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KR900002746B1 - Milon reagent formulation for cancer diagnosis using agar - Google Patents

Milon reagent formulation for cancer diagnosis using agar Download PDF

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KR900002746B1
KR900002746B1 KR1019880002512A KR880002512A KR900002746B1 KR 900002746 B1 KR900002746 B1 KR 900002746B1 KR 1019880002512 A KR1019880002512 A KR 1019880002512A KR 880002512 A KR880002512 A KR 880002512A KR 900002746 B1 KR900002746 B1 KR 900002746B1
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삼일제약 주식회사
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    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574Immunoassay; Biospecific binding assay; Materials therefor for cancer
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Abstract

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Description

한천을 이용한 암진단용 밀론시약 제형Milon reagent formulation for cancer diagnosis using agar

본 발명은 특허 제 21558호의 개량 발명으로서 종래의 방법보다 판독이 용이하고 안정된 암 진단용 시약의 제조방법에 관한 것이다.The present invention is an improved invention of Patent No. 21558, which relates to a method for preparing a reagent for diagnosis of cancer, which is easier to read and stable than a conventional method.

본 발명자는 선행발명(특허 제 21558호)에서 암환자의 소변을 핵자기 공명 분광기로 분석하면 비암환자와는 달리 3.00PPM -3.09PPM 범위내에 특성 신호기가 나타나며 이것은 타이로신(tyrosine)과 같은 방향족 아민의 존재에 의한 것임을 밝힌 바 있다. 그리고 타이로신의 검출시약인 밀론시약을 안전하고 취급이 간편하게 하기 위하여 제라틴을 가하여 겔 상태로 조성하는 시약의 제조방법을 제시하였다.In the present invention (Patent No. 21558), the urine of cancer patients is analyzed by nuclear magnetic resonance spectroscopy. Unlike the non-cancer patients, the characteristic signal group appears in the range of 3.00PPM -3.09PPM, and this is the result of the aromatic amine such as tyrosine. It has been revealed to exist. In addition, in order to safely and easily handle the milon reagent, which is a detection reagent for tyrosine, a method for preparing a reagent which is prepared by adding gelatin in a gel state is proposed.

그러나 제라틴을 사용하는 방법은 제라틴의 성분중에 소량 함유되어 있는 타이로신과 밀론시약의 서서히 반응하여 착색하는 결점이 있어 제조후 단기간내에 사용하여야 하며 시약의 장기간 보관이 어려운 단점이 발견되었다.However, the method of using gelatin has the drawback of coloring by slow reaction of tyrosine and millon reagent contained in a small amount of gelatin, and it has been found to be used within a short time after preparation and difficult to store the reagent for a long time.

이러한 단점을 보완하기 위하여 발명자는 타이로신을 함유하고 있지 않은 여러 가지 고분자 화합물을 사용하여 밀론시약과 배합 시험한 결과 젤라틴 대신에 정제된 한천(Agar)을 사용하는 경우 밀론 시약의 보존력이 우수하고 성형이 용이할 뿐만 아니라 구하기 쉽고 비교적 염가로 제조할 수 있음을 알게 되었다.In order to make up for these drawbacks, the inventors conducted a combination test with a millon reagent using various polymer compounds that do not contain tyrosine, and when using agar instead of gelatin, the retention of millon reagent is excellent and the molding is easy. It has been found that not only is easy but also easy to obtain and relatively inexpensive to manufacture.

본 발명은 원 밀론시약이 독성이 있는 수은 성분이 포함된 강산성의 액체이므로 취급에 주의를 요하는 바 밀론시약에 한천을 넣어 젤리형의 시약으로 조성하므로 안전하고 취급이 간편하며 장기 보관이 가능한 암진단용 시약을 제공한다.The present invention is a strong acidic liquid containing a toxic mercury component of the one-million reagents, which requires careful handling. Provide diagnostic reagents.

이 젤리형의 시약에 시료소변을 가하면 암환자의 경우에는 시약과 시료액의 경계면에서 부터 적자색으로 정색하게 되며 정상인의 경우에는 반응하지 않는다.When urine sample is added to this jelly type reagent, cancer patients will be colored in reddish purple from the interface between reagent and sample solution.

본 발명에서 사용하는 밀론시약은 모두 사용가능하나 황산수은을 황산에 용해한 것보다는 금속수은을 농질산에 용해하고 증류수로 희석한 것이 반응력이 더 우수하게 나타나며 금속수은과 농질산 및 니켈을 함유한 밀론시약이 특히 우수한 진단효과를 발휘한다. 한천은 약전품 규격 정도로 잘 정제된 것을 사용하는 것이 바람직하다.Although all the milon reagents used in the present invention can be used, metal mercury dissolved in concentrated nitric acid and diluted with distilled water is more reactive than mercuric sulfate dissolved in sulfuric acid, and the milon reagent containing metal mercury, concentrated nitric acid, and nickel is better. Especially excellent diagnostic effect. It is preferable to use agar that is well refined to the specifications of the pharmacopeias.

