Oral administration is the preferred mode of administration for most therapeutic drugs, but many drugs are degraded before entering the systemic circulation, including gastrointestinal degradation and metabolism, liver first-pass effects, etc., as biotechnology advances, more and more Many biochemical drugs (proteins and peptides) are used to treat various diseases, and these drugs are generally not suitable for oral administration, but are often administered by injection, but such administration is expensive, and patient compliance is poor. Long-term treatment. to this end. Pharmacists all over the world are dedicated to finding non-injection routes for peptide drugs. In the late 1980s and early 1990s, the nasal administration route attracted the attention of pharmaceutical researchers and became a hot research topic in the early 1990s. And developed nearly ten kinds of systemic nasal preparations (see Table 1), these preparations are solution sprays, using single (double) dose and multi-dose manual spray pump, but nasal spray solution There are some disadvantages as follows:
(1) The drug exists in liquid form and has poor stability. The pump valve system and the drug may have physical and chemical reactions such as adsorption. The pump and the liquid are separately packaged, and the manual pump is installed before use, and should be in a certain period of time after being opened. Run out (2 weeks).
(2) Multi-dose sprays should be pre-sprayed before use, and there is a certain residual dose after zui, which is easy to cause waste. Single-dose sprays are expensive and unaffordable in the domestic market.
In order to overcome the shortcomings of manual spray pumps in the administration of peptide drugs, foreign drug delivery device developers (Pfeiffer in Germany and Valois in France) introduced a single-dose delivery device for nasal powders to drug research and development personnel in various countries in 1999. In particular, the device of Pfeiffer Company of Germany, the drug is actively inhaled in powder form, and is more easily distributed in the nasal cavity absorption site, and the device has the advantages of simple structure, convenient use and low price. However, the nasal spray powders that have been used for systemic treatment have been in the research stage all over the world. Only Japanese patents (JP5032560) and US patents (USP5578324) have related patent reports on nasal powder formulations. However, capsule-type passive inhalation devices are used, and no product is currently available.
GC-MS method, radioimmunoassay, and enzyme immunoassay. In contrast, our research is concentrated in the practical stage due to economic strength, but there is a lack of research methods and needs to be improved.
Powder spray is a new type of research, and its research and development must integrate knowledge in pharmacy, medicine, powder engineering, mechanics, machinery and so on. The level of preparation research in China is not much different from that in foreign countries, mainly due to the lack of advanced equipment and equipment, and the type of powder and the type of drug delivery device are single. On the basis of foreign research, the country should seize the opportunity of biotechnology and genetic engineering development, develop new varieties of powder aerosols, and work closely with foreign device developers to shorten the gap with foreign countries and develop an international linger level. Powder products.
(1) The drug exists in liquid form and has poor stability. The pump valve system and the drug may have physical and chemical reactions such as adsorption. The pump and the liquid are separately packaged, and the manual pump is installed before use, and should be in a certain period of time after being opened. Run out (2 weeks).
(2) Multi-dose sprays should be pre-sprayed before use, and there is a certain residual dose after zui, which is easy to cause waste. Single-dose sprays are expensive and unaffordable in the domestic market.
In order to overcome the shortcomings of manual spray pumps in the administration of peptide drugs, foreign drug delivery device developers (Pfeiffer in Germany and Valois in France) introduced a single-dose delivery device for nasal powders to drug research and development personnel in various countries in 1999. In particular, the device of Pfeiffer Company of Germany, the drug is actively inhaled in powder form, and is more easily distributed in the nasal cavity absorption site, and the device has the advantages of simple structure, convenient use and low price. However, the nasal spray powders that have been used for systemic treatment have been in the research stage all over the world. Only Japanese patents (JP5032560) and US patents (USP5578324) have related patent reports on nasal powder formulations. However, capsule-type passive inhalation devices are used, and no product is currently available.
GC-MS method, radioimmunoassay, and enzyme immunoassay. In contrast, our research is concentrated in the practical stage due to economic strength, but there is a lack of research methods and needs to be improved.
Powder spray is a new type of research, and its research and development must integrate knowledge in pharmacy, medicine, powder engineering, mechanics, machinery and so on. The level of preparation research in China is not much different from that in foreign countries, mainly due to the lack of advanced equipment and equipment, and the type of powder and the type of drug delivery device are single. On the basis of foreign research, the country should seize the opportunity of biotechnology and genetic engineering development, develop new varieties of powder aerosols, and work closely with foreign device developers to shorten the gap with foreign countries and develop an international linger level. Powder products.
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