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

Do Chinese Herbs Carry Risks? — Which Class Has the Record, and How Malaysia Regulates It

中药也有风险?— 有记录的是哪一类,马来西亚怎么管

The saying that Chinese herbs can cause harm has a real origin, but a specific target: Aristolochia plants, which contain aristolochic acid. This part covers the reference material Hong Kong's Chinese Medicine Regulatory Office files this class under, which herbs Hong Kong stopped importing and selling from 1 June 2004, why Malaysia's NPRA lists all Aristolochia species as a prohibited ingredient, and why the difference between a plant family and a genus matters here.
「中药吃多了会不会出问题」这句话有真实的来源,但对象是特定的一类药材:含马兜铃酸的马兜铃属植物。这一篇说明香港卫生署中医药规管办公室把这一类列在什么资料里、香港从 2004 年 6 月 1 日起停止进口及销售哪几味、马来西亚 NPRA 为什么把马兜铃属全部品种列为禁用成分,以及「科」与「属」的分别为什么在这里要紧。
Part 1 of 6 in the "Chinese herb risks and checkpoints" series. The list of the other five is at the foot of this part.

"My friend said taking Chinese herbs for too long damages the kidneys. Is that true? And I still have a packet of herbal-tea ingredients I bought from a medical hall last week. Can I still drink it?" A question that comes up often is this pair: one is something heard, the other is something in hand.

The answer first. The class with a documented kidney record is a specific one: Aristolochia plants, which contain aristolochic acid. Malaysia's National Pharmaceutical Regulatory Agency (NPRA) lists all Aristolochia species among botanicals "banned due to reported adverse event", with the stated reason "Contain Aristolochic Acid reported to cause kidney toxicity" — those are the words in the appendix to NPRA's Guideline on Registration of Natural Products.

As for that packet of tea ingredients, check three things: you can say where it came from, there is no mould, insect damage or off-smell, and it has been stored properly throughout. If any one of the three fails, our practice is not to drink it. How to store it, and when "too long" starts, is part 5.

This part answers only the first question: which class has the record, and how Malaysia regulates that class.

The short version

  • What has a record is one specific class of herb: Aristolochia plants, which contain aristolochic acid — not "Chinese herbs" as a phrase.
  • Hong Kong's Chinese Medicine Regulatory Office files this class under its reference material on herbs associated with adverse events in Hong Kong, and stopped its import and sale from 1 June 2004.
  • NPRA lists all Aristolochia species among botanicals banned due to reported adverse event, and states that prohibited ingredients are not allowed in the formulation of registered natural products.
  • What the record says about its harm, and why registration screening is the checkpoint for this class, is part 2.
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.

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. "Do Chinese herbs harm the kidneys?" — where the phrase comes from, and the class it means

The phrase has a real origin, but a specific target.

Hong Kong's Department of Health, through its Chinese Medicine Regulatory Office, keeps reference material titled "Chinese herbs associated with adverse events in Hong Kong", and one of its pages is about herbs containing aristolochic acid. That page states the source: plants of the genera Aristolochia and Asarum in the Aristolochiaceae family.

From 1 June 2004 Hong Kong stopped the import and sale of Aristolochia herbs and their preparations — the same page lists them, including the formerly common 关木通, 广防己, 马兜铃, 青木香 and 天仙藤. Those five were names a medical hall once stocked.

Two words are worth keeping apart here. Aristolochiaceae (马兜铃科) is a family; Aristolochia (马兜铃属) is a genus. A family is the larger grouping and holds several genera. The source on that Hong Kong page is two genera inside the Aristolochiaceae family: Aristolochia and Asarum. The next part uses that distinction.

What harm it does, and how Hong Kong's recorded cases happened, is in part 2.

This does not mean every other herb can be taken freely. Anything with an effect has doses and people it does not suit. Which herb, how much and for how long is decided by a practitioner who has seen your situation, not by an article.

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. How Malaysia regulates it — a whole genus banned, and kept out of registered formulations

Malaysia handles it differently: not by stopping imports, but by writing it into the registration review.

NPRA's Guideline on Registration of Natural Products carries a table headed "Botanicals (and botanical ingredients) banned due to reported adverse event". Aristolochia is on it; the species column reads "All species", and the reason column reads "Contain Aristolochic Acid reported to cause kidney toxicity". The same guideline states what the table does: these prohibited ingredients are not allowed in the formulation of natural products registered by the Authority.

