《吳醫師保健養生堂第六十二講》— 澳大利亞的草藥限制和法規吳宇琛

澳大利亞的草藥限制和法規

吳宇琛

SUM WU

Sum Wu

Registered Chinese Medicine Practitioner

Bachelor of Health Science in Traditional Chinese Medicine (UTS)

Bachelor of Science Majoring in Psychology (UOW)

Specialising in pain management and mental wellbeing through Tradition Chinese medicine in combination with modern science in mental health, dieting and nutrition.

吳宇琛，澳洲政府註冊中醫師、針灸師，五龍崗大學心理學學士、悉尼科技大學中醫系學士，擅長用傳統針灸理傷手法和中藥治療各種新舊損傷痛症，特別採用中醫中藥和現代心理學、營養學相結合調理治療各種慢性病和亞健康。

Herbal medicine restrictions and regulations in Australia

澳大利亞的草藥限制和法規

Many herbal products that is commonly found in herbal prescriptions in TCM are subjected to strong regulations by the Australian government and the regulatory body is called the Therapeutic Goods Administration (TGA). This organisation evaluates, assess and monitors all goods and products that enter Australia that are defined as therapeutic goods or is used as a component in medicine and drugs.

中醫藥處方中常見的許多種類都受到澳大利亞政府的嚴格監管，這個監管機构稱為澳大利亞藥品管理局（TGA）。這個組織評估和監控進入澳大利亞的所有被定義為治療用品或用作醫藥和藥物成分的商品和產品。

Australia also has very strong biosecurity laws that help protect the countries native fauna and flora as well as its people from foreign diseases and sources of contamination.

澳大利亞還擁有非常强大的生物安全法，有助於保護本土動植物以及人民免受外來疾病和污染源的侵害。

Any medicinal goods that are imported into Australia must overcome these 2 barriers before they are to be safely used and sold in the country.

任何進口到澳大利亞的藥品必須解决這兩個問題才能在澳大利亞安全使用和銷售。

Herbal products such as patent pills or capsules are usually registered and listed with the TGA and receive a register or a listed number. If the product claims to have a therapeutic usage then it must be registered. If the product does not have a therapeutic usage but is made from herbal ingredients then it will be given a listed number.

草藥產品，如成藥藥丸或膠囊，通常會在澳大利亞藥品管理局（TGA）注册和列入清單，並獲得註冊號或列入號。如果產品聲稱具有治療用途，則必須注册。如果產品沒有治療用途，而是由草藥成分製成，則會給出一個列入的編號。

Raw herbal ingredients and most Chinese medicine products are listed medicines and label with “AUST L”. There is a significant financial and labour involved with apply through the TGA to import herbal products from overseas for importers and in a lot of causes auditors may travel overseas to the factory and the ingredient’s origin to determine whether the product meets Australian standards for import and most importantly if it is safe for public use.

中藥原料和大多數中藥產品都是列名藥品，並貼有“AUST L”標籤。進口商通過澳大利亞藥品管理局（TGA）申請從海外進口草藥產品需要大量的資金和勞動力，並且在很多情况下，審核員可能會前往海外的工廠和成分的原產地，以確定產品是否符合澳大利亞的進口標準，並且最重要的是它是否可供公眾安全使用。

There is a myriad of steps and procedures to obtain the necessary certifications and meeting standards which require more than this short summary to fully understand. Just know that Australia has some of the strictest regulations in the western world.

要獲得必要的認證和標準，需要執行無數的步驟和程式，這些步驟和程式需要的不僅僅是這個簡短的摘要才能完全理解，大家謹記澳大利亞有西方國家中最嚴格的法規。

Moving on from here, once a product is approved to be allowed into Australia they also must go through stringent biosecurity checks for pests and decontamination. Usually raw herbal ingredients are subjected to heat treatment or sulphuryl fluoride fumigation – hence why sometimes people say certain herbs such as Shan Yao have a sour taste.

接下來，一旦產品被準予進入澳大利亞，它們還必須經過嚴格的害蟲生物安全檢查和淨化。通常中藥都會經過熱處理或硫酰氟薰蒸（常稱為“焗硫磺”），因此有時人們會說某些草藥（例如山藥）有酸味。

OK now let’s have a closer look at some of the barriers TCM practitioners have when prescribing herbal medicine due to these strict regulations.

那現在讓我們仔細看看由於這些嚴格的規定，中醫執業者在開中藥處方時遇到的一些障礙。

There are actually a lot of very well-known and frequently used herbal ingredients that either restricted or outright banned from usage in Australia. Usually the reasons is because the product is a banned substance which can cause harm due to chemical composition, made from illegal animal trade or just toxic or deadly to humans and animals. In some cases these herbs are widely used in Asia, America and even Europe without restrictions but is deemed unsafe or dangerous by the TGA and Australian government.

