Validation of Microbial Limit Test Methods for Two Hospital Preparations
Objective To establish and verify a user-friendly and effective microbial limit test method for two hospital-made preparations-Xinshenyan capsules and Yanhuangbaoshen capsules.Methods The neutralization method(neutralizer 10 mol·L-1 NaOH)was adopted to test the applicability of this meth-od according to general rules 1105 and 1106 in ChP 2020 Vol Ⅳ.Recoveries were calculated.Results The antibacterial effect of Xinshenyan capsules and Yanhuangbaoshen capsules could be eliminated and the recoveries dropped to 0.5 to 2.0,when the pH value of pH 7.0 sterile sodium chlorine-peptone buffer was adjusted to 8.0 by using the neutralizer 10 mol·L-1 NaOH and the test solution dilution method was used.Conclusion The neutralization method(neutralizer 10 mol·L-1 NaOH)can be used for the microbi-al limit test of two hospital-made preparations.
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