Quality control in generic anthelmintics: is it adequate?
Quality control in generic anthelmintics: is it adequate?
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非专利驱虫药的质量控制：是否足够？
DOI：
10.1016/s0304-4017(97)00022-8
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发表时间：
1997
影响因子：
2.6
通讯作者：
M. Allan
中科院分区：
文献类型：
--
作者：
J. V. van Wyk;F. Malan;L. V. van Rensburg;P. Oberem;M. Allan
我们越来越关注一些非专利驱虫剂可能药效不达标的迹象，特别是在P.C.van Schalkwyk(Personal Communications，1990)发现从国际经纪商获得的一些批次进口非专利产品活性较差，尽管表面上是正常的物理特征之后。因此，考虑到这将对绵羊养殖业造成严重后果，决定测试南非市场上出售的一些非专利拉福沙尼产品的疗效。在三种商业制剂中，有一种对绵羊的已知易感缠绕血吸虫株进行了测试，其中一种明显不合格，算术平均效力为66.2%(B级，Reinecke，1973)，而其他两种商业制剂的A级效力，彼此之间也存在显著差异(Mann-Whitney；P=0.01)。与敏感株相比，三种产品对自然感染部分耐药螺旋体的效果差异更大，相应的算术平均有效率分别为28.7%(X类或无效)、71.3%(B类)和87.7%(B类)。结论是，出现差异的最可能原因是，国际经纪商没有披露不同批次有效成分的供应来源(结果是从他们那里购买驱虫药的公司无法知道何时改变了驱虫药的来源)；这些批次的药效不同；在某些情况下，对个别批次的药效测试不足。建议注册当局在每一批新活性成分上市前，应考虑简化药效测试。
We became increasingly concerned about indications of possible substandard efficacy of some generic anthelmintics, particularly after P.C. van Schalkwyk (personal communication, 1990) had found some batches of imported generic products obtained from international brokers to be poorly active, despite apparently normal physical characteristics. Therefore, considering the serious consequences this would have for sheep farming, it was decided to test the efficacy of some of the generic rafoxanide products available on the South African market. One of the three commercial formulations (of highly reputable companies) tested against a known susceptible strain of Haemonchus contortus in sheep was markedly substandard, with an arithmetic mean efficacy of 66.2% (Class B, Reinecke, 1973), compared to Class A efficacy of the other two, which also differed significantly from one another (Mann-Whitney; P = 0.01). Larger differences were found between the three products against a natural infection with a partially resistant strain of H. contortus than against the susceptible strain, with corresponding arithmetic mean efficacies of 28.7% (Class X, or ineffective), 71.3% (Class B) and 87.7% (also Class B). It is concluded that the most likely reason for the observed differences is that international brokers do not disclose the sources of supply of different batches of active ingredient (with the result that the companies buying anthelmintics from them have no way of telling when a source of suppy is changed); that the efficacy of such batches differs; and that efficacy testing of individual batches in some cases is inadequate. It is suggested that registering authorities should consider simplified efficacy testing of each new batch of active ingredient before it may be marketed.