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2022

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07

Classification and Performance Comparison of Medicinal Glass at Home and Abroad


1、 Relevant requirements for the classification of medicinal glass materials at home and abroad

China divides medicinal glass into four categories (high boron, medium boron, low boron, and sodium calcium) based on its composition and properties. The main indicators are the content of silicon trioxide and the average coefficient of thermal expansion; According to the water resistance of glass in Europe and America, glass is divided into four categories (I, II, III, IV), with the main indicators being surface water resistance, water resistance of glass particles, and water resistance of etched glass.

2、 The comparison of surface water resistance testing methods can be seen from the above table. Both surface water resistance and glass particle water resistance are judged based on the volume of hydrochloric acid consumed both domestically and internationally. If the measurement methods at home and abroad are the same, then high, medium, and low borosilicate glass in China is equivalent to Type I bottles in Europe and America; The domestic sodium calcium glass is slightly inferior to Type III bottles in Europe and America; In terms of acid resistance, YBB00342004-2015 gravimetric method is used in China, while titration method is used in Europe and America, and the measurement results are not comparable.

EP10.0 Glass containers and the general rules of the 2020 edition of the Chinese Pharmacopoeia< 4006> Comparison of measurement methods for water resistance of internal surfaces

From the above table, it can be seen that the internal surface water resistance measurement methods of EP10.0 and Chinese Pharmacopoeia 2020 are basically the same, and the measurement results are comparable.

3、 Comparison of testing methods for particle water resistance

EP10.0 Glass containers and the general rules of the 2020 edition of the Chinese Pharmacopoeia< 4001> Comparison of Measurement Methods for Particle Water Resistance

The determination method for internal surface water resistance in EP10.0 is basically the same as that in Chinese Pharmacopoeia 2020, and the results are comparable.

3、 Applicable scope of domestic and foreign medicinal glass bottles

There is no clear regulation on the scope of application for different types of medicinal glass in China. The European Union and the United States have recommended the scope of application for different performance medicinal glass, as shown in the table below

Domestic recommendations should also be made based on the performance of different materials of glass, indicating the direction for the selection of glass packaging materials for drug research and development.

4、 Thinking

To some extent, China's quality control of medicinal glass has reached international standards, with even more inspection items than Europe and America. For example, compared to European and American countries, there are more tests for 98 ℃ particle water resistance and alkali resistance in China. However, according to the current classification methods of medicinal glass (high, medium, low borosilicate glass, sodium calcium silicate glass), it is difficult to distinguish its scope of application, It is recommended that drug approval departments classify different glass materials based on their performance and recommend their applicability. When selecting pharmaceutical glass, pharmaceutical factories can choose appropriate pharmaceutical glass based on the characteristics of the drug (such as acid resistance, alkali resistance, high temperature resistance, etc.) to meet the requirements of drug safety, effectiveness, and controllable quality.