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Pharmaceutical glass materials (Part 2)

the stability of drugs is closely related to drug packaging. If the drugs are not packed properly, even if the drugs meet the national standards when leaving the factory, they are easy to be damaged and deteriorated during storage and transportation. Therefore, before choosing packaging for drugs, we must fully consider the various factors that packaging materials affect the stability of drugs

there are many external factors that affect the stability of drugs and make drugs deteriorate, including temperature, humidity, air, light, micro increase, harmonious development of society, biology and insects, etc. "Because glass has superior protective properties and good chemical stability, at the same time, because 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 glass can be adjusted by changing the chemical composition of glass, glass has become the most commonly used packaging container for drugs." Li Daoguo, director of the quality department of Shandong Pharmaceutical Glass Co., Ltd. (hereinafter referred to as Shandong Pharmaceutical glass), told that although Shandong Pharmaceutical glass is the largest pharmaceutical glass manufacturer in China, it is still constantly developing the pharmaceutical glass market, which is safe, convenient and fast "because we are optimistic about the market value and Prospect of pharmaceutical glass"

"in addition, according to the aesthetic and pollution-free principles of the selection of drug packaging materials, pharmaceutical glass is transparent, beautiful, cheap and recyclable. Unlike PVC materials, it is very difficult to post-treatment, which brings extremely serious environmental protection problems." Li Daoguo emphasized

Schott glass tube Co., Ltd. in Germany, which is internationally famous, has produced medicinal glass for hundreds of years. Dr. romec, its chief technical consultant, said in an interview that the reason why it is so persistent in the production of medicinal glass is that "hundreds of years of inspection have proved that glass is safe for drugs, and we don't want packaging materials to affect the quality of drugs." It has become an industry consensus to integrate with the world

although China's pharmaceutical glass production has achieved great development in recent years, there is still a large gap between China's pharmaceutical glass production and the international similar products with advanced level. The low level of product standards, poor physical quality, unreasonable structure, low product grade and added value make the contribution rate of medicinal glass to the pharmaceutical economy significantly lower than that of developed countries

Jiang Zhongao, director and senior engineer of Beijing glass and ceramics quality supervision and testing center, said that China is currently in a period of rapid economic and technological development through hr30t. Drug exports are increasing, and foreign businessmen pay more and more attention to the quality of glass used for packaging drugs. Therefore, the production of pharmaceutical glass should be in line with international standards from the following aspects as soon as possible

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

second, in terms of types, the international standard ISO 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, in the past, the Discoloration method of methyl red acid solution was used. Now UTM can also be used for product quality control. The total alkali titration method should be used. Internationally, Na, K and Ca should be quantitatively determined respectively

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