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

Abstract

The invention discloses a traditional Chinese medicine composition for treating herpes zoster and a preparation method thereof, and relates to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition for treating herpes zoster comprises the following raw materials in parts by weight: 7-9 parts of indigo naturalis, 3-5 parts of perfoliote knotweed herb, 3-5 parts of creeping oxalis, 7-9 parts of calcined gypsum, 3-5 parts of creeping rostellularia herb, 7-9 parts of golden cypress and 0.5-1.5 parts of borneol; according to the traditional Chinese medicine composition for treating herpes zoster and the preparation method of the traditional Chinese medicine composition, heat toxin in a body can be effectively removed, neuralgia caused by herpes zoster can be quickly relieved, healing of skin at an affected part is promoted, blister formation and rupture are reduced, skin lesion recovery is accelerated, and meanwhile postherpetic neuralgia is prevented; in addition, the composition is relatively simple in components, reasonable in compatibility, stable in curative effect, high in safety and suitable for long-term use by adopting natural traditional Chinese medicine raw materials, and part of the components have a certain immunoregulation effect and are beneficial to enhancing the immunity of the organism; and the preparation process is stable and feasible.

Description

Technical Field

[0001] The present invention relates to traditional Chinese medicine technology, and particularly relates to a traditional Chinese medicine composition for treating herpes zoster and a preparation method thereof. Background Art

[0002] Herpes zoster (snake string sore) is a skin disease caused by varicella-zoster virus. Its typical symptoms include erythema, blisters on the skin, and accompanied severe pain. Traditional Chinese medicine believes that the occurrence of snake string sore is closely related to factors such as stagnation of liver meridian heat, accumulation of damp-heat, and qi stagnation and blood stasis. Its main symptoms include the appearance of erythema and blisters on the skin, accompanied by obvious neuralgia. The degree of pain varies from person to person, and in the elderly or people with low immunity, the pain may be more severe and last longer. In addition, herpes zoster may also cause various complications, such as postherpetic neuralgia, bringing long-term pain to patients.

[0003] Currently, the clinical treatment methods for herpes zoster mainly include antiviral treatment, pain relief treatment, local care, etc. Commonly used antiviral drugs include acyclovir, valacyclovir, etc., but these drugs may produce drug resistance and have limited effect on relieving neuralgia. In addition, some traditional Chinese medicine prescriptions are also used to treat herpes zoster, but there are problems such as complex ingredients, unstable curative effects, and lack of systematic research and clinical verification. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating herpes zoster and a preparation method thereof to solve the above deficiencies in the prior art.

[0005] To achieve the above purpose, the present invention provides the following technical solution: A traditional Chinese medicine composition for treating herpes zoster, the raw materials of which include, by weight: 7-9 parts of indigo naturalis, 3-5 parts of polygonum perfoliatum, 3-5 parts of oxalis corniculata, 7-9 parts of calcined gypsum, 3-5 parts of justicia procumbens, 7-9 parts of phellodendron amurense, and 0.5-1.5 parts of borneol.

[0006] Further, the raw materials of which include, by weight: 8 parts of indigo naturalis, 4 parts of polygonum perfoliatum, 4 parts of oxalis corniculata, 8 parts of calcined gypsum, 4 parts of justicia procumbens, 8 parts of phellodendron amurense, and 1 part of borneol.

[0007] Further, the preparation form of the traditional Chinese medicine composition is powder.

[0008] A preparation method of a traditional Chinese medicine composition for treating herpes zoster includes the following steps:

[0009] S1. Select oxalis corniculata, polygonum perfoliatum, justicia procumbens, and phellodendron amurense according to the selected weight parts, clean them using a cleaning device, dry them after cleaning, and then add borneol and calcined gypsum and mix and pulverize to obtain a mixture;

[0010] S2. Add indigo naturalis to the mixture, pass through a 100-mesh sieve, mix evenly, and then divide and package to obtain the product.

[0011] Further, the drying conditions in S1 are: temperature 50°C, time 4 h.

[0012] Further, the mixing duration in S2 is 20 min to 40 min.

