青霉素V钾胶囊微生物限度检查法的方法学研究

目的:建立青霉素V钾胶囊的微生物限度检查方法。方法:分别采用平皿法、培养基稀释法和薄膜过滤法(每膜100、300、500 ml+青霉素酶)对青霉素V钾胶囊进行微生物限度检查法的研究及控制菌的检查(每膜100、200 ml)。结果 :细菌检查采用薄膜过滤法(每膜500 ml、大于300万u青霉素酶),霉菌和酵母菌采用平皿法,控制菌采用薄膜过滤法(每膜200 ml)时,细菌、霉菌和酵母菌回收率均大于70%。结论:采用薄膜过滤法检查青霉素V钾胶囊中的细菌,平皿法检查霉菌及酵母菌,薄膜过滤法检查控制菌,结果可靠。

Content Determination of 5 Heavy Metals in Shengmai Injections by ICP-MS

OBJECTIVE： To establish the method for the content determination of heavy metals in Shengmai injection as Cu, As, Cd, Hg and Pb. METHODS： ICP-MS was adopted with incident power of 1 550 W, extraction voltage of --143 V, sampling depth of 62 nm; high purity argon was used as carrier at the flow rate of 1.1 L/min. After Shengmai injection digested by micro- wave, the contents of Cu, As, Cd, Hg and Pb were determined by using scandium, germanium, indium and bismuth as internal standard, tea leaf as standard substance of quality control. RESULTS： The calibration curve of heavy metals was in linear relationship （r≥0.999 8） with recovery〉90% （RSD≤2.8%, n=3）. The detection limits of Cu, As, Cd, Hg and Pb were 0.10, 0.06, 0.03, 0.008 and 0.02 ng/ml, respectively. The contents of heavy metals were all in an acceptable range. CONCLUSIONS： The method is simple, accurate, reliable and specific, and it can be used for the content determination of heavy metal in Shengmai injection.