Current situation and development prospect of phar

Current situation and development prospects of pharmaceutical glass packaging in China

pharmaceutical glass is a major branch of the pharmaceutical packaging industry, and it is also 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 efforts during the "Eighth Five Year Plan" and "Ninth Five Year Plan", it can basically meet the needs of pharmaceutical packaging, and is developing into a pivotal industry

in order to have a clear understanding and positioning of the current situation and development prospect of pharmaceutical glass packaging in China, shorten the gap with the international advanced level as soon as possible, meet the opportunities and challenges brought by WTO to the industry, and promote the improvement of the overall level of pharmaceutical preparations in China, this paper intends to make a brief analysis of the main pharmaceutical glass packaging involved in several dosage forms

I. antibiotic powder injection

penicillin, the originator of antibiotic drugs, has made outstanding contributions to human health since it came out in 1929. The molded and controlled antibiotic glass bottle has become its first packaging material with irreplaceable advantages of other materials

molded antibiotic bottles: the basic chemical composition of these products is sodium calcium silicate glass, boron free or low boron neutral materials. The content of basic oxide (R2O) in the glass composition is generally controlled below 13%, and the products are subject to surface vulcanization treatment in the production process. Therefore, these products are widely used in the packaging of antibiotic powder injections with their excellent chemical stability, and the dosage is about 70% of the total amount of antibiotic powder injections. Harbin Pharmaceutical Group, Lukang Pharmaceutical Group and Shijiazhuang Pharmaceutical Group, among the "four giants" of domestic antibiotic subpackaging, basically adopt all of them, with an annual consumption of about 4billion

in recent years, with the rapid development of the pharmaceutical industry, the manufacturing process and product quality of this product have been greatly improved. Shandong Pharmaceutical Glass Co., Ltd., the largest manufacturer in China, in order to narrow the gap with similar products in foreign developed countries as soon as possible, while expanding its scale and increasing investment in technological transformation, introduced a bottle making production line of Emhart company (EM) in the United States in 1997, and its product quality level has reached and approached the advanced level of similar international products. Through the continuous innovation and transformation of the original process technology and equipment, the enterprise trial produced thin-walled lightweight bottles and high white material bottles, which improved the transparency and smoothness of the bottle appearance

at present, there are 10 production plants in China, with an annual output of about 10billion, and the annual output of most enterprises is less than 500million. There is still a big gap between the level of technical equipment and the level of product quality and the advanced level of similar international products. The task of lightweight has not been fully realized. More and more traditional 800000 units of penicillin have been replaced by large-dose sub packaging. The emergence of various new special drugs and high-grade drugs, coupled with the competition for tube bottles, The development trend of molded antibiotic bottles is lightweight, high-grade and large-scale standardization

controlled antibiotic bottles: these products are also used in the packaging of antibiotic insulation glass wool and its products gb/t13350 ⑵ 000 powder injections. In China, Huabei pharmaceutical factory has the largest use, with an annual consumption of about 1.2 billion. This product has developed rapidly in recent years, and has gradually replaced ampoules for freeze-drying agents and partially replaced molded bottles. Tube bottles are secondary processed products, and their quality level depends not only on the manufacturing process, but also on the quality level of glass tubes. Therefore, enterprises with glass tube production capacity should have certain advantages, but at present, many domestic manufacturers do not have tube drawing production capacity, resulting in large differences in product quality and fierce market competition. Compared with similar international products, there is also a certain gap in the material of glass. The content of boron oxide (B 2O 3) in the glass composition of tube bottles in foreign developed countries is generally more than 10%, while that in China is 2% - 7%. The glass material leads to the gap in the physical and chemical properties of products. In addition, the product standard level, physical quality level and packaging quality have not reached the advanced level of similar international products

judging from the current development trend of antibiotic powder injection packaging at home and abroad, this product will have great development potential. Improving glass material, increasing bottle strength, improving the stability of specification and size, appearance quality and packaging quality, and developing low expansion coefficient and printing controlled bottles will become the development direction in the future

in the development direction and objectives from the ninth five year plan to 2010, the former State Pharmaceutical Administration proposed: "the output targets of the five major preparations are expected to be: Based on an annual increase of 10%, the output of antibiotics is about 13billion bottles in 2000 and about 21billion bottles in 2010." Antibiotic powder injection is one of the "five dosage forms" of drugs, and the dosage of antibiotics is the largest among all kinds of conventional drugs

from the current situation and development needs of domestic and foreign markets 2 Due to the analysis of gapless transmission, the control bottle has a gradual upward trend, but the molded bottle has always occupied the dominant position, and more than 70% of antibiotic powder injections are still using molded bottles

the outline of the "Tenth Five Year Plan" for the development of pharmaceutical packaging industry puts forward in the development direction of each dosage form packaging: "powder injection (including biological and biochemical freeze-drying) We should develop high-quality controlled bottles and light-weight molded bottles. For a long time to come, these two kinds of products will give full play to their unique advantages in the fierce market competition, and will inevitably compete and replace each other in the development, and achieve greater development in the mutual substitution competition

