preparation of decoction described above. They are not ‘patented’ in the
western sense of the word because there are no exclusive rights to the formula.
Instead, ‘patent’ implies standardisation of the formula. All Chinese patent
medicines of the same name have the same proportions of ingredients.
A medicine known as ‘four gentleman decoction’ (si jun zi tang) is an
example of such a product.^155 It is used for fatigue, reduced appetite, loose
stools, pale tongue and weak pulse, which occur because of the deficiency
of spleen and stomach qiand dampness in the digestive system. The formula
comprises:
- Main herb: Radix panax ginseng (ren shen), to enhance spleen qi
- Associate: Rhizoma atractylodis macrocephalae (bai zhu), to
strengthen the spleen and dry off the ‘dampness’ - Adjuvant: Sclerotium poriae cocos (fu ling), to assist the main and
associate herbs - Guide: Radix glycyrrhizae uralensis (zhi gan cao), to harmonise the
other three herbs and regulate spleen qi.
The use of this formula is an example of tonification.Regulatory affairs
Licensing of CHMs in China
Remedies used in TCM are subject to rigorous licensing procedures.^156 The
pharmacological, toxicological and clinical studies required by the regula-
tory authorities depend on the class of TCM product being licensed. Nine
classes of medicines are recognised
- Single compound isolated from natural material(s)
- Newly discovered medicinal plants
- Medicines containing a substitute for a TCM raw material
- Medicines made from a medicinal plant part different to (and
combined with) a plant part traditionally – used in TCM raw material - Medicines containing effective fraction(s) isolated from natural
material(s) - A multi-ingredient TCM preparation
- Medicines involving a change in the route of administration
- Medicines involving a change in dose form
- Generic drug.
Under the Drug Administration Act 2001 post-marketing surveillance
of adverse drug reactions is mandatory in China. Whenever an adverse
reaction event occurs, the manufacturer, the medical institutions and the
seller are obliged to report it.
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