Yinhuang Technology Microscopic Counting Method Insoluble Particle Analyzer for Testing the Whole Process of Transdermal Ointment Experiment

1、 Experimental sample name: Transdermal plaster available for sale in a certain market.

Let's first understand the mechanism of action of transdermal plasters: Transdermal Therapeutic System; TTS transdermal therapy system (also known as transdermal therapy reservoir preparation) is a type of controlled release membrane preparation that exerts systemic therapeutic effects through transdermal administration. Transdermal drug delivery system or transdermal absorption formulation refers to a new dosage form that is administered on the surface of the skin, allowing the drug to pass through the skin at a constant rate (or near constant rate) and enter the systemic circulation to produce systemic or local therapeutic effects. Its advantages are reflected in: drug absorption is not affected by factors such as pH, food, and transport time in the digestive tract; Avoid the first pass effect of the liver; Overcoming adverse reactions caused by excessive blood drug concentration due to rapid absorption; Sustainable control of dosing speed, flexible dosing, etc. Transdermal drug delivery is a newly developed new type of drug delivery system, which has a broader prospect due to its more humanized drug delivery and treatment characteristics, as well as the continuous development of transdermal technology.

2、 Testing principle basis: Chinese Pharmacopoeia 2020 Edition 0982 Particle Size and Particle Size Distribution Determination Method First Method Microscopic method.

The particle size in this method is represented by the length observed under the microscope. Calibration of eyepiece micrometer for microscopic identification (General Principles 2001).

Measurement method: Take the test sample, shake it vigorously, and dilute it with an appropriate amount of glycerol solution (1-2) according to the regulations under each variety for those with high viscosity. Measure the test sample according to the regulations under this dosage form or variety, place it on a glass slide, cover it with a cover glass, and gently press it to ensure uniform particle distribution. Note to prevent air bubbles from mixing. Semi solid can be directly applied to the glass slide. Immediately inspect the entire field of view of the cover glass under a microscope at 50-100 times magnification, and there should be no coagulation phenomenon. Particles of 50 μ m or more specified under this dosage form or variety should not be detected. Then examine the total number of particles and the specified size of particles within the prescribed field of view of the dosage form or variety under a microscope at 200-500 times magnification, and calculate their proportion (%).

3、 Instrument and equipment used: Microscopic Counting Insoluble Particle Analyzer (Model: YH-MIP-0103)

The working principle of this instrument is the microscope method, which can obtain all particle morphologies through one scan and count them by size; At present, there has been a technological breakthrough in artificial intelligence learning, which not only provides accurate and fast counting, but also enables the determination of the possible source of particles through their morphology.

4、 Experimental process presentation: Microscopic counting method for insoluble particle inspection throughout the entire process

1. Preparation before the experiment: Rinse the glass slide and cover slide with a large amount of water for particle inspection and dry them for later use. Clean the appearance of the test preparation for later use (to prevent the introduction of foreign particles);

2. Experimental process: Apply the ointment evenly on a glass slide and cover it with a cover slip. Gently press to ensure even particle distribution. Place the glass slide steadily on the microscopic counting method storage platform, open the computer software, control the microscopic counting method insoluble particle analyzer to scan and provide data feedback to the computer. Scan completed and export experimental data.

3. Experimental result analysis: Directly export experimental reports according to pharmacopoeia requirements or experimental result requirements independently set by the enterprise, and can directly present the specific particle morphology of the eye curtain.

5、 The main advantages of a transdermal therapeutic system are:

With the continuous development of medical polymer compound materials and the rapid development of controlled release drug delivery systems, transdermal therapy systems have attracted attention from the pharmaceutical industry and are developing rapidly. There are over ten TTS models that have been successfully researched or commercialized, with the main advantages being:

1. It can avoid oral administration, as the medication is not affected by gastrointestinal physiological factors, and the individual differences in absorption and metabolism are relatively small.

2. Sustainable administration, therefore, also applicable to drugs with short biological half lives.

3. It can avoid the first pass effect of the liver, reduce metabolic amplitude, increase bioavailability, and relatively reduce side effects.

4. Can provide a drug release rate close to zero required for treatment.

5. Easy to use and patient friendly.

6. The medication system can be removed at any time to terminate the administration.

Therefore, TTS is a novel, feasible, and promising drug formulation, which has become one of the central topics in the development and research of third-generation formulations.

However, due to the fact that drugs mainly diffuse and release through microporous membranes before entering the capillary plexus through the skin and exerting their effects, the harm of particles is particularly concerned. Conventional microscopic particle inspection methods are no longer suitable for the current fast-paced research and experimental processes, so the microscopic counting method insoluble particle analyzer has emerged. One experiment can not only measure the number of particles, but also directly provide the corresponding proportion of particles with different sizes.