Traditional Chinese medicine gel for treating gynecological inflammation

Abstract

The invention provides traditional Chinese medicine gel for treating gynecological inflammation. Specifically, the invention develops a traditional Chinese medicine composition for treating gynecological inflammation for the first time, and the traditional Chinese medicine composition comprises the following raw material medicines: 3-20g of raw radix astragali, 3-15g of honeysuckle, 3-15g of fructus forsythiae, 3-15g of radix saposhnikoviae, 3-15g of radix paeoniae alba, 3-15g of cortex phellodendri, 3-15g of radix sophorae flavescentis, 3-15g of coptis chinensis, 3-15g of raw rhizoma atractylodis macrocephalae, 3-15g of scutellaria baicalensis, 3-15g of pseudo-ginseng, 3-15g of cassia twig and 3-15g of cortex mori radicis. The traditional Chinese medicine composition disclosed by the invention can be used for effectively treating cervical HPV infection.

Description

Technical Field

[0001] This invention relates to the field of medicine. Specifically, this invention relates to a traditional Chinese medicine gel for treating gynecological inflammation. Background Technology

[0002] Existing WHO guidelines recommend screening and treatment for cervical cancer prevention, including screening and treatment of precancerous lesions, treatment of CIN 2 / 3 and adenocarcinoma in situ, and cryotherapy and thermal ablation for CIN. However, there is no effective cure for HPV. Currently, the most commonly used treatments include Western medicine (interferon, imiquimod, anti-HPV biological protein excipients, cidofovir, trichloroacetic acid, etc.), physical therapy (cryotherapy, focused ultrasound, laser, microwave, photodynamic therapy), and surgical treatment (loop electrosurgical excision procedure and cold knife conization). For low-grade lesions or patients with negative TCT tests, guidelines generally recommend clinical observation and regular follow-up, without aggressive treatment.

[0003] There are many clinical treatments for cervicitis, especially HPV-infected cervicitis, but there is still no unified and highly effective treatment plan. Currently, traditional Chinese medicine (TCM) treatment has shown good results in many studies, whether used alone or in combination with Western medicine. Western medicine mainly focuses on eliminating the virus and destroying the virus's host cells. TCM, on the other hand, focuses on improving the body's or local microenvironment's immunity. TCM gel preparations have significant advantages as topical gynecological preparations, effectively delivering antibacterial components to the affected area to achieve both antibacterial and antiviral effects.

[0004] Therefore, there is an urgent need in this field to develop a more efficient and convenient topical Chinese medicine gel preparation that can inhibit gynecological inflammation, improve the clinical treatment effect of gynecological inflammation. Summary of the Invention

[0005] The purpose of this invention is to provide a more efficient and convenient topical Chinese medicine gel preparation that can inhibit gynecological inflammation, improve the clinical treatment effect of gynecological inflammation.

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition, the composition comprising raw medicinal materials or extracts thereof, wherein the raw medicinal materials include: raw Astragalus membranaceus, honeysuckle, forsythia suspensa, Saposhnikovia divaricata, white peony root, Phellodendron chinense, Sophora flavescens, Coptis chinensis, raw Atractylodes macrocephala, Scutellaria baicalensis, Panax notoginseng, cinnamon twig, and mulberry bark, and the weight parts of the raw medicinal materials are as follows: Raw Astragalus membranaceus 2-50 parts, better quality 3-20 parts; Honeysuckle 2-30 parts, better quality 3-15 parts; Forsythia suspensa: 2-30 parts, better quality: 3-15 parts; For wind protection, 2-30 parts; for better conditions, 3-15 parts. White peony root 2-30 parts, better quality 3-15 parts; Phellodendron bark 2-30 parts, better quality 3-15 parts; Sophora flavescens 2-30 parts, preferably 3-15 parts; Coptis chinensis 2-30 parts, better quality 3-15 parts; Raw Atractylodes macrocephala: 2-30 parts, preferably 3-15 parts; Scutellaria baicalensis 2-30 parts, better quality 3-15 parts; 2-30 parts of Panax notoginseng, or 3-15 parts for better quality; 2-30 parts of cinnamon twigs, 3-15 parts for better quality; 2-30 parts of mulberry bark, or 3-15 parts for better quality.

[0007] In another preferred embodiment, the total weight of the 13 raw medicinal materials or their extracts accounts for more than 35 wt% of the traditional Chinese medicine composition.

[0008] In another preferred embodiment, the raw medicinal materials include fresh medicinal materials, partially dried medicinal materials, dried medicinal materials, or a combination thereof.

[0009] In another preferred embodiment, when the composition contains raw medicinal materials, the weight parts are calculated based on the dry weight of the corresponding raw medicinal materials.

[0010] In another preferred embodiment, when the composition comprises an extract of a raw material, the compatibility of the extract is calculated based on the dry weight of the corresponding raw material.

[0011] In another preferred embodiment, the raw medicinal materials consist of raw Astragalus membranaceus, honeysuckle, forsythia, Saposhnikovia divaricata, white peony root, Phellodendron chinense, Sophora flavescens, Coptis chinensis, raw Atractylodes macrocephala, Scutellaria baicalensis, Panax notoginseng, cinnamon twig, and mulberry bark.

[0012] In another preferred embodiment, the traditional Chinese medicine composition is used to treat gynecological inflammation, preferably cervicitis.

[0013] In another preferred embodiment, the traditional Chinese medicine composition is used to treat cervical HPV infection.

[0014] In another preferred embodiment, the HPV infection includes refractory HPV infection.

[0015] In another preferred embodiment, the refractory HPV includes HPV18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59, with HPV39, 51, 58, and 59 being preferred.

[0016] In another preferred embodiment, the extract comprises an aqueous extract.

[0017] In another preferred embodiment, the dosage form of the traditional Chinese medicine composition includes gels, solutions, emulsions, ointments, creams, pastes, cakes, powders, and patches, with gels being preferred.

[0018] In another preferred embodiment, the composition is a decoction of the raw medicinal material.

[0019] In another preferred embodiment, the composition is an aqueous decoction.

[0020] In another preferred embodiment, the decoction includes a decoction with an unadjusted (or unchanged) concentration, a concentrated decoction, or a diluted decoction.

[0021] In another preferred embodiment, the active ingredient includes a single ingredient or a mixture of ingredients.

[0022] In another preferred embodiment, the proportion of raw Astragalus membranaceus in the raw medicinal materials is 2-50 parts by weight, for example, 3, 5, 8, 10, 15, 20, 30, 40, or 50 parts by weight.

[0023] In another preferred embodiment, the proportion of honeysuckle in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 8, 10, 12, 14, 15, 20, 25, or 30 parts by weight.

[0024] In another preferred embodiment, the proportion of Forsythia suspensa in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0025] In another preferred embodiment, the proportion of Saposhnikovia divaricata in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0026] In another preferred embodiment, the proportion of white peony root in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0027] In another preferred embodiment, the proportion of Phellodendron bark in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0028] In another preferred embodiment, the proportion of Sophora flavescens in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0029] In another preferred embodiment, the proportion of Coptis chinensis in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0030] In another preferred embodiment, the proportion of raw Atractylodes macrocephala in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0031] In another preferred embodiment, the proportion of Scutellaria baicalensis in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0032] In another preferred embodiment, the proportion of Panax notoginseng in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0033] In another preferred embodiment, the proportion of cinnamon twig in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0034] In another preferred embodiment, the proportion of mulberry bark in the raw medicinal materials is 2-30 parts by weight, for example, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, or 30 parts by weight.

