Traditional Chinese medicine composition for treating herpes zoster and preparation method thereof
Through the fermentation and coating technology of traditional Chinese medicine compositions, the synergistic effect of specific microorganisms is used to solve the problem of poor control of non-specific inflammation of shingles, and the effect of significant swelling inhibition and side effects reduction is achieved.
Patent Information
- Application Number
- CN202411693979.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-25
- Publication Date
- 2025-01-10
AI Technical Summary
Current Western medicines for the treatment of shingles have limited effects on non-specific inflammation control and may cause side effects, such as local pain, itching or burning sensation.
A traditional Chinese medicine composition is adopted, including scutellaria baicalensis-gentian-rulmonary combined fermentation, rehmannia, red peony, cypress, yam, albicans, atractylodes, ophiopogon japonicus and cicada shed, through the combination of fermentation and coating , utilize the synergistic effects of Trichoderma, Aspergillus and lactic acid bacteria to improve the anti-nonspecific inflammation effect.
The anti-nonspecific inflammation effect was significantly improved, the swelling inhibition rate reached more than 57.14%, and there were no obvious side effects, enhancing the stability of the drug effect and the consistency of release.
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Figure CN119280344A_ABST
Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating herpes zoster and a preparation method thereof. Background Art
[0002] Herpes zoster is an infectious skin disease caused by the reactivation of the varicella-zoster virus, which has long been dormant in the spinal cord ganglia or intracranial ganglia, due to factors such as aging or certain stimulation of the body leading to reduced immune function. Herpes zoster is more common in people over 50 years old and those with weakened immunity. The most common complication is postherpetic neuralgia, and some high-risk patients may even suffer from pain for several years.
[0003] Herpes zoster, in Chinese medicine, is called "Zhen Dai Chuan", "Huo Dai Chuan", "Cang Yao Huo Dan", "She Chuan Chuan", "Spider Chuan", "She Ke Chuan", "She Dan", "Cang Yao Long", "Chuan Yao Long", etc. The earliest record of this disease can be traced back to "Zhu Bing Yuan Hou Lun". Ancient doctors believed that this disease was mostly caused by wind, dampness, fire (heat), evil toxins and other factors. Modern Chinese dermatology believes that this disease is prone to occur in spring and autumn. In the early stage, it is mainly caused by damp heat and fire toxins, and in the later stage, it is caused by deficiency of the body and blood stasis with damp evil. Or because of emotional injury, liver qi is stagnant, and for a long time, it turns into fire and moves recklessly, so that the fire of the heart and liver is inflamed externally, and accumulates in the skin and causes it, or the damp heat of the lungs and spleen is accumulated internally, and it spreads to the skin for a long time, and then it is caused by damp heat evil toxins. If the heat toxins are accumulated in the blood, it will cause red patches, and if the damp heat blocks the skin, yellow and white blisters will appear; damp heat blocks the meridians, and if it is not unblocked, it will cause pain. Common clinical symptoms include liver meridian stagnation and heat syndrome, spleen deficiency and dampness accumulation syndrome, and qi stagnation and blood stasis syndrome.
[0004] The inflammatory response caused by herpes zoster may cause the blood flow in local blood vessels to increase, and the blood flow in other areas to slow down, making it easier for inflammatory cells to pass through the blood vessel wall and enter the tissue, causing increased capillary permeability and increased tissue fluid production, leading to swelling. Existing treatments are often based on Western medicine. Antiviral drugs such as acyclovir can effectively inhibit viral replication, thereby helping to alleviate symptoms and shorten the course of the disease. However, it has limited control effects on nonspecific inflammation. In addition, it may cause some side effects, such as local pain, itching or burning sensation. Summary of the invention
[0005] In order to solve the problems existing in the background technology, the present invention provides a Chinese medicine composition for treating herpes zoster and a preparation method thereof, which adopts pure Chinese medicine ingredients, has no obvious side effects, and has significant anti-nonspecific inflammatory effect.
[0006] In order to achieve the above-mentioned object, in a first aspect, the present invention provides a Chinese medicine composition for treating herpes zoster, comprising a medicinal substance and a pill coating; the medicinal substance comprises the following components by weight: 30-35 parts of a combined fermentation product of scutellaria baicalensis-gentiana scabra-rhubarb, 4-6 parts of lycium bark, 3-4 parts of red peony root, 3-4 parts of lithospermum officinale, 4-7 parts of smilax glabra, 3-4 parts of oriental water plantain, 4-5 parts of atractylodes lancea, 3-4 parts of ophiopogon japonicus and 0.8-1.2 parts of pericarp of cicada;
[0007] The scutellaria-gentian-rhubarb joint fermentation product is prepared by mixing scutellaria, gentian and rhubarb in a mass ratio of 1: (0.6-0.8): 1 and then fermenting with mixed strains;
[0008] The mixed strains include the following components:
[0009] Trichoderma, the number of live bacteria in the culture liquid is 10 6 -10 7 CFU / mL, the volume of Trichoderma liquid used for every 100g of the mixture of Scutellaria baicalensis, Gentiana scabra and Rhubarb is 4-5mL;
[0010] Aspergillus, the viable count of the culture solution is 10 6 -10 7 CFU / mL, the volume of Aspergillus liquid used for every 100g of the mixture of Scutellaria baicalensis, Gentiana scabra and Rhubarb is 2-2.5mL;
[0011] Lactic acid bacteria, the number of live bacteria in the culture solution is 10 6 -10 7 CFU / mL, the volume of lactic acid bacteria liquid used for every 100g of the mixture of Scutellaria baicalensis, Gentiana scabra and Rhubarb is 3.5-4mL.
