Wang Huasheng, Song Yuli Abstract: Objective To reduce and control the potential and long-term harm of insoluble microparticles entering the human body with liquid infusion during intravenous infusion, intravenous bolus injection and intramuscular injection. Methods The pre-clinical simulation test was used. The drug injection filter was used in the infusion set and the syringe terminal for clinical observation. There were no local or systemic adverse reactions for 24 hours. Results The clinical use of the drug injection filter effectively prevented and reduced the harm caused by insoluble particles to the human body; its rejection rate can reach 95% of the average effective filtration rate of the filter's nominal pore size insoluble particles. Conclusion Clinically, the drug injection filter is used to effectively test the insoluble microparticles with the infusion and injection therapy into the human body, and the purpose of purification treatment is achieved.
Key words: drug injection filter; insoluble particles; purification treatment intravenous infusion, intravenous bolus injection, intramuscular injection plays an important role in clinical treatment. They are not only an important means of supplementing body fluids, but also an effective measure for supplying various nutrients in the body, and also a necessary way to combine drugs. At present, with the continuous development of medical technology, clinically, there are more and more types of drugs injected into the human body through intravenous infusion, intravenous bolus injection, intramuscular injection, etc., and the combined use of drugs is also increasingly widespread. Since the first discovery of microparticles in Australian infusions in 1962, the "Insert Large Infusion Symposium" held in Washington, DC, in 1966, publicly addressed the problem of infusion particles, and the insoluble particles in the infusion have drawn attention.
1 Pollution path of particles in infusions Insoluble particles are particles that are insoluble in water, cannot be metabolized by the body, and are invisible to the naked eye. There are mainly rubber plugs, carbon particles, calcium carbonate, zinc oxide, clay, paper scraps, cellulose, glass shavings, metal shavings, bacteria, fungal spores and pharmaceutical micro-products. In the infusion production, with the continuous strengthening and improvement of modern production management methods and new technology applications in recent years, the quality of infusion has been greatly improved, and will not be discussed here. It mainly analyzes the heterogeneous particle pollution caused by many aspects such as operation, preparation, environment and combined use in clinical infusion, which should be paid enough attention.
1. 1 Contamination of foreign matter particles during infusion preparation operation During the clinical infusion preparation operation, foreign matter particles invisible to the naked eye are infiltrated due to intubation, venting, and cutting of ampoule, so that foreign particles in the infusion are significantly increased. In particular, foreign bodies and cellulose below 50 μm, in which the rubber plugs caused by needle insertion or disposable infusion bottle insertion needles are one of the important reasons for contamination of foreign bodies. The contamination rate is as high as 54.19% to 73%. The needle is inserted into the needle with a 16-gauge needle. The chipping rate of the rubber plug can reach 43.3%.
1. 2 Different infusion methods are used for particle contamination caused by infusion methods, and the degree of particulate foreign matter contamination is also different. Yu and Chen’s studies have shown that closed-type infusions contain more particles than open-type infusions, and closed-type infusions with ≥10–25 μm particles are open-ended 162% because of conventional closed infusions. The reason for the pressure difference between the inside and the outside of the bottle is 500 ml of liquid per 500 ml of liquid input into the bottle, which can bring more than 40,000 particles of 0.5 μm into the infusion, and 20,000 of 1 μm.
1. 3 Air and environment in the ward The particle in the infusion contains a large amount of dust, fiber and bacteria in the air. When infusion, it can contaminate the liquid with the inlet pipe at any time [1]. Some people in China have tested that the dust in the air before and after infusion can increase the contamination of the liquid by 40,000 times. When the liquid is infused, the remaining liquid is cultured, and the positive rate is as high as 71%. It can be seen that the particles in the infusion are significantly increased before the infusion.
1. 4 particulate contamination of infusion devices At present, some hospitals still use infusion bottles, latex tubes and cloths, and repeatedly use them to treat glass bottles and hoses for depyrogenation, strong acid and alkali. The glass bottle fission drops the fiber and the rubber tube aging slag, the cloth fiber falls off, the air in the operation room contains dust, fiber and other serious pollution; there is no need to wash with clean distilled water or only use ordinary water to rinse and sterilize methods exist. Particles are produced. It can be seen that the infusion set is the main way to bring in foreign particles. As early as the 1970s, it was proved that the infusion device is the main link that causes the increase of foreign matter in the infusion.
1. 5 The particulate contamination introduced by the addition of drugs in the infusion has not been stipulated by the injection and powder for many years. This inevitably brings insoluble particulate contamination to the infusion. It can increase the particles in the infusion by tens to hundreds of times than the original infusion, and more seriously, it also brings in foreign matter visible to the naked eye. The more liquid is added, the more foreign particles are added. Clinically, 95% of the infusions are added with 1 to 2 drugs, and more than 10 are used. More powder is added than the powder added to the injection. The former is 4 to 5 times that of the latter, and the foreign matter of 50 μm or more is also greatly increased.