[0035] In another preferred embodiment, the traditional Chinese medicine composition is basically composed of the following raw medicinal materials: 3-20g of raw Astragalus membranaceus, 3-15g of Lonicera japonica, 3-15g of Forsythia suspensa, 3-15g of Saposhnikovia divaricata, 3-15g of Paeonia lactiflora, 3-15g of Phellodendron chinense, 3-15g of Sophora flavescens, 3-15g of Coptis chinensis, 3-15g of raw Atractylodes macrocephala, 3-15g of Scutellaria baicalensis, 3-15g of Panax notoginseng, 3-15g of Cinnamomum cassia, and 3-15g of Morus alba root bark.

[0036] In another preferred embodiment, the raw medicinal materials include: raw Astragalus membranaceus, honeysuckle, forsythia suspensa, Saposhnikovia divaricata, white peony root, Phellodendron chinense, Sophora flavescens, Coptis chinensis, raw Atractylodes macrocephala, Scutellaria baicalensis, Panax notoginseng, cinnamon twig, and mulberry bark, and the content of the raw medicinal materials is as follows: Raw Astragalus membranaceus 2-50g, better quality 3-20g; Honeysuckle 2-30 g, better quality 3-15 g; Forsythia suspensa 2-30 g, preferably 3-15 g; For wind protection, use 2-30 g; for better results, use 3-15 g. White peony root 2-30 g, better quality 3-15 g; Phellodendron bark 2-30 g, better quality 3-15 g; Sophora flavescens 2-30 g, or 3-15 g for better quality; Coptis chinensis 2-30 g, better quality 3-15 g; Raw Atractylodes macrocephala 2-30 g, better quality 3-15 g; Scutellaria baicalensis 2-30 g, better quality 3-15 g; Panax notoginseng 2-30g, better quality 3-15g; Cinnamon twigs 2-30g, better quality 3-15g; 2-30g of mulberry bark, or 3-15g of better quality.

[0037] A second aspect of the present invention provides an extractant for a traditional Chinese medicine composition, the extractant being prepared by extraction of a traditional Chinese medicine composition as described in the first aspect of the present invention, wherein the extraction solvent of the extractant includes water.

[0038] In another preferred embodiment, the extractant includes an extractant with an unadjusted (or unchanged) concentration, a concentrated extractant, or a diluted extractant.

[0039] In another preferred embodiment, the extractant is a decoction or extract of the traditional Chinese medicine composition.

[0040] In another preferred embodiment, the extractant is a concentrated decoction or extract.

[0041] In another preferred embodiment, the relative density of the extract is 0.8-1.5, preferably 0.8-1.2.

[0042] A third aspect of the present invention provides a pharmaceutical composition comprising: (a) The traditional Chinese medicine composition described in the first aspect of the present invention or the extract of the traditional Chinese medicine composition described in the second aspect of the present invention; (b) Pharmaceutically acceptable carriers.

[0043] In another preferred embodiment, the dosage form of the pharmaceutical composition is selected from the group consisting of liquid preparations, suspension preparations, semi-solid preparations, or solid preparations.

[0044] In another preferred embodiment, the pharmaceutical composition is in the form of a topical skin formulation.

[0045] In another preferred embodiment, the dosage form of the pharmaceutical composition is selected from the group consisting of gels, solutions, emulsions, ointments, creams, pastes, cakes, powders, patches, or combinations thereof.

[0046] In another preferred embodiment, the pharmaceutical composition is a gel of extract from a traditional Chinese medicine composition.

[0047] In another preferred embodiment, the herbal composition extract gel comprises the herbal composition described in the first aspect of the present invention or the herbal composition extract described in the second aspect of the present invention as an active ingredient; and a base gel containing the following components, in weight percentages: CMC-Na 1%-3%, propylene glycol 10%-20%, ethanol 10%-20%, azone 0.5%-1%, Tween 0.5%-1%, and ethylparaben 0.1%-0.5%.

[0048] In another preferred embodiment, the herbal composition extract gel further includes water.

[0049] In another preferred embodiment, the herbal composition extract gel is composed of the following components, expressed as a percentage by weight: The traditional Chinese medicine composition described in the first aspect of this invention or the extract of the traditional Chinese medicine composition described in the second aspect of this invention comprises 15%-30%; CMC-Na 1%-3%; Propylene glycol 10%-20%; 10%-20% ethanol; Azone 0.5%-1%; Tween 0.5%-1%; Ethylparaben 0.1%-0.5%; Replenish water to 100%.

[0050] The fourth aspect of this invention provides a method for preparing a gel of extract from a traditional Chinese medicine composition, comprising the following steps: S1) Mix 10%-20% propylene glycol, 10%-20% ethanol, 0.5%-1% azone, 0.5%-1% Tween, 0.1%-0.5% ethylparaben, 15%-30% of the traditional Chinese medicine composition described in the first aspect of this invention or the extract of the traditional Chinese medicine composition described in the second aspect of this invention, and water to make up to 100% to obtain a drug mixture solution. S2) Add 1%-3% by weight of CMC-Na to the drug mixture solution to obtain a gel of traditional Chinese medicine composition extract.

[0051] The fifth aspect of the present invention provides the use of a composition or preparation containing the composition as described in the first aspect of the present invention, or an extract of a traditional Chinese medicine composition as described in the second aspect of the present invention, or a pharmaceutical composition as described in the third aspect of the present invention, for preparing a drug or preparation for treating gynecological inflammation, preferably cervicitis.

[0052] In another preferred embodiment, the drug or preparation is also used to treat cervical HPV infection.

[0053] The sixth aspect of this invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect of this invention or the extract of the traditional Chinese medicine composition described in the second aspect of this invention, comprising the steps of: (a) Providing raw medicinal materials, said raw medicinal materials comprising: raw Astragalus membranaceus, honeysuckle, forsythia suspensa, Saposhnikovia divaricata, white peony root, Phellodendron chinense, Sophora flavescens, Coptis chinensis, raw Atractylodes macrocephala, Scutellaria baicalensis, Panax notoginseng, cinnamon twig, and mulberry bark, and the weight parts of said raw medicinal materials are as follows: Raw Astragalus membranaceus 2-50 parts, better quality 3-20 parts; Honeysuckle 2-30 parts, better quality 3-15 parts; Forsythia suspensa: 2-30 parts, better quality: 3-15 parts; For wind protection, 2-30 parts; for better conditions, 3-15 parts. White peony root 2-30 parts, better quality 3-15 parts; Phellodendron bark 2-30 parts, better quality 3-15 parts; Sophora flavescens 2-30 parts, preferably 3-15 parts; Coptis chinensis 2-30 parts, better quality 3-15 parts; Raw Atractylodes macrocephala: 2-30 parts, preferably 3-15 parts; Scutellaria baicalensis 2-30 parts, better quality 3-15 parts; 2-30 parts of Panax notoginseng, or 3-15 parts for better quality; 2-30 parts of cinnamon twigs, 3-15 parts for better quality; 2-30 parts of mulberry bark, 3-15 parts for better quality; (b) Extracting the raw medicinal material to obtain an extract of the raw medicinal material, wherein the extract is the extractant of the traditional Chinese medicine composition.

[0054] In another preferred embodiment, in step (b), the raw medicinal material is decocted with water to obtain an extract of the raw medicinal material.