[0012] The efficacy of each component is as follows:
[0013] The main drug is the fermented product of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0014] Among them, Scutellaria baicalensis has the effects of clearing heat and drying dampness, purging fire and detoxifying; Gentiana scabra also has the effects of clearing heat and drying dampness, purging liver and gallbladder fire; Rhubarb is bitter and cold, enters the spleen, stomach, large intestine, liver, and pericardium meridians, clears heat and cools blood, purges fire and detoxifies, can purge and attack accumulation, and guide evil out through the stool. "Yaoyao Fenji Buzheng" says: "It can purge blood and divide the heat." All three are bitter and cold products, and they are used as the main ingredients. They are specialized and powerful, and they can play their effects of clearing heat, cooling blood, removing dampness, and detoxifying.
[0015] The minister medicine is composed of two groups of medicinal flavors.
[0016] First, the root bark of Rehmannia root has the effects of clearing heat, cooling blood and relieving deficiency fever, and is suitable for the condition of yin deficiency and internal heat; red peony root is bitter and slightly cold, belongs to the liver meridian, clears heat, cools blood, disperses blood stasis and relieves pain; purple grass has the effects of cooling blood, activating blood circulation, detoxifying and clearing rashes, and is suitable for skin diseases and symptoms caused by heat and toxins. The three medicines are used together to assist the main medicine, strengthen its cooling blood effect, and disperse blood stasis and relieve pain.
[0017] Secondly, Smilax glabra is sweet, light and neutral, and enters the liver and stomach meridians, detoxifies and removes dampness; Alisma orientalis is sweet, light and cold, and enters the kidney and bladder meridians, promotes diuresis and eliminates dampness, and relieves heat; Atractylodes macrocephala is pungent, bitter and warm, and enters the spleen, stomach and liver meridians, dries dampness and strengthens the spleen. The three are used together to assist the main medicine in removing dampness and promoting diuresis, and guide the evil out through urination.
[0018] The medicinal ingredients in this prescription are mostly bitter and dry, which can easily damage Yin. Therefore, Ophiopogon japonicus, which is sweet, cold and refreshing, is used to nourish Yin, produce body fluid, moisten the lungs and clear the heart, so as to prevent excessive bitterness and dryness.
[0019] Use less sweet and cold cicada shells, which enter the lungs and liver, dispel wind and clear rashes, and spread lightly and outward, leading the medicine directly to the affected area. This is what it does.
[0020] The combination of these medicines has the effects of clearing away heat, cooling blood, removing dampness and detoxifying, and hits the cause and pathogenesis of the syndrome of internal dampness and heat in herpes zoster.
[0021] Furthermore, the preparation method of the scutellaria-gentian-rhubarb joint fermentation product is as follows:
[0022] A1. Mix scutellaria baicalensis, gentian and rhubarb, and grind them into a particle size of 10-15 mesh to obtain a primary material;
[0023] A2, putting the mixed strains and the initial material obtained in S1 into a fermentation tank, mixing them evenly, ventilating them in stages, and fermenting them to obtain a fermentation material;
[0024] A3. Dry the fermented material obtained in A2 to a moisture content of 4-6%, crush it, and sieve the particle size through a 20-30 mesh sieve to obtain the combined fermented material of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0025] Furthermore, in A2, the fermentation temperature was controlled at 28-30°C and the fermentation time was 5 days.
[0026] Furthermore, in A2, the specific operation of staged ventilation is:
[0027] On the first day, ventilation was performed for 8 minutes every 2 hours, with a ventilation volume of 0.30 L / (h·kg);
[0028] On the second day, ventilation was carried out for 9 minutes every 2 hours, with a ventilation volume of 0.35 L / (h·kg);
[0029] On the third day, ventilate for 10 minutes every 2 hours, with a ventilation volume of 0.40 L / (h·kg);
[0030] On the 4th day, ventilate for 12 minutes every 2 hours, with a ventilation volume of 0.20 L / (h·kg);
[0031] On the 5th day, ventilate for 15 minutes every 2 hours, with a ventilation volume of 0.15L / (h·kg).
[0032] Furthermore, in A3, the drying temperature is 60-70°C.
[0033] Furthermore, the pill coating includes vegetable oil and white beeswax, and the mass ratio of the two is (4-7):100.
[0034] Furthermore, the preparation method of the pill coating is as follows: white beeswax is heated to 70-75° C., then vegetable oil is added, stirred, mixed, and cooled to room temperature to obtain the pill coating.
[0035] Furthermore, the vegetable oil includes any one of soybean oil, rapeseed oil and olive oil.
[0036] In a second aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition for treating herpes zoster, comprising the following steps:
[0037] S1. Mix the root bark of Lycium bark, red peony root, lithospermum officinale, Smilax glabra, Alisma orientalis, Atractylodes macrocephala, Ophiopogon japonicus and Periostracum cicadae, grind them, and pass through a 70-80 mesh sieve to obtain a mixed medicinal material;
[0038] S2, mixing the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb with the mixed medicinal material obtained in S1 to obtain the medicinal substance;
[0039] S3. Make pills with water and the medicinal substance obtained in S2 at a mass ratio of (0.6-0.8):1, and then coat them with a pill coating material to obtain a Chinese medicinal composition for treating herpes zoster.
