WO2016095772A1 - 用于治疗hpv乳头瘤病毒中药组合物、其制备方法及制剂 - Google Patents

用于治疗hpv乳头瘤病毒中药组合物、其制备方法及制剂 Download PDF

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WO2016095772A1
WO2016095772A1 PCT/CN2015/097249 CN2015097249W WO2016095772A1 WO 2016095772 A1 WO2016095772 A1 WO 2016095772A1 CN 2015097249 W CN2015097249 W CN 2015097249W WO 2016095772 A1 WO2016095772 A1 WO 2016095772A1
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parts
preparation
papillomavirus
hpv papillomavirus
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邓圣平
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邓圣平
程韵
赵晓军
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/487—Psoralea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Definitions

  • the present invention relates to a traditional Chinese medicine composition, in particular to a pharmaceutical composition for treating diseases such as condyloma acuminata caused by HPV papillomavirus infection, and to a preparation method of the traditional Chinese medicine composition and a preparation thereof.
  • Condyloma acuminata also known as genital warts, sexually transmitted diseases, etc., is a sexually transmitted disease caused by human HPV papillomavirus HPV infection.
  • the pathogen is HPV, belonging to the HPV papillomavirus family of the papovavirus family. More than 90 subtypes have been discovered so far, of which more than 30 are related to condyloma acuminata, mainly HPV-6, 11, 16, and 18.
  • HPV is easy to survive and thrive in humid and warm environment.
  • Condyloma acuminata usually occurs at the junction of skin and mucous membranes in the genital area. Men are more common in coronary sulcus, foreskin ligament, glans, urethral opening and stem, anus and rectum, etc. Found in the size of the labia, vaginal opening and other parts. Non-genital parts are found in the armpits, umbilical fossa, breasts, fingers, etc.
  • 35-fluorouracil (5-fu) ointment for topical use 35-fluorouracil (5-fu) ointment for topical use.
  • the present invention provides a traditional Chinese medicine composition for treating HPV papillomavirus disease, especially condyloma acuminata, which has a patient The pain is small and the effect is good, it is not easy to relapse, no scars are left, and the side effects are small.
  • the present invention further provides the above-described preparation for treating a HPV papillomavirus traditional Chinese medicine composition and a preparation method thereof.
  • a traditional Chinese medicine composition for treating HPV papillomavirus is prepared from the following components:
  • the traditional Chinese medicine composition for treating HPV papillomavirus is prepared from the following components:
  • the traditional Chinese medicine composition for treating HPV papillomavirus is prepared from the following components:
  • a preparation for treating HPV papillomavirus comprising the traditional Chinese medicine composition for treating HPV papillomavirus and a pharmaceutically acceptable adjuvant, the pharmaceutically acceptable adjuvant comprising a carbonate, a strong alkaline hydroxide and A mixture of quicklime, the mass ratio of the carbonate, strong alkali hydroxide and quicklime is (1-5): (1-5): (0.01-0.1).
  • the pharmaceutically acceptable excipients also include salicylic acid and/or white petrolatum.
  • a preparation method for treating a HPV papillomavirus preparation comprising the steps of:
  • step S3 Adding the cream prepared in step S3 to the fine powder prepared in step S1 to concentrate into a thick paste, and adding the pretreated pharmaceutical excipient, is used for treating the HPV papillomavirus preparation.
  • the pretreatment of the medicinal auxiliary material is: putting carbonate, strong alkaline hydroxide and quicklime into the container, stirring evenly after adding water to the container, and administrating for 48-90 hours.
  • the carbonate is sodium carbonate and/or potassium carbonate
  • the strong alkaline hydroxide is sodium hydroxide and/or potassium hydroxide.
  • the comfrey, Xanthium and psoralen are immersed in ethanol having a concentration of 75% (v/v), and the mixture is immersed for 8-12 days, and the filtrate after removing the residue is concentrated under reduced pressure. Thick paste.
  • the amount of ethanol there is no special requirement for the amount of ethanol, as long as it can pass the comfrey and the ear bones. It is often used to soak in a ratio of 40-60 ml of ethanol per 10 g of comfrey, 10 g of Xanthium and 10 g of psoralen.
  • the preparation for treating HPV papillomavirus is an applicator, cream, ointment or patch.
  • the selected Chinese medicine for treating the HPV papilloma virus of the present invention is a scorpion, a sylvestre, and a scorpion, and the medicinal herbs are comfrey, Xanthium and psoralen.
  • the adjuvant is a two-flavored drug of cantharidin and sea bream.
  • the efficacy of these 8 herbs is as follows:
  • Jun medicine wood scorpion, taste bitter, slightly sweet, sexual temperature, quality poisoning and scattering, there is scattered swelling, swelling, pain, attack and poisoning; soil shellfish, bitter, cool, there Anti-viral effect, the effect of dispersing and extracting poison; thousands of gold, spicy, warm, blood-breaking, detoxification and insecticidal effects.