[0055] In another preferred embodiment, in step (b), the raw medicinal material is provided, decocted twice with water, the filtrates are combined, and concentrated under reduced pressure to obtain an extract of the raw medicinal material.

[0056] In another preferred embodiment, water is added twice.

[0057] In another preferred embodiment, the amount of water added for the first time is 7-9 times the amount of the raw material.

[0058] In another preferred embodiment, the amount of water added in the second step is 3-5 times the weight of the raw material.

[0059] In another preferred embodiment, the method further includes the steps of boiling and keeping warm for 0.8-1.2 hours.

[0060] The seventh aspect of the present invention provides a method for preventing and / or treating gynecological inflammation by administering a medically effective amount of the traditional Chinese medicine composition described in the first aspect of the present invention, or the extract of the traditional Chinese medicine composition described in the second aspect of the present invention, or the pharmaceutical composition described in the third aspect of the present invention to a patient in need.

[0061] In another preferred embodiment, the patient is a patient with gynecological inflammation, preferably with cervicitis, and more preferably with cervical HPV infection.

[0062] In another preferred embodiment, the method can also be used to treat cervicitis, preferably to treat cervical HPV infection.

[0063] It should be understood that, within the scope of this invention, the above-described technical features of this invention and the technical features specifically described below (such as in the embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, they will not be described in detail here. Attached Figure Description

[0064] The following figures are used to illustrate specific embodiments of the present invention and are not intended to limit the scope of the invention as defined by the claims.

[0065] Figure 1 The flowchart shows the process before and 3 months after treatment for high-risk HPV-positive patients.

[0066] Figure 2 The results of the stability study of the ethanol-containing gel are shown. (A) Centrifugation at 5000 r / min for 30 min; (B) Place in a 50℃ oven for 6 hours; (C) Place in a 50℃ oven for 6 hours, then place in a -20℃ refrigerator for 120 hours; (D) Place in a -20℃ refrigerator for 120 hours.

[0067] Figure 3 The results of the stability study of the ethanol-free gel are shown. (A) Centrifugation at 5000 r / min for 30 min; (B) Place in a 50℃ oven for 6 hours; (C) Place in a 50℃ oven for 6 hours, then place in a -20℃ refrigerator for 120 hours; (D) Place in a -20℃ refrigerator for 120 hours.

[0068] Figure 4 The HPV test results are displayed.

[0069] Figure 5 The HPV test results are displayed.

[0070] Figure 6 The HPV test results are displayed.

[0071] Figure 7 The HPV test results are displayed.

[0072] Figure 8 The HPV test results are displayed. Detailed Implementation

[0073] Through extensive and in-depth research, this invention has, for the first time, developed a traditional Chinese medicine composition for treating gynecological inflammation, preferably cervicitis. The composition comprises: 3-20g of raw Astragalus membranaceus, 3-15g of Lonicera japonica, 3-15g of Forsythia suspensa, 3-15g of Saposhnikovia divaricata, 3-15g of Paeonia lactiflora, 3-15g of Phellodendron chinense, 3-15g of Sophora flavescens, 3-15g of Coptis chinensis, 3-15g of raw Atractylodes macrocephala, 3-15g of Scutellaria baicalensis, 3-15g of Panax notoginseng, 3-15g of Cinnamomum cassia, and 3-15g of Morus alba root bark. Clinical trials of this invention have demonstrated that the traditional Chinese medicine composition can treat cervical HPV infection. Based on this, this invention was completed.

[0074] the term Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0075] As used herein, the terms “comprising,” “including,” and “containing” are used interchangeably and include not only closed definitions but also semi-closed and open definitions. In other words, the terms include “consisting of” and “substantially consisting of”.

[0076] As used herein, the terms "parts by weight" and "number of parts by weight" are used interchangeably. A part by weight can be any fixed weight expressed in milligrams, grams, or kilograms (e.g., 1 mg, 1 g, 2 g, or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b can be a composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the aforementioned composition, the percentage content of a component = (the number of parts by weight of that component / the sum of the number of parts by weight of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%. In this invention, it is preferred that a composition consisting of 1 part by weight of component a and 9 parts by weight of component b is configured as 1 gram of component a + 9 grams of component b.

[0077] As used herein, the term "effective amount" refers to an amount that is functional or active in humans and / or animals and is acceptable to humans and / or animals. Those skilled in the art will understand that the "effective amount" can vary depending on the form of the pharmaceutical composition, the severity of the disease, and whether it is used in combination with other drugs.

[0078] As used herein, the term "consistently composed of" means that, in addition to the essential ingredients or components, the composition may contain small amounts of minor components and / or impurities that do not affect the active ingredients. For example, it may contain sweeteners to improve flavor, antioxidants to prevent oxidation, and other additives commonly used in the art. Typically, the essential components (or essential medicinal materials) of this invention constitute at least 70% of the total weight (dry weight) of the Chinese medicinal materials, preferably at least 80%, and more preferably at least 90%.

[0079] As used herein, the terms "pharmaceuticalally acceptable carrier" or "pharmaceutical excipient" are used interchangeably to refer to a carrier used for the administration of therapeutic agents, including various excipients and diluents. This term refers to pharmaceutical carriers that are not essential active ingredients themselves and do not cause excessive toxicity upon administration. Pharmaceutically acceptable carriers are suitable for use in humans and / or animals without excessive adverse side effects (such as toxicity, irritation, and allergic reactions), i.e., a reasonable benefit / risk ratio. Suitable carriers are well known to those skilled in the art. A thorough discussion of pharmaceutically acceptable excipients can be found in Remington's Pharmaceutical Sciences (Mack Pub. Co., NJ. 1991). Pharmaceutically acceptable carriers in compositions may contain liquids such as water, saline, glycerin, and ethanol. Additionally, these carriers may contain auxiliary substances such as wetting agents or emulsifiers, pH buffers, etc. Non-essential components derived from essential medicinal materials, other than the essential components (i.e. the main active components of the main medicinal materials), as well as other non-essential components (such as other auxiliary medicinal materials), are also included in the definition of pharmaceutically acceptable carriers.

[0080] Raw Astragalus Raw astragalus is the dried root of *Astragalus mongholicus* or *Astragalus membranaceus*, belonging to the legume family. It is cylindrical, with a light brownish-yellow surface and longitudinal wrinkles. The cross-section shows radial striations and fissures. It is hard and tough, and older roots often have a dark brown hollow center. It is sweet and slightly warm in nature, and enters the spleen and lung meridians. It has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting pus drainage and detoxification, and promoting wound healing and tissue regeneration.

[0081] honeysuckle Honeysuckle is a perennial, semi-evergreen, twining vine belonging to the genus *Lonicera* of the family Caprifoliaceae. Its name comes from the unique phenomenon of its flowers, which are initially silvery-white and gradually turn golden-yellow, creating a striking contrast. It is sweet and cold in nature, possessing properties that clear heat and detoxify, have antibacterial and anti-inflammatory effects, and enhance immunity. It is commonly used to relieve symptoms such as colds with fever, sore throat, and skin inflammation.

[0082] Forsythia Forsythia is a deciduous shrub belonging to the genus Forsythia in the family Oleaceae. It is named for its fruit, which resembles the ancient lotus cart and the forsythia vine. The fruit is used in medicine; it is bitter and slightly cold in nature, and enters the lung, heart, and gallbladder meridians. It has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules, and is known as the "holy medicine for sores".

