Pharmaceutical glass is a major branch of the pharmaceutical packaging industry and an important part of the entire pharmaceutical industry. Since the reform and opening up, China's pharmaceutical glass packaging industry has developed rapidly, especially through the "Eighth Five-Year Plan" and "Ninth Five-Year Plan" efforts, basically able to meet the demand for pharmaceutical packaging, is developing into a pivotal industry.
In order to facilitate a clearer understanding and positioning of the current status and development prospects of pharmaceutical glass packaging in China, the gap between international and advanced levels should be shortened as soon as possible to meet the opportunities and challenges that WTO brings to the industry and promote the improvement of the overall level of pharmaceutical preparations in China. This article intends to briefly analyze the main medical glass packages involved in several dosage forms.
1. Antibiotic powder injections The earliest ancestors of antibiotics penicillin since its inception in 1929. For more than half a century, it has made outstanding contributions to the health of mankind. The advantages of molded and controlled antibiotic glass bottles are irreplaceable with other materials. Become its preferred packaging material.
Molded antibiotic bottles: The basic chemical composition of this type of product is sodium-calcium-silicate glass, boron-free or boron-free neutral, and the basic oxide (R2O) content in the glass composition is generally controlled below 13%, and the product During the production process, it is surface-vulcanized, so this kind of product is widely used for antibiotic powder injection with its excellent chemical stability, and the dosage is about 70% of the total amount of antibiotic powder. The Harbin Pharmaceutical Group, Lukang Pharmaceutical Group and Shijiazhuang Pharmaceutical Group, which are the four major giants of domestic antibiotics, are all basically adopted. The annual consumption is about 4 billion.
In recent years, with the rapid development of the pharmaceutical industry, the level of product manufacturing and product quality have been greatly improved. The largest domestic manufacturer of Shandong Pharmaceutical Glass Co., Ltd., in order to reduce the gap with similar products in developed countries as soon as possible, while expanding the scale, increase investment in technological transformation, in 1997 to introduce an American Emhart company. (EM) bottle production line, its product quality level has reached and approached the international advanced level of similar products. The company through the continuous innovation and transformation of the original technology and equipment, trial production of thin-walled lightweight bottles, high white bottles, improved bottle appearance transparency and finish.
At present, there are 10 production plants in China, with an annual output of about 10 billion, and the annual output of most companies is less than 500 million. The level of technical equipment and product quality is still far from the advanced level of similar international products, and there is still a large gap between them. The task has not yet been fully realized. The traditional 800,000 units of penicillin are increasingly being replaced by large doses. The emergence of various new special drugs and high-grade drugs, coupled with the competition of bottle control, the development trend of molding antibiotic bottles is Lightweight, high-grade and large-scale.
Control antibiotic bottle: This kind of product is also used for the packaging of antibiotic powder injection. The domestic use of North China Pharmaceutical Factory is the largest, and the annual dosage is about 1.2 billion. The product has developed rapidly in recent years and has gradually replaced ampoules for lyophilizers and partially replaced molded bottles. The control bottle is a secondary processed product, and its quality level depends not only on the manufacturing process, but more importantly on the quality level of the glass pipe. Therefore, enterprises with glass tube production capabilities at the same time must have certain advantages, but at present, many domestic manufacturers do not have pull tube production capabilities, resulting in a large difference in the level of product quality and fierce market competition. Compared with similar products in the world, there is also a gap in the material of glass. The content of boron oxide (B 2 O 3) in the glass components of the developed countries is generally more than 10%, and that of the domestic ones is 2% to 7%. Glass materials have caused the difference in physical and chemical properties of the products. In addition, the level of product standards, physical quality and packaging quality have not reached the advanced level of similar international products.
From the current development trend of antibiotic powder needle packaging at home and abroad, this product will have great potential for development. Improve the glass material, increase the strength of the bottle, improve the size of the stability, appearance and quality of packaging, development of low expansion coefficient, printing bottle, will become the future direction of development.
