KR100319973B1 - Cervical epithelial tumor prophylaxis or treatment composition using green tea catechin as an active ingredient - Google Patents
Cervical epithelial tumor prophylaxis or treatment composition using green tea catechin as an active ingredient Download PDFInfo
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Abstract
본 발명은 차 카텐킨(茶 catechin)을 유효성분으로 하는 사람유두종비루스(human papilloma virus; 이하 "HPV"라 함) 유래의 여성의 자궁경부암 CIN Ⅰ, Ⅱ 및 Ⅲ에 예방 또는 치료제에 관한 것으로 부작용이 없고 장기간 사용해도 안전하고 더구나 현저한 치료효과를 나타내는 천연물로 일상 음용하고 있는 녹차의 성분인 카테킨류를 분리하여 약제로 제조한 후 임상실험한 결과, 녹차 카테킨 폴리페놀(Polyphenol)계 성분이 gel 형태나 분말을 캡슐로 한 형태의 약제는 암예방 치료뿐만 아니라 대부분의 악성 자궁경부암 치료에 뛰어난 효과가 있다.The present invention relates to a prophylactic or therapeutic agent for cervical cancer CIN I, II and III of a woman from human papilloma virus (hereinafter referred to as "HPV") containing tea catechin as an active ingredient. As a result of clinical experiment after separating catechin, which is a component of green tea, which is used for daily drinking, it is a natural product that is safe and long-term use and also has a remarkable therapeutic effect. Na-encapsulated medicinal forms are effective for treating cancer as well as for treating most malignant cervical cancers.
Description
본 발명은 여성 자궁경부 상피내종양(Cervical Intraepithelial Neoplasia; 이하, CIN이라 함) 예방 또는 치료제 조성물에 관한 것으로서, 더욱 상세하게는 차 카텐킨(茶catechin)을 유효성분으로 하는 사람유두종비루스(human papilloma virus; 이하, HPV라 함) 유래의 여성의 자궁경부 상피내종양 CIN Ⅰ, Ⅱ 및 Ⅲ에 예방 또는 치료제 조성물에 관한 것이다.The present invention relates to a composition for preventing or treating cervical Intraepithelial Neoplasia (hereinafter referred to as CIN), and more specifically, human papilloma virus comprising tea catenchin as an active ingredient. The present invention relates to a prophylactic or therapeutic composition for cervical epithelial tumors CIN I, II and III of women derived from HPV).
여성들의 자궁경부 상피내종양 발생 병리과정에서, 자궁경부암에 이르기까지, 전이악성 전구암(preneoplastic lesion) 단계인 CIN Ⅰ, Ⅱ 및 Ⅲ의 단계를 경유하여(CIN Ⅲ를 특히 carcinoma in situ라 한다) 악성암세포들이 다른 조직에 전이하게 돤다. 이 자궁경부 상피내종양의 원인은 현재 HPV 18 또는 16으로 알려져 있다.From malignant pathologic pathogenesis of cervical epithelial tumors to cervical cancer, through the stages of CIN I, II and III, the stages of preneoplastic lesions (CIN III, in particular carcinoma in situ) Cancer cells spread to other tissues. The cause of this cervical epithelial tumor is now known as HPV 18 or 16.
감염 후 1∼6개월, 평균 3개월에서 임상증상이 발현하지만 통상 자각증상은 없다. 자궁경부 상피내종양 CIN Ⅰ, Ⅱ 및 Ⅲ 병리적 단계의 조직 또는 경부 표면 조직을 채취하여 HPV의 DNA 정량분석 방법에 의하면 거의 100%의 검출률이 얻어진다. 바이러스에는 주로 HPV 18이나 16이 검출되지만 자궁경부암인 경우에는 주로HPV 16형이 검출이 되며 E6 와 E7 단백질이 자궁경부암 세포에 표현되는 것으로 보아 자궁경부암의 발생과정과 HPV 16형 바이러스가 악성화에 관여하고 있을 가능성이 강력히 시사된다.Clinical symptoms develop at 1 to 6 months after infection and on average 3 months, but usually no subjective symptoms. Cervical epithelial tumors CIN I, II and III pathological stage tissues or cervical surface tissues were collected and DNA detection of HPV yielded nearly 100% detection rate. HPV 18 or 16 is detected mainly in the virus, but HPV type 16 is detected mainly in cervical cancer, and E6 and E7 proteins are expressed in cervical cancer cells. Thus, cervical cancer and HPV type 16 virus are involved in malignancy. The possibility of doing so is strongly suggested.