[0013] Compared with the prior art, a traditional Chinese medicine composition for treating herpes zoster and its preparation method provided by the present invention have the effects of clearing heat and detoxifying, significant pain relief, promoting healing, preventing sequelae, simple ingredients, no toxic and side effects of hormone stimulation, and improving immunity. It can effectively remove the heat toxin in the body, quickly relieve the neuralgia caused by herpes zoster, promote the healing of the skin at the affected area, reduce the formation and rupture of blisters, accelerate the recovery of skin lesions, and at the same time prevent the occurrence of postherpetic neuralgia. In addition, the composition has relatively simple ingredients, reasonable compatibility, stable curative effect, reduces the interaction between drugs, uses natural traditional Chinese medicine raw materials, has high safety, is suitable for long-term use, and some ingredients also have a certain immunomodulatory effect, which helps to enhance the body's immunity and promote the overall recovery of the condition. And the preparation process is stable and feasible. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required in the embodiments. Obviously, the drawings described below are only some embodiments recorded in the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings.

[0015] Figure 1 It is a schematic diagram of the measurement result of the critical relative humidity (CRH) of the traditional Chinese medicine composition provided by the embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0016] In order to enable those skilled in the art to better understand the technical solutions of the present invention, the following will further introduce the present invention in detail with reference to the drawings.

[0017] Example 1:

[0018] A traditional Chinese medicine composition for treating herpes zoster, the raw materials of which include, by weight: 7 - 9 parts of indigo naturalis, 3 - 5 parts of polygonum perfoliatum, 3 - 5 parts of oxalis corniculata, 7 - 9 parts of calcined gypsum, 3 - 5 parts of justicia procumbens, 7 - 9 parts of phellodendron amurense, and 0.5 - 1.5 parts of borneol; the raw materials of which include, by weight: 8 parts of indigo naturalis, 4 parts of polygonum perfoliatum, 4 parts of oxalis corniculata, 8 parts of calcined gypsum, 4 parts of justicia procumbens, 8 parts of phellodendron amurense, and 1 part of borneol; the preparation form of the traditional Chinese medicine composition is powder.

[0019] Indigo Naturalis has the effects of clearing heat and detoxifying, cooling blood and dissipating macules. Its cold nature determines that it can play the role of clearing heat and detoxifying, and at the same time has the effect of cooling blood and dissipating macules. In the treatment of herpes zoster, Indigo Naturalis can relieve local inflammatory reactions, reduce pain and swelling, and may also be helpful for the regression of blisters.

[0020] Polygonum perfoliatum L. is a Chinese herbal medicine with the effects of clearing heat and detoxifying, promoting diuresis, detumescence and activating blood circulation. In the treatment of herpes zoster, Polygonum perfoliatum L. can relieve local pain and swelling, and promote the regression and healing of blisters.

[0021] Oxalis corniculata L. has the effects of clearing heat and detoxifying, detumescence and relieving pain. In the treatment of herpes zoster, Oxalis corniculata L. can reduce local inflammation, relieve pain, and promote the healing of skin lesions.

[0022] Calx Gypsum Fibrosi has the effects of clearing heat and purging fire, promoting granulation and astringing sore. In the treatment of herpes zoster, Calx Gypsum Fibrosi can reduce local inflammation and promote skin healing.

[0023] Rostellularia procumbens (L.) Nees has the effects of clearing heat and detoxifying, promoting diuresis and detumescence. In the treatment of herpes zoster, Rostellularia procumbens (L.) Nees can relieve local inflammatory reactions, reduce pain, and promote the healing of skin lesions.

[0024] Phellodendron amurense Rupr. has the effects of clearing heat and drying dampness, purging fire and detoxifying. In the treatment of herpes zoster, Phellodendron amurense Rupr. can reduce local inflammation, relieve pain, and promote the healing of skin lesions.

[0025] Borneolum Syntheticum has the effects of resuscitating the patient from unconsciousness, clearing heat and relieving pain. In the treatment of herpes zoster, Borneolum Syntheticum can relieve neuralgia and promote skin healing.

[0026] In summary, these ingredients work together to effectively treat herpes zoster caused by stagnation of heat in the liver meridian, relieve pain and inflammation, promote the healing of skin lesions, and reduce the occurrence of sequelae.