  • Chen medicine comfrey, bitter taste, cold, cold blood rash, heat and dampness, detoxification effect, anti-inflammatory, anti-tumor effect; Xanthium, bitter, sweet, spicy, warm, dehumidification Analgesic, hurricane and itching effect, anti-pathogenic microorganisms; psoralen, pungent, bitter, warm, fragrant and dry, have anti-tumor effect, have a role in skin cytochrome.
  • Adjuvant spotted, fragrant, warm, anti-pathogenic microorganisms, have the effect of attacking the acne, breaking blood and stagnation; sea bream, salty, sputum, temperature, external use, collecting sore efficacy.
  • the drug of the present invention is also sought after by the inventor through a large amount of experiments and creative labor, and the drug is sodium carbonate, sodium hydroxide and quicklime, and after being mixed for 48-90 hours, it is used as a medicine, which can effectively reconcile the genus 8-flavor, synergistic effect promotes transdermal absorption of drugs on corpus callosum lesions.
  • the medicines are combined and have a corpus callosum decomposing layer. It is used to treat diseases such as condyloma acuminata caused by HPV virus infection.
  • composition for treating HPV papillomavirus according to the present invention is prepared by using natural Chinese medicinal materials as raw materials according to the traditional Chinese medicine theory, and is applied to the affected part, which is caused by treating HPV virus infection.
  • HPV papillomavirus ointment for treatment is prepared from the following components.
  • Wood scorpion 15g soil fritillary 12g, thousand gold 5g, comfrey 20g, Xanthium 10g, psoralen 10g, spotted 3g, jellyfish 5g.
  • compositions 20 g of excipients prepared in step S0, 8 g of salicylic acid, and 5 g of white petrolatum.
  • the above preparation method for treating HPV papillomavirus ointment comprises the following steps:
  • S0 preparation method of medicinal auxiliary materials: 100 g of sodium carbonate, 100 g of raw lime (breaking into a powder by a pulverizer), 1 g of sodium hydroxide, and 500 g of distilled water are weighed. The ratio is 1:1:0.01:5. Put sodium carbonate, quicklime, and sodium hydroxide in a container, add steamed water, and stir with a wooden utensil to chemically react sodium carbonate, quicklime, and sodium hydroxide. You can use the medicine as an auxiliary material.
  • step S3 adding the paste prepared in step S2 to the fine powder prepared in step S1, concentrating to a thick paste, adding 20 g of S1 medicinal adjuvant, 8 g of salicylic acid, and 5 g of white petrolatum, and preparing for treating HPV papillomavirus Ointment.
  • HPV papillomavirus spreader is prepared from the following components.
  • Wood scorpion 8g soil fritillary 10g, thousand gold 9g, comfrey 3g, Xanthium 9g, psoralen 8g, cantharidin 3g, jellyfish 4g.
  • composition 10 g of excipients prepared in step S0, 7 g of salicylic acid.
  • the above preparation method for treating HPV papillomavirus spreader comprises the following steps:
  • S0 medicinal auxiliary preparation method: weigh 100g of sodium carbonate, quicklime (into the crusher into powder) 500g, sodium hydroxide 10g, distilled water 2500g. The ratio is 1:5:0.1:5. Make carbonate, raw Lime, sodium hydroxide is placed in the container, while adding steamed water, while mixing with wooden utensils, the sodium carbonate, quicklime, and sodium hydroxide are chemically reacted into a thin paste, which is cooled and dried for three nights. Excipients.
  • the paste prepared in step S2 is added to the fine powder prepared in step S1 to be concentrated into a thick paste, and 10 g of S0 excipient and 7 g of salicylic acid are added to prepare an HPV papillomavirus spread.
  • HPV papillomavirus cream for treatment is prepared from the following components.
  • Wood scorpion 28g soil fritillary 15g, thousand gold 13g, comfrey 20g, Xanthium 20g, psoralen 18g, cantharidin 5g, jellyfish 8g.
  • compositions 30 g of excipients prepared in step S0, 10 g of salicylic acid, and 10 g of white petrolatum.
  • the above preparation method for treating HPV papilloma virus cream comprises the following steps:
  • S0 preparation method of medicinal auxiliary materials: weigh 500 g of sodium carbonate, 100 g of quicklime (breaking into a powder by a pulverizer), 5 g of sodium hydroxide, and 2500 g of distilled water. The ratio is 5:1:0.05:5. Put sodium carbonate, quicklime, and sodium hydroxide into the container, add steamed water, and stir with wooden utensils to chemically react sodium carbonate, quicklime, and sodium hydroxide into a thin paste, cool and dry for three nights. You can use the medicine as an auxiliary material.
  • step S3 adding the paste prepared in step S2 to the fine powder prepared in step S1, concentrating to a thick paste, adding 30 g of S1 medicinal adjuvant, 10 g of salicylic acid, and 10 g of white petrolatum, and preparing for treating HPV papillomavirus Cream.
  • HPV papillomavirus ointment for treatment is prepared from the following components.
  • Wood scorpion 18g soil fritillary 15g, thousand gold 15g, comfrey 8g, Xanthium 12g, psoralen 10g, cantharidin 5g, jellyfish 6g.
  • compositions 15 g of excipients prepared in step S0, 10 g of salicylic acid, and 6 g of white petrolatum.
