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3款复方制剂通过一致性评价，来自华东医药、福元医药…

2020-09-17 医药魔方 医药魔方

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9月16日，药监局官网显示3款复方制剂通过一致性评价，分别为华东医药的吡格列酮二甲双胍片、华北制药的阿莫西林克拉维酸钾片和福元医药的氯沙坦钾氢氯噻嗪片。其中，后两者为首家通过一致性评价的企业。

9月16日，药监局官网显示3款复方制剂通过一致性评价，分别为华东医药的吡格列酮二甲双胍片、华北制药的阿莫西林克拉维酸钾片和福元医药的氯沙坦钾氢氯噻嗪片。其中，后两者为首家通过一致性评价的企业。

吡格列酮二甲双胍片

吡格列酮二甲双胍片是吡格列酮和二甲双胍组成的复方制剂，用于治疗 2型糖尿病。吡格列酮与二甲双胍联合是国内外权威指南推荐的 2 型糖尿病基础治疗方案之一，具有广泛的临床使用经验和丰富的循证医学证据。两种药物作用机制互补，全面提高胰岛素敏感性，有效降糖的同时正向调节血脂，改善患者血压，降低心血管风险，带来治疗的多重获益。

国内目前只有德源药业和华东医药的吡格列酮二甲双胍片获批上市，前者已经与8月10日首家通过一致性评价。中国药学会样本医院数据（CPA 数据）显示：2019 年国内吡格列酮二甲双胍样本医院总体销售额约 9016 万元。

氯沙坦钾氢氯噻嗪片

氯沙坦钾氢氯噻嗪片是氯沙坦和氢氯噻嗪组成的复方制剂，用于治疗高血压。默沙东原研药海捷亚早在1995年就获得FDA批准上市，峰值销售额超过35亿美元，2019年销售额为4.42亿美元。

国内生产销售氯沙坦钾氢氯噻嗪片的厂家有6家，福元医药为首家通过一致性评价的厂家。除此之外，乐普药业已经于2019年10月提交了一致性评价申请。

阿莫西林克拉维酸钾片

阿莫西林克拉维酸钾片具有广谱抗菌作用，可用于治疗产β-内酰胺酶而对阿莫西林耐药的革兰氏阴性和革兰氏阳性菌引起的各种感染。包括：上呼吸道和下呼吸道感染、中耳炎、急性鼻窦炎、肾炎和下尿道炎以及皮肤和软组织感染。

国内生产销售阿莫西林克拉维酸钾片超过10家，华北制药为该药首家通过一致性评价的厂家。除华北制药外，还有先声药业（4类）、鲁南贝特、湘北威尔曼制药和香港澳美4家企业提交了一致性评价申请。

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#插入话题
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    2021-04-01 zhanfl

    #一致性#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1906950, encodeId=8a9a190695098, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Thu Apr 01 09:22:46 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410060, encodeId=88441410060f2, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444649, encodeId=7cf91444649de, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1601059, encodeId=ae9d160105934, content=<a href='/topic/show?id=dd43426460c' target=_blank style='color:#2F92EE;'>#复方制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42646, encryptionId=dd43426460c, topicName=复方制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=279318829047, createdName=chengjn, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=)]
    2020-09-19 cathymary

    #医药#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1906950, encodeId=8a9a190695098, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Thu Apr 01 09:22:46 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410060, encodeId=88441410060f2, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444649, encodeId=7cf91444649de, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1601059, encodeId=ae9d160105934, content=<a href='/topic/show?id=dd43426460c' target=_blank style='color:#2F92EE;'>#复方制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42646, encryptionId=dd43426460c, topicName=复方制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=279318829047, createdName=chengjn, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=)]
    2020-09-19 huagfeg

    #评价#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1906950, encodeId=8a9a190695098, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Thu Apr 01 09:22:46 CST 2021, time=2021-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410060, encodeId=88441410060f2, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444649, encodeId=7cf91444649de, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1601059, encodeId=ae9d160105934, content=<a href='/topic/show?id=dd43426460c' target=_blank style='color:#2F92EE;'>#复方制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42646, encryptionId=dd43426460c, topicName=复方制剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=279318829047, createdName=chengjn, createdTime=Sat Sep 19 06:22:46 CST 2020, time=2020-09-19, status=1, ipAttribution=)]
    2020-09-19 chengjn

    #复方制剂#

    0