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How to installation dissolution tester?

Technical Knowledge 2019-11-21 09:19:31
The dissolution tester is used to check the speed and extent of dissolution of a drug from a solid preparation such as a tablet or a capsule in a prescribed solvent.

1.Install the mixing paddle (basket)

Mechanical verification is required when the dissolution apparatus is shipped and installed (or every 6 months). During the use after verification, the position of the paddle (basket) installed by us is different from the installation position during verification, which will affect the coaxiality of the paddle (basket) and the vessel, and thus affect the dissolution medium in the vessel. The flow state changes the dissolution data of the sample.

In addition, some manufacturers' dissolution paddles (baskets) need to adjust the installation height, but often we do not remove the mixing paddles (basket) when cleaning the equipment. It is always considered that the mixing paddles (basket) have been adjusted. ) Height, no need to adjust. However, the fixed paddle (basket) is loosened due to the shaking of the paddle (basket) during use. The height of the paddle (basket) may have decreased after prolonged use, and eventually, the dissolution of the sample is changed or the parallelism of dissolution in the group is deteriorated.

When applying the basket method, pay attention to the cleanliness of the basket, observe whether the basket gap is clogged, such as blockage, use ultrasonic treatment or boil in dilute nitric acid, then purify in water, otherwise it will affect the dissolution. The accuracy of the data. At the same time, it should also be noted that the shape of the basket is complete. If distortion occurs, the new basket should be replaced in time.

2. Install the dissolution cup

The vessel has the same number as the paddle (basket). The vessel should also be installed in the corresponding position when in use. In addition to the number of the dissolution cup, the dissolution apparatus is marked by the verticality and the coaxiality, and the upper edge of the dissolution cup is connected to the fixing device. Such as: vertical lines, arrows.

Therefore, in the dissolution test, each basket shaft, paddle and vessel should be placed in the original verified position to maintain the relative position of each vessel and fixture. However, when installing the dissolution apparatus, it is often overlooked that the axial extent of the dissolution vessel does not coincide with the axial extent of the agitating paddle, thereby changing the flow state of the dissolution medium in the dissolution cup, and the dissolution data is changed.

3. Install the filter head

Now the dissolution apparatus is generally fully automatic or semi-automatic sampling. At the sampling end of the automatic sampling and dissolution apparatus, the filter head must be installed. If the filter head is not installed at the sampling end of the sampling needle, the undissolved sample particles will enter the instrument pipeline with the sampling solution. ,

On the one hand, undissolved particles may block the tubing, making the instrument sample inaccurate; on the other hand, because the sample is transferred from the sampling end to the test tube (depending on the sample size), there will generally be a 2-5 min interval, undissolved. The particles will continue to dissolve as they migrate through the tubing, thus affecting the accuracy of the measurement or the final dissolution.

After the test, the used filter head should be sonicated in the solvent for 20-30min, then ultrasonically cleaned with purified water. It can not be washed only with the dissolution medium and then rinsed with water. Because this method can not clean the filter, it will affect the next use.

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