Traditional Chinese medicine pill for treating HPV infection and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, and particularly discloses a traditional Chinese medicine pill for treating HPV infection and a preparation method thereof, the traditional Chinese medicine pill is prepared from astragalus membranaceus, bighead atractylodes rhizome, divaricate saposhnikovia root, oldenlandia diffusa, radix angelicae pubescentis, semen coicis, rhizoma smilacis glabrae, cortex phellodendri, rhizoma atractylodis fried with honey and bran, ginseng, liquorice, stiff silkworm, cynanchum paniculatum, radix cyathulae and cyrtomium fortunei; the anti-HPV virus activity is remarkably improved through the synergistic effect of multiple components, the compound preparation has the dual advantages of virus resistance and immunoregulation, qi-tonifying and body resistance-strengthening components such as astragalus membranaceus and ginseng in the compound preparation can enhance the immunity of the organism, and heat-clearing and detoxifying medicinal materials such as oldenlandia diffusa and cyrtomium fortunei can directly inhibit virus replication; the accompanying damp-heat toxin accumulation symptoms such as abnormal leucorrhea and pruritus vulvae are relieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine pill for treating HPV infection and a preparation method thereof. Background Art

[0002] Human papillomavirus infection is the main cause of reproductive system diseases such as cervical cancer. At present, Western medical treatments such as interferon, antiviral drugs, and surgical resection are mainly used clinically.

[0003] Traditional chemical drugs often target a single target, making it difficult to comprehensively regulate the body's immunity and eliminate the virus. Moreover, long-term use is likely to cause adverse reactions such as gastrointestinal irritation and liver and kidney function damage. At present, most traditional Chinese medicines for treating HPV infection use single components or simple combinations, with obvious side effects, too strong cold nature of the prescription, and easy to cause spleen and stomach deficiency-cold after long-term use. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine pill for treating HPV infection and a preparation method thereof to solve the problems raised in the above background art.

[0005] To achieve the above purpose, the present invention provides the following technical solutions:

[0006] A traditional Chinese medicine pill for treating HPV infection, comprising the following components by weight:

[0007] Astragalus membranaceus 15 - 30 parts, Atractylodes macrocephala 10 - 20 parts, Saposhnikovia divaricata 8 - 15 parts, Hedyotis diffusa 20 - 40 parts, Scutellaria barbata 10 - 25 parts, Coix lacryma-jobi 15 - 30 parts, Smilax glabra 20 - 35 parts, Phellodendron amurense 10 - 20 parts, stir-fried Atractylodes lancea with bran 10 - 18 parts, Ginseng 5 - 12 parts, Glycyrrhiza uralensis 5 - 10 parts, Bombyx batryticatus 6 - 15 parts, Cynanchum paniculatum 10 - 20 parts, Cyathula officinalis 10 - 25 parts, Dryopteris crassirhizoma 15 - 30 parts.

[0008] Preferably, the preferred weight parts of each component in the formula are:

[0009] Astragalus membranaceus 25 parts, Atractylodes macrocephala 15 parts, Saposhnikovia divaricata 10 parts, Hedyotis diffusa 30 parts, Scutellaria barbata 18 parts, Coix lacryma-jobi 22 parts, Smilax glabra 28 parts, Phellodendron amurense 15 parts, stir-fried Atractylodes lancea with bran 14 parts, Ginseng 9 parts, Glycyrrhiza uralensis 7 parts, Bombyx batryticatus 10 parts, Cynanchum paniculatum 15 parts, Cyathula officinalis 18 parts, Dryopteris crassirhizoma 22 parts.

[0010] A preparation method of a traditional Chinese medicine pill for treating HPV infection, comprising the following steps:

[0011] S1. Weigh each medicinal material according to the formula ratio, pulverize and pass through an 80-mesh sieve;

[0012] S2. Decoct the crushed medicinal materials twice with water. For the first time, add 10 times the amount of water and decoct for 1.5 hours. For the second time, add 8 times the amount of water and decoct for 1 hour. After combining the filtrates, concentrate under reduced pressure to a relative density of 1.20 - 1.25 (measured at 60 °C);

[0013] S3. Mix the concentrated liquid and honey in a mass ratio of 1:0.3 - 0.5 to make pills, with each pill weighing 0.5 g;

[0014] S4. After sealing the pills with an aluminum-plastic bag, perform sterilization treatment.

