Traditional Chinese medicine compound preparation for regulating female immunity and eliminating high-risk HPV (human papillomavirus) infection

Abstract

The invention discloses a traditional Chinese medicine compound preparation for regulating female immunity and eliminating high-risk HPV infection, and relates to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 15-25 parts of Chinese yam, 12-18 parts of astragalus membranaceus, 15-25 parts of poria cocos, 10-15 parts of fried gordon euryale seed, 15-25 parts of coix seed, 15-25 parts of rhizoma atractylodis, 8-12 parts of golden cypress, 10-15 parts of rhizoma alismatis, 6-12 parts of semen plantaginis, 8-12 parts of sculellaria barbata, 8-12 parts of oldenlandia diffusa, 8-12 parts of sargentgloryvine stem, 8-12 parts of achyranthes bidentata and 5-8 parts of ginkgo. A synergistic effect system for strengthening the spleen and replenishing qi to support the healthy energy, clearing heat and promoting diuresis to remove pathogenic factors and detoxifying and dispersing blood stasis to improve the local microenvironment is formed, the local immune function of female organisms, especially cervix uteri, can be comprehensively adjusted from multiple links and multiple targets, and clearing of high-risk human papilloma viruses is promoted.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine preparation, in particular to a traditional Chinese medicine compound preparation for regulating female immunity to clear high-risk HPV infection. BACKGROUND

[0002] Human papillomavirus is a spherical DNA virus, and the persistent infection of its high-risk type is the main cause of cervical precancerous lesions and cervical cancer. Modern medicine has no recognized specific antiviral drugs for high-risk HPV infection that has occurred, and the clinical treatment strategy is mostly regular observation, expecting the immune system to clear it, or physical or surgical intervention when lesions occur. This "waiting-intervention" mode has certain limitations: on the one hand, some patients cannot achieve spontaneous clearance of the virus and face the risk of persistent infection and lesion progression; on the other hand, although physical or surgical methods can remove local lesions, they do not fundamentally solve the immunological basis of persistent virus existence and may relapse.

[0003] Traditional Chinese medicine has accumulated some experience in preventing and treating HPV infection. According to traditional Chinese medicine theory, HPV infection can be attributed to "leukorrhea" and "yin sore", and its pathogenesis mainly involves spleen and kidney deficiency, dampness and heat downward, and toxic stasis mutual knotting. Spleen governs transportation and transformation, and spleen deficiency leads to internal generation of dampness; kidney stores essence, and kidney deficiency leads to unstable chong and ren; dampness and heat evil invade the lower jiao by taking advantage of the deficiency, and form a persistent infection state by mutual knotting with blood stasis. Based on this pathogenesis, clinical treatment often uses heat-clearing and detoxifying, spleen-strengthening and dampness-eliminating, kidney-tonifying and root-consolidating methods, but existing treatments mostly focus on single method or simple combination, and fail to systematically integrate the relationship between "strengthening the body resistance" and "clearing heat, eliminating dampness, resolving toxin and removing stasis", resulting in limited effect in comprehensively regulating immune function and completely clearing the virus.

[0004] Therefore, a traditional Chinese medicine compound preparation is designed, which can systematically integrate various methods such as spleen-strengthening and qi-tonifying, heat-clearing and dampness-eliminating, toxin-resolving and stasis-removing, and body resistance strengthening, and effectively regulate female immune function through multi-target and multi-pathway synergistic effect, promote high-risk HPV clearance, and prevent the development of cervical lesions, so as to solve the above technical problems. SUMMARY

[0005] In view of the deficiencies of the prior art, the present application provides a traditional Chinese medicine compound preparation for regulating female immunity to clear high-risk HPV infection, which solves the technical problems in the background art.

[0006] To achieve the above object, the present application is implemented by the following technical scheme: A traditional Chinese medicine compound preparation for regulating immune clearance of high-risk HPV infection in women is prepared from the following raw medicinal materials by weight: Shanyao 15-25 parts, Huangqi 12-18 parts, Fuling 15-25 parts, Chaoqianshi 10-15 parts, Yiyiren 15-25 parts, Cangzhu 15-25 parts, Huangbai 8-12 parts, Zexie 10-15 parts, Cheqianzi 6-12 parts, Banzhi 8-12 parts, Baihuashexiang 8-12 parts, Daxueteng 8-12 parts, Niuxi 8-12 parts, Baigu 5-8 parts.