[0040] This application has the following beneficial effects:
[0041] 1. In the preparation of the Chinese medicine composition for treating herpes zoster of the present invention, Trichoderma is selected to ferment Scutellaria baicalensis, Gentiana scabra and Rhubarb, which can improve the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition; Aspergillus and lactic acid bacteria are selected to ferment Scutellaria baicalensis, Gentiana scabra and Rhubarb, which can also improve the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition; and there is a synergistic effect between Trichoderma, Aspergillus scabra and lactic acid bacteria, which can synergistically improve the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition. At the same time, when the particle size (10-15 mesh sieve) of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb is greater than the particle size (80 mesh sieve) of the mixed medicine, it is more conducive to improving the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition. And in the preparation of the pill coating, vegetable oil is added, which is conducive to further improving the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition.
[0042] 2. In the preparation of the combined fermentation product of scutellaria baicalensis-gentian-rhubarb of the present invention, Trichoderma is selected to ferment, and the looseness of the fermentation product can be improved. When the particle diameter (10-15 mesh sieve) of the combined fermentation product of scutellaria baicalensis-gentian-rhubarb is greater than the particle diameter (80 mesh sieve) of the mixed medicine, the loose structure is more conducive to carrying the mixed medicine in a corresponding proportion, so as to improve the effect of combining the drug effect (swelling inhibition) with each other, that is, to improve the swelling inhibition rate. In addition, Aspergillus and lactic acid bacteria are selected to cooperate with fermentation, which can reduce toxic and side effects, and then further improve the effect of suppressing swelling, that is, further improve the swelling inhibition rate. And, through experimental verification, in the fermentation process, Trichoderma can produce synergy with Aspergillus and lactic acid bacteria, reaching the effect of synergistically improving the anti-nonspecific inflammatory effect (swelling inhibition rate) of the obtained Chinese medicine composition.
[0043] 3. In the preparation of the pill coating of the present invention, vegetable oil is added to white beeswax, which can enhance the pore invasiveness of the obtained pill coating, and is conducive to further pushing the mixed medicinal materials (ministerial, adjuvant, and guiding drugs) carried on the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb (main drug) into the loose pores of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb, thereby avoiding the easy disintegration of the drug components in the subsequent release, and making the ratio of the combined release of multiple drug components better maintain consistency, thereby improving the efficacy (including anti-nonspecific inflammatory effect / swelling inhibition rate) and its stability. BRIEF DESCRIPTION OF THE DRAWINGS
[0044] Figure 1 , a comparative trend chart of the test data of the anti-nonspecific inflammatory effect-swelling inhibition rate of the traditional Chinese medicine composition obtained in Examples 1-7 of the present invention and Comparative Examples 1-5. DETAILED DESCRIPTION
[0045] The present application is further described in detail below with reference to the embodiments.
[0046] Unless otherwise specified, the raw materials used in the examples and comparative examples of the present application are all commercially available.
[0047] Example 1: (1) Preparation of Scutellaria baicalensis-Gentiana scabra-Rhubarb joint fermentation product, the preparation method is as follows:
[0048] A1. Mix scutellaria baicalensis, gentian and rhubarb in a mass ratio of 1:0.7:1, and grind them into a particle size of 10-15 mesh to obtain a primary material.
[0049] A2. Put the mixed strains and the initial material obtained from S1 into a fermentation tank, mix them evenly, ventilate them in stages, control the fermentation temperature at about 29°C, and ferment for 5 days to obtain the fermentation material.
[0050] Specifically, the mixed strains include the following components:
[0051] Trichoderma, the number of live bacteria in the culture liquid is 4.5*10 6 CFU / mL, the volume of Trichoderma liquid used for every 100g of initial material is 4.5mL;
[0052] Aspergillus, the number of live bacteria in the culture solution is 3.7*10 6 CFU / mL, the volume of Aspergillus liquid used for every 100g of initial material is 2.2mL;
[0053] Lactic acid bacteria, the number of live bacteria in the culture liquid is 3.1*10 6 CFU / mL, the volume of lactic acid bacteria liquid used for every 100g of initial material is 3.8mL.
[0054] Among them, Trichoderma was green Trichoderma (XK-JZ-1112) purchased from Shanghai Xuanke Biotechnology Co., Ltd. Aspergillus was Monascus (RN-03232) purchased from Noan Gene Technology (Wuhan) Co., Ltd. Lactic acid bacteria (QC-FD-025) were purchased from Shenzhen Haisian Biotechnology Co., Ltd.
[0055] The specific operation of staged ventilation is as follows:
[0056] On the first day, ventilation was performed for 8 minutes every 2 hours, with a ventilation volume of 0.30 L / (h·kg);
[0057] On the second day, ventilation was carried out for 9 minutes every 2 hours, with a ventilation volume of 0.35 L / (h·kg);
[0058] On the third day, ventilate for 10 minutes every 2 hours, with a ventilation volume of 0.40 L / (h·kg);
[0059] On the 4th day, ventilate for 12 minutes every 2 hours, with a ventilation volume of 0.20 L / (h·kg);
[0060] On the 5th day, ventilate for 15 minutes every 2 hours, with a ventilation volume of 0.15L / (h·kg).
[0061] A3. Dry the fermented material obtained in A2 at a drying temperature of 65° C. until the moisture content is about 5%, and then crush it to a particle size of 20-30 mesh to obtain the combined fermented material of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0062] (2) Preparing a pill coating, the preparation method is as follows: heating white beeswax to 72°C, then adding soybean oil, the mass ratio of soybean oil to white beeswax is 5.5:100, stirring, mixing, and cooling to room temperature to obtain a pill coating.
