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Radionuclide labelled specific sentinel node photographic developer and preparation method thereof

A technology of sentinel lymph node and imaging agent, applied in directions such as radioactive carriers, can solve the problems of poor stability of the medicine box and no inert gas protection of the medicine box, and achieve the effects of low cost, good clinical application prospect and convenient use.

Active Publication Date: 2015-06-03
YANTAI LANNACHENG BIOTECHNOLOGY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But the stability of this kit is relatively poor, and there is no protection of inert gas in the kit

Method used

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  • Radionuclide labelled specific sentinel node photographic developer and preparation method thereof
  • Radionuclide labelled specific sentinel node photographic developer and preparation method thereof
  • Radionuclide labelled specific sentinel node photographic developer and preparation method thereof

Examples

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Comparison scheme
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Embodiment 1

[0026] The preparation of embodiment 1 specific sentinel lymph node imaging agent precursor (1)

[0027] According to the mass molar ratio of rituximab and HYNIC bifunctional chelating agent of 1:20, mix at 25°C in the dark for 15 minutes, and separate and collect with PD-10 column after the reaction is completed.

Embodiment 2

[0028] The preparation of embodiment 2 specific sentinel lymph node imaging agent precursor (2)

[0029] Mix rituximab with HYNIC bifunctional chelating agent or 2-IT or mercaptoethanol at a ratio of 1:3, and react in the dark for 30 minutes at 4°C; after the reaction is completed, use a PD-10 column to separate, purify, and collect.

Embodiment 3

[0030] The preparation of embodiment 3 specific sentinel lymph node imaging agent kit (1)

[0031] 1. Subpackage the isolated monoclonal antibody, add 10 mg of fructose excipient according to 1.0 mg of antibody under sterile conditions, and freeze-dry for 10 h at 1 Pa and -100 °C in a freeze dryer; 2. After the freeze-drying is completed, the system is slowly charged with helium to standard atmospheric pressure to protect the system with inert gas. Then, the SLN-F kit is obtained by packaging under the condition of aseptic and below -20°C. Add 0.3mL PBS to the kit to dissolve, and perform Radio-HPLC analysis. The analysis results are shown in Figure 1A with Figure 1B , no radiochemicals were present in the radioactive detector ADC1. The corresponding retention time Rt = 6.19 min at VWD 280 nm. It shows that the monoclonal antibody maintains the original molecular weight.

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Abstract

The invention provides a radionuclide labelled specific sentinel node photographic developer and a preparation method thereof and belongs to the technical field of radioactive drug labeling and nuclear medicine. The radionuclide labelled specific sentinel node photographic developer provided by the invention is prepared by the following steps: by taking a rituximab monoantibody as a parent, separating, purifying and reducing the rituximab monoantibody to obtain a photographic developer precursor; preparing the precursor into a medicine box, wherein the storage life can reach 24 months; carrying out 99mTc radionuclide labeling on the photographic developer precursor to obtain the specific sentinel node photographic developer drug 99mTc-SLN-F, wherein the labeling rate is equal to or greater than 95%. The photographic developer prepared can precisely position the specific sentinel node, the development and biopsy times are not limited, and the photographic developer can develop well in a time interval of 30 minutes to 24 hours after injection. In addition, the photographic developer is low in uptake in a secondary lymph gland and low in retention at injection points. The photographic developer has a good application prospect in treating and diagnosing breast cancer.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a radionuclide-labeled specific sentinel lymph node imaging agent and a preparation method thereof. Background technique [0002] Surgery is the main method for the treatment of breast cancer. Since the status of axillary lymph nodes is an important independent prognostic factor affecting the survival of breast cancer patients, axillary lymph node dissection is often used clinically as a means of diagnosis and treatment of axillary lymph node status. Axillary lymph node dissection (ALND) is the most commonly used surgical method. With the screening and early diagnosis of breast cancer, 50% to 70% of newly discovered breast cancer patients have negative postoperative pathological axillary lymph nodes, and ALND for this part of patients is overtreatment; therefore, ALND is performed for all breast cancer patients. The rationality has been questioned, and an accurate and minimally...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K51/10A61K103/10
Inventor 杨志朱华刘菲
Owner YANTAI LANNACHENG BIOTECHNOLOGY CO LTD
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