  • the above preparation method for treating HPV papillomavirus ointment comprises the following steps:
  • S0 preparation method of medicinal auxiliary materials: 100 g of sodium carbonate, 100 g of raw lime (breaking into a powder by a pulverizer), 1 g of sodium hydroxide, and 500 g of distilled water are weighed. The ratio is 1:1:0.01:5. Put sodium carbonate, quicklime, and sodium hydroxide into the container, add steamed water, and stir with wooden utensils to chemically react sodium carbonate, quicklime, and sodium hydroxide into a thin paste, cool and dry for three nights. You can use the medicine as an auxiliary material.
  • S2 take the amount of comfrey, Xanthium, psoralen soaked in 75% (v / v) ethanol, according to every 10g comfrey, 10g Xanthium, 10g psoralen, need to be soaked in 50ml ethanol ratio, sealed Soak for 10 days, remove the residue by filtration, and concentrate to a thick paste after use under reduced pressure.
  • step S3 adding the paste prepared in step S2 to the fine powder prepared in step S1 to concentrate into a thick paste, adding 15 g of S0 pharmaceutical excipient, 10 g of salicylic acid and 6 g of white petrolatum, and preparing for treating HPV papillomavirus Ointment.
  • the patch for treating HPV papillomavirus is prepared from the following components.
  • Wood scorpion 10g soil fritillary 5g, thousand gold 7g, comfrey 15g, Xanthium 15g, psoralen 13g, cantharidin 4g, jellyfish 5g.
  • the above preparation method for treating HPV papillomavirus ointment comprises the following steps:
  • S0 preparation method of medicinal auxiliary material: 100 g of potassium carbonate, 100 g of quicklime (breaking into a powder by a pulverizer), 1 g of potassium hydroxide, and 500 g of distilled water are weighed. The ratio is 1:1:0.01:5. Put potassium carbonate, quicklime, and potassium hydroxide in a container, add steamed water, and stir with a wooden utensil to chemically react sodium carbonate, quicklime, and sodium hydroxide into a thin paste, cool and dry for three nights. You can use the medicine as an auxiliary material.
  • step S3 The paste prepared in step S2 is added to the fine powder prepared in step S1 to be concentrated into a thick paste, and 10 g of the S0 pharmaceutical excipient is added to prepare a patch for treating HPV papillomavirus.
  • HPV papillomavirus cream for treatment is prepared from the following components.
  • Wood scorpion 25g soil fritillary 20g, thousand gold 15g, comfrey 15g, Xanthium 12g, psoralen 12g, cantharidin 9g, jellyfish 10g.
  • compositions 30 g of excipients prepared in step S0, 20 g of salicylic acid, and 15 g of white petrolatum.
  • the above preparation method for treating HPV papillomavirus ointment comprises the following steps:
  • S0 medicinal auxiliary material preparation method: weigh 100 g of sodium carbonate, 100 g of quicklime (breaking into a powder by a pulverizer), 1 g of potassium hydroxide, and 500 g of distilled water. The ratio is 1:1:0.01:5. Put sodium carbonate, quicklime, and potassium hydroxide in a container, add steamed water, and stir with a wooden utensil to chemically react sodium carbonate, quicklime, and sodium hydroxide, into a thin paste, cool and dry for three nights. You can use the medicine as an auxiliary material.
  • step S3 adding the paste prepared in step S2 to the fine powder prepared in step S1, concentrating to a thick paste, adding 30 g of S0 medicinal adjuvant, 20 g of salicylic acid, and 15 g of white petrolatum, and preparing for treating HPV papillomavirus Cream.
  • HPV papillomavirus cream for treatment is prepared from the following components.
  • Wood scorpion 1g soil fritillaria 30g, thousand gold 10g, comfrey 10g, Xanthium 6g, psoralen 15g, cantharidin 15g, jellyfish 10g.
  • compositions 20 g of excipients prepared in step S0, 10 g of salicylic acid, and 20 g of white petrolatum.
  • the preparation method is the same as in Example 6.
  • HPV papillomavirus cream for treatment is prepared from the following components.
  • Wood scorpion 30g soil fritillary 1g, thousand gold 30g, comfrey 5g, Xanthium 1g, psoralen 15g, cantharidin 10g, jellyfish 15g.
  • compositions 25 g of excipients prepared in step S0, 15 g of salicylic acid, and 15 g of white petrolatum.
  • the preparation method is the same as in Example 6.
  • HPV papillomavirus spreader is prepared from the following components.
  • Wood scorpion 5g soil fritillary 7g, thousand gold 1g, comfrey 1g, Xanthium 5g, psoralen 1g, cantharidin 7g, jellyfish 3g.
  • compositions 15 g of excipients prepared in step S0, 15 g of salicylic acid, and 20 g of white petrolatum.
  • the preparation method is the same as in Example 2.
  • HPV papillomavirus spreader is prepared from the following components.
  • Wood scorpion 7g soil fritillary 25g, thousand gold 20g, comfrey 6g, Xanthium 5g, psoralen 6g, spotted scorpion 1g, jellyfish 7g.