2 Insoluble particulate hazard The visible small particles of zui are all above 50 μm. The diameter of human capillaries is 7 to 12 μm. When the diameter of the microparticles is larger than the diameter of the capillaries, the capillaries are blocked, causing severe reactions such as vascular granuloma and necrosis. The hazards are summarized as follows:
2. 1 Caused by pulmonary granuloma and pulmonary edema It was reported that in 201 children with autopsy of pulmonary granuloma, 19 cases were found to be caused by fibers and microparticles. The fibers and microparticles in the infusion enter the pulmonary microvasculature to cause macrophage to proliferate and form granuloma. What these cases have in common is that they have received a large number of intravenous infusions. Therefore, the consequences are caused by fibers and particles in the infusion solution.
2. 2 The causes of phlebitis caused by phlebitis infusion are various. Such as infusion agent osmotic pressure, the drug itself is irritating to blood vessels, but more importantly, too much particles in the infusion agent cause thrombosis, causing local blockage and insufficient blood supply, resulting in tissue hypoxia to produce edema and inflammation. If the infusion solution is filtered through a 0.2 μm microporous filter and then imported into the human body, the incidence of phlebitis is reduced from 62% to 23.3%, which confirms that the amount of microparticles in the infusion is related to the occurrence of phlebitis.
2. 3 Causes allergic reactions In 1995, Jones reported that microparticles can cause antigenic effects. In addition, the carrier liquid crystal particles, polymers, degradants and other foreign matter contained in the carrier infusion can react with tissue proteins at the injection site, causing allergies. reaction.
2. 4 The local tissue thrombosis and necrosis of the pulmonary capillary diameter is only 6 ~ 8μm small, if the input particle diameter exceeds the diameter of the pulmonary capillary, it can directly block the pulmonary capillaries. In addition, the microparticles can also adhere to the surface of blood cells, forming a thrombus, causing death of the pulmonary infarction. Insoluble particles are more likely to cause clogging in small blood vessels of the brain, lungs, kidneys, eyes, etc., causing varying degrees of necrosis and damage.
2. 5 cause tumor formation or tumor-like reaction. Because this reaction can not be immediately expressed, it is often overlooked, especially asbestos particles, which can often cause lung cancer. When a large amount of insoluble particles enter the human body, it can directly cause leukemia or leukopenia. It can also cause various other cancers.
3 The significance of the clinical use of the drug injection filter is summarized above. In the treatment of large intravenous infusion, intravenous bolus injection, intramuscular injection, the source of the microparticles is multi-faceted, which brings potential harm to the patient, sometimes Even a direct hazard. From the perspective of strengthening hospital management, improving infusion, injecting equipment, and strengthening management of clinical practices, it is unrealistic to completely eliminate infusions and injections of Chinese medicine liquid particles. At present, the terminal filter equipped on the disposable infusion set limits the particle size of the terminal filter and the large infusion to 15-20 μm due to the influence of the intercepting area and the material flow rate and the large infusion production conditions, etc., and the trapping infusion is not achieved. Particles that are harmful to the human body. Therefore, the significance of using the liquid medicine injection filter is to effectively remove the harmful particles in the infused liquid, and purify the medicine injected into the human body, thereby reducing the potential harm of the particles to the patient or directly Harm to achieve the purpose of treatment.
3. 1 Injection filter performance The current domestically developed injection filter uses advanced nuclear pore filter membrane as the filter medium, which has the advantages of large flow rate and high precision. Its specifications are mainly 25cm and 13cm in diameter. The filter has a pore size of 0. 2μm, 0.4 μm, 0.8 μm, 1.0 μm, 2.0 μm, 3.0 μm, 5.0 μm, and other seven specifications. The shell material is made of medical hygienic grade plastic, which adopts AS, ABS and PVC materials respectively. It is selected by the user according to the size of the particles retained during use. The outer casing material is packaged with medical grade plastic and medical wrapping paper. The mark on the packaging conforms to the national standard for disposable medical supplies [2]. It is sterilized by ethylene oxide or 60Co, and the shell is complete and burr-free, which is comparable to similar foreign products. The simulation test was carried out before clinical use, and the rejection rate was 95% of the average effective filtration rate of the filter's nominal pore-insoluble particles.
3. 2 Purpose and method of clinical use The purpose of clinical use is mainly to effectively prevent and reduce the harm caused by insoluble particles to the human body, and to ensure the safe use of infusion therapy and injection therapy in clinical practice. Generally, the clinical use of 25 A, 13 A of 1.0 to 3. 0 μm is provided on the syringe for intravenous bolus injection and intramuscular injection, 25 A, 13 A of 3. 0 ~ 5. 0 μm is equipped in the infusion set terminal for intravenous Infusion.
3. 3 The effect of clinical use The injection filter is in a single package. In clinical use, the outer packaging is opened. 25 A1. 0 μm is equipped with a syringe for intravenous bolus injection or intramuscular injection without resistance [3]; 25 A 3. 0μm is equipped at the end of the infusion set for intravenous infusion, fully meets the clinically required flow rate, no air leakage, leakage, no air blockage, easy to vent, clinical observation for 24 h no local and systemic adverse reactions .
4 Conclusion In the clinical use of liquid filter, the purpose is to effectively intercept the insoluble particles in the intravenous infusion, intravenous bolus injection, intramuscular injection, to achieve purification treatment or filtration sterility, to ensure the safety of clinical use and reliability. The clinical use of liquid medicine injection filters will play an important role in the health and medical care of our people.
Article from: China Filter Network
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