KR19990028933A - How to reduce the number of CD8 + cells using ipriflavones - Google Patents
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Abstract
본 발명은 적합한 불활성 고체 또는 액체 담체 및 임의로 일반적 치료 첨가제 및 보조제와의 혼합물로 7-이소프로폭시이소플라본을 활성 성분으로서 포함하는, CD8+ 세포의 수를 감소시키에 적합한 약제 조성물에 관한 것이다. 본 발명에 따르는 약제 조성물은 공지된 방법에 의해 제조되고, CD8+ 림프구의 선택적 억제가 바람직한 질환에 걸린 사람 또는 동물 환자의 치료에 적합하다.The present invention relates to pharmaceutical compositions suitable for reducing the number of CD8 + cells comprising 7-isopropoxyisoflavone as active ingredient in a mixture with a suitable inert solid or liquid carrier and optionally with general therapeutic additives and adjuvants. Pharmaceutical compositions according to the invention are prepared by known methods and are suitable for the treatment of human or animal patients with diseases in which selective inhibition of CD8 + lymphocytes is desired.
Description
본 발명은 활성 성분으로서 7-이소프로폭시이소플라본(IPRIFLAVONE)을 함유하는, CD8+ 세포의 수를 감소시키기에 적합한 약제 조성물에 관한 것이다.The present invention relates to pharmaceutical compositions suitable for reducing the number of CD8 + cells, containing 7-isopropoxyisoflavones (IPRIFLAVONE) as active ingredient.
IPRIFLAVONE은 공지된 항골다공증제이다. 이것의 제조 방법은 헝가리 특허 명세서 제 162377호 및 제 196981호에 기술되어 있다. 유기체가 2가지 기본적 보호 기능, 즉 체액 및 세포 중개 면역 반응을 갖는다는 것은 공지되어 있다. 소위 세포 중개 면역 반응은 주로 바이러스 또는 세포내 기생충에 의해 감염된 세포, 종양 세포, 화학적으로 변형된 세포 및 이종 조직에 대한 내인성 항원과 관련된다.IPRIFLAVONE is a known anti-osteoporosis agent. Its preparation method is described in Hungarian patent specifications 162377 and 196981. It is known that organisms have two basic protective functions: humoral and cellular mediated immune responses. So-called cell-mediated immune responses are mainly associated with endogenous antigens for cells, tumor cells, chemically modified cells and heterologous tissues infected by viruses or intracellular parasites.
세포 중개 면역 반응은 소위 흉선 의존성(흉선에서 성숙한 세포) 림프구(T 림프구)에 관련된다. 성숙 과정의 종료시에, 2가지 유형의 T-림프구가 이들의 표면 마아커, 명백히 분화될 수 있는 서브그룹에 근거하여 말초 부분으로 방출될 것이다. CD4+ 세포, 소위 헬퍼 세포는 외인성 항원의 제공시에 활성화되고, 이들의 시토킨 생성을 증가시킴으로써 면역 반응을 돕는다. CD8+ 세포, 소위 세포독성 세포는 내인성 항원의 인식시에 활성화된 후, 외인성으로서 인식되는 세포를 세포 용해에 의해 파괴시킨다.The cell mediated immune response is related to the so-called thymic dependency (mature cells in the thymus) lymphocytes (T lymphocytes). At the end of the maturation process, two types of T-lymphocytes will be released into the peripheral portion based on their surface markers, clearly subdifferentiable subgroups. CD4 + cells, so-called helper cells, are activated upon presentation of exogenous antigens and help the immune response by increasing their cytokine production. CD8 + cells, so-called cytotoxic cells, are activated upon recognition of endogenous antigens and then destroy cells recognized as exogenous by cell lysis.
말초 림프구의 약 2/3는 CD4+이고, 1/3은 CD8+이다. 이에 상응하여, 정상 CD4+/CD8+는 2:1이다 [참고문헌 : Andras Falus : Immunology pages 111-138 TEMPUS ITC Bp./1993].About two thirds of peripheral lymphocytes are CD4 + and one third are CD8 +. Correspondingly, normal CD4 + / CD8 + is 2: 1 [Andras Falus: Immunology pages 111-138 TEMPUS ITC Bp./1993].
세포독성 면역 반응은, 감염된 세포의 파괴에 의해, 병원균이 재생될 가능성이 제거되기 때문에, 세포내 감염의 경우에 기본적 보호 메카니즘이다. 유사하게는, 이것은 종양 세포의 파괴에 중요한 역할을 한다. 이들 경우에, 세포독성 면역 반응은 유기체의 일체성을 보호하는 역할을 한다.Cytotoxic immune responses are a fundamental protective mechanism in the case of intracellular infections, as the destruction of infected cells eliminates the possibility of pathogen regeneration. Similarly, this plays an important role in the destruction of tumor cells. In these cases, the cytotoxic immune response serves to protect the integrity of the organism.
