Will the development of nanomedicine products cool down?

Release date: 2009-01-21

——Xu Yukui
Editor's note:
At present, there are different opinions of experts in various countries in the world for the rapid development of nanomedicine products. Some experts believe that in view of the potential harm of nanomedicine products, there is still no conclusion, so the development of this field should be cooled down; other scholars said that nanotechnology is used in medicine, medical equipment, sanitary materials and cosmetics production. The broad prospects cannot limit its development. In view of concerns about the risks of nano-products, the US Food and Drug Administration (FDA) recently announced that it will add a “Nanotechnology Management Office” within the FDA, which is responsible for overseeing and managing all of the FDA's management responsibilities. The listing and approval of nanomedicine products. At present, China's nano-pharmaceutical industry has just started, and these new ideas and new management trends are worthy of attention.
In recent years, the nanomedicine industry has been generally favored by countries all over the world. At present, there are hundreds of companies in the United States that are engaged in research on nanomedicine, nanomedical devices, and nano-hygiene materials. Related products include nano-preparation and nano-scale targeted drug delivery systems (such as nano gold particle drug delivery systems, etc.), nano-scale robots (which can be injected into blood vessels through syringes to treat targeted organs), nano drug-coated cardiovascular stents , nano drug coated membrane implanted heart valve. However, behind the nano-heat, the controversy is one after another.

Square:
The potential hazards are still unknown. Some nanotechnology experts pointed out that although nanotechnology has been widely used in other industrial fields, pharmaceuticals, medical devices, cosmetics and sanitary materials are special products directly related to human body safety. However, nanomedicine and other medicines are currently available. The safety of the product has not been fully evaluated.
At the end of 2008, at the “National Nanotechnology Symposium” held in Maryland, USA, FDA invited experts to raise many sharp questions about nanomedicine devices – does nanomedical device products comply with existing medical device quality management regulations? Is there a comprehensive evaluation parameter or screening tool to assess the safety performance of nanomedical devices and how to fully evaluate the safety of nanomedical devices? How to evaluate the nanomaterials (including nanometer-scale drugs) used in the field of "pharmaceutical-integrated" nanotechnology products, such as the pre-filled pen-shaped syringes such as the currently sold insulin pens and human erythropoietin (EPO) pens. The potential impact of nanoscale device materials on patients (such as changes in bioavailability, the extent of disease index such as blood glucose levels, etc.)? Experts also suggested that countries should develop a regulation on the use of nanotechnology for cosmetics as soon as possible.
According to the US Nanotechnology Research and Development Center, as of December 2006, the United States has been in the preclinical, mid-clinical or marketed nano-drug or nano-scale drug release preparations, more than 130 kinds, and the development, the upcoming listing and There are about 125 new nano medical device products on the market. Currently, clinical medical researchers have found that at least 77 of these products have potential carcinogenic effects. According to this, Dr. Rejek, Director of the Nanotechnology R&D Center of the United States, said, “It should be poured a little cold water to the development of new nanomedicine products that are in full swing. After all, the properties of pharmaceutical raw materials will be significantly changed after being processed into nano-sized ultrafine powders. Once applied to the human body, it is possible to have an unpredictable effect." A few days ago, the US Nanotechnology Research and Development Center officially submitted a nanotechnology research report to FDA decision makers. The FDA will organize experts to conduct a research evaluation of this report in the near future.

Opposition:
Nanotechnology can overcome medical problems Of course, the scientific community has different views on this. Other scholars say that any new technology has both prospects of risk and interest. So far, no new technologies have been discovered that have advantages and no risks. Nanotechnology is a new type of industrial technology that began in the early 1990s. Its application in the pharmaceutical industry started late, and it is inevitable that such problems will arise. People cannot limit the new application of nanotechnology in medicine because of certain problems. The nano drug delivery system under development is optimistic by many pharmacy experts. Since these drug delivery systems can greatly improve the bioavailability of poorly soluble drugs, it can solve some of the drawbacks of the current traditional drug delivery system, and some diseases that are difficult for the medical community are expected to be effectively treated.

trend:
FDA plans to introduce new management regulations In light of the controversy in the field of nanomedicine products, FDA policymakers are drafting a comprehensive application of nanotechnology to pharmaceuticals, medical devices, cosmetics and dietary supplements (health foods) on the above issues raised by nanotechnology experts. Management regulations - FDA nanotechnology pharmaceutical product application regulations. The FDA will also hold a hearing on the nanomedicine product legislation in Congress, which will invite US authoritative nanotechnology experts to testify.

It is understood that the FDA nanotechnology pharmaceutical product application regulations will include the following:
1. Production approval. All pharmaceuticals, medical devices, food additives, pigments, and biological products that use nanomaterials are subject to all existing FDA regulations.
2. Product certification before listing. The nanomedicine products produced by the company are in full compliance with the relevant provisions of the United States Pharmacopoeia. Nano medical device products meet the 510(k) requirements, and their evaluation speed can be accelerated, otherwise the product evaluation time will be extended.
3. Supervision after the product is listed. The FDA will be responsible for feedback and regulatory efforts on various adverse reactions following the launch of nanomedicine products. In the event of a major quality problem with the product, the FDA has the right to request the nanomedicine manufacturer to recall the product and inform the general public as soon as possible.
4. FDA will conduct regular inspections on various nano drugs, medical device products, and nano-biological products on the market, periodically or irregularly.

Related Links:
The so-called nanotechnology refers to a science and technology that studies, controls and applies nanomaterials. Specifically, there are two main types of nanotechnology: one is the technology of processing existing materials into ultrafine powders; the other is molecular-level nanotechnology. The former has been used in industrial production more than a decade ago, while the latter is a new technology that has just begun to be studied. (China Medical News)

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