Safety & Misconceptions / Practitioner article安全与误区 · 医师专栏

The Class With the Record: What the Record Says, and Why Registration Screening Catches It

有记录的那一类:资料怎么记录它,为什么注册审查能把关

Hong Kong's Chinese Medicine Regulatory Office page sets out the cause, the symptoms and the management item by item; the same page sets the herbs "without aristolochic acid" beside those "with" it, each with its botanical source and appearance — and Hong Kong's recorded cases were exactly a mix-up between plants of two families. This part covers what that page records, why it is identification material for the person composing a mix, and how NPRA's List A, List B and testing requirement hold this class at the registration step.
香港卫生署中医药规管办公室的页面逐项写明它的成因、症状与处理;同一页还把「不含马兜铃酸」与「含马兜铃酸」的药材并排,各自写明来源与外形——香港记录过的个案,正是把两科植物认错了。这一篇说明那一页记录了什么、它为什么是一份给配药的人用的鉴别资料,以及 NPRA 的 List A、List B 与送检规定为什么能在注册这一关把住这一类。
Part 2 of 6 in the "Chinese herb risks and checkpoints" series. The list of the other five is at the foot of this part.

Part 1 drew the boundary: what has a record is Aristolochia plants, which contain aristolochic acid. This part takes the next question — how the record describes it, and how the recorded cases actually happened.

The short version

  • Hong Kong's Chinese Medicine Regulatory Office page sets out the cause of poisoning, the symptoms and the management item by item; it does not describe how the acid acts inside the body, so this part stops in the same place.
  • Hong Kong's recorded cases were a mix-up between plants of two families: similar names, similar looks, different botanical sources.
  • That is why the same page sets the herbs "without" beside those "with". It is identification material for the person composing a mix, not a self-check list for a reader.
  • What NPRA's step controls is the formulation: prohibited ingredients may not be in it, and products containing List A or List B plants must be tested. "Registered" means checked for this class, not that everything about it is safe.

First, the things that cannot wait

⚠️ A safety note: TCM and Western medicine complement each other; it is not a choice between them. If you experience a severe allergic reaction (such as difficulty breathing or facial swelling) or loss of consciousness after taking herbs, call 999 now, or go to the nearest hospital emergency department.

Who needs extra care, what to do first if you feel unwell, and the reason behind each item are in part 6.

A note: this section is general information only. For conditions like these, follow your doctor's diagnosis and treatment, and seek medical attention when you need it.

I. The four stations a medicine passes through, and the lines the record keeps

Three small heaps of dried herb pieces on separate squares of paper, with tweezers beside them

A medicine that enters the body passes four stations: absorption in the gut, entry into the blood and distribution through the body, metabolism in the liver, excretion by the kidneys — that is how the Hong Kong Hospital Authority's pharmacist and Chinese medicine pharmacist put it in a public lecture.

They use these four stations to show where Chinese and Western medicines affect each other: the first four routes each happen at one station, and the last two are the effects themselves adding up or cancelling out. The six routes, each with the Hospital Authority's own example, are in section II of "Can You Take Chinese Herbs With Western Medication?" (/chinese-herbs-with-western-medicine/); here we borrow only the four-station frame rather than repeat that article.

The reason for borrowing it is simple: when a class of herb causes a problem, the place it does so is one of those four stations.

① How the record describes it. Hong Kong's Chinese Medicine Regulatory Office page sets it out item by item. Cause of poisoning: aristolochic acid is highly toxic, can cause kidney failure and urinary-tract cancer, and the page states it has been classified by the World Health Organization as a 「甲級致癌物」 (甲级 carcinogen). Symptoms of poisoning: kidney failure and urinary-tract cancer, and in severe cases even death. Management: seek medical attention immediately.

That page records the consequences and what to do; it does not describe how the acid acts inside the body — nothing on the mechanism, nothing on whether it accumulates, nothing on dose. So this article stops there too.

A note: this section is general information only. For conditions like these, follow your doctor's diagnosis and treatment, and seek medical attention when you need it.

II. Where things went wrong: one name, plants from two families

② Hong Kong's recorded cases were 寻骨风 (Aristolochia family) used in place of 白英 (nightshade family), and 广防己 (Aristolochia family) in place of 防己 (of the 防己 family), leading to adverse reactions to Chinese medicine — the same page's account.

The page then sets the herbs "without aristolochic acid" beside those "with" it: 白毛藤 against 寻骨风, 川木通 against 关木通, 防己 and 川木香 against 广防己 and 青木香, each with its botanical source and appearance. Similar names, similar looks, different plants: that is why the checkpoint sits at identification and sourcing.