유기체에 대해, 세폭독성 면역 반응이 바람직하지 않거나 심지어는 해로운 경우가 또한 공지되어 있다. 특정 자가면역 질환의 경우에, 세포독성 반응은 결과적으로 심한 기능 장해를 야기시키는 유기체 고유의 세포와 관련된다. T 세포 중개 면역 질환의 특징적 예는 류머티스성 관절염이다.For organisms it is also known when the tritoxic immune response is undesirable or even harmful. In the case of certain autoimmune diseases, the cytotoxic response is associated with cells inherent in the organism that result in severe dysfunction. A characteristic example of T cell mediated immune disease is rheumatoid arthritis.
병리학적 세포독성 반응은 특정 무형성 빈혈 및 만성 활성 간염의 경우에 나타날 수 있다. 조직 또는 기관 이식 후의 거부 반응이 또한 세포독성 면역 반응에 근거한 것이다. 특정 기관(골수) 이식의 경우에, 소위 "이식 세포 대 숙주 반응"은 또한 세포독성 반응에 근거한 것이다.Pathological cytotoxic responses may occur in cases of certain aplastic anemia and chronic active hepatitis. Rejection after tissue or organ transplantation is also based on cytotoxic immune responses. In the case of certain organ (bone marrow) transplants, the so-called "graft cell-to-host response" is also based on a cytotoxic response.
이러한 경우에 CD4+/CD8+ 비는 증가하고, 주로 CD8+ 세포의 증가가 결과되고 CD4+ 세포의 감소가 덜 결과되는 특정 경우에는 그 반대이다. 조직/기관 이식 후의 자가 면역 및 거부 반응의 경우에, 면역 반응을 조절하여, 특정 경우에 심지어는 자가 면역을 급격히 감소시키는 것이 일반적 처리 과정이다 (면역 억제 처리).In this case the CD4 + / CD8 + ratio is increased, mainly in the case where the increase in CD8 + cells results and the decrease in CD4 + cells results in the opposite. In the case of autoimmune and rejection reactions after tissue / organ transplantation, it is a general treatment procedure to regulate the immune response, in particular cases to even sharply reduce autoimmunity (immunosuppressive treatment).
면역 억제 처리는 T 림프구의 수의 감소시킬 뿐만 아니라, CD4+/CD8+ 세포 비의 정상화에 대한 작용을 한다. CD8+ 세포를 함유하지 않는 동종 골수 이식의 경우에, "이식 세포 대 숙주" 반응은 상당히 더 적은 수로 관찰될 수 있다. 따라서, 언급된 질환에서는, 특히 CD8+ 세포를 감소시키는 치료가 유리할 수 있다.Immunosuppressive treatment not only reduces the number of T lymphocytes, but also acts on the normalization of CD4 + / CD8 + cell ratios. In the case of allogeneic bone marrow transplantation that does not contain CD8 + cells, a "graft cell to host" response can be observed in significantly fewer numbers. Thus, in the diseases mentioned, treatments that reduce CD8 + cells in particular may be advantageous.
상기의 이론적 고찰 및 실시적 실험에 기초하여, 본 발명자들은 세포 중개 면역 반응에 반응성인 T 림프구 및 CD4+ 헬퍼 및 CD8+ 세포독성 세포에 대해 이프리플라본이 갖는 작용의 유형을 시험하였다. 특정 유형의 림프구 및 서브그룹을 분리하기 위해, 본 발명자들은 유동 세포학을 사용하였다. 임상 실험에서, 절대 림프구 계수 및 특정 림프구 아군의 변동을 400 mg 이프리플라본의 매일 용량으로 60명의 환자에 대해 연구하였다. 51명의 환자에게서, 절대 림프구 계수의 완만하거나 중간 정도의 감소가 관찰되었다. 환자의 평균 절대 림프구 계수는 처리 후에 0.85x109/ℓ(범위 0.25-0.89)이었다 (정상 범위 : 0.9-3.22x109/ℓ). 9명의 환자에게서, 평균 절대 림프구 계수는 정상 범위(1.84x109/ℓ) 내에 있는 것으로 관찰되었다. 림프구 감소증이 있는 51명의 환자에게서, 소위 T 림프구에 대해서만 감소가 특징적이고, 그 중에서 CD8+ 아군에 대해서 주로 나타난다. 평균 CD8+ 계수는 0.08x109/ℓ(범위 0.02-0.23)이며, 이는 0.3-1.44x109/ℓ의 정상 범위를 고려하여 어느 정도 상당한 세포 계수 감소를 나타낸다.Based on the theoretical considerations and experimental experiments above, we tested the type of action of ipriflavones on T lymphocytes and CD4 + helpers and CD8 + cytotoxic cells that are responsive to cell-mediated immune responses. To separate certain types of lymphocytes and subgroups, we used flow cytology. In clinical trials, absolute lymphocyte counts and fluctuations in specific lymphocyte subgroups were studied in 60 patients at a daily dose of 400 mg ifriflavones. In 51 patients, moderate or moderate decreases in absolute lymphocyte counts were observed. The mean absolute lymphocyte count of the patients was 0.85x10 9 / l (range 0.25-0.89) after treatment (normal range: 0.9-3.22x10 9 / l). In nine patients, the average absolute lymphocyte count was observed to be within the normal range (1.84 × 10 9 / L). In 51 patients with lymphocytosis, the reduction is characteristic only for the so-called T lymphocytes, of which mainly the CD8 + subgroup. The average CD8 + count is 0.08x10 9 / l (range 0.02-0.23), which indicates some significant cell count reduction, taking into account the normal range of 0.3-1.44x10 9 / l.
