Effect of polydimethylsiloxane membrane on the quality characteristics of medium borosilicate glass tube injection bottles
10.19778/j.chp.2024.03.016
- VernacularTitle:聚二甲基硅氧烷膜对中硼硅玻璃管制注射剂瓶质量特性的影响研究
- Author:
Jianzhang LIU
1
;
Tao ZHANG
;
Jian BAO
;
Yuchi HU
;
Zhishun CHEN
;
Xu LIU
;
Nan JIANG
Author Information
1. 北京市药品包装材料检验所,北京 100035
- Keywords:
polydimethylsiloxane membrane;
medium borosilicate glass tube injection bottle;
quality characteris-tics;
inner surface water resistance;
physical properties;
element leaching amount
- From:
Drug Standards of China
2024;25(3):307-312
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate effects of polydimethylsiloxane coating on the quality characteristics and qual-ity control methods of medium borosilicate glass tube injection bottles,including appearance,identification,physi-cal properties,water resistance of inner surface and element leaching amount.Methods:Nine batches of coated medium borosilicate glass tube injection bottles and corresponding medium borosilicate glass tube injection bottles from three companies were used to evaluate whether the quality control method of medium borosilicate glass tube in-jection bottles after polydimethylsiloxane film was modified,and to evaluate the effect of coating on the quality char-acteristics of bottles.Results:The coating did not have effect on appearance,identification and physical properties of medium borosilicate glass tube injection bottle.The coating process did not damage the original performance of the medium borosilicate glass tube injection bottle,and lead to the matters with special attention on the inspection method.The water resistance of the inner surface of the coated medium borosilicate glass tube injection bottle was improved.The leaching amounts of harmful elements such as arsenic,antimony,lead and cadmium before and after coating were low,indicating that the coating process did not increase the leaching risk of these harmful elements.The leaching amounts of elements were determined by ICP-OES,and no significant changes were found in most metal elements.Conclusion:The appearance,identification,physical properties and element leaching quality con-trol method of medium borosilicate glass tube injection bottle after poly dimethylsiloxane film coating do not need to be changed.The water resistance of the inner surface after coating is improved,and there is no significant adverse effect on other quality characteristics.
