Chinese patent medicine

Chinese patent medicine (simplified Chinese: 科学中药; traditional Chinese: 科 學 中 藥 ; pinyin: kēxúe zhōngyào; literally:
'scientific Chinese medicine') are herbal medicines in Traditional Chinese medicine, modernized into a ready-to-use form such as
tablets, oral solutions or dry suspensions, as opposed to herbs that require cooking (hot water extraction).

Contents
Description
Herbal formulas
Criticisms
Heavy metal contamination
Pharmaceutical adulterants
Prohibited ingredients
Regulation
In Taiwan
Heavy metal contamination and pesticide residue
Pharmaceutical adulterants
In China
References
See also

Description
Chinese patent medicines generally consist of extracted condensed pills called teapills, and are usually small, spherical, and
black. They are called teapills because the herbs are cooked into an herbal tea to make the pills. Honey or water pills made from
ground raw herbs are also a popular format in China, and they tend to be larger and are slightly to significantly softer than
teapills.

Modern teapills are created from herbs extracted in stainless steel extractors to create either a water decoction or water-alcohol
decoction, depending on the herbs used. They are extracted at a low temperature (below 100 degrees Celsius) to preserve
essential ingredients. The extracted liquid is then further condensed and a small amount of raw herb powder from one of the
herbal ingredients is mixed in to form an herbal dough. This dough is then cut into tiny pieces by a machine, and a small amount
of excipients are added for a smoother and a more consistent exterior. The products are then made as pills.

Honey pills and water pills have been made since ancient times by combining several dried herbs and other ingredients, which are
grounded into powder, mixed with a binder and traditionally formed into pills by hand. Modern honey or water pills are formed
into pills by machine. The binder is traditionally honey for honey pills. For water pills the binder may simply be water, or may
include another binder, such as molasses. Modern manufacturers still produce many patent formulas as honey or water pills, such
as Wuji Baifeng Wan, a popular honey pill formula to "nourish qi and blood", to strengthen the body.

Patents may come in other forms such as dripping pills, liquids, syrups, powders, granules, instant teas, and capsules. Companies
make Chinese patent medicines both within and outside China.
Like other patent medicines, they are not patented in the traditional sense of the word. No one has exclusive rights to the formula.
Instead, "patent" refers to the standardization of the formula.

In China, all Chinese patent medicines of the same name have the same proportions of ingredients, and are manufactured in
accordance with the PRC Pharmacopoeia's monograph on that particular formula, which is mandated by Chinese law. Each
monograph details the exact herbal ingredients that make up the patent formula, usually accompanied by the specific tests that
should be used for correct herb identification, such as thin layer chromatography (TLC) or high performance liquid
chromatography (HPLC), the percentage of each ingredient, and specific cautions and contraindications. The monograph also
details the manufacturing methods that must be followed, how to process and cook the herbs, often including specific
requirements for finished product testing including authenticating and assessing the potency of the formula with active ingredient
markers where known, as well as testing for dissolution time and content uniformity. All good manufacturing practice (GMP)
certified factories must also test for heavy metal levels and microbials for all patent medicines they produce.[1]

However, many patents do not list all ingredients, presumably to protect the secrecy of the formula. An example of this is Yunnan
Baiyao, a popular formula used to stop bleeding, whose ingredients have never been revealed. This is an acceptable practice in
China, where no other protection exists to protect family or "secret" Chinese herbal formulas.

In western countries, there is considerable variation of ingredients and in the proportions of ingredients in products sharing the
same name. This is because the Chinese government allows foreign companies to apply for modifications of patent formulas to be
sold outside of China. For example, Hebei brand Lifei pills contain Kadsura (feng sha teng) and Morus (sang ye), whereas Plum
Flower brand Li Fei Pian contains Schizandra (we wei zi) and Gecko (ge jie) instead. Another example is Qing Qi Hua Tan Wan.
The Lanzou brand uses Citrus (ju hong). The Lanzhou Foci Min Shan brand and the Plum Flower brand do not, but use Ginger
(sheng jiang).

Herbal formulas
Chinese classic herbal formulas form the basis of Chinese patent medicine. These are the basic herbal formulas that students of
traditional Chinese medicine learn. Many of these formulas are quite old. For example, "Liu Wei Di Huang Wan" (六味地黄丸
liù wèi dì huáng wán) was developed by Qian Yi (钱乙 Qián Yǐ) (c. 1032–1113 CE). It was published in the "Xiao'er Yao Zheng
Zhi Jue" (also known as "Key to Therapeutics of Children's Diseases" 小儿药证直诀 xiǎoér yào zhèng zhí jué) in 1119 by Qian
Yi's student. Although Liu Wei Di Huang Wan can be prepared as a raw herb decoction (or herbal tea), it was originally created to
be made into honey pills. The last word in Liu Wei Di Huang Wan, "Wan" (丸) means "pill".[1]

Criticisms

Heavy metal contamination

Some Chinese patent medicines were tested and found to contain high to dangerous levels of heavy metals.[2] The most common
heavy metals found were mercury, lead, and arsenic. These ingredients can cause serious medical problems.