  • compositions 15 g of excipients prepared in step S0, 15 g of salicylic acid, and 20 g of white petrolatum.
  • the preparation method is the same as in Example 2.
  • the applicant of the present application selected 50 patients with mild condyloma and mild patients, and conducted clinical trials for treating HPV papillomavirus ointment according to Example 4 of the present invention.
  • patients with mild condyloma acuminata refer to: patients with a history of 1-8 months, the skin lesions are small and soft, reddish papules, and merge with each other to form uneven surface, moist papilla or cauliflower-like protrusions, which can be eroded. Exudate, easy to bleed.
  • Patients with severe condyloma acuminata refer to: patients with a history of more than 1 year, reddish papules increased significantly, and merged to form papillary or cauliflower-like, erosive, obvious exudate, easy to bleed, and formed a giant condyloma acuminata for too long.

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Abstract

一种用于治疗人乳头瘤状病毒（HPV）疾病的中药组合物及其制备方法和制剂。所述中药组合物由下述原料药制备而成（重量份数）：木鳖子（1-30），土贝母（1-30），千金子（1-30），紫草（1-20），苍耳子（1-20），补骨脂（1-18），斑蝥（1-15），海螵蛸（1-15）。用于治疗人乳头瘤状病毒（HPV）疾病，尤其是尖锐湿疣。

Description

用于治疗HPV乳头瘤病毒中药组合物、其制备方法及制剂 技术领域
本发明涉及一种中药组合物，特别涉及用于治疗HPV乳头瘤病毒感染所致的尖锐湿疣等疾病的药物组合物，本发明还涉及该中药组合物的制备方法及其制剂。
背景技术
尖锐湿疣又称生殖器疣，性病疣等，是由人HPV乳头瘤病毒HPV感染引起的一种性传播疾病，病原体为HPV，属于乳多空病毒科的HPV乳头瘤病毒属。迄今已发现90余种亚型，其中与尖锐湿疣相关的有30余种，主要是HPV-6、11、16、18型。
HPV易在潮湿温热环境下生存繁殖，尖锐湿疣一般好发于生殖器部位皮肤粘膜交界处，男性多见于冠状沟，包皮系带，龟头，尿道口及茎部，肛门和直肠等部位，女性多见于大小阴唇，阴道口等部位。非生殖器部位见于腋窝，脐窝，乳房，手指等处。初起为小而柔软，淡红色丘疹，逐渐增大增多，互相融合形成表面凹凸不平，湿润的乳头状或菜花状突起，可发生糜烂，渗液，易出血。症状一般多数无任何自觉症状，少部分有瘙痒，灼痛，白带增多等，肛门、直肠尖锐湿疣可有疼痛和里急后重。病理组织，表皮角化不全，显著棘层肥厚和乳头瘤样增生；颗粒层和棘层上部可见特征性的空泡细胞，胞浆淡染，中央有大而深染的核。真皮水肿，毛细血管扩大，周围有慢性炎性细胞浸润。
目前西医治疗尖锐湿疣疾病主要包括：
(1)、物理疗法：激光治疗，冷冻治疗，电凝或电灼治疗，这样疗法效果虽好，操作简单；但治疗时患者疼痛感强，而复发率相当高，因尖锐湿疣是HPV病毒所致，靠物理疗法很难断根。
(2)局部药物治疗：
①0.5％足叶草毒素酊，0.5％鬼臼毒素酊，外用。
②50％三氯醋酸溶液，外用。