[0063] (3) A method for preparing a Chinese medicine composition for treating herpes zoster, comprising the following steps:
[0064] S1. Mix 5 parts of Radix Lycii, 3.5 parts of Radix Paeoniae Rubra, 3.5 parts of Radix Lithospermi, 6 parts of Rhizoma Smilacis Glabrae, 3.5 parts of Rhizoma Alismatis, 4.5 parts of Rhizoma Atractylodis Macrocephalae, 3.5 parts of Radix Ophiopogonis and 1 part of Periostracum Cicadae by weight, grind them, and pass through an 80-mesh sieve to obtain a mixed medicinal material.
[0065] S2. According to the same standard weight proportions, 33 parts of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb are mixed evenly with the mixed medicinal material obtained in S1 to obtain the medicinal substance.
[0066] S3, water and the medicinal substance obtained in S2 are made into pills at a mass ratio of 0.7:1, and then coated with a pill coating material to obtain a Chinese medicine composition for treating herpes zoster. Specifically, water and the medicinal substance obtained in S2 are mixed at a mass ratio of 0.7:1 to prepare a soft material, which is "kneaded into a ball" and then refined for 20 minutes, and then the soft material is rolled into strips, put into a 5mm mold pill making machine, cut into pills, and the pills are placed in a pan pill pot to roll into round shapes, dried at 50°C for 1h, heated to 70°C, and 0.5% of its weight of the pill coating material is added, and coated / polished to obtain a Chinese medicine composition for treating herpes zoster.
[0067] Example 2: The difference between this example and Example 1 is that: (1) a combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb is prepared, and the preparation method thereof is as follows:
[0068] A1. Mix scutellaria baicalensis, gentian and rhubarb in a mass ratio of 1:0.6:1, and grind them into a particle size of 10-15 mesh to obtain a primary material.
[0069] A2. Put the mixed strains and the initial material obtained from S1 into a fermentation tank, mix them evenly, ventilate them in stages, control the fermentation temperature at about 29°C, and ferment for 5 days to obtain the fermentation material.
[0070] Specifically, the mixed strains include the following components:
[0071] Trichoderma, the number of live bacteria in the culture liquid is 4.5*10 6 CFU / mL, the volume of Trichoderma liquid used for every 100g of initial material is 4mL;
[0072] Aspergillus, the number of live bacteria in the culture solution is 3.7*10 6 CFU / mL, the volume of Aspergillus liquid used for every 100g of initial material is 2mL;
[0073] Lactic acid bacteria, the number of live bacteria in the culture liquid is 3.1*10 6 CFU / mL, the volume of lactic acid bacteria liquid used for every 100g of initial material is 3.5mL.
[0074] The specific operation of staged ventilation is as follows:
[0075] On the first day, ventilation was performed for 8 minutes every 2 hours, with a ventilation volume of 0.30 L / (h·kg);
[0076] On the second day, ventilation was performed for 9 minutes every 2 hours, with a ventilation volume of 0.35 L / (h·kg);
[0077] On the third day, ventilate for 10 minutes every 2 hours, with a ventilation volume of 0.40 L / (h·kg);
[0078] On the 4th day, ventilate for 12 minutes every 2 hours, with a ventilation volume of 0.20 L / (h·kg);
[0079] On the 5th day, ventilate for 15 minutes every 2 hours, with a ventilation volume of 0.15L / (h·kg).
[0080] A3. Dry the fermented material obtained in A2 at a drying temperature of 60° C. until the moisture content is about 5%, and then crush it to a particle size of 20-30 mesh to obtain the combined fermented material of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0081] Example 3: The difference between this example and Example 1 is that: (1) a combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb is prepared, and the preparation method thereof is as follows:
[0082] A1. Mix scutellaria baicalensis, gentian and rhubarb in a mass ratio of 1:0.8:1, and grind them into a particle size of 10-15 mesh to obtain a primary material.
[0083] A2. Put the mixed strains and the initial material obtained from S1 into a fermentation tank, mix them evenly, ventilate them in stages, control the fermentation temperature at about 29°C, and ferment for 5 days to obtain the fermentation material.
[0084] Specifically, the mixed strains include the following components:
[0085] Trichoderma, the number of live bacteria in the culture liquid is 4.5*10 6CFU / mL, the volume of Trichoderma liquid used for every 100g of initial material is 5mL;
[0086] Aspergillus, the number of live bacteria in the culture solution is 3.7*10 6 CFU / mL, the volume of Aspergillus liquid used for every 100g of initial material is 2.5mL;
[0087] Lactic acid bacteria, the number of live bacteria in the culture liquid is 3.1*10 6 CFU / mL, the volume of lactic acid bacteria liquid used for every 100g of initial material is 4mL.
[0088] The specific operation of staged ventilation is as follows:
[0089] On the first day, ventilation was performed for 8 minutes every 2 hours, with a ventilation volume of 0.30 L / (h·kg);
[0090] On the second day, ventilation was performed for 9 minutes every 2 hours, with a ventilation volume of 0.35 L / (h·kg);
[0091] On the third day, ventilate for 10 minutes every 2 hours, with a ventilation volume of 0.40 L / (h·kg);
[0092] On the 4th day, ventilate for 12 minutes every 2 hours, with a ventilation volume of 0.20 L / (h·kg);
[0093] On the 5th day, ventilate for 15 minutes every 2 hours, with a ventilation volume of 0.15L / (h·kg).