정상 림프구 계수를 나타내는 9명의 환자에게서, 평균 CD8+ 계수는 10.43x109/ℓ(범위 0.28-0.64)이었다. 상기 값이 정상 범위 내에 있을 지라도, 이 값은 더 낮은 4분위수이며, 이는 효과의 선택성을 지지하는 것으로 발견되었다.In nine patients with normal lymphocyte counts, the mean CD8 + count was 10.43 × 10 9 / L (range 0.28-0.64). Although the value is within the normal range, this value is the lower quartile, which was found to support the selectivity of the effect.
본 발명자들은 이프리플라본 처리하에, T 림프구의 수가 평균 66.6% 까지 감소됨을 발견하였다. CD4+ 헬퍼 및 CD8+ 세포독성 서브그룹을 고려하여, 평균 감소는 상당히 상이하다. 거의 50%의 헬퍼 세포가 감소하고, CD8+ 세포독성 세포의 감소는 77%이었다. CD4+/CD8+ 비는 상이한 수의 CD8+ 및 CD8+ 세포를 특징으로 하며, 그 비는 이프리플라본 처리시에 5:1로 변한다.We found that under the prepreflavone treatment, the number of T lymphocytes was reduced by an average of 66.6%. Taking into account the CD4 + helper and CD8 + cytotoxic subgroups, the mean reduction is quite different. Nearly 50% of helper cells were reduced and the reduction of CD8 + cytotoxic cells was 77%. The CD4 + / CD8 + ratio is characterized by a different number of CD8 + and CD8 + cells, which ratio changes to 5: 1 upon treatment with ipriflavones.
T 림프구, CD4+ 헬퍼 및 CD8+ 세포독성 세포의 수의 감소 및 이들의 비의 기본 변동은 2가지 일면에서 고려될 수 있다. 통상적인 면역 억제 처리 동안, 관찰된 세포수의 감소는 일반적으로 이프리플라본의 경우에 관찰된 것보다 적다. 추가의 상당한 상이점은 CD4+ 헬퍼 세포의 수에서보다 CD8+ 세포독성 세포의 수에서의 더욱 현저한 감소이다. 이러한 결과를 기초로 하여, 이프리플라본이 특히 세포독성 반응을 감소시키거나 억제시킬 수 있음이 가정될 수 있다.Reductions in the number of T lymphocytes, CD4 + helpers and CD8 + cytotoxic cells, and basic variations in their ratios, can be considered in two aspects. During conventional immunosuppressive treatment, the decrease in cell number observed is generally less than that observed for ifriflavones. A further significant difference is a more significant reduction in the number of CD8 + cytotoxic cells than in the number of CD4 + helper cells. On the basis of these results, it can be assumed that ipriflavones can in particular reduce or inhibit the cytotoxic response.
본 발명은 적합한 불활성 고체 또는 액체 담체 및 임의로 일반적 치료 첨가제 및 보조제와의 혼합물로 7-이소프로폭시이소플라본을 활성 성분으로서 포함하는, CD8+ 세포의 수를 감소시키기에 적합한 약제 조성물에 관한 것이다.The present invention relates to pharmaceutical compositions suitable for reducing the number of CD8 + cells comprising 7-isopropoxyisoflavone as active ingredient in a mixture with a suitable inert solid or liquid carrier and optionally with general therapeutic additives and adjuvants.
