金银花配方颗粒评价性抽验结果分析与建议
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摘要
目的:通过开展金银花配方颗粒评价性抽验,比较分析不同厂家金银花配方颗粒的质量情况,并提出监管建议。方法:收集各企业金银花配方颗粒质量标准,依据企业标准进行法定检验。结果:共抽验117批金银花配方颗粒,涉及9家生产企业。按各自企业标准进行检验,总体合格率为100%。但是各企业之间金银花配方颗粒含量差异较大且每克颗粒相当的药材(饮片)量不同,转移率不同。结论:通过本次抽验发现金银花配方颗粒的整体质量较高,但是不同厂家之间所用原料药材及生产工艺存在一定差异,导致最终产品质量参差不齐。因此,有必要规范中药配方颗粒生产工艺,尽快统一标准,加强监管。
Objective: To compare and analyze the qualities of Jinyinhua formula granules from different manufacturers through the nationwide sampling inspection of Jinyinhua formula granules, and to propose some regulatory suggestions. Methods: Quality standards of Jinyinhua formula granules from different manufacturers were collected, and the statutory inspection was carried out according to standards of the manufacturers. Results:A total of 117 batches of Jinyinhua formula granules were collected from 9 manufacturers. The overall pass rate of the inspections carried out according to standards of the manufacturers was 100%. However, the content of chlorogenic acid and cynaroside in the Jinyinhua formula granules varied greatly among different manufacturers and the amount of medicinal prepared slices(yinpian) equivalent to one gram granule was different. The transfer rate was also different. Conclusion: The overall qualities of the Jinyinhua formula granules are proved good through the sampling inspection. But there are some differences in raw materials and production process among different manufacturers, resulting in the uneven qualities of final products. Therefore, it is necessary to standardize the production process, unify the standards of Chinese medicinal formula granules as soon as possible, and strengthen the regulations.
Objective: To compare and analyze the qualities of Jinyinhua formula granules from different manufacturers through the nationwide sampling inspection of Jinyinhua formula granules, and to propose some regulatory suggestions. Methods: Quality standards of Jinyinhua formula granules from different manufacturers were collected, and the statutory inspection was carried out according to standards of the manufacturers. Results:A total of 117 batches of Jinyinhua formula granules were collected from 9 manufacturers. The overall pass rate of the inspections carried out according to standards of the manufacturers was 100%. However, the content of chlorogenic acid and cynaroside in the Jinyinhua formula granules varied greatly among different manufacturers and the amount of medicinal prepared slices(yinpian) equivalent to one gram granule was different. The transfer rate was also different. Conclusion: The overall qualities of the Jinyinhua formula granules are proved good through the sampling inspection. But there are some differences in raw materials and production process among different manufacturers, resulting in the uneven qualities of final products. Therefore, it is necessary to standardize the production process, unify the standards of Chinese medicinal formula granules as soon as possible, and strengthen the regulations.
引文
[1]原国家食品药品监督管理总局.《中药配方颗粒管理办法(征求意见稿)》意见的公告(2015年第283号)[EB/OL].(2015-12-24)[2018-10-30].http://samr.cfda.gov.cn/WS01/CL1037/140101.html.
[2]朱桂花,徐秀丽.浅谈中药配方颗粒的优劣势与发展前景[J].中医临床研究,2014,6(2):132-133.
[3]郑舟.中药配方颗粒的发展与革新探讨[J].中医临床研究,2017,9(23):132-134.
[4]李芹.单味中药浓缩颗粒的特点及发展前景分析[J].时珍国医国药,2006,17(10):2006-2007.
[5]浙江省人力资源和社会保障厅.关于开展中药配方颗粒纳入浙江省基本医疗保险支付范围试点工作的通知:浙人社发[2015]94号[EB/OL].(2015-08-20)[2015-08-25].http://www.zjhrss.gov.cn/art/2015/8/25/art_1443137_7666.html.
[6]李建会,张霄潇,荆志伟.中药配方颗粒合理放开竞争发展的思考[J].中医药管理杂志,2016,24(13):7-10.
[7]杨建文,石凤鸣.中药颗粒剂的成本-效益分析[J].遵义医学院学报,2003,26(1):80-83.
[8]杨蓉,曹俊岭,郑虎占,等.中药配方颗粒与传统汤剂对比性研究概述[C]//中华中医药学会2013年药房管理分会学术年会论文汇编,2013:381-385.
[9]韩振蕴,蔡舒婷,张斐姝,等.中药配方颗粒临床使用中存在问题的调研与分析[J].中华中医药杂志,2017,32(7):2862-2864.
[10]刘卉.配方颗粒角逐市场,标准仍待统一[N].医药经济报,2017-10-26(007).
[11]中国药典:一部[S].2015:221.