③5-氟脲嘧啶(5-fu)软膏，外用。
④5％咪喹莫特霜外用，这些药物都能使疣体消失，但都有复发可能。
发明内容
为了解决现有技术中治疗HPV乳头瘤病毒疾病的药物存在无法根治且复发率高的问题，本发明提供了一种治疗HPV乳头瘤病毒疾病，尤其是尖锐湿疣的中药组合物，其具有让患者痛感小而效果好，不易复发，不留瘢痕，毒副作用小的优点。
本发明进而提供上述用于治疗HPV乳头瘤病毒中药组合物的制剂及其制备方法。
本发明采用的技术方案如下：
一种用于治疗HPV乳头瘤病毒的中药组合物，所述用于治疗HPV乳头瘤病毒的中药组合物是由下述组分制备而成：
木鳖子1—30重量份，土贝母1—30重量份，千金子1—30重量份，
紫  草1—20重量份，苍耳子1—20重量份，补骨脂1—18重量份，
斑  蝥1—15重量份，海螵蛸1—15重量份。
优选地，所述用于治疗HPV乳头瘤病毒的中药组合物是由下述组分制备而成：
木鳖子5—18重量份，土贝母5—15重量份，千金子5—15重量份，
紫  草3—15重量份，苍耳子5—15重量份，补骨脂8—13重量份，
斑  蝥3—10重量份，海螵蛸3—10重量份。
进一步优选地，所述用于治疗HPV乳头瘤病毒的中药组合物是由下述组分制备而成：
木鳖子8—15重量份，土贝母7—15重量份，千金子9—13重量份，
紫  草5—10重量份，苍耳子6—12重量份，补骨脂8—12重量份，
斑  蝥4—9重量份，海螵蛸5—8重量份。
一种用于治疗HPV乳头瘤病毒制剂，包括所述的用于治疗HPV乳头瘤病毒的中药组合物和可药用辅料，所述可药用辅料包括碳酸盐、强碱性氢氧化物和生石灰的混合物，所述碳酸盐、强碱性氢氧化物和生石灰质量比为(1-5)：(1-5)：(0.01-0.1)。所述可药用辅料还包括水杨酸和/或白凡士林。
一种所述用于治疗HPV乳头瘤病毒制剂的制备方法，所述方法包括下述步骤：
S1、将木鳖子、千金子、海螵蛸、土贝母、斑蝥粉碎后过1000目细筛，筛成细粉；
S2、紫草、苍耳子和补骨脂加入溶剂浸泡8-12天，取浸泡液浓缩至膏状备用；
S3、向步骤S1制备的细粉中加入步骤S3制得的膏状液浓缩至稠膏状，加入预处理过的药用辅料，即得用于治疗HPV乳头瘤病毒制剂。
所述药用辅料的预处理为：将碳酸盐、强碱性氢氧化物和生石灰放入容器内，边向容器内加水边搅拌均匀，静止48-90小时即可入药。所述的碳酸盐为碳酸钠和/或碳酸钾，所述的强碱性氢氧化物为氢氧化钠和/或氢氧化钾。
优选地，所述步骤S2为将紫草，苍耳子和补骨脂浸泡于浓度为75％(v/v)的乙醇中，密闭浸泡8-12天，去除滤渣后的滤液减压浓缩至稠膏状液。乙醇的用量没有特别要求，只要能够没过紫草、苍耳子额补骨脂即可。经常采用的是按照每10g紫草，10g苍耳子和10g补骨脂使用用40-60ml乙醇比例进行浸泡。
所述用于治疗HPV乳头瘤病毒制剂为涂抹剂、乳膏剂、软膏剂或帖剂。
本发明提供的技术方案带来的有益效果是：
(1)本发明的用于治疗HPV乳头瘤病毒的中药组合物的选用的君药为木鳖子、土贝母和千金子，臣药为紫草、苍耳子和补骨脂三味药，佐药为斑蝥和海螵蛸两味药。这8味药的功效如下：
君药：木鳖子，味苦，微甘，性温，质毒攻散，有散结消肿，追风定痛，攻毒杀虫的作用；土贝母，味苦，性凉，有抗病毒作用，散结拔毒的功效；千金子、味辛，性温，有破血消癥，解毒杀虫的功效。
臣药：紫草，味苦，性寒，有凉血透疹，清热利湿，解毒的功效，有抗炎，抗肿瘤作用；苍耳子，味苦，甘，辛，性温，有除湿止痛，祛风止痒的功效，有抗病原微生物作用；补骨脂，味辛，苦，性温，香燥降敛，有抗肿瘤作用，有对皮肤细胞色素的作用。
佐药：斑蝥，味辛，性温，有抗病原微生物作用，有攻毒蚀疮、破血散结的功效；海螵蛸，味咸，涩，性温，外用有收湿敛疮的功效。
(2)本发明的使药也是发明人经过大量的实验和创造性劳动寻求到的，使药为碳酸纳、氢氧化钠和生石灰，其混合后静止48-90小时后入药，可以有效调和君臣佐8味药，产生协同作用促进药物在疣体病变组织上透皮吸收。诸药合用，具有分解疣体角质层。去腐生肌之功效，临床用于治疗HPV病毒感染所致的尖锐湿疣等疾病。
(3)本发明的用于治疗HPV乳头瘤病毒组合物根据传统中医理论选用天然中药材为原料制作成涂抹剂、乳膏剂、软膏剂或帖剂，敷在患部，是治疗HPV病毒感染所致的尖锐湿疣疾病的有效方法之一。临床试验证明，使用1-2个疗程病变组织即可与正常组织分离，病毒杀死，疣体自然脱落消失，痊愈本。治疗过程中痛感小而效果好，不复发，不留瘢痕，毒副作用小，克服了现有中西医治疗方法的不足等缺点。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将对本发明实施方式作进一步地详细描述。