[0015] Preferably, in step S2, the temperature for concentration under reduced pressure is 50 - 60 °C, and the concentration time is 3 - 4 hours.

[0016] Preferably, in step S3, the mass ratio of honey to the concentrated liquid for mixing is 1:0.4.

[0017] Preferably, in step S4, the sterilization treatment uses ultraviolet sterilization or high-temperature steam sterilization, with the sterilization temperature being 100 - 121 °C and the sterilization time being 20 - 30 minutes.

[0018] Compared with the prior art, the beneficial effects of the present invention are:

[0019] (1) Through the synergistic effect of multiple components, the anti-HPV virus activity is significantly enhanced, with both antiviral and immunomodulatory dual advantages. In the compound prescription, qi-tonifying and healthy qi-strengthening components such as Astragalus membranaceus and Panax ginseng can enhance the body's immunity, while heat-clearing and detoxifying medicinal materials such as Hedyotis diffusa and Dryopteris crassirhizoma directly inhibit virus replication and relieve symptoms of damp-heat toxin accumulation such as abnormal leucorrhea and vulvar pruritus.

[0020] (2) Through the processes of concentration under reduced pressure and making pills with honey, the active ingredients are effectively retained; ultraviolet or high-temperature steam sterilization effectively controls microbial contamination and extends the shelf life. The pill form sealed with an aluminum-plastic bag is convenient for carrying and taking quantitatively, and the patient compliance is significantly improved. Brief Description of the Drawings

[0021] Figure 1 It is the process flow chart of the present invention. Detailed Embodiments

[0022] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0023] Example 1:

[0024] Please refer to Figure 1 As shown, a traditional Chinese medicine pill for treating HPV infection includes the following components by weight:

[0025] 25 parts of Astragalus membranaceus, 15 parts of Atractylodes macrocephala, 10 parts of Saposhnikovia divaricata, 30 parts of Hedyotis diffusa, 18 parts of Scutellaria barbata, 22 parts of Coix lacryma-jobi, 28 parts of Smilax glabra, 15 parts of Phellodendron amurense, 14 parts of stir-fried Atractylodes lancea with bran and honey, 9 parts of Ginseng, 7 parts of Glycyrrhiza uralensis, 10 parts of Bombyx batryticatus, 15 parts of Cynanchum paniculatum, 18 parts of Cyathula officinalis, 22 parts of Dryopteris crassirhizoma.

[0026] A preparation method of a traditional Chinese medicine pill for treating HPV infection includes the following steps:

[0027] S1. Raw material treatment: Weigh each medicinal material accurately according to the above ratio, and use a high-speed pulverizer to pulverize it into fine powder of 80 meshes to ensure the uniformity of the powder;

[0028] S2. Extraction and concentration: Mix the pulverized medicinal materials evenly, add 10 times the amount (calculated based on the total weight of the medicinal materials) of purified water, decoct for 1.5 hours, filter and collect the filtrate; add 8 times the amount of water to the medicinal residues again, decoct for 1 hour, and combine the secondary filtrate with the primary filtrate; transfer the combined filtrate to a vacuum concentration tank, and concentrate it under reduced pressure at 60 °C to a relative density of 1.23 (measured at 60 °C), and the concentration time is about 3.5 hours;

[0029] S3. Pill making: Mix the concentrated liquid and honey in a mass ratio of 1:0.4 (for example, add 40 g of honey to 100 g of concentrated liquid), stir evenly until a viscous paste is formed; use a fully automatic pill making machine to make the paste into pills, with each pill weighing 0.5 g, and the pill shape is round and the surface is smooth;

[0030] S4. Packaging and sterilization: Pack the pills into an aluminum-plastic blister package, with 10 pills per board; use a high-pressure steam sterilizer to sterilize at 121 °C for 25 minutes, and seal and store after cooling.

