Analysis and Evaluation of Pharmaceutical Chemical Compositions

The necessity of pharmaceutical chemical compositions analysis and evaluation

• Type complexity and diversity of pharmaceutical chemical compositions

• The medical specificity of medicines: medicines are not an independent commodity, and they are closely integrated with medicine and complement each other. Only by the doctor's examination and diagnosis, and under the guidance of doctors and licensed pharmacists, the patient can achieve disease prevention and health protection.

• The rigorous standard of medical quality: medicines are directly related to people's physical health and even the survival of their lives. Therefore, their quality must not be sloppy. We must ensure that drugs are safe, effective, uniform and stable.

Table 1 Research objects of medicinal chemical composition analysis

The contents of pharmaceutical chemical compositions analysis and evaluation

In the process of drug development, revealing the quality of drugs and controlling the quality of drugs, it is usually necessary to determine the corresponding research and test items for the characteristics of the drug (physical properties of the drug and the quality requirements of the drug, etc.). And then according to the needs of the test project, establishing appropriate analytical methods (including method selection and method validation), and finally determine the limits of each test item based on drug quality requirements and safety studies.

First of all, the authenticity of a drug should be identified by using physical and chemical methods or biological methods. Then several traits of drugs to some extent reflect the purity of the drug are needed to test, including appearance, smell, taste, and stability, solubility, etc. More specific, distillation range, temperature range, melting point, condensation point, specific rotation, refractive index, viscosity, all these physical constants are essential to pharmaceutical chemical compositions analysis and evaluation.

Absorption coefficient impurity inspection reflects the effectiveness, purity, and safety of the drugs. The test item consists of effectiveness test, pH, clarity and color test, inorganic anions test, which mainly detect the contents of chlorides and sulfates, organic impurities test, dry weight loss and moisture test. Sulfated ash of ignition residue used to investigate the inorganic impurities mixed inorganic drugs. The general limit is 0.1%. Metal ions and heavy metals check the daily dose of more than 0.5g and long-term use of the variety. Selenium and arsenic test are mainly used for dexamethasone acetate, triamcinolone acetonide acetate, and fluocinolone acetate. Last but not least, the security check is the most important test item.

Table 2 The methods used for determination of content or titer

The meaning of pharmaceutical chemical compositions analysis and evaluation

• To elucidate the interaction between drug and their receptors at the molecular level for interpretation of drug function mechanism

• To study metabolize substances and its activity

• To validate the characteristics of drugs

• To understand the relationship between structure and physicochemical character

• To obtain new chemical entities for the clinical drug by molecular drug design or structural modification of bioactive compound

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