One thing needs saying plainly: that paired material is for the person composing the mix, not a checklist for you to run at home. What it gives is botanical source and morphology, usable only with the material in hand and training behind it. What you can do is not identify a herb but ask where the packet came from and who composed it — parts 3 and 4 cover both.

💡 Remember: the risk in this class is not in the words "Chinese herbs"; it is in a herb being mistaken for another one. So the checkpoint sits at sourcing and identification, not at drinking a little less.

III. Why "registered" is the checkpoint for this class

③ NPRA's guideline states that prohibited ingredients are not allowed in the formulation of natural products registered by the Authority, and that the whole Aristolochia genus is totally banned. For botanicals known or suspected to contain aristolochic acid (List A), and botanicals that may be adulterated with it (List B), products containing them must be sent to a governmental doping centre for testing, with the result attached to the registration form — all in the same guideline.

List B includes 木通 (Akebia), 川木通 (Clematis armandii), 川木香 (Vladimiria souliei), and Stephania species other than 粉防己. 川木通 and 川木香 are the very two herbs set beside 关木通 and 青木香 on the Hong Kong page. And 粉防己 itself (Stephania tetrandra, the "防己 of the 防己 family" on that Hong Kong page) is separately listed in NPRA's banned table, with the reason "Reported to cause kidney toxicity".

Put together: a product with a MAL number is one whose formulation was checked against the banned list, and, if it contains a List A or List B plant, was tested before registration. Hong Kong applies the same logic to proprietary medicines containing Asarum herbs: "no aristolochic acid detectable" is written into the quality standard. "Registered" means "checked for this class". It does not mean "everything about it is safe".

④ Where this checkpoint does not reach. Loose herbs and a practitioner's own dispensing are exempt from registration, so they do not pass through that formulation review — the wording of the exemption, what holds that kind instead, and how to check a packaged product are all in part 3.

These are the regulators' own listed examples, not a list where anything unlisted is safe.

A note: this section is general information only. For conditions like these, follow your doctor's diagnosis and treatment, and seek medical attention when you need it.

The words in this part

All four are words the material itself uses: the first from the Hospital Authority's lecture, the other three written into NPRA's registration guideline.

  • Absorption, distribution, metabolism, excretion (吸收、分布、代谢、排泄) — the Hospital Authority's four stations for a medicine's journey through the body: absorption in the gut, entry into the blood and distribution through the body, metabolism in the liver, excretion by the kidneys.
  • List A and List B — two lists in NPRA's guideline. List A is "Botanicals Known or Suspected to contain Aristolochic Acid"; List B is "Botanicals that may be Adulterated with Aristolochic Acid". Both do the same job: a product containing a listed plant must be tested before registration.
  • Adulterated (掺入) — something mixed into a formulation that should not be in it. List B's title uses this word, so what it targets is not what a plant contains in itself.
  • Totally banned (整属禁用) — the guideline's footnote states that products containing other listed herbs may be tested and the result attached, except for Aristolochia species, which are totally banned: not some species, all of them.

Frequently asked

If it has a MAL number, does that mean this bottle is safe? No. The number means this product went through the registration review — under NPRA's guideline its formulation has to be checked against the banned list, and if it contains a List A or List B plant it has to be tested too. What the review controls is whether the formulation contains anything it should not, not whether this bottle suits you — that second question belongs to the consultation. How to check a number is in part 3. If you have an existing kidney condition, follow your doctor's diagnosis and treatment.

Loose herbs weighed out at a medical hall have no number — then what? NPRA's guideline states that loose herbs and a practitioner's own on-the-spot dispensing are exempt from registration, so they never had a MAL number; that is how the system works. The checkpoint sits at sourcing and identification: ask what is in the packet, what situation it was composed for, and whether the person composing it knows those herbs. Storage is part 5.

Do not: work through the paired names above against the packets in your kitchen. That material is used for botanical identification, not text matching; names that match while the material does not is the whole starting point of this story.

A note: this section is general information only. For conditions like these, follow your doctor's diagnosis and treatment, and seek medical attention when you need it.

The other five parts

👉 If you are unsure whether "this packet of herbs, or this bottle of proprietary medicine in my hand, is actually right for me to use", you are welcome to book an online consultation with HansMed, where a practitioner registered under the T&CM Act 2016 assesses it with you.

Sit with a licensed TCM practitioner from wherever you are.

HansMed Modern TCM

For general wellness education only — not medical advice. Consult a registered TCM practitioner for personal guidance.

