Application of micro-nano laser particle size analyzer in research and industrialization of pharmaceutical preparations

Application of micro-nano laser particle size analyzer in research and industrialization of pharmaceutical preparations

The pharmaceutical dosage form is the form in which the drug is present and administered to the body. The research and application of this technology plays an extremely important role in medical practice and industrial practice, and plays a role in promoting the advancement of medical and pharmaceutical science. In recent years, new drug preparations have become an important growth point in the pharmaceutical industry. Jinan Weiner's efficient and reliable laser particle size analysis technology has been widely used in various aspects of pharmaceutical preparation research and production, accelerating the innovation and progress of domestic pharmaceutical preparation technology. .

First, the microcapsule:
Microencapsulation technology is a technology that is developing rapidly, versatile and mature in the world today. The process of preparing microcapsules is called microencapsulation, which encapsulates a solid, liquid or gas in a tiny capsule. The particle size of the microcapsules varies depending on the preparation process and the application. Theoretically, microcapsules of 0.1 to 1000 nm can be prepared. The preparation of the microcapsules includes physical chemical methods, physical mechanical methods, and chemical methods. Among them, the phase separation process in physical and chemical methods has become one of the main processes of microencapsulation of drugs. The process still involves some quantitative problems that cannot be quantitatively studied and is difficult to accurately evaluate, such as the ubiquitous microcapsule adhesion and aggregation problems. Products obtained by similar processes vary widely in particle size range and release data. The distribution of the particles is in the nanometer range, which cannot be detected by the general particle size detection technology. The WINNER801 nanometer particle size analyzer (the only nanometer laser particle size analyzer with independent intellectual property rights in China) is used to measure the particle size range of the microcapsules. The production process can be controlled to monitor whether the sensitivity of the microencapsulation reaction is appropriate, and small changes in conditions can cause controllability in the case of significant effects.
2. Microspheres Microspheres refer to microparticle dispersions in which a drug is dispersed or adsorbed in a polymer matrix. The drug can be dissolved or dispersed in the base layer of the polymer material to form a solid skeleton of the base layer type microspherical entity. The particle size is generally from 1 to 300 μm, or even larger. WINNER2005 wide-distribution laser particle size analysis can obtain a particle size distribution curve with an upper limit of particle size distribution up to 780 microns. The microscopic or electron microscope can be used to fully understand the distribution range and morphology of the preparation. The quality control of the microsphere system is of great significance.

Third, powder (powderinhalation)
A powder spray is a drug delivery system that delivers systemic or local effects in a dry powder form after being administered by a special drug delivery device. It has a targeted, high-efficiency, quick-acting, toxic side effect. Small and other characteristics. According to the different parts of the medication, it can be divided into nasal powder and oral (pulmonary inhalation) powder. Different dosing sites have different requirements on the particle size. For example, the lung inhalation powder requires the main drug particle size to be less than 5 μm, and the nasal powder particle size should be 30 to 150 μm. The quality study of powder is a particle quality check. WINNER3003 dry particle size analyzer is applied to the test of powder. Because it uses dry air turbulent flow dispersion technology for powder, it is especially suitable for powder test in response to water. Weiner's unique WINNER318 spray test particle size analyzer is specially developed for spray formulations, specializing in the testing of liquid mist drop type agents.
Fourth, the size and distribution of liposomes Liposomes particle size and distribution uniformity is related to its encapsulation efficiency and stability, directly affecting the behavior and disposal of liposomes in the body tissues. The particle size of the liposome is less than 100 nm, and the blood circulation time is longer. If the particle size of the liposome is more than 200 nm, the liposome is easily phagocytized by the macrophages as foreign foreign matter, and the circulation time of the liposome in the body. very short. There are many factors affecting the size and distribution of liposomes. It can be said that all factors affecting the stability of liposome aggregation are related to the particle size and distribution of liposomes. For the detection of liposome, Jinan micro-nano main particle size analyzer product WINNER2000ZD (distribution range: 0.1-300 micron) covers its distribution range, can quickly and easily display the particle size of liposome, can measure the average particle size, medium The particle size and distribution map can determine whether the particles are uniform and stable.

5. Liposomal ophthalmic drug system Liposomes are used as ocular drug delivery systems. The constituent materials are phospholipid bilayer membranes, similar to biofilms, which are easy to fuse with organisms and promote the penetration of drugs into biofilms. The trans-corneal transport efficiency of the external eye drops is relatively high; by selecting different preparation methods, the liposome has a particle size of 0.02 to 5 μm, and there is no foreign body sensation in the eye, which does not affect the normal physiological function of the eye.
The preparation of liposome ophthalmic administration systems is similar to that of general liposomes. The WINNER801 nanometer particle size analyzer (distribution range 0.001-5μm) should be sampled and analyzed after homogenization in quality control.
6. New emulsion stability emulsions are two immiscible liquids which are emulsified by a surfactant to disperse one liquid in another to form a non-uniform micro or nano dispersion system. Microscopic examination of the emulsion is carried out in this range, and the size and distribution of the emulsion microparticles can be determined by using a laser particle size analyzer. The micro-nano wet particle size analyzer WINNER2000/2005/2008 series all have a “free distribution” mode, which can reflect the bimodal distribution curve after two or more kinds of particles are dispersed and mixed, and visually observe the overall particle distribution through the distribution curve. And uniformity; common technical parameters can also be collected by using a distribution chart.

7. Nanoparticles Generally, the particle size of nanoparticles is defined in the range of 1 to 1000 nm. Nanoparticles that have been studied include polymer nano and nanospheres, drug bodies, lipid nanoparticles, nanoemulsions, and polymer capsules. It is still recommended to use the only nano-scale particle size analyzer WINNER801 (distribution range 1-5000nm).
For example, the oil phase can be obtained by using liquid paraffin to obtain an average particle diameter of 820 nm of nanospheres, and the average particle diameter of nanospheres of cottonseed oil is 560 nm.

Summary: With the rapid development of pharmaceutical preparation technology, new preparations are gradually transferred from laboratories to pharmaceutical production enterprises. Micro-nano laser particle size analyzer series products are widely used in many domestic and international pharmaceutical companies and research institutes. We are committed to popularizing laser particle size testing technology into the field of pharmaceutical preparations with the unique technical advantages of micro-nano in the laser particle size analyzer industry. Nano products have been recognized by more and more users in the pharmaceutical industry, and will play a greater role in the research and industrialization of pharmaceutical preparations.