[0007] Preferably, the preparation is prepared from the following raw medicinal materials by weight: Shanyao 20 parts, Huangqi 15 parts, Fuling 20 parts, Chaoqianshi 12 parts, Yiyiren 20 parts, Cangzhu 20 parts, Huangbai 10 parts, Zexie 12 parts, Cheqianzi 6 parts, Banzhi 10 parts, Baihuashexiang 10 parts, Daxueteng 10 parts, Niuxi 10 parts, Baigu 6 parts.

[0008] Preferably, the preparation is prepared from the following raw medicinal materials by weight: Shanyao 20 parts, Huangqi 15 parts, Fuling 20 parts, Chaoqianshi 12 parts, Yiyiren 20 parts, Cangzhu 20 parts, Huangbai 10 parts, Zexie 12 parts, Cheqianzi 6 parts, Banzhi 10 parts, Baihuashexiang 10 parts, Daxueteng 10 parts, Niuxi 10 parts, Baigu 6 parts.

[0009] Preferably, the preparation is prepared from the following raw medicinal materials by weight: Shanyao 20 parts, Huangqi 15 parts, Fuling 20 parts, Chaoqianshi 12 parts, Yiyiren 20 parts, Cangzhu 20 parts, Huangbai 10 parts, Zexie 12 parts, Cheqianzi 6 parts, Banzhi 10 parts, Baihuashexiang 10 parts, Daxueteng 10 parts, Niuxi 10 parts, Baigu 6 parts.

[0010] Preferably, the preparation is prepared from the following raw medicinal materials by weight: Shanyao 20 parts, Huangqi 15 parts, Fuling 20 parts, Chaoqianshi 12 parts, Yiyiren 20 parts, Cangzhu 20 parts, Huangbai 10 parts, Zexie 12 parts, Cheqianzi 6 parts, Banzhi 10 parts, Baihuashexiang 10 parts, Daxueteng 10 parts, Niuxi 10 parts, Baigu 6 parts.

[0011] Preferably, the preparation is prepared from the following raw medicinal materials by weight: Shanyao 20 parts, Huangqi 15 parts, Fuling 20 parts, Chaoqianshi 12 parts, Yiyiren 20 parts, Cangzhu 20 parts, Huangbai 10 parts, Zexie 12 parts, Cheqianzi 6 parts, Banzhi 10 parts, Baihuashexiang 10 parts, Daxueteng 10 parts, Niuxi 10 parts, Baigu 6 parts. Beneficial effects

[0012] The present application provides a traditional Chinese medicine compound preparation for regulating immune clearance of high-risk HPV infection in women, which is based on the combination of the TCM theory of "strengthening the body resistance to eliminate pathogenic factors" and the modern medical immune regulation mechanism. The preparation forms a synergistic system of spleen and kidney tonification for strengthening the body resistance, heat-clearing and dampness-removing for eliminating pathogenic factors, and detoxification and blood stasis removal for improving the local microenvironment through the reasonable combination of monarch, minister, assistant and guide. The preparation can comprehensively regulate the immune function of the female body, especially the local immune function of the cervix, from multiple links and multiple targets, which is helpful for promoting the clearance of high-risk human papilloma virus, thereby providing a new treatment scheme for blocking the persistent infection process of the virus and preventing the occurrence and development of cervical lesions. Compared with some existing treatment methods, the preparation of the present application considers both traditional theory and modern pathological knowledge, the effects of the components are complementary, and the raw materials are all clinically common traditional Chinese medicines, which are expected to have the characteristics of clear mechanism of action, overall regulation and good safety. DETAILED DESCRIPTION

[0013] The technical solutions in the embodiments of the present application will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the protection scope of the present application.

[0014] The present application provides a technical solution: a traditional Chinese medicine compound preparation for regulating immune clearance of high-risk HPV infection in women, which is prepared from the following raw medicinal materials by weight: Shanyao 15-25 parts, Huangqi 12-18 parts, Fuling 15-25 parts, Chaoqianshi 10-15 parts, Yiyiren 15-25 parts, Cangzhu 15-25 parts, Huangbai 8-12 parts, Zexie 10-15 parts, Cheqianzi 6-12 parts, Banzhi 8-12 parts, Baihuasheshecao 8-12 parts, Daxueteng 8-12 parts, Niuxi 8-12 parts, Baigu 5-8 parts.

[0015] The present embodiment is further provided to be prepared from the following raw medicinal materials by weight: Shanyao 20 parts, Huangqi 15 parts, Fuling 20 parts, Chaoqianshi 12 parts, Yiyiren 20 parts, Cangzhu 20 parts, Huangbai 10 parts, Zexie 12 parts, Cheqianzi 6 parts, Banzhi 10 parts, Baihuasheshecao 10 parts, Daxueteng 10 parts, Niuxi 10 parts, Baigu 6 parts.