[0094] A3. Dry the fermented material obtained in A2 at a drying temperature of 70° C. until the moisture content is about 5%, and then crush it to a particle size of 20-30 mesh to obtain the combined fermented material of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0095] Example 4: The difference between this example and Example 1 is that: (2) preparing a pill coating, the preparation method is as follows: heat white beeswax to 70°C, then add soybean oil, the mass ratio of soybean oil to white beeswax is 1:25, stir, mix well, and cool to room temperature to obtain the pill coating.
[0096] Example 5: The difference between this example and Example 1 is that: (2) preparing a pill coating, the preparation method is as follows: heat white beeswax to 75°C, then add soybean oil, the mass ratio of soybean oil to white beeswax is 7:100, stir, mix well, and cool to room temperature to obtain the pill coating.
[0097] Example 6: The difference between this example and Example 1 is that: (3) A method for preparing a Chinese medicine composition for treating herpes zoster comprises the following steps:
[0098] S1. Mix 4 parts of Radix Lycii, 3 parts of Radix Paeoniae Rubra, 3 parts of Radix Lithospermi, 4 parts of Rhizoma Smilacis Glabrae, 3 parts of Rhizoma Alismatis, 4 parts of Rhizoma Atractylodis Macrocephalae, 3 parts of Radix Ophiopogonis and 0.8 parts of Periostracum Cicadae by weight, grind them, and pass through a 70-mesh sieve to obtain a mixed medicinal material.
[0099] S2. According to the same standard weight proportions, 30 parts of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb are mixed evenly with the mixed medicinal material obtained in S1 to obtain the medicinal substance.
[0100] S3. Make pills with water and the medicinal substance obtained in S2 at a mass ratio of 0.6:1, and then coat them with a pill coating material to obtain a Chinese medicine composition for treating herpes zoster.
[0101] Example 7: The difference between this example and Example 1 is that: (3) A method for preparing a Chinese medicine composition for treating herpes zoster comprises the following steps:
[0102] S1. Mix 6 parts of Radix Lycii, 4 parts of Radix Paeoniae Rubra, 4 parts of Lithospermum Officinale, 7 parts of Smilax Glycyrrhizae, 4 parts of Rhizoma Alismatis, 5 parts of Rhizoma Atractylodis Macrocephalae, 4 parts of Radix Ophiopogonis and 1.2 parts of Periostracum Cicadae by weight, grind them, and pass through an 80-mesh sieve to obtain a mixed medicinal material.
[0103] S2. According to the same standard weight proportions, 35 parts of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb are mixed with the mixed medicinal material obtained in S1 to obtain the medicinal substance.
[0104] S3. Make pills with water and the medicinal substance obtained in S2 at a mass ratio of 0.8:1, and then coat them with a pill coating material to obtain a Chinese medicinal composition for treating herpes zoster.
[0105] Comparative Example 1: The difference between this comparative example and Example 1 is that the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb is replaced by a mixture of Scutellaria baicalensis-Gentiana scabra-Rhubarb; that is, no fermentation treatment is performed.
[0106] Specifically, the preparation method of the scutellaria-gentian-rhubarb mixture is as follows: scutellaria, gentian and rhubarb are mixed in a mass ratio of 1:0.7:1, and then crushed to a particle size of 10-15 mesh sieve to obtain the scutellaria-gentian-rhubarb mixture.
[0107] Comparative Example 2: The difference between this comparative example and Example 1 is that Trichoderma is deleted in the preparation of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0108] Specifically, the scutellaria baicalensis-gentiana scabra-rhubarb joint fermentation product is prepared, and the preparation method thereof is as follows:
[0109] A1. Mix scutellaria baicalensis, gentian and rhubarb in a mass ratio of 1:0.7:1, and grind them into a particle size of 10-15 mesh to obtain a primary material.
[0110] A2. Put the mixed strains and the initial material obtained from S1 into a fermentation tank, mix them evenly, ventilate them in stages, control the fermentation temperature at about 29°C, and ferment for 5 days to obtain the fermentation material.
[0111] Specifically, the mixed strains include the following components:
[0112] Aspergillus, the number of live bacteria in the culture solution is 3.7*10 6 CFU / mL, the volume of Aspergillus liquid used for every 100g of initial material is 2.2mL;
[0113] Lactic acid bacteria, the number of live bacteria in the culture liquid is 3.1*10 6 CFU / mL, the volume of lactic acid bacteria liquid used for every 100g of initial material is 3.8mL.
[0114] The specific operation of staged ventilation is as follows:
[0115] On the first day, ventilation was performed for 8 minutes every 2 hours, with a ventilation volume of 0.30 L / (h·kg);
[0116] On the second day, ventilation was carried out for 9 minutes every 2 hours, with a ventilation volume of 0.35 L / (h·kg);
[0117] On the third day, ventilate for 10 minutes every 2 hours, with a ventilation volume of 0.40 L / (h·kg);
[0118] On the 4th day, ventilate for 12 minutes every 2 hours, with a ventilation volume of 0.20 L / (h·kg);
[0119] On the 5th day, ventilate for 15 minutes every 2 hours, with a ventilation volume of 0.15L / (h·kg).
[0120] A3. Dry the fermented material obtained in A2 at a drying temperature of 65° C. until the moisture content is about 5%, and then crush it to a particle size of 20-30 mesh to obtain the combined fermented material of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0121] Comparative Example 3: The difference between this comparative example and Example 1 is that in the preparation of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb, Aspergillus and lactic acid bacteria are deleted.
[0122] Specifically, the scutellaria baicalensis-gentiana scabra-rhubarb joint fermentation product is prepared, and the preparation method thereof is as follows:
[0123] A1. Mix scutellaria baicalensis, gentian and rhubarb in a mass ratio of 1:0.7:1, and grind them into a particle size of 10-15 mesh to obtain a primary material.