[0027] Example 2:

[0028] A preparation method of a traditional Chinese medicine composition for treating herpes zoster includes the following steps:

[0029] S1. Select Oxalis corniculata L., Polygonum perfoliatum L., Rostellularia procumbens (L.) Nees and Phellodendron amurense Rupr. according to the selected weight parts, and use a cleaning device for cleaning. After cleaning, dry at 50 °C for 4 h, and then add Borneolum Syntheticum and Calx Gypsum Fibrosi and mix and pulverize to obtain a mixture;

[0030] Take 1621.6 g of Oxalis corniculata L., 1621.6 g of Polygonum perfoliatum L., 1621.6 g of Rostellularia procumbens (L.) Nees and 3243.2 g of Phellodendron amurense Rupr., use a cleaning device for cleaning. After cleaning, dry at 50 °C for 4 h, and then add 405.4 g of Borneolum Syntheticum and 3243.2 g of Calx Gypsum Fibrosi and mix and pulverize to obtain a mixture;

[0031] S2. Add indigo naturalis to the mixture, pass through a 100-mesh sieve, mix for 20 min to 40 min, and then subpackage to obtain the product.

[0032] Add 3243.2 g of indigo naturalis to the mixture, pass through a 100-mesh sieve, mix for 20 min to 40 min, and then subpackage to obtain the product.

[0033] Example 3:

[0034] On the basis of Example 2, this example provides a technical solution: research on drying and pulverizing processes.

[0035] Design an orthogonal table 1 with baking temperature, baking time, and particle size as the investigation factors, and use the pulverizing yield as the evaluation index to determine the optimal drying and pulverizing processes.

[0036] Table 1 Factor and level table of drying and pulverizing processes

[0037] Horizontal Baking Temperature (A) Baking Time (B) Particle Size (C) 1 40℃ 2h 60 Mesh 2 50℃ 3h 80 Mesh 3 60℃ 4h 100 Mesh

[0038] The results are shown in Table 2. It can be seen from Table 1 and Table 2 that, taking the powder yield as the index, the importance of each factor in the pulverizing process is evaluated. Among them, baking time > baking temperature > sieving rate, and the optimal combination is A2B3C3.

[0039] Table 2 Orthogonal experimental design and results of pulverizing process

[0040]

[0041]

[0042] Example 4:

[0043] On the basis of Example 2, this example provides a technical solution: research on mixing process.

[0044] To ensure that each medicine is mixed as evenly as possible, sampling is carried out in accordance with the "Technical Guidelines for the Study of Mixing Uniformity and In-process Dosage Unit Uniformity of Chemical Oral Solid Preparations (Trial)" (2022 Edition). Taking the indirubin content (mg / g) and uniformity (uniform color, no patterns and color spots) as the judgment criteria, the mixing time of the mixing equipment is investigated.

[0045] Table 3 Research on mixing process

[0046]

[0047] The calculation formula for material balance is: weight after mixing / weight before mixing × 100%.

[0048] It can be seen from Table 3 that the samples can be mixed evenly within the three mixing times of 20 min, 30 min, and 40 min.

[0049] Example 5:

[0050] On the basis of Example 1 or Example 2, this example provides a technical solution: the powder properties investigation of the traditional Chinese medicine composition.

[0051] 1. Method for investigating hygroscopicity: Dry the medicinal powder in an oven until constant weight. Place a glass desiccator with a supersaturated sodium chloride solution at the bottom in a constant temperature incubator at 25°C for 24 hours. At this time, the relative humidity in the desiccator is 75%. Place dry medicinal powder about 2 mm thick at the bottom of a pre-weighed weighing bottle. After accurately weighing, place it in the above-mentioned glass desiccator (with the weighing bottle cap open), store it at 25°C, take it out at regular intervals (1, 2, 4, 8, 12, 24, 48, 72 h) for weighing, and calculate the hygroscopic percentage according to the following formula. The calculation formula is:

[0052]

[0053] For specific test results, please refer to Table 4.

