At present, with the continuous innovation of the pharmaceutical industry and the increasing attention of society to drug safety, glass container products as drug packaging materials are also facing great challenges Some industry experts pointed out that China's pharmaceutical glass containers must be upgraded, and it is urgent to vigorously develop high-precision first-class water-resistant neutral borosilicate glass
5.0 glass has a significant advantage
it is understood that medicinal glass containers are usually used for the packaging of liquid drug injections, oral agents, and solid drug powder injections (dissolved before use) and tablets Among them, the injection products have the strictest requirements for the neutrality of glass - the drugs do not react with the glass packaging containers, so the reaction is learned in the purchase process, and the glass containers will not precipitate their constituent substances under the action of liquid drugs In recent years, the technology and equipment level of China's pharmaceutical industry has been constantly improving, which puts forward higher requirements for packaging materials. The market needs high-precision first-class water-resistant glass At the same time, the pharmaceutical industry pays special attention to the influence of the precipitation of some substances in glass products on drugs in the study of the compatibility between drugs and packaging products, and the detection of the physical and chemical functions of packaging products is becoming more and more strict Therefore, it is urgent to produce medicinal glass containers that meet the international advanced level
in developed countries, neutral borosilicate pharmaceutical glass is widely used in the pharmaceutical industry at present Neutral borosilicate medical glass is strictly defined in USP Ⅹxi, and corresponding standards are formulated for the anti-aging, water resistance, alkali resistance, acid resistance, corrosion resistance and other functions of glass products The expansion coefficient of neutral borosilicate medical glass is ×/℃ (℃), also known as "5.0 glass" This kind of product has high dimensional accuracy, which can adapt to the improvement of the filling equipment of the predecessors; The physical and chemical functions of the products are not disordered, and the shelf life of pornographic drugs is relatively long
according to industry expert lideyu, the pharmaceutical glass packaging containers currently produced and used in China are called "semi neutral borosilicate pharmaceutical glass" products in the industry Except for a few developing countries, most countries in the world do not have such formulas and products The coefficient of expansion of this glass is 70 ×/℃, also known as "7.0 glass", its chemical stability cannot meet the neutral requirements. When taking drugs with high pH value, alkaline substances in the glass are very easy to precipitate, thus affecting the quality of drugs; There is no clear specification for the content of heavy metals in glass; Because of the poor size accuracy, this kind of products cannot be applied in the filling machine that pharmaceutical manufacturers improve their predecessors. Therefore, at present, 7.0 pharmaceutical packaging glass containers are difficult to be internationally recognized, and it is also one of the main reasons why it is difficult for China's pharmaceutical products to automatically collect and process experimental data to enter the international market
the current materials need to be replaced urgently
Li Deyu was once the technical director of Baoji pharmaceutical glass factory and the distinguished expert of Beijing glassware factory. He once guided the establishment of China's leading neutral pharmaceutical glass production line, and guided the prospect of the first new energy vehicle in China to score 10 points. He created borosilicate glass 3.3 velo process to produce solar glass tubes (this project won the second prize of national technology improvement in 2000) Li Deyu is worried about the current situation of domestic pharmaceutical glass container industry "The production of domestic 7.0 glass has the phenomenon of repeated construction with low level, high energy consumption and low output, forming a vicious competition with low scale, low quality and low price, which will only lead to the decline of product quality and affect the quality and safety of drugs."
the imperfect industry scale and product scale, and the low threshold of industry access lead to vicious competition in the pharmaceutical packaging glass industry Shen Changzhi, director of the glass container Expert Committee of China Pharmaceutical Packaging Association, pointed out that in order to regulate the investment behavior of pharmaceutical glass, promote structural adjustment, reduce energy consumption, protect the environment, and achieve coordinated and sustainable development, relevant parties should speed up the pace to formulate the access prerequisites for the pharmaceutical glass industry
however, for the pharmaceutical industry, the urgent task is to eliminate the "semi neutral borosilicate pharmaceutical glass" as soon as possible and replace it with high-precision "5.0 glass", so as to shorten the gap between China's pharmaceutical glass and the world's advanced level, and create a good premise for domestic drugs to enter the international market while ensuring drug safety According to relevant statistics, at present, the annual demand for high-precision first-class water-resistant borosilicate glass (i.e. 5.0 glass) in China is about 3000 tons, which basically depends on imports
"in fact, China is fully capable of producing high-precision first-class water resistant glass." Li Deyu said that as early as the late 1980s, Baoji pharmaceutical glass factory had produced high-quality 5.0 glass At that time, the former National Medical Administration Bureau determined through bidding that Baoji pharmaceutical glass factory introduced the neutral glass (7800) production line of Corning Corporation of the United States, and officially put into production in November 1989. The 7800 (5.0 glass) neutral glass tubes produced were sent to Corning Corporation of the United States for testing three times, which fully reached the quality standard of similar products of Corning Corporation Since then, Beijing glassware factory has introduced a full set of pharmaceutical neutral glass production technology and process equipment from Japan neg, and has achieved rich results in practical application It can be seen from this that China has the technology and ability to produce 5.0 glass "I hope that enterprises can seize the opportunity, display the existing technology at home and make our own first-class medical glass packaging products. The relevant parts should standardize the domestic medical glass packaging product market, improve the product quality standard, and vigorously promote the production of high-precision 5.0 glass. Once the production volume of 5.0 glass is achieved, one furnace of second-line and one furnace of third line will rise one after another, and its economies of scale and environmental protection effects will appear. At that time, China's medical glass bags The clothing industry is expected to step into the ranks of the world's advanced. "
China has established a long-term strategic cooperative relationship in aluminum supply and demand, technical cooperation, management and talent exchange. Cai Hong, vice president of the China Pharmaceutical Packaging Association, said that the "premise for access to the pharmaceutical glass industry" (discussion draft) prepared by the China Pharmaceutical Packaging Association will be defined from the aspects of production enterprise layout, process and equipment, variety and quality, energy consumption, environmental protection, etc, The progress of access threshold will also open the way for the development of high-precision 5.0 glass products