盐酸氨溴索口服溶液质量评价

Quality evaluation ambroxol hydrochloride oral solution

目的:评价国产盐酸氨溴索口服溶液的质量现状。方法:按照法定标准检验127批次产品,结合标准内检验结果对产品的抑菌剂、甜味剂、有关物质和开瓶稳定性等开展探索性研究。结果:按法定标准检验所有批次样品,合格率为100.0%。探索性研究结果表明抑菌剂、甜味剂的添加种类和用量各企业之间存在较大差异;各企业杂质水平差异明显,且有22%的产品杂质B超出拟定限度;大部分产品开瓶后稳定性较好,但仍有7.9%的产品发生了不同程度的降解。结论:目前盐酸氨溴索口服溶液总体质量较好,但仍存在一定的可提示性质量安全风险;现行质量标准有待完善和统一。

Objective:To evaluate the quality of ambroxol hydrochloride oral solution.Methods:The 127 batches of ambroxol hydrochloride oral solutions were tested according to the statutory quality standards,antibacterial agent,sweetener,related substance and stability after opening of samples were studied based on inspected results within standard.Results:The qualified rate of all samples detected by the statutory quality standards was 100.0%.The results of exploratory research indicated that the types and dosage of bacteriostatic agent and sweetener were quite different among different enterprises,The impurity level of the enterprises were significantly different,and the results of determinated impurity B showed that 22% of the sample exceeded the proposed limit.Most of the samples had good stability after opening the bottle,but 7.9% of the samples were degraded to different degrees.Conclusion:At present,the overall quality of ambroxol hydrochloride oral solution is good,but there are still some suggestive quality and safety risks.The current standard should be improved and unified.