Search

CN-121991236-A - Cetirizine monoclonal antibody, nucleic acid molecule, vector, detection kit and application thereof

CN121991236ACN 121991236 ACN121991236 ACN 121991236ACN-121991236-A

Abstract

The invention belongs to the technical field of colloidal gold immunochromatography, and relates to a cetirizine monoclonal antibody, a nucleic acid molecule, a carrier, a detection kit and application thereof. The cetirizine monoclonal antibody comprises a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region comprises a VH-CDR1, a VH-CDR2 and a VH-CDR3, the light chain variable region comprises a VL-CDR1, a VL-CDR2 and a VL-CDR3, the sequence of the VH-CDR1 is shown as SEQ ID NO.1, the sequence of the VH-CDR2 is shown as SEQ ID NO.2, and the sequence of the VH-CDR3 is shown as SEQ ID NO. 3. The monoclonal antibody has high sensitivity to cetirizine, the minimum detection limit is 0.007ng/mL, the quantitative range is 0.017-0.282ng/mL, and the specificity is strong.

Inventors

  • GUO CHENGXIAN
  • LEI HONGTAO
  • TAN HONGYI
  • LUO HEWEN
  • YIN JIYE
  • ZHOU BOTING

Assignees

  • 中南大学湘雅三医院

Dates

Publication Date
20260508
Application Date
20260410

Claims (10)

  1. 1. A cetirizine monoclonal antibody comprising a heavy chain variable region comprising a VH-CDR1, a VH-CDR2 and a VH-CDR3, and a light chain variable region comprising a VL-CDR1, a VL-CDR2 and a VL-CDR3, characterized in that the sequence of VH-CDR1 is shown in SEQ ID No.1, the sequence of VH-CDR2 is shown in SEQ ID No.2, the sequence of VH-CDR3 is shown in SEQ ID No.3, the sequence of VL-CDR1 is shown in SEQ ID No.4, the sequence of VL-CDR2 is KVS, and the sequence of VL-CDR3 is shown in SEQ ID No. 5.
  2. 2. The cetirizine monoclonal antibody according to claim 1, wherein the heavy chain variable region has an amino acid sequence shown in SEQ ID No.6 and/or the light chain variable region has an amino acid sequence shown in SEQ ID No. 7.
  3. 3. Use of a cetirizine monoclonal antibody according to claim 1 or 2 for the preparation of a reagent for assessing the level of cetirizine.
  4. 4. A nucleic acid molecule encoding the cetirizine monoclonal antibody of claim 1 or 2.
  5. 5. Use of the nucleic acid molecule of claim 4 for the preparation of a reagent for assessing the level of cetirizine.
  6. 6. The use according to claim 3 or 5, wherein the reagent comprises a kit.
  7. 7. The use according to claim 3 or 5, wherein the evaluation is based on the detection of cetirizine content in a sample of chinese patent medicine, food or cosmetic.
  8. 8. A vector comprising the nucleic acid molecule of claim 4.
  9. 9. A test kit comprising the cetirizine monoclonal antibody according to claim 1 or 2 or the nucleic acid molecule according to claim 4.
  10. 10. The use of the detection kit according to claim 9, wherein the use is for detecting the content of cetirizine in a sample of chinese patent medicine, food or cosmetic.

Description

Cetirizine monoclonal antibody, nucleic acid molecule, vector, detection kit and application thereof Technical Field The invention belongs to the technical field of colloidal gold immunochromatography, and relates to a cetirizine monoclonal antibody, a nucleic acid molecule, a carrier, a detection kit and application thereof. Background Cetirizine (Cetirizine), chemical formula C 21H25ClN2O3, is a second generation H1 antihistamine, a long-acting, selective oral potent antiallergic agent. Can be used for treating seasonal or perennial allergic rhinitis, urticaria caused by allergen, and skin pruritus. Although cetirizine is an over-the-counter drug, the safety is higher, but the blood concentration monitoring is still needed under specific clinical scenes (1) when cetirizine is mainly excreted in an original shape through kidneys, the drug clearance rate of patients with renal hypofunction is obviously reduced, the drug accumulation and adverse reaction risks are easily increased, (2) when the individual administration is carried out, the curative effect and tolerance of different individuals to cetirizine are different, partial patients have poor curative effect or have adverse reactions such as somnolence and dry mouth, and the dosage needs to be adjusted to balance the curative effect and the safety, (3) when the cetirizine is combined with central nervous system inhibitors (such as alcohol and benzodiazepine drugs), the central inhibitory effect is possibly enhanced, the blood concentration monitoring is helpful for evaluating the combined drug risk, (4) the drug compliance judgment is carried out, in clinical experiments or long-term treatment, the drug compliance of patients can be judged through the blood concentration detection, and the curative effect caused by poor objective compliance and abnormal pharmacokinetics is poor. In recent years, some of Chinese patent medicines, health foods and cosmetics which are declared to have antiallergic and antipruritic effects are detected to be illegally added with chemical medicines such as cetirizine. The illegal addition not only violates the regulation of the medicine, but also can lead to repeated administration and overdose administration of the medicine under the unknowing condition of consumers, and cause serious adverse reactions. Therefore, the establishment of a rapid, sensitive and specific cetirizine detection method has important significance for guaranteeing public safety. Currently, the detection methods of cetirizine mainly include chromatography and immunoassay. High Performance Liquid Chromatography (HPLC) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) are classical methods for cetirizine detection. The method has the advantages of high accuracy, distinguishing cetirizine enantiomer from levocetirizine enantiomer and the like. However, the chromatography has the following limitations of (1) complex sample pretreatment, complex and time-consuming operation due to extraction, concentration and other steps, (2) expensive instrument and equipment, high maintenance cost, inapplicability to basic laboratory and on-site rapid detection, and (3) limited detection flux, and difficulty in meeting the requirement of large-scale screening. The immunoassay methods such as enzyme-linked immunosorbent assay (ELISA) and the like have the advantages of simple operation, rapid detection, high flux, low cost, suitability for field screening and the like, and are important development directions of cetirizine detection. The core of the immunoassay is to obtain high-specificity, high-affinity anti-cetirizine antibodies. However, there is no research on monoclonal antibodies against cetirizine. Disclosure of Invention The invention aims to provide a cetirizine monoclonal antibody with high specificity and high affinity, a nucleic acid molecule, a carrier, a detection kit and application thereof. In order to achieve the above purpose, the technical scheme adopted by the invention is as follows: A cetirizine monoclonal antibody comprising a heavy chain variable region (VH) comprising VH-CDR1, VH-CDR2 and VH-CDR3, and a light chain variable region (VL) comprising VL-CDR1, VL-CDR2 and VL-CDR3, the sequence of VH-CDR1 being as shown in SEQ ID No.1, the sequence of VH-CDR2 being as shown in SEQ ID No.2, the sequence of VH-CDR3 being as shown in SEQ ID No.3, the sequence of VL-CDR1 being as shown in SEQ ID No.4, the sequence of VL-CDR2 being KVS, the sequence of VL-CDR3 being as shown in SEQ ID No. 5. SEQ ID NO.1 has the sequence GFTFTDNY. SEQ ID NO.2 has the sequence ISNKADGYTT. SEQ ID NO.3 has the sequence ARDYGTMAWFAY. SEQ ID NO.4 has the sequence QNTVHSDGNTY. The sequence of SEQ ID No.5 is FQGSHVPLT. According to the embodiment of the invention, the invention can be further optimized, and the following technical scheme is formed after the optimization: In one preferred embodiment, the heavy chain variable region has the amino acid sequence shown in S