Standard operating procedure for detecting foreign particles in eye drops using insoluble particle analyzer with microscopic counting method

In the past three years, due to the prevalence of the epidemic, more and more office work and learning rely on the Internet and mobile phones, followed by an increase in ophthalmic diseases.

With the improvement of people's awareness and attention to health, the current society is paying more and more attention to the safety of eye drops. Among them, there are clear standards for particle foreign body examination in the Japanese Pharmacopoeia and the United States Pharmacopoeia, as well as recommendations for microscopic counting as an important examination method to ensure that approved ophthalmic solutions do not cause secondary harm to the human body.

Below, I will introduce the specific operation process of Yinhuang Technology's micro counting method insoluble particle analyzer series products in the inspection of insoluble particles in eye drops.

1、 Firstly, let's understand what eye drops are:

Eye drops generally refer to eye drops, which are commonly used for ophthalmic diseasesOne of the drug preparations, eye drops have a direct and rapid therapeutic effect on many eye diseases. With the changes in people's lifestyles and working conditions, they spend more and more time using their eyes, such as watching computers, playing mobile phones, watching TV, playing video games, etc., which can easily lead to visual fatigue and dry eye syndrome.

2、 Eye drops-Why conduct insoluble particle inspection?

We all know that the eyes are the windows to the soul. In order to alleviate visual fatigue and dry eye syndrome, many people have turned eye drops into a daily necessityDrugs. In the process of using eye drops, if there are a large number or size of insoluble particles in the eye drops, it will not only cause discomfort to the eyes, but also lead to various eye diseases and secondary injuries. Therefore, the European and American Pharmacopoeias and the Japanese Pharmacopoeia have dedicated chapters for the examination standards and instrument recommendations for insoluble particles in eye drops, and the microscopic counting method insoluble particle analyzer is prominently listed.

2、 Principle of insoluble particle detection in eye drops

1There are two methods specified in the pharmacopoeia for detecting insoluble particles1The method is photoresist method, and the second method is microscopic counting method. The second method is microscopic counting method used for the examination of insoluble particles in eye drops;

2Why is the second method of microscopic counting used for the examination of insoluble particles in eye drops? Because eye drops usually contain surfactants, which can easily generate bubbles during testing, affecting the detection results of insoluble particles. According to the Chinese Pharmacopoeia2020edition0903The inspection requirements for insoluble particles require the use of the second method microscopic counting method for detecting insoluble particles in formulations that are prone to bubble formation and high viscosity (see figure below for details).

3、 Criteria for determining insoluble particles in eye drops

The criteria for determining insoluble particles in eye drops are currently mainly based on the Chinese Pharmacopoeia2020年版0903Chapters and Japanese Pharmacopoeia6.08Related standards for examination of insoluble particles in eye drops. In the actual inspection process of R&D and production, the requirements for internal control, original research, and particle quality control for release are far higher than the testing standards of pharmacopoeia.

4、 Standard Experimental Procedure for Insoluble Particle Examination of Eye Drops (Microscopic Counting Insoluble Particle Analyzer)

1The instruments and equipment used:Microscopic Counting Insoluble Particle Analyzer（YH-MIP-0103）

2Check sample information: Different batches of eye drops under development by a certain manufacturer

3Preparation of consumables and cleaning of instruments before the experiment

① Microporous membrane: white pore size0.45Mm, diameter25mm

② Filtering device: After the environmental detection meets the regulations, rinse the filter with deionized water on the purification table and pick it up with flat headed tweezers25mmfilter membrane After rinsing with deionized water, place it on the filter holder for fixation.

4Experimental process

① Filtering: Take out four small bottles of eye drops and slowly pour the liquid into the filtering device. After the sample is filtered, clean the inner wall of the filtering device with an appropriate amount of deionized water;

② Drying: Use flat headed tweezers to place the filter membrane into a culture dish and dry it in a drying oven.

③ Detection and counting: Remove the filter membrane and place it in the insoluble particle sample stage of the microscopic counting method. Click on the software to test and obtain the results.

④ Observing high-definition photos: Observing the original high-definition photos, determining the possible sources (exogenous or endogenous) of particles based on their morphology and size, in order to improve or avoid them in the research and development production process.

⑤ Result judgment

5、 Research and development progress of Yinhuang Technology's insoluble particle analyzer series products using microscopic counting method

new generationYH-MIP-0205 ProThe fully automatic microscopic counting method insoluble particle analyzer has been upgraded based on the technological advantages of the previous generation of instruments. The new product integrates functions such as automatic filtering, automatic drying, and automatic sample loading on the basis of the original step-by-step automatic scanning, automatic testing, and automatic counting, truly achieving the complex operation process of the original microscopic counting method without human supervision; At the same time, on the basis of the original super-resolution algorithm, addAIIntelligent algorithms facilitate customers to better classify and organize sources of insolubility, and avoid them in future experimental production processes.