[0083] windproof Fangfeng (Saposhnikovia divaricata) is a commonly used herb in Traditional Chinese Medicine (TCM) for dispelling wind and releasing the exterior, hailed as a "universal medicine for treating wind," its name directly reflecting its core efficacy—defending against wind-evil. Fangfeng can disperse wind-evil, treating symptoms such as headache, body aches, and chills caused by wind-cold or wind-heat colds. Its diaphoretic effect is mild, and it can be used in combination with other herbs for both wind-cold and wind-heat conditions. Through its wind-dispelling effect, it indirectly eliminates dampness, making it suitable for rheumatic pain, joint pain, and other ailments. TCM believes that "wind can overcome dampness," and Fangfeng's strong wind-dispelling power allows it to overcome dampness. It is effective against both internal wind (such as tetanus and infantile convulsions) and external wind (such as colds and rheumatism). Its antispasmodic effect targets muscle spasms or limb tremors.

[0084] White peony root White peony root is the dried root of the peony plant (Paeonia lactiflora), belonging to the Ranunculaceae family. It is a commonly used traditional Chinese medicine with effects such as nourishing blood and regulating menstruation, astringing yin and stopping sweating, soothing the liver and relieving pain, and calming liver yang.

[0085] Huangbai Phellodendron bark is the dried bark of the Phellodendron amurense or Phellodendron chinense tree, both belonging to the Rutaceae family. It is commonly known as "Sichuan Phellodendron" or "Guan Phellodendron." It is bitter and cold in nature, and enters the kidney and bladder meridians. It has the effects of clearing heat and drying dampness, purging fire and eliminating steaming heat, and detoxifying and healing sores.

[0086] Sophora flavescens Sophora flavescens is the dried root of the legume Sophora flavescens. It is bitter and cold in nature, and enters the heart, liver, stomach, large intestine, and bladder meridians. It has the effects of clearing heat and drying dampness, killing parasites and relieving itching, and promoting diuresis. Its root is long and cylindrical, with a grayish-brown or brownish-yellow surface and a yellowish-white cross-section with radial striations. It tastes extremely bitter.

[0087] Coptis chinensis Coptis chinensis is the dried rhizome of Coptis chinensis, Coptis triangularis, or Coptis yunnanensis, all belonging to the Ranunculaceae family. Based on origin and morphology, it is classified into three categories: "Wei Lian," "Ya Lian," and "Yun Lian."14 Its rhizomes often grow in clusters, resembling chicken feet. The surface is grayish-yellow or yellowish-brown, with nodular protuberances and fibrous root remnants. The smooth internodes are called "bridges." The cross-section shows an orange-red cortex and bright yellow xylem, with a faint odor and an extremely bitter taste.

[0088] Coptis chinensis is bitter and cold in nature, and enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. It is mainly used to treat damp-heat fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever with delirium, restlessness and insomnia, red eyes and toothache, etc. It is also used externally to treat eczema, damp sores, and ear discharge.

[0089] Raw Atractylodes macrocephala Raw Atractylodes macrocephala is the dried rhizome of Atractylodes macrocephala, a plant in the Asteraceae family. It is mainly produced in Jiangsu, Zhejiang, Fujian and other places. It is bitter, sweet and warm in nature, and enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating and calming the fetus.

[0090] Scutellaria baicalensis Scutellaria baicalensis is the dried root of Scutellaria baicalensis, a perennial herb belonging to the Lamiaceae family. Its rhizome is thick and yellow in cross-section. As an important traditional Chinese medicine, Scutellaria baicalensis is bitter and cold in nature, and enters the lung, gallbladder, spleen, large intestine, and small intestine meridians.

[0091] Scutellaria baicalensis has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus.

[0092] Sanqi Panax notoginseng is a perennial herb belonging to the genus Panax in the family Araliaceae. Its dried root is the main medicinal part, and it is mainly produced in Yunnan and Guangxi. Panax notoginseng has an erect stem and palmate compound leaves. Each plant has three petioles, and each petiole bears seven leaflets, hence the name "Sanqi" (meaning "three-seven"). It flowers from July to August, and its ripe fruit is bright red and resembles small pearls.

[0093] Panax notoginseng has the effects of dispersing blood stasis, stopping bleeding, reducing swelling and relieving pain.

[0094] cinnamon twig Cinnamon twigs are the dried tender branches of the cinnamon tree (Cinnamomum cassia), a plant in the Lauraceae family. They are harvested in spring and summer, then dried or sliced ​​for medicinal use. They are pungent, sweet, and warm in nature, and enter the heart, lung, and bladder meridians. They have the effects of inducing sweating and relieving muscle tension, warming and unblocking the meridians, and assisting yang and promoting qi circulation.

[0095] Mulberry bark Mulberry bark is the dried root bark of the mulberry tree (Morus alba), a plant in the Moraceae family. It is harvested from late autumn to the following spring, the roots are dug up, the rough yellowish-brown outer skin is scraped off, and the root bark is then dried. Its outer surface is yellowish-white or light brownish-yellow, while the inner surface is yellowish-white or grayish-yellow. It is tough and fibrous.

[0096] Mulberry bark is cold in nature and sweet in taste, and enters the lung meridian. Its main functions are to clear lung heat and relieve asthma, and promote diuresis and reduce swelling. It is suitable for symptoms such as cough due to lung heat, edema, scanty urine, and facial and skin swelling. Ancient books record that it can "remove water vapor from the lungs" and "promote urination." Modern research has confirmed that it has antitussive, expectorant, asthma-relieving, and anti-inflammatory effects.

[0097] In the traditional Chinese medicine composition of this invention, Astragalus membranaceus, Atractylodes macrocephala, and Saposhnikovia divaricata are the principal herbs, with Lonicera japonica, Forsythia suspensa, Phellodendron chinense, Sophora flavescens, Coptis chinensis, and Scutellaria baicalensis as assistant herbs, and Paeonia lactiflora, Cinnamomum cassia, Panax notoginseng, and Morus alba root bark as adjuvant herbs. The efficacy is as follows: The principal herbs, selected from the Yu Ping Feng San formula, support the body's vital energy and protect the cervical mucosa; the assistant herbs Lonicera japonica, Forsythia suspensa, Phellodendron chinense, Sophora flavescens, Coptis chinensis, and Scutellaria baicalensis work together to clear heat, detoxify, and fight viruses. Panax notoginseng is added to invigorate blood and stop bleeding; Cinnamomum cassia and Paeonia lactiflora work together to disperse and astringe, protecting the mucosa; and Morus alba root bark promotes diuresis, reduces swelling, and has antibacterial and anti-inflammatory effects.

[0098] The composition of the present invention As used herein, "traditional Chinese medicine composition" or "traditional Chinese medicine composition of the present invention" refers to a traditional Chinese medicine composition that can effectively treat gynecological inflammation, preferably cervicitis, obtained by preparing a certain proportion of raw Astragalus membranaceus, honeysuckle, forsythia, Saposhnikovia divaricata, white peony root, Phellodendron chinense, Sophora flavescens, Coptis chinensis, raw Atractylodes macrocephala, Scutellaria baicalensis, Panax notoginseng, cinnamon twig, and mulberry bark according to a certain preparation method.

[0099] The traditional Chinese medicine composition of the present invention contains raw medicinal materials or extracts of said raw medicinal materials, wherein the raw medicinal materials include: raw Astragalus membranaceus, honeysuckle, forsythia suspensa, Saposhnikovia divaricata, white peony root, Phellodendron chinense, Sophora flavescens, Coptis chinensis, raw Atractylodes macrocephala, Scutellaria baicalensis, Panax notoginseng, cinnamon twig, and mulberry bark.