The two regulators therefore land in different places — Hong Kong on import and sale, Malaysia on the formulation of a registered product. Why that rule is a real checkpoint, and where it does not reach, is split between parts 2 and 3.

Worth noting too: "banned" is said of an ingredient, not of any one company's product. What is banned is a plant and a constituent; whether a product passes depends on what is in its formulation.

💡 Remember: Hong Kong and Malaysia are not regulating the same thing — one covers import and sale, the other the formulation of registered products. Neither is making a statement about "Chinese herbs" as a whole; both are talking about one specific genus.

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 regulators use themselves, and you meet them directly on a regulatory page or in product-registration material.

  • Aristolochic acid (马兜铃酸) — both regulators use this name for the same thing: a constituent found in plants of the Aristolochiaceae family. NPRA gives "Contain Aristolochic Acid" as the reason the whole genus is banned, and the Hong Kong page is titled "herbs containing aristolochic acid".
  • Aristolochiaceae (马兜铃科) and Aristolochia (马兜铃属) — a family is the larger grouping, a genus the smaller, and a family holds several genera. The Hong Kong page gives the source as two genera inside Aristolochiaceae, Aristolochia and Asarum; what NPRA bans is all species of the genus Aristolochia.
  • Prohibited (banned) ingredient (禁用成分) — NPRA's own usage: an ingredient on the banned tables, not allowed in the formulation of natural products registered by the Authority. It is a rule about formulations.
  • Adverse event (不良事件) — an unwanted occurrence reported after something was taken. NPRA's table uses it as the reason for the ban, and Hong Kong's reference material as the criterion for inclusion.

Frequently asked

Do Chinese herbs harm the kidneys? The class with a record is Aristolochia herbs containing aristolochic acid. NPRA lists all Aristolochia species among botanicals banned due to reported adverse event, with the reason that they contain aristolochic acid reported to cause kidney toxicity, and registered products may not contain these prohibited ingredients in their formulation; Hong Kong stopped importing and selling these herbs and their preparations from 1 June 2004. What harm it does, and why registration screening is the checkpoint for this class, is in part 2. Whether any other herb suits you is decided by a practitioner who has seen your situation. If you have an existing kidney condition, follow your doctor's diagnosis and treatment.

If the genus is banned, can a medical hall still have it? That takes two answers. Packaged Chinese proprietary and traditional medicines must be registered with the Ministry of Health in Malaysia before they can be sold, and their formulation is checked against the banned list — how to read and check that is part 3. Loose herbs and a practitioner's own on-the-spot dispensing sit outside that number system, where the checkpoint is sourcing and identification: see part 2.

Do not: treat "Chinese herbs" as one thing to judge. What has a record is one specific genus; reading that as "all herbs", or as "so none of it matters", both walk away from the material.

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
本文是「中药的风险与把关」系列的第 1 篇,共 6 篇。另外五篇的清单在文末。

「医师,我朋友说中药吃多了会伤肾,是真的吗?我家里还有一包上个星期在药材店买的凉茶料,到底还能不能喝?」不少读者常问这两句话,一句是听来的传言,一句是手上的实物。

先给答案。 有记录会伤肾的,是一类特定的药材:含马兜铃酸的马兜铃属植物。马来西亚国家药品监管机构(NPRA)把马兜铃属全部品种列为「因不良事件报告而禁用」的植物,理由写明「含马兜铃酸,有报告指会造成肾毒性」——这是 NPRA《天然产品注册指南》附录里写的理由(原文为英文)。

至于那包凉茶料,看三样:来源说得清、没有霉点虫蛀异味、一直存放得当。三样有一样不对,我们的做法是不喝。怎么存放、放多久算太久,第 5 篇说。

这一篇只回答第一句:有记录的是哪一类,以及马来西亚怎么管这一类。

一分钟看完

  • 有记录的是一类特定的药材:含马兜铃酸的马兜铃属植物——不是「中药」这三个字。
  • 香港卫生署中医药规管办公室把这一类列在「曾与香港不良事件有关的中药材」参考资料里,并自 2004 年 6 月 1 日起停止进口及销售。
  • NPRA 把马兜铃属全部品种列入「因不良事件报告而禁用的植物」,并列明禁用成分不得出现在注册天然产品的配方中。
  • 资料怎么记录它的伤害、为什么注册审查能把关这一类,第 2 篇说。
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。