The former State Administration of Pharmacy stated in the “Ninth Five-Year Plan†to 2010 development direction and goal: “The five major agents' development output targets are estimated to be: the annual volume of antibiotics will increase by 10%, and the output in 2000 will be about 13 billion bottles in 2010. About 21 billion bottles.†Antibiotic powder is one of the “five formulations†of medicines, with the largest amount of antibiotics used in various conventional medicines.
Analysis of the status quo of the domestic and international markets and development needs, there is a gradual rise in the control bottle, but the molded bottle has always occupied the dominant position, more than 70% of the antibiotic powder injection molding bottles are still used.
The Outline of the “Tenth Five-Year†Development Plan for Pharmaceutical Packaging Industry puts forward in the development direction of each dosage form packaging: “Fluid injections (including biological and biochemical freeze-dried) should develop high-quality control bottles and light-weight molded bottles. Over a long period of time in the future, These two types of products will give full play to their unique advantages in the fierce market competition, and will inevitably appear to compete with each other in the development and replace each other, and achieve greater development in mutual alternative competition.
Second, the water injection of water injection agent is mainly glass ampoule, the current domestic market demand for 29 billion, many domestic manufacturers. The original State Administration of Pharmacy began mandatory elimination of non-flexible ampoules in 1990, and the product has reached a level of upgrading. However, the current quality problem of ampoules is particularly prominent. One of the reasons for the difficulty in folding the ampoules is the low level of product standards. Second, the indicators of product quality, wall thickness and breaking force cannot meet the requirements. In addition, some small and medium-sized enterprises and pharmaceutical companies ignore the social benefits and ignore the safety and safety of ampoules. This has contributed to the low-quality, low-price, competitive sales situation in the Anfu market.
According to market research analysis, China's pharmaceutical injections will increase at a rate of 5% per year and reach 37.5 billion in 2010. 10% to 15% of injections require ampoules resistant to strong acids, alkalis, and light, and 5% of ampoules are needed. High quality printing.
Third, the infusion bottle filled with drugs infusion of pharmaceutical packaging is still the main glass infusion bottle, the product's good airtightness, transparency, stability and many other advantages make it widely used. However, the repeated use of glass infusion bottles has become a major problem that currently threatens people's safe use of drugs.
According to the requirements of the Chinese Pharmacopoeia, the glass bottles used to contain infusion fluids for injection must have the water resistance of the inner surface of the glass bottles that meet the requirements of H C1 and H C2 in GB12416.1 (the standard is equivalent to ISO4802). There are two kinds, one is borosilicate glass containing 10% of boron oxide (B2O3), referred to as type I glass, which has excellent chemical stability. There is no such infusion bottle made of glass at present in China, and there are not many internationally. The other is the inner surface treated sodium-calcium-silicate glass, abbreviated as type II glass, and its inner surface has a very thin layer of silicon-rich layer, which can achieve the effect of type I glass and is widely used in the world. At present, China's 1/3 infusion bottle is made of this glass, and the remaining 2/3 infusion bottle is made of 2% non-I and non-II type glass containing boron oxide (B2O3). Tests have shown that type II glass is superior to non-I and non-type II glass in water resistance, but type II glass is only desalinated on the inner surface to form a very thin silicon-rich layer and close to type I glass, such as repeated use Due to the damage during the washing and filling sterilization process, the extremely thin silicon-rich layer will be destroyed and the performance will be degraded. Therefore, the national standard GB2639 clearly stipulates that type II glass is only suitable for single use infusion bottles.
At present, there is a big gap between the quality of infusion bottles and the quality of similar products in the international market. They are mainly light weight, cleanliness, transparency and uniformity of packaging and appearance.
Fourth, the development trend of the pharmaceutical industry impact on the pharmaceutical glass packaging The pharmaceutical industry is internationally recognized as "the never-fading sunrise industry," human survival and health can not be separated from medicine. In recent years, the economic development of China's pharmaceutical industry has been very rapid. According to the forecast of experts, by 2005 China's demand for drugs will reach 218 billion yuan, a net increase of 94 billion yuan over 2000. It is expected that during the 10th Five-Year Plan period, the annual average demand for pharmaceuticals will increase by about 12%. The three factors that are irreversible, namely the growth of the total population, the aging of the population structure, and the flow of rural population to the cities, will be the basic conditions for the steady growth of the domestic pharmaceutical market. During the "10th Five-Year Plan" period, China's rural medicine market will be rapidly expanded. It is predicted that by 2010, the total amount of rural drug consumption is expected to reach 40 billion yuan. Undoubtedly, the vast rural medicine market will provide huge opportunities for generic antibiotics.
