Endoscope Storage Cabinet,Endoscope Cabinet In Hospital,Cabinet For Endoscope,Innerspace Endoscope Storage Cabinets Taizhou Gaogang District Dixin Medical Equipment Co., Ltd. , https://www.dixinmedical.com
Injectables have been widely used in clinical practice because of their rapid efficacy, accurate dose and reliable function. Especially in the rescue of patients with critical illness such as coma, convulsions and convulsions, the drug solution can be directly injected into the blood circulation by intravenous injection, which quickly works. It has always been the first choice in clinical emergency medicine. The development of injections has been more than 100 years old, and the annual consumption in China is about 40 billion.
With the large-scale use of injections, the potential adverse reactions of pyrogens in clinical application have attracted people's attention. Moreover, the injection of microparticles as an important indicator of safe medication is gradually attracting attention.
Concept 2 fine particles and harmful Pharmacopoeia requirements <br> <br> particle injection means is generated via various routes in the production and use of fine particulate impurities. Injectables may be brought into fibers, glass swarf, carbonized blocks, metal particles, etc. during the production process. In the course of clinical use, particles such as fibers, rubber swarf, and insoluble materials compatible with the liquid may be generated.
A large number of animal tests and human anatomy have proven that particles can cause potentially serious hazards that are difficult to detect at one time. The microparticles in the injection mainly cause the following hazards: (1) The fibers contained in the injection tend to enter the pulmonary capillaries with the blood during the infusion, causing the proliferation of macrophages and causing granuloma. Granuloma is a proliferative reaction of the body, which can directly interfere with the functions of organs such as lungs, spleen, brain, heart, liver, kidney, etc., and even life-threatening; (2) glass chips, colloidal particles, etc. can also enter the blood vessels in clinical practice. Causes harm. In 1981, China's "Pharmaceutical Bulletin" reported a case in which a hospital in Beijing added sulfadiazine injection to 10% glucose infusion, which precipitated drug crystal particles due to pH change, causing death due to vascular failure around the patient; (3) containing rubber Injections of microparticles such as chips and fibers are intravenously administered to rabbits. As a result, the body temperature of the rabbit changes, which may be a pyrogen-like reaction caused by microparticles; (4) The metal contained in the injection is mixed into the infusion, which may cause osteosarcoma and cancer. (5) Excessive particles in the infusion can cause thrombosis, causing local blockage and insufficient blood supply, tissue hypoxia and edema, causing phlebitis.
As early as the 1930s, many scholars reported the harm caused by particles. In the late 1960s, reports on particle damage increased sharply, and the scope of research was becoming more extensive and deep. In the 1970s, particles caused clinical The point of view of harm has been generally accepted by the medical community. Scholars have studied the method of particle removal, set limits and officially entered the National Pharmacopoeia.
In the 2005 edition of the Chinese Pharmacopoeia, the particles in the injection are divided into two steps according to the particle size, and both the foreign matter inspection and the insoluble particle inspection can be seen. It can be seen that the inspection of the foreign matter is checked one by one for the finished product of the injection, and the inspection of the insoluble particles is carried out to check the size and quantity of the insoluble particles of the sample taken by the injection.
It can be seen that the foreign matter refers to an insoluble substance which is visually observed under the predetermined conditions in an injection or an eye drop, and its particle diameter or length is usually >50 μm. Pharmacopoeia stipulates: Before the injection of the injection product, it should be checked one by one and the unqualified product should be removed at the same time. At the same time, it is stipulated that injections such as solution-type intravenous injections should not detect visible foreign objects such as metal chips, glass swarf, length or cilia and lumps with a large particle size of more than 2 mm, and no smoke should be detected when rotating. Particle column. For example, if only one of the other visible foreign objects (such as short-fiber hairs and points, blocks, etc. of 2 mm or less) is detected, only 20 other samples should be retested, and no test should be taken.
