Traditional Chinese medicine for treating HPV infection in women

Abstract

The present application relates to a kind of traditional Chinese medicine for treating female HPV infection, which is prepared from the following weight ratio of traditional Chinese medicine raw materials: 2-4 parts of catechu, 2-4 parts of half lotus, 2-4 parts of snakeberry, 1-2 parts of longjin, 1-2 parts of gotu kola, 1-2 parts of wintergreen, 1-2 parts of coptis, and 1-2 parts of sophora. The present application can effectively treat female HPV infection.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically a traditional Chinese medicine for treating HPV infection in women. Background Technology

[0002] HPV stands for Human Papillomavirus, a sexually transmitted disease caused by a spherical DNA virus. The main types are HPV 1, 2, 6, 11, 16, 18, 31, 33, and 35. Long-term infection with HPV types 16 and 18 may be associated with the development of cervical cancer in women.

[0003] In recent years, with the promotion of HPV screening, people have paid more and more attention to this issue. HPV infection is mainly transmitted sexually, and people with weak immune systems are also more susceptible to HPV infection.

[0004] Persistent infection with high-risk HPV is a necessary condition for the development of cervical cancer. Cervical cancer has become the only cancer with a clearly defined cause among all cancers currently known to mankind, and it is also the only cancer that can be prevented.

[0005] Persistent HPV infection is closely related to the development of cervical cancer; therefore, cutting off HPV infection can effectively prevent cervical cancer.

[0006] Currently, the main treatments for HPV infection are: 1. Drug therapy (interferon, lactobacillus, and Rebecca protein excipients); 2. Physical therapy (focused ultrasound); 3. Traditional Chinese medicine (oral and topical); 4. HPV vaccine. Traditional Chinese medicine does not have a specific disease name for HPV infection, but it can be categorized under "leukorrhea," "abdominal masses," and "red and white leukorrhea," etc. For the treatment of HPV infection, topical medications in traditional Chinese medicine mainly use suppositories, powders, ointments, and lotions. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine for treating HPV infection, which can effectively eliminate the HPV virus.

[0008] The technical solution of the present invention is as follows: a traditional Chinese medicine for treating HPV infection in women, which is a medicine made from the following traditional Chinese medicine raw materials in the following weight ratios: 2-4 parts of catechu, 2-4 parts of lobelia chinensis, 2-4 parts of scabies, 1-2 parts of Cynanchum paniculatum, 1-2 parts of Centella asiatica, 1-2 parts of Rabdosia rubescens, 1-2 parts of Coptis chinensis, and 1-2 parts of Sophora flavescens.

[0009] The preparation method of the above-mentioned traditional Chinese medicine for treating HPV infection in women is as follows: First, take catechu, Lobelia chinensis, Duchesnea indica, Cynanchum paniculatum, Centella asiatica, Rabdosia rubescens, Coptis chinensis, and Sophora flavescens according to the above formula ratio. Process the raw materials with an ultra-low temperature pulverizer. When pulverizing the raw materials at low temperature, control the temperature at 1-10℃ to form ultra-fine powder. Then, sterilize and package the powder after conventional irradiation.

[0010] Take 1.0g of the above-mentioned ultrafine powder of traditional Chinese medicine and insert it deep into the vagina using a disposable vaginal applicator. Use it externally every other day (excluding menstruation). One course of treatment consists of 10 applications, and three consecutive courses should be used. A follow-up examination can be performed three months after stopping the medication.

[0011] Solution of this invention:

[0012] catechu:

[0013] [Properties and Channels Entered] Bitter, astringent, and slightly cold in nature. Enters the Lung and Heart channels.

[0014]

Functions and Indications

[0015] Sophora flavescens:

[0016] [Properties and Channels Entered] Bitter, cold. Enters the Heart, Liver, Stomach, Large Intestine, and Bladder channels.