At present, China has become the world's second-largest producer of pharmaceutical raw materials, and the output of antibiotics and vitamins is among the best in the world. China's antibiotic raw materials have been exported in large quantities. In addition, the growth in demand for imported drugs was curbed, the import volume of pharmaceutical preparations declined, the antibiotic imports were the most affected, and its market share has been replaced by domestic and joint-venture drugs, combined with widespread antibiotic abuse in Asian developing countries. The proportion of antibiotics used is too high. Therefore, for a long period of time in the future, antibiotic drugs will continue to play a leading role in popular medicine. Their quality and low price will meet the needs of more than one billion Chinese people. For glass bottles containing antibiotics, there will still be steady development. With the progress of society, people’s living standards will increase, and the proportion of various types of new drugs, special drugs, and high-grade and valuable drugs will gradually increase. This type of medicine will put higher demands on the upgrading and upgrading of medical glass, driving Increase the added value of medicinal glass packaging products.
Fifth, the impact of other packaging materials on pharmaceutical glass packaging In recent years, all types of packaging materials are competing with each other in the packaging field with their unique performance advantages. However, drugs are special commodities. As pharmaceutical packaging, its most important function is to ensure stable compatibility and compatibility with drugs, that is, to ensure that chemical products do not change or deteriorate in chemical properties during storage and use. Pharmaceutical glass packaging has become a preferred material for pharmaceutical packaging because of its good chemical stability, air tightness, clear, transparent, high temperature resistance, and easy sterilization. As far as antibiotic powder is concerned, other packaging materials are not yet able to get into this area. The main package for water injection is glass ampoule, but plastic ampules and injection-integrated packages are already available in foreign countries (that is, water needle liquid is directly encapsulated in syringes). The quality of the printing and printing of the ampoules, the brown light and the low expansion coefficient of the ampoules still have great potential for development. More than 95% of domestic infusion preparations are glass-wrapped, but in Europe, America, and Japan, in addition to high-grade nutritional infusion bottles, conventional infusion packaging has been replaced by high-quality plastic bottles and hoses. It is expected that in the next 10 years, China's soft plastic infusion packaging will also show a steady development trend. The function of brown glass bottles for tablets has been largely replaced by plastic bottles and blister packs. Nowadays, various types of oral liquid preparations are mainly used. With the improvement of people's living standards and the enhancement of health care awareness, various types of oral liquid medicines and health care products are expected to have great potential for development. Brown glass bottles will occupy this market space with advantages such as smoothness, transparency, darkness, and stability.
VI. Influence of "W TO" on Pharmaceutical Glass Packaging The impact of "W TO" on pharmaceutical glass packaging can be said to be both challenges and opportunities. The challenge is mainly reflected in the product structure and product quality. With the tremendous enrichment of human material civilization and the emergence of new special drugs, the requirements for packaging quality will also become higher and higher. This will be a serious issue for the development of pharmaceutical glass packaging in China. However, adding WTO will also accelerate the pace of pharmaceutical glass packaging into the international market. Large-scale foreign products entering the Chinese market will still face barriers to price factors.
VII. Impact of pharmaceutical-related policies on pharmaceutical glass packaging The three major reforms in medical and health care, namely the reform of the urban medical insurance system, the reform of the pharmaceutical and health system, and the reform of the pharmaceutical distribution system, have entered a substantive stage of operation. These reforms will have significant impact on the pharmaceutical market. The impact will also bring new vitality to the closely related drug packaging. The implementation of drug classification management will also bring historic changes to pharmaceutical packaging, and the OTC market has great potential.
The State Drug Administration Bureau's drug packaging material management method issued under the No. 21 decree, which implements classified registration management, will shut out a considerable number of small businesses and play a role in avoiding vicious competition in the industry and standardizing the pharmaceutical packaging market.
