Current situation of pharmaceutical glass packaging (II)
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 analysis of domestic and foreign market status and development needs, controlled bottles have a gradual upward trend. In addition, molded bottles have always occupied the leading 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 do not 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 situation of low-quality and low-cost competition in the ampoule Market and poor anti-interference ability, and the standard configuration of pressure testing machine
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
III. infusion bottle
at present, the drug packaging containing infusion agent is still mainly glass infusion bottle, which is widely used due to its 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 Chinese Pharmacopoeia, the water resistance of the inner surface of glass bottles used for infusion for injection must meet the requirements of grade HC1 and HC2 in gb12416.1 (the standard adopts iso4802 equally). 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. (to be continued)
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