实施例1
用于治疗HPV乳头瘤病毒软膏剂由下述组分制备而成。
木鳖子15g，土贝母12g，千金子5g，紫草20g，苍耳子10g，补骨脂10g，斑蝥3g，海螵蛸5g。
药用辅料：步骤S0制备的辅料20g，水杨酸8g，白凡士林5g。
上述用于治疗HPV乳头瘤病毒软膏剂的制备方法包括下述步骤：
S0、药用辅料制法：称取碳酸纳100g，生石灰(入粉碎机打碎成粉未)100g，氢氧化钠1g，蒸溜水500g。比例为1：1：0.01：5。使碳酸纳，生石灰，氢氧化钠放入容器内，一边加入蒸溜水，一边用木制器物搅和，使碳酸纳、生石灰、氢氧化钠发生化学反应，成稀糊状，凉晾、静置72即可入药为辅料。
S1、取木鳖子(去壳)、千金子、海螵蛸、土贝母、斑蝥(去头、去翅)粉碎后过1000目细筛，筛成细粉；
S2、取份量紫草，苍耳子、补骨脂浸泡于75％(v/v)乙醇内，按照每10g紫草，10g苍耳子，10g补骨脂，需用60ml乙醇比例浸泡，密闭浸泡8天，滤渣取液，减压浓缩至稠膏状备用。
S3、向步骤S1制备的细粉中加入步骤S2制得的膏状液浓缩至稠膏状，加入S1药用辅料20g，水杨酸8g，白凡士林5g，制得用于治疗HPV乳头瘤病毒软膏剂。
实施例2
用于治疗HPV乳头瘤病毒涂抹剂由下述组分制备而成。
木鳖子8g，土贝母10g，千金子9g，紫草3g，苍耳子9g，补骨脂8g，斑蝥3g，海螵蛸4g。
药用辅料：步骤S0制备的辅料10g，水杨酸7g。
上述用于治疗HPV乳头瘤病毒涂抹剂的制备方法包括下述步骤：
S0、药用辅料制法：称取碳酸纳100g，生石灰(入粉碎机打碎成粉未)500g，氢氧化钠10g，蒸溜水2500g。比例为1：5：0.1：5。使碳酸纳，生 石灰，氢氧化钠放入容器内，一边加入蒸溜水，一边用木制器物搅和，使碳酸纳、生石灰、氢氧化钠发生化学反应，成稀糊状，凉晾、过三夜即可入药为辅料。
S1、取份量木鳖子(去壳)、千金子、海螵蛸、土贝母、斑蝥(去头、去翅)粉碎后过1000目细筛，筛成细粉；
S2、取份量紫草，苍耳子、补骨脂浸泡于75％(v/v)乙醇内，按照每10g紫草，10g苍耳子，10g补骨脂，需用50ml乙醇浸泡，密闭浸泡8天，滤渣取液，减压浓缩至稠膏状备用。
S3、向步骤S1制备的细粉中加入步骤S2制得的膏状液浓缩至稠膏状，加入S0药用辅料10g，水杨酸7g，制得用于治疗HPV乳头瘤病毒涂抹剂。
实施例3
用于治疗HPV乳头瘤病毒乳膏剂由下述组分制备而成。
木鳖子28g，土贝母15g，千金子13g，紫草20g，苍耳子20g，补骨脂18g，斑蝥5g，海螵蛸8g。
药用辅料：步骤S0制备的辅料30g，水杨酸10g，白凡士林10g。
上述用于治疗HPV乳头瘤病毒乳膏剂的制备方法包括下述步骤：
S0、药用辅料制法：称取碳酸纳500g，生石灰(入粉碎机打碎成粉未)100g，氢氧化钠5g，蒸溜水2500g。比例为5：1：0.05：5。使碳酸纳，生石灰，氢氧化钠放入容器内，一边加入蒸溜水，一边用木制器物搅和，使碳酸纳、生石灰、氢氧化钠发生化学反应，成稀糊状，凉晾、过三夜即可入药为辅料。
S1、取份量木鳖子(去壳)、千金子、海螵蛸、土贝母、斑蝥(去头、去翅)粉碎后过1000目细筛，筛成细粉；
S2、取份量紫草，苍耳子、补骨脂浸泡于75％(v/v)乙醇内，，按照每10g紫草，10g苍耳子，10g补骨脂，需用40ml乙醇比例浸泡，密闭浸泡12天，滤渣取液，减压浓缩至稠膏状备用。
S3、向步骤S1制备的细粉中加入步骤S2制得的膏状液浓缩至稠膏状，加入S1药用辅料30g，水杨酸10g，白凡士林10g，制得用于治疗HPV乳头瘤病毒乳膏剂。
实施例4
用于治疗HPV乳头瘤病毒软膏剂由下述组分制备而成。
木鳖子18g，土贝母15g，千金子15g，紫草8g，苍耳子12g，补骨脂10g，斑蝥5g，海螵蛸6g。
药用辅料：步骤S0制备的辅料15g，水杨酸10g，白凡士林6g。
上述用于治疗HPV乳头瘤病毒软膏剂的制备方法包括下述步骤：
S0、药用辅料制法：称取碳酸纳100g，生石灰(入粉碎机打碎成粉未)100g，氢氧化钠1g，蒸溜水500g。比例为1：1：0.01：5。使碳酸纳，生石灰，氢氧化钠放入容器内，一边加入蒸溜水，一边用木制器物搅和，使碳酸纳、生石灰、氢氧化钠发生化学反应，成稀糊状，凉晾、过三夜即可入药为辅料。
