[以抗生素片的稳定性作为其质量的指标之一]。

Antibiotiki Pub Date : 1984-11-01
T P Galkina, I N Khvoshchevskaia, S P Rezvan, S M Chaĭkovskaia
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引用次数: 0

摘要

结合对片剂中抗生素含量的新要求和片剂标示的新程序,采用自然贮存法和加速老化贮存法对片剂中抗生素的稳定性进行了研究。结果表明,加速老化法不适用于检测光盘中的抗生素稳定性,因为使用这种方法观察到抗生素活性的显著下降,这与自然条件下储存方法确定的活性的实际下降不符。装有青霉素或半合成青霉素的盘片在10℃储存时的有效期确定为1.5年。装有耐热抗生素的盘片在10℃储存时的有效期确定为3年。虽然观察到某些抗生素失活,但盘片中的含量仍在规定的限度内,即标签上所示活性的75- 135%。
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[Stability of antibiotics in disks as one of the indicators of their quality].

In connection with the new requirements to the content of antibiotics in discs and a new procedure for the disc labeling stability of antibiotics in discs was studied with the methods of storage under natural conditions and under conditions of accelerated ageing. It was shown that the method of accelerated ageing was not applicable to testing antibiotic stability in discs, since with the use of this method a significant decrease in the antibiotic activity was observed which did not correspond to the real decrease in activity determined with the method of storage under natural conditions. The expiry date of the discs with benzylpenicillin or semisynthetic penicillins was determined to be equal to 1.5 years when stored at 10 degrees C. The expiry date of the discs with thermostable antibiotics was determined to be equal to 3 years when stored at 10 degrees C. Though certain inactivation of the antibiotics was observed, their content in the discs remained within the required limits, i.e. 75-135 per cent of the activity indicated on the label.

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