[0016] The present embodiment is further provided to be a clinically acceptable dosage form prepared by a conventional preparation method of traditional Chinese medicine preparations.

[0017] The present embodiment is further provided to include a decoction, granules, tablets, capsules, pills or oral liquid.

[0018] The present embodiment is further provided to include the following steps: weighing each raw medicinal material according to the ratio, wherein the Cheqianzi is wrapped with gauze; mixing each raw medicinal material, soaking after adding water, decocting, filtering, combining the filtrates, concentrating to obtain a traditional Chinese medicine extract; mixing the traditional Chinese medicine extract with a pharmaceutically acceptable excipient to prepare a required dosage form.

[0019] The present embodiment is further provided to be decocted for 2-3 times, and the water added each time is 6-10 times the total weight of the medicinal materials, and the decocting time is 1-2 hours.

[0020] The detailed connection means is a well-known technology in the art, and the working principle and process are mainly introduced below, and the specific work is as follows.

[0021] Embodiment one: preparation of the traditional Chinese medicine compound decoction in the present application Weigh out the following processed medicinal slices after cleaning, slicing, or processing: 20g of Dioscorea opposita, 15g of Astragalus membranaceus, 20g of Poria cocos, 12g of stir-fried Euryale ferox, 20g of Coix lacryma-jobi, 20g of Atractylodes lancea, 10g of Phellodendron chinense, 12g of Alisma plantago-aquatica, 6g of Plantago asiatica (wrapped in a non-woven fabric decoction bag), 10g of Scutellaria barbata, 10g of Hedyotis diffusa, 10g of Sargentodoxa cuneata, 10g of Achyranthes bidentata, and 6g of Ginkgo biloba (crushed). Place all the medicinal materials except Plantago asiatica in a multi-functional extraction vessel, add drinking water equal to 8 times the total weight of the medicinal slices, add the wrapped Plantago asiatica, and soak for 30 minutes to facilitate the dissolution of active ingredients. Then turn on the heat, first bring to a boil over high heat, then reduce to a simmer and cook for 1.5 hours, observing the water level in real time and adding water as needed to compensate for evaporation loss. After decoction, filter the first decoction through a 200-mesh sieve while hot and collect the liquid. Add drinking water, six times the total weight of the medicinal herbs, to the dregs again and decoct for a second time for one hour. Filter and combine the two decoctions. After allowing the combined filtrate to cool, pour off the supernatant and concentrate it under reduced pressure using a triple-effect vacuum concentrator at 60℃ and -0.08MPa to a total volume of approximately 450-500mL, yielding a decoction with a relative density of approximately 1.05 (60℃). This decoction can be taken directly, one dose daily, divided into two servings, taken warm half an hour after meals. This is the standard clinical usage in Traditional Chinese Medicine.

[0022] Example 2: Preparation of the traditional Chinese medicine compound granules (sugar-free) of the present invention Prepare the medicinal materials according to the formulation and pretreatment method of Example 1, and obtain a combined decoction using the same decoction and filtration process. Transfer the decoction to a vacuum concentrator and concentrate it to an extract (thick extract) with a relative density of 1.10-1.15 measured at 60°C. Transfer the obtained extract to the feed tank of a spray drying tower, set the inlet air temperature to 160-180°C and the outlet air temperature to 80-90°C, and perform spray drying to obtain a dry powder with good flowability. Mix the above dry powder with excipients in a three-dimensional mixer according to the weight ratio of dry powder: soluble starch: microcrystalline cellulose = 1:0.5:0.3. Use 70% ethanol as a wetting agent to prepare a soft mass using a wet granulator, and granulate it through a 14-mesh sieve. Dry the wet granules in a hot air circulating oven at 60-65°C until the moisture content is ≤5.0%, and then granulate them through a 16-mesh sieve. Magnesium stearate (0.5% of the total weight of the granules) is added as a lubricant to the granules after granulation. After thorough mixing, the mixture is packaged and sealed in 10g bags (equivalent to approximately 45g of total raw medicinal material) using an automatic granule packaging machine to obtain the finished product of the traditional Chinese medicine compound granules of this invention. This dosage form is convenient to carry and take, and conforms to the conventional process of modern traditional Chinese medicine preparation.

