Medical Degree Program in China - Pharmaceutical Analysis
1. Introduction
Pharmaceutical Analysis (habitually called pharmaceutical inspection) is a discipline that studies the quality of synthetic drug or natural drug and its preparations with clear chemical structure through the application of chemical, physical, biological and microbiological methods and techniques. It includes the chemical inspection of drug products, quality control of the drug production process, the quality inspect of drug storage process, clinical drug analysis, drug analysis in vivo and so on.
Pharmaceutical analysis is an important branch of chemistry. With the development of medicinal chemistry, it has gradually become a subject relatively independent of the chemical analysis and is widely used in drug quality control, new drug research, drug metabolism, analysis of chiral drug. With the development of life science, environmental science, materials science, the introduction of biology, information science, computer technology, and analytical chemistry develops rapid and has entered analytical science, which is a new field. Pharmaceutical analysis plays a more and more important role, existing everywhere in scientific research, production and life, plays an important role especially in the research and development of new drug and drug production.
2. Basic Procedures
Sampling
Character observation
Identify
Inspect
Determination of content
Inspection records and reports
Common Analytical Methods of Medical Instrument:
Chromatography: high performance liquid chromatography, gas chromatography, ion exchange chromatography, supercritical fluid chromatography, capillary chromatography, thin layer chromatography/scanning, gel chromatography, multidimensional chromatography
Spectral method: UV Visible spectrophotometry, atomic absorption spectrometry, fluorescence spectrometry, infrared spectroscopy, near infrared spectroscopy
Others: biological chip technology, in vivo drug analysis, in vitro analysis
3. Principles and Basic Contents of Drug Quality Standards Making
Principles: safe, effective, advanced technology, economical, reasonable.
Test method:
(1). Name
(2). Character:
(a). appearance, smell, taste and stability
(b). solubility: reflects the purity of drug to a certain extent.
(c). physical constants
(3). Identification: the method that uses physical and chemical methods or biological methods to prove the authenticity of drug. To known objects.
(4). Impurity inspection: effectiveness, purity requirements and safety.
(5). Determination of content or potency: it is called content determination by physical and chemical methods, called potency determination by biological or biochemical methods.
