What Are Microparticles?

Microparticles refer to extremely fine particles, including molecules, atoms, ions, etc. that are not visible to the naked eye, and combinations thereof. For example, Newton believed that light is a kind of particle, called a particle called light. In clinical medicine, particles can cause clinical harm. China's Pharmacopoeia's regulations on microparticles are only equivalent to those of the US 83 edition. The pore diameter of infusion filter media used in China is generally 15 microns, which has almost no effect on the retention of 6-10 microns in diameter. Adverse reactions and long-term effects of infusion are inevitable. Of course, there is also a precision infusion device, which can limit insoluble particles to less than 5 microns. Clinical experiments using cellulose filters on some common infusion sets have proven that fiber shedding can cause self-contamination, and adsorption can reduce drug efficacy. The longer the infusion time is, the more severe the detachment is, and the filtering ability is also reduced.

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Particles, particles are extremely small

In the 1950s, many scholars reported the harm of microparticles in infusions and made a preliminary discussion on the pathogenesis of microparticles in humans. The results of studies over the next few decades have repeatedly confirmed that the clinical response caused by the infusion was due to the infusion of harmful particles into the blood vessels while infusion of the drug solution.

In the 1960s and 1970s, the phenomenon of microparticles causing clinical harm was widely accepted by the medical community in advanced countries. Researchers have given it a formal name-insoluble particles. These harmful particles, which enter the medicinal solution from various channels during the production or operation process, are between 2-50 microns in diameter, are invisible to the naked eye, move, and cannot be metabolized in the body. Entering blood vessels can cause acute, subacute, and chronic infusions. Pollution disease.

For different situations, adverse reactions to infusion can be divided into short-term and long-term. The recent response is immediately visible. A large number of particles enter the blood vessels during the infusion. Some people will appear during or after the infusion.

A. Microparticles produced in the production process: During the production process, many stages will cause contamination of the medicinal solution to different degrees, especially Chinese herbal medicine preparations. Due to the limited purification process, there are a lot of intolerances in the medicinal solution.

Microcirculation disorders when particles are larger than microvascular diameter

Capillaries in adults are 6-8 microns, while capillaries in infants are only 3 microns. in

Pharmacopoeia Regulation Microparticle Control Index

1. What is infusion pollution disease?

It is a consequence of the super-standard amount of "insoluble particles" input into the human body during infusion.

2. Why does the qualified sterile liquid still appear contaminated?

Researchers have done a lot of work on the source of microparticles, and it can be seen that the source of infusion pollution exists in various aspects, such as: carbon black microparticles are produced during the production of medicinal liquids, etc .: colloidal microparticles in Chinese herbal medicine preparations; clinical operations produce: rubber Particles, plastic particles, glass debris particles generated when the ampoule is opened; Addition of drugs (mixed drugs): crystal particles, the more times and types of mixed drugs, the more particles appear; the infusion environment produces: hair debris, dust particles, fibers Microparticles such as pigments; when the storage time and storage conditions of the medicinal solution are unfavorable (such as being unable to effectively protect from light): crystalline particles, cellulose particles; fat plug particles in the whole nutrient solution used by heavy patients.

3. Can the particles be exchanged out of the body by the kidneys?

Only particles with a diameter of less than 2 microns can participate in the exchange with the kidneys and be excreted from the body. So we not only control the number of particles, but also the size of the particles.

4. What is the difference between vascular damage caused by insoluble particles and arteriosclerosis caused by hyperlipidemia?

Most of the lesions caused by insoluble particles are in the terminal arteries, which are commonly referred to as thickening and fibrosis of the inner layer of the nourishing arteries, which are not atherosclerosis of the large and middle arteries of hyperlipidemia.

5. How can I achieve a safe infusion?

Strict implementation of aseptic, pollution-free operation specifications. Use a dispensing hopper when injecting drugs. Strictly check the storage time, dissolution time of injectable preparations, and drugs that need to be protected from light should be protected from light. There should not be too many types of drugs when dispensing, and more attention should be paid to the compatibility of drugs. For Chinese herbal medicine injections, it is necessary to strictly control them. They cannot be used for intravenous injection and must not be used as infusion medication. For departments that require repeated infusion treatments and are prone to infusion reactions, such as: operating room, ICU CCU, chemotherapy room, infants and children's ward, it should be as good as possible when intravenous infusion. Under stress, epinephrine, adrenaline, and high-molecular substances (insoluble particles, polysaccharides) trigger microcirculation disorders within hours or days. When injecting contrast agents, injecting spinal sheath anesthesia, and hemodialysis, special precision filter infusion devices must be used to ensure safe infusion.