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Preparation of soluble microneedle patch with fusion protein nanoparticles secreted by Mycobacterium tuberculosis and application of tuberculosis skin test
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Fan CHEN1, Rong-sheng ZHU1, Jing ZHOU2, Yue HU1, Yun XUE3, Jian-hua KANG4, *, Wei WANG4, *
Acta Pharmaceutica Sinica | 2024, 59(6) : 1804 - 1811
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Acta Pharmaceutica Sinica | 2024, 59(6): 1804-1811
• Original Articles •
Preparation of soluble microneedle patch with fusion protein nanoparticles secreted by Mycobacterium tuberculosis and application of tuberculosis skin test
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Fan CHEN1, Rong-sheng ZHU1, Jing ZHOU2, Yue HU1, Yun XUE3, Jian-hua KANG4, *, Wei WANG4, *
Affiliations
  • 1. State Key Laboratory of Biocatalysis and Enzyme Engineering, Life Science School of Hubei University, Wuhan 430062, China
  • 2. Clinical Laboratory of Wuhan Pulmonary Hospital, Wuhan 430030, China
  • 3. College of Medical Technology and Engineering, Henan University of Science and Technology, Luoyang 471003, China
  • 4. Department of Laboratory Medicine, Dongguan Chang′an Hospital, Dongguan 523843, China
Published: 2024-06-12 doi: 10.16438/j.0513-4870.2023-0895
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Rapid epidemiological screening for tuberculosis (TB) usually uses tuberculin pure protein derivative (PPD) skin test, which has limitations such as low specificity and high side effects. ESAT-6 and CFP-10 are secreted proteins of Mycobacterium tuberculosis, but the related genes are missing from Bacillus Calmette-Guerin (BCG). In this study, the fusion protein ESAT6-CFP10 (EC) was expressed and purified, and prepared into chitosan nanoparticles (EC-NPs), which were loaded into the microneedle patch and carried out the preliminary test of tuberculosis skin test. The drug loading capacity of MNP-EC-NPs (microneedle patch, MNP) can reach 0.03 μg per needle and 1.92 μg per patch. The shelf life of MNP-EC-NPs can reach 6 months at room temperature, and it can effectively penetrate the epidermis. Volunteer skin test results showed that MNP-EC-NPs can effectively distinguish between BCG vaccinators, and can effectively show positive reaction in the skin of tuberculosis patients without significant side effects. The experiment was approved by the Ethics Committee of Wuhan Pulmonary Hospital [2022 (2)]. In this study, a TB skin test method was established, using ESAT6-CFP10 fusion protein instead of PPD, and using soluble microneedle dosage form, which improved the specificity of TB skin test diagnosis and provided a new technical scheme for TB epidemic screening.

tuberculosis  /  skin test  /  nanoparticle  /  microneedle patch
Fan CHEN, Rong-sheng ZHU, Jing ZHOU, Yue HU, Yun XUE, Jian-hua KANG, Wei WANG. Preparation of soluble microneedle patch with fusion protein nanoparticles secreted by Mycobacterium tuberculosis and application of tuberculosis skin test[J]. Acta Pharmaceutica Sinica, 2024 , 59 (6) : 1804 -1811 . DOI: 10.16438/j.0513-4870.2023-0895
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Article Info
doi: 10.16438/j.0513-4870.2023-0895
  • Receive Date：2023-07-24
  • Online Date：2025-11-26
  • Published：2024-06-12
Article Data
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History
  • Received：2023-07-24
  • Revised：2024-03-28
Funding
Affiliations
    1. State Key Laboratory of Biocatalysis and Enzyme Engineering, Life Science School of Hubei University, Wuhan 430062, China
    2. Clinical Laboratory of Wuhan Pulmonary Hospital, Wuhan 430030, China
    3. College of Medical Technology and Engineering, Henan University of Science and Technology, Luoyang 471003, China
    4. Department of Laboratory Medicine, Dongguan Chang′an Hospital, Dongguan 523843, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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