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Dissolution test is an important indicator for evaluating the quality and daily supervision of medicine preparations. It is an in vitro test method that simulates the disintegration and dissolution of oral solid preparations in the gastrointestinal tract. What are the external factors that need to be considered when conducting dissolution tests with a dissolution tester?
1. Dissolution phenomenon
The dissolution test results are not only dissolution data. When examining or comparing dissolution curves, people only pay attention to dissolution data and ignore the observation of dissolution phenomenon. In fact, dissolution phenomenon has guiding significance for the prescription analysis of original preparations and the prescription process adjustment of homemade preparations.
2. Surrounding environment
The shaking of the stirring paddle (basket) of the dissolution apparatus will affect the coaxiality between the stirring paddle (basket) and the dissolution cup. The shaking of the stirring paddle (basket) comes from the shaking caused by the instrument itself on the one hand, and the environment around the equipment on the other hand, such as the vibration caused by the centrifuge, vacuum pump and other equipment, which will also cause the stirring paddle (basket) to shake.
3. Water bath height
The water in the water tank outside pharmaceutical dissolution tester will evaporate due to heat, causing the liquid level to drop. If the height of the water bath outside the dissolution tester is lower than the liquid level of the dissolution medium in the dissolution cup, it will affect the temperature of the dissolution liquid, causing the dissolution rate of the sample to change,and affecting the dissolution result.