《中国药典》2020年版第一增补本中药各论品种增修订梳理及参考方案-医疗器械网

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《中国药典》2020年版第一增补本中药各论品种增修订梳理及参考方案

来源：岛津（上海）实验器材有限公司分类：动态 2023-12-07 17:53:36 12阅读次数

导读

10月12日，国家药监局发布公告，《中国药典》2020年版第一增补本已编制完成，将于明年3月12日正式实施。

岛津技术团队对药典一部中药增修订项目变化进行了汇总。津津老师发现多个品种标准【含量测定】项目发生了较大变化，为了帮助广大用户更好应对即将实施的第一增补本药典，做好相关检测项目调整，岛津对增修订标准做了梳理，并提供参考方案。

PARTY 01

中药各论品种部分增修订项目变化汇总表

以上汇总项目均使用HPLC方法测定，标准并未提到使用小粒径色谱柱，常规色谱柱即可满足要求。

从表格可以看到，修订品种中有3个主要变化：

1、含牛黄和人工牛黄处方的中成药在含量测定项目增加了“胆红素”测定项目

2、三七总皂苷及血塞通、血栓通系列品种含量测定方法修订为一标多测法

3、石淋通片增订了指纹图谱项目和含量测定项目

PARTY 02

含牛黄和人工牛黄处方的中成药“胆红素”测定参考方案

● 分析条件

分析仪器：岛津 Nexera LC-40 D液相色谱仪

色谱柱：Shim-pack GISS C18 (5 μm， 4.6×250 mm；P/N：227-30061-07)

柱温：30 ℃

检测波长：450 nm

流速：1 mL/min

进样量：5 μL

流动相：乙腈-1%冰醋酸溶液（95：5）

● 胆红素对照品溶液

结果显示，胆红素峰形良好，理论塔板数大于5000，满足人参再造丸、牛黄降压胶囊、牛黄降压丸标准要求，可为含牛黄和人工牛黄处方的中成药“胆红素”项目提供参考。

PARTY 03

三七总皂苷含量测定参考方案

● 分析条件

分析仪器：岛津LC-20AD液相色谱仪

色谱柱：ShimNex UP C18（ 5 μm，4.6×250 mm；P/N：380-01231-49）

柱温：25 ℃

检测波长：203 nm

流速：1.5 mL/min

进样量：10 μL

流动相：A：水 B：乙腈

● 对照提取物溶液

结果显示，人参皂苷 Rg₁与人参皂苷 Re的分离度大于2.0（第一增补本三七总皂苷及血塞通、血栓通系列品种要求大于1.8），理论塔板数按人参皂苷大于48000（第一增补本三七总皂苷及血塞通、血栓通系列品种要求大于6000），技术指标满足第一增补本标准要求，可为相关制剂含量测定提供参考。

更多第一增补本增修订品种应用方案即将推出，敬请期待！

本文内容非商业广告，仅供专业人士参考。

更多色谱柱选型

可参考《岛津液相色谱柱综合目录》

点击立即阅读

往期回顾

从前处理到上机分析，马兜铃酸检测完整解决方案

赛事聚焦｜药斯卡争霸赛半期排行榜揭晓！

2020药典｜益母草膏中盐酸水苏碱的含量测定

特色方案｜麦角固醇有关物质分析

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[8]未定义数组索引: page
[8]未定义数组下标: 0
[2]Declaration of app\common\model\News::getAllList($filter = Array, $limit = 16, $order = Array, $with = Array) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[2]Declaration of app\common\model\Company::getAllList($filter = Array, $limit = 20) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8]未定义数组索引: center
[8]Only variables should be passed by reference
[2]Declaration of app\common\model\NewsComment::getAllList($filter = Array, $limit = 16) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8192]Function create_function() is deprecated
[8192]Function create_function() is deprecated
[8]未定义数组索引: area
[8]未定义数组索引: st
[2]Declaration of app\common\model\Topic::getList($filter = Array) should be compatible with app\common\model\BaseModel::getList($filter = Array, $sort = Array)
[2]Declaration of app\common\model\Topic::getAllList($filter = Array, $field = 'id,md5,tit...', $limit = 0) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[2]Declaration of app\common\model\TopicInfoList::getAllList($filter = Array, $limit = 8) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[8]未定义数组索引: center
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: cid
[8]未定义数组索引: goods_list
[8]未定义数组下标: 0
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[8]未定义数组索引: center
[2]Declaration of app\common\model\Tag::getAllList($filter = Array, $with = Array, $limit = 5) should be compatible with app\common\model\BaseModel::getAllList($filter = Array, $with = Array, $limit = 0, $sort = Array, $field = 'a.*', $join = Array)
[2]Declaration of app\common\model\Tag::remove($filter) should be compatible with app\common\model\BaseModel::remove($filter = Array)
[8]未定义数组索引: center
[8]未定义数组索引: wtt_list