[0100] In some embodiments, the traditional Chinese medicine compositions of the present invention further comprise pharmaceutically acceptable carriers or excipients. Such carriers include (but are not limited to): saline, buffer solutions, glucose, water, glycerol, ethanol, and combinations thereof. The pharmaceutical formulation should be matched to the route of administration. The pharmaceutical compositions of the present invention can be formulated into gel formulations, for example, prepared by conventional methods. The dosage of the active ingredient is a therapeutically effective amount, for example, about 1 microgram / kg body weight to about 5 milligrams / kg body weight per day. Furthermore, the present invention can be used with other therapeutic agents.

[0101] When using the traditional Chinese medicine composition, a safe and effective amount of the composition of the present invention is administered to mammals, wherein the dosage of the active ingredient of the present invention is typically 0.001 mg / kg to 1,000,000 mg / kg body weight. Of course, the specific dosage should also take into account factors such as the route of administration and the patient's health condition, which are all within the scope of the skills of a skilled physician.

[0102] Preparation method This invention provides a method for preparing the traditional Chinese medicine composition according to the first aspect of this invention or the extract of the traditional Chinese medicine composition according to the second aspect of this invention, comprising the steps of: (a) Providing raw medicinal materials, said raw medicinal materials comprising: raw Astragalus membranaceus, honeysuckle, forsythia suspensa, Saposhnikovia divaricata, white peony root, Phellodendron chinense, Sophora flavescens, Coptis chinensis, raw Atractylodes macrocephala, Scutellaria baicalensis, Panax notoginseng, cinnamon twig, and mulberry bark, and the weight parts of said raw medicinal materials are as follows: Raw Astragalus membranaceus 2-50 parts, better quality 3-20 parts; Honeysuckle 2-30 parts, better quality 3-15 parts; Forsythia suspensa: 2-30 parts, better quality: 3-15 parts; For wind protection, 2-30 parts; for better conditions, 3-15 parts. White peony root 2-30 parts, better quality 3-15 parts; Phellodendron bark 2-30 parts, better quality 3-15 parts; Sophora flavescens 2-30 parts, preferably 3-15 parts; Coptis chinensis 2-30 parts, better quality 3-15 parts; Raw Atractylodes macrocephala: 2-30 parts, preferably 3-15 parts; Scutellaria baicalensis 2-30 parts, better quality 3-15 parts; 2-30 parts of Panax notoginseng, or 3-15 parts for better quality; 2-30 parts of cinnamon twigs, 3-15 parts for better quality; 2-30 parts of mulberry bark, 3-15 parts for better quality; (b) Extracting the raw medicinal material to obtain an extract of the raw medicinal material, wherein the extract is the extractant of the traditional Chinese medicine composition.

[0103] The main advantages of this invention include: (1) This invention is the first to develop a traditional Chinese medicine composition for treating gynecological inflammation, preferably cervicitis. The composition comprises: 3-20g of raw Astragalus membranaceus, 3-15g of Lonicera japonica, 3-15g of Forsythia suspensa, 3-15g of Saposhnikovia divaricata, 3-15g of Paeonia lactiflora, 3-15g of Phellodendron chinense, 3-15g of Sophora flavescens, 3-15g of Coptis chinensis, 3-15g of raw Atractylodes macrocephala, 3-15g of Scutellaria baicalensis, 3-15g of Panax notoginseng, 3-15g of Cinnamomum cassia, and 3-15g of Morus alba root bark. Clinical trials of this invention have demonstrated that the traditional Chinese medicine composition of this invention can treat cervical HPV infection.

[0104] (2) This invention develops a special Chinese medicine gel to inhibit gynecological inflammation, improves the clinical treatment effect of gynecological inflammation, and provides female patients with gynecological inflammation with a more efficient and convenient external Chinese medicine gel preparation.

[0105] (3) This invention optimizes the gelation process by adding traditional Chinese medicine compound extracts to the gel formulation, developing a stable gel with a high concentration of traditional Chinese medicine compound extracts and a long shelf life at room temperature. This is a unique traditional Chinese medicine gel that has a significant inhibitory effect on gynecological cervical inflammation. The inhibitory effect and clinical efficacy of this unique traditional Chinese medicine gel on cervical HPV virus infection are evaluated, and its mechanism is preliminarily explored. The traditional Chinese medicine gel of this invention is composed of 3-20% raw Astragalus membranaceus, 3-15% honeysuckle, 3-15% forsythia, 3-15% saposhnikovia divaricata, 3-15% white peony root, 3-15% phellodendron bark, 3-15% sophora flavescens, 3-15% coptis chinensis, 3-15% raw atractylodes macrocephala, 3-15% scutellaria baicalensis, 3-15% notoginseng, 3-15% cinnamon twig, and 3-15% mulberry bark (by weight percentage) (based on the total weight of the raw medicinal materials).

[0106] (4) This invention, through research and optimization of gelation process, adds Chinese herbal compound extract to gel formulation, develops a special Chinese herbal gel with stable process, high concentration of Chinese herbal compound extract gel, long shelf life at room temperature, and significant inhibitory effect on gynecological inflammation. The clinical efficacy of the special Chinese herbal gel for patients with gynecological inflammation and HPV infection is evaluated, and the inhibitory mechanism of the special Chinese herbal gel on gynecological inflammation and cervical HPV virus is explored.

[0107] (5) This invention observes the improvement of patients’ clinical symptoms and auxiliary examinations before and after treatment with special Chinese medicine gel, compares the changes in HPV detection of cervical exfoliated cells, vaginal environment of cervical tissue, cytokines and Chinese medicine symptoms before and after treatment, and explores the therapeutic effect and mechanism of Chinese medicine in treating patients with cervical HPV infection.

[0108] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed under conventional conditions as described in Sambrook et al., Molecular Cloning: A Laboratory Manual (New York: Cold Spring Harbor Laboratory Press, 1989), or as recommended by the manufacturer. Unless otherwise specified, all materials and reagents used in the embodiments are commercially available products.

[0109] Experimental instruments and materials 1. Experimental apparatus Electronic balance (Model: AL-204; Manufacturer: Shanghai Jingke Balance) Rotary evaporator (Model: R-501; Manufacturer: Shanghai Kexing Instrument Co., Ltd.) Circulating water vacuum pump (Model: SHZ-95B; Manufacturer: Shanghai Kexing Instrument Co., Ltd.) Vacuum drying oven (Model: DZF-6050; Manufacturer: Shanghai Yiheng Scientific Instruments Co., Ltd.) Benchtop centrifuge (Model: TDL-5-A; Manufacturer: Shanghai Anting Scientific Instrument Factory) 2. Experimental reagents Carbomer (pharmaceutical excipient) Sodium carboxymethyl cellulose (pharmaceutical excipient) Xanthan gum (pharmaceutical excipient; Hubei Gedian Renfu Pharmaceutical Excipients Co., Ltd.) Glycerin (pharmaceutical excipient) Propylene glycol (pharmaceutical excipient; Nanjing Chemical Reagent Co., Ltd.) Azone (pharmaceutical excipient; Xinxiang Gaojin Pharmaceutical Co., Ltd.) Ethylparaben (pharmaceutical excipient; Hunan Ercon Pharmaceutical Co., Ltd.) Sodium hydroxide (analytical grade; Shanghai Lingfeng Chemical Reagent Co., Ltd.) Ethanol (analytical grade; Sinopharm Chemical Reagent Co., Ltd.)

