[0029] Example 5 Main pharmacodynamic test data 1. Drugs and reagents: Tinctures were prepared by the method of Example 1 of the present invention - herpes pain and itch tincture, 0.2g total medicinal materials / mL, described in the material as a low-dose group of herpes pain and itch tincture; 2 times the concentration of herpes pain and itch tincture, 0.4g total medicinal materials / mL, described in the material as a medium-dose group of herpes pain and itch tincture; 4 times the concentration of herpes pain and itch tincture, 0.8g total medicinal materials / mL, described in the material as a high-dose group of herpes pain and itch tincture. The solvent is 70% ethanol, all of which are provided by Laibin People's Hospital. The positive control drug is Huahong detumescence and analgesia tincture, batch number: 20210111, produced by Guangxi Zhuang Autonomous Region Huahong Pharmaceutical Group Co., Ltd., which has the effects of relaxing muscles and activating collaterals, reducing swelling and relieving pain, and is used for bruises, sprains, and rheumatism. Sanjiu Piyanping Ointment, batch number: 20110033, produced by Sanjiu Pharmaceutical Company, has the effects of anti-inflammatory and antipruritic, and is used for dermatitis, eczema, tinea pedis and body tinea. Histamine phosphate, Source Leaf Biotechnology, batch number: M03GS140411.

[0030] 2. Animals: SPF-grade KM mice were provided by the Experimental Animal Center of Guangxi Medical University, license number: SCXK Gui 2020-0003. Ordinary-grade Hartly guinea pigs were provided by Hunan Taiping Biotechnology Co., Ltd., license number: SCXK Xiang 2020-0005. They were raised in an environment of 20-25°C and relative humidity of 60±10%, fed with pelleted feed, and had free access to water.

[0031] 3. Experimental groups: Set up blank control, solvent control group, positive drug group, and herpes pain and itch tincture high, medium, and low dose groups.

[0032] 4. Method of administration: Use an application method consistent with the clinical medication route.

[0033] 5. Statistical analysis: SPSS 22.0 software was used for statistical analysis, and the measured data were expressed as mean ± standard deviation. One-way analysis of variance was used, and P < 0.05 was considered statistically significant.

[0034] 6. Test methods and results 6.1 Hot plate pain test in mice Preliminary screening was performed before the experiment: female mice weighing 18-22 g were selected, and the temperature of the hot plate was within the range of 55±0.5℃. The pain threshold was measured twice, and the reaction of licking the hind foot was used as an indicator. The average pain threshold within 5-30 s was qualified. 60 qualified mice were selected and randomly divided into 6 groups, namely, blank group, solvent control group, Huahong Xiaozhong Zhitong Tincture group, and herpes pain and itching tincture high, medium, and low doses (4 times the clinical dose, 2 times the clinical dose, and clinical dose) groups. The medicine was applied to the toes of the mice, once a day, for 7 consecutive days. The time (s) from the mouse being placed on the hot plate to licking the foot was recorded as the pain threshold at 30, 60, and 120 min after the last administration, and the pain threshold of each drug group and the blank group was statistically analyzed. The results are shown in Table 1.

[0035]

[0036] The results showed that compared with the blank group, the pain threshold did not change significantly after solvent treatment, but the pain threshold of the Huahong Xiaozhong Zhitong Tincture group increased significantly after administration, and the difference was significant ( P <0.05, P <0.01), the pain threshold of the high-dose group of herpes pain and itch tincture increased significantly after administration, and the difference was significant ( P <0.05, P <0.01), indicating that herpes pain and itch tincture can effectively increase the pain threshold of mice.

[0037] 6.2 Mouse writhing experiment 60 KM mice, half male and half female, weighing 18-22 g, were randomly divided into 6 groups: blank group, solvent control group, Huahong Xiaozhong Zhitong Tincture group, and herpes pain and itch tincture high, medium, and low dose (4 times the clinical dose, 2 times the clinical dose, and clinical dose) groups, with 10 mice in each group. The hair on the abdomen of the mice was cut with scissors, and the hair cutting area was about 2×2 cm. The medicine was applied to the abdomen of the mice once a day for 7 consecutive days. 0.2 mL of 6 mL / L glacial acetic acid solution was injected intraperitoneally 1 h after the last administration, and the number of twisting reactions of the mice within 15 minutes (twisting reaction: abdomen concave, trunk and hind legs extended, buttocks raised) was observed and recorded for statistical analysis. The results are shown in Table 2.

