Methods for the analysis of peptide and protein based drugs

Peptide and protein drugs refer to peptide and protein biological drugs used for prevention, ** and diagnosis. Peptides are compounds formed by linking amino acids together with peptide chains, and it is also an intermediate product of protein hydrolysis. N polypeptide chains are wound and entangled according to a certain spatial structure to form a protein.

Macromolecular protein hydrolysis produces peptides. Such drugs are biochemical preparations, and the requirements for storage and transportation environment are relatively strict.

With the rapid development of bioengineering technology, biotechnology active substances continue to come out, there have been a lot of biotechnology drugs used in clinical practice, about 40 kinds of domestic and foreign approved marketing, the number of development in 1995 was 234, and the number of research is increasing exponentially, in these varieties, a large number of peptide and protein drugs. Due to the instability of peptide and protein drugs in vitro and in vivo, the main clinical dosage forms are solution-type injections and lyophilized powder injections. In order to solve the problem of long-term drug use and overcome the inconvenience and shortcomings of injections, it is a challenge for pharmacy to develop a non-injection delivery system with appropriate route of administration.

1) Chemical synthesis methods.

The development of peptide and protein drugs by chemical synthesis has become an effective method widely used. Through liquid-phase synthesis, solid-phase synthesis, solid-liquid synthesis and fragment ligation, many peptide and protein drugs have been successfully developed.

2) Modification of bioactive peptides and existing peptide drugs.

Taking bioactive peptides or existing peptide drugs as a reference, simplifying or substituting amino acid sequences through combination screening is an effective way to develop peptide drugs.

3) Improve the grade of active peptides and existing peptide drugs.

It is an important channel for the development of new peptide protein drugs by structural modification of endogenous peptides or existing peptide drugs to overcome the weaknesses of the original products, reduce the drug efficacy, and improve the efficacy.

4) R&D of biologically active peptide natural products.

It is an important direction for the development of new peptide protein drugs to carry out structure-activity relationship research with bioactive natural peptides, especially marine bioactive polypeptides, as a template to improve the activity and potency, simplify the structure and reduce the quality of peptides.

5) Biotechnology for the preparation of peptide and protein drugs.

The use of biotechnology to prepare peptide drugs is an important method for the development of new peptide and protein drugs. The combination of biotechnology and chemical synthesis methods will complement each other and better improve the efficiency of R&D.