S1、取份量木鳖子(去壳)、千金子、海螵蛸、土贝母、斑蝥(去头、去翅)粉碎后过1000目细筛，筛成细粉；
S2、取份量紫草，苍耳子、补骨脂浸泡于75％(v/v)乙醇内，按照每10g紫草，10g苍耳子，10g补骨脂，需用50ml乙醇比例浸泡，密闭浸泡10天，滤渣取液，减压浓缩至稠膏状备用。
S3、向步骤S1制备的细粉中加入步骤S2制得的膏状液浓缩至稠膏状，加入S0药用辅料15g，水杨酸10g，白凡士林6g，制得用于治疗HPV乳头瘤病毒软膏剂。
实施例5
用于治疗HPV乳头瘤病毒贴剂由下述组分制备而成。
木鳖子10g，土贝母5g，千金子7g，紫草15g，苍耳子15g，补骨脂13g，斑蝥4g，海螵蛸5g。
药用辅料：步骤S0制备的辅料10g。
上述用于治疗HPV乳头瘤病毒软膏剂的制备方法包括下述步骤：
S0、药用辅料制法：称取碳酸钾100g，生石灰(入粉碎机打碎成粉未)100g，氢氧化钾1g，蒸溜水500g。比例为1：1：0.01：5。使碳酸钾，生石灰，氢氧化钾放入容器内，一边加入蒸溜水，一边用木制器物搅和，使碳酸纳、生石灰、氢氧化钠发生化学反应，成稀糊状，凉晾、过三夜即可入药为辅料。
S1、取份量木鳖子(去壳)、千金子、海螵蛸、土贝母、斑蝥(去头、去翅)粉碎后过1000目细筛，筛成细粉；
S2、取份量紫草，苍耳子、补骨脂浸泡于75％(v/v)乙醇内，按照每10g紫草，10g苍耳子，10g补骨脂，需用60ml乙醇比例浸泡，密闭浸泡8天，滤渣取液，减压浓缩至稠膏状备用。
S3、向步骤S1制备的细粉中加入步骤S2制得的膏状液浓缩至稠膏状，加入S0药用辅料10g，制得用于治疗HPV乳头瘤病毒贴剂。
实施例6
用于治疗HPV乳头瘤病毒乳膏剂由下述组分制备而成。
木鳖子25g，土贝母20g，千金子15g，紫草15g，苍耳子12g，补骨脂12g，斑蝥9g，海螵蛸10g。
药用辅料：步骤S0制备的辅料30g，水杨酸20g，白凡士林15g。
上述用于治疗HPV乳头瘤病毒软膏剂的制备方法包括下述步骤：
S0、药用辅料制法：称取碳酸纳100g，生石灰(入粉碎机打碎成粉未)100g，氢氧化钾1g，蒸溜水500g。比例为1：1：0.01：5。使碳酸纳，生石灰，氢氧化钾放入容器内，一边加入蒸溜水，一边用木制器物搅和，使碳酸纳、生石灰、氢氧化钠发生化学反应，成稀糊状，凉晾、过三夜即可入药为辅料。
S1、取份量木鳖子(去壳)、千金子、海螵蛸、土贝母、斑蝥(去头、 去翅)粉碎后过1000目细筛，筛成细粉；
S2、取份量紫草，苍耳子、补骨脂浸泡于75％(v/v)乙醇内，按照每10g紫草，10g苍耳子，10g补骨脂，需用60ml乙醇比例浸泡，密闭浸泡8天，滤渣取液，减压浓缩至稠膏状备用。
S3、向步骤S1制备的细粉中加入步骤S2制得的膏状液浓缩至稠膏状，加入S0药用辅料30g，水杨酸20g，白凡士林15g，制得用于治疗HPV乳头瘤病毒乳膏剂。
实施例7
用于治疗HPV乳头瘤病毒乳膏剂由下述组分制备而成。
木鳖子1g，土贝母30g，千金子10g，紫草10g，苍耳子6g，补骨脂15g，斑蝥15g，海螵蛸10g。
药用辅料：步骤S0制备的辅料20g，水杨酸10g，白凡士林20g。
其制备方法同实施例6。
实施例8
用于治疗HPV乳头瘤病毒乳膏剂由下述组分制备而成。
木鳖子30g，土贝母1g，千金子30g，紫草5g，苍耳子1g，补骨脂15g，斑蝥10g，海螵蛸15g。
药用辅料：步骤S0制备的辅料25g，水杨酸15g，白凡士林15g。
其制备方法同实施例6。
实施例9
用于治疗HPV乳头瘤病毒涂抹剂由下述组分制备而成。
木鳖子5g，土贝母7g，千金子1g，紫草1g，苍耳子5g，补骨脂1g，斑蝥7g，海螵蛸3g。
药用辅料：步骤S0制备的辅料15g，水杨酸15g，白凡士林20g。
其制备方法同实施例2。
实施例10
用于治疗HPV乳头瘤病毒涂抹剂由下述组分制备而成。
木鳖子7g，土贝母25g，千金子20g，紫草6g，苍耳子5g，补骨脂6g，斑蝥1g，海螵蛸7g。
药用辅料：步骤S0制备的辅料15g，水杨酸15g，白凡士林20g。
其制备方法同实施例2。
上述本发明实施例序号仅仅为了描述，不代表实施例的优劣。
尖锐湿疣临床试验
本申请的申请人选取了尖锐湿疣轻度患者、重度患者各50例，采用本发明实施例4的用于治疗HPV乳头瘤病毒软膏剂进行了临床试验。
其中尖锐湿疣轻度患者是指：患者病史1-8个月，皮损初起为小而柔软，淡红色丘疹，互相融合形成表面凹凸不平，湿润的乳头状或菜花状突起，可发生糜烂，渗液，易出血。