Pharmaceutical adulterants
Some Chinese patent medicines were found to contain pharmaceutical drugs such as decongestants, analgesics or antihistamines.
The most common Chinese patent medicines found to carry pharmaceutical drugs were for the treatment of asthma, pain, and
arthritis.[2]
Many contaminants and drug adulterants named in the context of herbal medicine is intentionally added and declared on product
labels. The mercury salt cinnabar (Chinese: 朱砂; pinyin: zhūshā), the arsenic salt realgar (Chinese: 雄黄; pinyin: xíong hung)
and the strychnine containing Strychnos nux-vomica (Chinese: 马 钱 子 ; pinyin: Mǎqiánzǐ) are used traditionally and kept in
China despite the known harm and little proven benefit.[3]

In the case of drugs, the entry for "Vitamin C/Lonicera/Forsythia tablet" (Chinese: 维C银翘片; pinyin: Wéi C Yínqiào Piàn) in
the Chinese Pharmacopoeia (ChP) calls for 105 mg of paracetamol and 1.05 mg of chlorpheniramine maleate each pill. Such a
combination is common for Chinese cold medicine. In a more hidden case, the herb Ephedra naturally contains ephedrine and
pseudoephedrine, and is required by the ChP to have more than 0.8% of the two decongestants (as hydrochloride salts) in its dry
weight.[3]

Prohibited ingredients
Some Chinese patent medicines contain ingredients which are banned in other countries. The two most common prohibited herbs
are Ma Huang (麻黄 má huáng) (Ephedra) and Ban Xia (半夏 bàn xià) (Pinellia). On 30 December 2003, the FDA in the US
announced a ban (effective 12 April 2004), on these herbs from all dietary supplements.[4] Traditional Chinese herbal remedies
are exempt from this law.

Regulation

In Taiwan
In modern-day Taiwan, regulations to address the criticisms are introduced due to Chinese patent medicines being prescription
drugs since the 1970s and a part of the public health system since 1995.

Taiwan Herbal Pharmacopeia (ISBN 9789860354157) provides information on acceptable herbs in Taiwan.

Heavy metal contamination and pesticide residue

All Chinese patent medicine products sold in aTaiwan must pass a heavy metal limitation test and pesticide residue test according
to Taiwan Herbal Pharmacopeia. There are several manufacturers in Taiwan certified ISO 17025 Lab, for example: Sun-Ten
(Chinese: 順天堂), Chuang Song Zong Pharmaceutical Co., Ltd. (Chinese: 莊松榮)

Pharmaceutical adulterants
According to Taiwanese government law, products licenses will be suspended if there exists pharmaceutical adulterants.
Furthermore, it could cause GMP certificate to be cancelled. In Taiwan, those main manufacturer in order to export products
abroad, few of them has passed PIC/S GMP audition. For example: Sun-Ten (Chinese: 順 天 堂 ), Chuang Song Zong
Pharmaceutical Co., Ltd. (Chinese: 莊松榮).

In China
As with more traditional formulae, standards for Chinese patent medicine are found in Volume 1 of Chinese Pharmacopoeia.
Some of the resultant medications require a prescription to purchase, while others are considered over-the-counter drugs. Heavy
metal limits are present for a few herbs, although they tend to be laxer than those defined for foods. As listed above, intentionally
added heavy metals and drug adulterants are found in many products.[3]

References
 1. State Pharmacopoeia Commission of the PRC (2005). "Pharmacopoeia of The People's Republic of China
(Volume I)". Chemical Industry Press. ISBN 7117069821
2. Adulteration and Contaminants in Chinese Patent Medicines (http://home.caregroup.org/clinical/altmed/interactio
ns/Herb_Groups/Adulteration_an.htm) Archived (https://web.archive.org/web/20061208070818/http://home.careg
roup.org/clinical/altmed/interactions/Herb_Groups/Adulteration_an.htm) December 8, 2006, at the Wayback
Machine
3. Chinese Pharmacopoeia. 2015. ISBN 978-7-5067-7337-9. 1:50,137,320,336,1570.
4. http://www.fda.gov/oc/initiatives/ephedra/february2004/ "Archived copy" (https://web.archive.org/web/200702100
03231/http://www.fda.gov/oc/initiatives/ephedra/february2004/). Archived from the original on February 10, 2007.
Retrieved October 30, 2008. Sales of Supplements Containing Ephedrine Alkaloids (Ephedra) Prohibited]

Fratkin, Jake (2001). Chinese Herbal Patent Medicines. Shya Publications. ISBN 0-9626078-4-3.
Taylor, Mark (1998). Chinese Patent Medicines: A Beginner's Guide. Global Eyes International Press. ISBN 0-
9662973-0-X.
Taiwan herb pharmacopeia (https://web.archive.org/web/20150128134249/http://www.mohw.gov.tw/MOHW_Uplo
ad/doc/%E8%87%BA%E7%81%A3%E4%B8%AD%E8%97%A5%E5%85%B8%E7%AC%AC%E4%BA%8C%E
7%89%88-%E9%9B%BB%E5%AD%90%E6%9B%B8%20%5B%20PDF%20%E6%AA%94%20%5D_00004540
02.pdf)

See also
Kampo (Japanese adaptation of Chinese medicine)
Kampo list (list of Japanese versions of Chinese patent medicines)

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