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眼膏剂溢漏试验是《中国药典》1985年版(二部)新增加的检查项目,笔者共考查眼膏剂31批,检验结果符合规定的只有4批,不符合规定的达27批(详见附表)。由此看出眼膏溢漏试验不符合规定现象十分严重,值得引起重视.就此提出几点建议供商榷。 1试验中溢漏一般都产生在眼管头部,尾部较少,主要原因系塑料螺帽耐热性及螺帽与锡管头匹配性差所致,建议眼膏生产厂家对上述包装问题进行探讨和改进。 2试验在60±3℃下保温8h,根据自然高温一般都在45℃以下的特点,保温度可订在50±3℃较宜。 3标准规定“不得发生明显溢漏”,概念较模糊不好控制,没有一定的量值,可否采用度量滤纸上溢漏浸润斑点大小作为判断依据。
Eye ointment spill test is “Chinese Pharmacopoeia” 1985 edition (two) new inspection items, the author a total of 31 batches of eye ointment inspection, the test results meet the provisions of only 4 batches, not up to the provisions of up to 27 batches (see attached table). This shows that the ointment spill test does not comply with the provisions of the phenomenon is very serious, deserves attention. In this regard to make a few suggestions for discussion. 1 Spillage in the test are generally produced in the eye tube head, the tail less, mainly due to the plastic nut heat resistance and poor matching nut and tin head, it is recommended eye ointment manufacturers to explore the packaging issues discussed And improve. 2 test incubated at 60 ± 3 ℃ 8h, according to the natural high temperature are generally below 45 ℃, the holding temperature can be set at 50 ± 3 ℃ is appropriate. 3 standard stipulates that “no significant spillage occurs,” the concept of fuzzy control is not good, there is no certain amount of value, can be used to measure the size of the filter paper overflow leak wet spots as a basis for judging.