dvances in production
and quality control technology have been a major factor behind today's wide
acceptance of Kampo medicines by the public and medical profession in Japan.
Until recently, Kampo medicines were almost always administered in the form of decoctions prepared by boiling raw herbs according to classical formulas. Thus, variations in the characteristics of herbs used, storage conditions and decoction methods made creating standardized decoctions of uniform quality virtually impossible. However, the development of extracts produced by concentrating and drying traditionally prepared decoctions has resulted in a more standardized product, allowing health care providers to easily and safely administer Kampo medicines and enabling Kampo researchers to make more verifiable studies.
As Japan's leading manufacturer of Kampo, Tsumura has been at the forefront of efforts to create Kampo medicinal extract granules of uniform, high quality for prescription (ethical) use. From 1982 to 1985, Tsumura participated in a cooperative study sponsored by the Ministry of Health and Welfare (MHW) that investigated how differences in raw herbs, decoction methods and manufacturing conditions affected product quality. In accordance with the resulting Good Manufacturing Practice (GMP) standards set by the MHW, Tsumura developed proprietary manufacturing technology for extract preparation and control technology and built new production facilities. The company then submitted New Drug Applications based on the new specifications and test methods and was subsequently granted approval for manufacturing Kampo extract preparations for ethical use. Moreover, at its own initiative, Tsumura established strict procedures for the selection of raw herbs, appointed a raw herb control manager, and established its own standards for manufacturing and quality control to ensure the high quality of its products.
The Japan Kampo-Medicine Manufacturers Association later adopted self-imposed regulations for Kampo extract preparations intended for ethical use, and in compliance with these guidelines Tsumura created an integrated production system of uniform procedures for the entire spectrum of its operations - from procurement of raw herbs through inspection of finished product. The system ensures consistent quality and efficacy, general ease of preparation and ingestion, and an excellent safety profile.
Essential to the production of high quality Kampo extract preparations is a secure supply of superior raw herbs. At Tsumura, ancient herbal literature is studied, the scientific names of the herbs are ascertained, and various appearance, purity, sensory and morphological tests at the cellular and genetic levels, as well as physicochemical property tests, are performed to evaluate overall quality. Tsumura provides suppliers with guidance in herb cultivation, and raw materials are evaluated in their original, uncut state. Acceptable lots of herbs are subjected to rigorous testing, and comprehensive measures are taken to avoid deterioration during storage and contamination from agricultural chemicals or toxins.
After the selected herbs are cut to size, weighed, and compounded to specifications, they are subjected to a process of extraction and separation and then concentrated and spray-dried to produce the extract powder. The extract powder is further weighed, blended, compressed and, finally, molded into granules to create the finished product. Not only are multiple tests performed on all the raw materials and on various aspects of each component of the extracts, but inspections are carried out at every stage of the manufacturing process.
Kampo extract preparations have been shown to retain the efficacy of standard decoctions in accordance with classical formulas. Moreover, extracts offer a number of significant advantages, including: greatly reduced risk of deterioration or contamination; simplified storage and portability; elimination of the need to inspect raw herbs at the prescribing facility; consistency of quality; ease of dispensing and administration; and facilitation of Kampo research.