[0110] Example 1: Gel Preparation and Extraction Method 1. Excipients and reagents Carbomer, glycerin, propylene glycol, ethanol, azone, sodium hydroxide, purified water, pH test paper.

[0111] 2. Extract Formula 2.1 Gel Formulation Raw Astragalus, Honeysuckle, Forsythia, Saposhnikovia, White Peony Root, Phellodendron Bark, Sophora Root, Coptis Root, Raw Atractylodes Rhizome, Scutellaria Root, Panax Notoginseng, Cinnamon Twig, Mulberry Bark.

[0112] 3. Extraction Method One portion of extract was extracted using both water extraction and alcohol extraction methods.

[0113] 3.1 Water extraction Weigh out 100g of the following herbs according to the prescription: Astragalus membranaceus 3g, 6g, 12g, 16g, 20g; Lonicera japonica 3g, 6g, 9g, 15g; Forsythia suspensa 3g, 6g, 9g, 15g; Saposhnikovia divaricata 3g, 4g, 8g, 15g; Paeonia lactiflora 3g, 5g, 10g, 15g; Phellodendron chinense 3g, 7g, 10g, 15g; Sophora flavescens 3g, 7g, 10g, 15g; Coptis chinensis 3g, 7g, 10g, 15g; Atractylodes macrocephala 3g... The following ingredients were added: 6g, 8g, 15g, Scutellaria baicalensis 3g, 7g, 10g, 15g, Panax notoginseng 3g, 5g, 10g, 15g, Cinnamomum cassia 3g, 5g, 10g, 15g, and Morus alba root bark 3g, 5g, 10g, 15g. The decoction was prepared twice with water, adding 8 times the amount of water for the first decoction and 4 times the amount of water for the second decoction. After boiling, the decoction was kept warm for 1 hour each time. The decoction was filtered, and the filtrates were combined and concentrated under reduced pressure to a concentration of 1g extract / 1g crude drug (relative density).

[0114] 3.2 Alcohol Extraction Prescription dosage 100g (raw Astragalus membranaceus 3g, 6g, 12g, 16g, 20g, honeysuckle 3g, 6g, 9g, 15g, forsythia suspensa 3g, 6g, 9g, 15g, saposhnikovia divaricata 3g, 4g, 8g, 15g, white peony root 3g, 5g, 10g, 15g, phellodendron bark 3g, 7g, 10g, 15g, sophora flavescens 3g, 7g, 10g, 15g, coptis chinensis 3g, 7g, 10g, 15g, raw white peony root) Atractylodes macrocephala 3g, 6g, 8g, 15g, Scutellaria baicalensis 3g, 7g, 10g, 15g, Panax notoginseng 3g, 5g, 10g, 15g, Cinnamomum cassia 3g, 5g, 10g, 15g, Morus alba root bark 3g, 5g, 10g, 15g), soak for half an hour, add 8 times 60% ethanol, extract twice, the first time for 1 hour, the second time add 4 times ethanol, extract for 1 hour, combine the two filtrates, concentrate under reduced pressure to 1g extract / 1g crude drug.

[0115] 4. Gel preparation To obtain a gel with a higher content of raw medicinal materials and a good appearance, the gel formulation was determined as follows: 15%-30% water extract (1g extract / 1g raw medicinal materials), 1%-3% CMC-Na, 10%-20% propylene glycol, 10%-20% ethanol, 0.5%-1% azone, 0.5%-1% Tween, 0.1%-0.5% ethylparaben, and 15%-40% water.

[0116] Preparation method: Mix all components except CMC-Na thoroughly to obtain a drug mixture solution. Slowly add CMC-Na to the drug mixture solution while stirring to allow the gel to fully swell and become homogeneous, thus obtaining a drug-containing gel.

[0117] Example 2: Gel Stability Study 1. Stability assessment 1.1 Centrifugation test Take a sample, place the gel in a centrifuge, centrifuge at 5000 r / min for 30 min, and then take it out to observe whether the gel has layering and color change.

[0118] 1.2 Heat and cold resistance tests Take a sample, place the gel in a 55℃ oven for 6 hours, and then place it in a -20℃ refrigerator for 120 hours. Observe whether the gel has layering and color changes.

[0119] Take another sample and place the gel in a -20°C refrigerator for 120 hours to observe whether the gel separates into layers and changes color.

[0120] 1.3 Results For ethanol-containing gels, such as Figure 2As shown, after centrifugation, the gelling agent showed no separation or discoloration after all air bubbles were removed; after being placed in a 50℃ oven for 6 hours, no separation occurred, but the color deepened; after being placed in a 50℃ oven for 6 hours and then in a -20℃ refrigerator for 120 hours, no separation occurred, but the color deepened further; after being placed in a -20℃ refrigerator for 120 hours, no separation occurred, but the color deepened. Figure 2 In the following tests, (A) after centrifugation, the air bubbles were completely removed, and there was no layering or discoloration; (B) after being placed in a 50℃ oven for 6 hours, there was no layering, but the color deepened; (C) after being placed in a 50℃ oven for 6 hours and then in a -20℃ refrigerator for 120 hours, there was no layering, but the color deepened further; (D) after being placed in a -20℃ refrigerator for 120 hours, there was no layering, but the color deepened.

[0121] For ethanol-free gelling agents, such as Figure 3 As shown, after centrifugation, the ethanol-free gelling agent showed no air bubbles, no stratification, and no discoloration. After being placed in a 50℃ oven for 6 hours, no stratification occurred, but the color deepened. After being placed in a 50℃ oven for 6 hours and then in a -20℃ refrigerator for 120 hours, the gelling agent stratified and its clarity decreased. After being placed in a -20℃ refrigerator for 120 hours, no stratification occurred, but the color deepened. Figure 3 In the following tests, (A) after centrifugation, the air bubbles in the ethanol-free gel were completely removed, and there was no layering or discoloration; (B) after being placed in a 50℃ oven for 6 hours, there was no layering, but the color deepened; (C) after being placed in a 50℃ oven for 6 hours and then in a -20℃ refrigerator for 120 hours, the gel layered and the clarity decreased; (D) after being placed in a -20℃ refrigerator for 120 hours, there was no layering, but the color deepened.

[0122] Stability tests showed that the gel containing ethanol was more stable than the gel without ethanol. The formula was determined as follows: 15% water-extracted alcohol immersion paste (1g extract / 2g crude drug), 3% CMC-Na, 20% propylene glycol, 20% ethanol, 1% azone, 1% Tween-80, 0.1% ethylparaben, and 39.9% water.

[0123] Example 3 Clinical Study Flowcharts for high-risk HPV-positive patients before and 3 months of treatment are as follows: Figure 1 As shown. The clinical study of this invention has been registered with the Chinese Clinical Trial Registry (https: / / www.chictr.org.cn / showproj.html?proj=230555) and has been approved by the Medical Ethics Committee of Tongji University Affiliated Oriental Hospital.

[0124] The study included 60 patients with HPV-positive cervicitis who visited the Department of Traditional Chinese Medicine and the Department of Gynecology at the Affiliated Oriental Hospital of Tongji University in Shanghai between November 2024 and May 2025. These patients were diagnosed with leukorrhea and spleen deficiency syndrome by Western medicine. Those who met the inclusion criteria and those who did not meet the exclusion criteria were included.

