Chinese patent medicine
Encyclopedia
Traditional Chinese medicine
Traditional Chinese Medicine refers to a broad range of medicine practices sharing common theoretical concepts which have been developed in China and are based on a tradition of more than 2,000 years, including various forms of herbal medicine, acupuncture, massage , exercise , and dietary therapy...
. Many kinds of Chinese patent medicines are still sold today.
Description
Chinese patent medicinePatent medicine
Patent medicine refers to medical compounds of questionable effectiveness sold under a variety of names and labels. The term "patent medicine" is somewhat of a misnomer because, in most cases, although many of the products were trademarked, they were never patented...
s generally consist of extracted condensed pills called teapills, which are usually small, spherical, and black, appearing like black pearls. 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 tend to be bigger and slightly to significantly softer than teapills.
Modern teapills are created from herbs extracted in stainless steel extractors to create either a water decoction
Decoction
Decoction is a method of extraction, by boiling, of dissolved chemicals, or herbal or plant material, which may include stems, roots, bark and rhizomes. Decoction involves first mashing, and then boiling in water to extract oils, volatile organic compounds, and other chemical substances...
or water-alcohol decoction, depending on the herbs used. They are extracted at a low temperature (below 100 degrees Celsuis) to preserve essential ingredients. The extracted liquid is then further condensed and a bit of raw herb powder from one of the herbal ingredients is mixed in to form an herbal dough. This dough is then machine cut into tiny pieces, a small amount of excipients are added for a smooth and consistent exterior, and they are spun into pills.
Honey pills and water pills have been made since ancient times by combining several dried herbs and other ingredients, which are ground into a 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
Binder (material)
-See also:*Adhesive or Glue*Cement*Paint...
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
Wuji Baifeng Wan
Wuji Baifeng Wan is a blackish-brown pill used in Traditional Chinese medicine to "replenish qi and blood , regulate menstruation and arrest excessive leukorrhea". It is slightly aromatic and tastes sweet and slightly bitter...
, 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 patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
ed in the traditional sense of the word. No one has exclusive right
Exclusive right
In Anglo-Saxon law, an exclusive right is a de facto, non-tangible prerogative existing in law to perform an action or acquire a benefit and to permit or deny others the right to perform the same action or to acquire the same benefit. A "prerogative" is in effect an exclusive right...
s to the formula. Instead, "patent" refers to the standardization
Standardization
Standardization is the process of developing and implementing technical standards.The goals of standardization can be to help with independence of single suppliers , compatibility, interoperability, safety, repeatability, or quality....
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
Pharmacopoeia
Pharmacopoeia, pharmacopeia, or pharmacopoea, , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.In a broader sense it is...
's monograph
Monograph
A monograph is a work of writing upon a single subject, usually by a single author.It is often a scholarly essay or learned treatise, and may be released in the manner of a book or journal article. It is by definition a single document that forms a complete text in itself...
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
Thin layer chromatography
Thin layer chromatography is a chromatography technique used to separate mixtures. Thin layer chromatography is performed on a sheet of glass, plastic, or aluminum foil, which is coated with a thin layer of adsorbent material, usually silica gel, aluminium oxide, or cellulose...
(TLC) or high performance liquid chromatography
High performance liquid chromatography
High-performance liquid chromatography , HPLC, is a chromatographic technique that can separate a mixture of compounds and is used in biochemistry and analytical chemistry to identify, quantify and purify the individual components of the mixture.HPLC typically utilizes different types of stationary...
(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
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
(GMP) certified factories must also test for heavy metal levels and microbials for all patent medicines they produce.
However, many patents do not list all ingredients, presumably to protect the secrecy of the formula. An example of this is Yunnan Baiyao
Yunnan Baiyao
Yunnan Baiyao is a hemostatic powdered medicine famous for being carried by the Vietcong to stop bleeding during the Vietnam War. The medicine, developed by Qu Huangzhang in 1902, is designated as one of two Class-1 protected traditional medicines, which gives it 20 years protection. In China,...
, 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).
Chinese patent medicines are easy to use and convenient, but they do not lend themselves to customized or acute treatment. They are best used when a patient's condition is not severe and the medicine can be taken as a long-term treatment.