HPV유래의 치료법에는 외과적 절제, 전기부식 (electroacuterization), 동결치료, 레이저 등의 물리적 절제외에 항암치료제인 씨스프라틴(Cisplatin) 또는 카보프라틴(Carboplatin) 등으로 치료를 하고 있다. 그러나 외과적 치료법은 자궁 전체를 수술 제거함으로 아기를 원하는 여성들에 있어서는 이 방법은 고려할 수 없으며 또 항암제는 심각한 부작용과 치료후 불임의 가능성과 또 난자의 돌연변이로서 기형 또는 불임의 가능성이 높을 심각한 부작용의 우려가 있다. 그 때문에 임신을 하고 아기 출산을 원하는 여성들의 필요한 절대적인 치료법이 없는 것이 현상이다.HPV-derived treatments are treated with anti-cancer drugs such as cisplatin or carboplatin, in addition to physical resection such as surgical resection, electroacuterization, cryotherapy, and laser. Surgical treatment, however, cannot be considered in women who wish to have a baby by surgical removal of the entire uterus, and anticancer drugs have serious side effects, the possibility of post-treatment infertility, and severe side effects that may result in malformations or infertility as mutants of eggs. There is concern. That is why there is no absolute remedy for women who are pregnant and want to give birth to a baby.
자궁경우 상피내종양 CIN Ⅰ, Ⅱ 및 Ⅲ 발암단계에 진단이 규명됐을 때 치료하지 않으면 생명이 위험하다. 특히 CIN Ⅲ 암단계에서 항암치료의 반응이 없을 경우 수술제거를 신속히 하지 않으면 암전이가 일어나 생명이 위험하므로 안전성이 우수하고 더구나 간편한 치료방법의 출현이 강력히 요망되고 있다.In the case of the uterus, when the diagnosis is established at the stage of carcinogenesis of CIN I, II and III carcinoma, life is dangerous if not treated. In particular, if there is no response of chemotherapy at the CIN III cancer stage, if the surgery is not removed quickly, cancer metastasis occurs and the risk of life is excellent. Therefore, the emergence of an easy treatment method is strongly desired.
따라서, 본 발명의 목적은 HPV 유래의 자궁경부 상피내종양 CIN Ⅰ, Ⅱ 및 Ⅲ 단계의 치료에 있어서 환자에게 있어서 간편한 치료방법 예를 들면 환자자신의 손으로 자궁경부의 질에 삽입하여 도포할 수 있고 동시에 캡슐 경구투여로 단기간의 사용으로 충분한 치료효과를 얻을 수 있는 암예방제 또는 암치료제를 제공함에 있다. 본 발명의 다른 목적은 안정성이 우수한 치료방법을 제공함에 있다.Accordingly, an object of the present invention is to provide a convenient treatment method for the patient in the treatment of HPV-derived cervical epithelial tumors CIN I, II and III, for example, by inserting the cervical vagina with the patient's own hand. At the same time, capsule oral administration provides a cancer preventive agent or cancer treatment agent that can obtain a sufficient therapeutic effect through short-term use. Another object of the present invention is to provide a therapeutic method having excellent stability.
본 발명자들은 부작용이 없고 장기간 사용해도 안전하고 더구나 현저한 치료효과를 나타내는 물질을 천연물 중에서 구하여 검토를 계속한 결과 일상 음용하고 있는 녹차의 성분인 카테킨류가 유효한 것을 발견하여 그러한 발견에 기초하여 본 발명을 완성하기에 이르렀다.The inventors of the present invention conducted a review of natural substances that have no side effects, are safe even for long-term use, and have a remarkable therapeutic effect, and found that catechins, which are components of green tea, which are routinely consumed, are effective. It was completed.
본 발명의 상기 목적은 녹차 카테킨을 주성분으로 하는 HPV 유래의 자궁경부상피내종양 CIN Ⅰ, Ⅱ 및 Ⅲ 치료제를 얻은 다음, 이를 자궁경부 상피내종양 CIN Ⅰ,Ⅱ, Ⅲ 및 Ⅳ 단계에 있는 환자들에게 치료를 실시한 후 그 결과를 평가하므로써 달성하였다.The object of the present invention is to obtain a therapeutic agent for cervical epithelial tumors CIN I, II and III derived from HPV mainly composed of green tea catechins, and then to treat patients in cervical epithelial tumors CIN I, II, III and IV stages. This was achieved by evaluating the results after the implementation.
이하, 본 발명의 구체적인 구성 및 작용을 설명한다.Hereinafter, the specific configuration and operation of the present invention.
본 발명에 사용되는 차 카테킨류는 하기 화학구조식 Ⅰ로 표시한 것이다.Tea catechins used in the present invention are represented by the following chemical structural formula (I).