[0124] A2. Put the strain and the initial material obtained from S1 into a fermentation tank, mix them evenly, ventilate them in stages, control the fermentation temperature at about 29°C, and ferment for 5 days to obtain the fermentation material.
[0125] Specifically, the strain is Trichoderma, and the number of live bacteria in the bacterial solution is 4.5*10 6 CFU / mL, the volume of Trichoderma liquid used for every 100g of initial material is 4.5mL.
[0126] The specific operation of staged ventilation is as follows:
[0127] On the first day, ventilation was performed for 8 minutes every 2 hours, with a ventilation volume of 0.30 L / (h·kg);
[0128] On the second day, ventilation was carried out for 9 minutes every 2 hours, with a ventilation volume of 0.35 L / (h·kg);
[0129] On the third day, ventilate for 10 minutes every 2 hours, with a ventilation volume of 0.40 L / (h·kg);
[0130] On the 4th day, ventilate for 12 minutes every 2 hours, with a ventilation volume of 0.20 L / (h·kg);
[0131] On the 5th day, ventilate for 15 minutes every 2 hours, with a ventilation volume of 0.15L / (h·kg).
[0132] A3. Dry the fermented material obtained in A2 at a drying temperature of 65° C. until the moisture content is about 5%, and then crush it to a particle size of 20-30 mesh to obtain the combined fermented material of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0133] Comparative Example 4: The difference between this comparative example and Example 1 is that in the preparation of the Chinese medicine composition for treating herpes zoster, the particle size of the mixed medicinal material is similar to that of the initial material, both of which are 10-15 mesh sieves.
[0134] Specifically, (1) preparing a combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb, the preparation method thereof is as follows:
[0135] A1. Mix scutellaria baicalensis, gentian and rhubarb in a mass ratio of 1:0.7:1, and grind them into a particle size of 10-15 mesh to obtain a primary material.
[0136] A2. Put the mixed strains and the initial material obtained from S1 into a fermentation tank, mix them evenly, ventilate them in stages, control the fermentation temperature at about 29°C, and ferment for 5 days to obtain the fermentation material.
[0137] Specifically, the mixed strains include the following components:
[0138] Trichoderma, the number of live bacteria in the culture liquid is 4.5*10 6 CFU / mL, the volume of Trichoderma liquid used for every 100g of initial material is 4.5mL;
[0139] Aspergillus, the number of live bacteria in the culture solution is 3.7*10 6CFU / mL, the volume of Aspergillus liquid used for every 100g of initial material is 2.2mL;
[0140] Lactic acid bacteria, the number of live bacteria in the culture liquid is 3.1*10 6 CFU / mL, the volume of lactic acid bacteria liquid used for every 100g of initial material is 3.8mL.
[0141] The specific operation of staged ventilation is as follows:
[0142] On the first day, ventilation was performed for 8 minutes every 2 hours, with a ventilation volume of 0.30 L / (h·kg);
[0143] On the second day, ventilation was performed for 9 minutes every 2 hours, with a ventilation volume of 0.35 L / (h·kg);
[0144] On the third day, ventilate for 10 minutes every 2 hours, with a ventilation volume of 0.40 L / (h·kg);
[0145] On the 4th day, ventilate for 12 minutes every 2 hours, with a ventilation volume of 0.20 L / (h·kg);
[0146] On the 5th day, ventilate for 15 minutes every 2 hours, with a ventilation volume of 0.15L / (h·kg).
[0147] A3. Dry the fermented material obtained in A2 at a drying temperature of 65° C. until the moisture content is about 5%, and then crush it to a particle size of 20-30 mesh to obtain the combined fermented material of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
[0148] (2) Preparing a pill coating, the preparation method is as follows: heating white beeswax to 72°C, then adding soybean oil, the mass ratio of soybean oil to white beeswax is 5.5:100, stirring, mixing, and cooling to room temperature to obtain a pill coating.
[0149] (3) A method for preparing a Chinese medicine composition for treating herpes zoster, comprising the following steps:
[0150] S1. Mix 5 parts of Radix Lycii, 3.5 parts of Radix Paeoniae Rubra, 3.5 parts of Radix Lithospermi, 6 parts of Rhizoma Smilacis Glabrae, 3.5 parts of Rhizoma Alismatis, 4.5 parts of Rhizoma Atractylodis Macrocephalae, 3.5 parts of Radix Ophiopogonis and 1 part of Periostracum Cicadae by weight, grind them into a particle size of 10-15 mesh sieve to obtain a mixed medicinal material.
[0151] S2. According to the same standard weight proportions, 33 parts of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb are mixed evenly with the mixed medicinal material obtained in S1 to obtain the medicinal substance.
[0152] S3, water and the medicinal substance obtained in S2 are made into pills at a mass ratio of 0.7:1, and then coated with a pill coating material to obtain a Chinese medicine composition for treating herpes zoster. Specifically, water and the medicinal substance obtained in S2 are mixed at a mass ratio of 0.7:1 to prepare a soft material, which is "kneaded into a ball" and then refined for 20 minutes, and then the soft material is rolled into strips, put into a 5mm mold pill making machine, cut into pills, and the pills are placed in a pan pill pot to roll into round shapes, dried at 50°C for 1h, heated to 70°C, and 0.5% of its weight of the pill coating material is added, and coated / polished to obtain a Chinese medicine composition for treating herpes zoster.
[0153] Comparative Example 5: The difference between this comparative example and Example 1 is that the vegetable oil is deleted from the pill coating; that is, the pill coating is white beeswax.