[0031] Experimental example 1: In vitro anti-HPV activity test

[0032] Using the HPV pseudovirus neutralization experiment, dilute the pill extract prepared in this example to different concentrations (0.1 mg / mL, 0.5 mg / mL, 1.0 mg / mL), and at the same time set a control group with a single component being the extract of Hedyotis diffusa (1.0 mg / mL). Incubate the extracts at different concentrations with HPV-16 pseudovirus (simulating high-risk HPV infection) for 2 hours at 37 °C;

[0033] Infect human cervical cancer cells (HeLa cells), and detect the fluorescence signal (reflecting the virus invasion efficiency) after culturing for 48 hours. The specific experimental data are shown in the following table:

[0034]

[0035] As can be seen above, the inhibition rate of traditional Chinese medicine pills increased significantly with the increase of concentration (0.1→1.0mg / mL: 68.5%→92.3%), indicating a clear dose-effect relationship in its anti-HPV activity;

[0036] At a concentration of 1.0mg / mL, the inhibition rate of the traditional Chinese medicine compound (92.3%) was significantly higher than that of the single drug control group (65.8%), confirming the synergistic effect of multi-component compatibility (p<0.001);

[0037] The differences between all experimental groups and the blank control were highly statistically significant (p<0.01), and the data were highly reliable.

[0038] Experimental Example 2: Clinical Efficacy Observation

[0039] Basic information of the patient: Female, 41 years old, occupation is physical education teacher, the initial diagnosis time is May 10, 2021. Chief complaint: Persistent infection with positive HPV16 and 18 for more than half a month, accompanied by abnormal leucorrhea, vulvar pruritus, and burning and distending pain in the lower abdomen; Western medicine diagnosis is persistent high-risk HPV infection (positive for HPV16 and 18, TCT is normal); Traditional Chinese medicine diagnosis is leukorrhagia disease (syndrome of deficiency of healthy qi, dampness-heat and toxin accumulation);

[0040] Treatment method: The treatment principle is to replenish qi and strengthen the spleen, clear heat and resolve toxins, and remove dampness;

[0041] Initial diagnosis prescription (May 10, 2021): Astragalus membranaceus 18g, Saposhnikovia divaricata 6g, Atractylodes macrocephala 12g, Armeniaca vulgaris 9g, Amomum kravanh 6g, Coix lacryma-jobi 30g, Magnolia officinalis 12g, Pinellia ternata 9g, Smilax glabra 30g, Lonicera japonica 30g, Cynanchum paniculatum 15g, Bombyx batryticatus 8g, Dioscorea septemloba 15g, Hedyotis diffusa 30g, Glycyrrhiza uralensis 6g, 1 dose per day, taken continuously for 7 days;

[0042] Adjustment at the second diagnosis (May 17, 2021): Remove Armeniaca vulgaris, Amomum kravanh, and Magnolia officinalis from the original prescription, add Phellodendron chinense 10g, Atractylodes lancea 10g, and Cyathula officinalis 15g, taken continuously for 14 days;

[0043] Adjustment at the third diagnosis (May 31, 2021): Add Cyrtomium fortunei 9g and Artemisia capillaris 15g, taken continuously for 14 days;

[0044] Subsequent consolidation (June - August 2021): Based on Yupingfeng Powder (strengthening healthy qi) combined with Sini Powder and Sanren Decoction (clearing heat and removing dampness), with symptomatic addition and subtraction: Add Salvia miltiorrhiza 15g and Leonurus japonicus 15g before menstruation; Add Citrus reticulata 9g, Germinated Barley 15g, and Six-Flavor Medicinal Leaven 9g for loose stools;

[0045] Efficacy evaluation: After 7 days of the initial diagnosis, the amount of leucorrhea decreased, the vulvar pruritus alleviated, and the sleep became peaceful; After 14 days of the second diagnosis, the color of the leucorrhea turned white, the vulvar pruritus disappeared, and the distending pain in the lower abdomen was relieved; After 14 days of the third diagnosis, the amount of leucorrhea was normal, white in color, and the burning sensation in the lower abdomen occurred occasionally;

[0046] Laboratory indicators: Before treatment (April 15, 2021), HPV16 and 18 were positive, and TCT was normal; after treatment (August 25, 2021), HPV became negative, and TCT showed "no intraepithelial lesion or malignant cells".

[0047] Traditional Chinese medicine syndrome score: The syndrome of damp-heat toxin accumulation (such as sticky mouth, yellow urine, yellow and greasy tongue coating) was significantly improved, and the pulse condition changed from thready and slow to thready, stringy and slow.