(식중에서, R1은 H 또는 OH를 나타내고, R2는 H 또는Wherein R 1 represents H or OH and R 2 represents H or
를 나타낸다.) Is displayed.)
차 카테킨류(Camellia Sinensis)에는 구체적으로 에피카테킨(epicatechin), 에피카테킨갈레이트(epicatechingallate), 에피갈로카테킨갈레이트(epigallocatech ingallate), 갈로카테킨(gallocatechin)(이성체를 포함한다)등이 있다.Tea catechins (Camellia Sinensis) specifically include epicatechin (epicatechin), epicatechin gallate (epicatechingallate), epigallocatechin gallate (epigallocatech ingallate), gallocatechin (including isomers) and the like.
이들 차 카테킨류는 단독으로 또는 2종 이상을 적절히 조합해서 사용할 수가 있다. 이들 중에서 특히 유효한 것은 (-)-에피갈로카테킨갈레이트{(-)- Epigallo- catechin-3-Gallate}를 함유하는 것이다. 예를 들면, 상품명 "폴리페논E" (미쓰이노린가부시끼가이샤제, 조성 : (-)에피갈로카테킨갈레이트 54.8%, (-)-에피카테킨 14.7%, (-)-에피카테킨갈레이트 6.7%, (-)-에피칼로카테킨 6.0%, (-)-갈로카테킨갈레이트 4.0%)등이 있으며 총 카테킨 함량은 86.2%이다.These tea catechins can be used individually or in combination of 2 or more types as appropriate. Particularly effective among these are those containing (-)-epigallocatechin gallate {(-)-Epigallocatechin-3-Gallate}. For example, the product name "Polyphenone E" (Mitsinoringa Co., Ltd., Composition: (-) epigallocatechin gallate 54.8%, (-)-epicatechin 14.7%, (-)-epicatechin gallate 6.7%, (-)-Epicalcatechin 6.0%, (-)-gallocatechin gallate 4.0%) and the total catechin content is 86.2%.
본 발명의 자궁경부 상피내종양 CIN Ⅰ,Ⅱ 및 Ⅲ 단계 예방 약제 및 치료제는, 예를 들면 크림상, 젤리상, 유액상 등의 도포제나 캡슐상등의 제제등의 형태로 사용하고 차 카테킨을 부형제, 중량제, 유화제, 분산제등과 배합해서 조제한다. 차 카테킨의 배합량은 도포제의 경우 5∼20중량%, 바람직하게는 12∼18중량%, 보다 바람직하게는 15중량%이다. 또, 캡슐제제의 경우 차 카테킨의 배합량은 100∼500㎎/캡슐이다.Cervical epithelial tumors CIN I, II and III prophylactic agents and therapeutic agents of the present invention, for example, in the form of a coating such as cream, jelly, emulsion, or preparations such as capsules, tea catechin as an excipient, It mixes with a weighting agent, an emulsifier, a dispersing agent, etc., and is prepared. The blending amount of the tea catechin is 5 to 20% by weight, preferably 12 to 18% by weight, more preferably 15% by weight in the case of the coating agent. In addition, in the case of capsule formulation, the compounding quantity of tea catechin is 100-500 mg / capsule.
도포제의 대표적인 사용 예를 나타내면 자궁경부 환부에 5∼20중량%의 차 카테킨을 포함하는 와셀린을 매주 2∼3회, 1∼3개월 계속해서 직접 도포한다. 또 제제의 대표적인 사용 예로서는 예를 들면, 자궁경부 환부의 경우 차카테킨을 1캡슐당100∼500㎎를 포함한 것을 매일 2∼수회 경구복용과 더불어 매주 2∼3회씩 gel 도포를 1∼4개월간 병행 치료한다.Representative examples of the application of the coating agent are directly applied to the cervix affected area was Waselin containing 5 to 20% by weight of tea catechin 2 to 3 times a week for 1 to 3 months. In addition, as a representative example of the use of the preparation, for example, in the case of cervical lesions, one or four doses of chacatechin containing 100 to 500 mg per capsule are administered two to three times a day or two to three times a week for one to four months. do.
하기 실시예들은 본 발명을 더욱 상세히 설명하지만 본 발명의 권리범위는 이들 실시예에만 한정되는 것이 아니며 다양한 변경의 실시가 가능하므로 이들 변겨 실시예도 모두 포함함은 물론이다.The following examples illustrate the present invention in more detail, but the scope of the present invention is not limited only to these examples, and various modifications are possible, of course, including all of these modified examples.