Insoluble microparticles refer to microparticle impurities contaminated by various routes in production or application. The particle size is between 1 and 50 μm, and it is a non-metabolic harmful particle that is invisible to the naked eye and is easily movable. The Pharmacopoeia stipulates that the solution type intravenous injection must be inspected for the size and quantity of insoluble particles after the visible foreign matter inspection meets the requirements. At the same time, it is stipulated that: the volume of intravenous injection below 100ml, the sterile powder for intravenous injection and the concentrated solution for injection, unless otherwise specified, the particles containing 10μm or more in each test container shall not exceed 6000, including 25μm. The above particles must not exceed 600.
It can be seen that the Chinese Pharmacopoeia specifies that the insoluble fine particles contained in the injection are: 50 μm or more is necessary to be detected, and 50 μm or less is limited.
In recent years, the state has paid more and more attention to the inspection of particles contained in injections. The "Chinese Pharmacopoeia" 2005 version of the implementation of the injection particle detection method from the "clearness inspection rules and judgment criteria" revised to "visible foreign object detection method." On July 13, the National Bureau issued a supplementary regulation to re-specify the visible foreign matter acceptance criteria for injections such as solution-based intravenous injections.
In the national drug sampling inspection in 2009, a batch of Yinzhihuang injection produced by a pharmaceutical company in Jiangsu was found to be unqualified. In this regard, the State Bureau ordered it to stop production and recall the Yinzhihuang injection that has been sold. Some batches of pantoprazole sodium for injection in a pharmaceutical company in Jilin can be found to be inconsistent with the regulations and notified by the national bureau. The provincial and municipal food and drug administrations also conducted frequent sampling of visible foreign bodies on the injections circulating in the market. It can be seen that the foreign body inspection in the injection is very critical for both the patient's safe medication and the normal production of the pharmaceutical manufacturer.
3 <br> <br> visible foreign matter inspection method according to the pharmacopoeia, visible foreign matter inspection injections must be checked one by one and the same time eliminate substandard products, which requires drug manufacturers have this quality index for industrial inspection of large quantities. The Chinese Pharmacopoeia 2005 edition stipulates that the visible foreign matter inspection method is divided into two types: the light detection method and the light scattering method. Light scattering methods should be used for varieties that are not suitable for lamp inspection (such as those packaged in colored transparent containers or those with darker liquid color).
3.1 Light detection method detection principle: visual discrimination.
Inspection method: The operator whose visual acuity meets the requirements of the Pharmacopoeia standard examines the contents of the injection one by one under the light detector under visual illumination at a certain light intensity in a dark room.
Disadvantages: The light inspection personnel have different visual acuity, different test results, and the quality is not uniform; the operator's eyes are easy to fatigue, easy to be misdetected or missed; the long-term work has certain damage to the operator's eyes, and the employees' ideological pressure is high, which may cause quality fluctuations. , resulting in missed inspection; low production efficiency, about 1,500 to 2,000 inspections per person per hour, is a large-scale production capacity bottle diameter.
3.2 Light scattering method detection principle: When a monochromatic laser irradiates a solution, the insoluble matter present in the solution scatters the incident light, and the scattered energy is related to the size of the insoluble matter. The method checks the visible foreign matter by measuring the light scattering energy caused by the insoluble matter in the solution and comparing it with a prescribed threshold.
Inspection method: The test sample is sent to the rotary bottle device through the upper bottle device, and the test product is rapidly stopped after rotating at a high speed along the vertical central axis for a certain time on the rotary bottle device, and the uniform laser beam emitted by the laser light source is irradiated on the test sample. When the vortex of the liquid medicine disappears substantially, the liquid medicine in the bottle continues to rotate due to the inertia, and the image collector continuously photographs the scattered light energy caused by the insoluble matter suspended in the rotating liquid at a specific angle; the sequence image of the collected data processing system The processing is performed, and then the presence or absence of a certain amount of insoluble matter is automatically determined according to a preset threshold value, and the detection result is recorded, and the lower bottle device is instructed to automatically separate the qualified and unqualified test articles.
The light scattering method is the detection principle of the fully automatic light inspection machine that people often say. The automatic light inspection machine is a kind of testing equipment integrating electromechanical technology. Compared with the manual light detection, it has very obvious advantages: all particles above 50μm can be detected, which fully meets the requirements of the pharmacopoeia; the quality of the finished product is stable and non-existent. Fluctuation in quality can reduce quality risks; large-scale industrial production can be realized; the cause of failure can be preserved for each defective product, and the data analysis can better optimize the injection production process.