[0017]

Functions and Indications

[0018] Coptis chinensis:

[0019] [Properties and Channels Entered] Bitter, cold. Enters the Heart, Spleen, Stomach, Liver, Gallbladder, and Large Intestine channels.

[0020]

Functions and Indications

[0021] Lobelia:

[0022] [Properties and Channels Entered] Pungent, neutral. Enters the Heart, Small Intestine, and Lung channels.

[0023]

Functions and Indications

[0024] Snakeberry:

[0025] [Properties and Channels Entered] It is sweet and bitter in taste, cold in nature, and enters the lung, liver, and large intestine channels.

[0026]

Functions and Indications

[0027] Xu Changqing:

[0028] [Properties and Channels Entered] Pungent, warm, enters the liver and stomach channels.

[0029]

Functions and Indications

[0030] Centella asiatica:

[0031] [Properties and Channels Entered] Bitter, pungent, cold; enters the liver, spleen, and kidney channels.

[0032]

Functions and Indications

[0033] Wintergreen:

[0034] [Properties and Channels Entered] It is bitter, sweet, and slightly cold in nature, and enters the lung, stomach, and liver channels.

[0035]

Functions and Indications

[0036] Cervical HPV infection is often caused by early marriage, promiscuity, and unclean sexual practices, coinciding with a period of spleen and kidney deficiency. This leads to exposure to damp-heat toxins, compounded by emotional distress and blood stasis, resulting in internal dampness and turbidity. Prolonged dampness transforms into heat, and the damp-heat toxins accumulate in the uterus. Clinical treatment focuses on clearing heat and detoxifying, resolving turbidity and eliminating carbuncles. A topical Chinese medicine powder has been developed. The main ingredients include catechu, Lobelia chinensis, Duchesnea indica, Cynanchum paniculatum, Centella asiatica, Rabdosia rubescens, Coptis chinensis, and Sophora flavescens. The dosage form is primarily powder, applied topically to deliver the medication directly to the affected area. This formula is based on traditional Chinese medicine theory. Rabdosia rubescens and Centella asiatica are bitter and cold, clearing heat and detoxifying; Sophora flavescens and Coptis chinensis clear heat, dry dampness, and detoxify; catechu, Duchesnea indica, and Lobelia chinensis remove stagnant heat; and Cynanchum paniculatum dispels wind and promotes diuresis. This invention is an innovative formula guided by the theory of turbid toxins in traditional Chinese medicine, integrating multiple Chinese herbal components, specifically formulated for the treatment of HPV infection in women. We believe that prolonged heat toxins residing in the lower burner, stagnating and accumulating, transforming into turbid toxins. Therefore, we propose a treatment method of clearing heat and detoxifying, resolving turbidity and eliminating carbuncles. This is significantly different from other formulas because this formula can clear heat and detoxify while also eliminating long-standing stagnation and turbidity, effectively combating cervical lesions caused by persistent HPV infection. (The theory of turbid toxins is a traditional Chinese medicine theory that studies the pathogenesis of turbid toxins and the pathological changes, evolution, diagnosis, and treatment when the body is in a state of turbid toxins. Turbidity and toxins, as basic terms in traditional Chinese medicine, have origins that can be traced back to the era of the *Neijing* (Inner Canon of Medicine) or even earlier, while the theory of turbid toxins was primarily proposed and established by Professor Li Diangui, a master of traditional Chinese medicine at the Hebei Academy of Traditional Chinese Medicine.) Furthermore, this invention uses low-temperature pulverization of raw medicinal materials to form ultrafine powder, effectively improving the bioavailability of traditional Chinese medicine and enhancing its efficacy.

