Protective effect of Fangyouling on Schistosoma japonicum infection / 中国血吸虫病防治杂志

Objective To evaluate the protective effect of Fangyouling extracted from herb on Schistosoma japonicum in-fection in the field. Methods The residents in 2 villages Zhaonao Village and Miaochang Village were divided into Group A 139 persons and Group B 162 persons and the residents in Group A embrocated Fangyouling before their contacting the in-fested water and the residents in Group B did not. All the residents were investigated with questionnaires and received the blood and stool examinations for schistosomiasis. Results The positive rates of blood tests were 3.13%and 9.34%in Group A and Group B respectively, the positive rates of stool examinations were 1.92%and 6.44%in Group A and Group B respectively both P values<0.05 . Conclusion Fangyouling has a good protective effect on S. japonicum infection.

Current situation analysis and countermeasures on contamination of heavy metal in traditional Chinese medicinal materials in China / 中草药

Recent years, with the rapid development of industrialization in China, the contamination of heavy metal was worsening, and traditional Chinese medicinal materials (TCMM) were also suffered. The data were collected in the literatures in the past five years, and Green Trade Standard of Importing & Exporting Medicinal Plants & Preparations was used as the standard to evaluate the pollution conditions of lead (Pb), cadmium (Cd), mercury (Hg), arsenic (As), and copper (Cu). The five heavy metals exceeded the limits of the standard and the percentages were 9.66%, 26.35%, 13.0%, 9.32%, and 16.09%, respectively. Moreover, statistics on the residues of the heavy metals in different categories of TCMM from various origins were also carried out in this paper. The results showed that the contamination of heavy metals in TCMM differently depended on the origins and categories. Studies on the rapid detection methods and the limit standards of heavy metal should be established immediately. At the same time, the regulations should be formulated timely and supervision also should be intensified. To solve the problems of excessive amounts of heavy metals in TCMM, necessary measures should be taken to control the contamination of TCMM.

Non-Clinical Studies of Botanical Medicines as New Drugs-U.S. Regulatory Perspectives / 日本東洋医学雑誌

To encourage development of new drugs from botanical sources, the U. S Food and Drug Administration (FDA) has published a draft Guidance for Industry: Botanical Drug Products (www.fda.gov/cder/guidance/1221.dft.pdf) in August of 2000.<br>The Guidance stipulates that for herbal preparations with substantial marketing history, past human experiences may be taken into consideration for safety assessment. In contrast with development of pure chemical drugs, clinical studies on herbal medicines can thus be initialed with less extensive lesting of non-clinical toxicity. However, most of the historical human experlences are not well documentad and often of poor quality data. In such cases, animal toxicity and toxicology studies may still be required for many botanical preparations, especially to support large scale or long term clinical trials. In this presentation, conventional non-clinical requirements for approval of pure chemical drugs will be reviewed briefly and how such requirements may be modified in scale/timing and applied to the development of botanical new drugs will be discussed.

Clinical Studies of Botanical Medicines as New Drugs-U.S. Regulatory Perspectives / 日本東洋医学雑誌

While numerous herbal preparations have been used to treat human illnesses for extensive period of time in many different cultures, very few have been subject to rigorous clinical testing of modern scientific standards. To facilitate more clinical development of new drugs from botanical sources, the US FDA has published a draft Guidance for Industry: Botanical Drug Products in August 2000.<br>www.fda.gov/cder/guidance/1221dft.pdf. For herbal preparations with substantial marketing history, past human experiences may be taken into consideration for safety assessment and clinical studies may be initiated with less extensive product characterization and non-clinical testing. However, efficacy of almost all herbal products remains to be established with clinical trials that should be no different from those required for non-botanical new drugs. The objective of the regulatory approach is to confer the same degree of confidence in the clinical effectiveness of herbal medicines as that of modem non-botanical drugs. In this presentation, basic principles of clinical trial in all new drug development will be described, and unique issues related to studies of herbal medicines discussed.