Sources

  • Chinese Medicine Regulatory Office, Department of Health, Hong Kong, reference material on Chinese herbs associated with adverse events in Hong Kong: herbs containing aristolochic acid — https://www.cmro.gov.hk/html/b5/useful_information/public_health/publication/AdverseEvents13.html
  • National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia, Drug Registration Guidance Document, Third Edition, 12th Revision July 2026, Appendix 7: Guideline on Registration of Natural Products — https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-7-Guideline-on-Registration-of-Natural-Products.pdf
  • Hong Kong Hospital Authority Smart Patient, lecture slides "當中藥師遇見藥劑師——認識中西藥相互作用", Mr. Chui Chun Ming (Chief Pharmacist) and Ms. Lam Kit Yu (Manager, Chinese Medicine) — https://www.smartpatient.ha.org.hk/smart-patient-web/useful-information/sp-series/sp-series-details/%E8%97%A5-%E5%AF%86-%E8%A7%A3%E9%8E%96%E8%AC%9B%E5%BA%A7
本文是「中药的风险与把关」系列的第 2 篇,共 6 篇。另外五篇的清单在文末。

第 1 篇把范围划出来了:有记录的是含马兜铃酸的马兜铃属植物。这一篇讲接下来那个问题——资料是怎么记录它的,出事的个案又是怎么发生的。

一分钟看完

  • 香港卫生署中医药规管办公室的页面逐项写明中毒原因、症状与处理;它没有写这成分在体内的作用过程,所以这一篇也停在同一个地方。
  • 香港记录过的个案,是把两个科的植物认错了:名字像、外形像,来源不同。
  • 同一页因此把「不含」与「含」的药材并排。这是给配药的人用的鉴别资料,不是给读者的自查清单。
  • NPRA 这一关管的是配方:禁用成分不得入配方,List A、List B 的植物须送检。「注册」等于这一类查过了,不等于什么都安全。

先说不能等的几件事

⚠️ 安全提醒:中医与西医是互相补位的关系,不是二选一。服用中药后若出现严重的过敏反应(如呼吸急促、脸部肿胀)或意识不清,请立刻拨打 999,或前往最近的医院急诊部。

哪些人要特别小心、不舒服时该先做什么、每一项的理由,见第 6 篇。

小提醒:本段仅为一般知识说明。相关情况请以西医的诊断与治疗为主,并在需要时及时就医。

一、一颗药在人体走的四站,和资料记下的那几行

三小堆分别放在纸上的干药材,旁边有一把镊子

一颗药进了身体会走四站:胃肠吸收,进入血液并在体内分布,肝脏代谢,肾脏排泄——这是香港医院管理局的药剂师与中药师在一场公开讲座里用的说法。

他们用这四站说明中药与西药在哪里互相影响:前四种方式各发生在一站,后两种是作用本身的叠加与抵消。 六种方式各有医院管理局举的例子,在〈中药和西药可以一起吃吗〉(/chinese-herbs-with-western-medicine/)第二节;这里只借四站这个框架,不重复那一篇。

借它的原因很简单:所谓「这一类会出问题」,出的地方就在这四站上的某一站。

① 资料是怎么记录它的。 香港卫生署中医药规管办公室的页面逐项写明。中毒原因:马兜铃酸毒性强,可导致肾衰竭及尿道癌,该页写明世界卫生组织已将其定为「甲级致癌物」。中毒症状:肾衰竭及尿道癌,严重者甚至可致死亡。中毒处理:立即求医。

这一页记录的是后果与处理,没有写它在体内的作用过程——怎么作用、是不是积累、剂量怎么算,页面上都没有。这篇也就停在这里。

小提醒:本段仅为一般知识说明。相关情况请以西医的诊断与治疗为主,并在需要时及时就医。

二、出事的地方:同一个名字,两个科的植物

② 香港记录过的个案,是把马兜铃科的寻骨风当作茄科的白英、把马兜铃科的广防己当作防己科的防己使用,导致中药不良反应——同一页写的。

那一页接着把「不含马兜铃酸」与「含马兜铃酸」的药材并排:白毛藤对寻骨风,川木通对关木通,防己、川木香对广防己、青木香,各自写明来源与外形。名字像、外形像、来源不同——把关的重点,因此落在鉴别与货源。

这里要讲清楚一件事:那份并排的资料是给配药的人看的,不是给您自查的清单。 它写的是植物学来源与外形特征,要手上有实物、受过训练才用得上。您能做的不是认药,是问清这包药是哪里来的、是谁配的——第 3 篇与第 4 篇讲这两件。

💡 记住:这一类的风险不在「中药」三个字上,在认错了药材上。所以把关的位置是货源与鉴别,不是少喝一点。

三、为什么「注册」是这一类的把关

③ NPRA 的指南列明,禁用成分不允许出现在注册天然产品的配方中;马兜铃属全部品种整属禁用。对已知或疑似含有马兜铃酸的植物(List A),以及可能被掺入马兜铃酸的植物(List B),含这些成分的产品须送政府兴奋剂检测中心检验,结果附于注册表格——都写在同一份指南里。