[0037] The combined effects of these herbs in this formula work synergistically to clear heat and detoxify, resolve turbidity and eliminate carbuncles. Both resolving turbidity and detoxifying are methods of expelling pathogens. Simply clearing heat and detoxifying will not remove dampness and turbidity, nor will merely promoting diuresis and resolving turbidity eliminate toxins. Therefore, these herbs interact and coordinate to provide an outlet for pathogens, resolving turbidity and clearing toxins, thus achieving the therapeutic goal. The formula is exquisite, concise yet effective, using high-quality herbs and drawing on modern pharmacological research. From the principles of diagnosis and treatment to the prescription and medication, it aligns with the pathogenesis of HPV infection, effectively improving and clearing the infection.

[0038] The following is the clinical data of this invention:

[0039] Between 2019 and 2021, this invention's traditional Chinese medicine was used to treat 135 female patients diagnosed with HPV infection. Each treatment involved administering 1g of the ultrafine powder of the medicine deep into the vagina using a disposable vaginal applicator, once every other day. Generally, patients received 10 doses per month for one course of treatment, continuing for 3 months followed by a 3-month break. HPV testing in 130 patients showed negative results. A follow-up of 100 of these patients one year later also revealed negative results.

[0040] Clinical diagnostic criteria for HPV infection: Virological diagnosis: Positive HPV DNA test.

[0041] Patients must have a history of sexual activity, be screened at intervals of 6 months or more, and have two consecutive positive HPV tests; liquid-based thin-layer cytology (TCT) pathological examination must show benign reactive changes or histopathology must show CIN I or chronic inflammation; no related disease treatment must have been received in the past 3 months; and no participation in other clinical studies is allowed. A positive histopathological diagnosis of CIN I with HCII in newly diagnosed patients also confirms HPV infection. Exclusion criteria: other genital tract infections; immunodeficiency combined with severe heart, liver, kidney, hematopoietic system diseases, and mental illness are excluded.

[0042] Efficacy evaluation criteria: The evaluation criteria are HPV seroconversion and non-seroconversion. Seroconversion is considered effective, and non-seroconversion is considered ineffective.

[0043] Effective according to the present invention: A negative HPV screening result after three courses of treatment is considered effective. Ineffective according to the present invention: A negative HPV screening result after three courses of treatment is considered ineffective.

[0044] 1. Patient Gu, female, 32 years old, consulted on April 15, 2020. HPV screening was positive for HPV-18, but TCT examination showed no significant abnormalities. She was of slender build and generally had average immunity. She had a history of good health, regular menstruation, and no other genital tract infections. Following the doctor's instructions, she began using the aforementioned traditional Chinese medicine after her menstrual period. Each time, she took 1g of the ultrafine powder and used a disposable vaginal applicator to insert the powder deep into the vagina, once every other day, for 10 times per month as one course of treatment. She used the medicine continuously for 3 months, followed by a 3-month break. HPV screening afterward was negative. One year later, the patient underwent a follow-up HPV screening, which was also negative, with no recurrence.

[0045] 2. Patient Zhang, female, 48 years old, consulted on March 20, 2021. HPV screening showed positive for HPV-52, while TCT examination showed no significant abnormalities. She was overweight and had generally weak immunity. She had a history of good health, irregular menstruation, poor sleep quality, and occasional perimenopausal symptoms such as hot flashes and sweating. She had no other genital tract infections. Following the doctor's instructions, she began using the aforementioned traditional Chinese medicine after her menstrual period ended. Each time, she took 1g of the ultrafine powder and used a disposable vaginal applicator to insert the powder deep into the vagina, once every other day, for 10 times per month as one course of treatment. She used the medicine continuously for 3 months, followed by a 3-month break. HPV screening afterward was negative. One year later, the patient underwent a follow-up HPV screening, which was also negative, with no recurrence.

[0046] 3. Patient Li, female, 59 years old, consulted on October 22, 2019. HPV screening was positive for HPV-66, but TCT examination showed no significant abnormalities. She was of medium build and generally had average immunity. She had been healthy previously, menopausal for 7 years, had average sleep quality, and no other genital tract infections. Following the doctor's instructions, she began using the aforementioned traditional Chinese medicine. Each time, 1g of the ultrafine powder was administered deep into the vagina using a disposable vaginal applicator, once every other day, for 10 times per month as one course of treatment. She used the medicine continuously for 3 months, followed by a 3-month break. HPV screening afterward was negative. One year later, the patient underwent a follow-up HPV screening, which was also negative, with no recurrence.

