The Current Situation of Japanese Medicinal Plants Industry and its Significance on the Pharmaceutical Industry 1-3 - 農業知識入口網

1. Current situation of crude drugs

1-3. Standard of quality control of The Japanese Pharmacopoeia (JP)

Crude drugs must meet The Japanese Pharmacopoeia (JP)4) criteria to qualify as medicine. In 2001, 121 crude drug species and their 52 powdered forms were listed in JP 14th edition (JP14). However, revisions and new advances from the non-JP crude drug standards (internal regulations for approval) after 2006 led to the addition of Supplement I in JP 15 in 2007 which expanded the list to 153 crude drugs and their 54 powdered forms.

The following characteristics of crude drugs are standardized in the official monographs of JP:

(1) Name, (2) Origin, (3) Medicinal part, (4) Preparation process, (5) Content of specific constituents (lower limit setting), (6) Description, (7) Identification, (8) Purity (includes heavy metals, arsenic, residual pesticides), (9) Loss of drying, (10)
Total ash, (11) Acid-insoluble ash, (12) Extract content, (13) Assay.

Nonetheless, some characteristics have not been specified yet depending on the species.

Recent stringent provisions of original species have succeeded in eliminating loose nomenclatures such as “other species of the same genus” when referring to them. JP has permitted the Japanese experiential use of substituting crude drugs for Chinese
species; hence, Japanese species must be differentiated from the Chinese species with identical characters. For example, the original Angelica plant that JP prescribes is Angelica acutiloba or Angelica actiloba Kitagawa var. sugiyama Hikino (Umbelliferaae). In contrast, the Phamacopoeia of the People’s Republic of China employs Angelica sinensis.

Some pharmaceutical companies devise their own in-house standards in addition to the legally minimal JP standards. Non-JP crude drug standards are used as a reference for drugs that are not listed in the JP, and each company must develop their own approval standards for drugs that are not listed in the former references.