With the improvement of China's pharmaceutical market and the classification and treatment of prescription drugs and non-prescription drugs, they have put forward higher requirements for drug packaging. Nowadays, domestic packaging materials companies are in terms of enterprise scale, production technology, governance level, product variety and quality. Significant progress has been made, new products and new technologies have been widely applied, and backward products and technologies are gradually being phased out.
The medicinal glass has been widely used in the field of pharmaceutical packaging, and is still in the rising stage of development. Manufacturers should pay more attention to the replacement of medicinal glass itself, product upgrades and integration with international standards.
The stability of the drug deteriorates due to the influence of temperature, humidity, air, light, microorganisms and insects. In this case, the upper hand of the glass bottle appears, because of its superior protection and good chemical stability, at the same time, the glass is not affected by the atmosphere, and is not decomposed by solid or liquid substances of different chemical composition. Characteristics, and by changing the chemical composition of the glass, the chemical properties and radiation resistance of the glass can be adjusted. Therefore, the glass becomes a good packaging container for the pharmaceutical industry. It further increases the market value and prospect of medicinal glass. In addition, according to the aesthetic principle and non-polluting principle of drug packaging materials selection, medicinal glass is transparent, beautiful, and low in price and recyclable, unlike PVC materials, it is very difficult to post-process. , bringing extremely serious environmental problems.
Nowadays, because medicinal glass has many incomparable characteristics and advantages, it has been widely used in various types of injections, powder injections, biological drugs, blood products, freeze-dried agents, tablets, oral liquids and other packaging. field.
According to the different uses of products, they can be roughly divided into the following categories:
Infusion package: Domestic large infusion packaging is based on glass infusion bottles. Plastic infusion containers are gradually increasing, but high-quality and lightweight Type II infusion bottles still have certain competitive advantages. The glass infusion bottle has the characteristics of smooth and transparent, easy to disinfect, corrosion resistance, high temperature resistance and good sealing performance. It is still the preferred packaging for common infusion agents.
Oral liquid packaging: Oral liquid preparations are mostly health care products, most of which are packaged in medicinal glass, mainly controlled white and brown oral liquid bottles and molded brown glass bottles.
Freeze-drying agent packaging: The lyophilized agent is packaged in a controlled bottle and a molded bottle. It has been packaged in ampoule and has been basically eliminated.
Tablet and capsule packaging: In recent years, tablets and capsules have been continuously replaced by plastic bottles, aluminum foils, etc., but high-quality, lightweight and dark-proof yellow or white glass bottles still have their irreplaceable advantages and development. space.
Powder injection packaging: powder injection is one of the five major pharmaceutical preparations in China. It is mainly based on various antibiotics. Its packaging is mainly molded injection bottles and controlled injection bottles. At present, in domestic powder injection packaging, molded injection bottles account for 70% to 80%, and controlled injection bottles account for 20% to 30%. The former is characterized by dimensional stability and high strength; the latter is characterized by light weight and good appearance transparency. At present, the control of injection bottles has gradually increased at home and abroad.
Water injection package: The main form of water injection package is ampoule. There are two types of curved necks that are easy to fold in China: one has a nick on the neck of the ampoule, and one mark on the top of the score; the other is a ring of low-melting glass on the neck of the ampoule, due to the color circle and Ampoule glass itself has different expansion coefficients, which can generate local stress and are easily broken.
China is currently in a period of rapid economic and technological development, and the export of medicines is increasing. Foreigners are paying more and more attention to the quality of glass used for packaging medicines. In recent years, although the production of medicinal glass in China has made great progress, it is similar in the international market. Compared with products, there is still a big gap in the production of medicinal glass in China.
The main performances are: low product standard level, poor physical quality, unfair structure, low product grade and low added value, so that the contribution rate of medicinal glass to the pharmaceutical economy is significantly lower than that of developed countries. Therefore, the production of medicinal glass should be in line with the international level as soon as possible. At the standard level, it is necessary to actively adopt international standards, comprehensively improve the product quality level, and establish and improve the standardization system of medicinal glass in China as soon as possible. In terms of type, the international standard ISO12775-1997 clearly states that there are three main types of medicinal glass: 3.3 borosilicate glass, international neutral glass and soda lime glass. Due to the limited technical level in China, it has not been possible to produce international neutral glass with high water resistance, acid resistance and alkali resistance. In the future, it should gradually transition and focus on the development of international neutral glass. In terms of material properties, international neutral glass and 3.3 borosilicate glass particles can reach level 1 water resistance. Although China's low borosilicate glass particle method is mostly grade 1 and some is grade 2, if the amount of alkali precipitation is slightly observed, it is several times larger than international neutral glass. In terms of the limit of harmful substances, the amount of precipitation of As, Sb, Pb and Cd in glass is regulated internationally. As a medicinal glass with high safety and hygiene requirements, China should limit the amount of harmful elements to ensure the safety of the people. The test method should be developed from the original qualitative, semi-quantitative to quantitative and separately quantitative. For example, if the inner surface is water-resistant, the color change method of methyl red acid solution has been used in the past. Now, the total alkali titration method is used, and the Na, K, and Ca are quantitatively determined internationally.