II. Water injection

the packaging of water injection is mainly glass ampoules. At present, the annual demand of the domestic market is 29billion pieces, and there are many domestic manufacturers. The former State Pharmaceutical Administration began to force the elimination of non collapsible ampoules in 1990, and the product has reached the upgrading level, but the quality problem of ampoules is particularly prominent at present. The reasons why easy to fold ampoules are not easy to fold are: first, the low level of product standards; second, the product quality, ampoule wall thickness and breaking force indicators cannot meet the requirements; in addition, some small and medium-sized enterprises and pharmaceutical enterprises ignore social benefits and ignore ampoule quality and drug safety, which contributes to the low-quality and low-cost competitive situation in the ampoule Market

according to market research and analysis, it is predicted that China's pharmaceutical injections will grow at a rate of 5% per year, reaching 37.5 billion in 2010. 10% - 15% of the injections need ampoules that are resistant to strong acids, strong bases and light, and 5% of the ampoules need high-quality printing. It is expected that the exhibitors will reach nearly 10000 people

III. infusion bottles

currently, the drug packaging containing infusion agents is still mainly glass infusion bottles, which are widely used due to their good air tightness, transparency, stability and many other advantages. However, the reuse of glass infusion bottles has become a major problem threatening people's safe medication

according to the requirements of the Chinese Pharmacopoeia, the water resistance of the inner surface of the glass bottle used to contain the technical parameters of the xjl 300B drop hammer impact tester for infusion for injection must meet the requirements of grade HC1 and HC2 in gb12416.1 (the standard is equivalent to iso4802). There are two kinds of glasses that meet this requirement, one is borosilicate glass containing 10% boron oxide (B2O3), referred to as type I glass, which has excellent chemical stability. At present, there is no infusion bottle made of this kind of glass in China, and there are not many in the world. The other is sodium calcium silicate glass with internal surface treatment, referred to as type II glass for short. Its internal surface has a very thin silicon rich layer, which can achieve the effect of type I glass. It is widely used internationally. At present, 1/3 of China's infusion bottles are made of this kind of glass, and the remaining 2/3 of the infusion bottles are made of non type I and non type II glass containing about 2% boron oxide (B2O3). The test shows that the water resistance of type II glass is better than that of non type I and non type II glass, but type II glass is only dealkylated on the inner surface, forming an extremely thin silicon rich layer close to type I glass. If it is reused, due to the damage in the process of bottle washing and filling disinfection, the extremely thin silicon rich layer will be destroyed and the performance will decline. Therefore, the national standard gb2639 clearly stipulates that type II glass is only applicable to disposable infusion bottles

at present, there is a big gap between the manufacturing quality level of infusion bottles and similar international products, mainly in the lightweight, cleanliness, packaging and appearance transparency and uniformity of bottles

IV. the impact of the development trend of the pharmaceutical industry on pharmaceutical glass packaging

the pharmaceutical industry is internationally recognized as a "sunrise industry that will never decline", and human survival and health cannot be separated from medicine. In recent years, the economic development of China's pharmaceutical industry is very rapid. According to experts' prediction, China's drug demand will reach 218 billion yuan by 2005, a net increase of 94 billion yuan over 2000. It is estimated that during the Tenth Five Year Plan period, China's drug demand will increase at an average annual rate of about 12%. Three irreversible factors, namely, the growth of the total population, the aging of the population structure and the migration of rural population to cities, will be the basic conditions for the steady growth of the domestic pharmaceutical market. During the Tenth Five Year Plan period, China's rural pharmaceutical market will be rapidly expanded. It is predicted that by 2010, the total rural pharmaceutical consumption is expected to reach 40billion yuan. There is no doubt that the broad rural pharmaceutical market will provide huge business opportunities for antibiotic generic drugs

at present, China has become the second largest producer of bulk drugs in the world, and the output of antibiotics and vitamins is among the best in the world. China has been exporting a large number of antibiotic raw materials. In addition, the growth of the demand for imported drugs has been curbed, and the import volume of preparations has declined. The most affected is the imported antibiotics, whose market share has been replaced by domestic and joint-venture drugs. In addition, there are factors such as the high proportion of antibiotics used due to the widespread abuse of antibiotics in developing countries in Asia. Therefore, for a long time to come, the leading role of antibiotics is still generic drugs, which are of high quality and low price, It meets the needs of more than one billion Chinese people. As for the glass bottle containing antibiotics, it will still show a steady growth trend. With social progress and the improvement of people's living standards, the proportion of all kinds of new drugs, special drugs and high-end precious drugs will gradually increase. Such drugs will put forward higher demand for the upgrading and upgrading of pharmaceutical glass, driving the increase of the added value of pharmaceutical glass packaging products

v. impact of other packaging materials on pharmaceutical glass packaging

in recent years, all kinds of packaging materials are competing and replacing 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 cannot change or deteriorate in chemical properties during storage and use. Pharmaceutical glass packaging has become the preferred material for pharmaceutical packaging because of its good chemical stability, air tightness, bright and transparent, high temperature resistance, easy disinfection and a series of physical and chemical properties. As far as antibiotic powder injection is concerned, other packaging materials can't get involved in this field. The main packaging of water injection is glass ampoules, but plastic ampoules and injection integrated packaging (i.e. water injection liquid is directly encapsulated in syringes) have been established abroad. High quality printing ampoules, brown ampoules with dark color and low expansion coefficient still have great development potential. More than 95% of the domestic infusion preparations are packaged in glass, but in the European, American and Japanese markets, except for the glass bottle packaging for high-grade nutritional infusion, the 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