[0125] 1. Diagnostic criteria: 1.1 Western medicine diagnostic criteria for cervicitis: The diagnosis of cervicitis is based on the guidelines outlined in the 8th edition of "Obstetrics and Gynecology" edited by Xie Xing et al., published in 2013. 1.1.1 Cervicitis: One of two characteristic signs observed during a gynecological examination: (1) Purulent or mucopurulent discharge is visible to the naked eye on the cervical canal or cervical canal swab specimen; (2) Wiping the cervical canal with a cotton swab can easily induce bleeding in the cervical canal.

[0127] Microscopic examination: (1) Increased white blood cells in cervical or vaginal secretions 1.1.2 Cytopathological diagnostic criteria: Diagnosis is based on the TBS classification system.

[0128] 1.1.3 Histopathological diagnostic criteria: CIN grade I: Mild dysplasia. Subepithelial cells show enlarged nuclei with a slightly increased nucleoplasm ratio, slightly darker nuclear staining, and fewer mitotic figures. Cell polarity is present.

[0129] CIN grade II: This refers to moderate dysplasia. The nuclei of the subepithelial cells are significantly enlarged, with an increased nucleoplasm-to-cytoplasm ratio, deeply stained nuclei, numerous mitotic figures, a significantly increased cell number, and cell polarity is still present.

[0130] CIN grade III: This refers to severe dysplasia and carcinoma in situ. Diseased cells occupy almost or entirely the entire epithelial layer, with abnormally enlarged nuclei, a significantly increased nucleoplasm-to-nucleus ratio, irregular nuclei shape, deep staining, increased mitotic figures, crowded cells, disordered arrangement, and lack of polarity.

[0131] 1.1.4 Human papillomavirus (HPV) infection criteria: Human papillomavirus (HPV) genotyping of cervical exfoliated cells using gene chip method: Among them are 18 high-risk HPV virus types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82, and 83.

[0132] Six low-risk HPV virus types: 6, 11, 42, 43, 44, and 81.

[0133] A positive result indicates infection, while a negative result indicates normal status.

[0134] 1.2 Diagnostic criteria for leukorrhea due to spleen deficiency in Traditional Chinese Medicine The TCM diagnosis of leukorrhea due to spleen deficiency is based on the first edition of "Traditional Chinese Medicine Gynecology" edited by Luo Songping et al. in 2008 and "Guiding Principles for Clinical Practice of New Chinese Medicine Drugs".

[0135] Main symptoms: Excessive vaginal discharge, white in color, thin in texture, resembling mucus or saliva, and odorless; Secondary symptoms: ① Sallow or pale complexion, ② Fatigue and weakness, ③ Shortness of breath and reluctance to speak, ④ Lethargy and drowsiness, ⑤ Poor appetite and loose stools, ⑥ Tongue: Swollen and pale tongue with teeth marks on the edges, thin white or greasy white coating; Pulse: Thready and slow pulse. Primary symptom ① is mandatory, one of the other symptoms is sufficient, and any two of the secondary symptoms are sufficient.

[0136] 1.3 Clinical Symptom Scoring Criteria: Based on our clinical observations, we selected common clinical symptoms and signs, and formulated a symptom scoring system by comprehensively improving upon the symptom scoring criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" issued by the National Medical Products Administration.

[0137]

[0138] 1.4 Inclusion Criteria (1) Meets the diagnostic criteria for HPV-positive cervicitis.

[0139] (2) Liquid-based cytology test (TCT) or cervical colposcopy results exclude CIN and cancer.

[0140] (3) The patient is at least 18 years old and has a history of sexual activity.

[0141] (4) No immune system diseases or serious organ diseases.

[0142] (5) The patient has no history of drug allergies.

[0143] (6) Those who have not received hormone drugs or radiotherapy / chemotherapy in the six months prior to enrollment.

[0144] (7) Those who voluntarily accept traditional Chinese medicine treatment, are able to follow up on time, and complete the clinical treatment observation as required.

[0145] 1.5 Exclusion Criteria (1) Cervical cancer, pelvic inflammatory disease, vulvitis and condyloma acuminata visible to the naked eye.

[0146] (2) Women during pregnancy and lactation.

[0147] (3) The patient has other organic lesions.

[0148] (4) Patients who are unable to follow the research methods or do not follow medical advice.

[0149] 1.6 Criteria for Terminating the Test: (1) If a serious safety problem occurs during the test, the test should be stopped immediately.

[0150] (2) If the drug treatment is found to be too ineffective or even ineffective and has no clinical value during the trial, the trial should be terminated to avoid delaying the effective treatment of the subjects and to avoid unnecessary economic losses.

[0151] 1.7 Case dropout criteria: (1) Individuals who experience serious adverse events, complications, or special physiological changes and are not suitable to continue the trial.

[0152] (2) Those who withdraw from the experiment on their own.

[0153] (3) Cases of patients who withdrew from the trial before the course of treatment was completed, were lost to follow-up, or died for various other reasons.

[0154] 2. Research Methods 2.1 Overall Design Patients meeting the inclusion criteria signed informed consent forms and underwent their first visit. Follow-up was conducted six months after the completion of the treatment course. Before treatment and three months after treatment, routine vaginal discharge tests, cervical exfoliative cell HPV testing, cytokine testing (interleukin series, interferon, tumor necrosis factor), TCT testing, and Traditional Chinese Medicine clinical symptom scoring were performed.

[0155] 2.2 Treatment Plan Traditional Chinese Medicine Gel Treatment Group: Treatment involved external application of a specialized traditional Chinese medicine gel, starting on the first day after menstruation ends, three times a week. Each time, the cervix was fully exposed using a speculum, and the medication was applied to cover the cervical surface. Approximately 2ml of medication was used each time, ensuring 30 applications. Medication was discontinued during menstruation. Before treatment and three months after treatment, follow-up examinations were performed on cervical exfoliated cells for HPV testing, TCT testing, cytokine testing (interleukin series, interferon, tumor necrosis factor), and TCM clinical symptom scores.

[0156] Blank group: The blank group received no treatment and was followed up for 3 months. Before enrollment and 3 months later, cervical exfoliated cells were retested for HPV, TCT, cytokine (interleukin series, interferon, tumor necrosis factor) and TCM clinical symptoms were scored.

[0157] Patients meeting the inclusion criteria signed informed consent forms and underwent their first visit. Follow-up was conducted six months after the completion of the treatment course. Vaginal discharge routine examination, cervical exfoliative cell HPV testing, cytokine testing (interleukin series, interferon, tumor necrosis factor), TCT testing, and TCM clinical symptom scoring were performed before and three months after treatment to clarify the changes in the vaginal environment, cytokines, and TCM symptoms before and after TCM treatment.

[0158] 2.3 Efficacy observation indicators (1) Changes in clinical manifestations before and after treatment.

[0159] (2) The status of infection turning negative.

[0160] 2.4 Safety observation indicators This includes liver and kidney function tests, complete blood count, and urinalysis, and recording any adverse reactions that occur during treatment.

[0161] 2.5 Time Points for Efficacy Evaluation Before treatment and 3 months after treatment, follow-up examinations were conducted on cervical exfoliated cells for HPV testing, TCT testing, cytokine testing (interleukin series, interferon, tumor necrosis factor), and TCM clinical symptom scores, for a total of 2 times.

