补中益气丸(颗粒)质量分析  

Quality analysis of Buzhong Yiqi Wan(Keli)

作　　者：刘伟[1,2] 蒋秋桃[2] 龙海燕[2] 李顺祥[1] 林海[2] 

机构地区：[1]湖南中医药大学药学院,长沙410208 [2]湖南省药品检验所,长沙410001

出　　处：《中南药学》2011年第12期940-943,共4页Central South Pharmacy

基　　金：国家科技部支撑计划子课题"重大新药创制-中药质量标准研究和信息化体系建设平台"(编号:2009ZX09308-004);国家药典委员会国家药品标准提高行动计划课题(编号:562)

摘　　要：目的对国家评价性抽验品种补中益气丸(颗粒)的检验及探索性研究结果进行统计和分析,评价全国范围内补中益气丸(颗粒)的质量状况,并提出建议。方法采用各品种的法定质量标准对262批补中益气丸蜜丸、水丸、浓缩丸及颗粒剂抽验样品进行检验;针对4种剂型的各自现行质量标准,采取填平补齐,统筹考虑的思路,并结合生产工艺,开展如下探索性研究:①大叶柴胡检查及柴胡TLC鉴别;②有机氯农药残留量检测;③重金属及有害元素测定;④蜂蜜检查;⑤白术、甘草、陈皮、升麻、当归TLC鉴别;⑥含量测定;⑦风险评估。结果 129批蜜丸按法定标准检验有4批不合格(不合格率为3.1%),不合格项目为细菌数超标(2批),甘草薄层鉴别不合格(1批),水分超标(1批);1批浓缩丸按注册标准检验,结果甘草含量不合格;其余98批浓缩丸、30批水丸、4批颗粒剂按中国药典2010年版一部标准检验,全部符合规定。探索性研究方法检验结果为:蜜丸不合格率为22.4%,水丸不合格率为12.6%,浓缩丸不合格率为8.0%,颗粒剂不合格率为0。比较依据中国药典2010年版一部标准检验结果和探索性研究方法检验结果,增加探索性研究方法后可见不合格率增加。结论各剂型现行标准存在或多或少的缺陷,不能有效地控制产品质量,建议加以完善提高;所有企业对法定标准有控制的项目认真对待,对法定标准之外的项目采取的质量控制措施不严格,建议国家食品药品监督管理局组织力量加强对这类企业的GMP检查,以保障患者用药安全有效。Objective To appraise the national quality of Buzhong Yiqi Wan （Keli） and analyze the inspection and ex- ploratory investigations. Methods We used legal criteria to test 262 batches of Buzhong Yiqi Wan, Shuiwan, Nong- suowan and Keli. Considering different production processes, we carried out exploratory investigations as follows： Radix Bupleuri and its analogues, Rhizoma Atractylodis Macrocephalae, Radix et Rhizoma Glycyrrhizae Pra- eparata Cure Melle , Pericarpium Cirri Reticulatae , Rhizorna Cimici f ugae , and Radix Angelicae Sinensis were iden- tified by thin layer chromatography. Chlorine pesticide residues, heavy metal, harmful elements, and honey were de- tected. The contents were determined, and the risk index was evaluated. Results Four out of the 128 batches of Buzhong Yiqi Wan were unqualified （3.1%）. Most batches of Shuiwan, Nongsuowan and Keli were qualified except for 1 batch of Nongsuowan. With the exploratory methods, the unqualified rate of Buzhong Yiqi Wan was 22.4%, and that of Shuiwan was 12.6%, Nongsuowan was 8. 0%, while that of Keli was 0. Conclusion The criteria of Buzhong Yiqi Wan （Keli） are incomplete and may fail to control the quality. We suggest manufacturers take the legal criteria seriously, and the SFDA should strengthen the manufacturers＇ GMP standards to ensure the drug safety.

关 键 词：补中益气丸(颗粒) 质量分析 

分 类 号：R917[医药卫生—药物分析学] R95[医药卫生—药学]