Classification and packaging production of the mos

2022-08-26
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Classification and packaging production of pharmaceutical packaging materials in China

from pharmacy to Interpack, from chinapharm to the hot drug opportunities every year, pharmaceutical packaging has become one of the hottest topics. With the completion of GMP certification, after the fundamental guarantee of drug production quality, drug packaging has become an important means of competition for drugs, especially OTC products. At the same time, the emergence of soft capsules, freeze-dried powder injections, transdermal drug delivery, etc. also provides manufacturers with more choices. Therefore, let's look back on the past of pharmaceutical packaging and feel its future

pharmaceutical packaging, as the name suggests, refers to the packaging materials used for pharmaceutical products, which plays an important role in protecting the safety and effectiveness of drugs and facilitating transportation, storage, sales and use. With China's entry into WTO, more and more international pharmaceutical enterprises began to enter China, which not only intensified the competition in China's pharmaceutical industry, but also improved the quality and technical level of the whole industry

at present, the main pharmaceutical packaging materials mainly include the following categories:

rubber packaging materials

rubber is mainly used in the packaging of drugs in the form of plugs and gaskets of containers, which are divided into natural rubber and butyl rubber. Natural rubber has been eliminated due to common sealing faults 5: poor sealing performance, need to be supplemented by sealing wax, and unstable chemical properties. Butyl rubber has excellent sealing performance and is increasingly used in the packaging of antibiotic powder injections

metal packaging materials

are mainly used for the aluminum cap of powder injection packaging, the bottle body of paste and aerosol, and the medicinal aluminum foil of aluminum plastic blister packaging. Aluminum plastic composite cover has been accepted by more and more markets because of its convenient opening, safe and hygienic use. Aluminum aluminum packaging developed in recent years is a new packaging material with strong barrier, which can prolong the shelf life of drugs, especially for drugs with poor chemical stability

glass packaging materials

glass packaging materials are widely used in injection, powder injection, biological drugs, blood products, freeze-drying agents, oral liquids and other fields. Glass has good chemical stability, which is not affected by the atmosphere and is not decomposed by solid or liquid substances with different chemical compositions. The chemical properties and radiation resistance of glass can be adjusted by changing the chemical composition of glass. Moreover, glass is transparent, beautiful, cheap and recyclable, which will not cause environmental problems

composite packaging materials

mainly include plastic bottles for oral solids, plastic bottles for liquids, etc. These plastic bottles are mostly made of high-density polyethylene or polypropylene, polyester materials

overview of laws and regulations

drugs are special commodities, so their quality is directly related to people's health.? Looking at foreign pharmaceutical packaging, the laws and regulations related to packaging have relatively strict provisions. The Ministry of health of Canada has strengthened the management of Chinese herbal medicine and its products, and formulated a series of regulations, such as the food and drug safety administration act, the drug identification number administration act, to obtain the sports limit of low carbon steel by dividing the load value corresponding to the point by the original cross-sectional area of the test piece according to the popular rules of the sports limit of all materials by the light and cheap dynamic limit. It is stipulated that any product with therapeutic effect should be treated as a drug, and products that do not meet the health standards are not allowed to be listed. All Chinese herbal medicine products must apply for a drug license from Health Canada, that is, a drug identification number management license. In addition, the U.S. Department of agriculture has also made new regulations on the packaging of all imported products, including Chinese herbal medicine. All pure wood packaging materials must be treated with high-temperature fumigation or protective agents, otherwise all transported goods will be refused entry. France has stricter regulations on wood packaging, stipulating that all imported products are not allowed to use wood packaging. FDA has formulated corresponding laws and regulations for all links of drug sales, and stipulated that all drug-related materials should be subject to clinical scientific inspection. The content of drug labels must not only include the use of drugs, precautions for use by special groups (such as children, pregnant women, etc.), dosage instructions, use methods and time, but also indicate the side effects, contraindications and efficacy of drugs. Any label that does not meet the requirements of the regulations is recognized as a "false label", which is a serious violation of federal law

in contrast, although China promulgated and implemented the drug administration law in 1985, drug packaging materials have not been included in the scope of supervision and management due to the limitations of drug administration and insufficient understanding of drug packaging materials at that time. For a long time, the supervision and management of drug packaging materials in China has been using the former order No. 10 of the State Administration of medicine "measures for the production and management of drug packaging materials and containers". Due to the lack of legal basis for the implementation of industry management, the management is insufficient, resulting in the phenomenon of low quality and unlicensed production of drug packaging materials often found in the market, and there is no legal basis to punish; The promotion and application of high-quality drug packaging materials is slow, and the problem of backward drug packaging materials that affect the quality of drugs has been circulating in the market is difficult to solve