In summary, facing the rapid development of the 21st century pharmaceutical industry, in the face of the arrival of international economic integration,
In order to facilitate a clearer understanding and positioning of the current status and development prospects of pharmaceutical glass packaging in China, the gap between international and advanced levels should be shortened as soon as possible to meet the opportunities and challenges that WTO brings to the industry and promote the improvement of the overall level of pharmaceutical preparations in China. This article intends to briefly analyze the main medical glass packages involved in several dosage forms.
1. Antibiotic powder injections The earliest ancestors of antibiotics penicillin since its inception in 1929. For more than half a century, it has made outstanding contributions to the health of mankind. The advantages of molded and controlled antibiotic glass bottles are irreplaceable with other materials. Become its preferred packaging material.
Molded antibiotic bottles: The basic chemical composition of this type of product is sodium-calcium-silicate glass, boron-free or boron-free neutral, and the basic oxide (R2O) content in the glass composition is generally controlled below 13%, and the product During the production process, it is surface-vulcanized, so this kind of product is widely used for antibiotic powder injection with its excellent chemical stability, and the dosage is about 70% of the total amount of antibiotic powder. The Harbin Pharmaceutical Group, Lukang Pharmaceutical Group and Shijiazhuang Pharmaceutical Group, which are the four major giants of domestic antibiotics, are all basically adopted. The annual consumption is about 4 billion.
In recent years, with the rapid development of the pharmaceutical industry, the level of product manufacturing and product quality have been greatly improved. The largest domestic manufacturer of Shandong Pharmaceutical Glass Co., Ltd., in order to reduce the gap with similar products in developed countries as soon as possible, while expanding the scale, increase investment in technological transformation, in 1997 to introduce an American Emhart company. (EM) bottle production line, its product quality level has reached and approached the international advanced level of similar products. The company through the continuous innovation and transformation of the original technology and equipment, trial production of thin-walled lightweight bottles, high white bottles, improved bottle appearance transparency and finish.
At present, there are 10 production plants in China, with an annual output of about 10 billion, and the annual output of most companies is less than 500 million. The level of technical equipment and product quality is still far from the advanced level of similar international products, and there is still a large gap between them. The task has not yet been fully realized. The traditional 800,000 units of penicillin are increasingly being replaced by large doses. The emergence of various new special drugs and high-grade drugs, coupled with the competition of bottle control, the development trend of molding antibiotic bottles is Lightweight, high-grade and large-scale.
Control antibiotic bottle: This kind of product is also used for the packaging of antibiotic powder injection. The domestic use of North China Pharmaceutical Factory is the largest, and the annual dosage is about 1.2 billion. The product has developed rapidly in recent years and has gradually replaced ampoules for lyophilizers and partially replaced molded bottles. The control bottle is a secondary processed product, and its quality level depends not only on the manufacturing process, but more importantly on the quality level of the glass pipe. Therefore, enterprises with glass tube production capabilities at the same time must have certain advantages, but at present, many domestic manufacturers do not have pull tube production capabilities, resulting in a large difference in the level of product quality and fierce market competition. Compared with similar products in the world, there is also a gap in the material of glass. The content of boron oxide (B 2 O 3) in the glass components of the developed countries is generally more than 10%, and that of the domestic ones is 2% to 7%. Glass materials have caused the difference in physical and chemical properties of the products. In addition, the level of product standards, physical quality and packaging quality have not reached the advanced level of similar international products.
From the current development trend of antibiotic powder needle packaging at home and abroad, this product will have great potential for development. Improve the glass material, increase the strength of the bottle, improve the size of the stability, appearance and quality of packaging, development of low expansion coefficient, printing bottle, will become the future direction of development.
The former State Administration of Pharmacy stated in the “Ninth Five-Year Plan†to 2010 development direction and goal: “The five major agents' development output targets are estimated to be: the annual volume of antibiotics will increase by 10%, and the output in 2000 will be about 13 billion bottles in 2010. About 21 billion bottles.†Antibiotic powder is one of the “five formulations†of medicines, with the largest amount of antibiotics used in various conventional medicines.
