Research Report V on the development of the hottes

Research Report on the market development of pharmaceutical packaging materials in Chinese Mainland (V)

§ 3 pharmaceutical glass packaging materials

pharmaceutical glass has been widely used in the packaging of various injections, powder injections, biological drugs, blood products, lyophilizers, tablets, oral liquids, etc. in China. Not 1 according to the purpose of the product If the jaw is not properly clamped, it can be roughly divided into six categories:

(1) powder injection packaging. Powder injection is one of the five major pharmaceutical preparations in China. It is mainly composed of various antibiotic drugs. Its packaging is mainly molded injection bottles and controlled injection bottles. At present, in the domestic powder injection packaging, molded injection bottles account for 70% - 80%, and controlled injection bottles account for 20% - 3. China's economy has begun to move into modernization 0%. The former is characterized by stable size and high strength; The latter is characterized by light weight and good appearance transparency. At present, controlled injection bottles are gradually increasing at home and abroad

(2) water injection packaging. The main form of water injection packaging is ampoule. There are two kinds of curly neck easy to break ampoules produced in China: one is that there is a notch on the neck of the ampoule, and there is a color dot mark above the notch; The other is that there is a ring of low melting point glass color ring at the neck of the ampoule. Because the color ring has different expansion coefficient from the ampoule glass itself, it can produce local stress and is easy to break

(3) infusion packaging. Domestic large infusion packaging is mainly glass infusion bottles. In recent years, plastic infusion containers have gradually increased, but high-quality and light-weight type II infusion bottles still have certain competitive advantages. The glass infusion bottle has the characteristics of smooth and transparent, easy disinfection, corrosion resistance, high temperature resistance and good sealing performance. At present, it is still the preferred packaging for ordinary infusion agents

(4) lyophilizer packaging. Lyophilizers are packaged in controlled bottles and moulded bottles. Previously, ampoules were packaged, but now they are basically eliminated

(5) packaging of tablets and capsules. In recent years, the packaging of tablets and capsules has been constantly replaced by plastic bottles, aluminum foil and other materials, but the high-quality, light-weight and light proof yellow or white glass bottles still have irreplaceable advantages and development space

(6) oral liquid packaging. Oral liquid preparations are mostly health products, most of which are packaged in medicinal glass, mainly controlled white and brown oral liquid bottles and molded brown glass bottles

some people believe that the traditional glass bottle has high energy consumption and the production cost is gradually rising; In the manufacturing process of glass, dust, waste water, noise and other environmental pollution will be produced. Therefore, the profits of glass bottle production enterprises are generally low, which restricts the new technological transformation of enterprises. Therefore, the application of glass in pharmaceutical packaging materials will gradually be replaced by plastic in many aspects

however, glass has superior protective properties and good chemical stability; At the same time, because the glass is not affected by the atmosphere and is not decomposed by solid or liquid substances with different chemical compositions, and the chemical properties and radiation resistance of the glass can be adjusted by changing the chemical composition of the glass; In addition, according to the aesthetic and pollution-free principles of the choice of drug packaging materials, medicinal glass is transparent, beautiful, cheap and recyclable. Therefore, glass has been widely used in pharmaceutical packaging, and is still in the rising stage of development, and will not be eliminated in the end. At present, domestic production enterprises should make more efforts in the renewal of medicinal glass itself, product upgrading and integration with international standards:

first, at the standard level, we should actively adopt international standards, comprehensively improve the product quality level, and establish and improve the standardization system of medicinal glass in China as soon as possible

second, in terms of types, the international standard iso12775-1997 clearly stipulates that there are three main types of medicinal glass: 3.3 borosilicate glass, international neutral glass and sodium calcium glass. Due to the limitation of China's technical level, it has been unable to produce international neutral glass with strong water resistance, acid resistance and alkali resistance on a large scale. In the future, it should gradually transition and focus on the development of international neutral glass

third, in terms of material properties, the water resistance of international neutral glass and 3.3 borosilicate glass particle method can reach grade 1. Although the water resistance of low borosilicate glass particle method in China is mostly grade 1, and some are grade 2, the amount of alkali precipitation from the microscopic point of view is several times larger than that of international neutral glass

fourth, in terms of the limit of harmful substances, there are international regulations on the precipitation of as, Sb, Pb and Cd in glass. As the medical glass with the highest requirements for safety and health, China should limit the amount of harmful elements to ensure the safety of people's medication

fifth, the test method should be developed from qualitative and semi quantitative to quantitative and respectively quantitative. For example, for the water resistance of the inner surface, the Discoloration method of methyl red acid solution was used in the past, but now the total alkali titration method is used. Internationally, Na, K and Ca should be quantitatively determined respectively

§ 4 pharmaceutical metal packaging materials

pharmaceutical metal packaging materials mainly refer to aluminum caps, pastes and aerosol bottles used for powder injection packaging, as well as pharmaceutical aluminum foil packaged with aluminum plastic blisters. There are several kinds of aluminum caps for powder injection: E-type non flowering aluminum cap (often used with natural rubber plug with wax sealing process), C-type three bridge flowering aluminum cap and aluminum plastic composite cap. The aluminum strip used for processing is usually semi-rigid pure aluminum or h14-h16 alloy aluminum strip. Aluminum plastic composite cover has been more and more accepted by the market because of its convenient opening and safe and sanitary use. Chapter III development trend of China's pharmaceutical packaging industry

the development of pharmaceutical packaging is closely related to the development of the pharmaceutical industry, and in recent years, China's pharmaceutical industry has shown a more rapid development trend than the pharmaceutical packaging industry. In China, three irreversible factors, namely, the growth of the total population, the aging of the population structure and the migration of rural population to cities, have promoted the rapid growth of the domestic pharmaceutical market to varying degrees. At present, China has become the second largest producer of bulk drugs in the world, and antibiotics and vitamins have ranked among the best in the world. It is predicted that by 2005, the demand for drugs in China will reach 218 billion yuan, a net increase of 94 billion yuan over 2000