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、「中药会伤肾吗」——这句话的来源,和它指的那一类

这句话有真实的来源,但对象是特定的。

香港卫生署中医药规管办公室有一份参考资料,题目是「曾与香港不良事件有关的中药材」,其中一页讲的就是含马兜铃酸药材。那一页写明来源:马兜铃科的马兜铃属及细辛属植物。

香港自 2004 年 6 月 1 日起停止进口及销售马兜铃属的中药材及其制剂——同一页写的,包括以往常用的关木通、广防己、马兜铃、青木香和天仙藤。这五味,以前是药材铺里会见到的名字。

这里要分清两个字。马兜铃科(Aristolochiaceae)是「科」,马兜铃属(Aristolochia)是「属」;科比属大,一个科底下有好几个属。香港那一页写的来源,是马兜铃科里的马兜铃属与细辛属。下一篇会用到这个分别。

它造成什么伤害、香港记录的个案是怎么发生的,第 2 篇说。

这不等于其余药材可以随便吃。 药材有作用,就有不适合的用量与对象。哪一味、多少、多久,是医师看过您的情况之后决定的,不是一篇文章能替您决定的。

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、马来西亚怎么管——全部品种都禁,不许进注册产品的配方

马来西亚管的方式不一样:不是「停止进口」,是写进注册审查。

NPRA 的《天然产品注册指南》有一张表,题目是「因不良事件报告而禁用的植物(及植物性成分)」。马兜铃属在表上,品种那一栏写的是「全部品种」,理由那一栏写的是「含马兜铃酸,有报告指会造成肾毒性」。同一份指南另有一句话,是这张表的实际作用:这些禁用成分,不允许出现在由该机构注册的天然产品的配方中。

两边的落点因此不同——香港管进口与销售,马来西亚管注册产品的配方。为什么这一条能把关、它又管不到哪里,第 2 篇与第 3 篇各讲一半。

还要留意,「禁用」说的是成分,不是某一家的产品。 禁的是植物与成分;一件产品过不过关,看配方里有没有这些东西。

💡 记住:香港与马来西亚写的不是同一件事——一个管进口与销售,一个管注册产品的配方。两边都不是在说「中药」整体,而是在说一个具体的属。

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

四个都是监管机构自己在用的词,看规管页面或药品注册资料时会直接遇到。

  • 马兜铃酸(aristolochic acid)——两家监管机构用这个名字指同一样东西:马兜铃科植物里的一种成分。NPRA 把「含马兜铃酸」写成整属禁用的理由;香港那一页的标题就叫「含马兜铃酸药材」。
  • 马兜铃科(Aristolochiaceae)与马兜铃属(Aristolochia)——科大、属小,一个科底下有几个属。香港那一页写的来源是马兜铃科里的马兜铃属与细辛属;NPRA 禁的是马兜铃属的全部品种。
  • 禁用成分(prohibited/banned ingredient)——NPRA 指南里的用法:列在禁用表上的成分,不允许出现在该机构注册的天然产品的配方中。这是配方层面的规定。
  • 不良事件(adverse event)——用药之后被报告上来的不良情况。NPRA 那张表以它为禁用理由,香港那份参考资料以它为收录标准。

常见问题

中药会伤肾吗? 有记录的是含马兜铃酸的马兜铃属药材。NPRA 把它列为因不良事件报告而禁用的植物,理由是含马兜铃酸、有报告指会造成肾毒性,注册产品的配方不允许含有这类禁用成分;香港自 2004 年 6 月 1 日起停止进口及销售这类药材及其制剂。它造成什么伤害、为什么注册审查能把关这一类,见第 2 篇。其余药材适不适合您,由医师看过您的情况决定。已有肾脏问题的读者,请以西医的诊断与治疗为主。

马兜铃属既然禁了,药材铺里还会有吗? 分两种东西回答。包装好的中成药与传统药在马来西亚须先向卫生部注册才能销售,配方按禁用名单核对过——怎么看、怎么查,见第 3 篇。散装药材与医师即场配制的药不在这个编号制度里,把关靠货源与鉴别,见第 2 篇。

不要这样做: 不要把「中药」当成一个整体来判断。有记录的是一个具体的属;读成「所有中药」,和读成「所以都没问题」,两种都离开了资料。

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
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