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[ SQL ] SHOW COLUMNS FROM `news_category` [ RunTime:0.001058s ]
[ SQL ] SELECT `id`,`name` FROM `news_category` WHERE `is_show` = 1 [ RunTime:0.000252s ]
[ SQL ] SELECT * FROM `news_category` WHERE `parent_id` = 0 AND `is_show` = 1 ORDER BY `sort` ASC,`id` DESC [ RunTime:0.000322s ]
[ SQL ] SHOW COLUMNS FROM `company` [ RunTime:0.000874s ]
[ SQL ] SHOW COLUMNS FROM `news` [ RunTime:0.000789s ]
[ SQL ] SELECT * FROM `news` WHERE `md5` = 'c0c2371b5bd5465f' AND `review_status` = 1 LIMIT 1 [ RunTime:0.000275s ]
[ SQL ] SHOW COLUMNS FROM `user_info` [ RunTime:0.000789s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` = 203 [ RunTime:0.000731s ]
[ SQL ] SELECT * FROM `company` WHERE `id` = 321 [ RunTime:0.000223s ]
[ SQL ] SHOW COLUMNS FROM `news_text` [ RunTime:0.000770s ]
[ SQL ] SELECT * FROM `news_text` WHERE `news_id` = 3201 [ RunTime:0.034301s ]
[ SQL ] SHOW COLUMNS FROM `news_belong_category` [ RunTime:0.000973s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 3201 [ RunTime:0.001647s ]
[ SQL ] SELECT * FROM `news_category` WHERE `id` IN (7) [ RunTime:0.000195s ]
[ SQL ] SHOW COLUMNS FROM `user_follow` [ RunTime:0.000825s ]
[ SQL ] SELECT `id` FROM `user_follow` WHERE `user_id` IS NULL AND `follow_user_id` = 203 LIMIT 1 [ RunTime:0.000203s ]
[ SQL ] SHOW COLUMNS FROM `news_comment` [ RunTime:0.000805s ]
[ SQL ] SELECT * FROM `news_comment` WHERE `news_id` = 3201 AND `parent_id` = 0 ORDER BY `id` DESC [ RunTime:0.000222s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `news_comment` WHERE `news_id` = 3201 LIMIT 1 [ RunTime:0.000176s ]
[ SQL ] SELECT * FROM `news` WHERE `is_show` = 1 AND `review_status` = 1 AND `id` IN (3201,5896,4607,3512,3492,4298,3513,3491,539,7857) ORDER BY field(id,3201,5896,4607,3512,3492,4298,3513,3491,539,7857) [ RunTime:0.000434s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` IN (203,1,252) [ RunTime:0.000790s ]
[ SQL ] SHOW COLUMNS FROM `topic` [ RunTime:0.000946s ]
[ SQL ] SELECT `id`,`md5`,`title`,`created_time` FROM `topic` WHERE `review_status` = 1 ORDER BY `id` DESC LIMIT 4 [ RunTime:0.000189s ]
[ SQL ] SHOW COLUMNS FROM `topic_info_list` [ RunTime:0.000847s ]
[ SQL ] SELECT * FROM `topic_info_list` WHERE `topic_id` = 1 ORDER BY `id` DESC LIMIT 2 [ RunTime:0.000180s ]
[ SQL ] SELECT * FROM `news` WHERE `id` IN (864,849) [ RunTime:0.000283s ]
[ SQL ] SELECT `id`,`md5`,`title`,`created_time` FROM `news` WHERE `review_status` = 1 AND `is_show` = 1 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.000209s ]
[ SQL ] SHOW COLUMNS FROM `user` [ RunTime:0.000817s ]
[ SQL ] SELECT `a`.* FROM `user` `a` INNER JOIN `news` `b` ON `a`.`id`=`b`.`user_id` GROUP BY `a`.`id` ORDER BY `b`.`id` DESC LIMIT 10 [ RunTime:0.009531s ]
[ SQL ] SELECT * FROM `user_info` WHERE `user_id` IN (351,466,458,209,372,521,819,385,657,412) [ RunTime:0.000774s ]
[ SQL ] SHOW COLUMNS FROM `seo` [ RunTime:0.000869s ]
[ SQL ] SELECT * FROM `seo` WHERE `column_type` = '02' AND `page_type` = 'news' AND `info_id` = 3201 LIMIT 1 [ RunTime:0.000204s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 3201 [ RunTime:0.001813s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 5896 [ RunTime:0.001739s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 4607 [ RunTime:0.001636s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 3512 [ RunTime:0.001596s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 3492 [ RunTime:0.001616s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 4298 [ RunTime:0.001590s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 3513 [ RunTime:0.001609s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 3491 [ RunTime:0.001602s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 539 [ RunTime:0.001597s ]
[ SQL ] SHOW COLUMNS FROM `tag` [ RunTime:0.000953s ]
[ SQL ] SELECT `md5` FROM `tag` WHERE `is_open` = 1 AND `tag` = '中国空间站' LIMIT 1 [ RunTime:0.000232s ]
[ SQL ] SELECT * FROM `news_belong_category` WHERE `news_id` = 7857 [ RunTime:0.001646s ]
[ SQL ] SELECT * FROM `user` WHERE `id` = 203 LIMIT 1 [ RunTime:0.000188s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 351 LIMIT 1 [ RunTime:0.000198s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 351 LIMIT 1 [ RunTime:0.000162s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 466 LIMIT 1 [ RunTime:0.000157s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 466 LIMIT 1 [ RunTime:0.000167s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 458 LIMIT 1 [ RunTime:0.000158s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 458 LIMIT 1 [ RunTime:0.000154s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 209 LIMIT 1 [ RunTime:0.000156s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 209 LIMIT 1 [ RunTime:0.000172s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 372 LIMIT 1 [ RunTime:0.000160s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 372 LIMIT 1 [ RunTime:0.000157s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 521 LIMIT 1 [ RunTime:0.000159s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 521 LIMIT 1 [ RunTime:0.000162s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 819 LIMIT 1 [ RunTime:0.000161s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 819 LIMIT 1 [ RunTime:0.000156s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 385 LIMIT 1 [ RunTime:0.000159s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 385 LIMIT 1 [ RunTime:0.000161s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 657 LIMIT 1 [ RunTime:0.000159s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 657 LIMIT 1 [ RunTime:0.000156s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `follow_user_id` = 412 LIMIT 1 [ RunTime:0.000159s ]
[ SQL ] SELECT COUNT(*) AS tp_count FROM `user_follow` WHERE `user_id` = 412 LIMIT 1 [ RunTime:0.000160s ]

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