[0038]

[0039] The results showed that compared with the blank group, the number of body twists did not change significantly after solvent treatment, while the number of body twists in the Huahong Xiaozhong Zhitong Tincture group was significantly reduced after administration, and the difference was significant ( P <0.01), the number of body twisting in each dose group of herpes pain and itch tincture was significantly reduced after administration, and the difference was significant ( P <0.01), indicating that herpes pain and itch tincture can significantly reduce the number of writhing reactions induced by glacial acetic acid in mice.

[0040] 6.3 Mouse ear swelling experiment Sixty KM mice, half male and half female, weighing 18-22 g, were randomly divided into 6 groups: blank group, solvent control group, Huahong Xiaozhong Zhitong Tincture group, and herpes pain and itching tincture high, medium, and low doses (4 times the clinical dose, 2 times the clinical dose, and clinical dose) groups, with 10 mice in each group. The corresponding drugs or solvents were applied to the front and back of the left and right ears of the mice in each group, and the blank group was given normal saline once a day for 7 consecutive days. 30 minutes after the last administration, the inflammatory agent xylene was applied to the front and back of the right auricle of the mice at 0.03 mL / mouse, and the left ear was used as a control. The mice were killed 0.5 hours after inflammation, and the two ears were cut along the baseline of the auricle. The two ears were overlapped, and the ear pieces were taken with a punch of 8 mm in diameter, weighed, and the swelling degree (x) and swelling inhibition rate (y) of each group were calculated.

[0041] x = right ear piece mass - left ear piece mass, y = (blank group swelling - drug group swelling) / blank group swelling × 100%. The results are shown in Table 3.

[0042]

[0043] The results showed that compared with the blank group, the swelling of the mouse ear pinna did not change significantly after solvent treatment, while the swelling of the mouse ear pinna in the Huahong Xiaozhong Zhitong Tincture group was significantly reduced after administration, and the difference was significant ( P <0.01), the ear swelling of mice in each dose group was significantly reduced after administration of herpes pain and itch tincture, and the difference was significant ( P <0.01), indicating that herpes pain and itch tincture can effectively reduce xylene-induced ear swelling in mice.

[0044] 6.4 Cotton ball granuloma experiment in mice 60 KM mice, half male and half female, weighing 18-22 g, were randomly divided into 6 groups: blank group, solvent control group, Huahong Xiaozhong Zhitong Tincture group, and herpes pain and itch tincture high, medium, and low doses (4 times the clinical dose, 2 times the clinical dose, and clinical dose) groups, with 10 mice in each group. During the experiment, the mice were anesthetized with ether, and an incision was made on the right side of the mouse abdomen after routine disinfection. The weighed sterilized cotton balls (10 mg each) were implanted into the contralateral armpit of the mouse, and the wound was sutured. Each group began to apply the corresponding drug or solvent to the cotton ball implantation site on the day of surgery, and the blank group was given normal saline once a day for 10 consecutive days. One hour after the last administration, the mice were killed, the cotton ball granulation tissue was removed, dried in a 60℃ oven for 4 hours, and the weight of the cotton ball granuloma was weighed for statistical analysis. The results are shown in Table 4.

[0045]

[0046] The results showed that compared with the blank group, the weight of cotton ball granuloma did not change significantly after solvent treatment, while the weight of cotton ball granuloma in the Huahong Xiaozhong Zhitong Tincture group was significantly reduced after administration, and the difference was significant ( P <0.01), there was no significant change in the weight of cotton ball granuloma after administration of herpes pain and itch tincture in each dose group ( P >0.05), indicating that herpes pain and itch tincture could not inhibit the proliferation of cotton ball granuloma in mice.