[0154] Test Example 1: Test item: Anti-nonspecific inflammatory effect-swelling inhibition rate.
[0155] Experimental content and methods: 70 ICR mice, half male and half female, weighing 19±1g, were randomly divided into 14 groups according to weight level, namely blank control group, acyclovir treatment group, Example 1-7 and Comparative Example 1-5 treatment group, 5 mice in each group.
[0156] Mice were orally administered 0.2g / 10g, once a day, for 3 consecutive days, and the blank control group was given distilled water under the same conditions. 1 hour after the last administration, 30μl / mouse of xylene was evenly applied to the front and back of the right auricle of the mouse, and the left ear was smeared with normal saline as a blank control. One hour later, the cervical vertebra of the mouse was broken, the two ears were cut and aligned along the auricle baseline, and a round ear piece (diameter 8mm) was punched out with a puncher, and weighed with an electronic balance. The difference in weight between the two ears was the degree of inflammation and swelling, and the swelling inhibition rate was calculated according to the following formula.
[0157] Swelling rate (%) = (right ear weight - left ear weight) / left ear weight × 100%;
[0158] Swelling inhibition rate (%) = (swelling rate of blank control group - swelling rate of drug group) / swelling rate of blank control group × 100%.
[0159] Test results: See Table 1.
[0160] Table 1. Test data of Experimental Example 1
[0161]
[0162]
[0163] Result analysis: Analyze Examples 1-7 and combine the data in Table 1 and Figure 1 It can be seen that the Chinese medicine composition prepared by the present invention has a significant effect on anti-nonspecific inflammation, the swelling inhibition rate is as high as 57.14% or more, and the effect is stable and reliable.
[0164] Analyze Example 1 and Comparative Examples 1-3 and combine the data in Table 1 and Figure 1 It can be seen that in the preparation of the Chinese medicine composition of the present invention, the use of Trichoderma to ferment Scutellaria baicalensis, Gentiana scabra and Rhubarb can improve the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition; the use of Aspergillus and lactic acid bacteria to ferment Scutellaria baicalensis, Gentiana scabra and Rhubarb can also improve the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition; and there is a synergistic effect between Trichoderma and Aspergillus and lactic acid bacteria, which can synergistically improve the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition.
[0165] Analyze Example 1 and Comparative Example 4 and combine the data in Table 1 and Figure 1 It can be seen that when the particle size of the scutellaria-gentian-rhubarb joint fermentation product (10-15 mesh sieve) is larger than the particle size of the mixed medicinal material (80 mesh sieve), it is more conducive to improving the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition; as in Comparative Example 4, when the particle size of the scutellaria-gentian-rhubarb joint fermentation product is similar to the particle size of the mixed medicinal material (both are 10-15 mesh sieve), the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition is reduced.
[0166] Analyze Example 1 and Comparative Example 5 and combine the data in Table 1 and Figure 1 It can be seen that the addition of vegetable oil in the preparation of the pill coating is beneficial to improving the anti-nonspecific inflammatory effect (swelling inhibition rate) of the prepared Chinese medicine composition.
[0167] Test Example 2: Test item: therapeutic effect on herpes zoster.
[0168] Test subject: Example 1.
[0169] Experimental methods and contents: CV-1 cells were added to the culture medium DMEM / F12 to prepare a cell suspension. After counting the cells, 5×10 4 / cm 2 The concentration of 100 μg / mL was inoculated into a culture flask, and then varicella-zoster virus (VZV) was used to infect CV-1 cells. When about 80% of the cells were infected, the infected cells were collected and prepared into a virus-inoculated cell suspension in PBS. The final concentration was about 11.6×10 6 / 100μL to obtain the virus inoculum. Then, 6 rats were randomly selected as the blank control group, and the left toe of the blank control group rats were injected with 50μL of normal saline. Another 20 rats were injected with 50μL of virus inoculum in the left toe. The abnormal mechanical pain threshold appeared 3d later, indicating that the model was successful; 12 rats with successful modeling were selected and randomly divided into a model group and an Example 1 medication group, with 6 rats in each group. The blank control group and the model group orally administered 15g / kg*d of normal saline, and the Example 1 medication group orally administered 15g / kg*d of the traditional Chinese medicine composition prepared in Example 1 of the present invention, for 21 consecutive days. 24 hours after the last administration, the rats in each group were decapitated and blood was collected, centrifuged at 3000r / min for 15min, and the ELISA kit was used to determine the IL-2 and TNF-α levels in plasma.
[0170] Test results: See Table 2.
[0171] Table 2. Test data of Experimental Example 2
[0172] IL-2 (pg / mL) TNF-α(pg / mL) Blank control group 4.5±0.6 257.2±34.7 Model Group 1.9±0.4 527.8±48.5 Example 1 Medication Group 3.3±0.5 314.2±37.4
[0173] Analysis of results: Compared with the blank control group, the IL-2 level of rats in the model group was decreased, and the TNF-α level was increased, indicating that herpes zoster patients (model group) had abnormal inflammation or immune response.
[0174] Specifically, IL-2 (interleukin-2) is an important immunomodulatory factor, mainly produced by activated T cells, which promotes the proliferation and differentiation of T cells and also enhances the activity of NK cells. Under normal circumstances, the level of IL-2 can reflect the body's immune status and disease resistance. Therefore, the decrease in IL-2 levels in the model group rats means that their immune function has been suppressed or damaged to a certain extent.