발명에 의한 젤리형 밀론시약의 제조방법은 우선 금속수은을 농질산에 용해하고 증류수로 희석시킨 다음 한천을 넣어 30 내지 60。C 의 수욕상에서 교반하고 유리시험관에 부어 상온에서 굳히면 본 발명에 젤리형 시약제형을 얻게된다.Method for producing a jelly-type milon reagent according to the invention is first dissolved metal mercury in concentrated nitric acid and distilled with distilled water and then put agar, stirred in a water bath of 30 to 60 ° C. and poured into a glass test tube to solidify at room temperature jelly type in the present invention Reagent formulation is obtained.

밀론시약에 대한 한천의 사용 비율은 특별히 중요하지는 않지만 통상 적당한 형태와 강도를 유지할 수 있을 정도의 양, 즉 밀론시약 1ml에 대하여 약 0.5 내지 2g정도의 한천을 사용하는 것이 좋다. 그러나 한천의 양이 너무 많으면 밀론시약의 비율이 상대적으로 약해져서 그 효과가 떨어지고 너무 적으면 젤리상 제형을 얻기 어렵게 된다.Although the ratio of agar to milon reagent is not particularly important, it is generally preferable to use an agar of about 0.5 to 2 g with respect to 1 ml of milon reagent. However, if the amount of agar is too large, the ratio of milon reagent is relatively weak, so that the effect is low, and if it is too small, it is difficult to obtain a jelly-like formulation.

이와같이 제조된 젤리형 시약은 젤라틴을 이용한 시약제형에 비하여 정확도가 훨씬 우수하고 장기간 보관이 가능하며 그 제조가 용이한 장점을 가진다.Jelly-type reagents prepared as described above have advantages of much higher accuracy, long-term storage, and ease of preparation compared to reagent preparation using gelatin.

[실시예]EXAMPLE

금속수은 10그람을 15미리리터의 농질산에 넣고 약간 가열하여 용해한 후 이 액과 동일한 용적의 증류수를 가해 희석시킨 액 30미리리터를 취해 30그람의 한천(약전품)과 혼합한 후 수욕상에서 40-50。C 의 온도에서 약 20분간 잘 교반하고 직경 1cm정도의 유리시험관에 기벽에 묻지 않도록 조심하면서 3미리리터씩 부어 넣은 후 상온에서 굳힌다.10 grams of metallic mercury is added to 15 milliliters of concentrated nitric acid and slightly heated to dissolve. Take 30 milliliters of the diluted solution with the same volume of distilled water, mix it with 30 grams of agar (pharmaceutical product), and 40-50. Stir well at a temperature of C for about 20 minutes, pour 3 ml each carefully and cure at room temperature.

여기에 암환자의 소변을 5미리리터를 가하고 5-10분간 방치하면 경계면에서 부터 적자색으로 변하는 정색반응이 나타난다. 비 암환자나 정상인의 경우에는 정색반응이 일어나지 않는다.When 5 milliliters of cancer patients' urine is added and left for 5-10 minutes, a color reaction that turns red from the boundary surface occurs. In non-cancer patients or normal people, the color reaction does not occur.

실시예에서 얻은 젤리형 밀론시약을 이용하여 암 및 기타 질환자 40명을 대상으로 암진단효과를 시험한 결과 본 시약의 암에 대한 진단율은 다음 표에서 보는 바와 같이 Sensitivity 82.6%, Specificity 76.5%의 결과를 얻었으며 본 발명의 젤리형 밀론시약을 이용한 진단결과 양성으로 한정된 환자의 대부분이 정밀진단 결과 실질적인 암환자로 밝혀졌다.The cancer diagnosis effect was tested in 40 patients with cancer and other diseases using the jelly-type milon reagent obtained in the Example. As a result, the diagnosis rate of cancer of the reagents was 82.6% and 76.5%, respectively. The majority of patients who were positively diagnosed with the jelly-type milon reagent of the present invention were found to be substantial cancer patients.

[표 1]TABLE 1

젤리형 밀론시약의 임상적 효능 평가표Clinical efficacy evaluation table of jelly type milon reagent

Figure kpo00001
Figure kpo00001

Claims (2)

밀론시약 1ml당 정체 한천 0.5 내지 2g의 비율로 혼합 조성된 젤리형 암진단용 시약 조성물.Reagent composition for jelly type cancer diagnostics mixed in a ratio of 0.5 to 2g of agar agar per 1 ml of milon reagent. 제 1 항에서 밀론시약이 수은, 질산 및 증류수로 이루어진 시약 조성물.The reagent composition of claim 1, wherein the milon reagent comprises mercury, nitric acid, and distilled water.
KR1019880002512A 1988-03-11 1988-03-11 Milon reagent formulation for cancer diagnosis using agar Expired KR900002746B1 (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008148308A1 (en) * 2007-06-05 2008-12-11 Yongjian Pi Urinoscopy reagent for detecting breast malignant disease and its application
CN105203537A (en) * 2015-09-23 2015-12-30 杭州欣叶生物科技有限公司 Urine testing reagent for tyrosine phenol metabolin

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008148308A1 (en) * 2007-06-05 2008-12-11 Yongjian Pi Urinoscopy reagent for detecting breast malignant disease and its application
CN105203537A (en) * 2015-09-23 2015-12-30 杭州欣叶生物科技有限公司 Urine testing reagent for tyrosine phenol metabolin

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