[0023] Example 3: Preparation of the compound capsule formulation of traditional Chinese medicine of the present invention The dry paste powder prepared according to the method of Example 2 is taken, or each raw medicinal decoction piece meeting the pharmacopoeia standard is respectively crushed by a pulverizer and passed through an 80-mesh sieve to obtain fine powder of each medicinal material. Each medicinal material fine powder (among which the dosage of plantago seed powder is calculated according to the conversion) is accurately weighed according to the prescription proportion, placed in a V-type mixer for 30 minutes until the color is uniform. The uniformly mixed medicinal powder is filled into No. 0 hollow gelatin capsules, and the filling amount of each capsule is 0.4 g of medicinal powder. The quality inspection of the amount difference, disintegration time limit and the like is carried out according to the requirements in the capsule item of Chinese Pharmacopoeia, and after the quality inspection is qualified, an aluminum plastic blister packaging machine is used for packaging, thereby obtaining the finished product of the traditional Chinese medicine compound capsule of the application. The dosage form can cover up the bad smell of the medicine, the dosage is accurate, and the stability is good.

[0024] Example Four: Preparation of the traditional Chinese medicine compound tablet of the application The dry paste powder prepared according to the method of Example 2 is taken, and appropriate conventional tablet excipients are added for preparation. Specifically, 100 parts by weight of the dry paste powder is uniformly mixed with 30 parts by weight of pregelatinized starch, 20 parts by weight of microcrystalline cellulose and 8 parts by weight of cross-linked povidone (part of which is added inside) in a high-efficiency mixing granulator. Appropriate purified water is used as a binder for granulation, and the wet granules are dried in a fluidized bed to about 3% of moisture. 1 part by weight of magnesium stearate and 2 parts by weight of the remaining cross-linked povidone are added to the dry granules as lubricants and disintegrants (the rest is added outside), and the mixture is uniformly mixed. The mixture is compressed into a substrate tablet with a weight of about 0.5 g per tablet using a rotary tablet press, and the tablet hardness is controlled at 50-80 N. The substrate tablet is coated by a film coating machine using Opadry gastroresistant coating powder for coating, and the weight is increased by about 3%, thereby obtaining the finished product of the traditional Chinese medicine compound film-coated tablet of the application. The dosage form is suitable for large-scale production, and the patient compliance is high.

[0025] It should be noted that, in this text, relational terms such as first and second are used only to distinguish one entity or operation from another entity or operation, without necessarily requiring or implying any such actual relationship or order between such entities or operations.

Claims

1. A traditional Chinese medicine compound preparation for regulating female immunity to clear high-risk HPV infection, characterized in that, It is made from the following raw materials in parts by weight: 15-25 parts of Dioscorea opposita, 12-18 parts of Astragalus membranaceus, 15-25 parts of Poria cocos, 10-15 parts of stir-fried Euryale ferox, 15-25 parts of Coix lacryma-jobi, 15-25 parts of Atractylodes lancea, 8-12 parts of Phellodendron chinense, 10-15 parts of Alisma plantago-aquatica, 6-12 parts of Plantago asiatica, 8-12 parts of Scutellaria barbata, 8-12 parts of Hedyotis diffusa, 8-12 parts of Sargentodoxa cuneata, 8-12 parts of Achyranthes bidentata, and 5-8 parts of Ginkgo biloba.

2. The traditional Chinese medicine compound preparation for regulating female immunity and clearing high-risk HPV infection according to claim 1, characterized in that... It is made from the following raw materials in parts by weight: 20 parts of yam, 15 parts of astragalus, 20 parts of poria cocos, 12 parts of stir-fried euryale ferox, 20 parts of coix seed, 20 parts of atractylodes lancea, 10 parts of phellodendron bark, 12 parts of alisma plantago-aquatica, 6 parts of plantain seed, 10 parts of scutellaria barbata, 10 parts of oldenlandia diffusa, 10 parts of sarsaparilla vine, 10 parts of achyranthes bidentata, and 6 parts of ginkgo.

3. The traditional Chinese medicine compound preparation for regulating female immunity and clearing high-risk HPV infection according to claim 1, characterized in that... The preparation is a clinically acceptable dosage form made using conventional methods for preparing traditional Chinese medicine preparations.

4. The traditional Chinese medicine compound preparation for regulating female immunity and clearing high-risk HPV infection according to claim 3, characterized in that... The dosage forms include decoctions, granules, tablets, capsules, pills, or oral liquids.

5. A method for preparing a traditional Chinese medicine compound preparation as described in any one of claims 1-4, characterized in that, Includes the following steps: Weigh each raw material according to the specified ratio, with the plantain seed wrapped in gauze; mix all raw materials, soak in water, decoct, filter, combine the filtrates, concentrate, and obtain the Chinese medicine extract; mix the Chinese medicine extract with pharmaceutically acceptable excipients to prepare the desired dosage form.

6. The preparation method according to claim 5, characterized in that, The decoction is performed 2-3 times, with each time the amount of water added being 6-10 times the total weight of the medicinal materials, and the decoction time being 1-2 hours.