상기 조성물은 CD8+ 림프구의 선택적 억제가 바람직한 질환에 걸린 사람 또는 동물 환자의 치료에 사용될 수 있다.The composition can be used for the treatment of human or animal patients with diseases in which selective inhibition of CD8 + lymphocytes is desirable.
본 발명에 따르는 조성물은 공지된 방법에 의해 주사제, 주입제, 캡슐, 정제, 용액, 시럽, 경피 제제 등의 형태로 제조될 수 있다.The compositions according to the invention can be prepared in the form of injections, infusions, capsules, tablets, solutions, syrups, transdermal preparations and the like by known methods.
세포독성 반응의 억제가 갖는 질병 또는 질환에서, 치료적 값은 이들의 상태, 외관 및 질환 진행 과정에서 어느 정도 상이하다. 따라서, 투여량은 진단, 림프구의 초기 수 및 CD4+/CD8+ 세포의 비의 확인으로 결정되어야 한다.In diseases or disorders with inhibition of cytotoxic responses, therapeutic values differ to some extent in their condition, appearance, and disease progression. Therefore, the dosage should be determined by diagnosis, confirming the initial number of lymphocytes and the ratio of CD4 + / CD8 + cells.
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1995
- 1995-07-21 HU HU9502198A patent/HU9502198D0/en unknown
-
1996
- 1996-07-16 WO PCT/HU1996/000038 patent/WO1997003664A1/en not_active Application Discontinuation
- 1996-07-16 JP JP50646497A patent/JP2001503371A/en active Pending
- 1996-07-16 CN CN96195722A patent/CN1191483A/en active Pending
- 1996-07-16 SK SK32-98A patent/SK3298A3/en unknown
- 1996-07-16 AU AU63670/96A patent/AU6367096A/en not_active Abandoned
- 1996-07-16 EP EP96923004A patent/EP0841915A1/en not_active Withdrawn
- 1996-07-16 KR KR1019980700235A patent/KR19990028933A/en not_active Application Discontinuation
- 1996-07-16 EE EE9800020A patent/EE9800020A/en unknown
- 1996-07-16 CZ CZ9827A patent/CZ2798A3/en unknown
- 1996-07-16 PL PL96324460A patent/PL324460A1/en unknown
- 1996-07-16 BR BR9610187A patent/BR9610187A/en not_active Application Discontinuation
- 1996-07-16 EA EA199800146A patent/EA199800146A1/en unknown
- 1996-07-16 IL IL12275196A patent/IL122751A0/en unknown
- 1996-07-16 CA CA002227421A patent/CA2227421A1/en not_active Abandoned
- 1996-07-16 MX MX9800603A patent/MX9800603A/en unknown
- 1996-07-17 ZA ZA9606079A patent/ZA966079B/en unknown
- 1996-07-18 HR HRP9502198A patent/HRP960345A2/en not_active Application Discontinuation
- 1996-07-19 YU YU42796A patent/YU42796A/en unknown
- 1996-07-22 AR ARP960103677A patent/AR002905A1/en unknown
-
1998
- 1998-01-12 NO NO980127A patent/NO980127L/en unknown
- 1998-01-14 BG BG102182A patent/BG102182A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| MX9800603A (en) | 1998-04-30 |
| BG102182A (en) | 1998-08-31 |
| NO980127D0 (en) | 1998-01-12 |
| PL324460A1 (en) | 1998-05-25 |
| EP0841915A1 (en) | 1998-05-20 |
| WO1997003664A1 (en) | 1997-02-06 |
| ZA966079B (en) | 1998-01-19 |
| EA199800146A1 (en) | 1998-08-27 |
| CZ2798A3 (en) | 1998-06-17 |
| YU42796A (en) | 1999-03-04 |
| HRP960345A2 (en) | 1998-02-28 |
| NO980127L (en) | 1998-01-12 |
| EE9800020A (en) | 1998-08-17 |
| JP2001503371A (en) | 2001-03-13 |
| BR9610187A (en) | 1998-07-28 |
| AR002905A1 (en) | 1998-04-29 |
| WO1997003664A8 (en) | 1999-08-05 |
| CN1191483A (en) | 1998-08-26 |
| IL122751A0 (en) | 1998-08-16 |
| CA2227421A1 (en) | 1997-02-06 |
| AU6367096A (en) | 1997-02-18 |
| SK3298A3 (en) | 1998-07-08 |
| HU9502198D0 (en) | 1995-09-28 |
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| Date | Code | Title | Description |
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| WITN | Application deemed withdrawn, e.g. because no request for examination was filed or no examination fee was paid |