As a major branch of the pharmaceutical packaging industry, medicinal glass will continue to be an important pharmaceutical packaging material for a long period of time. We are looking forward to the continuous development of China's medicinal glass packaging bottle market, and actively develop its potential, and will take a share in the world pharmaceutical packaging stage in the near future.
The medicinal glass has been widely used in the field of pharmaceutical packaging, and is still in the rising stage of development. Manufacturers should pay more attention to the replacement of medicinal glass itself, product upgrades and integration with international standards.
The stability of the drug deteriorates due to the influence of temperature, humidity, air, light, microorganisms and insects. In this case, the upper hand of the glass bottle appears, because of its superior protection and good chemical stability, at the same time, the glass is not affected by the atmosphere, and is not decomposed by solid or liquid substances of different chemical composition. Characteristics, and by changing the chemical composition of the glass, the chemical properties and radiation resistance of the glass can be adjusted. Therefore, the glass becomes a good packaging container for the pharmaceutical industry. It further increases the market value and prospect of medicinal glass. In addition, according to the aesthetic principle and non-polluting principle of drug packaging materials selection, medicinal glass is transparent, beautiful, and low in price and recyclable, unlike PVC materials, it is very difficult to post-process. , bringing extremely serious environmental problems.
Nowadays, because medicinal glass has many incomparable characteristics and advantages, it has been widely used in various types of injections, powder injections, biological drugs, blood products, freeze-dried agents, tablets, oral liquids and other packaging. field.
According to the different uses of products, they can be roughly divided into the following categories:
Infusion package: Domestic large infusion packaging is based on glass infusion bottles. Plastic infusion containers are gradually increasing, but high-quality and lightweight Type II infusion bottles still have certain competitive advantages. The glass infusion bottle has the characteristics of smooth and transparent, easy to disinfect, corrosion resistance, high temperature resistance and good sealing performance. It is still the preferred packaging for common infusion agents.
Oral liquid packaging: Oral liquid preparations are mostly health care products, most of which are packaged in medicinal glass, mainly controlled white and brown oral liquid bottles and molded brown glass bottles.
Freeze-drying agent packaging: The lyophilized agent is packaged in a controlled bottle and a molded bottle. It has been packaged in ampoule and has been basically eliminated.
Tablet and capsule packaging: In recent years, tablets and capsules have been continuously replaced by plastic bottles, aluminum foils, etc., but high-quality, lightweight and dark-proof yellow or white glass bottles still have their irreplaceable advantages and development. space.
Powder injection packaging: powder injection is one of the five major pharmaceutical preparations in China. It is mainly based on various antibiotics. Its packaging is mainly molded injection bottles and controlled injection bottles. At present, in domestic powder injection packaging, molded injection bottles account for 70% to 80%, and controlled injection bottles account for 20% to 30%. The former is characterized by dimensional stability and high strength; the latter is characterized by light weight and good appearance transparency. At present, the control of injection bottles has gradually increased at home and abroad.
Water injection package: The main form of water injection package is ampoule. There are two types of curved necks that are easy to fold in China: one has a nick on the neck of the ampoule, and one mark on the top of the score; the other is a ring of low-melting glass on the neck of the ampoule, due to the color circle and Ampoule glass itself has different expansion coefficients, which can generate local stress and are easily broken.
China is currently in a period of rapid economic and technological development, and the export of medicines is increasing. Foreigners are paying more and more attention to the quality of glass used for packaging medicines. In recent years, although the production of medicinal glass in China has made great progress, it is similar in the international market. Compared with products, there is still a big gap in the production of medicinal glass in China.
The main performances are: low product standard level, poor physical quality, unfair structure, low product grade and low added value, so that the contribution rate of medicinal glass to the pharmaceutical economy is significantly lower than that of developed countries. Therefore, the production of medicinal glass should be in line with the international level as soon as possible. At the standard level, it is necessary to actively adopt international standards, comprehensively improve the product quality level, and establish and improve the standardization system of medicinal glass in China as soon as possible. In terms of type, the international standard ISO12775-1997 clearly states that there are three main types of medicinal glass: 3.3 borosilicate glass, international neutral glass and soda lime glass. Due to the limited technical level in China, it has not been possible to produce international neutral glass with high water resistance, acid resistance and alkali resistance. In the future, it should gradually transition and focus on the development of international neutral glass. In terms of material properties, international neutral glass and 3.3 borosilicate glass particles can reach level 1 water resistance. Although China's low borosilicate glass particle method is mostly grade 1 and some is grade 2, if the amount of alkali precipitation is slightly observed, it is several times larger than international neutral glass. In terms of the limit of harmful substances, the amount of precipitation of As, Sb, Pb and Cd in glass is regulated internationally. As a medicinal glass with high safety and hygiene requirements, China should limit the amount of harmful elements to ensure the safety of the people. The test method should be developed from the original qualitative, semi-quantitative to quantitative and separately quantitative. For example, if the inner surface is water-resistant, the color change method of methyl red acid solution has been used in the past. Now, the total alkali titration method is used, and the Na, K, and Ca are quantitatively determined internationally.
As a major branch of the pharmaceutical packaging industry, medicinal glass will continue to be an important pharmaceutical packaging material for a long period of time. We are looking forward to the continuous development of China's medicinal glass packaging bottle market, and actively develop its potential, and will take a share in the world pharmaceutical packaging stage in the near future.
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