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国家药监局等4部门联合发布关于结束中药配方颗粒试点工作的公告

阅读量：4

发布时间：2021-08-25

来源：酯香香化学采购网

　　【化工仪器网政策标准】近日，国家药监局、国家中医药局、国家卫生健康委、国家医保局共同发布了《关于结束中药配方颗粒试点工作的公告》，旨在规范中药配方颗粒的生产，引导产业健康发展，更好地满足中医临床需求。

文件为结束中药配方颗粒试点工作提出13条具体要求

　　《公告》指出，为加强中药配方颗粒的管理，规范中药配方颗粒的生产，引导产业健康发展，更好满足中医临床需求，经研究决定结束中药配方颗粒试点工作。

　　具体事项共计13条，分别为一是中药配方颗粒是由单味中药饮片经水提、分离、浓缩、干燥、制粒而成的颗粒，在中医药理论指导下，按照中医临床处方调配后，供患者冲服使用；二是中药配方颗粒品种实施备案管理，不实施批准文号管理，在上市前由生产企业报所在地省级药品监督管理部门备案；三是生产中药配方颗粒的中药生产企业应当取得《药品生产许可证》，并同时具有中药饮片和颗粒剂生产范围；四是中药配方颗粒生产企业应当履行药品全生命周期的主体责任和相关义务，实施生产全过程管理，建立追溯体系，逐步实现来源可查、去向可追，加强风险管理；五是省级药品监督管理部门会同省级中医药主管部门应当结合国家及地方产业政策的有关规定以及临床实际需求制定相应的管理细则，坚持中药饮片的主体地位，确保辖区内中药配方颗粒的平稳有序发展及合理规范使用；六是中药配方颗粒应当按照备案的生产工艺进行生产，并符合国家药品标准；七是国家药典委员会结合试点工作经验组织审定中药配方颗粒的国家药品标准，分批公布。八是跨省销售使用中药配方颗粒的，生产企业应当报使用地省级药品监督管理部门备案。无国家药品标准的中药配方颗粒跨省使用的，应当符合使用地省级药品监督管理部门制定的标准；九是中药配方颗粒不得在医疗机构以外销售；十是中药饮片品种已纳入医保支付范围的，各省级医保部门可综合考虑临床需要、基金支付能力和价格等因素，经专家评审后将与中药饮片对应的中药配方颗粒纳入支付范围，并参照乙类管理；十一是中药配方颗粒调剂设备应当符合中医临床用药习惯，应当有效防止差错、污染及交叉污染，直接接触中药配方颗粒的材料应当符合药用要求；十二是直接接触中药配方颗粒包装的标签至少应当标注备案号、名称、中药饮片执行标准、中药配方颗粒执行标准、规格、生产日期、产品批号、保质期、贮藏、生产企业、生产地址、联系方式等内容；十三是本公告自2021年11月1日起施行。

　　中药配方颗粒试点工作结束三问

　　1.为何结束中药配方颗粒试点工作?

　　根据国家药品监督管理局政策解读来看，在试点期间，中药配方颗粒经过了长期、广泛的临床使用。根据已有的临床观察和医生、患者的感受，中药配方颗粒在中医药理论指导下经配伍使用后在临床显示了一定疗效和使用方便、调配灵活的优势，在患者中确实存在一定的需求。此外，中药配方颗粒产业已发展到一定的市场规模，急需结束中药配方颗粒试点工作。国家药监局经会商国家卫生健康委、国家医保局和国家中医药局，均同意结束中药配方颗粒试点工作。国家药监局、国家中医药局、国家卫生健康委、国家医保局共同发布了《关于结束中药配方颗粒试点工作的公告》，以规范中药配方颗粒的生产，引导产业健康发展，更好地满足中医临床需求。

　　2.结束试点是否意味着对中药配方颗粒监管要求有所改变？

　　结束试点不意味着对中药配方颗粒放松监管，药品监督管理部门将按照“四个严”的要求，强化属地监管，着力加强事中事后监管。根据2018年机构改革“市场监管实行分级管理”的精神和职责分工，省级药品监督管理部门负责药品生产环节的许可、检查和处罚，因此，对中药配方颗粒强化属地监管符合中央的改革要求。强化属地监管绝不是对中药配方颗粒管理的削弱，而是加强，国家药监局也会结合年度考核等事项加强对省级药品监督管理部门的指导和监督。