[0048] Result analysis: The total treatment course was 3 months. The symptom remission rate was that symptoms such as abnormal leucorrhea, vulvar pruritus, and lower abdominal discomfort were completely relieved. No gastrointestinal irritation or other adverse reactions were reported during the treatment.

[0049] The typical comparison before and after treatment is shown in the following table:

[0050] Observation indicators Before treatment After treatment HPV Testing HPV16, 18 positive HPV negative Leucorrhea characteristics Large quantity, yellow color, thick texture Small amount, white color, normal texture Associated symptoms Itching of vulva, burning and distension in lower abdomen Symptoms disappear Tongue and pulse Pale red tongue, thin yellow greasy coating, thready and slow pulse Pale red tongue, thin white fur, thin, stringy and slow pulse

[0051] As can be seen from the above, in this case, through syndrome differentiation and treatment of traditional Chinese medicine, with the methods of supplementing qi and strengthening the spleen, clearing heat and detoxifying dampness, and adopting the strategy of dynamically adjusting prescriptions, high-risk HPV became negative within 3 months, and clinical symptoms were completely relieved. The results show that the traditional Chinese medicine compound has significant efficacy in regulating the body's immunity, clearing HPV virus and improving the syndrome of damp-heat toxin accumulation, and has good safety, providing a clinical reference for the treatment of HPV infection with traditional Chinese medicine.

[0052] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made in these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine pill for treating HPV infection, characterized in that: The following components are included by weight: 15-30 parts of Astragalus, 10-20 parts of Atractylodes, 8-15 parts of Saposhnikovia, 20-40 parts of Oldenlandia Diffusa, 10-25 parts of Scutellaria barbata, 15-30 parts of Coix seeds, 20-35 parts of Smilax glabra, 10-20 parts of Phellodendron, 10-18 parts of Atractylodes lancea stir-fried with honey bran, 5-12 parts of Ginseng, 5-10 parts of Licorice, 6-15 parts of Bombyx Batryticatus, 10-20 parts of Cynanchum wilfordii, 10-25 parts of Cyathula capitata, and 15-30 parts of Cyperus rotundus.

2. A Chinese medicine pill for treating HPV infection according to claim 1, characterized in that: The preferred weight proportions of each component in the formula are: 25 parts of Astragalus, 15 parts of Atractylodes, 10 parts of Saposhnikovia, 30 parts of Oldenlandia Diffusa, 18 parts of Scutellaria barbata, 22 parts of Coix seeds, 28 parts of Smilax glabra, 15 parts of Phellodendron chinense, 14 parts of Atractylodes macrocephala stir-fried with honey bran, 9 parts of Ginseng, 7 parts of Licorice, 10 parts of Bombyx batryticatus, 15 parts of Cynanchum chinense, 18 parts of Cyathula capitata, and 22 parts of Cyperus rotundus.

3. A method for preparing a Chinese medicine pill for treating HPV infection, characterized in that: The following steps are involved: S1. Weigh each medicinal material according to the formula ratio and crush it through an 80-mesh sieve; S2, the crushed medicinal materials were decocted twice, the first time with 10 times the amount of water and decocted for 1.5 hours, the second time with 8 times the amount of water and decocted for 1 hour, the filtrate was combined and concentrated under reduced pressure to a relative density of 1.20-1.25 (measured at 60°C); S3, the concentrate and honey are mixed in a mass ratio of 1:0.3-0.5 to prepare pills, each weighing 0.5 g; S4. Seal the pills in an aluminum-plastic bag and sterilize them.

4. The method for preparing a Chinese medicine pill for treating HPV infection according to claim 3, characterized in that: The temperature of the reduced pressure concentration in step S2 is 50-60° C., and the concentration time is 3-4 hours.

5. The method for preparing a Chinese medicine pill for treating HPV infection according to claim 3, characterized in that: The mixing mass ratio of the honey to the concentrated liquid in step S3 is 1:0.

4.

6. The method for preparing a Chinese medicine pill for treating HPV infection according to claim 3, characterized in that: The sterilization treatment in step S4 adopts ultraviolet sterilization or high-temperature steam sterilization, the sterilization temperature is 100-121° C., and the sterilization time is 20-30 minutes.

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