重度尖锐湿疣患者是指：患者病史1年以上，淡红色丘疹明显增大增多，互相融合形成乳头状或菜花状，糜烂，渗液明显，易出血，时间过长形成巨型尖锐湿疣。
尖锐湿疣轻度患者采用的治疗方式如下：
取医用胶布一块，用弯剪剪与病变组织相等的圆孔，并贴于患部暴露出疣体并保护好周围健康组织，然后敷上用于治疗HPV乳头瘤病毒软膏在疣体上，敷药厚度为1.5mm，再剪医用胶布一块贴盖固定并封牢，2天换药一次。看到疣体残体和正常组织分离脱落后，停止换药，然后用手术刀刮去疣体残体。敷上鱼石脂软膏保护好创口，三至五天痊愈。如不用手术刀刮去疣体残体，让其自行脱落消失也可，一般本讲疣体病毒杀死，疣体残体一周左右自然消失。不留瘢痕。
尖锐湿重度患者采用的治疗方式和轻度患者相同。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发 明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种用于治疗HPV乳头瘤病毒的中药组合物，其特征在于，所述用于治疗HPV乳头瘤病毒的中药组合物是由下述组分制备而成：
    木鳖子1—30重量份，土贝母1—30重量份，千金子1—30重量份，
    紫草1—20重量份，苍耳子1—20重量份，补骨脂1—18重量份，
    斑蝥1—15重量份，海螵蛸1—15重量份。
  2. 根据权利要求1所述的用于治疗HPV乳头瘤病毒的中药组合物，其特征在于，所述用于治疗HPV乳头瘤病毒的中药组合物是由下述组分制备而成：
    木鳖子5—18重量份，土贝母5—15重量份，千金子5—15重量份，
    紫草3—15重量份，苍耳子5—15重量份，补骨脂8—13重量份，
    斑蝥3—10重量份，海螵蛸3—10重量份。
  3. 根据权利要求2所述的用于治疗HPV乳头瘤病毒的中药组合物，其特征在于，所述用于治疗HPV乳头瘤病毒的中药组合物是由下述组分制备而成：
    木鳖子8—15重量份，土贝母7—15重量份，千金子9—13重量份，
    紫草5—10重量份，苍耳子6—12重量份，补骨脂8—12重量份，
    斑蝥4—9重量份，海螵蛸5—8重量份。
  4. 一种用于治疗HPV乳头瘤病毒制剂，其特征在于，所述的用于治疗HPV乳头瘤病毒制剂包括权利要求1-3任一所述的用于治疗HPV乳头瘤病毒的中药组合物和可药用辅料，所述可药用辅料包括碳酸盐、强碱性氢氧化物和生石灰的混合物，所述碳酸盐、强碱性氢氧化物和生石灰质量比为(1-5)：(1-5)：(0.01-0.1)。
  5. 一种权利要求4所述用于治疗HPV乳头瘤病毒制剂，其特征在于，所述可药用辅料还包括水杨酸和/或白凡士林。
  6. 一种权利要求4或5所述用于治疗HPV乳头瘤病毒制剂的制备方 法，其特征在于，所述方法包括下述步骤：
    S1、将木鳖子、千金子、海螵蛸、土贝母、斑蝥粉碎后过1000目细筛，筛成细粉；
    S2、紫草、苍耳子和补骨脂加入溶剂浸泡8-12天，取浸泡液浓缩至膏状备用；
    S3、向步骤S1制备的细粉中加入步骤S3制得的膏状液浓缩至稠膏状，加入预处理过的药用辅料，即得用于治疗HPV乳头瘤病毒制剂。
  7. 根据权利要6所述用于治疗HPV乳头瘤病毒制剂的制备方法，其特征在于：
    所述药用辅料的预处理为：将碳酸盐、强碱性氢氧化物和生石灰放入容器内，边向容器内加水边搅拌均匀，静止48-90小时即可入药。
  8. 根据权利要7所述用于治疗HPV乳头瘤病毒制剂的制备方法，其特征在于：
    所述的碳酸盐为碳酸钠和/或碳酸钾，所述的强碱性氢氧化物为氢氧化钠和/或氢氧化钾。
  9. 根据权利要求6所述用于治疗HPV乳头瘤病毒制剂的制备方法，其特征在于，
    所述步骤S2为将紫草，苍耳子和补骨脂浸泡于浓度为75％(v/v)的乙醇中，密闭浸泡8-12天，去除滤渣后的滤液减压浓缩至稠膏状液。
  10. 根据权利要求8所述用于治疗HPV乳头瘤病毒制剂的制备方法，其特征在于，
    所述用于治疗HPV乳头瘤病毒制剂为涂抹剂、乳膏剂、软膏剂或帖剂。
PCT/CN2015/097249 2014-12-16 2015-12-14 用于治疗hpv乳头瘤病毒中药组合物、其制备方法及制剂 WO2016095772A1 (zh)

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