Chinese patent medicine
In the 1950s, Japanese man Otozo Nagakura founded a business that makes Kampo medicine in granule form by dehydrating the extract liquid.
Taiwanese man Xu Hong-yuan visited Nagakura's factory and was impressed by its convenience and efficiency, bringing the technology to Taiwan.
[1] Xu Hong-yuan later also invented the single-herb "granules for use in combination", which grants similar convenience to customized prescriptions.
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.
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.
These forms give the no-boil convenience of CPMs to TCM practitioners who provide customized prescriptions for each patient.
[1] Fixed-formula Chinese patent medicine have also made use of similar approaches to simplify manufacture and to use more modern extraction methods.
Originally an attempt at rationing herb use during the Second Sino-Japanese War,[8] numerous TCM-derived injections have been formulated and used in China.
Unlike Western "patent medicine" of old, these products have a fixed proportion of ingredients, as they are put under a modern regulatory framework.
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.
All good manufacturing practice (GMP) certified factories must also test for heavy metal levels and microbials for all patent medicines they produce.
The Ministry of Health, Labour and Welfare manages a Kampo list which contains specific approved forms of mixed and single-herb herbal medicine.
This is because the Chinese government allows foreign companies to apply for modifications of patent formulas to be sold outside of China.
[citation needed] For comparison, the monograph for Qīng Qì Huà Tán Wán in the 2020 edition of the PRC Pharmacopoeia uses chénpí 陈皮 and no ginger.
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.
[21][25] Under Chinese regulations, non-injection-type CPM applications based on a classical formula are given a fast-tracked approval process.
[27] Some notable new formulas are: Some Chinese patent medicines were tested and found to contain high to dangerous levels of heavy metals.
Many heavy metal contaminants named in the context of herbal medicine is intentionally added and declared on product labels.
The most common Chinese patent medicines found to carry pharmaceutical drugs were for the treatment of asthma, pain, and arthritis.
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.
[citation needed] The 2020 version of the Chinese Pharmacopoeia removed pangolin scale and Aristolochia debilis from allowed ingredients.
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.