List B 里有木通(Akebia 属)、川木通(Clematis armandii)、川木香(Vladimiria souliei),以及 Stephania 属除粉防己以外的品种。川木通、川木香,正是香港页面里与关木通、青木香并排的那两味。而粉防己(Stephania tetrandra,香港页面所说「防己科的防己」)在 NPRA 另列于禁用表,理由是「有报告指会造成肾毒性」。

合起来看:一件有 MAL 编号的产品,它的配方按禁用名单核对过;配方里若有 List A、List B 的植物,注册前还经过检验。香港对含细辛属药材的中成药,同样把「不得检出马兜铃酸」列入质量标准。「注册」等于「这一类查过了」,不等于「什么都安全」。

④ 这个把关管不到的地方。 散装药材与医师即场配制的药免于注册,不经过这道配方审查——免于注册的条文、它把关靠什么、以及包装产品怎么查,都在第 3 篇。

这些是监管机构名单上的例子,不是「没列到就安全」的清单。

小提醒:本段仅为一般知识说明。相关情况请以西医的诊断与治疗为主,并在需要时及时就医。

这篇出现的几个词

四个都是资料本身在用的词:第一个来自医院管理局的讲座,后三个写在 NPRA 的注册指南上。

  • 吸收、分布、代谢、排泄(absorption, distribution, metabolism, excretion)——医院管理局用来描述一颗药在人体历程的四站:胃肠吸收、进入血液并在体内分布、肝脏代谢、肾脏排泄。
  • List A 与 List B——NPRA 指南里的两张名单。List A 是「已知或疑似含有马兜铃酸的植物」,List B 是「可能被掺入马兜铃酸的植物」。作用相同:含名单上植物的产品,注册前须送检。
  • 掺入(adulterated)——指配方里被混进了不该有的成分。List B 的标题用的就是这个词,所以它针对的不是植物本身含什么。
  • 整属禁用(totally banned)——指南的脚注写明,名单上其他植物的产品可以送检后附上结果,马兜铃属是例外:不是某几个品种,是全部品种。

常见问题

有 MAL 编号,是不是就表示这瓶东西安全? 不是。编号表示这件产品走过了注册审查——按 NPRA 的指南,配方要按禁用名单核对过,含 List A、List B 植物的还要经过检验。审查管的是配方里有没有不该有的成分,不是「这瓶东西适不适合您」——后者是问诊的事。怎么查编号,见第 3 篇。已有肾脏问题的读者,请以西医的诊断与治疗为主。

药材铺秤的散装药材没有编号,那怎么办? NPRA 的指南列明,散装药材与医师即场配制的药免于注册,所以本来就没有 MAL 编号——制度如此。把关因此落在货源与鉴别:问清这包是什么、给什么情况配的,以及配药的人认不认得这几味。存放见第 5 篇。

不要这样做: 不要照着上面那几组名字,自己去翻家里的药包对号。那份资料的用法是植物学鉴别,不是文字比对;名字对得上、东西对不上,正是整件事的起点。

小提醒:本段仅为一般知识说明。相关情况请以西医的诊断与治疗为主,并在需要时及时就医。

这个系列的另外五篇

👉 如果您不确定「我手上这包药材、这瓶中成药,到底能不能用」,欢迎透过汉方中医的线上问诊,由依 2016 年 T&CM 法令注册的医师为您评估。

无论身在何处,与持证中医师对坐。

汉方现代中医

本内容仅供健康知识分享,不构成医疗建议。如需个人化建议,请咨询注册中医师。

资料来源

  • 香港卫生署中医药规管办公室,〈曾与香港不良事件有关的中药材参考资料:含马兜铃酸药材〉— https://www.cmro.gov.hk/html/b5/useful_information/public_health/publication/AdverseEvents13.html
  • 马来西亚卫生部国家药品监管机构(NPRA),《药品注册指引文件》第三版第 12 次修订(2026 年 7 月)附录 7:天然产品注册指南 — https://www.npra.gov.my/easyarticles/images/users/1153/drgd_appendices/APPENDIX-7-Guideline-on-Registration-of-Natural-Products.pdf
  • 香港医院管理局「智友站」,《當中藥師遇見藥劑師——認識中西藥相互作用》讲座简报,崔俊明總藥劑師 · 林潔茹中藥師 — https://www.smartpatient.ha.org.hk/smart-patient-web/useful-information/sp-series/sp-series-details/%E8%97%A5-%E5%AF%86-%E8%A7%A3%E9%8E%96%E8%AC%9B%E5%BA%A7
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