實際上，有許多非常知名且經常使用的中藥材在澳大利亞受到限制或完全禁止使用。通常原因是因為該產品是違禁物質，其化學成分可能造成傷害，由非法動物貿易的材料製成，或者對人類和動物有毒或致命。在某些情况下，這些中藥在亞洲、美洲甚至歐洲可以不受限制地廣泛使用，但被澳大利亞藥品管理局（TGA）和澳大利亞政府視為不安全或危險的草藥。

Some examples of this is Fuzi, Ma Huang, Xi Xin and Ban Bian Lian. These are herbal ingredients that have been used throughout the history of Traditional Chinese medicine and many famous herbal formulas will contain these herbs. Unfortunately for us these 4 examples are heavily regulated here as they are items that have been listed in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) or The Poisons Standard for short. As the name implies, The Poisons Standard is a record of classifications of medicines, chemicals and poisons into a Schedule which provides information on how the ingredient is controlled and how it is used. This Schedule is divided into 10 categories from 1 to 10 in danger. Most substances that’s in this Schedule for therapeutic use are found in category 2,3 and 4 but there are substances in all categories as well.

附子、麻黃、細辛、半邊蓮就是這樣的例子，這些是中藥歷史上一直使用的草藥成分，許多著名的草藥配方都會含有這些中藥材。不幸的是，對我們來說，這4種藥材在澳大利亞這裡受到嚴格監管，因為它們是“藥物和毒物的統一調度標準”（SUSMP）或簡稱毒藥標準中列出的項目。顧名思義，毒物標準是將藥物、化學品和毒物的分類記錄在附表中，提供有關如何控制及其使用成分的資訊。清單按危險等級從1級到10級分為10個類別，清單中用於治療用途的大多數物質都屬於第2,3和4類，但每個類別都有列入的中藥材。

The lowest category in use is actually Schedule 2 which are classified as pharmacy medicines may require advice from a pharmacist to use or buy. Schedule 3 is pharmacist only medicines which require professional advice to use but can be bought from a pharmacist without prescription. Schedule 4 are prescription only substances. At Schedule 6 they are listed as poisons and Schedule 10 are dangerous substances that are illegal to obtain, supply or use.

使用的最低類別實際上是2類，它們被歸類為藥房藥品，可能需要藥劑師的建議才能使用或購買。3類是只能在藥房銷售的藥物，需要專業建議才能使用，但無需處方即可從藥劑師處購買。4類為僅限處方藥物。在6類中，它們被列為毒藥，在10類中，它們被列為非法獲取、供應或使用的危險物質。

Fuzi or Aconite is a Schedule 2 substances and is listed under the name Aconitum which is an extremely poisonous plant and requires special preparation to reduce the toxicity for consumption. Fuzi is commonly used to strengthen heart yang, invigorate kidney and dispel cold but sadly as it is a Schedule 2 substances that means TCM clinics cannot buy or sell this ingredient.

附子是2類物質，並以烏頭名稱列出，烏頭是一種劇毒植物，需要特殊製備以降低服用時的毒性。附子通常用來强心陽、補腎祛寒，但遺憾的是它被列為2類物質，意味著中醫診所不能買賣這種中藥材。

Ma Huang is a Schedule 4 herb listed as Ephedra which is a substances that requires a doctor’s prescription to buy and the substance Ephedra is one of the key ingredients in manufacturing the drug Methamphetamine. A recent popular medicine called Lianhua Qingwen is banned in Australia is mainly for this reason.

麻黃是一種被列為4類物質的中藥，麻黃是一種需要醫生處方才能購買的藥材，而麻黃這種原材料是製造藥物甲基苯丙胺的關鍵成分之一。最近流行的一種名為蓮花清瘟的中成藥在澳大利亞被禁止主要就是因為這個原因。

Xi Xin contains a substance called Aristocholic acid which can cause liver and kidney damage as well as cancer but it has a long history of being used around the world as a medicine. In TCM it is used to dispel cold, warm lungs and transform phlegm. It is listed as a Schedule 10 substance.

細辛含有一種叫做馬兜鈴酸的物質，它會導致肝腎損傷以及癌症，但它在世界各地作為藥物使用已有悠久的歷史。中醫用於散寒、溫肺、化痰。它被列為10類物質。

These are just a few of the examples of herbs that are restricted or completely banned from use. There are many more that are banned by being on this Schedule or for completely different reasons such as endangered animal products or products that find their into Australia via illegal means or without TGA approval.

這些只是限制或完全禁止使用的中藥材的一小部分例子，還有許多產品因列入這個清單或其他不同的原因而被禁止，例如瀕臨滅絕的動物產品或通過非法手段或未經被澳大利亞藥品管理局（TGA）準予進入澳大利亞的產品。

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