Okada K, Kawamura N, Ohkoshi M
Jpn J Antibiot. 1985 Oct;38(10):2815-20.
Variations in the actual doses with vials and ampules due to causes of dosage forms and human operations have been discussed. The differences between the labeled doses and actually administered doses with ampules and vials have been studied. The comparison of resulting blood levels revealed peaks of 4.88 +/- 1.08 micrograms/ml and 3.85 +/- 0.71 micrograms/ml actually determined with ampule preparations and vial preparations, respectively, showing some appreciable differences. These values were analyzed with compartment models. Cmax values were 5.13 micrograms/ml and 3.94 micrograms/ml, respectively, showing significant differences (P less than 0.05) between the ampule and vial preparations. However, AUC and Tmax values were equal to each other, so that it was assumed that there would be no problem about the similarity of the 2 types of dosage forms. As to the differences due to human operations, the nurse A did normally collect only 83.0% (75.2 mg) volume of the labeled doses of vials, and, even when she did it with greater care, she collected still 90.0% (81.5 mg) of the labeled doses. On the other hand, the nurse B normally collected 89.8% (81.4 mg) of the labeled dose of vials, and when she used greater care, she collected 92.4% (83.7 mg) of the labeled doses. In the group of ampule preparations, the nurses A and B collected 93.1% (94.8 mg) and 98.1% (99.9 mg), respectively. It was beyond the amount expected in advance for the actually collected dose from ampules. The differences in the collected doses between ampules and vials were within the expected range because ampule preparations usually contain approximate 10% overage, but as to the differences added to this difference due to the human operations, the nearly twice as much speed for collecting the filled preparation by the nurse A would not have been denied for the smaller doses collected on the basis of the above-mentioned results. It was noted therefore that care should be taken in collecting the filled doses from containers into injection syringes.
已讨论了由于剂型和人为操作原因导致的小瓶和安瓿实际剂量的差异。研究了安瓿和小瓶的标示剂量与实际给药剂量之间的差异。对所得血药浓度的比较显示，安瓿制剂和小瓶制剂实际测定的峰值分别为4.88±1.08微克/毫升和3.85±0.71微克/毫升，显示出一些明显差异。这些值用房室模型进行了分析。Cmax值分别为5.13微克/毫升和3.94微克/毫升，安瓿制剂和小瓶制剂之间显示出显著差异（P<0.05）。然而，AUC和Tmax值彼此相等，因此假定这两种剂型的相似性不存在问题。至于人为操作造成的差异，护士A通常仅收集小瓶标示剂量的83.0%（75.2毫克）体积，即使她更加小心地操作，她仍收集了标示剂量的90.0%（81.5毫克）。另一方面，护士B通常收集小瓶标示剂量的89.8%（81.4毫克），当她更加小心操作时，她收集了标示剂量的92.4%（83.7毫克）。在安瓿制剂组中，护士A和护士B分别收集了93.1%（94.8毫克）和98.1%（99.9毫克）。这超出了预先预期的安瓿实际收集剂量。安瓿和小瓶之间收集剂量的差异在预期范围内，因为安瓿制剂通常含有约10%的过量，但至于由于人为操作而叠加在此差异上的差异，根据上述结果，对于收集的较小剂量，护士A收集灌装制剂的速度几乎快两倍是不可否认的。因此，注意从容器中收集灌装剂量到注射器中时应小心。