[0054] Table 4 Investigation of hygroscopicity

[0055] Time / h Moisture Absorption Percentage (%) Physical Appearance of Medicinal Powder 1 5.75 Light Bluish Green or Bluish Green Powder 2 6.32 Light Bluish Green or Bluish Green Powder 4 6.47 Light Bluish Green or Bluish Green Powder 8 6.78 Light Bluish Green or Bluish Green Powder 12 6.79 Light Bluish Green or Bluish Green Powder 24 6.78 Light Bluish Green or Bluish Green Powder 48 6.75 Light Bluish Green or Bluish Green Powder 72 6.75 Light Bluish Green or Bluish Green Powder

[0056] As can be seen from Table 4 of the specific test results, the traditional Chinese medicine composition powder reaches moisture absorption equilibrium in 3 days at 25°C and 75% relative humidity, and the moisture absorption percentage at equilibrium is 6.75%.

[0057] 2. Method for measuring the angle of repose: Adopt the fixed funnel method: Connect 3 funnels in series and fix them at a height of 1 cm on the horizontally placed coordinate paper. Carefully pour the powder along the funnel wall into the uppermost funnel until the tip of the powder cone formed on the coordinate paper touches the funnel mouth. Measure the diameter of the bottom of the cone from the coordinate paper and calculate the angle of repose. The specific test results are shown in Table 5.

[0058] Table 5 Investigation of the angle of repose of the powder of the dried traditional Chinese medicine composition

[0059]

[0060] As can be seen from Table 5, the angle of repose of the traditional Chinese medicine composition powder is 31°, showing a loose state and relatively good fluidity.

[0061] 3. Determination of the critical relative humidity (CRH): Prepare different concentrations of H2SO4 or saturated salt solutions according to Table 6, place them in glass desiccators respectively, and place them in a constant temperature at 20°C for 48 hours to make the internal humidity balance to form different relative humidity environments. Place dry traditional Chinese medicine composition powder about 2 mm thick in a dried and weighed bottle, weigh it, dry it to constant weight, accurately weigh it, open the weighing bottle cap, put it into the above-mentioned different RH desiccators, absorb moisture to constant weight in the constant temperature, and accurately weigh and calculate the moisture absorption rate. The specific test results are shown in Table 6.

[0062] Table 6 Moisture Absorption Rates of Different RH Traditional Chinese Medicine Powders

[0063] Reagent Relative Humidity / % Moisture Absorption Percentage / % 54% Sulfuric Acid 28 1.18 48% Sulfuric Acid 40 2.67 44% Sulfuric Acid 48 3.01 Saturated Sodium Bromide 60 7.39 Saturated Sodium Chloride 75 10.13 Saturated Potassium Chloride 85 13.59 Saturated Potassium Nitrate 95 17.23

[0064] Please refer to Figure 1 , when the RH is 48%, the moisture absorption rate of the traditional Chinese medicine composition powder begins to increase significantly. By the graphical method, with the moisture absorption percentage as the vertical coordinate and the relative humidity as the horizontal coordinate, a moisture absorption curve is obtained. Then, tangents are drawn from both ends of the curve, and the abscissa corresponding to the intersection point of the tangents is the critical relative humidity. The critical relative humidity of the traditional Chinese medicine composition powder is 63%.

[0065] Example Six:

[0066] This example provides a technical solution on the basis of Example Two: stability study of the preparation method.

[0067] According to the preparation method, three batches of pilot-scale tests are carried out, that is, the medicinal materials required to prepare 1000 bags of preparations are taken and made into 15000 g. Three consecutive batches of pilot-scale tests are carried out, and the pilot-scale parameters are recorded and detected according to the quality standards. The results are shown in Table 7 and Table 8.

[0068] Table 7 Pilot-Scale Research Data of Traditional Chinese Medicine Composition

[0069]

[0070] Table 8 Detection Data of Pilot-Scale Products of Traditional Chinese Medicine Composition

[0071]

[0072] The results show that the results of the three batches of samples produced in the pilot-scale production are relatively stable, indicating that the formulated process is stable and feasible.

[0073] Example Seven:

[0074] This example provides a technical solution on the basis of Example One or Example Two: clinical application research of traditional Chinese medicine composition.