Analysis of the status quo of the domestic and international markets and development needs, there is a gradual rise in the control bottle, but the molded bottle has always occupied the dominant position, more than 70% of the antibiotic powder injection molding bottles are still used.
The Outline of the “Tenth Five-Year†Development Plan for Pharmaceutical Packaging Industry puts forward in the development direction of each dosage form packaging: “Fluid injections (including biological and biochemical freeze-dried) should develop high-quality control bottles and light-weight molded bottles. Over a long period of time in the future, These two types of products will give full play to their unique advantages in the fierce market competition, and will inevitably appear to compete with each other in the development and replace each other, and achieve greater development in mutual alternative competition.
Second, the water injection of water injection agent is mainly glass ampoule, the current domestic market demand for 29 billion, many domestic manufacturers. The original State Administration of Pharmacy began mandatory elimination of non-flexible ampoules in 1990, and the product has reached a level of upgrading. However, the current quality problem of ampoules is particularly prominent. One of the reasons for the difficulty in folding the ampoules is the low level of product standards. Second, the indicators of product quality, wall thickness and breaking force cannot meet the requirements. In addition, some small and medium-sized enterprises and pharmaceutical companies ignore the social benefits and ignore the safety and safety of ampoules. This has contributed to the low-quality, low-price, competitive sales situation in the Anfu market.
According to market research analysis, China's pharmaceutical injections will increase at a rate of 5% per year and reach 37.5 billion in 2010. 10% to 15% of injections require ampoules resistant to strong acids, alkalis, and light, and 5% of ampoules are needed. High quality printing.
Third, the infusion bottle filled with drugs infusion of pharmaceutical packaging is still the main glass infusion bottle, the product's good airtightness, transparency, stability and many other advantages make it widely used. However, the repeated use of glass infusion bottles has become a major problem that currently threatens people's safe use of drugs.
According to the requirements of the Chinese Pharmacopoeia, the glass bottles used to contain infusion fluids for injection must have the water resistance of the inner surface of the glass bottles that meet the requirements of H C1 and H C2 in GB12416.1 (the standard is equivalent to ISO4802). There are two kinds, one is borosilicate glass containing 10% of boron oxide (B2O3), referred to as type I glass, which has excellent chemical stability. There is no such infusion bottle made of glass at present in China, and there are not many internationally. The other is the inner surface treated sodium-calcium-silicate glass, abbreviated as type II glass, and its inner surface has a very thin layer of silicon-rich layer, which can achieve the effect of type I glass and is widely used in the world. At present, China's 1/3 infusion bottle is made of this glass, and the remaining 2/3 infusion bottle is made of 2% non-I and non-II type glass containing boron oxide (B2O3). Tests have shown that type II glass is superior to non-I and non-type II glass in water resistance, but type II glass is only desalinated on the inner surface to form a very thin silicon-rich layer and close to type I glass, such as repeated use Due to the damage during the washing and filling sterilization process, the extremely thin silicon-rich layer will be destroyed and the performance will be degraded. Therefore, the national standard GB2639 clearly stipulates that type II glass is only suitable for single use infusion bottles.
At present, there is a big gap between the quality of infusion bottles and the quality of similar products in the international market. They are mainly light weight, cleanliness, transparency and uniformity of packaging and appearance.
Fourth, the development trend of the pharmaceutical industry impact on the pharmaceutical glass packaging The pharmaceutical industry is internationally recognized as "the never-fading sunrise industry," human survival and health can not be separated from medicine. In recent years, the economic development of China's pharmaceutical industry has been very rapid. According to the forecast of experts, by 2005 China's demand for drugs will reach 218 billion yuan, a net increase of 94 billion yuan over 2000. It is expected that during the 10th Five-Year Plan period, the annual average demand for pharmaceuticals will increase by about 12%. The three factors that are irreversible, namely the growth of the total population, the aging of the population structure, and the flow of rural population to the cities, will be the basic conditions for the steady growth of the domestic pharmaceutical market. During the "10th Five-Year Plan" period, China's rural medicine market will be rapidly expanded. It is predicted that by 2010, the total amount of rural drug consumption is expected to reach 40 billion yuan. Undoubtedly, the vast rural medicine market will provide huge opportunities for generic antibiotics.
