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. 2022 Sep 5;12(11):4075–4097. doi: 10.1016/j.apsb.2022.08.025

Table 3.

Application of biotechnology in pharmaceutical product analysis.

Techniques Characteristic Application
Toxicity analysis
Network toxicology Multiple gene and target Hepatotoxicity analysis of esculentoside A98
Transcriptomics Most widely used; high sensitivity; high resolution The potential toxic components and hepatotoxic targets analysis of vine tea121
Proteomics High sensitivity; high resolution The toxicities analysis of Herba Lysimachiae123
Metabolomics High sensitivity; high resolution Toxic components related to drug-induced liver injury of Heshouwu127
Mass spectrometry imaging technology High sensitivity; Visual The damage to liver cell of acetaminophen217
Transgenic animal Humanized; rapid large-scale screening Drug reaction analysis of abacavir in HLA mice103
Disease model animal Short life, low cost, and efficient reproduction The cardiotoxicity analysis of four typical MALs108
Immunofluorescence and its derivative High specificity, sensitivity, and speed Evaluation the side effects of hydrazide drugs116
Flow cytometry Speed-up, high precision, good accuracy The cytotoxicity of Drosophila ginsenoside119
Effectiveness analysis
Target-based biosensors High sensitivity, low cost, excellent practicability Early identification of designer drugs of abuse, the development of 5-HT2AR-dependent non-hallucinogenic therapeutics139,141,142
3D-biological printing organoid Self-organizing, self-renewing, physiologically relevant, automatic, economic Dynamic and combinatorial drug screening, personalized drug delivery, assessment in tumor patient-derived organoid-like models144,147,150,151
Microfluidic-combined organ-on-a-chip Low consumption of reagents, rapid actuation and response Drug potency evaluation, application at the cell, tissue, and organ levels, analysis of the molecular process in various enteropathies153,159,218
Omics-based artificial intelligence Improved the efficiency and accuracy, no requirement of clinical trials with low costs Discovery of innovative drugs, identification of bioactive components in natural medicines166,167
Quality controllability analysis
DNA mini-barcoding Accurate for natural products preparation Angelica sinensis, Panax notoginseng170,174
DNA meta-barcoding Use universal PCR primers to identify multiple species Jiuwei Qianghuo Wan
Single nucleotide polymorphism Short DNA sequence unique to a species, highly conserved, rapidly Ginseng products in Chinese patent medicines
DNA melting analysis Sensitivity, avoids sequencing Rhizoma Paridis Herrmann170
Electronic tongue Fast and simple Taste masking
Luciferase reporter transfected cell lines Highly related to pharmacological effect Differentiate Huangqin Tang preparations, Uraria crinita, Ephedrae Herba and Astragali Radix
COX-2 inhibitor; iNOS activity Fast and simple
Thrombosis model Easy for observation, rapid and high-throughput, holistic effect Distinguish XST; Q-marker identification200
Oxidative stress Low number of somatic cells; evolution of each cell Distinguish Ganoderma lucidum quality
Chip with enzyme/cells Automation of operation, more repeatable than cell-based models Evaluate the quality of Qishen Yiqi Pill from different batches
Intestine/liver/kidney Reducing time and cost of drug development, high-throughput Pharmacokinetic parameters153,154,218