检索规则说明:AND代表“并且”;OR代表“或者”;NOT代表“不包含”;(注意必须大写,运算符两边需空一格)
检 索 范 例 :范例一: (K=图书馆学 OR K=情报学) AND A=范并思 范例二:J=计算机应用与软件 AND (U=C++ OR U=Basic) NOT M=Visual
作 者:许永彬 唐立超 王亚君 郑淑凤 XU Yong-bin;TANG Li-chao;WANG Ya-jun;ZHENG Shu-feng(Xiamen Institute of Food and Drug Quality Control,Xiamen 361012,China)
机构地区:[1]厦门市食品药品质量检验研究院,福建厦门361012
出 处:《海峡药学》2023年第8期30-33,共4页Strait Pharmaceutical Journal
基 金:2021年国家药品抽检计划项目(编号:2021-82)。
摘 要:目的 对不同厂家右美沙芬愈创甘油醚糖浆包材的质量进行评价。方法 采用气相色谱-质谱联用法,对3个厂家6批次不同加速时间的右美沙芬愈创甘油醚糖浆塑化剂的含量进行测定;用药品附带的量杯,按照说明书规定的用法用量量取药品,用重量法考察分剂量结果,并进行统计分析。结果 3个厂家共6批样品加速试验至0 d、45 d、60 d均未检出所测18种塑化剂,在加速试验至第90天时,B厂家有一批检出邻苯二甲酸二异丁酯(DIBP),含量为0.03 mg·kg-1。4个分剂量体积准确性总体均在90%~100%范围内;量取药液体积越小,分剂量的准确性、均一性及合格率越差;三个厂家所附分剂量量杯不能完全满足分剂量需求。结论 包材质量良好,量杯分剂量准确性有待提高。建议调整分剂量的工具和方法。OBJECTIVE To evaluate the quality of packaging materials of Dextromethorphan Hydrobromide and Guaifenesin Syrup from different manufacturers.METHODS Determination of plasticizers in 6 batches of Dextromethorphan Hydrobromide and Guaifenesin Syrup from 3 manufacturers with different acceleration time by gas chromatography-mass spectrometry.Dextromethorphan Hydrobromide and Guaifenesin Syrup was divided using the measuring devices included in the products and operated as the usage and dosage according to the drug instructions.Accuracy of divided doses was evaluated according to weight method and statistically analyzed.RESULTS A total of 6 batches of samples from 3 manufacturers did not detect 18 kinds of plasticizers at 0 d,45 d and 60 d after accelerated test.When the accelerated test reached 90d,one batch of manufacturer B detected diisobutyl phthalate(DIBP),with the content of 0.03 mg·kg-1.The overall accuracy of 4 sub-dose volumes was 90%-100%.The smaller the volume of the liquid,the worse the accuracy,uniformity and qualification rate of the dose.The measuring devices included in the products from three manufacturers cannot completely meet the requirements of divided doses.CONCLUSION The quality of packaging materials is good.There is still left to be improved about the accuracy of the measuring devices included in the products.It is suggested to modify the tools and methods of dose division.
关 键 词:右美沙芬愈创甘油醚糖浆 包材 塑化剂 分剂量
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在链接到云南高校图书馆文献保障联盟下载...
云南高校图书馆联盟文献共享服务平台 版权所有©
您的IP:216.73.216.7