ABSTRACT
OBJECTIVE: To evaluate the clinical safety differences between 2-chamber drug delivery system method and syringe method in preparation of intravenous fluids. METHODS: The light blockage method was used to record the count of insoluble particals in samples of before and after preparation through the 2-chamber drug delivery system method or syringe method. RESULTS: After preparation by the syringe method, the number of insoluble particles of each particle size increased significantly, P < 0.05; while the 2-chamber drug delivery system method does not increase the insoluble particle number after preparation; the solution contains significantly more ≥ 10 μm insoluble particles in the syringe method than in the 2-chamber drug delivery system method, P < 0.05. CONCLUSION: 2-Chamber drug delivery system method can significantly reduce the introduction of insoluble particles in the process of intravenous infusion preparation comparing with the syringe method, and despite of what the environment is, has a better clinical safety.
ABSTRACT
OBJECTIVE: To determine the insoluble particles in human immunoglobulin (pH 4) for intravenous injection and human hepatitis B immunoglobulin(pH 4) for intravenous injection in both liquid and freeze-dried forms from 14 domestic manufacturers. METHODS: Thirty-two batches of human immunoglobulin products including 19 batches of human immunoglobulin (pH 4) for intravenous injection, 5 batches of human immunoglobulin (pH 4) for intravenous injection (freeze-dried), 5 batches of human hepatitis B immunoglobulin (pH 4) for intravenous injection, and 3 batches of human hepatitis B immunoglobulin(pH 4) for intravenous injection (freeze-dried) were tested by light obscuration particle count test method recommend by appendix of 2010 CHP by GWF-8JA laser particle size analyzers. Insoluble particles greater than 10 and 25 μm were counted, respectively. Microscopy counting was carried out if the test results from light blockage method did not meet the qualification criteria in 2010 ChP. Trend analysis and comparison of the results from NIFDC and enterprises were done. RESULTS: The test results of insoluble particles in 32 batches of human immunoglobulin products indicate that 90.6%(29/32) of the products complied with the requirement of 2010 ChP and the results were in agreement between NIFDC and enterprises. Unfortunately, 3 batches of human immunoglobulin(pH 4) for intravenous injection(freeze-dried) failed in light obscuration particle count test, however, they met the requirement of 2010 ChP when microscopy counting method was used. CONCLUSION: The quality control of human immunoglobulin products in China market is generally fine, and the test results from different laboratories are basically consistent. Test result of insoluble particles in freeze-dried IVIG by microscopy counting method and light obscuration particle count test method show significant difference.
ABSTRACT
OBJECTIVE:To detect the insoluble particles in six kinds of traditional Chinese medicine injections. METHODS: The insoluble particles in six kinds of traditional Chinese medicine injections were detected by light blockage method specified in China Pharmacopeia (2005 edition). RESULTS: Insoluble particles of different size and number were noted in all the 6 kinds of traditional Chinese medicine injections. CONCLUSION:It is necessary to tighten control on the quality of traditional Chinese medicine injections and attach great importance to the monitoring of insoluble particles in drug use.