[0162] 2.6 Criteria for Evaluating Therapeutic Effect 2.6.1 Clinical Symptom Efficacy Evaluation Criteria: (Formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" issued by the National Medical Products Administration) Cure: Clinical symptom and sign score ratio ≥90%; Significant effect: 70% ≤ clinical symptom and sign score ratio < 90%; Effective: 30% ≤ clinical symptom and sign score ratio < 70%; Ineffective: Clinical symptom and sign score ratio <30%; Score ratio = (Total score before treatment - Total score after treatment) / Total score before treatment x 100%; 2.6.2 Clinical indicators and efficacy evaluation criteria for exfoliated cell HPV testing: Cure: The original HPV subtype becomes negative after treatment.

[0163] Effective: The number of the original subtypes decreased after treatment.

[0164] Ineffective: The original subtype remains positive after treatment.

[0165] 3. Statistical methods: Excel software was used to collect relevant data and process symptoms; SPSS 22.0 statistical software package was used for statistical analysis. Count data were analyzed using the test, and paired t-tests were used to compare pre- and post-treatment data within groups. P < 0.05 was considered statistically significant.

[0166] Sixty patients with HPV-positive cervicitis were treated. After 3 months of treatment, 48 patients tested negative, with a negative conversion rate of 80%. After 6 months of treatment, the negative conversion rate was 90%.

[0167] Five typical cases are introduced below: Case 1: A 59-year-old woman underwent cervical cytology testing for 18 high-risk HPV types and 6 low-risk HPV types. The result was positive for HPV51 and negative for low-risk HPV. After continuous treatment with the gel described in Example 1, a follow-up test showed negative results for both high-risk and low-risk HPV. Figure 4 As shown, all relevant indicators have returned to normal.

[0168] Case 2: A 44-year-old woman underwent cervical cytology testing for 18 high-risk HPV types and 6 low-risk HPV types. The result was positive for HPV58 and negative for low-risk HPV. After continuous treatment with the gel described in Example 1, a follow-up test showed negative results for both high-risk and low-risk HPV. Figure 5 As shown, all relevant indicators have returned to normal.

[0169] Case 3: A 54-year-old woman underwent cervical cytology testing for 18 high-risk HPV types and 6 low-risk HPV types. The results showed positive for HPV51 and HPV39, but negative for low-risk HPV. After continuous treatment with the gel described in Example 1, a follow-up test showed negative results for both high-risk and low-risk HPV. Figure 6 As shown, all relevant indicators have returned to normal.

[0170] Case 4: A 38-year-old woman underwent cervical cytology testing for 18 high-risk HPV types and 6 low-risk HPV types. The results showed positive for HPV51 and HPV59, but negative for low-risk HPV. After continuous treatment with the gel described in Example 1, a follow-up test showed negative results for both high-risk and low-risk HPV. Figure 7 As shown, all relevant indicators have returned to normal.

[0171] Case 5: A 27-year-old woman underwent cervical cytology testing for 18 high-risk HPV types and 6 low-risk HPV types. The results showed positive for HPV16 and low-risk HPV44. After continuous treatment with the gel described in Example 1, a follow-up test showed positive for HPV16 and negative for low-risk HPV44. Figure 8 As shown, all relevant indicators have returned to normal.

[0172] All documents mentioned in this invention are incorporated herein by reference as if each document were individually incorporated by reference. Furthermore, it should be understood that after reading the foregoing teachings of this invention, those skilled in the art can make various alterations or modifications to this invention, and these equivalent forms also fall within the scope defined by the appended claims.

Claims

1. A pharmaceutical composition, characterized by, Comprise: (a) a traditional Chinese medicine composition or a traditional Chinese medicine composition extract, the traditional Chinese medicine composition comprising raw medicinal materials or an extract of the raw medicinal materials, wherein the raw medicinal materials consist of Astragalus root, honeysuckle, forsythia, wind-protecting plant, white peony root, golden cypress, bitter apricot seed, goldthread, raw white atractylodes, scutellaria, panax, cassia twig, mulberry root-bark, and the weight parts of the raw medicinal materials are as follows: Astragalus root 3-20 parts; Honeysuckle 3-15 parts; Forsythia 3-15 parts; Wind-protecting plant 3-15 parts; White peony root 3-15 parts; Golden cypress 3-15 parts; Bitter apricot seed 3-15 parts; Goldthread 3-15 parts; Raw white atractylodes 3-15 parts; Scutellaria 3-15 parts; Panax 2-30 parts; Cassia twig 2-30 parts; Mulberry root-bark 2-30 parts; The traditional Chinese medicine composition extract is prepared by extraction of the traditional Chinese medicine composition, wherein the extraction solvent of the traditional Chinese medicine composition extract comprises water; (b) a pharmaceutically acceptable carrier; The pharmaceutical composition is a traditional Chinese medicine composition extract gel, which comprises the traditional Chinese medicine composition or the traditional Chinese medicine composition extract as an active ingredient; and a base gel containing the following components by weight percentage: CMC-Na 1%-3%, propylene glycol 10%-20%, ethanol 10%-20%, azone 0.5%-1%, Tween 0.5%-1%, and nipagin ethyl ester 0.1%-0.5%, and further comprising water.

2. The traditional Chinese medicine composition of claim 1, wherein, The traditional Chinese medicine composition is used for treating cervical HPV infection, preferably refractory HPV infection.

3. The traditional Chinese medicine composition of claim 2, wherein, The refractory HPV includes HPV18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, preferably HPV39, 51, 58, and 59.

4. A method for preparing a Chinese medicine composition extract gel, characterized in that, Comprise the following steps: S1) mixing propylene glycol 10%-20%, ethanol 10%-20%, azone 0.5%-1%, Tween 0.5%-1%, nipagin ethyl ester 0.1%-0.5%, traditional Chinese medicine composition or traditional Chinese medicine composition extract 15%-30%, and water to make up 100% by weight ratio, and uniformly mixing to obtain a drug mixture solution, wherein the traditional Chinese medicine composition comprises raw medicinal materials or an extract of the raw medicinal materials, wherein the raw medicinal materials consist of Astragalus root, honeysuckle, forsythia, wind-protecting plant, white peony root, golden cypress, bitter apricot seed, goldthread, raw white atractylodes, scutellaria, panax, cassia twig, and mulberry root-bark, and the weight parts of the raw medicinal materials are as follows: Astragalus root 3-20 parts; Honeysuckle 3-15 parts; Forsythia 3-15 parts; Wind-protecting plant 3-15 parts; White peony root 3-15 parts; Golden cypress 3-15 parts; Bitter apricot seed 3-15 parts; Goldthread 3-15 parts; Raw white atractylodes 3-15 parts; Scutellaria 3-15 parts; Panax 2-30 parts; Cassia twig 2-30 parts; Mulberry root-bark 2-30 parts; The traditional Chinese medicine composition extract is prepared by extraction of the traditional Chinese medicine composition, wherein the extraction solvent of the traditional Chinese medicine composition extract comprises water; S2) adding CMC-Na 1%-3% by weight ratio to the drug mixture solution to obtain a traditional Chinese medicine composition extract gel.

5. Use of a pharmaceutical composition according to claim 1, characterized in that, For preparing a medicine or preparation for treating cervical HPV infection.

6. Use according to claim 5, characterized in that, The HPV infection includes a refractory HPV infection.

7. Use according to claim 6, characterized in that, The refractory HPV includes HPV 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, preferably HPV 39, 51, 58, 59.

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