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2026
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Biocompatibility Verification of Medicinal Silicon Dioxide: Safety Barrier from In Vitro Tests to Clinical Application
Biocompatibility is the core threshold for medicinal silicon dioxide to enter the pharmaceutical field.
Biocompatibility is the core threshold for medicinal silicon dioxide to enter the pharmaceutical field, which requires systematic verification in three major dimensions: chemistry, physics and biology, to ensure that it has no adverse interaction with human tissues and drug components. Chemical verification covers acid-base stability and redox stability, ensuring that it does not degrade in gastric fluid (pH 1.2) and intestinal fluid (pH 6.8) environments, and does not undergo chemical reactions with drugs.
Biocompatibility verification includes three key tests: in vitro cytotoxicity test using L929 cell line to ensure cell survival rate >90%; animal toxicity test through oral administration to mice with no toxic reaction observed within 7 days; human skin irritation test showing no adverse reactions such as redness, swelling and itching. In addition, drug compatibility tests are required to verify its impact on drug content and dissolution rate. For example, when mixed with amoxicillin and stored for 6 months, the drug content decline rate is less than 2%.
The Company has a complete verification system: it has established a laboratory compliant with Good Laboratory Practice (GLP) standards, which can carry out 12 biocompatibility tests. The products have passed ISO 10993 certification, and separate verification schemes are formulated for injectable grade and oral grade. Among them, injectable grade products are additionally subjected to hemolysis test and sensitization test to ensure the safety of clinical application, and have obtained long-term qualified supplier qualifications from many pharmaceutical companies.
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