　　3.如何保障中药配方颗粒的质量？

　　一是是制定“严谨的标准”。国家药监局已在国家药典委员会设立中药配方颗粒专项办公室，组织国家药典委员会制定《中药配方颗粒质量控制及标准制定技术要求》，着手开展标准统一、专家审核工作。《中药配方颗粒质量控制及标准制定技术要求》与公告同步发布。在技术要求中，引入了“标准汤剂”的概念，这使中药配方颗粒工艺制定的合理性和质量控制有了衡量的依据，而且规定了特征图谱质量控制技术的应用，强化了中药配方颗粒的整体质量控制水平。此外，国家药典委员会还制定了《中药配方颗粒标准审评原则要点》《中药配方颗粒申报资料审查表(形式审查)》《中药配方颗粒申报资料审查表(专家用)》及《申报资料目录及要求》等，保证了药品标准审核工作的公平、公正。

　　二是实施生产全过程管理。中药配方颗粒生产企业应履行药品上市许可持有人的相关义务，实施全过程管理，并具有全过程追溯及风险管理能力。生产企业应具备饮片炮制、提取、浓缩、干燥、制粒等完整的生产能力，并制定每个品种详细的生产工艺、标准操作规程，严格执行药品生产质量管理规范(GMP)中的有关规定。中药配方颗粒生产所需中药材，凡是能人工种植养殖的，应当优先使用来源于符合中药材生产质量管理规范要求的中药材种植养殖基地的中药材。

　　三是通过建立专职检查员队伍以及开展抽检等加强事中事后监管。

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/www/dev/zhihuagong/thinkphp/library/think/model/concern/RelationShip.php ( 20.60 KB )
/www/dev/zhihuagong/thinkphp/library/think/model/concern/ModelEvent.php ( 6.04 KB )
/www/dev/zhihuagong/thinkphp/library/think/model/concern/TimeStamp.php ( 2.58 KB )
/www/dev/zhihuagong/thinkphp/library/think/model/concern/Conversion.php ( 7.84 KB )
/www/dev/zhihuagong/application/cms/service/ComponentsService.php ( 12.91 KB )
/www/dev/zhihuagong/application/admin/model/Config.php ( 3.34 KB )
/www/dev/zhihuagong/application/links/model/Links.php ( 0.84 KB )
/www/dev/zhihuagong/application/admin/model/Poster.php ( 0.07 KB )
/www/dev/zhihuagong/application/admin/model/Base.php ( 4.15 KB )
/www/dev/zhihuagong/thinkphp/library/think/facade/Session.php ( 2.05 KB )
/www/dev/zhihuagong/application/admin/model/GoodsCategory.php ( 0.09 KB )
/www/dev/zhihuagong/thinkphp/library/think/exception/ErrorException.php ( 1.68 KB )
/www/dev/zhihuagong/thinkphp/library/think/Exception.php ( 1.61 KB )
/www/dev/zhihuagong/thinkphp/library/think/exception/Handle.php ( 8.96 KB )
/www/dev/zhihuagong/thinkphp/library/think/db/Expression.php ( 1.11 KB )
/www/dev/zhihuagong/thinkphp/library/think/model/Collection.php ( 3.23 KB )
/www/dev/zhihuagong/thinkphp/library/think/Collection.php ( 13.60 KB )
/www/dev/zhihuagong/runtime/temp/b275df7f7078649353258fc8c4a5003e.php ( 37.86 KB )
/www/dev/zhihuagong/thinkphp/library/think/Response.php ( 9.68 KB )
/www/dev/zhihuagong/thinkphp/library/think/debug/Html.php ( 4.02 KB )