3. The influence of wood flour selection on the mechanical properties of products

in order to integrate with the international pharmaceutical industry, since the end of 1999, the State Food and drug administration has successively issued a series of laws and regulations to rectify medicinal materials, such as order No. 23 of the food and Drug Administration in 2000, "Regulations on the administration of drug packaging, labels and instructions" (Provisional), which not only standardized the standards of China's pharmaceutical packaging industry, but also unified the form of pharmaceutical packaging, In addition to improving the requirements for hygiene and protection functions, medical packaging emphasizes the convenience and scientificity of use; The measures for the administration of pharmaceutical packaging materials and containers (Provisional) strengthened the supervision and administration of pharmaceutical packaging materials and containers, and implemented a product registration system for pharmaceutical packaging materials; In 2001, the "Drug Administration Law of the people's Republic of China" added a chapter on "drug packaging and subpackaging", which made special provisions on pharmaceutical packaging. Including: the name, specification, manufacturer, approval number, batch number, main ingredients, indications, usage, dosage, contraindications, adverse reactions and precautions of the drug must be indicated on the label or instruction manual of the drug package

at present, China has gradually introduced a standardized standard system for the pharmaceutical industry, which has effectively promoted the improvement of product quality of drug manufacturers and drug packaging material manufacturers, but there is still a certain distance from international standards

production status

at present, China's pharmaceutical enterprises are mainly distributed in Jiangsu, Zhejiang and Guangdong. In terms of quantity and scale, pharmaceutical enterprises in Guangdong and Jiangsu and Zhejiang occupy a leading position. From the development of the past two years, the large-scale production of pharmaceutical enterprises is becoming more and more obvious, and the grade is also gradually improving. A development trend of modern pharmaceutical enterprises is that larger pharmaceutical factories are equipped with packaging enterprises themselves. In terms of packaging materials, there are two industrial models in the domestic pharmaceutical packaging industry, which have gradually emerged and are becoming the mainstream of the development of the industry: one is a powerful enterprise group represented by leading enterprises such as Lianyungang Zhongjin pharmaceutical packaging and Nanfang packaging; The other is Anbu in Guangdong, Xiongxian in Hebei, Jiangyin in in Jiangsu and Longgang in Zhejiang (the four are collectively referred to as the "four major production bases of flexible packaging in China"). Although the scale of local enterprises is generally small, they are numerous. These small enterprises gather together to support each other, form a strong joint force, and occupy a considerable market share. In general, the extensive growth with high speed, low efficiency and high consumption is a typical feature of the development of pharmaceutical packaging in China. The packaging quality of most domestic pharmaceutical products is low, and there is still a large gap with developed countries. It can be found from the following two data that at present, 65% of China's pharmaceutical packaging products are less than the level of developed countries in the 1980s, and the quality of packaging materials and the contribution rate of packaging to the pharmaceutical industry are low. In developed countries, pharmaceutical packaging accounts for 30% of the value of drugs, while the proportion in China is less than 10%. At present, for the domestic large-scale pharmaceutical packaging enterprises, there is little gap in equipment compared with foreign countries, but the software environment is very unsatisfactory

problems and deficiencies

now, the main problems in China's pharmaceutical packaging industry are as follows. First of all, the overall level of China's pharmaceutical industry is low, and the technology of pharmaceutical production enterprises is relatively backward. From the perspective of the scale of pharmaceutical enterprises, China's pharmaceutical enterprises are many and small, the repeated production of drugs is serious, and the management level of pharmaceutical enterprises is low. Secondly, the relevant regulations and technical standards of China's pharmaceutical packaging industry are backward. Although the regulatory standard system of the pharmaceutical industry has been gradually introduced, there is still a certain distance from international standards. The lack of industry standard system leads to the situation that the packaging of pharmaceutical products is mixed. Third, the technical level of pharmaceutical packaging machinery and materials is backward. Finally, there are drawbacks in the drug circulation system. Pharmaceutical products have been mainly sold in hospitals for a long time, and the drugs sold in pharmacies account for only a small part of the total. This situation restricts the direct participation of drugs in market competition, and the lack of market competition also restricts the development of pharmaceutical packaging

development trend

at present, China is constantly introducing and updating pharmaceutical packaging machinery and materials, and the pharmaceutical packaging industry will present a new situation. The diversification of drug types also brings diversification to the form of pharmaceutical packaging. In terms of chemical drugs, in recent years, the packaging of solid drugs in China, such as tablets, capsules and externally applied drugs, has been updated rapidly. At the same time, the use of disposable plastic syringes has brought a great change to the packaging and application of injections in China. The labels of ampoules, plastic bottles and small medicine bottles are directly engraved by laser to help build the next generation space system on the bottles. Glass containers are also laser engraved with English digital passwords, signs or various patterns, and then covered with colored bottle rings. Now 400 laser labels can be engraved per minute. The improvement direction of large infusion packaging is also moving towards the direction of composite flexible packaging bags and plastic bottle packaging

in terms of traditional Chinese medicine, in addition to the outdated production technology and the prejudice of European and American countries against traditional Chinese medicine, the failure of pharmaceutical packaging to implement national standards is also an important reason. The standard of traditional Chinese medicine (TCM) has been a barrier for TCM manufacturers to expand to overseas markets. From the perspective of the market, the culprit of the difficulty in exporting Chinese patent medicine is actually the problem of material selection rather than the packaging material itself. It is wise to choose the appropriate packaging material according to the characteristics of the drug itself. In particular, plastic hollow containers for traditional Chinese medicine should be made of HDPE, PP, pet, pen and other materials, and plastic hollow containers made by injection blow molding and other molding processes. The mouth of the hollow container is sealed with aluminum foil electromagnetic induction gasket to enhance the safety protection of drugs, and speed up the promotion and application of plastic composite membrane bag packaging of traditional Chinese medicine

finally, the safety of drugs should not be ignored, especially how to reduce accidents caused by children's exposure to drugs or misuse of drugs. Statistics show that 30% of child deaths in many countries are caused by misuse of drugs. Moreover, the government legislates to control all blister packaged drugs, because the packaging of these drugs is similar to that of many candies, which requires special attention from manufacturers

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