Pharmaceutical workers all over the world are dedicated to finding non-injection drug delivery routes for peptide drugs. In the late 1980s and early 1990s, the nasal drug delivery route attracted the attention of drug researchers and became a popular research abroad in the early 1990s. The topic, and announced nearly ten kinds of nasal administration formulations with systemic effects. These formulations are all solution spray pumps. Single (double) and multiple dose manual spray pumps are used. However, the nasal solution sprays have the following defects : (1) The drug exists in a liquid method, and the stability is poor. The pump valve system and the drug can have physical and chemical reactions such as adsorption. The pump and the drug solution are packaged separately. Install the manual pump before use, and it should be within a certain time after opening Used up within (2 weeks). (2) The multi-dose spray pump should be pre-sprayed before use, and there will be a certain residual dose in the end, which is easy to cause spoilage. However, single-dose sprays are expensive and unbearable in the domestic market.
The development of powder aerosol is closely related to drug delivery equipment. However, there is no special organization for research and development of drug delivery equipment in China. The research on powder aerosol in China has been carried out since 1990, and the research on beclomethasone dipropionate powder aerosol has been passed through the national "Eighth Five-Year Plan" research and "Ninth Five-Year Plan" Tackling key problems-the research of powder aerosol engineering, has the research and production skills of capsule powder aerosol, and has established the quality control method and standard of powder aerosol research and production, but there is still a certain distance compared with foreign countries . Specifically, the research methods and techniques are now behind. Foreign countries have deepened the study of dosage forms to the selection of biological, electrochemical, and physical chemical techniques for molecular-level studies of absorption mechanisms, and all studies have been conducted on the mechanisms of drug delivery, metabolism, accumulation and targeting in the respiratory tract, such as: In vitro safety assessment of the absorption of nasal drugs in the same species and nasal administration; an in vitro model for evaluating drug absorption; a new investigation of the rules of drug transport through alveolar epithelium; in vitro determination of the correlation with in vivo dose; Targeted drug delivery at the same site; the effect of breathing methods on drug absorption in the lungs, etc. In vivo studies mostly use the isotope "99mTc symbol, GC-MS method, radioimmunoassay, and enzyme immunoassay. In comparison, our research is more concentrated in the practical period due to economic strength, and there is a shortage of research methods. Need to be improved.
The powder aerosol is a new dosage form, and its research and development must summarize common knowledge in pharmacy, medicine, powder engineering, mechanics, and machinery. The level of preparation research in China is not much different from that of foreign countries, mainly due to the lack of leading instruments and equipment, and the single type of powder aerosol and drug delivery equipment. On the basis of foreign research, the country should grasp the key to the development of biological skills and genetic engineering, carry out the development of new types of powder aerosols, and work closely with foreign equipment developers to shorten the distance with foreign countries, and develop a world-leading level Powder aerosol products.