4 automatic comparison <br> <br> automatic light inspection machine zui light inspection machine early development in Europe, pharmaceutical companies and put into use in the 1960s. Because it is a high-end equipment integrating light source generation system, visual recognition system, image processing system, calculation and analysis system, and high-precision machinery manufacturing, the price is relatively expensive, and the current usage in the world is about 2,000. However, due to many unsolvable problems in manual light inspection, more and more enterprises tend to use automatic light inspection machines instead of manual light inspection.
At present, there are two major technology camps in the field of light inspection machines: one is the SD detection method of Japan Eisai, and the other is the high-speed camera detection method of European Pharmaceutical Machinery. There are also many high-tech companies in China that are doing research and development work on fully automatic light inspection machines. Their detection principle and performance comparison are shown in Table 1.
project Japanese Eisai European company Domestic company Detection method SD detection Continuous camera detection Continuous camera detection Detection principle The container and the liquid inside are rotated at a high speed to stop rotating the container, the liquid inside continues to move, and the particles move with the liquid; through the collecting lens, the foreign object shadow of the container is accurately projected on the DA sensor, causing a voltage change. , to determine whether there is a foreign object. The container and the liquid inside are rotated at a high speed to stop rotating the container, the liquid inside continues to move, and the particles move with the liquid; the central mirror moves synchronously with the conveyance of the container; the image continuously emitted by the camera transmits image processing The particles are overlapped and contrasted with each pixel, and the particles whose position is changed are considered to be foreign objects. The container and the liquid inside are rotated at a high speed to stop rotating the container, the liquid inside continues to move, and the particles move with the liquid; the central mirror moves synchronously with the conveyance of the container; the image continuously emitted by the camera transmits image processing The particles are overlapped and contrasted with each pixel, and the particles whose position is changed are considered to be foreign objects. Sensitivity Method for adjusting voltage Standard test content Swarf, fiber, carbonization in liquid Swarf, fiber, carbonization in liquid Swarf, fiber, carbonization in liquid examination range Ampoule, vial Ampoule, vial Ampoule, vial Optional detection station Bottle mouth carbonization Bottle mouth carbonization (dynamic measurement) Optional test content Bottle mouth bubble Bottle mouth bubble (static measurement) Detection speed 300 bottles / min 300 bottles / min 300 bottles / min
5 automatic light inspection machine application status and problems
Although the automatic light inspection machine is expensive, it has many advantages compared with manual light inspection, and has many users in China. Some well-known domestic enterprises such as Wuhan Institute of Biology, Chengdu Institute of Biology, Zhengda Youthbao, Yunnan Baiyao, Lianyungang Kangyuan, Nanjing Jinling, Yangzijiang Pharmaceutical, etc. have been used. The quality of their medicines is also more reliable, and people are safer to use. However, the fully automatic light inspection machine is a mechanized operation, which is executed according to the set procedure. There are still some problems in the application process: (1) Water mist occurs on the upper part of the bottleneck of the injection, which will seriously affect the inspection result, resulting in errors. The increase of the judgment rate; (2) the bubble generated by the liquid has an influence on the detection of visible foreign matter, resulting in missed detection or misjudgment; (3) the relatively light internal carbon floating in the liquid is mixed with the bubble, resulting in the inner The rate of missed detection of carbon is relatively high; (4) The internal carbonization caused by injection sealing must be increased by corresponding detection function; (5) The metal particles contained in the injection can not be detected, and the pharmacopoeia has no corresponding limit index. .
6 conclusion
With the further development of camera technology and further in-depth study of visual recognition technology, some problems in the application of automatic light inspection machine will be solved. With the large-scale industrial production of automatic light inspection machine, the price will not be It is so expensive, I believe that in the near future, injection manufacturers will be popularized.
Brief introduction of injection particle inspection method and equipment application
Advantages and use status of 1 injection
Table 1 Comparison table of detection principle of automatic light inspection machine at home and abroad
Next Article
How to prevent quail eggs
Prev Article
Two Prevention Experiences of Meat Pigeons