Polypeptide and protein drugs With the rapid development of biotechnology, polypeptide and protein drugs are constantly emerging. At present, 35 important therapeutic drugs have been listed, and the development of biotechnology and biopharmaceutical enterprises is becoming increasingly global. The focus of biotechnology drug research is to use DNA recombination technology to develop peptides, protein, enzymes, hormones, vaccines, cell growth factors and monoclonal antibodies that can be used in clinic. According to parexl's pharmaceutical r&; D Statistical sources report that there are currently 723 biotechnological drugs under FDA review (including phase I-III clinical and FDA evaluation), 700 drugs are in the early research stage (research and pre-clinical), and more than 200 drugs have entered the final approval stage (phase III clinical and FDA evaluation). The basic dosage form of biotechnology drugs is freeze-drying agent. Although the efficacy of conventional preparations has been confirmed in clinic for a long time, it is an unacceptable problem from the perspective of patients' psychological and economic burden because of its short half-life and long-term frequent injection. Therefore, scholars from all over the world mainly study and develop convenient and reasonable routes of administration and new preparations from two aspects: ① implants and sustained-release injections. ② Non-injection type, such as respiratory inhalation, rectal administration, nasal administration, oral administration and transdermal administration. Sustained-release injection of biotechnology drugs is a new dosage form with great application prospect. Some varieties, such as luteinizing hormone-releasing hormone (LHRH) microsphere injection with sustained release 1 to 3 months, have been put on the market. This paper focuses on this kind of preparation work. The research and development of polypeptide 1 polypeptide, the main types of sustained-release drug preparations in protein and protein, can be divided into implants and microsphere injections according to the research and development process and dosage forms. 1. 1 implant 1.65438+ The cavity is filled with a mixture of drugs and silica gel (polydimethylsiloxane). The implant is buried under the skin of human body, and the drug is slowly released through the opening of silica gel matrix. The American Physician's Handbook (PDR) contains the trade name Norplant? The drug is levonorgestrel-18, which is used for family planning. Each tablet has a diameter of 2.4 mm and a length of 34 mm. The doctor implanted six thin rods on the inner side of the patient's upper arm through surgery. The drug can be released in the body in zero-order mode for 5 years, and then taken out after release. 1. 1.2 Micro-osmotic pump implant In the 1970s, Alza Company of the United States developed an implant which looks like a capsule. This preparation is implanted under the skin or other parts, and the body fluid can penetrate through the shell to dissolve the electrolyte layer of the interlayer, so that the volume-expanded interlayer is close to the plastic cavity, and the drug solution is released from the opening at a constant speed. Biomacromolecule drugs, such as insulin, heparin and nerve growth factor, have been reported as animal model drugs in vivo and in vitro. Implant is of positive significance for the treatment of chronic patients who need long-term medication, but it has the following defects: ① It must be implanted through surgical approach. ② The skeleton material of the preparation is a non-biodegradable polymer, which needs to be taken out by surgery after drug release. ③ The preparation is irritating and uncomfortable to local tissues. Evaluation methods of polypeptide protein drugs: 1, liquid chromatography 2, spectrometry 3, electrophoresis 4, biological activity determination and immunoassay. The general prescription of polypeptide protein drugs consists of protein drug injections used in clinic at present, one is solvent injection and the other is freeze-dried powder injection. The solvent is easy to use, but it needs to be stored at low temperature (2-8 degrees Celsius).