[12]国家药典委员会.中药配方颗粒质量控制与标准制定技术要求(征求意见稿)[EB/OL].(2016-08-02)[2018-10-30].http://www.chp.org.cn/view/ff808081559d1ea301565ac24962560d?a=XWJX.
[13]国家药品监督管理局.国家药品监督管理局颁布中药配方颗粒质量标准研究的技术要求[S].2001.
[14]代云桃,李琦,范自全,等.中药饮片标准汤剂的质量评价案例-金银花[J].中国中药杂志,2017,42(5):809-811.
[15]韩志祥,范志红,刘敏,等.中药配方颗粒标准化研究现状分析[J].中国医院药学杂志,2010,30(1):84-85.
[16]李汉成,邓仙梅,彭孝鹏,等.中药配方颗粒标准化研究现状分析[J].中国中医药信息杂志,2017,24(7):1367-1375.
[17]陈士林,刘安,李琦,等.中药饮片标准汤剂研究策略[J].中国中药杂志,2016,41(8):11-14.
[18]贺爱玲.中药配方颗粒临床应用现状分析及展望[J].中国药事,2017,31(10):1205-1209.
[19]高彩霞.中药配方颗粒临床应用医学理论商榷[J].中国药事,2011,25(8):758-760.
[20]张国平,刘媛媛.中药配方颗粒临床应用标准探讨[J]临床合理用药,2011,4(5B):105-106.
[21]韩振蕴,蔡舒婷,张斐姝,等.中药配方颗粒临床使用中存在问题的调研与分析[J].中华中医药杂志,2017,32(7):2862-2864.
[2]朱桂花,徐秀丽.浅谈中药配方颗粒的优劣势与发展前景[J].中医临床研究,2014,6(2):132-133.
[3]郑舟.中药配方颗粒的发展与革新探讨[J].中医临床研究,2017,9(23):132-134.
[4]李芹.单味中药浓缩颗粒的特点及发展前景分析[J].时珍国医国药,2006,17(10):2006-2007.
[5]浙江省人力资源和社会保障厅.关于开展中药配方颗粒纳入浙江省基本医疗保险支付范围试点工作的通知:浙人社发[2015]94号[EB/OL].(2015-08-20)[2015-08-25].http://www.zjhrss.gov.cn/art/2015/8/25/art_1443137_7666.html.
[6]李建会,张霄潇,荆志伟.中药配方颗粒合理放开竞争发展的思考[J].中医药管理杂志,2016,24(13):7-10.
[7]杨建文,石凤鸣.中药颗粒剂的成本-效益分析[J].遵义医学院学报,2003,26(1):80-83.
[8]杨蓉,曹俊岭,郑虎占,等.中药配方颗粒与传统汤剂对比性研究概述[C]//中华中医药学会2013年药房管理分会学术年会论文汇编,2013:381-385.
[9]韩振蕴,蔡舒婷,张斐姝,等.中药配方颗粒临床使用中存在问题的调研与分析[J].中华中医药杂志,2017,32(7):2862-2864.
[10]刘卉.配方颗粒角逐市场,标准仍待统一[N].医药经济报,2017-10-26(007).
[11]中国药典:一部[S].2015:221.
[12]国家药典委员会.中药配方颗粒质量控制与标准制定技术要求(征求意见稿)[EB/OL].(2016-08-02)[2018-10-30].http://www.chp.org.cn/view/ff808081559d1ea301565ac24962560d?a=XWJX.
[13]国家药品监督管理局.国家药品监督管理局颁布中药配方颗粒质量标准研究的技术要求[S].2001.
[14]代云桃,李琦,范自全,等.中药饮片标准汤剂的质量评价案例-金银花[J].中国中药杂志,2017,42(5):809-811.
[15]韩志祥,范志红,刘敏,等.中药配方颗粒标准化研究现状分析[J].中国医院药学杂志,2010,30(1):84-85.
[16]李汉成,邓仙梅,彭孝鹏,等.中药配方颗粒标准化研究现状分析[J].中国中医药信息杂志,2017,24(7):1367-1375.
[17]陈士林,刘安,李琦,等.中药饮片标准汤剂研究策略[J].中国中药杂志,2016,41(8):11-14.
[18]贺爱玲.中药配方颗粒临床应用现状分析及展望[J].中国药事,2017,31(10):1205-1209.
[19]高彩霞.中药配方颗粒临床应用医学理论商榷[J].中国药事,2011,25(8):758-760.
[20]张国平,刘媛媛.中药配方颗粒临床应用标准探讨[J]临床合理用药,2011,4(5B):105-106.
[21]韩振蕴,蔡舒婷,张斐姝,等.中药配方颗粒临床使用中存在问题的调研与分析[J].中华中医药杂志,2017,32(7):2862-2864.