The hottest new challenge of drug packaging

2022-10-04
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New challenges of drug packaging

the development of China's pharmaceutical packaging industry has been an extensive growth with high speed, low efficiency and high consumption. The packaging quality of most pharmaceutical products is low, and nearly 70% of the pharmaceutical packaging cannot reach the international level. The State Food and drug administration plans to organize the production of 95% of the pharmaceutical packaging products that directly contact drugs according to national or industrial standards by 2010, of which 80% of the products have reached the domestic or foreign advanced standard level; For the eight major drug formulations, the domestic satisfaction rate of pharmaceutical packaging is more than 95%

in this increasingly open global competitive environment, in order to better improve core competitiveness and meet new challenges, we must strengthen the following aspects of work

improve the corresponding regulations and standards

◆ health standards and corresponding supervision and testing systems should be introduced as soon as possible

taking PVDC film as an example, since the 1970s, the United States and Japan have carried out multiple tracking and sampling inspections of PVDC film for drug packaging, and a large amount of data have been accumulated on the residual amount of monomers and the amount of monomers in contact with drugs transferred to drugs, while China has not promulgated the health standards for PVDC film (used for drug and food packaging), This will leave a gap for fake and inferior commodities and directly endanger the high barrier drug packaging. Secondly, some imported or domestic PVDC raw materials are declared to comply with FDA standards, and some only declare to comply with their own industry standards. For example, Japan meets the PL specification, and the detailed rules will not be disclosed. This not only does not guarantee the health and safety of drug packaging, but also lacks data on the impact of processing on the environment

◆ the regulations and management system of drug packaging and labeling are relatively backward

before 2000, China's law on drugs was only the drug administration law, but there were no unified provisions on the packaging, labeling and instructions of drugs, and various enterprises wrote by themselves, which was relatively chaotic; Some enterprises even print misleading patterns and ingredients on labels. Serious adverse reactions occur from time to time due to unclear labels and instructions or incomplete information. The case of "carbamazepine" in 1995 is a typical example. With the implementation of the classified management system of prescription drugs and over-the-counter drugs, some experts have called for the revision of the relevant provisions of the drug administration law and the formulation of a special drug packaging and Labeling Law in recent two years, so as to strengthen the supervision and management of drug packaging and integrate with the international community as soon as possible. For this reason, the State Drug Administration published the "measures for the administration of materials and containers for drug packaging (Provisional)" (order 21) and the "Regulations on the administration of drug packaging labels and instructions" (order 23) in 2000, which made detailed provisions on drug packaging. Although they are not very satisfied, they have made a big step forward after all. In terms of drug packaging label management, we can learn from the FDA's evaluation standards for drugs. Compared with the previous two months, the drug label must not only include the use of drugs, precautions for use by special groups (such as children, pregnant women, etc.), dose instructions, use methods and time, but also indicate the side effects, contraindications and efficacy of drugs. Any label that does not meet the specified requirements is recognized as a "false label", Is a serious violation of federal law

it is urgent to package anti-counterfeiting medicines

medicines are special commodities to prevent and treat diseases and ensure people's health, but what is shocking is that there are often reports of all kinds of fake medicines cheating people in the media. Since 1998, the country has investigated and dealt with manufacturing and sales. There have been more than 280000 cases of fake and inferior drugs, with a total value of 1.8 billion yuan. 3088 dens for the production and sale of fake drugs have been destroyed, 116 illegal market markets have been banned, and more than 40000 unlicensed businesses have been operated, effectively curbing the momentum of the production and sale of fake and inferior drugs and severely cracking down on the arrogance of counterfeiters. However, we should also be clearly aware that the packaging of most drugs in China is very simple. Some of them only stick anti-counterfeiting labels on the outer packaging box, and do not use advanced technology in the manufacturing and printing of the box, which objectively provides convenience for counterfeiters. In Germany, there are nearly ten kinds of anti-counterfeiting signs on a palm sized medicine box. It uses anti-counterfeiting signs that can be recognized by the naked eye, such as microfilm, glazing and gravure printing technology on banknotes, as well as anti-counterfeiting signs that can be seen only with special lenses. At present, there are seven categories of technologies that can be used for pharmaceutical anti-counterfeiting, including digital anti-counterfeiting, ink anti-counterfeiting, paper anti-counterfeiting, special printing anti-counterfeiting, nuclear track anti-counterfeiting, biological anti-counterfeiting, etc., but some technologies have not been adopted by Chinese pharmaceutical enterprises, such as DNA anti-counterfeiting technology often used by pharmaceutical enterprises in developed countries in Europe and the United States

objectively speaking, China's pharmaceutical enterprises are still relatively backward in anti-counterfeiting packaging technology. Although they gradually have a deep understanding of the importance of packaging anti-counterfeiting, they still invest less in specific technology. The following are the anti-counterfeiting measures and investment scale of several famous large pharmaceutical enterprises in China

this is the standard practice of Beijing Shuanghe Pharmaceutical Co., Ltd.: it used to use planar laser anti-counterfeiting, but the technical content is not high, and it is easy to be imitated. Since last year, three-dimensional laser anti-counterfeiting has been adopted. The technical content and anti-counterfeiting effect are better than plane laser anti-counterfeiting, but unfortunately, it is difficult for consumers to identify the authenticity through this anti-counterfeiting method. The annual investment is over one million yuan

Jilin Aodong Pharmaceutical Co., Ltd; In the past, laser anti-counterfeiting technology and digital anti-counterfeiting technology were used, but the company was not satisfied with its effect. Since last year, we have combined digital anti-counterfeiting with laser anti-counterfeiting to double anti-counterfeiting and crack down on counterfeit products. Although the cost has increased, the effect is remarkable. The annual investment is nearly one million yuan