실시예 1Example 1
강남성모병원(서울시 강남구 소재) 산부인과에서 자궁경부 상피내종양 진단 단계 CIN Ⅰ, Ⅱ 및 Ⅲ 및 Ⅳ 환자 22명에 본 발명품(Polyphenol E gel)를 자궁경부에 매주 2회씩 2∼4개월간 도포치료하고 치료반응이 없는 환자에게는 gel 도포를 계속하면서 Polyphenol E (200㎎/캡슐)를 매일 2회씩 (400㎎/일당) 복용하여 치료효과를 평가하였다. 최악성 자궁경부 상피내암 환자 4명의 경우 8주간 자궁경부 도포 치료만으로도 3명이 완치되고 1명은 치료반응을 보이지 않았다(75% 완치반응). 또 9명의 CIN Ⅰ 환자의 6∼8주후에 경부부의 도포 치료 결과를 보면 7명이 완치되고 2명은 완치되지 않았지만 치료반응이 좋은 것으로 나타났다(78% 완치반응). 또 4명의 CIN Ⅱ 환자 중 2명이 경부부의 도포 치료로만 완치되었고 1명은 도포치료와 경구투여를 병용하였을 때 완치되었다(75% 완치반응). 또 4명의 CIN Ⅲ 단계의 자궁경부 상피내종양 환자에 6∼12주간의 치료효과를 보면 1명은 자궁경부부의 도포 치료만으로 6주후에 완치 되였고 1명은 자궁경부부의 도포 치료 및 경구투여 (매일 2회씩 1회 200㎎ 캡슐)로 12주후에 완치, 그리고 1명은 치료반응은 있으나 10주에서 완치로 가는 호전을 보였고, 나머지 1명은 8주후에도 경구투여를 겸한 치료에도 불구하고 치료반응을 보이지 않아 계속 치료가 지속되고 있다.Stages of diagnosis of cervical epithelial tumor at Obstetrics and Gynecology, Gangnam St. Mary's Hospital (Gangnam-gu, Seoul) Polyphenol E gel was applied to cervical cervix twice a week for 2 to 4 months Patients who did not respond were treated with Polyphenol E (200mg / capsule) twice daily (400mg / day) while continuing to apply gel. Four patients with acute cervical epithelial carcinoma were cured by cervical application for 8 weeks and one patient did not respond (75% cure). In 6 to 8 weeks after 9 CIN I patients, 7 patients were cured and 2 were not cured, but the response was good (78% cured response). Two of four CIN II patients were cured only by cervical application and one was cured by application of oral administration (75% complete response). In addition, 6 to 12 weeks of treatment effect was observed in 4 CIN III patients with cervical epithelial neoplasia. One patient was cured after 6 weeks only by cervical application, and one patient was treated orally administered twice a day. 1 week 200mg capsule) cured after 12 weeks, and 1 patient was cured, but improved to 10 at 10 weeks, the other one continued treatment after 8 weeks did not show any response despite oral administration Is continuing.
악성자궁경부 상피내종양 CIN Ⅳ 단계 한 환자의 도포·복용 치료에서 좋은 치료반응을 보이고 있으나 8주 치료기간에 완치는 관찰되지 않고 있어 계속 치료가 지속되고 있다(표 1 및 표 2).The malignant cervical epithelial tumor, CIN IV stage, showed good response in the treatment and application of one patient, but no cures were observed during the 8-week treatment period (Table 1 and Table 2).
본 발명은 상기 임상 실험결과에서 명배한 바와 같이 녹차 카테킨 폴리페놀(Polyphenol)계 성분이 겔(gel) 형태나 분말을 캡슐로 한 형태에서도 암예방 치료의 효과뿐만 아니라 대부분의 악성 자궁경부 상피내종양에서도 치료제로서의 효과가 있는 것으로 나타났다. 이 치료 효과는 HPV 바이러스의 DNA가 완전히 제거되거나 유의한 감소가 치료반응에 비례하는 것을 볼 때 이들 Polyphenols (Camellia sinensis) 녹차 카테킨 성분들이 항바이러스, 항염증, 항산화성 또는 암세포 자연사의 촉진등 다양한 화학적 작용으로 치료 효과를 나타낸다고 판단되므로 본 발명은 생물의약 산업상 매우 유용한 발명인 것이다.The present invention, as noted in the above clinical trial results, green tea catechin polyphenol-based component in the form of a gel (gel) or powder capsule form of the prevention of cancer prevention as well as in most malignant cervical epithelial tumor It has been shown to be effective as a therapeutic agent. This therapeutic effect is based on the complete removal of the DNA of the HPV virus or a significant decrease in proportion to the response to treatment.These polyphenols (Camellia sinensis) green tea catechins have various chemical properties such as antiviral, anti-inflammatory, antioxidant or cancer cell natural death. The present invention is very useful in the biopharmaceutical industry because it is judged to have a therapeutic effect by the action.
