2种军队医院制剂微生物限度检查方法的建立

Validation of Microbial Limit Test Methods for Two Hospital Preparations

目的建立新肾炎胶囊和炎黄保肾胶囊2种军队医院制剂方便有效的微生物限度检查方法,并对该方法进行验证。方法按《中国药典》2020年版(四部)通则1105、1106检查法,采用中和法(中和剂为10 mol·L^(-1) NaOH)进行方法适用性试验,计算试验菌回收比值。结果采用中和剂10 mol·L^(-1) NaOH调节pH 7.0无菌氯化钠-蛋白胨缓冲液的pH值为8.0,并结合培养基稀释法,可消除新肾炎胶囊和炎黄保肾胶囊的抑菌作用,使各试验菌回收比值均在0.5~2.0,符合《中国药典》要求。结论中和法(中和剂为10 mol·L^(-1) NaOH)可用于2种医院制剂的微生物限度检查。

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 method according to general rules 1105 and 1106 in ChP 2020 VolⅣ.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 microbial limit test of two hospital-made preparations.