Shandong Dong'e Ejiao Co., Ltd.: since 2000, digital anti-counterfeiting has been adopted, with an annual dosage of about 200million labels and an annual investment of nearly 7million yuan

Guangxi golden throat Pharmaceutical Co., Ltd.: it first adopted laser anti-counterfeiting technology, and later used anti-counterfeiting. Now it is ready to adopt film pressing anti-counterfeiting, with an annual investment of more than 1 million yuan

take the road of packaging automation

the equipment designed and manufactured by foreign companies can accurately transport containers, covers and items of various shapes and structures to the rotating disc, with the same arrangement state and direction, and then transport them to the next packaging program. The equipment is cleverly designed and practical. We can also produce a complete set of filling and packaging production lines according to the needs of customers

most of the packaging work of domestic pharmaceutical factories, especially the arrangement and assembly of more complex packaging items, is basically manual operation. Many operators not only cannot guarantee the unity and stability of packaging, but also will cause pollution to the packaged products. Improving the automation level and quality level of packaging is a very important link for modern pharmaceutical enterprises to implement GMP norms

all kinds of complete sets of Chinese and Western medicine processing equipment, especially the important modern mechanical equipment processing, are important topics in the industry today. To solve the packaging problems of traditional Chinese medicine slicing, film making, injections, creams, powders and pills, there is an urgent need for all kinds of pharmaceutical processing and packaging equipment to solve the adaptability, compatibility and reliability of products, especially high-speed, automatic, multi-functional packaging machinery and corresponding supporting composite packaging materials

improve the overall level of drug packaging materials

with the rapid development of China's pharmaceutical industry, drug packaging materials and packaging containers, which have always been "foil", have begun to come to the front stage and become an important part of the pharmaceutical industry. A survey from the State Drug Administration shows that the overall technical level of China's pharmaceutical packaging materials industry is not high, the grade is low, far behind developed countries, 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 in China, it is less than 10%. Among them, the current production capacity of plastic containers such as oral liquid, eye drops and infusion is far from meeting the needs of the drug market

the author interviewed Caihong, Secretary General of China Pharmaceutical Packaging Association, on the safety and environmental protection of pharmaceutical packaging materials. She believed that the consumption of pharmaceutical plastic packaging materials is increasing rapidly. Although it seems to be contrary to the environmental protection policy, medicine is a special industry. The primary function of pharmaceutical packaging materials is to ensure the safety of drugs within the period of validity, and the proportion of the consumption of pharmaceutical packaging materials in the country is very low, As long as attention is paid to recycling, it will not cause adverse effects on the environment. However, the development of environmental friendly plastic packaging materials is still the direction of drug packaging development

in fact, after years of development, China's pharmaceutical packaging industry has also made great progress. At present, almost all of the world's top 100 pharmaceutical enterprises have established joint ventures or wholly-owned pharmaceutical enterprises in China, which not only brings more new drug varieties, but also advanced pharmaceutical packaging concepts and standards. In terms of sales, the separation of "medicine" and "medicine" in China has become inevitable. The change of sales mode makes the drug packaging emphasize the convenience of use and the publicity of advertisements in addition to its hygiene and protection functions; Put forward higher requirements for the cost control of packaging. It can be predicted that the world pharmaceutical packaging will tend to extend shelf life, optimize barrier performance, and advocate clear quantitative dispensing

◆ western medicine packaging

a, western medicine tablets and capsules will mainly use blister packaging and aluminum plastic blister packaging. The development of drug slow-release technology has gradually led to the rise of blister packaging. Dose reduction has greatly narrowed the gap in the packaging cost of drugs

B. there is more room for the development of drug cartons

the outer packaging of cartons has more room to play in the taking instructions and decoration design of drugs. The technology of coding and anti-counterfeiting drugs will be more applied to the outer packaging

c, automatic blister packaging machines will be used more and more

d. in order to reduce the possibility of children taking drugs by mistake, drug packaging should also have certain requirements in terms of packaging tear strength, bottle cap twist strength, etc. in addition, some interesting packaging design forms should be added

◆ Chinese patent medicine packaging

A, traditional Chinese medicine honey pill packaging

in the past, the honey pill packaging of traditional Chinese medicine used cartons as the outer packaging, and the inner layer of a box of ten pills was sealed with wax paper or round plastic containers. Blister packaging is now used. In the blister packaging of traditional Chinese medicine, cartons are also used as the outer packaging. The difference is that the outer packaging of cartons has more room to play in the taking instructions and decoration design of drugs. In order to improve the use safety of drugs and meet the anti-counterfeiting requirements, the outer packaging equipment will be affected in measurement, and the box will adopt more destructive open box design

b. The yield strength of Chinese patent medicine powder is the main basis for the design of machine parts or components that bear static load. Granular packaging

in the past, such traditional Chinese medicine dosage forms were packed in paper bags and plastic bags. Now, SP strip packaging is used, which is especially suitable for automatic packaging in large quantities

c, medium and high-grade herbal medicines will appear in small and medium-sized packaging forms such as vacuum packaging or modified atmosphere packaging

d. Cartons as outer packaging will also be more popular, and colored tiled cartons will be more and more adopted

◆ large infusion packaging

large infusion is one of the most active areas of drug packaging reform in China at present

a. the annual output of large infusion in China in 2001 was about 3billion

b. There are two directions for the improvement of large infusion packaging: composite flexible packaging bags and plastic bottles

◆ oral liquid bag

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