[0047] The beneficial effects of this invention can be summarized as follows: This invention integrates multiple Chinese herbal medicine components, making full use of the functions of clearing heat and detoxifying, promoting diuresis and removing blood stasis, etc., which can effectively eliminate HPV virus. At the same time, this invention uses low-temperature pulverization of Chinese herbal medicine, which is conducive to preserving the bioactive components of the original Chinese herbal medicine, increasing its effective components by several times. Ultrafine pulverization can effectively improve the bioavailability of Chinese herbal medicine and enhance its efficacy.

[0048] Previous reports in the field of Traditional Chinese Medicine (TCM) have documented treatments for this disease, but the effectiveness rates have not been very high. This invention is a pure TCM external application formula targeting HPV infection. Clinical trials involving 135 HPV-infected patients have validated its effectiveness. Five patients, due to personal reasons, did not test negative upon re-examination (one patient discontinued medication midway due to an allergic reaction to the herbal medicine; two patients did not continue medication due to business trips; and two patients did not complete the full course of treatment, discontinuing medication after a negative HPV test at their workplace, only to test positive again upon re-examination). The remaining 130 patients tested negative upon re-examination after treatment, achieving an effectiveness rate of 96.3%, reaching a leading level in this field in China. Furthermore, the formula of this invention was finalized after years of clinical trials and actual treatment of hundreds of HPV-infected patients. This TCM formula has no toxic side effects, exhibits ideal efficacy, and has been highly praised by patients.

[0049] The combined effects of these herbs in this formula work synergistically to clear heat and detoxify, resolve turbidity and eliminate carbuncles. Both resolving turbidity and detoxifying are methods of expelling pathogens. Simply clearing heat and detoxifying will not remove dampness and turbidity, nor will merely promoting diuresis and resolving turbidity eliminate toxins. Therefore, these herbs interact and coordinate to provide an outlet for pathogens, resolving turbidity and clearing toxins, thus achieving the therapeutic goal. The formula is exquisite, concise yet effective, using high-quality herbs and drawing on modern pharmacological research. From the principles of diagnosis and treatment to the prescription and medication, it aligns with the pathogenesis of HPV infection, effectively improving and clearing the infection. Detailed Implementation

[0050] The technical solution of the present invention will be further described in detail below with reference to specific embodiments. The following embodiments are only some embodiments of the present invention and not all embodiments. Technical solutions obtained by simple substitutions or superpositions based on the embodiments of the present invention and the pharmacological aspects of the invention should be within the protection scope of the present invention.

[0051] The following are specific embodiments of the present invention.

[0052] Example 1: A traditional Chinese medicine for treating HPV infection in women is a preparation made from the following herbal raw materials in the following weight ratios: 2 parts catechu, 2 parts lobelia chinensis, 2 parts duchesnea indica, 1 part Cynanchum paniculatum, 1 part Centella asiatica, 1 part Rabdosia rubescens, 1 part Coptis chinensis, and 1 part Sophora flavescens.

[0053] The preparation method is as follows: Take 2 parts of catechu, 2 parts of Lobelia chinensis, 2 parts of Duchesnea indica, 1 part of Cynanchum paniculatum, 1 part of Centella asiatica, 1 part of Rabdosia rubescens, 1 part of Coptis chinensis, and 1 part of Sophora flavescens according to the above formula ratio. Process the raw materials with an ultra-low temperature pulverizer to pulverize them at a low temperature, controlling the temperature at 1-10℃ to form ultra-fine powder, and then sterilize them by conventional irradiation.

