苏州市域内不同厂家阿莫西林口服制剂的质量分析

Quality Analysis of Amoxicillin Oral Preparations from Different Manufacturers in Suzhou

目的:分析近3年苏州市域内生产和流通的阿莫西林口服制剂的质量状况,为阿莫西林口服制剂的质量安全保驾护航。方法:抽取苏州市域内不同厂家阿莫西林口服制剂43批次(其中胶囊剂34批次、分散片剂6批次和颗粒剂3批次)作为研究资料,参照《中国药典》和国家标准等规范性资料,分析不同批次阿莫西林口服制剂的杂质含量、药物含量、溶出度和聚合物含量等指标。结果:在杂质含量方面,34批次胶囊剂中23批次的总杂质含量为0.30%~1.90%,余11批次胶囊剂按国家标准检验杂质含量且结果符合标准要求,6批次分散片剂的总杂质含量为0.18%~0.28%;在药物含量方面,34批次胶囊剂的结果为91.42%~101.95%,6批次分散片剂的结果为93.30%~97.44%,3批次颗粒剂的结果为98.93%~101.31%;在溶出度方面,34批次胶囊剂的测定结果为85.67%~103.80%,6批次分散片剂的测定结果为81.33%~100.64%;在聚合物含量方面,34批次胶囊剂中有33批次采用Sephadex G-10型凝胶柱分离测定,测得结果为0.01%~0.18%,另有1批次采用TSK-GEL G2000SWXL型凝胶色谱柱的分子排阻反相高效液相色谱法(reverse phase-high performance liquid chromatography,RP-HPLC)检测,测得结果为0.60%。结论:抽检的43批次阿莫西林口服制剂在杂质含量、药物含量、溶出度和聚合物含量等指标方面均符合国家标准,且同一企业药品在相关指标上波动较小,但不同企业药品在相关指标上存在较大差异,故相关行政管理部门有必要持续开展药品的质量检查,确保患者的用药安全。

Objective:To investigate the quality status of amoxicillin oral preparations produced and circulated in Suzhou in the past three years,so as to protect the quality and safety of amoxicillin oral preparations.Methods:A total of 43 batches of amoxicillin oral preparations(including 34 batches of capsules,6 batches of dispersible tablets and 3batches of granules)from different manufacturers in Suzhou were selected as the study data,and the impurity content,drug content,dissolution and polymer content of amoxicillin oral preparations in different batches were analyzed with reference to the normative data such as the Chinese Pharmacopoeia and national standards.Results:In terms of impurity content,the total impurity content of 23 of 34 batches of capsules was 0.30%-1.90%;the impurity content of the remaining 11 batches of capsules was tested according to the national standard,and the test results met the standard requirements,and the total impurity content of 6 batches of dispersible tablets was 0.18%-0.28%.In terms of drug content,the results of 34 batches of capsules were 91.42%-101.95%,the results of 6 batches of dispersible tablets were 93.30%-97.44%,and the results of 3 batches of granules were 98.93%-101.31%.In terms of dissolution,the determination results of 34 batches of capsules were 85.67%-103.80%,and the determination results of 6 batches of dispersible tablets were81.33%-100.64%.In terms of polymer content,33 of 34 batches of capsules underwent separation test with Sephadex G-10 gel column,and the results were 0.01%-0.18%.Another batch was tested by molecular exclusion reverse phase high performance liquid chromatography(RP-HPLC)with TSK-GEL G2000SWXL gel column,and the results were0.60%.Conclusion:The indicators of the 43 batches of amoxicillin oral preparations such as impurity content,drug content,dissolution and polymer content meet the national standards,and drugs from the same manufacturer fluctuate slightly in the relevant indicators,but drugs from different manufacturers have great differences in the relevant indicators,so it is necessary for the relevant administrative departments to continue to carry out quality inspection on drugs to ensure the drug safety of patients.