it can be seen that although China's pharmaceutical packaging industry has made considerable progress in recent years, compared with the rapid development of the pharmaceutical industry, the development speed of the pharmaceutical packaging industry is still relatively slow. It is predicted that pharmaceutical packaging will have faster development in the next few years, with good prospects and large space. On the one hand, after China's accession to the WTO, domestic pharmaceutical enterprises will participate in the competition in the international market. In order to eliminate the technical barriers caused by pharmaceutical packaging and other reasons, advanced packaging equipment and materials meeting international standards will be required to cooperate with it, which also puts forward higher requirements and broader market space for domestic pharmaceutical packaging enterprises. At the same time, foreign pharmaceutical enterprises began to flow into the Chinese market, Almost all the top 100 pharmaceutical enterprises in the world 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, which will naturally become a good opportunity for Chinese pharmaceutical packaging enterprises to learn foreign advanced technologies and concepts. On the other hand, with the gradual acceleration of the reform of the domestic pharmaceutical system, it is inevitable that "medicine" and "medicine" should be separated. The reform of the sales mode makes the pharmaceutical packaging not only have hygienic and protective functions, but also emphasize the convenience of use and pay attention to advertising, which undoubtedly puts forward higher requirements for the pharmaceutical packaging materials and forms. Experts said that both western medicine and traditional Chinese medicine should be innovated in packaging. Drug packaging is becoming the product with the best efficiency and the highest technical content in the packaging industry

then, how to seize this opportunity to strive for better development has become a problem worthy of consideration for China's pharmaceutical packaging enterprises. Medicine is a special industry. The primary function of pharmaceutical packaging materials is to ensure the safety of drugs within the period of validity. Experts said that in the future, the packaging industry will develop in the direction of "green" packaging, less metering packaging, environmental regulation packaging, serialized packaging, high barrier packaging, "bacteria free" packaging, antibacterial packaging and nano packaging

therefore, our pharmaceutical packaging industry should first strengthen the R & D capacity of enterprises and improve the grade of packaging materials. In the future, the trend of oligopoly of pharmaceutical enterprises will become more and more obvious, and their procurement will be collectivized, which is a severe challenge for packaging materials enterprises, which requires pharmaceutical packaging enterprises to have a long-term vision and implement the development strategy of going out and standing; We should constantly innovate in new materials and products, have our own R & D team, have packaging products with independent property rights, and take the road of high-quality packaging and green packaging. From the perspective of the enterprise itself, the packaging of drugs should be more concise, clear and beautiful. On the premise of ensuring that it is not easy to be damaged during transportation, materials should be saved as much as possible, and excessive packaging should not be allowed. The market competitiveness of the enterprise should be improved by continuously improving the quality of its employees

the outline of the Tenth Five Year Plan for the development of pharmaceutical packaging industry in China points out that we should speed up the adjustment of product structure, strengthen product development, promote the further implementation of quality management system, and meet the requirements of pharmaceutical enterprises for the development of pharmaceutical packaging. After joining the WTO, one of the basic conditions for pharmaceutical enterprises to participate in competition is to obtain the drug GM P certificate from the State Drug Administration. Thousands of pharmaceutical factories in China will speed up the GMP transformation during the Tenth Five Year Plan period, which requires that the pharmaceutical packaging industry must be comprehensively improved, especially the enterprises (workshops) that produce direct contact with pharmaceutical packaging must meet the requirements of GMP in the whole process of product production, sales and use

the "Tenth Five Year" development policy of the pharmaceutical packaging industry proposed in the outline is:

(1) we should strengthen the research on the impact of pharmaceutical packaging waste on the environment, support the development and production of environmentally friendly packaging products, and explore the application of polymer degradation in pharmaceutical packaging

(2) support the development and production of OTC packaging

(3) support the research and development of children's safety packaging and promote the formulation of corresponding regulations

(4) for powder injection (including biological, biochemical and freeze-drying), develop high-quality controlled bottles and light-weight molded bottles, accelerate the elimination of natural rubber corks, realize butyl on the basis of steadily improving the quality level of butyl rubber corks, and develop high-quality aluminum-plastic composite caps

(5) water injection improves the quality of easy break ampoules, develops low expansion coefficient and printing ampoules, and accelerates the development of color ring easy break ampoules

(6) develop high-quality plastic infusion containers for infusion agent packaging, improve the quality of glass infusion bottles, and strictly prohibit the second use of various infusion containers. Eliminate natural rubber plugs, promote butyl rubber plugs, and develop high-quality aluminum-plastic composite covers

(7) the production of capsules and tablets by hand is strictly prohibited, and the supervision and inspection of capsule production quality and health indicators are strengthened. Vigorously develop the development of green capsules of non animal capsule types, and support the technological research and development of seaweed capsules. Support the development and production of various high barrier composite materials and containers. The sealing performance of plastic bottles should be achieved by improving the accuracy of molds and other technical means to reduce the use of bottle mouth sealing film. Improve the quality of glass yellow round bottles, and completely eliminate soft (broken) corks dipped in wax

(8) ointment should completely eliminate lead tin tubes and low-quality plastic products, and develop internally sprayed aluminum tubes. Support the research of high-level aluminum-plastic composite pipe on the premise of taking into account the requirements of environmental protection and medicine

(9) cooperate with the development of dosage forms, research and develop pharmaceutical packaging materials

it can be seen that the low-end aluminum powder production capacity is seriously redundant in countries