[0054] Usage and dosage: (For use outside of menstruation) Take 1g of the ultrafine powder of Chinese medicine each time and use a disposable vaginal applicator to insert the powder into the deep part of the vagina. Use it once every other day. One course of treatment consists of 10 doses per month. Use it continuously for 3 months. After stopping the medication for 3 months, perform HPV screening.

[0055] Example 2: A traditional Chinese medicine for treating HPV infection in women is a preparation made from the following herbal raw materials in the following weight ratios: 3 parts catechu, 3 parts lobelia chinensis, 3 parts duchesnea indica, 1.5 parts cynanchum paniculatum, 1.5 parts centella asiatica, 1.5 parts scutellaria barbata, 1.5 parts coptis chinensis, and 1.5 parts sophora flavescens.

[0056] The preparation method is as follows: Take 3 parts of catechu, 3 parts of Lobelia chinensis, 3 parts of Duchesnea indica, 1.5 parts of Cynanchum paniculatum, 1.5 parts of Centella asiatica, 1.5 parts of Rabdosia rubescens, 1.5 parts of Coptis chinensis, and 1.5 parts of Sophora flavescens according to the above formula ratio. Process the raw materials with an ultra-low temperature pulverizer to pulverize them at a low temperature, controlling the temperature at 1-10℃ to form ultra-fine powder, and then sterilize them by conventional irradiation.

[0057] Usage and dosage: (For use outside of menstruation) Take 1g of the ultrafine powder of Chinese medicine each time and use a disposable vaginal applicator to insert the powder into the deep part of the vagina. Use it once every other day. One course of treatment consists of 10 doses per month. Use it continuously for 3 months. After stopping the medication for 3 months, perform HPV screening.

[0058] Example 3: A traditional Chinese medicine for treating HPV infection in women is a traditional Chinese medicine preparation made from the following traditional Chinese medicine raw materials in the following weight ratios: 4 parts catechu, 4 parts lobelia chinensis, 4 parts duchesnea indica, 2 parts cynanchum paniculatum, 2 parts centella asiatica, 2 parts scutellaria barbata, 2 parts coptis chinensis, and 2 parts sophora flavescens.

[0059] The preparation method is as follows: Take 4 parts of catechu, 4 parts of Lobelia chinensis, 4 parts of Duchesnea indica, 2 parts of Cynanchum paniculatum, 2 parts of Centella asiatica, 2 parts of Rabdosia rubescens, 2 parts of Coptis chinensis, and 2 parts of Sophora flavescens according to the above formula ratio. Process the raw materials with an ultra-low temperature pulverizer to pulverize them at a low temperature, controlling the temperature at 1-10℃ to form ultra-fine powder, and then sterilize them by conventional irradiation.

[0060] Usage and dosage: (For use outside of menstruation) Take 1g of the ultrafine powder of Chinese medicine each time and use a disposable vaginal applicator to insert the powder into the deep part of the vagina. Use it once every other day. One course of treatment consists of 10 doses per month. Use it continuously for 3 months. After stopping the medication for 3 months, perform HPV screening.

Claims

1. A traditional Chinese medicine composition for treating HPV infection in women, characterized in that: It is made from the following Chinese medicinal materials in the indicated weight proportions: 2-4 parts catechu, 2-4 parts lobelia chinensis, 2-4 parts duchesne, 1-2 parts cynanchum paniculatum, 1-2 parts centella asiatica, 1-2 parts scutellaria barbata, 1-2 parts coptis chinensis, and 1-2 parts sophora flavescens. The preparation method of the traditional Chinese medicine composition is as follows: take catechu, lobelia, wild strawberry, cynanchum paniculatum, centella asiatica, scutellaria barbata, coptis chinensis and sophora flavescens according to the above weight proportions, process them with an ultra-low temperature pulverizer, control the temperature at 1-10℃ when pulverizing the raw materials to form ultra-fine powder, and then sterilize and package them by conventional irradiation.