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. 1032–113 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. Interestingly, 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".Heavy metal contamination
Some Chinese patent medicines were tested and found to contain high to dangerous levels of heavy metalsHeavy metals
A heavy metal is a member of a loosely-defined subset of elements that exhibit metallic properties. It mainly includes the transition metals, some metalloids, lanthanides, and actinides. Many different definitions have been proposed—some based on density, some on atomic number or atomic weight,...
. The most common heavy metals found were mercury
Mercury (element)
Mercury is a chemical element with the symbol Hg and atomic number 80. It is also known as quicksilver or hydrargyrum...
, lead
Lead
Lead is a main-group element in the carbon group with the symbol Pb and atomic number 82. Lead is a soft, malleable poor metal. It is also counted as one of the heavy metals. Metallic lead has a bluish-white color after being freshly cut, but it soon tarnishes to a dull grayish color when exposed...
, and arsenic
Arsenic
Arsenic is a chemical element with the symbol As, atomic number 33 and relative atomic mass 74.92. Arsenic occurs in many minerals, usually in conjunction with sulfur and metals, and also as a pure elemental crystal. It was first documented by Albertus Magnus in 1250.Arsenic is a metalloid...
. These ingredients can cause serious medical problems.
Pharmaceutical adulterants
Some Chinese patent medicines were found to contain pharmaceutical drugsPharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
such as decongestant
Decongestant
A decongestant or nasal decongestant is a type of drug that is used to relieve nasal congestion.-Pharmacology:The vast majority of decongestants act via enhancing norepinephrine and epinephrine or adrenergic activity by stimulating the α-adrenergic receptors...
s, analgesic
Analgesic
An analgesic is any member of the group of drugs used to relieve pain . The word analgesic derives from Greek an- and algos ....
s or antihistamine
Antihistamine
An H1 antagonist is a histamine antagonist of the H1 receptor that serves to reduce or eliminate effects mediated by histamine, an endogenous chemical mediator released during allergic reactions...
s. The most common Chinese patent medicines found to carry pharmaceutical drugs were for the treatment of asthma
Asthma
Asthma is the common chronic inflammatory disease of the airways characterized by variable and recurring symptoms, reversible airflow obstruction, and bronchospasm. Symptoms include wheezing, coughing, chest tightness, and shortness of breath...
, pain
Pain
Pain is an unpleasant sensation often caused by intense or damaging stimuli such as stubbing a toe, burning a finger, putting iodine on a cut, and bumping the "funny bone."...
, and arthritis
Arthritis
Arthritis is a form of joint disorder that involves inflammation of one or more joints....
.
Prohibited ingredients
Some Chinese patent medicines contain ingredients which are bannedBan (law)
A ban is, generally, any decree that prohibits something.Bans are formed for the prohibition of activities within a certain political territory. Some see this as a negative act and others see it as maintaining the "status quo"...
in other countries. The two most common prohibited herbs are Ma Huang
Ephedra
Ephedra refers to the plant Ephedra sinica. E. sinica, known in Chinese as ma huang , has been used in traditional Chinese medicine for 5,000 years for the treatment of asthma and hay fever, as well as for the common cold...
(麻黄 má huáng) (Ephedra) and Ban Xia
Pinellia
Pinellia is a genus of plants in the family Araceae native to Asia. Its species are commonly called Green Dragons due to the color and shape of the inflorescence, which possesses a green, hooded spathe from which protrudes a long, tongue-like extension of the spadix...
(半夏 bàn xià) (Pinellia). On 30 December 2003, the FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
in the US
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
announced a ban (effective 12 April 2004), on these herbs from all dietary supplements. Traditional Chinese herbal remedies are exempt from this law.
See also
- KampoKampo, alternatively shortened as just , is the Japanese study and adaptation of Traditional Chinese medicine. The basic works of Chinese medicine came to Japan between the 7th and 9th centuries. Since then, the Japanese have created their own unique herbal medical system and diagnosis...
(Japanese adaptation of Chinese medicine) - Kampo listKampo listKampō medicine is the Japanese study and adaptation of Traditional Chinese medicine. Today in Japan, Kampo is integrated into the national health care system. In 1967, the Ministry of Health, Labour and Welfare approved 4 kampo medicines for reimbursement under the National Health Insurance program...
(list of Japanese versions of Chinese patent medicines)