Peptide protein drugs With the rapid development of biotechnology, peptides, protein drugs continue to emerge. At present, 35 kinds of important therapeutic drugs are listed, and the development of biotechnology and biopharmaceutical enterprises is becoming more and more global. Biotechnology drug research focuses on the use of DNA recombination technology can be applied to clinical peptide, protein, enzymes, hormones, vaccines, cell growth factors and monoclonal antibodies.
According to Parexl's Pharmaceutical R & D Statistical Source Book, there are currently 723 biotech drugs undergoing FDA review (including Phase I and Phase III clinical and FDA assessments), 700 drugs in early research (research and preclinical), and More than 200 drugs have entered the final approval phase (Phase III clinical and FDA assessment). The basic dosage form of biotechnology drugs is a freeze-drying agent. Conventional preparations, although proven in clinical practice, but because of short half-life, the need for long-term frequent injection, from the patient's psychological and economic burden of view, these are difficult to accept the problem. To this end, scholars from two countries to study the development of convenient and reasonable route of administration and new formulations: ① implants and sustained-release injection. ② non-injection formulations, such as respiratory inhalation, rectal administration, nasal, oral and transdermal administration. (LHRH) analog microspheres injection has been listed, this article focuses on the introduction of a new type of luteinizing hormone releasing hormone (LHRH) analogue microsphere injection that can be released for a period of 1 to 3 months. Such preparations.
Peptides, protein drugs sustained release preparations of the main types of peptides, protein drug release preparation research and development, from the development process and dosage forms, the main sub-implantation and micro-ball injection two categories. 1.1 implant (implant) 1.1.1 bar-type implants buried agent shape for a hollow micro-bar, one closed, the other end of the opening, the bar is polytetrafluoroethylene and other non-biodegradable polymers. Cavity filled with drugs and silica gel (silastic, polydimethylsiloxane) mixture. The implant is buried in the human body and the drug is slowly released through the silicone substrate opening. The US Physician Handbook (PDR) contains a plant containing Norplant's name, L-18-N-Norethindrone, for family planning. The preparation of each of the diameter of 2.4 mm, length 34 mm, the doctor through the operation of six thin rods buried in the patient's medial arm, the drug can be released in the body by zero-order mode for 5 years, the drug release and then removed by surgery The 1.1.2 micro-osmotic pump implant US Alza company in the 20th century, 70 years developed a shape like a capsule implant, the preparation buried in the subcutaneous or other parts, body fluids can penetrate the shell, dissolve the interlayer electrolytic layer, so that volume expansion Of the sandwich pressure to the plastic cavity, to promote the drug solution from the opening speed release. There are many biological macromolecules drugs, such as insulin, heparin, nerve growth factor as a model drug in vivo and in vivo studies reported. The implant has a positive effect on the treatment of chronic patients requiring long-term use, but it has the following drawbacks: ① must be implanted surgically. ② preparation of the skeleton material for the non-biodegradable polymer, after the release of drugs need to be removed after surgery. ③ preparation in the local tissue to stimulate and discomfort. Peptide protein drug evaluation methods: 1, liquid chromatography 2, spectroscopy 3, electrophoresis 4, biological activity determination and immunoassay Peptide protein drugs General prescription composition: the current clinical application of protein drug injection, one for the solvent-based injection , The other for the freeze-dried powder injection. Solvent type is easy to use, but needs to be stored at low temperature (2-8 degrees Celsius).