Claims (2)
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1019980053322A KR100319973B1 (en) | 1998-12-05 | 1998-12-05 | Cervical epithelial tumor prophylaxis or treatment composition using green tea catechin as an active ingredient |
| PCT/KR1999/000651 WO2000033832A1 (en) | 1998-12-05 | 1999-10-29 | Chemical composition for treating cervical intraepithelial neoplasia i, ii, iii, iv and cervicitis |
| AU63715/99A AU6371599A (en) | 1998-12-05 | 1999-10-29 | Chemical composition for treating cervical intraepithelial neoplasia i, ii, iii,iv and cervicitis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1019980053322A KR100319973B1 (en) | 1998-12-05 | 1998-12-05 | Cervical epithelial tumor prophylaxis or treatment composition using green tea catechin as an active ingredient |
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| Publication Number | Publication Date |
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| KR20000038352A KR20000038352A (en) | 2000-07-05 |
| KR100319973B1 true KR100319973B1 (en) | 2002-04-22 |
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| KR1019980053322A KR100319973B1 (en) | 1998-12-05 | 1998-12-05 | Cervical epithelial tumor prophylaxis or treatment composition using green tea catechin as an active ingredient |
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| Country | Link |
|---|---|
| KR (1) | KR100319973B1 (en) |
| AU (1) | AU6371599A (en) |
| WO (1) | WO2000033832A1 (en) |
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| JP4495459B2 (en) | 2001-11-19 | 2010-07-07 | メディジーン・アクチェンゲゼルシャフト | Drugs for the treatment of viral skin diseases and tumor diseases |
| DE10156794B4 (en) * | 2001-11-19 | 2006-05-18 | Medigene Ag | Medicines for the treatment of warts |
| KR100449228B1 (en) * | 2002-03-19 | 2004-09-18 | 주식회사 태평양 | EGCG derivatives, Preparation method thereof and cosmetic composition containing thereof |
| BRPI0415215B8 (en) | 2003-10-09 | 2021-05-25 | Medigene Ag | use of polyphenol in drug preparation |
| US20050090564A1 (en) * | 2003-10-28 | 2005-04-28 | Wegener Paul T. | Compositions and treatments of bacterial vaginosis |
| JP2008508252A (en) | 2004-07-27 | 2008-03-21 | ゲンプロファイラー エス．アール．エル． | Catechin extracted from Chinese green tea or other vegetables, more precisely a mixture of polyphenols, with a chemical preventive effect for the prevention of prostate cancer pathogenesis and effective treatment of the overall symptoms of prostate hypertrophy (BPH) |
| KR100801891B1 (en) * | 2006-11-02 | 2008-02-12 | 한상진 | Natural compositions for prevention or treatment of varginal infections |
| US9145444B2 (en) * | 2007-11-02 | 2015-09-29 | Ruprecht-Karls-Universität Heidelberg | Compounds and methods associated with differential methylation of human papilloma virus genomes in epithelial cells |
| EP2179722A1 (en) * | 2008-10-24 | 2010-04-28 | Heinrich-Pette-Institut für experimentelle Virologie und Immunologie | Topical formation for preventing sexual transmission of viral infection |
| EP2952182B1 (en) * | 2014-06-04 | 2022-11-23 | Universität Heidelberg | Compounds and methods for increasing the immune response to papillomavirus |
| CN104922409A (en) * | 2015-06-29 | 2015-09-23 | 孙霞 | Traditional Chinese medicine for treating chronic cervicitis |
| CN104906449A (en) * | 2015-06-30 | 2015-09-16 | 孙霞 | Traditional Chinese medicine for treating cervicitis |
| CN107349197A (en) * | 2017-07-13 | 2017-11-17 | 黄冈师范学院 | A kind of application of catechin on the medicine for preparing treatment cutaneous papilloma |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0842660A1 (en) * | 1996-11-18 | 1998-05-20 | Cancer Institute (Hospital) Chinese Acadamy Of Medical Sciences | Composition for treating condyloma acuminata |
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1998
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- 1999-10-29 AU AU63715/99A patent/AU6371599A/en not_active Abandoned
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP0842660A1 (en) * | 1996-11-18 | 1998-05-20 | Cancer Institute (Hospital) Chinese Acadamy Of Medical Sciences | Composition for treating condyloma acuminata |
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| WO2000033832A1 (en) | 2000-06-15 |
| KR20000038352A (en) | 2000-07-05 |
| AU6371599A (en) | 2000-06-26 |
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