At present, China has become the world's second-largest producer of pharmaceutical raw materials, and the output of antibiotics and vitamins is among the best in the world. China's antibiotic raw materials have been exported in large quantities. In addition, the growth in demand for imported drugs was curbed, the import volume of pharmaceutical preparations declined, the antibiotic imports were the most affected, and its market share has been replaced by domestic and joint-venture drugs, combined with widespread antibiotic abuse in Asian developing countries. The proportion of antibiotics used is too high. Therefore, for a long period of time in the future, antibiotic drugs will continue to play a leading role in popular medicine. Their quality and low price will meet the needs of more than one billion Chinese people. For glass bottles containing antibiotics, there will still be steady development. With the progress of society, people’s living standards will increase, and the proportion of various types of new drugs, special drugs, and high-grade and valuable drugs will gradually increase. This type of medicine will put higher demands on the upgrading and upgrading of medical glass, driving Increase the added value of medicinal glass packaging products.
Fifth, the impact of other packaging materials on pharmaceutical glass packaging In recent years, all types of packaging materials are competing with each other in the packaging field with their unique performance advantages. However, drugs are special commodities. As pharmaceutical packaging, its most important function is to ensure stable compatibility and compatibility with drugs, that is, to ensure that chemical products do not change or deteriorate in chemical properties during storage and use. Pharmaceutical glass packaging has become a preferred material for pharmaceutical packaging because of its good chemical stability, air tightness, clear, transparent, high temperature resistance, and easy sterilization. As far as antibiotic powder is concerned, other packaging materials are not yet able to get into this area. The main package for water injection is glass ampoule, but plastic ampules and injection-integrated packages are already available in foreign countries (that is, water needle liquid is directly encapsulated in syringes). The quality of the printing and printing of the ampoules, the brown light and the low expansion coefficient of the ampoules still have great potential for development. More than 95% of domestic infusion preparations are glass-wrapped, but in Europe, America, and Japan, in addition to high-grade nutritional infusion bottles, conventional infusion packaging has been replaced by high-quality plastic bottles and hoses. It is expected that in the next 10 years, China's soft plastic infusion packaging will also show a steady development trend. The function of brown glass bottles for tablets has been largely replaced by plastic bottles and blister packs. Nowadays, various types of oral liquid preparations are mainly used. With the improvement of people's living standards and the enhancement of health care awareness, various types of oral liquid medicines and health care products are expected to have great potential for development. Brown glass bottles will occupy this market space with advantages such as smoothness, transparency, darkness, and stability.
VI. Influence of "W TO" on Pharmaceutical Glass Packaging The impact of "W TO" on pharmaceutical glass packaging can be said to be both challenges and opportunities. The challenge is mainly reflected in the product structure and product quality. With the tremendous enrichment of human material civilization and the emergence of new special drugs, the requirements for packaging quality will also become higher and higher. This will be a serious issue for the development of pharmaceutical glass packaging in China. However, adding WTO will also accelerate the pace of pharmaceutical glass packaging into the international market. Large-scale foreign products entering the Chinese market will still face barriers to price factors.
VII. Impact of pharmaceutical-related policies on pharmaceutical glass packaging The three major reforms in medical and health care, namely the reform of the urban medical insurance system, the reform of the pharmaceutical and health system, and the reform of the pharmaceutical distribution system, have entered a substantive stage of operation. These reforms will have significant impact on the pharmaceutical market. The impact will also bring new vitality to the closely related drug packaging. The implementation of drug classification management will also bring historic changes to pharmaceutical packaging, and the OTC market has great potential.
The State Drug Administration Bureau's drug packaging material management method issued under the No. 21 decree, which implements classified registration management, will shut out a considerable number of small businesses and play a role in avoiding vicious competition in the industry and standardizing the pharmaceutical packaging market.
In summary, facing the rapid development of the 21st century pharmaceutical industry, in the face of the arrival of international economic integration,
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