[0175] TNF-α (tumor necrosis factor-α) is a cytokine with a wide range of biological activities. It is mainly produced by monocytes / macrophages and plays an important regulatory role in inflammatory and immune responses. In cases of inflammation or infection, the level of TNF-α will increase significantly to promote inflammatory and immune responses. Therefore, the increase in TNF-α levels in rats in the model group indicates that there is an activation of inflammatory or immune responses in their bodies.
[0176] In the medication group of Example 1, the level of IL-2 in rat plasma was significantly higher than that in the model group, and the level of TNF-α in rat plasma was significantly lower than that in the model group, indicating that the Chinese medicine composition prepared by the present invention has a significant effect on the treatment of herpes zoster.
[0177] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.
[0178] In addition, various embodiments of the present invention may be arbitrarily combined, and as long as they do not violate the concept of the present invention, they should also be regarded as the contents disclosed by the present invention.
Claims
1. A Chinese medicine composition for treating herpes zoster, characterized in that: The invention comprises a medicinal substance and a pill coating; the medicinal substance comprises the following components by weight: 30-35 parts of a combined fermentation product of scutellaria baicalensis-gentiana-rhubarb, 4-6 parts of lycium bark, 3-4 parts of red peony root, 3-4 parts of lithospermum officinale, 4-7 parts of smilax glabra, 3-4 parts of oriental water plantain, 4-5 parts of atractylodes, 3-4 parts of ophiopogon japonicus and 0.8-1.2 parts of periostracum cicadae; The scutellaria-gentian-rhubarb joint fermentation product is prepared by mixing scutellaria, gentian and rhubarb in a mass ratio of 1: (0.6-0.8): 1 and then fermenting with mixed strains; The mixed strains include the following components: Trichoderma, the number of live bacteria in the culture liquid is 10 6 -10 7 CFU / mL, the volume of Trichoderma liquid used for every 100g of the mixture of Scutellaria baicalensis, Gentiana scabra and Rhubarb is 4-5mL; Aspergillus, the viable count of the culture solution is 10 6 -10 7 CFU / mL, the volume of Aspergillus liquid used for every 100g of the mixture of Scutellaria baicalensis, Gentiana scabra and Rhubarb is 2-2.5mL; Lactic acid bacteria, the number of live bacteria in the culture solution is 10 6 -10 7 CFU / mL, the volume of lactic acid bacteria liquid used for every 100g of the mixture of Scutellaria baicalensis, Gentiana scabra and Rhubarb is 3.5-4mL.
2. The Chinese medicine composition for treating herpes zoster according to claim 1, characterized in that: The preparation method of the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb is as follows: A1. Mix scutellaria baicalensis, gentian and rhubarb, and grind them into a particle size of 10-15 mesh to obtain a primary material; A2, putting the mixed strains and the initial material obtained in S1 into a fermentation tank, mixing them evenly, ventilating them in stages, and fermenting them to obtain a fermentation material; A3. Dry the fermented material obtained in A2 to a moisture content of 4-6%, crush it, and sieve the particle size through a 20-30 mesh sieve to obtain the combined fermented material of Scutellaria baicalensis-Gentiana scabra-Rhubarb.
3. The Chinese medicine composition for treating herpes zoster according to claim 2, characterized in that: In A2, the fermentation temperature was controlled at 28-30°C and the fermentation time was 5 days.
4. The Chinese medicine composition for treating herpes zoster according to claim 2, characterized in that: In A2, the specific operations of phased ventilation are: On the first day, ventilation was performed for 8 minutes every 2 hours, with a ventilation volume of 0.30 L / (h·kg); On the second day, ventilation was carried out for 9 minutes every 2 hours, with a ventilation volume of 0.35 L / (h·kg); On the third day, ventilate for 10 minutes every 2 hours, with a ventilation volume of 0.40 L / (h·kg); On the 4th day, ventilate for 12 minutes every 2 hours, with a ventilation volume of 0.20 L / (h·kg); On the 5th day, ventilate for 15 minutes every 2 hours, with a ventilation volume of 0.15L / (h·kg).
5. The Chinese medicine composition for treating herpes zoster according to claim 2, characterized in that: In A3, the drying temperature is 60-70°C.
6. The Chinese medicine composition for treating herpes zoster according to claim 1, characterized in that: The pill coating material comprises vegetable oil and white beeswax, and the mass ratio of the two is (4-7):
100.
7. The Chinese medicine composition for treating herpes zoster according to claim 6, characterized in that: The preparation method of the pill coating is as follows: white beeswax is heated to 70-75° C., then vegetable oil is added, stirred, mixed, and cooled to room temperature to obtain the pill coating.
8. The Chinese medicine composition for treating herpes zoster according to claim 6, characterized in that: The vegetable oil includes any one of soybean oil, rapeseed oil and olive oil.
9. A method for preparing a Chinese medicine composition for treating herpes zoster according to any one of claims 1 to 8, characterized in that: The steps include: S1. Mix the root bark of Lycium bark, red peony root, lithospermum officinale, Smilax glabra, Alisma orientalis, Atractylodes macrocephala, Ophiopogon japonicus and Periostracum cicadae, grind them, and pass through a 70-80 mesh sieve to obtain a mixed medicinal material; S2, mixing the combined fermentation product of Scutellaria baicalensis-Gentiana scabra-Rhubarb with the mixed medicinal material obtained in S1 to obtain the medicinal substance; S3. Make pills with water and the medicinal substance obtained in S2 at a mass ratio of (0.6-0.8):1, and then polish and coat them with a pill coating material to obtain a Chinese medicine composition for treating herpes zoster.