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.
To facilitate a clearer understanding and positioning of the current status and development prospects of pharmaceutical glass packaging in China, to shorten the gap with the international advanced level as soon as possible, to meet the opportunities and challenges brought by the WTO to the industry, and to promote the improvement of the overall level of pharmaceutical preparations in China, This article intends to make a brief review of the major medicinal glass packages involved in several dosage forms.
One, antibiotic powder injection
The penicillin (penicillin), the earliest antibiotic drug, has been making outstanding contributions to human health since its introduction in 1929. For more than half a century, the molded and controlled antibiotic glass bottles have not been shaken and replaced by other materials. Become its preferred packaging material.
Molded antibiotic bottles: The basic chemical composition of these products 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 and extensively used for the packaging of antibiotic powder injections with its excellent chemical stability and other properties, 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 largest 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. In order to reduce the gap with similar products in developed countries as quickly as possible, the largest domestic manufacturer of pharmaceutical glass companies in Shandong Province, while expanding its scale, paid attention to accelerating the pace of technological transformation and increasing investment in technological transformation, it introduced an American Emme in 1997. The bottle production line of EMHART has reached and reached the advanced level of similar products in the world. Through the continuous innovation and transformation of the original technology and equipment, the company has produced thin-walled lightweight bottles and high White bottles improve the transparency and finish of the bottles.
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, combined with the competition of bottle control, will make the molding of antibiotic bottles face lighter. Quantitative, high-grade and large-scale development trend.
Control antibiotic bottle: This kind of product is also used for the packaging of antibiotic powder injection. China North China Pharmaceutical Factory has the largest amount of use, with an annual consumption of about 1.2 billion pieces. This product has developed rapidly in recent years and has gradually replaced the ampoules for lyophilized agents. 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 (B2O3) in the glass components of the developed countries is generally more than 10%, while that of the domestic countries is 2%-7%. Glass materials have caused a gap in the 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 injection 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 quality and packaging quality, the development of low expansion coefficient and printing of the control bottle, will become the future direction of development. The former State Administration of Pharmacy stated in the "Ninth Five-Year Plan" to the 2010 Development Guidelines, Policies and Objectives: "The five major formulation development output targets are estimated to be: annual growth of antibiotics by 10%, and annual production of about 13 billion bottles in 2000, 2010 About 21 billion bottles a year.†Antibiotic powder is one of the “five dosage forms†for medicines. Among various types of conventional medicines, antibiotic dosage is the largest.
From the analysis of the international and domestic market status and development needs, there is a gradual increase in the control bottle, but molded bottles have always dominated and more than 70% of antibiotic powder injections are still in molded bottle packaging.
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 achieve greater development in mutual alternative competition.
Second, water injection
Aqueous injection packaging, mainly glass ampoule, currently has an annual demand of 29 billion in the domestic market, and there are numerous domestic manufacturers. The original State Administration of Pharmacy began to eliminate non-flexible ampoules in 1990, and the product has been upgraded and replaced. However, the current problem of easy-to-fold amputees is particularly prominent. The purpose of implementing the easy-to-fold ampoule is to make the ampoule easy to fold, so as to avoid the glass particles formed by the frustration when the ampoule is used to enter the liquid medicine. Studies have shown that glass particles will have serious consequences if they enter the human body with liquid medicine. In addition, the victims are medical personnel. The incidents in which the injection of the teeth is not easy to be cut are repeated, giving people the safety of medicine and the medical personnel. Use brings great risks and threats. The main reasons for the above problems are the low level of product standards and the failure to meet the requirements for product quality, wall thickness and breakage force indicators, coupled with the social benefits of some small and medium-sized enterprises and pharmaceutical companies, ignoring the quality and medication of ampoules. Security has contributed to the low-quality, low-price, competitive sales situation in the market.
According to market research and analysis, China's pharmaceutical injections will increase at a rate of 5% per year. In 2010, it will reach 37.5 billion units, 10%-15% of the injections need to be resistant to strong acids, alkalis and dark, and 5% of the ampoules need high quality printing.
Three, infusion bottle
The pharmaceutical packaging containing transfusion agents is still dominated by glass infusion bottles. This product has been widely adopted due to its many advantages such as good airtightness, cleanness, transparency, and non-deterioration. 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 bottles to the HC1 and HC2 levels in GB12416.1 (the standard is equivalent to ISO4802). There are two glasses that meet this requirement. One type, borosilicate glass containing boron oxide (B2O3) 10%, referred to as type I glass, 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 internal surface treatment of sodium - calcium - silicate glass, referred to as type II glass, its inner surface has a very thin layer of silicon, can achieve the effect of type I glass, 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 non-II type glass containing boron oxide (B2O3). Tests have shown that the water resistance of type II glass is better than non-I non-type II glass, but type II glass is only dealkalized 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 process, the extremely thin silicon-rich layer will be destroyed and the performance will be reduced. Therefore, the national standard GB2639 clearly states 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 pharmaceutical glass packaging
The pharmaceutical industry is recognized internationally as a "sunrise industry that never fades." Human existence and health cannot be separated from medicine. In recent years, the economic operation of our country's pharmaceutical industry is full of confidence. According to the prediction of experts, by 2005, the demand for drugs in China will reach 218 billion yuan, a net increase of 94 billion yuan over 2000. It is expected that during the Ninth Five-Year Plan period, the average annual growth rate of drug demand in China will reach 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 rural medicine consumption will reach RMB 40 billion. There is no doubt that the vast rural medicine market will give antibiotics generic medicine. Provide huge business opportunities. The potential development space of the Chinese pharmaceutical market plays a decisive role in the development and growth of pharmaceutical glass packaging.
At present, China has become the world's second largest producer of pharmaceutical raw materials, and antibiotics and vitamins are 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, the improvement of people’s living standards and accession to the WTO will increase the proportion of various types of new drugs, special drugs and high-grade valuable drugs. Such drugs will impose higher requirements on the upgrading and upgrading of medicinal glass. However, this development trend can promote 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 drugs do not change or lose their 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, all kinds of oral liquid preparations are mainly filled. With the improvement of people's living standards and health awareness, it is expected that various types of oral liquid medicines and health care products will have great development potential. Brown glass bottles will occupy this market space with advantages such as smoothness, transparency, darkness, and stability.
Sixth, the 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 medical and health system, and the reform of the pharmaceutical distribution system, have entered a substantive stage of operation. These reforms will have a major impact on the pharmaceutical market and will also give them closely related pharmaceutical packaging. Bringing new vitality and implementing drug classification management will also bring historic changes to pharmaceutical packaging. The potential for over-the-counter (OTC) market is huge, and it will be a serious issue for the development of pharmaceutical glass packaging.
The State Drug Administration has adopted the method of management of pharmaceutical packaging materials issued under the Decree No. 21, which implements classified registration management and will shut out a considerable number of small businesses, which will play a role in preventing the vicious competition in the industry and standardizing the pharmaceutical packaging market.
In summary, in the face of the rapid development of the pharmaceutical industry in the 21st century, in the face of the arrival of international economic integration, in the face of various types of packaging materials that infiltrate and replace each other, pharmaceutical glass packaging in China will face a new history. Development period. We believe that through the joint efforts of all sectors of society, the pharmaceutical industry, and people of insight throughout the industry, medicinal glass packaging will stand in the 21st century pharmaceutical packaging forest with even better performance.
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