Research and development of coagulation factor products assisted by flow dynamic image method particle size analyzer

1Introduction to coagulation factors

Coagulation factors refer to the procoagulant substances, also known as coagulation factors, present in plasma, at least16Seed. According to the order in which they were discovered, use Roman numerals to give the official FangNaming, such as factor II, factor VII, etc. Later, it was discovered that factor IV was a calcium ion and factor VI was an activated factor V, leading to the cancellation of the naming of factor IV and factor VI. Most coagulation factors are synthesized in the liver, with a few synthesized in endothelial cells and other locations. The synthesis of factors II, VII, IX, and X requires vitamin EKParticipation, also known as Weisheng SuKDependent coagulation factors. The reference range for the activity of most coagulation factors in the body is50%-150%Between them, fibrinogen, also known as factor I, is determined by the Klaus method to determine the content of functional fibrinogen. Fibrinogen is converted into soluble fibrin monomers under the action of thrombin, and in the presence of factor XIII and calcium ions, it is transformed into a cross-linked fibrin network, ultimately playing a role in hemostasis. Plasma coagulation factors can promote blood clotting and are used to treat bleeding caused by deficiencies in coagulation factors II, VII, IX, and X, such as hemophilia B (factor IX deficiency) and bleeding caused by coagulation factor deficiency in liver disease. With the expansion of market demand, the research and development of coagulation products are becoming increasingly mature. In previous articles, we also mentioned the importance of insoluble particle detection in the development of pharmaceutical products. Below, Yinhuang Technology will take you to understand its specific role in the development of coagulation factor products through the detection process of flow dynamic image particle size analyzer

IIYH-FIPS-10Flow dynamic image method particle size detection analyzer

YH-FIPS-10 Flow dynamic image method particle size analyzer (as shown in the figure)1）It is an instrument that uses a high-speed camera to capture real-time images for particle analysis. The sample is recorded and photographed in real-time during the flow process, and enough particle images can be collected (as shown in the figure)2）The test results are representative and statistically significant. It can accurately capture the morphological characteristics of different particles in the actual production process, thereby improving the stability, solubility, and flowability of the product,YH-FIPS-10Having independent intellectual property rights of Yinhuang Technology, its main features and technical parameters are as follows:

image1：YH-FIPS-10Flow dynamic image method particle size analyzer

image2：YH-FIPS-10Working principle diagram of flow dynamic image method particle size analyzer

table1:Technical Specifications

Wide detection range0.3nm - 3000μmThe detection concentration is as high as1*107/mL；

Professional remote zoom lens, eliminating morphological distortion, compatible with different sample types;

Specialized in LiofFIPSSuper resolution andAIOnly algorithms can ensure the accuracy of data;

Simultaneously provide all data such as particle size distribution, concentration, and morphology to achieve the most accurate statistics;

comply with21CFR Part11andGMPRequirements for data integrity.

IIIPartial test results display

1Sample information

image3A coagulation factor product

2Result Display

image4Partial image acquisition information recording

image5Particle Statistical Chart

The experimental results clearly show that the sample is mainly composed of two particle types, and the particle size distribution is also relatively uniform.YH-FIPS-10The flow dynamic image method particle size analyzer can not only obtain detailed information about the particle concentration in the sample, the proportion distribution of particles of different sizes, etcPSDInformation enables counting of sub micron to micron sized particles, as well as obtaining actual particle morphology information of the sample, achieving the most accurate statistics of particles. It can be widely used in various fields such as biomedicine, semiconductors, and new materials.

Yinhuang Technology( (YinHuang Technology))We are a high-tech company dedicated to providing testing and analysis equipment and technical services for industries such as pharmaceuticals, semiconductors, and chemical materials. We are committed to providing customers with comprehensive and accurate testing, analysis, and solutions. Our main products include insoluble particle analyzer, visible foreign matter inspection analyzer, raw liquid particle size andZetaPotential analyzer,CHDFHigh precision nanometer particle size analyzer, high-resolution nanometer particle size analyzer, solution color analyzer, clarity analyzer, etc., independently developed by the companyYH-MIPSeries Microscopic Counting Insoluble Particle AnalyzerYH-FIPSSeries flow dynamic image method particle size analyzer,YH-FIPSThe series of microfluidic imaging particle analyzers have been widely used in the fields of biomedicine, semiconductors, and materials chemistry.