[0047] 6.5 Guinea pig antipruritic test 60 guinea pigs, half male and half female, were randomly divided into 6 groups: blank group, solvent control group, dermatitis ping group, high, medium and low dose (4 times clinical dose, 2 times clinical dose, clinical dose) groups of herpes pain and itch tincture, 10 in each group. The hind paw of each group of guinea pigs was shaved 2cm×2cm. The tested drug solution or solvent was evenly applied to the shaved area, twice a day for 2 consecutive days, with a dosage of 1 ml / kg. On the third day of administration, the shaved area was scratched with coarse sandpaper to the extent of damaging the epidermis and slight bleeding. The tested drug solution or solvent was applied to the wound once, and the blank group was coated with normal saline. Ten minutes after the application of the medicine, 0.05 ml of 0.01% histamine phosphate solution was dripped on the wound surface of each guinea pig. After that, the concentration of histamine phosphate was gradually reduced every 3 minutes (0.01%, 0.02%, 0.03%, 0.04%...), until the guinea pig turned back to lick its feet. The total amount of histamine given to each guinea pig was recorded, and this total amount was taken as the itch threshold. The itch thresholds of each group were compared. The results are shown in Table 5.

[0048]

[0049] The results showed that compared with the blank group, the itch threshold of guinea pigs after solvent treatment had no significant change. The high-dose and medium-dose groups of Huahong Xiaozhong Zhitong Tincture and Herpes Pain and Itch Tincture could significantly increase the itch threshold of histamine phosphate on the local skin itch reaction of guinea pigs, and the difference was significant ( P <0.05), indicating that herpes pain and itch tincture has a significant antipruritic effect on local skin itching.

[0050] 7. Conclusion The herpes pain and itch tincture product of the present invention is used for local medication, which can significantly increase the pain threshold of the hot plate of mice, reduce the number of twisting of mice caused by glacial acetic acid, inhibit the swelling of the ear of mice caused by xylene, and increase the itch threshold of the itch reaction of histamine phosphate on the local skin of guinea pigs. It is suggested that the herpes pain and itch tincture has anti-inflammatory, analgesic and antipruritic effects.

Claims

1. A Chinese medicine preparation for treating herpes pain and itching, characterized in that: The invention comprises the following Chinese medicinal materials in parts by weight: 80-100 parts of fenugreek, 30-45 parts of cynanchum wilfordii, 25-35 parts of lithospermum officinale, 25-35 parts of scutellaria baicalensis and 8-12 parts of borneol.

2. The Chinese medicine preparation for treating herpes pain and itch according to claim 1, characterized in that: The invention comprises the following Chinese medicinal materials in parts by weight: 90 parts of fenugreek, 40 parts of radix scutellariae, 30 parts of lithospermum officinale, 30 parts of scutellaria baicalensis and 10 parts of borneol.

3. The Chinese medicine preparation for treating herpes pain and itch according to claim 1 or 2, characterized in that, The traditional Chinese medicine preparation for treating herpes pain and itching is prepared from the traditional Chinese medicine materials in the aforementioned weight proportions as raw materials into tincture, spray, external water preparation, liniment, film coating, plaster or other pharmaceutically acceptable dosage forms.

4. The Chinese medicine preparation for treating herpes pain and itch according to claim 3, characterized in that: The preparation method of tincture is as follows: take Chinese medicinal materials according to weight proportions for use, crush the other four medicinal materials except borneol into coarse powder, add 6 to 7 times amount of 70% ethanol, stir evenly and then soak, stir once every 5 days, soak for 30 days, filter, add borneol to the filtrate and stir to dissolve, add appropriate amount of 70% ethanol to make up the total amount of filtrate to the specified amount, stir evenly, fill, and obtain.

5. The Chinese medicine preparation for treating herpes pain and itch according to claim 4, characterized in that: The preparation method of the tincture is as follows: take the Chinese medicinal materials by weight: 90g of Vaccaria segetalis, 40g of Cynanchum wilfordii, 30g of Lithospermum officinale, 30g of Herba Creepersii, and 10g of Borneol, and set them aside; grind the remaining 4 medicinal materials except the borneol into coarse powder, add 6 to 7 times the amount of 70% ethanol, stir evenly, and then soak, stir once every 5 days, soak for 30 days, filter, add borneol to the filtrate, stir to dissolve, add appropriate amount of 70% ethanol to make 1000ml, stir evenly, and fill.

6. Use of the Chinese medicinal preparation for treating herpes pain and pruritus as claimed in claim 3 in preventing / treating pain and pruritus caused by herpes, wherein the herpes includes herpes zoster and herpes simplex.

7. Use of the Chinese medicinal preparation for treating herpes pain and itch as claimed in claim 3 in preventing / treating pain and pruritus caused by postherpetic neuralgia.

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