[0075] This trial adopts a retrospective research method. 118 inpatients from the Affiliated Miao Medicine Hospital of Qiandongnan Prefecture Institute of National Medicine from 2019 to 2024 are collected, including 7 cases in 2019, 16 cases in 2020, 19 cases in 2021, 29 cases in 2022, 20 cases in 2023, and 27 cases in 2024; all 118 patients meet the diagnosis of shingles (herpes zoster) caused by stagnation of liver qi and heat.

[0076] Before medication, 118 patients had mild or moderate papulovesicles / blisters, erosion, erythema / edema, pain level, tongue coating, and pulse condition around the affected area. Among them, 9 patients had no papulovesicles / blisters, 106 had no erosion, 4 had no erythema / edema, and all 118 patients had pain.

[0077] Medication regimen: The traditional Chinese medicine composition was mixed with sesame oil and applied topically to the affected area; the medication time was calculated from the starting time of the patient's medication.

[0078] The specific curative effect results are as follows:

[0079] 1. Evaluation of the healing effect of the affected area:

[0080] Among them, the evaluation criteria for the healing of the affected area are as follows:

[0081] Clinical control: The rash has scabbed over and the pain has disappeared;

[0082] Marked effect: Most of the rash has scabbed over and the pain has been significantly reduced;

[0083] Effective: Some of the rash has scabbed over and the pain has been reduced;

[0084] Ineffective: The symptoms have basically not changed.

[0085] Please refer to Table 9 below for the healing results of the affected area:

[0086] Table 9 Evaluation of the healing effect of the affected area

[0087]

[0088] From the healing results of the affected area, among the 118 patients, 99 were clinically controlled and 19 had a marked effect, indicating that the patients had a good healing effect.

[0089] 2. Condition of papulovesicles / blisters after medication:

[0090] After medication, the differences in papulovesicles / blisters, erosion, erythema / edema, and pain level among the 118 patients compared with before were statistically significant (P < 0.0001), indicating that Qingdai Qingzhen Powder had a good protective effect on the affected area and had a certain improvement effect on papulovesicles / blisters, erosion, erythema / edema, and pain on the skin around the affected area. The scoring details of each symptom are shown in Table 10 below:

[0091] Table 10 Scoring details of each symptom

[0092]

[0093]

[0094] Among them, the improvement of papulovesicles / blisters after use is shown in Table 11.

[0095] Table 11 Improvement of papules / vesicles after use

[0096] Index Item Number of People and Proportion Before Use Number of People and Proportion After Use 0 Points 9(7.63％) 109(92.37％) 1 Point 11(9.32％) 9(7.63％) 2 Points 59(50.00％) 0(0.00％) 3 Points 39(33.05％) 0(0.00％)

[0097] Among them, the improvement of skin erosion after use is shown in Table 12.

[0098] Table 12 Improvement of skin erosion after use

[0099] Index Item Number of People and Proportion Before Use Number of People and Proportion After Use 0 Points 106(89.83％) 118(100.00％) 1 Point 11(9.32％) 0(0.00％) 2 Points 0(0.00％) 0(0.00％) 3 Points 1(0.85％) 0(0.00％)

[0100] Among them, the improvement of skin erythema / edema after use is shown in Table 13.

[0101] Table 13 Improvement of skin erythema / edema after use

[0102] Index Item Number of People and Proportion Before Use Number of People and Proportion After Use 0 Points 4(3.39％) 109(92.37％) 1 Point 28(23.73％) 9(7.63％) 2 Points 72(61.02％) 0(0.00％) 3 Points 14(11.86％) 0(0.00％)

[0103] Among them, the improvement of pain after use is shown in Table 14.

[0104] Table 14 Improvement of pain after use

[0105] Index Item Number of People and Proportion Before Use Number of People and Proportion After Use 0 Points 0(0.00％) 114(96.61％) 1 Point 0(0.00％) 1(0.85％) 2 Points 1(0.85％) 3(2.54％) 3 Points 7(5.93％) 0(0.00％) 4 Points 8(6.78％) 0(0.00％) 5 Points 14(11.86％) 0(0.00％) 6 Points 36(30.51％) 0(0.00％) 7 Points 25(21.19％) 0(0.00％) 8 Points 22(18.64％) 0(0.00％) 9 Points 3(2.54％) 0(0.00％) 10 Points 2(1.69％) 0(0.00％)

[0106] Among them, the adverse reaction situation after use is shown in Table 15.