[ DB ] CONNECT:[ UseTime:0.000306s ] mysql:host=127.0.0.1;port=3306;dbname=yzncms;charset=utf8
[ SQL ] SHOW COLUMNS FROM `yzn_poster` [ RunTime:0.001136s ]
[ SQL ] SELECT * FROM `yzn_poster` WHERE `cate_id` = 99 AND `p_c_id` = 52 AND `status` = 1 LIMIT 1 [ RunTime:0.000351s ]
[ SQL ] SELECT * FROM `yzn_poster` WHERE `cate_id` = 99 AND `p_c_id` = 55 AND `status` = 1 LIMIT 1 [ RunTime:0.000284s ]
[ SQL ] SHOW COLUMNS FROM `yzn_goods_property` [ RunTime:0.001120s ]
[ SQL ] SELECT `g`.`name`,`p`.`price`,`p`.`unit`,`p`.`type`,`p`.`thumb`,p.id as p_id,`p`.`value`,`p`.`is_where`,`p`.`sku_unit`,`p`.`repeat_type`,`p`.`goods_id` FROM `yzn_goods_property` `p` LEFT JOIN `yzn_goods` `g` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `p`.`recommend` = 1 GROUP BY `p`.`goods_id`,`p`.`repeat_type` ORDER BY `p`.`sort` DESC,`g`.`id` DESC LIMIT 0,15 [ RunTime:0.002426s ]
[ SQL ] SHOW COLUMNS FROM `yzn_goods_category` [ RunTime:0.000834s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `hot_search` = 1 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000389s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `is_show` > 0 AND `status` = 1 ORDER BY `listorder` ASC [ RunTime:0.000296s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `id` IN (1,2,7,16,17,34,92,95,38) [ RunTime:0.000254s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 1 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000233s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 2 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000205s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 7 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000209s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 16 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000223s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 17 AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000203s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` IN (34,92) AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000209s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` IN (95,38) AND `status` = 1 ORDER BY `listorder` ASC,`id` DESC [ RunTime:0.000215s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 1 AND `status` = 1 [ RunTime:0.000186s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 1 [ RunTime:0.000192s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,1,%' ) [ RunTime:0.000219s ]
[ SQL ] SHOW COLUMNS FROM `yzn_goods` [ RunTime:0.000596s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (25,26,29,30,48,1) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000976s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 2 AND `status` = 1 [ RunTime:0.000234s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 2 [ RunTime:0.000212s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,2,%' ) [ RunTime:0.000192s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (42,43,2) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000921s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 7 AND `status` = 1 [ RunTime:0.000219s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 7 [ RunTime:0.000209s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,7,%' ) [ RunTime:0.000193s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (10,14,32,33,49,50,51,52,53,54,55,56,57,58,96,97,7) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000941s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 16 AND `status` = 1 [ RunTime:0.000206s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 16 [ RunTime:0.000196s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,16,%' ) [ RunTime:0.000190s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (59,60,61,62,63,16) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000881s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 17 AND `status` = 1 [ RunTime:0.000213s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` = 17 [ RunTime:0.000196s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,17,%' ) [ RunTime:0.000191s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (40,64,65,66,67,68,100,17) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000896s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 34 AND `status` = 1 [ RunTime:0.000219s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 92 AND `status` = 1 [ RunTime:0.000189s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` IN (34,92) [ RunTime:0.000227s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,34,%' or arrparentid like '0,92,%' ) [ RunTime:0.000212s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (35,70,71,93,94,34,92) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000910s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 95 AND `status` = 1 [ RunTime:0.000204s ]
[ SQL ] SELECT `id`,`catname` FROM `yzn_goods_category` WHERE `pid` = 38 AND `status` = 1 [ RunTime:0.000189s ]
[ SQL ] SELECT * FROM `yzn_goods_category` WHERE `status` = 1 AND `id` IN (95,38) [ RunTime:0.000251s ]
[ SQL ] SELECT `id` FROM `yzn_goods_category` WHERE `status` = 1 AND ( arrparentid like '0,38,%' or arrparentid like '0,95,%' ) [ RunTime:0.000210s ]
[ SQL ] SELECT `g`.`name`,p.id as p_id,`p`.`price`,`p`.`type`,`p`.`thumb`,`p`.`unit`,`p`.`is_where`,`p`.`goods_id`,`p`.`repeat_type` FROM `yzn_goods` `g` LEFT JOIN `yzn_goods_property` `p` ON `p`.`goods_id`=`g`.`id` WHERE `p`.`status` = 1 AND `p`.`is_del` = 0 AND `g`.`is_del` = 0 AND `p`.`is_where` LIKE '%1%' AND `g`.`cate_id` IN (47,74,75,76,77,78,79,80,81,82,83,99,95,38) AND `p`.`hot_sale` = '1' GROUP BY `p`.`repeat_type`,`p`.`goods_id` ORDER BY `p`.`sort` DESC,`p`.`id` DESC LIMIT 0,10 [ RunTime:0.000918s ]
[ SQL ] SHOW COLUMNS FROM `yzn_article` [ RunTime:0.000814s ]
[ SQL ] SELECT `A`.*,`AD`.*,`C`.`catname` FROM `yzn_article` `A` INNER JOIN `yzn_article_data` `AD` ON `A`.`id`=`AD`.`did` INNER JOIN `yzn_category` `C` ON `C`.`id`=`A`.`catid` WHERE `A`.`id` = 5854 AND `A`.`status` = 1 LIMIT 1 [ RunTime:0.000589s ]
[ SQL ] SHOW COLUMNS FROM `yzn_category` [ RunTime:0.000577s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` = 35 AND `status` = 1 [ RunTime:0.000194s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` IN (36,37,38,39,40,41,42) AND `status` = 1 [ RunTime:0.000188s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` = 43 AND `status` = 1 [ RunTime:0.000193s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` IN (44,45,46,47,48,49,50) AND `status` = 1 [ RunTime:0.000193s ]
[ SQL ] SELECT `id` FROM `yzn_category` WHERE `parentid` = 6 AND `status` = 1 [ RunTime:0.000169s ]
[ DB ] CONNECT:[ UseTime:0.000236s ] mysql:host=127.0.0.1;port=3306;dbname=yzncms;charset=utf8
[ SQL ] SELECT `A`.`id`,`A`.`title` FROM `yzn_article` `A` INNER JOIN `yzn_category` `C` ON `C`.`id`=`A`.`catid` WHERE `A`.`status` = 1 AND `A`.`catid` IN (35,36,37,38,39,40,41,42) ORDER BY `A`.`flag` DESC,`A`.`listorder` ASC,`A`.`updatetime` DESC [ RunTime:0.020396s ]
[ SQL ] UPDATE `yzn_article` SET `hits` = `hits` + 1 WHERE `id` = 5854 [ RunTime:0.000283s ]
[ SQL ] SELECT * FROM `yzn_poster` WHERE `cate_id` = 10 AND `p_c_id` = 41 ORDER BY `listorder` ASC LIMIT 4 [ RunTime:0.000345s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `yzn_article` `a` INNER JOIN `yzn_category` `c` ON `a`.`catid`=`c`.`id` WHERE `catid` = 38 AND `a`.`status` = 1 [ RunTime:0.002638s ]
[ SQL ] SELECT `a`.*,`c`.`catname` FROM `yzn_article` `a` INNER JOIN `yzn_category` `c` ON `a`.`catid`=`c`.`id` WHERE `catid` = 38 AND `a`.`status` = 1 ORDER BY `flag` DESC,`listorder` ASC,`updatetime` DESC LIMIT 0,6 [ RunTime:0.004555s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `yzn_article` `a` INNER JOIN `yzn_category` `c` ON `a`.`catid`=`c`.`id` WHERE `catid` = 37 AND `a`.`status` = 1 [ RunTime:0.002497s ]
[ SQL ] SELECT `a`.*,`c`.`catname` FROM `yzn_article` `a` INNER JOIN `yzn_category` `c` ON `a`.`catid`=`c`.`id` WHERE `catid` = 37 AND `a`.`status` = 1 ORDER BY `flag` DESC,`listorder` ASC,`updatetime` DESC LIMIT 0,6 [ RunTime:0.004861s ]