[0107] Table 15 Adverse reaction situation after use

[0108]

[0109] To sum up, in this study, 118 cases of patients were retrospectively collected for this prescription. 99 cases were clinically controlled and 19 cases were markedly effective, indicating that the affected area of the patients recovered well. Regarding the skin symptoms and signs around the affected area: for the 118 patients, the papules / vesicles, erosion, erythema / edema, pain, etc. of the skin around the affected area were all improved to varying degrees after medication, indicating that Qingdai Qingzhen Powder has a good protective effect on the affected area. The average medication time for the 118 patients was 12.11 days, and the maximum medication time was 22 days. Therefore, a treatment course of 12 days is relatively reasonable and can be continuously used for 2 treatment courses according to the condition. In the safety analysis, none of the 118 cases had adverse reactions.

[0110] Qingdai Qingzhen Powder has good clinical efficacy for shingles (herpes zoster) caused by stagnation of liver fire syndrome, has good protective and certain improvement effects on the affected area and the surrounding skin, has no adverse reactions, and its functions and indications are to clear heat, astringe dampness, and relieve itching. For shingles (herpes zoster) caused by stagnation of liver fire, there may be papules / vesicles, erosion, erythema / edema, pain, etc. on the local area; for external use, mix it with sesame oil and apply it to the affected area; 12 days is a course of treatment. This product is for external use only and oral administration is prohibited; there may be caking phenomenon after long-term placement of this product, which does not affect its use; use it with caution on damaged skin; if adverse reactions occur during the medication process, stop using it and consult a doctor; if you are using other medications, please consult a doctor or a pharmacist before using this product.

[0111] Only some exemplary embodiments of the present invention are described above by way of illustration. Undoubtedly, for those of ordinary skill in the art, the described embodiments can be modified in various different ways without departing from the spirit and scope of the present invention. Therefore, the above drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating herpes zoster, characterized in that, Its raw materials by weight include: 7-9 parts of Indigo Naturalis, 3-5 parts of Polygonum perfoliatum L., 3-5 parts of Oxalis corniculata L., 7-9 parts of calcined gypsum, 3-5 parts of Rostellularia procumbens (L.) Nees, 7-9 parts of Phellodendron amurense Rupr. and 0.5-1.5 parts of borneol.

2. The traditional Chinese medicine composition for treating herpes zoster according to claim 1, wherein, Its raw materials by weight include: 8 parts of Indigo Naturalis, 4 parts of Polygonum perfoliatum L., 4 parts of Oxalis corniculata L., 8 parts of calcined gypsum, 4 parts of Rostellularia procumbens (L.) Nees, 8 parts of Phellodendron amurense Rupr. and 1 part of borneol.

3. The traditional Chinese medicine composition for treating herpes zoster according to claim 1, wherein, The preparation form of the traditional Chinese medicine composition is powder.

4. A preparation method of a traditional Chinese medicine composition for treating herpes zoster, characterized in that, It includes the following steps: S1. Select Oxalis corniculata L., Polygonum perfoliatum L., Rostellularia procumbens (L.) Nees and Phellodendron amurense Rupr. according to the selected weight parts, clean them by using a cleaning device, dry them after cleaning, and then add borneol and calcined gypsum and mix and crush them to obtain a mixture. S2. Add Indigo Naturalis to the mixture, pass through a 100-mesh sieve, mix evenly, and package to obtain the traditional Chinese medicine composition.

5. The preparation method of a traditional Chinese medicine composition for treating herpes zoster according to claim 4, characterized in that, The conditions of drying in S1 are: temperature 50 °C, time 4 h.

6. The traditional Chinese medicine composition for treating herpes zoster and its preparation method according to claim 4, characterized in that, The mixing duration in S2 is 20 min to 40 min.

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